By Giovanni Comandé Scuola Superiore Sant'anna, Pisa, Italy This Monograph Has Been Reviewed by the Author and Is Up-To-Date

Italy by Giovanni Comandé Scuola Superiore Sant’Anna, Pisa, Italy

This monograph has been reviewed by the Author and is up-to-date as of October 2019

2020

Medical Law – Suppl. 119 (2020) Italy – 1 Published by: Kluwer Law International B.V. PO Box 316 2400 AH Alphen aan den Rijn The Netherlands E-mail: [email protected] Website: lrus.wolterskluwer.com Sold and distributed in North, Central and South America by: Wolters Kluwer Legal & Regulatory U.S. 7201 McKinney Circle Frederick, MD 21704 United States of America Email: [email protected] Sold and distributed in all other countries by: Air Business Subscriptions Rockwood House Haywards Heath West Sussex RH16 3DH United Kingdom Email: [email protected]

The monograph Italy is an integral part of Medical Law in the International Encyclopaedia of Laws series.

Printed on acid-free paper.

ISBN 978-90-654-4943-6 Medical Law was ﬁrst published in 1993.

Comande´, Giovanni. ‘Italy’. In International Encyclopaedia of Laws: Medical Law, edited by Herman Nys. Alphen aan den Rijn, NL: Kluwer Law International, 2020.

This title is available on www.kluwerlawonline.com

© 2020, Kluwer Law International BV, The Netherlands All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Permission to use this content must be obtained from the copyright owner. More information can be found at: lrus.wolterskluwer.com/policies/permissions-reprints-and-licensing Printed in the United Kingdom.

2 – Italy Medical Law – Suppl. 119 (2020) The Author

Prof. Dr Giovanni Comandé, LLM (Harvard), Esq., is Full Professor of Private Comparative Law at the Scuola Superiore Sant’Anna, in Pisa (Italy), mediator and arbitrator. He is the co-founder and director of LIDER-Lab (www.lider- lab.org). He has led research projects approved and funded by national, international, public and private entities such as Italian CNR and MIUR, the European Science Foundation, the European Union, private foundations, banks and regulators. Among other things, he is the author of monographs, editor or co-editor of collective works, several articles and notes published in Italian, Spanish, English and French, on topics such as medical malpractice and insurance, privacy and e- commerce, tort law, information technology, data protection and artificial intelligence regulation. He is a member of both the New York Bar and the Italian State Bar in Pisa, the American Law Institute, the European Law Institute, the European Centre of Tort and Insurance Law and the European Tort Law Group. He visited Laval University (2013 and 2019), Maastricht University (2018–2020), Fordham School of Law (2012), Paris II (2008), Wake Forest University School of Law (2003), the Hebrew University of Jerusalem (2001), the University of South Carolina School of Law (2000) and held the Jean Monnet Chair entitled Human Rights and Remedies for Personal Injuries, in European Community Law: An Interdisciplinary Approach from 1994 to 2001. He is Scientific and Ethics Expert for the European Research Agency and the EU Research Executive Agency and other national and international agencies. His areas of interest currently revolve around comparative law, tort, European private law, insurance law, information society law (mainly data protection, artificial intelligence, privacy and e-commerce), bio-right and life sciences, health and the law. Contact: Piazza Martiri della Libertà, 33, 56127 Pisa Italy, tel. (+39) 050 883111; fax: (+39) 050 883530; email: [email protected].

Medical Law – Suppl. 119 (2020) Italy – 3 The Author

4 – Italy Medical Law – Suppl. 119 (2020) Table of Contents

The Author 3

List of Abbreviations 15

Preface to the First Edition 21

Preface to the Second Edition 23

General Introduction and Overview 25

Reference 1 28

Chapter 1. General Background of the Country 31

§1. GEOGRAPHY AND CLIMATE 31

§2. POPULATION 31

§3. THE POLITICAL AND JUDICIAL SYSTEM 32

§4. POPULATION AND VITAL STATISTICS 35

§5. HEALTH STATUS 35

§6. SOCIAL AND CULTURAL VALUES REGARDING HEALTH 37

§7. THE CONSTITUTIONAL PRINCIPLES UNDERLYING THE PROTECTION OF HEALTH 38 I. Health as a Fundamental Right 39 II. Autonomy and Human Dignity 43 III. The Role of Healthcare 43

Chapter 2. Medical Law Versus Health Law? 46

§1. DEFINITION AND FUNCTIONS OF MEDICAL LAW 46

§2. SOURCES OF MEDICAL LAW 47 I. Sources 47

Medical Law – Suppl. 119 (2020) Italy – 5 Table of Contents

II. European Union Law 50 III. National Sources 51

§3. THE ROLE OF CODES OF PROFESSIONAL ETHICS 53

Chapter 3. The Healthcare System 58

§1. HISTORY AND EVOLUTION OF THE ITALIAN HEALTHCARE SYSTEM 59 I. From Uniﬁcation to WWII 59 II. From the Post WWII Era to 1978 60 A. Department of Health 61 B. The Mutual System 62 III. From the Institution of the NHS to Date 63

§2. THE ACTUAL ORGANIZATION OF THE HEALTHCARE SYSTEM AND ITS PLANNING 67 I. The National Level 68 II. The Regional Levels 69 III. The Local Structure 69

§3. ELIGIBILITY,COVERED BENEFITS AND ACTUAL ACCESS 69 I. Essential Levels of Assistance 72 II. Rationing Instruments 72

§4. THE FINANCING OF HEALTHCARE 73 I. Historical Evolution and … 74 II. … and the State of the Art 75 III. Financing and Purchasing Services 78

§5. INTEGRATING PUBLIC HEALTHCARE COVERAGE INSURANCE 79

§6. TERRITORIAL SERVICES AND HEALTHCARE PROTECTION 79 I. Delivery of Services (Persons) 79 II. Delivery of Services (Structures) 82 A. Main Services and Organization 82 B. Speciﬁc Services and Related Strategies 84 C. Pharmacies 87

Part I. The Medical Profession(s) and the Healthcare System 89

Chapter 1. Access to the Medical Profession 89

§1. MEDICAL EDUCATION 89 I. Historical Note and Overview 89 II. Constitutional Competence 91

6 – Italy Medical Law – Suppl. 119 (2020) Table of Contents

III. Undergraduate Medical Education 92 IV. Graduate Medical Education 93 V. Continuous Education in Medical Science 96

§2. LICENSING OF GENERAL PRACTITIONERS AND MEDICAL SPECIALISTS: POSTGRADUATE MEDICAL EDUCATION 99

§3. MANPOWER PLANNING:FREEDOM OF ESTABLISHMENT 100

Reference 2 102

Chapter 2. Practice of Medicine 104

§1. LEGAL CONDITIONS FOR THE PRACTICE OF MEDICINE 104 I. Historical Note (and Interplay with Other Healthcare Professions) 104 II. Healing Arts and Medicine 105 III. Legal Monopoly of Physicians 106 A. Legal Conditions for the Practice of Medicine 106 1. Legal Diploma 106 B. Visa 110 1. Exemption from the Visa 111 2. Withdrawal of the Visa 111 C. Inscription on the List of the Order of Physicians 111

§2. THE PRACTICE OF MEDICINE AND HEALTH-RELATED PROFESSIONS 111 I. General Introduction and Discipline 111 II. The Practice of Medicine and the NHS 114 A. Primary Care 114 B. Ambulatory Care 115 C. Secondary/Inpatient Care 116 III. Speciﬁc Medical Activities 116 A. Preventive Medicine 118 B. Self-care 119 C. Taking of Blood: Venepunctures 119 D. Radiographies 120 E. Blood Pressure Measuring and the Use of Other Simple Measuring Appliances 120 F. Eye Examination and the Measuring of Eye Deviations 120 G. Psychoanalysis and Psychotherapy 121 H. Group Therapy 121 I. Acupuncture 121 J. Written and Oral Advice and Recommendations 122

Chapter 3. Illegal Practice of Medicine 123

§1. LEGAL DEFINITION OF THE OFFENCE 123

Medical Law – Suppl. 119 (2020) Italy – 7 Table of Contents

§2. WHO ISANUNAUTHORIZED PERSON (CRIMINAL AND CIVIL CONSEQUENCES) 123

§3. THE CONDUCT 124

§4. SANCTIONS 125

Chapter 4. Control over the Practice of Medicine 126

§1. THE ORDER OF PHYSICIANS 126 I. Historical Note 126 II. Registration on the List of the Order 127 A. Obligation to Register on the List 127 B. Exceptions 128 1. Nationals of EC Member States 128 2. Military Doctors and Physicians Working Exclusively for the NHS 128 C. The Obligation to Register and the Freedom of Association 129 D. Competent Provincial Council 130 E. Refusal or Delay of Registration 130 F. Registration after Being Struck Off the Register 130 G. Removal from the List 131 III. Disciplinary Competence of the Order of Physicians 132 A. Control over the Observance of the Rules of Professional Ethics 132 1. General Description of the Disciplinary Competence 132 2. Rules of Professional Ethics and Standards of Discretion, Probity and Dignity 133 3. Limitations to the Disciplinary Power of the Provincial Councils 137 4. Disciplinary Sanctions 138 5. The Disciplinary Procedure and Article 6 of the European Convention on Human Rights 139 6. Disciplinary Procedure Before the Provincial Councils and the Appeals Councils 140 IV. Organs of the Order of Physicians and Their Function 144 A. Provincial Councils 144 1. Composition 144 2. Functions 145 B. The National Council 146 1. Composition 146 2. Functions 146

§2. MEDICAL ETHICS COMMITTEES 148 I. General Remarks 148 II. Ethics Committees in Hospitals 150 A. Composition of the Committee 151

8 – Italy Medical Law – Suppl. 119 (2020) Table of Contents

B. The Competences of the Committee 152 III. The National Committee on Bioethics 153 A. Composition of the Council 153 B. The Competences of the Council 154

Chapter 5. Medical-Related Accidents and Compensation 155

§1. THE MEDICAL ACT AND ITS LEGITIMACY 155 I. Consent to Contract Versus Consent to Medical Treatment 156 II. Legitimate Medical Intervention and the Limits of Consent: Damages for Lack of Consent 157

§2. PROFESSIONAL LIABILITY 157 I. Introduction and History 157 II. Civil Liability 159 A. Classiﬁcation of Physician Liability 159 B. Contents of the Physician’s Duty 160 C. The Basis of Liability and Burden of Proof 163 1. Fault 163 2. Causation 163 3. Damages 166 D. Aspects of Vicarious Liability 171 1. Liability of Hospitals and ASL for the Acts of Their Medical Staff 171 III. Criminal Liability 173 A. Medical Acts Resulting in Personal Injury or Death (Crimes) 175 B. Medical Acts Resulting in Crimes Against Individual Freedoms 176 1. Private Violence and Procured Incapacity 176 2. Kidnapping 176 3. Professional Medical Negligence 177

§3. SPECIAL INDEMNIZATION PROGRAMMES 177 I. Compensation for Victims of Vaccinations 177 A. History 177 B. Discipline 178 II. Compensation for Victims of Blood Transfusions 179 A. History 179 B. Discipline 179 III. Other 179

Reference 3 181

Chapter 6. Quality Assurance and Risk Management 183

§1. QUALITY ASSURANCE AND RISK MANAGEMENT:INTRODUCTION 183

Medical Law – Suppl. 119 (2020) Italy – 9 Table of Contents

§2. THE NOTION OF RISK MANAGEMENT 184

§3. REGIONAL AND NATIONAL INTERPLAY 185

§4. RISK MANAGEMENT,INSURANCE AND LIABILITY 185

§5. QUALITY ASSURANCE AND THE ROLE OF ORDER OF PHYSICIANS 187

§6. QUALITY ASSURANCE AND INTERNAL MANAGING CONTROLS 187

§7. HEALTHCARE-ASSOCIATED INFECTIONS (HCAI) 187

Part II. The Physician-Patient Relationship Within and Outside the Healthcare System 189

Chapter 1. General Description 189

§1. RIGHTS AND DUTIES OF PATIENTS AND PHYSICIANS 189 I. The Rights of Patients 189 A. The Duty of the Patient to Cooperate 190 B. The Right to Quality Care 191 C. The Right to Free Choice 191 D. Rights Related to Information about the State of Health 193 1. The Right to Information about One’s State of Health 193 2. The Right Not to Know about One’s State of Health 195 3. Relinquishing the Right to Information 197 4. Not Informing Based on the Physician’s Initiative (the Therapeutic Exception) 198 E. The Right to Give Consent 198 1. The Right to Well-informed, Free and Prior Consent 204 2. Modes of Giving Consent 205 3. Content of the Information 205 4. Presumed Consent in Cases of Emergency 207 F. The Right to Refuse or Withdraw Consent 208 G. Compulsory Treatments 212 H. Rights Related to the Patient’s Medical Record 215 1. The Right to a Medical Record 215 2. The Right to Add to the Medical Record 217 3. The Right to Access 217 4. The Right to a Copy 217 5. Access by Next of Kin after the Death of the Patient 218 I. The Right to Protection of Privacy and Intimacy 218 J. The Right to Representation in the Event of Incompetence 220 K. The Right to Lodge a Complaint 221 II. Medical Obligations in General 222 A. The Legal Duty to Help 222

10 – Italy Medical Law – Suppl. 119 (2020) Table of Contents

1. Rules on the Practice of Medicine 222 2. Article 593 of the Criminal Code 222 3. Article 328 Criminal Code (rifiuto di atti d’ufficio. Omissione) Refusal to Perform Official Functions: Omission 223 4. Rules on Emergency Medical Care 223 B. Respect for the Privacy of the Patient 224 1. General Rule for Processing Personal Medical Data 224 2. Exceptions 226 3. Guarantees with Respect to the Processing of Personal Health-Related Data 230 4. Rights of the Data Subject 230 5. National and Regional Electronic Data Records 234 6. Privacy or Other Concerns Related to Electronic Health Record Systems EHRS (Fascicolo Sanitario Elettronico, FSE) 235 7. Special Cases 237 C. Duty of Medical Secrecy 239 1. General Principle 239 2. Exceptions 240 3. Notification of Criminal Acts 241 4. Consent of the Patient or Waiver 244 5. Deliverance of Medical Certificates to Third Parties 244 D. Medical Fees 246 1. Right to Fees or Remuneration for Services 246 2. Amount of the Fee 246 3. Fee-Splitting 247 E. Unlawful Enrichment 247

Reference 4 248

Chapter 2. The Physician-Patient Relationship: Speciﬁc Cases 251

§1. THE MINOR PATIENT 251 I. General Principles 251 A. Children’s Consent 251 B. The Role of Parents (and Legal Representatives) 253 C. Parental Denial of Consent 255 D. Information 256 II. Cases of Exclusive Child Consent 256 III. Cases in Which Child Consent Is ‘Forbidden’ 257 IV. Special Cases 257 A. Mandatory Vaccinations 257 B. Blood Transfusions 257 C. Cancer Treatments 258

Medical Law – Suppl. 119 (2020) Italy – 11 Table of Contents

D. Compulsory Sampling of Biological Materials (Treaty of Prüm) 258

§2. INTERDICTION,NON-(FULLY)-AUTONOMOUS PATIENTS AND ‘AMMNISTRAZIONE DI SOSTEGNO’ 258

§3. THE MENTAL PATIENT AND INVOLUNTARY PLACEMENT 262 I. Legal Framework 262 II. Involuntary Placement in a Mental Hospital 264 A. Admission for Observation 265 1. Simple Procedure (Non-emergency Cases) 265 2. Emergency Procedure 265 3. Practical Modalities of the Admission for Observation 265 B. Prolonged Stay (TSO) 266 C. Compulsory Treatment Outside the Hospital 267 D. ASO and TSO for Minors 268 III. The Rights of an Involuntary Placed Mental Patient 269 IV. The Closing of Judicial Psychiatric Hospitals (Ospedali Psichiatrici Giudiziari, OPGs) 270

§4. THE DYING PATIENT 270 I. Euthanasia 271 II. Withholding or Withdrawing (Cessation) of Treatment 271 III. Termination of Treatment (at the Request of the Patient) 272 IV. Pain Relief and Palliative Care 274 V. Physician-Assisted Suicide 278

Chapter 3. Speciﬁc Activities 280

§1. TERMINATION OF PREGNANCY (ABORTION) 280 I. Short Overview of the Existing Legal Rules on Termination of Pregnancy 280 A. Scope of the Law 280 B. Conditions 280 C. (So-Called) Therapeutic Termination of Pregnancy 281 D. Father’s ‘Participation’ 282 II. Termination of Pregnancy by a Physician 282 III. The (So-Called) Morning after Pill 283 IV. Pharmacological Termination of Pregnancy (RU 486) 283

§2. STERILIZATION 283 I. Surgical Contraception 284 II. Sterilization of Mentally Handicapped 284

§3. MEDICALLY ASSISTED CONCEPTION 285 I. Legal Framework 285 II. Use of Donor Gametes 286

12 – Italy Medical Law – Suppl. 119 (2020) Table of Contents

III. Surrogacy 287

§4. HUMAN GENETICS 287 I. Overview and Possibilities 287

§5. REMOVAL AND TRANSPLANTATION OF ORGANS AND TISSUES 288 I. Scope of the Organ Transplantation Law 288 II. Removal of Organs from Living Donors 289 A. The Organ Transplantation (Donation) Law 289 1. General Conditions 289 2. Minor Donors 289 3. Informed Consent 289 4. Special Cases 290 5. Duties of the Physician Removing Organs 291 B. Therapeutic Substances of Human Origin 291 1. Stem Cells and Cord Blood Banks 292 2. Transfusions and Blood Donation 293 3. Bone Marrow 295 III. Removal of Organs after Death 295 A. (Incomplete) Opting-Out System 295 B. Ways to Object 296 C. Establishment of Death 296 D. Special Cases (Prohibitions in Law 91/1999) 297 E. Anonymity 297 F. Autopsies 298

§6. RESEARCH 298 I. Research with Human Beings 298 A. Field of Application 298 B. General Provisions Concerning the Protection of Subjects of Experiments 299 1. Respect for Ethical and Scientific Quality Requirements 301 2. Scientific Acceptability 302 3. Proportionality (Balance Between Benefits and Risks) 302 4. Informed Consent of the Subject 302 5. Primacy of the Human Being 303 6. Favourable Opinion of an Ethics Committee 303 7. Intervention of a Qualified Healthcare Practitioner 304 8. Liability Rules (Civil, Administrative and Criminal) 305 9. Insurance-Related Issues 305 C. Specific Provisions for the Protection of Minors Participating in Experiments 306 1. Informed Consent of the Parents or the Guardian 307 2. Respecting the Explicit Will of the Minor 307 D. Specific Provisions for the Protection of Adults Incapable to Consent to an Experiment 307

Medical Law – Suppl. 119 (2020) Italy – 13 Table of Contents

E. Speciﬁc Provisions for the Protection of Persons Whose Consent Cannot Be Obtained Due to Emergency 308 F. Research with Embryos In Vitro 309 1. Prohibited Procedures with Embryos In Vitro 309 2. Prohibition to Create Embryos In Vitro Solely for Research Purposes 310

§7. PROFESSIONAL FREEDOM:PRESCRIBING DRUGS –TREATMENT WITH DRUG-SUBSTITUTES 310 I. Legal Framework of Professional Freedom 310 II. Control over Professional Freedom 312 III. Prescription of Drugs 313 IV. Treatment with Drug-Substitutes 313 V. Off-Label Prescriptions 313

Selected Bibliography 315

Index 319

14 – Italy Medical Law – Suppl. 119 (2020) List of Abbreviations

ACIS Alto Commissariato per l’Igiene e la Sanità Pubblica (Department of Interior to the High Commissioner for Hygiene and Public Health) ADI Assistenza Domiciliare Integrate (Integrated Home Care) AEP Average European Price AIC Autorizzazione Immissione in Commercio AIDS Acquired Immunodeﬁciency Syndrome AIFA Agenzia Italiana del Farmaco (Italian Agency for Pharmaceutical Drugs) AO Aziende Ospedaliere AOU Azienda Ospedaliera Universitaria ASL Azienda Sanitaria Locale (Local Health Enterprise) ASO Compulsory Medical Examination/Observation ASSR Agenzia per i Servizi Sanitari Regionali (Agency for Regional Health Care Services) (since 2007, AGENAS (National Agency for Regional Healthcare)) BMI Body Mass Index CAM Complementary and Alternative Medicine CARK Central Asian Republics and Kazakhstan Cass. SSUU Corte di Cassazione Sezioni Unite (Court of Cassation United Sections) CCEPS Commissione Centrale per gli Esercenti le Professioni Sanitarie (Central Commission for Health Care Professionals) CCM Centro Nazionale per la Prevenzione e il Controllo delle Malattie (National Centre for Disease Prevention and Control) CCRQ Comitato Consultivo Regionale per la Qualità dal lato del Cittadino (Advisory Committee for Quality from the Citizen’s Perspective)

Medical Law – Suppl. 119 (2020) Italy – 15 List of Abbreviations

CdS La Casa della Salute (‘health house’) CEM Continuing Education in Medicine CFU Credito Formativo Universitario CIS Commonwealth of Independent States CME Code of Medical Ethics CNAQ National Committee for Quality and Accreditation CNB Consiglio Nazionale di Bioetica (National Council of Bioethics) CNS National Centre for Blood SRC Regional Blood Coordinating Centres COE Code of Ethics Cost Costituzione (Constitution) CRS Regional Services Card CUP Centro Unico di Prenotazione (Central Booking Point) DAEs Automated External Deﬁbrillators DALE Disability-Adjusted Life Expectancy DAT Advance Treatment Directives (DIrettive Anticipate di Trattamento) D.L: Decreto Legge D.Lgs Decreto Legislativo DDD Deﬁned Daily Dose DPA Data Protection Act DRG Diagnosis-related group DSM Departments of Mental Health (Dipartimenti di Salute Mentale) EBM Evidence-Based Medicine EBP Evidence-Based Practice ECHR European Convention on Human Rights ECM Educazione continua in medicina (continuing education in medicine) = CME EHR Electronic Health Records EMEA European Agency for the Evaluation of Medicinal Products ENPAS Ente Nazionale Previdenza e Assistenza Dipendenti Statali (National Institute for Civil Servants) ESTAV Ente per i Servizi Tecnico-amministrativi di Area Vasta (wider area organizations) EU European Union EU12 Countries that joined the EU in May 2004 and in January 2007 EU15 Countries belonging to the EU before May 2004

16 – Italy Medical Law – Suppl. 119 (2020) List of Abbreviations

EUCJ European Union Court of Justice FNOMCEO Federazione Nazionale degli Ordini dei Medici Chirurghi e degli Odontoiatri Foro It. Foro Italiano FPN Fondo di Perequazione Nazionale FSE Fascicolo Sanitario Elettronico (Electronic Health Records) G8 Group of Eight Industrialized Countries GCP Good Clinical Practice GDP Gross Domestic Product GDPR General Data Protection Regulation (Reg. EU 2016/679) Giur. it. Giurisprudenza Italiana GM Direttore Generale = General Manager GP General Practitioner GU Gazzetta Ufficiale (official publication containing the text of new laws) GUP Giudice Udienza Preliminare HALE Health-Adjusted Life Expectancy HCAI Healthcare-associated infections HF Health Files HiT Health Systems in Transition HIV Human Immunodeficiency Virus HTA Health Technology Assessment Hub Hospitals INAIL National Institute for Insurance against Industrial Accidents ICT Information and Communication Technology IMF International Monetary Fund INADEL Istituto Nazionale Assistenza Dipendenti Enti Locali (National Institute for Local Authority Employees) INAM Istituto Nazionale per l’Assicurazione Contro le Malattie (National Institute for Disease Control) INPS Istituto Nazionale della Previdenza Sociale (National Social Welfare Institution) IPAB Istituzioni Pubbliche di Assistenza e Beneficenza IPASVI Provincial Colleges of Professional Nurses IRAP Imposta Regionale sulle Attività Produttive (regional business tax) IRCCS Istituto di Ricovero e Cura a Carattere Scientifico (National Institutes for Scientific Research) IRPEF Imposta sui Redditi delle Persone Fisiche (personal income tax)

Medical Law – Suppl. 119 (2020) Italy – 17 List of Abbreviations

ISPESL Istituto Superiore Prevenzione e Sicurezza sul Lavoro (National Institute for Occupational Safety and Prevention) ISS Istituto Superiore di Sanità (National Institute of Health) ISTAT Istituto Nazionale di Statistica (National Institute of Statistics) ITCBN Italian Cord Blood Network LEA/LEP Livelli Essenziali di Assistenza (basic health beneﬁts package previously referred to as LEA) MMG Medico Medicina Generale MoH Ministry of Health MURST Ministero Università Ricerca Scientiﬁca e Tecnologica (today MIUR- Ministero del’Istruzione dell’Università e della Ricerca) NCB The Italian National Committee on Bioethics NCCED National Commission on Continuing Education in Medicine NCP Nuclei di Cure Primarie (Centres of Primary Care) NGCC Nuova Giurisprudenza Civile e Commentata NGDP National Gross Domestic Product NHP National Health Plan NPCEM National Programme on Continuing Education in Medicine NSIS Nuovo Sistema Informativo Sanitario (New Health Care Information System) OC Ospedale di Comunità (Community Hospital) OECD Organisation for Economic Co-operation and Development OMCEO Ordine dei Medici Chirurghi ed Odontoiatri OPGs Ospedali Psichiatrici Giudiziari (Judicial Psychiatric Hospitals) OsMES Osservatorio Nazionale di Monitoraggio degli Eventi Sentinella (National Observatory for the Monitoring of Sentinel Events) OTC Over-the-counter P Paediatrician PLS Pediatri di Libera Scelta PNLG Piano Nazionale Linee Guida (National Programme on Clinical Guidelines) PPI Presidi di Primo Intervento PPP Purchasing Power Parity PSN Piano Sanitario Nazionale (National Health Plan)

18 – Italy Medical Law – Suppl. 119 (2020) List of Abbreviations

RD Royal Decree RSA Residenze Sanitarie Assistenziali (skilled nursing facility) RSSP Relazione sullo Stato Sanitario del Paese (National report on health status) SARS Severe Acute Respiratory Syndrome SASN Servizi Assistenza Sanitaria Naviganti (Seafaring and Flight Personnel) SAUB Strutture Amministrative Uniﬁcate di Base SIMES Sistema Informativo per il Monitoraggio degli Eventi Avversi (Information System for the Monitoring of Adverse Events) SISS Health Care Information System SOP Senza Obbligo di Prescrizione (drugs that do not require prescription and cannot be advertised) SPA Società per azioni/Corporation Spoke Territorial Structures and networks of General Practitioners SRCs Strutture regionali di coordinamento SSN Servizio Sanitario Nazionale (National Health Service) SSR Regional Healthcare Service STP Stranieri Temporaneamente Presenti (foreigners temporarily present) TU Testo Unico (Consolidated Texts) TAR Tribunali Amministrativi Regionali (Regional Administrative Courts) TFEU Treaty on the Functioning of the European Union TFR Total Fertility Rate Trib Tribunale TSO Mandatory Medical Treatment TULLSS Testo Unico delle Leggi Sanitarie (Consolidated Text of Health Laws) USL Unità Sanitarie Locali (Local Health Unit) UCCP Unità Complesse delle Cure Primarie (Complex Primary Care Units) UNESCO United Nations Educational, Social and Cultural Organization URP Ufficio Relazioni con il Pubblico (Office for Public Relations) USL Unità Sanitarie Locali (Local Health Units) UTAP Unità Territoriali di Assistenza Primaria (Territorial Units for Primary Care)

Medical Law – Suppl. 119 (2020) Italy – 19 List of Abbreviations

VAT Value Added Tax VHI Voluntary health insurance WTO World Trade Organization

20 – Italy Medical Law – Suppl. 119 (2020) Preface to the First Edition

Any entry of an Encyclopaedia is a complex scientific work in all instances. The project of writing entire monographs as entries of an International Encyclopaedia has revealed an even more challenging and demanding scholarly task. While an encyclopaedic entry is intended to be, as much as possible, neutral, destined to illustrate the state of the art, a monograph seeks to assert ground-breaking thoughts, or, at least, to organize and expose the subject matter in an innovative way. Merging and balancing these two contrasting scientific approaches has proven a rather difficult, albeit intellectually rewarding endeavour. As a result of the necessary com- promises, the house citation style has left out most of the highly important legal literature consulted throughout this venture, thus producing a result which, if read without such clarifications, might appear somewhat unsatisfactory. It has been our aim to try to grasp the best from both writing a monograph and an encyclopaedic entry. The result reveals itself to be highly instructive in its covering of a large array of topics in health law, interdisciplinary span of issues, nour- ished by national private, constitutional, criminal and administrative law, as much as EU and international law. The expression ‘health law’ instead of ‘medical law’ is used intentionally. As explained in the first pages of the General Introduction, we define, throughout the monograph – with the above-mentioned constraints – the expanding and complex role of medical law in modern societies, which today, at least in our understanding, is better defined and circumscribed as health law. In this vein, we assumed that health law (or, alternatively, medical law) relates to the inherent multilevel (international, supranational, EU, national, regional) and complex (legislative, judicial, self-imposed) legal and regulation frameworks of health-related matters. Taking the Italian state of art as such an illustration, the present contribution seeks to further explain and demonstrate how the contemporary field of health law is, indeed, an offspring of several legal sources and the complex interplay between science, law and political choices which shall revolve around the protection of fundamental human rights. The extensive research, which underlies this work, is not the sole credit of the author. This entry would not have seen the light were not it for the important research and linguistic assistance of Denise Amram, Cristiane Avancini, Keiva Carr. I am grateful for their important contributions, and any remaining error is my responsibility. My gratitude also goes to Herman Nys, whose friendly patience and wise advice was very helpful in bringing this work to completion.

San Giuliano Terme, 31 December 2013

Medical Law – Suppl. 119 (2020) Italy – 21 Preface to the First Edition

22 – Italy Medical Law – Suppl. 119 (2020) Preface to the Second Edition

Any entry of an Encyclopaedia is a complex scientific work in all instances. The project of writing entire monographs as entries of an International Encyclopaedia has revealed an even more challenging and demanding scholarly task. While an encyclopaedic entry is intended to be, as much as possible, neutral, destined to illustrate the state of the art, a monograph seeks to assert ground-breaking thoughts, or, at least, to organize and expose the subject matter in an innovative way. Merging and balancing these two contrasting scientific approaches has proven a rather difficult, albeit intellectually rewarding endeavour. As a result of the necessary com- promises, the house citation style has left out most of the highly important legal literature consulted throughout this venture, thus producing a result which, if read without such clarifications, might appear somewhat unsatisfactory. It has been our aim to try to grasp the best from both writing a monograph and an encyclopaedic entry. The result reveals itself to be highly instructive in its covering of a large array of topics in health law, interdisciplinary span of issues, nour- ished by national private, constitutional, criminal and administrative law, as much as EU and international law. The expression ‘health law’ instead of ‘medical law’ is used intentionally. As explained in the first pages of the General Introduction, we define, throughout the monograph – with the above-mentioned constraints – the expanding and complex role of medical law in modern societies, which today, at least in our understanding, is better defined and circumscribed as health law. In this vein, we assumed that health law (or, alternatively, medical law) relates to the inherent multilevel (international, supranational, EU, national, regional) and complex (legislative, judicial, self-imposed) legal and regulation frameworks of health-related matters. Taking the Italian state of art as such an illustration, the present contribution seeks to further explain and demonstrate how the contemporary field of health law is, indeed, an offspring of several legal sources and the complex interplay between science, law and political choices which shall revolve around the protection of fundamental human rights. Many changes in case law and legislation have occurred since the first edition was published. The Code of Ethics for physicians was deeply reformed; many important legislative reforms have been enacted. The EU has deeply rewritten its rules in many fields related to this work, the GDPR being only one of them. The extensive research, which underlies this work, is not the sole credit of the author. This new edition of the entry would not have seen the light were not it for

Medical Law – Suppl. 119 (2020) Italy – 23 Preface to the Second Edition the important research assistance of Danielle Da Costa Leite Borges, Filippo Ven- turi, Francesca Vitarelli. I am grateful for their important contributions, and any remaining error is my responsibility. My gratitude also goes to Herman Nys, whose friendly patience and wise advice was very helpful in bringing this work to completion.

Quebec, 28 November 2019

24 – Italy Medical Law – Suppl. 119 (2020) General Introduction and Overview

The dividing lines between ‘medical law’, ‘health law’ and ‘law and medicine’ – which, when combined encompass most of the issues this contribution deals with – are becoming increasingly blurred.1 Although ‘medical law’ traditionally refers mostly to the ‘law governing the interactions between doctors and patients and the organization of health care’2 while ‘health law’ refers to the ‘law applied to the health care field’,3 we can easily agree that ‘applying the law to medicine has expanded from medical law to health law’4 extending and renewing the interplay between medicine and ethics reflected by what today is often referred to as bioethics or bio-law. Yet, today the interplay between law and medicine, including all the foreseeable ethical implications this relationship conjures, not only encompasses the legal issues strictly related to medicine (or the application of law to the practice and organization of medicine) but also includes the interaction between the scientific application of law and of medicine in relation to the regulation of health matters regardless of whether or not they come under the ambit of either healthcare delivery or the doctor-patient relationship. This phenomenon is perhaps to a greater extent visible in those areas considered more ethically sensitive. However, it can also be termed as the offspring of scientific and technological achievements in health-related matters – an offspring that has deeply influenced even traditional subject matters of medical law such as medical (malpractice) liability, forensic pathology or forensic psychiatry. See 528, 1100ff. It is also important to note that over time the interplay between science and law has changed. Science has often been perceived as external to law, meaning that scientific data (as well as ‘natural’ events) were often assumed (for instance, birth and death). In recent times, however, this mode of interplay has been altered and – thanks to, among other factors, the precautionary principle – the law tends to regulate and evaluate science and ‘its scientific value’ (for instance, in causation; see 528, 1110–1123) by permitting – or not – a specific technique or assuming in legislative terms one notion over another (e.g., ascertaining death by heartbeat interruption in Law 644/1975 or by ‘irreversible cessation of all functions of the brain’ in Law 578/1993; see infra 1059,1080, 1085). Similarly, the language adopted by legislation tends, increasingly, to express political values. This is the case, for instance, when we consider the term ‘mutilazione’ (mutilation) – a term adopted by

1. See Reference 1 at the end of General Introduction. 2. See, H. Nys, Belgium in International Encyclopaedia of Laws - Medical Law Kluwer International. 3. G. J. Annas, Doctors, Patients, and Lawyers – Two Centuries of Health Law, N Engl J Med, 367:445–450 (2012). 4. Ibid.

Medical Law – Suppl. 119 (2020) Italy – 25 General Introduction and Overview

Law 9 January 2009 no. 7 – replacing the traditional medical terms (e.g., cut, inci- sion or female circumcision). It is obvious that these different approaches define the interaction (and relative supremacy) of self-determination, individual consent and the political views and consent of the community. See 836; see on self- determination 669–721, 814, 881. One more key feature in the metamorphosis of law and health-related matters is the role individual rights (both in terms of human and fundamental rights) have acquired across the board Post-WWII. It is our understanding that the above statements are generally valid in all healthcare systems. Yet, when we turn to consider medical/health law in Italy, it is impera- tive that we heed the complexities added by the EU level of regulation in addition to the role the Constitution of the Italian Republic plays in the judicial and legislative (re)interpretation of legal rules and principles in all traditional subdivisions of law: private, constitutional, administrative, and criminal. As a result health law (or alternatively medical law) relates to the extensively multilevel (international, supranational, EU, national, regional) and complex (legislative, judicial, self-imposed) legal regulation of health-related matters. We are aware such a broad definition might expand indeterminately the reach of medical/health law. However, in this book, we will confine ourselves to applying the methodological underpinnings of this premise to the ‘traditional’ issues selected by the International Encyclopaedia of Medical law (IEML), issues that already cut across the traditional definitions we mentioned earlier. The expression ‘medical law’ will not be used often as it would limit our understanding of the subject to issues connected to the medical profession whereas our goal is to consider issues of cure, professional understanding and self-perception, and organization of the medical field as a whole. In the nineteenth century already, medical developments exposed different areas of research and regulation related to legal expertise, especially concerning medical law. In addition, historical elements indicate that after 1848, alongside the socialist movement, governments addressed healthcare problems and issues in a more organic way. The healthcare policy needs at that time expressed themselves in various ways, among which we can certainly mention the increasing importance of ‘social medicine’ and the inception of State-driven medical insurance – at least for the impoverished and the working class. Along these lines, ‘medicine moved from being a private question (the aspiration of liberalism) to being a public and political responsibility’.5 Simultaneously, a shift occurred in considering healthcare as a public safety concern for considering health as an individual right protected by the public. This particular shift gained momentum after WWII driving the emerging of a specific field of work and research concerning the subject we deal with. Scholars, in and around the beginning of WWI, made reference to a primary definition of medical law considered as a subtopic of administrative law. Today, however, medical law can be considered as part of a group of legal texts related to public and individual health that is influenced by several areas of law (civil, international, administrative, constitutional, criminal and bio-law) in the sense we have defined above.

5. D. Gracia, The Economy and Medicine in the Twentieth Century, 43 Dolentium Hominum 1, 47 (2000).

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In the last years, the prominence of the discussions on health-related matters – especially considering health as a fundamental right and how it could or should be protected – has led to a rich debate concerning issues of civil liability and healthcare regulation. This is in addition to the ﬂourishing of ethical issues related to health, healthcare delivery, and the balance between concerned rights and liberties. We organize the exposition of several of these issues apportioning them along the traditional lines of the IEML. However, we reorganize the relevant issues around Italy and its healthcare delivery system in the Introduction, the agents of the healthcare services (mainly the physician and their profession within the healthcare delivery system) in Part I, patients’ rights in Part II, and the interplay between patients and healthcare providers, a relationship that potentially produces liability and entails risk governance which is dealt with in Chapter 5 of Part I.

Medical Law – Suppl. 119 (2020) Italy – 27 General Introduction and Overview

Reference 1

For basic and further information on topics dealt with in this part see also the following monographs and essays among the many consulted (we confine ourselves mostly to monographic contributions and extensive collective works here): Backman, Hunt, Khosla, Jaramillo-Strouss, Fikre, Rumble, Pevalin, Acurio Páez, Armijos Pineda, Frisancho, Tarco, Motlagh, Farcasanu, Vladescu, Health systems and the right to health: an assessment of 194 countries, Lancet, Vol 372 13 December 2008, 2046ff. Ferré F, de Belvis AG, Valerio L, Longhi S, Lazzari A, Fattore G, Ricciardi W, Maresso A. Italy: Health System Review. Health Systems in Transition, 2014, 16(4):1–168. Available at http://www.euro.who.int/__data/assets/pdf_file/0003/2 63253/HiT-Italy.pdf?ua=1 McDaid D., Drummond M. and Suhrcke M., European health systems support investment in and the implementation of population health strategies?, World Health Organization 2008 and World Health Organization, on behalf of the Euro- pean Observatory on Health Systems and Policies 2008. Coulter A., Parsons S. and Askham J., Where are the patients in decision-making about their own care?, World Health Organization 2008 and World Health Orga- nization, on behalf of the European Observatory on Health Systems and Policies 2008. Smith P. C., Papanicolas I, Health system performance comparison: an agenda for policy, information and research, POLICY SUMMARY 4, WHO. OECD, Eurostat, WHO (2011), A System of Health Accounts, OECD Publishing. Lo Scalzo A, Donatini A, Orzella L, Cicchetti A, Profili S, Maresso A. Italy: Health system review. Health Systems in Transition, 2009; 11(6)1–216. Figueras J. – McKee M., Health systems, health, wealth and societal well-being. Assessing the case for investing in health systems, Published by Open University Press European Observatory on Health Systems and Policies series, 2011. F.D. Busnelli – U. Breccia, Tutela della salute e diritto privato, Milano, 1978. F.D. Busnelli – U. Breccia, Il diritto alla salute e il diritto privato, Bologna, 1979. Maio V. and Manzoli L., The Italian Health Care System: W.H.O. Ranking Versus Public Perception, P&T, June 2002, Vol. 27 no. 6, 302ff. G. Alpa-G. Resta, Le persone fisiche e i diritti della personalità, in Trattato Sacco, I, Le Persone e la Famiglia, Torino, Utet, 2006. Bottari, Tutela della Salute ed Organizzazione Sanitaria. Giappichelli, Torino, 2009. F.D. Busnelli, Bioetica e diritto privato: frammenti di un dizionario, Giappichelli, Torino, 2001. F.D. Busnelli, E. Palmerini, Bioetica e diritto privato,inEnciclopedia del Diritto, Agg. V, Milano, 2001, 142ss. V.M. Caferra, Diritti della persona e Stato sociale. Il diritto dei servizi socio- sanitari, Bologna, Zanichelli, 2004, II ed. M.C. Cherubini, Diritto alla salute, in Digesto IV ed., Disc. Priv. sez. civ., VI, Torino, Utet, 1990, 83. R. Ciliberti, Medicina, etica e diritto nella rivoluzione biotecnologica. Torino, C.G. Edizioni Medico Scientifiche, 2001. G. Corbellini, Breve storia delle idee di salute e malattia, Roma, Carocci, 2004.

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G. Cosmacini, La qualità del tuo medico. Per una filosofia della medicina, Bari- Roma, Laterza, 1995. V. Crupi-M. Motterlini, Decisioni mediche: Un punto di vista cognitivo, Milano, Raffaello Cortina Editore, 2005. M. Cocconi, Il diritto alla tutela della salute, Padova, 1998. C.M. D’arrigo, I, in Enciclopedia del Diritto, Aggiornamento, V, Milano, Giuffrè, 2001, 1009. L.K. Dosi, Assistenza Sanitaria e Tutela del Cittadino: Modelli Privatistici e Oriz- zonte Europeo. Torino, Giappichelli, 2008. G. De Cesare, Enciclopedia del Diritto, XLI, Voce Sanità, Giuffrè, 1989. E. Jorio, Diritto Sanitario, Milano, Giuffrè, 2005. S. Rodotà, La vita e le regole. Tra diritto e non diritto, Milano, Feltrinelli, 2006. S. Rodotà. Dal soggetto alla persona, Napoli, Editoriale Scientifica, 2007. Presidente del Consiglio dei Ministri Relazione Generale sulla Situazione Eco- nomica del Paese 2011,15 giugno 2012. ISTAT Annuario statistico del servizio sanitario nazionale – anno 2010. Ministero della Salute Direzione Generale del Sistema Informativo e Statistico Sani- tario, Report on the Health Status of Country, 2011(2012). Ministero salute, Piano sanitario nazionale 2006–2008. Ministero salute, Piano Sanitario Nazionale 2011–2013 – Bozza (http:// www.governo.it). National Committee on Bioethics, Opinions and Responses available in English at http://www.governo.it/bioetica/eng/opinions.html. Ministero della Salute Direzione Generale del Sistema Informativo e Statistico Sani- tario, Report on the Health Status of Country, 2011 (2012). Rechel B., Doyle Y., Grundy E., McKee M., How can health systems respond to population ageing?, World Health Organization 2009 and World Health Organi- zation, on behalf of the European Observatory on Health Systems and Policies 2009. UNESCO, 2011. Casebook on Human Dignity and Human Rights, Bioethics Core Curriculum Casebook Series, no. 1, UNESCO: Paris, 144ff. World Health Organization, The Right to Health Fact Sheet no. 31. World Health Organization, International Health Regulations (2005), A brief introduction to Implementation in national legislation, January 2009 (WHO/HSE/ IHR/2009.2). World Health Organization, The world health report 2007: a safer future: global public health security in the 21st century. Wilson K., McDougall C., Fidler D.P. & Lazar H., Strategies for implementing the new International Health Regulations in federal countries, Bulletin of the World Health Organization, March 2008, 86 (3). See also individual contributions in the following collective works: AA. VV. Il diritto alla salute alle soglie del terzo millennio. Profili di ordine etico giuridico ed economico, Torino. Ferrara R. (edt), Salute e sanità,inTrattato di Biodiritto diretto da S. Rodotà E P. Zatti, Giuffrè, Milano, 2011. P. Funghi – F. Giunta, Medicina, bioetica e diritto. I problemi e la loro dimensione normativa. Pisa, Edizioni ETS, 2005.

Medical Law – Suppl. 119 (2020) Italy – 29 General Introduction and Overview

R. Sangiuliano (ed.), Diritto Sanitario e Servizio Sanitario Nazionale (20th ed., Edizioni Giuridiche 2010). Rodotà S. – Tallacchini M. (edts), Ambito e fonti del biodiritto,inTrattato di Biodi- ritto diretto da S. Rodotà E P. Zatti, Giuffrè, Milano, 2011.

30 – Italy Medical Law – Suppl. 119 (2020) 1–4

Chapter 1. General Background of the Country

§1. GEOGRAPHY AND CLIMATE

1. Italian territory is mainly surrounded by the Mediterranean Sea and includes two large islands (Sicily and Sardinia) and several minor ones totalling 301,316 km2. The territory is largely mountainous (about 77%) with a signiﬁcant portion of forested territory (about 23%). The Peninsula land borders Slovenia, France, Swit- zerland and Austria. Fully enclosed in the mainland are two entirely independent states: the Republic of San Marino and the Vatican State City.

2. The northern part of the country is a vast plain (Pianura Padana) bordered by the Alps in the north. This is and has always been the richest part of the country hosting a few multinational companies and a large number of small and medium- sized private ﬁrms. The southern part remains the poorest part of Italy despite its rich agricultural, industrial and most importantly its natural-touristic potential. In economic terms, the divide is exempliﬁed by marked differences in unemployment and in its contribution to the National Gross Domestic Product (NGDP) (which is about 75% of the total in the north).

3. Italy is a founding member of the EU and constitutes a market economy. It participates in major multilateral economic organizations such as the so-called G8 (Group of Eight Industrialized Countries), the World Trade Organization (WTO), the International Monetary Fund (IMF) and the Organisation for Economic Co-operation and Development (OECD). Despite Italy’s contribution to the total GDP of the G8 countries (Italy’s total GDP – USD 2.399 trillion in 2018) and of the EU’s total GDP (USD 18748.57 billion in 2018 ), per capita, income remains much lower than that of industrialized countries such as the USA (USD 33,706.) and even of the EU average (USD 37,417 in 2018). This situation is also due to high structural and conjunctural unemployment (10.03%), which again is much higher in southern Italy than in the northern part.6

§2. POPULATION

4. On the 1 January 2018, Italy had 60,494 million residents out of which around 8.5% (more than 5 million) have foreign citizenship according to ISTAT7. There is a ratio of 94.5 men for every 100 women. Foreign residents are mostly located in the northern and central part of the country, and the increase in their presence has compensated the shrinking Italian population (a reduction of 250,000 units from 2001). The rate of natural increase in 2016 was of 141,823 units. The ageing phenomenon is shown by the sharp increase in those aged one hundred and over (more

6. See www.istat.it. 7. Data available at https://www.istat.it/en/archive/resident+population – accessed 21 August 2018.

Medical Law – Suppl. 119 (2020) Italy – 31 5–8 General Introduction, Ch. 1, General Background of the Country than doubled from 2001 up to 17,630), 65 and over (22.3% or 13.5 million)8 coupled with a very low fertility rate (1.34).

5. Italian is the official language, although linguistic minorities are constitutionally protected (Article 6 Cost.), and there are small areas in which German (in parts of the Trentino-Alto Adige Region), French (in the Valle d’Aosta Region) and Slov- ene (in the Trieste-Gorizia area) are widely spoken and used in official acts and procedures.

6. The Constitution also guarantees freedom of religion. While the dominant religion is Roman Catholicism, religious minorities – traditionally including Prot- estant, Muslim and Jewish – are increasing in numbers and diversity.

§3. THE POLITICAL AND JUDICIAL SYSTEM

7. The Republic is organized into cities, provinces, metropolitan cities, regions, and the State (Article 114 Cost.). Among the twenty Regions, ﬁve enjoy special autonomy.9 The State and Regions share legislative competences on health. Italy has been a parliamentary republic since 1948. The Parliament consists of two chambers (Camera dei Deputati and Senato). The President of the Republic is elected for seven years by a joint session of the Chamber and Senate supplemented by del- egates of the Regions. The Prime Minister is appointed by the President of the Republic after having gained the conﬁdence of a majority of senators and deputies from both chambers.

8. Law n. 165/2017 amended the electoral system introducing a mixed system that includes both single-member districts – allocated by means of a majority system – and multi-member districts – allocated through a proportional system. As regards the Chamber of Deputies, the threshold to access the allocation of seats is 3% of the votes validly cast at a national level for single lists, and 10% of the votes validly cast at a national level for coalitions, provided that at least one of the lists of the coalition obtained 3% of the votes validly cast at a national level (the threshold for inter-coalition lists is 3% of the votes validly cast at a national level, also in case the coalition does not reach the 10% threshold). As far as coalitions are concerned, the votes obtained by the lists not exceeding the threshold of 1% will not be taken into account. As regards the Senate, the threshold to allocate the seats is set – as it happens with the Chamber of Deputies – at 3% of the votes validly cast at a national level for individual lists, and 10% for coalitions, provided that at least one of the lists in the coalition obtains 3% of the votes validly cast nationally or 20% in a Region (the threshold for inter-coalition lists is in any case 3% of the votes

8. Statistics available at www.istat.it. 9. According to Art. 116 Cost, they include Friuli Venezia Giulia, Sardegna, Sicilia, Trentino-Alto Adige/Südtirol, and Valle d’Aosta/Vallee d’Aoste. They are mostly border regions with a historically distinctive identity, speciﬁc language, and demographic and socioeconomic traits whose special autonomy is guaranteed also in their statutes granted by national constitutional laws.

32 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 9–15 validly cast at a national level or 20% of the valid votes in at least one Region, even in case the coalition does not reach the threshold of 10%). As far as coalitions are concerned, the votes obtained by the lists not exceeding the threshold of 1% will not be taken into account. The allocation of regional seats to the Senate also involves the lists – either individual or in coalition – that obtained at least 20% of votes validly cast in at least one Region.

9. The Constitution organizes Italy’s territory into twenty Regions, which are extremely varied. They differ in size (Piedmont, for example, is 25,000 km2, while Valle d’Aosta is only 3,000 km2), population (Lombardy hosts 15% of the total population, whereas Molise hosts less than 1%), and levels of economic development. The Regions also differ in population age distribution. For example, in Italy, the average percentual ratio between the population aged 65 years or older and the population aged 14 years or younger is 165.2, while in southern Italy it is 145.0, in central Italy it is 175.4 and in northern Italy it is 173.2. The presence of foreigners and the levels of economic development are rather diversiﬁed as well.

10. Internally, the Regions are subdivided into provinces. In each province, a Prefettura (Prefect) structure is in place whose head represents – and is appointed by – the national government. The Prefettura structure is an institutional setting that has played a signiﬁcant role in healthcare structuring and management for a long time.

11. Municipalities (cities/towns) also concur in constituting the Republic and are the basic units of local government. Their size can vary from a small village to a large city such as Palermo or Milan, all with an ancient tradition of independent self-government. Residents directly elect Mayors of municipalities of over 15,000 residents.

12. An Executive and Regional Council, both of which are democratically elected, govern each Region.

13. Regions, provinces and municipalities, are granted some limited ﬁscal autonomy that, within the limits determined by national laws, contributes to their healthcare ﬁnancing.

14. Since the 1990s, both at the normative and constitutional level, there has been an extension of the powers and responsibilities of Regions in several areas including healthcare ﬁnancing, management and delivery. This process reached its normative peak with the constitutional reforms in 2001 that steered State organization towards a federalist oriented structure impacting healthcare ﬁnancing, organization and delivery.

15. The Italian procedural legal system is characterized by the presence of specialized courts alongside ordinary courts, among which we ﬁnd administrative courts.

Medical Law – Suppl. 119 (2020) Italy – 33 16–19 General Introduction, Ch. 1, General Background of the Country

16. The ordinary process has two levels of judgment: the ﬁrst instance is heard before the Justices of the Peace (‘Giudici di Pace’) or, depending on the economic value and on the matter, before a ‘Tribunale’ (Tribunal). Appeals are sent before the Court of Appeal (‘Corte d’Appello’) and on some occasions before Tribunals if the case originates from a Justice of the Peace. Finally, there is a sort of third level of judgment before the Supreme Court (‘Corte di Cassazione’) where only questions pertaining to the legal correctness of the appealed decision can be heard. In other words, the facts ascertained by the trial judge are not subject to review.

17. Administrative courts are organized according to two levels of judgment: the Regional Administrative Courts (‘Tribunali Amministrativi Regionali’, hereinafter ‘TAR’) and the Council of State (‘Consiglio di Stato’) (see Articles 5–6 of the Code of Administrative Process). The appeals against the decisions rendered by the TAR of Sicily take place before the Council of Administrative Justice of the Sicilian Region (‘Consiglio di Giustizia Amministrativa per la Regione Siciliana’; see Article 6, 6 of the Code of Administrative Process). In the interplay between ordinary and administrative courts, the only role for the ‘Corte di Cassazione’isto verify that either an administrative or an ordinary court has jurisdiction in the actual matter at hand.

18. For civil and criminal matters, overall in the country, there are 1,426 judicial structures, including prosecution offices. Among them, at the judicial level, there is one Supreme Court (the aforementioned Corte Suprema di Cassazione), twenty- nine Appellate Courts covering both civil and criminal trials, twenty-nine Courts of Appeal (organized according to territorial districts) the jury of which comprises citizens where criminal matters are at issue (Corti di Assise di Appello), and first instance courts which again are comprised of a jury of citizens where criminal matters are at stake (Corti di Assise). There are 140 Ordinary Tribunals covering both civil and criminal matters to which twenty-nine specialized Tribunals for Minors (Tribunali per i Minorenni) should be added. For criminal matters, each of the twenty-nine districts of Court of Appeal has also a Tribunale di Sorveglianza to monitor detainees and to process their requests. Prosecution is organized around the Procure Generali: one for the Corte di Cassazione, twenty-nine for the appellate districts, twenty-nine for the Tribunals for Minors and twenty-nine for the regular Tribunals. At first instance, there are 391 Justice of Peace offices. They are competent in issues concerning small claims and criminal matters. Finally, there are also specialized Tribunals for issues relating to public water: one at the national level and eight at the regional level. Notification and other administrative offices complete the list that constitutes the judicial structure.10

19. The Italian judicial system is unfortunately renowned for the duration of its trials. In civil lawsuits, according to ISTAT data, there were 4,271,689 pending cases at ﬁrst instance and 524,332 at appeal level in 2018. In criminal matters on appeal, there were 258,798 and 5,020,662 overall at the level of public prosecution and trial (in 2014).

10. Please visit the Ministry of Justice at http://www.giustizia.it/giustizia/ (accessed 20 Oct. 2019).

34 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 20–23

§4. POPULATION AND VITAL STATISTICS11

20. In statistical terms, overall the healthcare system of the territory is comprised of 9,214 ambulatory care centres (assistenza specialistica ambulatoriale), 5,694 ‘other’ outpatient care centres (altra assistenza territoriale), 2,886 semi- residential healthcare facilities (assistenza semiresidenziale) and 1,022 residential healthcare facilities (assistenza residenziale sanitaria). Those outpatient and residential facilities are divided according to their main activity: specialized clinical activity (6,146 attività clinica), diagnostic activity (3,007 diagnostica strumentale), laboratory activity (3,722 attività di laboratorio), maternal and infant healthcare (2,575 consultorio materno infantile), psychiatric care (2,467 assistenza psichiat- rica), hospice (2757 assistenza ai pazienti terminali), mental healthcare (1,574 cen- tri salute mentale), healthcare in SPA (334 assistenza idrotermale), healthcare for the elderly (3,905 assistenza agli anziani), healthcare for physically disabled people (1,569 assistenza ai disabili ﬁsici) and healthcare for mentally disabled people (1,142 assistenza ai disabili psichici).

21. The overall death rate (9.7) per 100 habitants is higher than the birth rate (8.6 births/1,000 population in 2017)12 leading to a negative substitution rate remedied only by immigration. Infant mortality per 1,000 births reached a total of 2.8 in 2016 while estimates for 2012 forecast 3.36 for Italy, against a 4.3 in 201613 for the EU, 4.3 in Canada and 5.6 in 2016 for the USA.14

§5. HEALTH STATUS

22. In 2017, the total public health spending was 113,063 billion euros, which represents 6.7% of Italy’s GDP. The difference across regions on per capita public health spending ranged between 1.698 euros in Calabria and 2.198 euros in Trentino-Alto Adige. The Regional deficit cuts were first implemented by Law 311/ 2004. This statute, while respecting institutional responsibilities, permitted State participation – alongside the Regional Authorities – in the process of drafting new ‘Realignment Plans for the Health Deficit’ by way of reorganization, requalification and strengthening of the Regional Health Service. Realignment plans are part of a general agreement between Regions and the State – setting goals, interventions, and expected results – that Regions with a structural deficit are obliged to sign. They effectively outline a road map aimed at reducing deficits. Results are varied among the Regions in deficit. See also 22, 222.

23. The overall perceived level of health of Italian residents is good, even though it considerably differs when compared to the official evaluation. Indeed, at

11. This data relates to 2018 and is available on the ISTAT website (accesses 18 Aug. 2018). 12. This data relates to 2018 and is available on the ISTAT website (accessed 18 Aug. 2018). 13. according to World Bank data (https://data.worldbank.org/indicator/SP.DYN.IMRT.IN?locations= CA (accessed 21 August 2018). 14. According to World Bank data https://data.worldbank.org/indicator/SP.DYN.IMRT.IN?locations= US (accessed 21 August 2018).

Medical Law – Suppl. 119 (2020) Italy – 35 24–29 General Introduction, Ch. 1, General Background of the Country the international level, the Italian healthcare system is considered among the most advanced in the world, with excellent results in terms of healthcare and well-being. The NHS covers the entire population and life expectancy, and infant mortality rates are among the best in the world.

24. According to Italy’s Health Proﬁle released in 2017, almost two-thirds of all deaths in the country were attributable to either cardiovascular diseases or cancer in 2014. The leading causes of death related to cardiovascular diseases are: ischemic heart diseases (69.653 deaths – 11.6%), cerebrovascular diseases (57.230 deaths – 9.6%) and other heart diseases (49.554 – 8.3%). Regarding cancer, lung cancer is still the leading cause of cancer mortality, followed by colorectal cancer, breast cancer and pancreatic cancer. Deaths from Alzhe- imer’s disease and other dementias have increased substantially since 2000, not only due to population ageing but also as a result of better diagnosis and an improved recording of different forms of dementia as the primary cause of death.15

25. Data from ISTAT released in 2017 show a decrease in the number of healthcare providers, exception made to paediatricians and the number of elderly in need of home care has risen about 14% between 2008 and 2013.

26. Overall, individual perception of one’s own state of health was largely positive in 2016 (good health 7.01%).16

27. The Total Fertility Rate (TFR) remains rather low for Italian citizens (1.35). The TFR rises to an estimated 1.95 on average if coupled with that of foreign residents (data refer to 2015).17

28. Life expectancy for those born in 2009 is 84.128 and 79.14 respectively for female and male individuals at birth. These ﬁgures illustrate a higher life expectancy than, for instance, that of the USA,18 and even Canada.19 In comparison to other EU countries, in 2009 France had the highest male life expectancy with Italy coming a close second.20

29. In 2016, around 5.3% of the population declared to have diabetes, from which 16.5% were over 65 years old. For those between 45 and 64 years old, the percentage affected by diabetes corresponds to 28.9% (men) and 32.8% (woman). Among those, 47.5% of men and 64.2% of women declared that they do not practice any physical activities.

15. http://www.euro.who.int/__data/assets/pdf_ﬁle/0008/355985/Health-Proﬁle-Italy-Eng.pdf?ua=1. 16. Data refers to the year 2012 and is taken from the ISTAT website (accessed 18 Jan. 2013). 17. http://dati.istat.it/Index.aspx?lang=en. 18. http://www.census.gov/compendia/statab/cats/births_deaths_marriages_divorces/life_ expectancy.html. 19. http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health26-eng.htm. 20. http://epp.eurostat.ec.europa.eu/tgm/refreshTableAction.do;jsessionid=9ea7d07e30e64ce88e3eb973 43b2b3a1ba105de2c81c.e34OaN8Pc3mMc40Lc3aMaNyTaNaLe0?tab=table&plugin=1&pcode=tps 00025&language=en.

36 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 30–34

§6. SOCIAL AND CULTURAL VALUES REGARDING HEALTH

30. Dignity, solidarity, autonomy, professionality are the keywords surrounding the protection of health. With specific reference to healthcare and in line with the actual apportionment of competences, it is to the national parliament to approve framework legislation defining the general principles for organizing, financing and monitoring the NHS. Yet those principles, as we shall see, are somehow negotiated and bound to some general principles which have been made explicit in the National Health Plan for 1998–2000 – significantly titled ‘A solidarity pact for health’ – and have since been followed.

31. The following principles indicate some keywords that capture the result to date of a long normative evolution on the protection of health. Indeed, the ﬁrst two, human dignity and human health, represent the main lines through which the spirit of Article 32 of the Constitution is reﬂected in the organization and management of healthcare. According to the former, ‘Every individual must be treated with equal dignity and have equal rights irrespective of his or her personal or social characteristics.’ According to the latter, ‘everyone in need has a right to healthcare and resources should be allocated with priority given to satisfying the basic needs of the population’.

32. Equity as a key principle reﬂects the notion of Article 3 of the Constitution according to which it is a ‘duty of the Republic to remove those obstacles of an economic and social nature which constrain the freedom and equality of citizens, prevent the full development of the human person and the effective participation of all workers in the political, economic and social organization of the country’. Accord- ingly, in the words of the NHP 1998–2000:

The NHS resources should be used to eliminate geographical and/or economic barriers that constitute an obstacle to citizens’ demand for appropriate services. Behavioural and information gaps among the population should be reduced to provide the same opportunity for access to healthcare services.

33. The proactive role of the State and its components (e.g., Regions) is embedded in the notion of Protection for which ‘The NHS should give the highest priority to protecting and promoting citizens’ health status.’

34. The idea of universal access that involves solidarity in ﬁnancing the system has evolved over time in Italy making it clear that it does not imply free access for all but rather answers to the needs of individuals by way of removing obstacles to their development. Henceforth, solidarity with the most vulnerable people requires that ‘Resources should be allocated primarily to the individuals, groups or groups of diseases with the most relevant social, clinical and epidemiological impact.’ Yet this process is not pursued in a blind way.

Medical Law – Suppl. 119 (2020) Italy – 37 35–37 General Introduction, Ch. 1, General Background of the Country

35. The final two principles/keywords we should mention reflect these changes in an attempt to combine solidarity with efficiency and clinical appropriateness. Therefore the principle of effectiveness and appropriateness of health interventions implies that ‘Resources must be channelled to services with scientifically demonstrated effectiveness and to individuals who can benefit the most from them.’ At the same time, sustainability of the system is needed to offer effective protection. There- fore, in principle at least, cost-effectiveness – according to which ‘Services should be provided by the relevant organizations pursuing financial balance through effi- cient and effective management’ – should be aimed at providing increased and better services. Indeed, the term ‘appropriateness’ officially entered the Italian healthcare system with the National Health Plan 1998–2001 in relation to LEP. It has the twofold significance of (a) clinical appropriateness (now ruled by a specific Ministry Decree n. 15/2016), and (b) organizational appropriateness, meaning the promotion of treatments at the lowest possible level of the healthcare delivery system that is compatible with the severity and complexity of their specific clinical condition. However effective the appropriateness policy has been, the creation of incentives for health authorities to begin treating patients in settings other than ordinary inpatient admissions (day-surgery, day-hospital or, where possible, outpatient services) has often been perceived as a mere cost-cutting mechanism. In fact, they were frequently connected to a process of reducing DRG rates for ordinary admissions to make the alternative treatment options more attractive to the providers. Here we want only to emphasize that deeper analysis for the interplay between clinical and organizational appropriateness would be a proper scientific move.

§7. THE CONSTITUTIONAL PRINCIPLES UNDERLYING THE PROTECTION OF HEALTH

36. The text of Article 32 of the Constitution states that:

The Republic safeguards health as a fundamental right of the individual and as a collective interest and guarantees free medical care to the indigent.

No one may be obliged to undergo any health treatment except under the provisions of the law. The law may not violate under any circumstances the limits imposed by respect for the human person.

37. Article 32 clearly severs the ties with the liberal and (even more so) the fascist understanding of the protection of health. It clearly stresses the shift in focus from sanitation and public order (see, for instance, Law 5849/1888, ‘Sulla Tutela della Igiene e della Sanità Pubblica’ or Law 6972/1890 nationalizing a number of healthcare providers in the aftermath of Italian uniﬁcation) to the right to health. In constitutional terms, it represents a sort of revolution that overrides the distinction between positive and negative constitutional freedoms.

38 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 38–40

38. Similarly, it acquires a normative value that supersedes any claim to read it as a programmatic principle. The instruments of its implementation shape its content. The changing related notion of health is incorporated as the normative principle making it possible to fulﬁl, in an evolutionary manner, the international understanding of the highest attainable right to health. In its syncretism, Article 32 combines the basis of individual fundamental rights (The Republic safeguards health as a fundamental right of the individual … ), personal obligations towards the community ( … and as a collective interest) and entitlement to beneﬁts (and guarantees free medical care to the indigent). It sets negative freedoms (No one may be obliged to undergo any health treatment except under the provisions of the law)in relation to the limits of legislative powers (The law may not under any circumstances violate the limits imposed by respect for the human person).

39. In its eclectic formulation, Article 32 creates the basis for a variety of instruments to play its music allocating a role for each traditional power of the State (legislative, executive and the judiciary) avoiding the exclusion of polyphonic interpretations and ‘solos’. From this metaphor, we can deduce that the implementation of Article 32 can be, and indeed has been, the fruit of a coordinate action of State powers (today including more extensively the Regions) and sometimes the offspring of ‘solo’ jumps ahead of the judiciary or of the legislator. For instance, in the 1970s the legislator was charged with overcoming the minimalistic (programmatic) reading of Article 32 by way of promoting a move away from a mutually based system towards a universal tax-based national healthcare system21 according to which everybody had the right to seek treatments mostly paid for by the State. In another vein of development, in the late 1970s and early 1980s, responsibility shifted to the judiciary to expand the scope of protection of Article 32 by way of incorporating personal injury compensation for the impairment of health as such regardless of any lost income (Cost. 184/1986). See, for instance, 16, 40, 60, 64, 84, 86, 159, 161, 672.

I. Health as a Fundamental Right

40. Against this backdrop, today, the protection of health as a fundamental right in Italian law is sheltered fully by international and EU principles (see 41, 49, 66–81, 875, 876). However, its key reference remains Article 32 of the Constitution it being among the ﬁrst binding legal texts of the Post-WWII era to describe the right to health as a fundamental right. Judicial, legislative and scholarly interpretations of this text have given content to it moving beyond the borders of what the WHO Constitution of 1946 described as ‘the right to the highest attainable health’, a concept restated in the 1978 Alma Ata Declaration (WHO 1978) and in the World Health Declaration of 1998 (WHO 1998).

21. Based on Art. 1 of Law 833/1978, the realization of the National Health System was tied to principles of ‘globalità delle prestazioni’, ‘universalità dei destinatari’ and ‘uguaglianza del trattamento’.

Medical Law – Suppl. 119 (2020) Italy – 39 41–43 General Introduction, Ch. 1, General Background of the Country

41. Several international human rights documents recognize the right to health (see infra and, for instance, infra 99, 155). Within the meaning of ‘a state of complete physical, mental and social well-being and not merely the absence of disease or inﬁrmity’,22 the right to health is the only one expressly named as ‘fundamental right’ in the Italian Constitution. Today, it is clear that the various determinants of the right to health23 encompass both freedoms and actual entitlements that should be guaranteed by the State at an attainable level. This necessarily implies that differences will occur between various countries according to levels of development. Yet, some of these freedoms and entitlements have to be honoured without exceptions. Among the freedoms are the right to be free from non-consensual medical treatment, such as medical experiments and research or forced sterilization, and to be free from torture and other cruel, inhuman or degrading treatment or punishment. See 413ff, 1019f, 1095ff. Among the entitlements, we can identify the right to equal opportunity for everyone to enjoy the highest attainable level of health; the right to prevention, treatment and control of diseases; access to essential medicines; maternal, child and reproductive health; equal and timely access to basic health services; health-related education and information; and democratic participation in health-related decision-making at all levels.

42. Clearly, both freedoms and entitlements are enjoyed within the framework of the healthcare system, a system that should offer its services and goods without any discrimination. All services, goods and facilities must be: available in sufficient quantity; physically and ﬁnancially accessible for all individuals (see paragraph II of Article 32 Cost.); culturally acceptable and respectful of medical ethics; and gender-sensitive and of good quality. All these elements are linked with the organization of the healthcare system and funding. Quality is additionally linked to the appropriateness of treatment, to the quality of trained health professionals, medical equipment, and sanitation.24

43. Although with the passing of time different countries can attain different levels of protection of the right to health, all must, at least, operate in a non- discriminatory manner, prepare a national plan for healthcare aimed at enhancing accessibility in all its dimensions (physical access in rural areas for example and ﬁnancial access for the more needy of the population), have a minimum package of

22. See the preamble of the 1946 Constitution of the World Health Organization (WHO) in stressing that ‘the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition’. 23. The Committee on Economic, Social and Cultural Rights, that is responsible for monitoring the International Covenant on Economic, Social and Cultural Rights, describes safe drinking water and adequate sanitation; safe food; adequate nutrition and housing; healthy working and environmental conditions; health-related education and information; gender equality as ‘underlying determinants of health’. As we shall see, the Italian Healthcare System somehow takes all these determinants into account. 24. See, for these and many other important characteristics of the right to health, Committee on Eco- nomic, Social and Cultural Rights, General Comment 14, The right to the highest attainable standard of health (Twenty-second session, 2000), U.N. Doc. E/C.12/2000/4 (2000), reprinted in Compilation of General Comments and General Recommendations Adopted by Human Rights Treaty Bodies, U.N. Doc. HRI/GEN/1/Rev.6 at 85 (2003).

40 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 44–46 health-related services and facilities, and arrange the largest possible democratic participation in health-related decision-making. See, for instance, 108ff.

44. Even though the Italian Constitution is older than the international instruments sustaining these rights and freedoms, the mentioned ductility of Article 32 Cost. has permitted gradual incorporation of the said instruments under its scheme. Clearly, Article 32 Cost. affirms the right to health as a fundamental right (the only occasion the Constitution explicitly uses this expression) automatically enabling, on the one hand, the entitlement to speciﬁc public results and to some levels of public refrainment from interfering with individual choices, while, on the other hand, it establishes rights and duties towards fellow citizens. From these, for instance, it ensures that a basket of instruments (for instance, injunctive and compensatory remedies) are available aimed at preventing or limiting any infringement to a person’s health by a third party. In the event of a failure of the effects of these instruments, however, individuals can claim adequate treatments in protection of their health from the State. Among the former, we can highlight the right to compensation for personal injury damages (see infra on medical accidents) and the right to seek a healthy environment (at work, in daily life, etc.), while among the latter we can make reference to all tools in place aimed at treating/preventing illnesses and ame- liorating health.

45. The change instigated by the constitutional provisions is rendered even clearer when we juxtapose those rules that were in existence prior to the enactment of the Constitution and were never abolished. For instance, Article 5 of the Civil Code prohibits any permanent impairment of physical integrity (see 353, 712, 1049, 1054). The meaning of the rule has changed over time in that the unitary notions of health (not only in relation to physical integrity but also including mental health) and of the human being have made it impossible to consider severed parts of a body as mere objects upon which one’s own rights could be exercised. Rather, the trans- formation means that body parts are now considered objects upon which liberty is exercised.

46. Clearly enough, the first paragraph of Article 32 Cost. establishes a human right to be medically treated by way of purporting the Republic’s duty to provide free treatments for the needy. Yet, as scholars and case law have stressed in coherence with the international dimension we described above, the right to health is somehow a financially conditioned right. The right to treatment becomes a right to treatment free of charge only for the needy. However, everybody has a right to require access to treatments both against public and private providers. Therefore, according to the financial ability and choice of the Italian State, benefits can be for free or offered against a payment or a co-payment, without automatically violating Article 32 Cost. or international covenants. In establishing this, borderline constitutional case law was not linear in reaching this conclusion as legislative intervention was absent. In a descriptive spectrum, we find decisions clearly establishing a full entitlement to free treatment – based upon the prominence of the right to health on financial parameters (see Cost. 992/1988), – to subsequent decisions sustaining that when it comes to treatments, heath is subject to the ‘instruments, timing, and

Medical Law – Suppl. 119 (2020) Italy – 41 47–50 General Introduction, Ch. 1, General Background of the Country modalities of implementation established by the legislative power’ that has to balance the right to health with ‘other interests of equal constitutional protection’ and ﬁnancial constraints. In this way, the Constitutional Court is called to test the limits the legislator has in shaping the instruments aimed at providing beneﬁts. However, the test of rationality conducted by the court remains unclear (see Cost. 455/1990 but see already Cost. 175/1982, 212/1983, 1011/1988).

47. The contextual protection of health as an individual right and a collective interest somehow summarizes the inner problematic relationship between the sig- niﬁcant notion embodying the right to health and other constitutionally protected rights and liberties. The traditional interplay of powers means the legislature must set the balance, and the courts must check the rationality of the reached balance at any given moment in time. Nevertheless, the Italian Constitution gives clear ‘instruction’ to public powers in implementing the right, both in terms of allocating powers and in terms of the substantive content of the right and its balance against other constitutionally protected values. The former has changed with the passing of time inﬂuenced, among other things, by changes to the constitutional text itself. Indeed, the duty to protect health is attributed to the Republic which, after the reforms of the 2000s is now a complex entity comprising ‘Municipalities, the Prov- inces, the Metropolitan Cities, the Regions and the State’ (Article 114 Cost.) thereby setting out a plurality of institutional players.

48. Moreover, constitutional reforms have reshaped the role each of these players performs. It allocates the protection of health among the various subjects by granting concurrent legislative power to the State and the Regions (Article 117, 3° co.119). Therefore, the State is in charge of setting the fundamental principles, whereas the Regions must regulate according to the established principles. Never- theless, the complex notion of health we have described so far encompasses subject matters Regions have exclusive competence over (e.g., welfare support ‘assistenza sociale’) according to Article 117 paragraph 4 Cost. In addition, the State maintains the exclusive power to establish, according to Article 117, 2 (lett. m), ‘the basic level of beneﬁts relating to civil and social entitlements to be guaranteed throughout the national territory’, international prophylaxis according to lett. q, and environmental protection according to lett. s. See also 63, 106, 137, 182, 484.

49. Last, but not least, the subsidiarity principle applies both in vertical (Article 118, 1) and horizontal relationships (Article 118, 4). Accordingly, it is for local entities and private individuals to actually implement the right to health respecting legal rules and in fulﬁlment of the principle of loyal collaboration. This way it seems oriented the Constitutional Court since its ﬁrst decisions after the 2001 Constitutional Reforms (see Cost., 88/2003, in Le Regioni 1199 (2003) 1199 ss., and also A. Simo- ncini, Non c’è alternativa alla leale collaborazione. Dalla Corte le prime indi- cazioni su regolamenti del Governo e ‘livelli essenziali’ nelle materie regionali,in 6, Le Regione, 1200 (2003)).

50. When we move to consider the substantial elements embedded in the Con- stitution, we uncover the balancing outcome already settled in the Constitution itself

42 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 51–54 depending on whether the right to health comes to the fore as a ‘fundamental right’ or as a ‘collective interest’. In the ﬁrst case, it operates as a (counter) limit to actions that involve the individual and multiplies the entitlements set out in the Constitu- tion. When the right to health presents as a ‘collective interest’ it limits other freedoms or constitutionally protected rights.

51. To name but a few instances of the ﬁrst option, health as an individual right acts as a counter-limit enhancing protection by (a) making it clear that full protection against any ‘physical and moral violence’ will counter those deprived of personal freedom (paragraph 4 of Article 13 on personal freedom), and (b) expanding the reach of the provisions on ‘maximum daily working hours’ and the non- waivable ‘right to a weekly rest day and paid annual holidays’ (Article 36 paragraphs 2 & 3), as well as (c) the protections enshrined in Article 37.1 and 2 requiring that conditions of work ensure ‘appropriate protection’ to mothers and children. Similarly, Articles 38 and 41 can be read as substantive applications of the principles embedded in Article 32 by requiring, according to paragraph (d), ‘adequate means for their [citizens’] needs and necessities in the case of accidents, illness, disability, old age’, and (e) which makes it clear that freedom of economic initiative cannot ‘be carried out against the common good or in such a manner that could damage safety, liberty and human dignity’.

52. Once health as a collective interest comes to the fore, it works as a limit to other liberties. For instance, for public safety concerns, it is possible to limit (a) the freedom of movement (Article 16, 1) or (b) the right to assembly (Article 17, 3).

II. Autonomy and Human Dignity

53. The two sides of the right to health we mentioned are often integrated and operate in synergy. In relation to the right to treatment, for example, it is established that both an entitlement to treatment and the right to refuse treatment, to choose one’s physician and which treatment to opt for are included. See infra 638, 669, 706. Human dignity also limits the power of the State to impose a treatment for public safety concerns (Article 32 paragraph 2: ‘The law may not under any circumstances violate the limits imposed in respect of the human person’).

III. The Role of Healthcare

54. ‘The deﬁnitions of health systems put forward by analysts and organizations vary enormously, especially in the way that health system boundaries are determined. At one end of the spectrum are narrow deﬁnitions that focus on medical care, with “patients, clear exit and entry points and services regarding disease, disability

Medical Law – Suppl. 119 (2020) Italy – 43 55–58 General Introduction, Ch. 1, General Background of the Country and death”. At the other end are broad approaches that encompass all those determinants that contribute directly or indirectly to health.’25 The World Health Report 2000 deﬁnes a health system as ‘all the activities whose primary purpose is to promote, restore or maintain health’.26 Accordingly, ‘a health system consists of all organizations, people and institutions producing actions whose primary intent is to promote, restore or maintain health’. Article 2 (a) of Directive 2011/24/EU suggests that ‘healthcare means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices’.

55. The Italian NHS assumed these goals right from its creation in 1978 and interpreted them in terms of universality and equality in relation to access for the whole population by way of a system mainly financed by general taxation. Since the 1990s, the reforms have reinterpreted these principles making clear that universal access does not mean that it is gratis for everyone. Contribution has been progressively linked to wealth, by way of co-payments or exemptions, leading to an understanding of universality that can be organized in different ways across the country. It is important to note that the concept of universality still aims to overcome inequalities by way of assuring equality in the essential levels of benefits provided, while not necessarily overcoming inequalities in the way they are offered. Therefore, equality is guided by the idea of appropriate treatment in the meaning of clinical appropriateness and organizational appropriateness in its supply. Still, cream-skimming in integrative insurance policies is forbidden. This also applies to the whole healthcare system in relation to the selection of patients by beneficiaries according to their lawful residency.

56. Over the years, an understanding of equal treatment according to which the more needy and the less healthy require more assistance (vertical equity which means vertical solidarity) has been accompanied by an understanding of equal treatment linked to equal needs.

57. At the same time, the above-described notion of health as a fundamental right and a collective interest in its holistic structure explains the reason why the NHS also entails a regulatory and monitors role for safety in relation to food and the workplace environment.

58. Essential levels of assistance require the fulﬁlment of a minimum level of beneﬁts (Cost., decisions n. 88 of 1979, n. 184 of 1986, n. 559 of 1987, nn. 992 and 1011 of 1988, n. 307 of 1990) without which the essence of the inviolable right is infringed (Corte cost., decision. n. 27 of 1998; Corte cost., n. 185 of 1998, n. 267

25. European Observatory on Health Systems and Policies Series, Health Systems, Health, Wealth and Societal Well-being: Assessing the Case for Investing in Health Systems 4–5 (J. Figueras and M. McKee ed., Open U. Press 2012). 26. World Health Org., The World Health Report 2000 – Health Systems: Improving Performance,5 (2000).

44 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 1, General Background of the Country 58–58 of 1998, n. 188 of 2000). It is for this reason that defining the LEA (Livelli Essen- ziali di Assistenza (essential levels of healthcare)) and finding the required resources to fund them is prescribed by the law as a simultaneous activity (Article 1, 3 of Law n. 502/1992 (as modified in 1999)). Accordingly, the LEA must be defined in respect of five general principles: human dignity, health needs, equal access to healthcare, quality and appropriateness of treatment with reference to peculiar needs, and effi- cient use of resources. See also 35, 105–108, 145f, 163ff, 1002.

Medical Law – Suppl. 119 (2020) Italy – 45 59–62

Chapter 2. Medical Law Versus Health Law?

§1. DEFINITION AND FUNCTIONS OF MEDICAL LAW

59. The indication that the ﬁelds of ‘medicine’ and ‘health’ do not overlap entirely is attested by the perception that health is a social and natural phenomenon whereas medicine is a phenomenon that interacts with it but is more a human product. Yet, medicine and health relate to each other: medicine encompasses theories and practices to maintain or restore health, and health requires medicine and healthcare to maintain and improve itself. Accordingly, their interplay with law is inex- tricably related. They, in conjunction with the notion of health that has been emerging in the international and in the Italian legal system (see above General Introduction and Overview and 31ff, 59ff), explain both the interdisciplinary nature of health law – within which the boundaries between private, criminal, administrative, international and constitutional law are blurred and are even counterintuitive – and the reason we prefer to talk of health law instead of medical law when referring to the subjects we deal with here.

60. The term ‘medicine’ derives from the Latin medicina meaning the art of cur- ing. It is the science dealing with the study of illnesses and of the remedies capable of preventing or healing them. Ian Kennedy and Andrew Grubb affirm that ‘Medi- cal Law has come a long way since its early days.’ They point out that the subject was once dominated by medical negligence actions and disciplinary cases. Accord- ing to these authors, the last decade or so has seen judicial and legislative intervention into the healthcare setting in an unprecedented way.

61. ‘Health’ is a word that descends from the Latin salus, indicating not only the absence of illness or infirmity but also the state of physical, mental and social welfare. This definition is in line with the changes, emphasized above (see General Introduction and Overview), that occurred in relation to the concept of health after WWII. In 1946, the Constitution of the World Health Organization (WHO), placed under the control of the United Nations, defined health as ‘a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’.27 This extension indicated a clear expansion of the original scope of the concept, giving a new centrality to preventive actions for the preservation of (the right to) health. Healthcare activities monitoring possible pathogenic realities and promoting adequate working environments or lifestyles, and hygienic actions in connection, as well, with the notion of a healthy (salubre) environment have become the constitutive elements for enjoying the right to health as opposed to the fruit of public security concern. See 108ff.

62. Technically and originally, the notion of ‘healthcare’ referred to the condition of living environments and more speciﬁcally that they had been rendered hygienically clean and healthy by providing a sewage system and an adequate, clean

27. Available at: http://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf (accessed 10 May 2010).

46 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 2, Medical Law Versus Health Law? 63–66 water supply. Based on this, when a place is said to be unhealthy this effectively means that it is not hygienically clean. Indeed, for a long time healthcare and sanitation almost coincided and were related to public health concerns.

§2. SOURCES OF MEDICAL LAW

63. At ﬁrst glance, the legal sources related to health law can be described as a hierarchical tree, although their interplay is more complex as we shall see (see, for instance, 280ff, 320ff). In a theoretical order of priority, we can delineate the Con- stitution, primary legislation (by the State or Regions according to the allocation of competences; see 30, 48, 63f, 77, 88, 137ff, 242ff) enacting EU law and even prevailing over national law, secondary norms provided by the executive branches of the national or local governments (e.g., ministerial decrees, ordinances of territorial institutions of the Regions), contract, and self-regulation (e.g., deontological codes or the self-regulation imposed by local health authorities on its actors) including the so-called atto unico di indirizzo (which may be translated as a programme of governance stipulated by each healthcare facility in view of the effective provision of healthcare) that are delineated by the General Manager of each ASL ‘Azienda Sani- taria Locale’ (Local Health Facility). Note that ASLs are incorporated as public entities and are afforded signiﬁcant autonomy (see 105, 143, 149–154, 206–216 infra).

64. Although this description is technically correct, it does not capture the complexity of the subject matter. Indeed, the different layers of legislation/regulation are strictly interconnected. One clear example is the repartition of healthcare system competences between the State and the Regions. Beyond this, however, international principles often play(ed) a significant role in judicial decision-making even when international conventions were not legally binding (see, for instance: 587 and 919ff). In addition, administrative decisions have played and continue to play an important role covering (by way of derogating, as in the di Bella case (see infra 88, 906 and footnote 37), and sometimes by filling in statutory gaps) deficiencies in the legal framework. Accordingly, we can merely describe here the different layers making reference to the specific paragraphs below that expand on these issues.

65. Finally, we should mention collective agreements that regulate much of the professional activities involved in administering the healthcare system.

I. Sources

66. Italy, as all EU Member States, has formally recognized the right of everyone to the highest attainable standard of physical and mental health. This right has been enshrined in numerous international and European legal instruments to which Italy has agreed.

Medical Law – Suppl. 119 (2020) Italy – 47 67–69 General Introduction, Ch. 2, Medical Law Versus Health Law?

67. Among the international sources, we can outline a number of treaties signed by Italy. In particular, the International Covenant on Economic, Social and Cul- tural Rights, Article 12 of which recognizes ‘the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’. This Covenant obliges Italy to take steps to fully realize:

(a) The provision for the reduction of the stillbirth rate and of infant mortality and for the healthy development of the child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness.

68. Several international documents bear a signiﬁcant importance as sources of medical/health law even though they may not be entirely or directly devoted to health and/or healthcare as such. Among these we can point to: the 1965 Interna- tional Convention on the Elimination of All Forms of Racial Discrimination: Article 5 (e) (iv); the 1979 Convention on the Elimination of All Forms of Discrimination against Women: Articles 11 (1) (f), 12 and 14 (2) (b); the 1989 Convention on the Rights of the Child especially Article 24, Articles 28, 43 (e) and 45 (c); the 1990 International Convention on the Protection of the Rights of All Migrant Workers and Members of Their Families; and Article 25 of the 2006 Convention on the Rights of Persons with Disabilities.

69. With specific reference to women, motherhood and children we can recall Article 12 of the Convention on the Elimination of All Forms of Discrimination against Women, according to which ‘States Parties shall take all appropriate measures to eliminate discrimination against women in the field of healthcare in order to ensure, on a basis of equality of men and women, access to healthcare services, including those related to family planning,’ and they will also ensure ‘to women appropriate services in connection with pregnancy, confinement and the post-natal period, granting free services where necessary, as well as adequate nutrition during pregnancy and lactation’. We can also recall Article 10(2) of the International Cov- enant on Economic, Social and Cultural Rights which offers special protection ‘to mothers during a reasonable period before and after childbirth. During such period working mothers should be accorded paid leave or leave with adequate social security benefits’. In addition, we should recall Article 24 of the Convention on the Rights of the Child which recognizes ‘the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health’ and forces signatory states ‘to ensure that no child is deprived of his or her right of access to such healthcare services’.28 States must also,

28. Among the appropriate measures to be taken are enumerated to: (a) diminish infant and child mortality; (b) ensure the provision of necessary medical assistance and healthcare to all children with emphasis on the development of primary healthcare;

48 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 2, Medical Law Versus Health Law? 70–73 according to the same, ‘take all effective and appropriate measures with a view to abolishing traditional practices prejudicial to the health of children’.

70. Often speciﬁc conventions stress the interdependence among the various international covenants, as for example, Article 3 of the Convention on the Rights of Persons with Disabilities, adopted by the United Nations General Assembly in its Resolution 61/106 of 13 December 2006, according to which:

The right to health of persons with disabilities cannot be achieved in isolation. It is closely linked to non-discrimination and other principles of individual autonomy, participation and social inclusion, respect for difference, accessibility, as well as equality of opportunity and respect for the evolving capacities of children.

71. Vulnerable individuals are encompassed by speciﬁc covenants such as the International Convention on the Protection of the Rights of All Migrant Workers and Members of Their Families. For example, Article 28 stipulates that ‘all migrant workers and their families have the right to emergency medical care for the preservation of their life or the avoidance of irreparable harm to their health’. In line with the International Covenant, Italy provides these beneﬁts ‘regardless of any irregularity in their stay or employment’.29

72. The Declaration of Alma Ata resulting from the International Conference on Primary Health Care in 1978 plays a special role emphasizing access to primary healthcare as the key to attaining a level of health that will permit all individuals to lead socially and economically productive lives (Article 5).

73. It is worth mentioning that reference to the highest attainable right to health does not constitute mere wishful thinking in legal terms. Indeed, the Committee on Economic, Social and Cultural Rights has clearly stressed that States have a core minimum obligation to ensure the satisfaction of minimum essential levels of each of the rights under the Covenant underlining that, in relation to the right to health, States must ensure:

(c) combat disease and malnutrition, including within the framework of primary healthcare, through, inter alia, the application of readily available technology and through the provision of adequate nutritious foods and clean drinking water, taking into consideration the dangers and risks of environmental pollution; (d) ensure appropriate prenatal and postnatal healthcare for mothers; (e) ensure that all segments of society, in particular parents and children, are informed, have access to education and are supported in the use of basic knowledge of child health and nutrition, the advantages of breastfeeding, hygiene and environmental sanitation and the prevention of accidents; (f) develop preventive healthcare, guidance for parents and family planning education and services. 29. The Convention further protects migrant workers in the workplace and stipulates that they shall enjoy treatment not less favourable than that which applies to nationals of the State of employment in respect of conditions of work, including safety and health (Art. 25).

Medical Law – Suppl. 119 (2020) Italy – 49 74–77 General Introduction, Ch. 2, Medical Law Versus Health Law?

– the right of access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups; – access to the minimum essential food which is nutritionally adequate and safe; – access to shelter, housing and sanitation and an adequate supply of safe drinking water; – the provision of essential drugs; – equitable distribution of all health facilities, goods and services.

II. European Union Law

74. The delimitation of the notion of health and the related notion of health law can be viewed as a process or combination of many elements. Besides its historical evolution and changes, the balance between Member State legislation and the Euro- pean community principles and guidelines presents the underlying challenge currently facing Europe in this ﬁeld. The constitutional protection afforded to health calls for a vested interest at both national and international levels in relation to developing a shared set of general principles.

75. This scenario reﬂects the growing importance of health protection that has become a fundamental value incorporated into many international documents. Although not approved, the draft of the European Constitution indicated that public health was considered as one of the issues related to ‘Common Security’ and an issue that was to be jointly tackled by the European Union and the Member States.

76. The protection of health was also embodied as part of the Treaty of Amster- dam since added a new article entirely dedicated to public health. It paves the way for the adoption of any necessary measure aimed at ensuring a high level of human health protection throughout the community. It is interesting to observe that the definition of the right to health protection potentially raises different issues. For example, the legislator, in searching for a legal delimitation of health protection can in fact offset a limitation of the concept itself. In this sense, the legislator is challenged to find in EU law the source of the concept – which is not limited to legal definitions – and that should be also connected with international references.

77. Despite limited competences on health and the extensive limits posed by the subsidiarity principle, EU law is increasingly contributing to defining the content and scope of health law in all respects, for instance, from defining/regulating the medical profession to healthcare education and delivery in cross-border situations. In addition, EU norms in the Lisbon Treaty have reiterated that respect for human rights is one of the values upon which the EU is founded. Both public health policies and healthcare delivery remain MS matters. However, their actual practice is deeply influenced by EU law and will continue to be in the future. Indeed the Lis- bon Treaty has set ‘well-being’ as an objective of the EU according to the importance attributed to it corresponding to the internationally recognized notion of health.

50 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 2, Medical Law Versus Health Law? 78–82

78. Additionally, it is important to note here that Articles 9 and 168 of the Treaty on the Functioning of the European Union (the TFEU Consolidated) constrain Euro- pean Commission proposals to take into account possible adverse effects on health and to legislate accordingly. Article 168 in particular, devoted to public health, aims, among other things, at attaining ‘A high level of human health protection … in the deﬁnition and implementation of all Union policies and activities.’ It encourages ‘cooperation between the Member States to improve the complementarity of their health services in cross-border areas’, enabling the Commission to ‘take any useful initiative to promote … in particular initiatives aiming at the establishment of guidelines and indicators, the organization of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation’.

79. Several other lines of intervention set forth by Article 168 clearly interact with areas of health law at the national level30 establishing the principle that the EU now shares competence ‘with Member States where common safety concerns in public health have been identiﬁed, and can introduce legally-binding legislation’.

80. Moreover, all EU interventions must today face the fact that the Charter of Fundamental Rights of the European Union has now legally binding force, and it sets out the right of everyone to access preventive healthcare and to beneﬁt from medical treatment ‘under the conditions established by national laws and practices’.

81. Directive 2011/24/UE on the application of patients’ rights in cross-border healthcare has recently revised the transborder rights and has clariﬁed their relationships with Regulation (EC) no. 883/2004 or Council Regulation (EEC) no. 1408/71 of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the community enlarging the possibilities for MS citizens without unifying the social security and healthcare systems.

III. National Sources

82. There is not one comprehensive source at the national level since the Con- solidated Text of Health Laws (TULLSS – Testo Unico delle Leggi Sanitarie), which organically restructured Public Health in its essential organization in 1934 (R.D. 27 July 1934 n. 1265), offers only a backbone upon which subsequent reforms had a large impact. As we shall see, different layers of legislation (national and regional) deal with healthcare organization and delivery (see 104–232), while each

30. (a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures; (b) measures in the veterinary and phytosanitary ﬁelds which have as their direct objective the protection of public health; (c) measures setting high standards of quality and safety for medicinal products and devices for medical use.

Medical Law – Suppl. 119 (2020) Italy – 51 83–86 General Introduction, Ch. 2, Medical Law Versus Health Law? healthcare-related profession is connected to a specific law establishing and governing it in addition to a Code of Ethics (see, for instance, for physicians 280ff). Spe- cific legislation deals with sensitive issues such as abortion (Law 22 May 194/1978; see infra 998ff), assisted reproduction (Law 19 February 2004 n. 40; see infra 1025ff), transplants and organ donation (see infra 1040), and family counselling centres (Law 29 July 405/1975). In addition, with reference to personnel working in the NHS, specific legislation (see infra 200ff) in conjunction with negotiated contracts determine the applicable regulation.

83. General rules apply as well. For instance, the codes containing the rules relating to public tenders (D. Lgs 19 April 2016, no. 50) govern the procedures mostly used in the healthcare system while rules of civil law still regulate birth or conception dealing with them as (natural) phenomena external to law (see, for instance, Article 1, 462, 784 Codice Civile).

84. Sometimes, the absence of a legislative regulation is combated with administrative regulation. For example, we can note various ministerial decrees (for instance, the Health Ministry Decree of 11 February 1997 governing authorization procedures in relation to the importation of RU486) or ministerial circulars (e.g., the circular of the then Minister Degan of 1 March 1985 on the limits and legitimacy of human artiﬁcial insemination procedures). In other circumstances, it is the judiciary that assumes responsibility by offering general principles as a (at least temporary) solution or by judging on the constitutionality of a legislative choice (as occurred several times in relation to Law 40/2004 with the Constitutional Court decision of 8 May 2009 n. 151 concerning the ban on creating more than three embryos per procedure). The Court has again intervened on the law with three judgments: no. 162 of 9 April 2014, no. 96 of 14 May 2015 and no. 229 of 11 November 2015.

85. It is worth noting as well that other secondary ‘sources’ can have a very high impact on medical law. In this regard, we can refer to (scientific) decisions taken by ministerial or permanent committees. In this regard, we can refer to the Pharmaceu- tical Commission that has the power to define and revise the list of innovative drugs that can be administered when there is no other suitable therapeutic alternative. The Decree of 21 October 1996 n. 536 does not list the characteristics of potential innovative drugs nor the procedures and methodology of administration thereby devolving the regulatory decision to the scientific committee. Indeed, with reference to health-related issues, it often occurs that the legislator defers the approval of manu- als or technical instructions, guidelines and technical requirements to national scientific organs. In those instances, the legislator transfers its discretional decision- making authority effectively deferring to technical solutions.

86. Both medical doctors and judges, although not technically ‘sources of law’, de facto play an important role in the actual cases by way of either filling in the gaps in the absence of specific regulation or revising the legislative choices according to constitutional principles (specifically the judge) or in lending their technical discretion and judgment to patients in line with their codes of ethics. In both cases, their activity might run the risk of assuming the role of custodian of freedoms and/or of

52 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 2, Medical Law Versus Health Law? 87–89 authority. Such an ambiguous role comes to the fore rather clearly when the law calls on them to reinforce or protect the will of vulnerable individuals (for instance, in cases concerning gender reassignment and its consequences in relation to official registration or, in the case of abortion for minors that can be only ordered by a judicial decision after adequate medical consultancy). See also 421.

87. Among sources, we should also mention contingibili and urgent orders issued by the Government or ministries. These orders are possible in the Italian legal system according to Article 32 paragraph 1 of the law instituting the NHS and to Article 117 paragraph 1 of Legislative Decree March 31 1998 n. 112.31 These orders that are essentially exceptional in nature have sometimes anticipated normative decisions such as the extension of healthcare benefits to immigrants temporarily present on the national territory (OM 15 November 1996; see 168). On other occasions, they have literally ‘suspended’ the legal order to fix a specific case.32 The ‘normative’ role of these ‘temporary’ ordinances can be both temporally and spa- tially limitless due to possible prorogation or renewal of them or due to reference to undeterminable external conditions (e.g., adequate experimental protocols as in the case of RU486). See 721.

88. Note that all these possible avenues of regulation harp the tune of different interplays between law and science, putting one or the other at the centre of the scene at various points in time. For instance, d.l. 17 February 1998 n. 23 expressly excluded drugs that have not reached phase 2 of experimentation transforming a sci- entiﬁc criterion into a law. See 64, 906.

§3. THE ROLE OF CODES OF PROFESSIONAL ETHICS

89. The professional Code of Ethics is a document that contains norms aimed at regulating the practice of a speciﬁc profession from an ethical and disciplinary perspective. Note that they are often referred to as deontological codes. It is worth highlighting that Jeremy Bentham ﬁrst introduced the modern notion of deontology in his post-mortem two volumes of 1834 Deontology or Science of Morality. Bentham did not deal expressly with medicine but rather discussed the neologism’s meaning in relation to a ‘discussion on duties’. Indeed, moral obligations for medical professionals can be traced to ancient times (e.g., the Hippocratic Oath or that

31. The latter establishes that ‘In the case of health emergencies or public health in local ordinances, urgent contingency measures shall be adopted by the mayor as a local representative of the community. In other cases, the adoption of emergency measures, including the establishment of centers and bodies, are left to the State or regions because of the size of the emergency and any involvement of more than one regional territories.’ 32. See the so-called Ordinanza Di Bella of 20 Nov. 1998 in which the Ministry of Health allowed the extraordinary administrative permitting the administration of the so-called multitrattamento di Bella for cancer in derogation to the rules on human experimentation of drugs or the OM 22 Nov. 2000 which excluded as a precaution blood donation from individuals who visited the UK between 1980 and 1996.

Medical Law – Suppl. 119 (2020) Italy – 53 90–92 General Introduction, Ch. 2, Medical Law Versus Health Law? contained in the Hammurabi’s Code or, much later, in the prayer of Moses Mai- monides). However, such commitments were voluntarily agreed to (ponder the formula of the Hippocratic Oath) and were not considered, in legal terms, as duties characterized by an imposing force upon the physician. Often Italian professional codes of ethics reflect this fact in the language used making it clear that the individual professional chooses to act in a specific way to the benefit of patients and is not acting in an obliged manner. Against this background, the medical profession – and soon after all other health-related professions – internalized the notion of deontology discussing it in reference to the codification of professional rules of ethics. Today, it is clear that within the provision of healthcare services, self-regulation of the profession (although not contracted for with the patient) has entered a bilateral dimension according to which duties take into account patients’ rights. This metamorphosis has certainly assisted a progressive overcoming of the paternalistic approach that characterized medical attitude in the past.

90. Since the last years of the twentieth century, Italy has experienced an extensive revision of existing codes of ethics in addition to newly enacted codes for almost all health-related professions. At the same time, the number of healthcare professions acknowledged by the legal system has increased to cover all professionals involved in the delivery of healthcare services. Yet, the idea of duties embedded in codes of ethics is not always present in this realm of self-regulation. For instance, the codes of ethics for nurses does not mention terms such as ‘duty’ or ‘duly’ or ‘must’ but rather regulates using terms such as ‘commit(ment)’ or ‘engage- (ment)’ (see, for example, Articles 1, 16, 18, 19, and 34).

91. Statutory provisions basically ignored codes of ethics until the Data Protec- tion Act (DPA) 1996 (Law no. 675/1996, today superseded by Legislative Decree 196/2003 to which we will refer, and to Regulation EU 2016/679, known as GDPR General Data Protection Regulation), implementing Directive 95/46/EC, made explicit reference to the importance of codes of ethics and professional practice in respect of the protection of personal data. The DPA and the GDPR request that the Data Protection Authority promotes deontology codes (among other things) for all healthcare-related professionals. Such codes, once approved according to the procedure provided for by law, are binding for all. Codes of ethics for healthcare professionals are mentioned as well by the two statutes governing nurses and nurses and other professionals that provide healthcare technical, rehabilitative or preventive services (Law 42/1999 and Law 251/2000 respectively) establishing that the scope of the profession is determined (also) with reference to its relevant Code of Ethics. Nevertheless, no law provides for speciﬁc procedures to produce and adopt the codes of ethics.

92. That being said, even if only the provision regarding nurses and obstetricians (Article 1 paragraph 1 of Law 251/2000) expressly refers to codes of ethics, to date codes of ethics have been drawn up for a total of twenty-six healthcare professions (including physicians).

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93. All codes follow their own model. Yet, and at the risk of oversimplifying, all contain a description of the professionals according to their role and particular skills. While restating professional autonomy, they also call upon their members to follow up-to-date and validated scientific knowledge. They all make reference to the duty of continuous education, however do so without mentioning the official system of Continuous Education in Medicine (CEM) established in 1992, a system that is compulsory for every healthcare professional and is managed by the Ministry of Health. See 238, 241 and especially 263–268. All codes take into account the issue of consent to treatment and related information. In all codes, confidentiality of information acquired is considered, and the duty of confidentiality goes beyond information on the health of patients or relatives. In some cases, certain codes suggest making clear to all healthcare actors that they are also bound by the duty of confidentiality (see 774ff and 826ff), and, as a practical matter, punishable according to Article 622 of the Criminal Code for violation of that duty. Quite often, codes also consider rules on discretion and privacy (most probably due to the statutory reference in the DPA mentioned earlier) and limit data processing to the essential needs of assuring the service.

94. Codes occasionally tackle the issue of anonymity. For instance, the deontological code for physicians expressly refers to the statutory duty to report speciﬁc data, such as venereal illnesses, AIDS and the prohibition to annotate on compulsory psychiatric treatments. The Code for Obstetricians recalls the right of a mother to remain anonymous at childbirth (contained in Article 700 Law 1238/1939 and subsequent amendments).

95. Most codes refer to abusive exercise of the profession (which is a crime according to Article 348 of the Criminal Code), sometimes forbidding the exercise of the profession while in collaboration with individuals abusively exercising the same.

96. It is worth noting (mostly in line with the code for physicians) that codes of ethics often deal specifically with vulnerable individuals, such as children or the elderly and handicapped persons. They are also concerned with specific instances that are disciplined by statutory provisions (such as artificial insemination, experimentation, abortion, healthcare advertising, etc.).

97. Note that statutory provisions and codes of ethics do not always exactly coexist. This can be particularly noted when it comes to anonymity, particularly in the context of medically assisted procreation, in that Law 40/2004 and the Code of Ethics of Physicians outline different rules when it comes to heterologous fecunda- tion and genetic testing in attempting to anticipate malformations and illnesses (see 1036ff). The law referred to forbid them altogether, whereas the Code is silent on the former and does not expressly forbid the latter. The result is that, for instance, a physician realizing heterologous fertilization would be sanctioned by the law but not exposed to disciplinary sanctions. This situation has been changed by the Con- stitutional Court with decision n. 162/2014 that declared the prohibition on heterologous fertilization imposed by Article 4(3) of Law no. 40/2004 to be

Medical Law – Suppl. 119 (2020) Italy – 55 98–102 General Introduction, Ch. 2, Medical Law Versus Health Law? constitutionally unlawful. Today, Article 44 prohibits ‘any practice of medically assisted procreation for ethnic or genetic selection purposes’.

98. Some codes deal with the duty to intervene in urgent matters like organ transplants even though the general principle (see infra 1040ff) is guided by donation.

99. Ethical matters are rarely addressed in a speciﬁc way although all codes of ethics – more or less explicitly – recall Article 32 of the Constitution and the respect for dignity, autonomy and freedom it guarantees along with human rights and non- discrimination. With regard to this latter issue, it is worth mentioning the approach of the code for nurses that requests members to provide ‘assistance in accordance with principles of fairness and justice, taking into account ethical, religious and cultural rights, and the gender and social status of the person’ (Article 4). Clearly, this is a positive approach that considers those elements not only in terms of potential discrimination but also in terms of cultural intricacies to be valorized while providing the service.

100. Only three codes of ethics expressly refer to moral objections. The Code for Obstetricians provides the possibility of abstention in abortion procedures if cases where there is no imminent risk to the mother’s life that cannot be tackled by a colleague. This Code was amended in 2014 introducing a provision (Article 3.16) that refers to conﬂicts between professional ethical principles and personal moral values. The Code for Dieticians discusses the issue in general terms suggesting that a suitable solution be found, one that respects dignity and autonomy in cases where there occurs a clash with the dietician’s own personal conscience. The Medical Code of Ethics refers to obiezione di coscienza (moral objections) on three occasions related to abortion, assisted fertilization and animal experiments. More generally, the Code also establishes that:

The physician from whom performances are required which are in conﬂict with her conscience or her clinical conviction may reject the work, unless this behaviour does not risk immediate and serious harm to the health of the patient and must provide every citizen with useful information and clariﬁcation [related to the rejection] (Art. 22).

101. The Italian Medical Code of Ethics indicates principles and norms that surgeons and the dentists have to follow while carrying out their professional activity. Only the codes of ethics for physicians and nurses deal with the issue of assisted suicide (i.e., the refusal of it), end of life treatments, and living wills. With reference to the latter, these codes are slightly different from the Oviedo Convention since they request some form of documentation evidencing the will of the patient.

102. For physicians, the COE (see Arts 32, 33, 35, 37) establishes clear principles to be followed. The physician should follow, as part of the autonomy and independence of the profession, the freely expressed will of the person to heal and

56 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 2, Medical Law Versus Health Law? 103–103 must act in accordance with the dignity, liberty and autonomy of the patient. The physician, in consideration of the age of the patient and in understanding the maturity of the individual, has the obligation to give adequate information to the child and to take account of her will. In the event of irreconcilable differences with respect to the demands of the legal representative, the physician must report the case to the relevant judicial authority; a similar course of action must be taken in relation to adult patients. In cases where the patient is unable to express their will, the physician must take into account any choices/preferences previously expressed by the patient in an assertive and documented way. For nurses, Article 37 states that ‘The nurse, when the assisted person is unable to express her will, must take into account what the patient clearly expressed and documented previously.’

103. The last issue to be dealt with is disciplinary sanctions. They are mentioned in all codes and are a consequence of any violations. Nevertheless, codes only make generic references to legal sanctions and only seldom refer to the legislative rules provided for by Article 40 of Law 221/1950: warning, censure, suspension (up to six months), and cancellation from the albo (the Register). In addition, Law 221/1950 offers clear criteria only in relation to the cancellation sanction which, according to Article 41, can be employed ‘against any member who by her conduct has seriously affected the reputation and dignity of the class of professionals’. See for medical doctors 399–406.

Medical Law – Suppl. 119 (2020) Italy – 57 104–106

Chapter 3. The Healthcare System

104. ‘An equitable health system is a core social institution, no less than a fair court system or democratic political system. Because of its importance, a health system is reinforced and protected by the right to the highest attainable standard of health and other human rights.’33 This description reﬂects very well our understanding of the role of the national healthcare system in modern society.

105. Today the Italian National Healthcare System (NHS)/Servizio Sanitario Nazionale (SSN) is a national system albeit regionally based. It provides universal coverage mostly free of charge at the point of service. National, regional and local levels all share responsibilities and duties. While the national level ensures the pursuit of general objectives and fundamental principles, it also guarantees uniformity in the delivery of its services. The Regions, by way of their healthcare departments, are charged with delivering the benefits packages established in line with maintaining an essential level of service (so-called livelli essenziali di prestazione – LEPs). Citizens actually receive their benefits through public and private accredited hospitals and a network of population-based health management organizations (azienda sanitaria locale, the ASLs). Patients are free to move and receive services by ASL or hospitals outside their area of residence. This is actually quite common as patients pursue high-level and/or faster care giving rise to significant cross-regional patient flows.

106. Rather recent constitutional reforms devolve from the State to the Regions competence to compile the lists of NHS benefits, that is, those benefits that may or may not be uniformly provided across the national territory (these lists are called the Essential Levels of Benefits – LEP – previously referred to as LEA; see 163 infra). The LEPs enumerate both the services that all Regions must provide uniformly and those services excluded from their mandate. Exclusion is decided on according to criteria such as proven clinical ineffectiveness and includes cosmetic surgery except for malformation and injury, ritual circumcision, non-conventional medicine, medical examinations and vaccinations for employment and vacation purposes. Regions can – and actually often do – provide to their residents a larger basket of services than that agreed and outlined in the LEP lists. The LEPs also list diagnostic and therapeutic ambulatory services provided on a case-by-case basis were appropriate for the clinical condition (e.g., bone density testing). Finally, LEPs enumerate potentially inappropriate hospital admissions, classified in terms of diagnosis-related groups (DRGs). Regions should substitute those inappropriate hospitalizations with treatment at other levels of the healthcare delivery system (e.g., day-hospital surgeries and ambulatory care). The National Pharmaceutical Formulary is another list provided by the NHS that enumerates the drugs that will or will not be reimbursed by the NHS.

33. G. Backman, P. Hunt, R. Khosla, C. Jaramillo-Strouss, B.M Fikre, C. Rumble, D. Pevalin, D.A. Páez, M.A. Pineda, A. Frisancho, D. Tarco, M. Motlagh, D. Farcasanu, C. Vladescu, Health Systems and the Right to Health: An Assessment of 194 Countries, 372, 2082 (13 Dec. 2008).

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107. Although this brief description sketches the actual system, the NHS is marked by its historical normative evolution that also deserves some attention here.

§1. HISTORY AND EVOLUTION OF THE ITALIAN HEALTHCARE SYSTEM

108. The overall organization of the healthcare system revolves around the Con- stitution and the principles embedded therein. The Constitution, combining Articles 32 and 38,34 does not limit itself to protect health as such, but also forces all levels of government to provide the necessary welfare guarantees. Yet, the key principle remains that contained in Article 32.35 This legal framework comprehends the balance and connection between healthcare protection and social security. In reference to this, see supra 30–58.

109. The universal NHS was introduced by Law no. 833 of 23 December of 1978. It replaced nearly 100 health insurance funds. This statute was preceded by other legal rules and mechanisms related to health that tried to build, over several decades, a uniﬁed and uniform healthcare system across the country. Historically, we could identify three main regulatory periods: (a) from Italian uniﬁcation to the end of WWII, (b) from the enactment of the Constitution of the Republic to the institution of the NHS in 1978, and (c) from 1978 to date.

I. From Uniﬁcation to WWII

110. After Italian unification, the so-called Rattazzi Law (of 3 August 1862, no. 753) introduced the first hypothesis of a coordinated framework to the numerous ‘solidarity’ institutions (hospitals, foundations, charitable institutions, etc.), which until then had guaranteed healthcare and social needs in favour of the most needy of the population (mostly by way of centres sponsored by the Catholic Church). The first draft of an ‘organic’ legislative process on health occurred with the approval of the Law of 20 March 1865, no. 2248, Annex C. In this statute, health concerns continued to be mainly considered as public safety issues. Special jurisdiction was left to the Department of Interior. It would exercise its control on healthcare by func- tionaries (prefects, police commissioners) who had no specific training for tackling health and healthcare problems.

34. Article 38: ‘Every citizen unable to work and without the necessary means of subsistence is entitled to welfare support. Workers have the right to be assured adequate means for their needs and necessities in the case of accidents, illness, disability, old age and involuntary unemployment. Disabled and handicapped persons are entitled to receive education and vocational training. Responsibilities under this article are entrusted to entities and institutions established by or supported by the State. Private-sector assistance may be freely provided.’ 35. Article 32: ‘The Republic safeguards health as a fundamental right of the individual and as a collective interest, and guarantees free medical care to the indigent. No one may be obliged to undergo any health treatment except under the provisions of the law. The law may not under any circumstances violate the limits imposed by respect for the human person.’

Medical Law – Suppl. 119 (2020) Italy – 59 111–115 General Introduction, Ch. 3, The Healthcare System

111. After several failed reform attempts, the Law of 22 December 1888, no. 5849 – which remained effective until the end of World War II – offered a major reform of the system. It sketched the architecture of a new, more functional and less bureaucratic public health organization, better rooted in local realities and more in line with the needs expressed by the peripheral areas of the country. For example, the law provided for the establishment of a central health office and, at the periph- ery, provided for the establishment of provincial physicians and veterinarians (at provincial health offices). In line with the perception of health-related issues as public safety risks, both offices were closely associated with the Prefect, who locally represented the central government and retained decision-making authority.

112. Historically, another key legislation, the Crispi Law, adopted on 17 July 1890, no. 6972, can be recalled. This law, among other things, gave legal personality to the existing charitable institutions (‘Opere Pie’) rendering them public institutions of charity. Later, these institutions were known with the acronym IPAB (Istituzioni Pubbliche di Assistenza e Beneﬁcenza).

113. The Law of 26 June 1902, no. 271, and the subsequent Royal Decree (R.D.) 16 November 1902, no. 463, establishing the General Directorate of Public Health at the Department of Interior, took the ﬁrst step in separating the protection of health from mere public policy concerns. In the aftermath of these laws, several statutes reformed the then-existing healthcare system(s) and consolidated health laws in a single code (R.D. 30 December 1923, n. 2889). The new Consolidated Text of Health Laws (TULLSS – Testo Unico delle Leggi Sanitarie), which organically restructured Public Health in its essential organization, is still the main legal reference text for the existing health legislation. Indeed, later legislations focused on the organization and attributions of health administration.

II. From the Post WWII Era to 1978

114. At the end of WWII, D.L. 12 July 1945, no. 417, transferred the responsibility for the protection of public health from the Department of Interior to the High Commissioner for Hygiene and Public Health (ACIS – Alto Commissariato per l’Igiene e la Sanità Pubblica), under the direct control of the Council of Min- isters. The ACIS had the power to coordinate the technical supervision of healthcare organizations and entities dealing with the prevention of and ﬁghting against social illness. In addition, it had competence over the ‘Red Cross’, the Institute for ‘National Work for Maternity and the Protection of Children’ created through Law 10 December 1925, no. 2277, and on the Institute for Malaria ‘Ettore Marchiafava’ (that was suppressed in 1967).

115. However, the organizational and administrative autonomy of the health sector was only achieved by way of Law of 13 March 1958, no. 296 that, in abolishing

60 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 116–119

ACIS, established the Department of Health which gained all the competences previously belonging to the Department of Interior.36

116. Under the Constitution of the Republic, after WWII and the decline of the liberal conception of health, a concept of social security linking the individual right to health to the establishment of quasi-public and private institutions emerged leading to the delivery of healthcare services in connection with insurance mechanisms. In this changed legal and political approach towards health, during the sixties of the last century, the organization of healthcare reﬂected a corporative and insurance- based philosophy.

A. Department of Health

117. The political debate concerning the creation of the then Department of Healthcare (‘Ministero della Sanità’ that later became the Department of Health –‘Ministero della Salute’37) was mainly based on the competences that should be given to this new public office. It was ﬁnally instituted through Law 13 March 1958, no. 296. The prevalent opinion indicated that the Department would receive the attributions of other Departments in order to become a centre of permanent interest and activities related to health protection. It absorbed the competences of the ACIS and of all other administrations that worked with public health matters in order to provide the protection of public health.

118. Later, the Presidential Decrees nos. 249, 257 and 264 of 1961 established several institutions called to collaborate with the Department of Healthcare at cen- tral38 and local level.39

119. It was with D.L. 300/1999 that the Department of Healthcare proposed the establishment of one single Department charged with absorbing welfare matters

36. Such as the direct surveillance of the Ministry of Interior regarding ‘opere pie’, hospitals, institutions of assistance and charity. 37. The changing from ‘Ministero della Sanità’ to ‘Ministero della Salute’ occurred a cause of two different moments. D.Lgs. 300/1999 proposed the Constitution of one single Ministry, that should absorb the welfare matters through the union of health, labour and insurance areas (the so-called Ministero del Lavoro, della Salute e delle Politiche Sociali). D.L. of 12 Jun. 2001, n. 217, converted to Law 3 Aug. 2001, n. 317, changed this composition, giving to health an autonomous ﬁeld, and the then ‘Ministero della Sanità’ was denominated ‘Ministero della Salute’. 38. A technical-consultative organ, denominated ‘Consiglio Superiore di Sanità’ (High Council for Health), and a technical-scientiﬁc organ, denominated ‘Istituto Superiore di Sanità’ (High Institute for Health). 39. At a peripheral level, there were the offices of the so-called Medici Provinciali (provincial physicians) and Veterinari Provinciali (Provincial Veterinary), the offices of municipal health workers (sanitari comunali) and of municipal consortium (consorzi comunali), the offices of maritime, aerial and frontier health, and a technical-consultative organ denominated Consiglio provinciale di sanità (Provincial Health Council) chaired by the Prefect that remained, until the entrance into force of regional order, the peripheral organ of the Ministry of Health, in a provincial scale.

Medical Law – Suppl. 119 (2020) Italy – 61 120–122 General Introduction, Ch. 3, The Healthcare System through the union of competences on health, labour and welfare (the so-called Min- istero del Lavoro, della Salute e delle Politiche Sociali). D.L. of 12 June 2001, no. 217, amended and renamed Law 3 August 2001, no. 317, changed this composition again converting health to an autonomous ﬁeld and denominating the then ‘Minis- tero della Sanità’as‘Ministero della Salute’. These changes ﬁnally shifted the core concerns from public policy-oriented healthcare to the protection of individual health as a right and social concern.

120. After several reforms and counter-reforms, the Department of Health (reinstituted by Law no. 172, from 13 November 2009) is today the central organ of the NHS. It exercises, according to Law 317 of 2001, ‘the State functions regarding the protection of human health, the coordination of the national health system, veterinary health in the workplace, hygiene and food safety’. The Department operates within the institutional framework established by the 2001 reform of the Constitu- tion, particularly Article 117, which gave the power to legislate to the State and the Regions and further granted regulatory powers to the Regions in matters of health protection and other related areas such as health protection, safety at work, food and scientiﬁc research.

B. The Mutual System

121. Well before the Healthcare Reform of 1978, the healthcare service was organized in a so-called mutual system; a mandatory insurance system that covered illness risks and was based on the solidarity of the employees and on the financial profit sharing of the employers. In light of their contributions, employees acquired the right to healthcare and to economic compensation in case of illness. This combination of work performance, contribution and healthcare excluded those individuals deprived of a regular labour relation. The only option they were left with was private insurance or, in the case of a definite certified level of poverty, treatment by charitable institutions or access to a basket of free healthcare services in favour of those registered in the so-called list of needy people (‘elenco dei poveri’). In a steady increase, after WWII, several welfare and healthcare assistance institutions were established covering a majority of private/public workers and professionals. This way a large list of medical-welfare institutions or entities was created, almost one to each protected category of workers leading to unequal delivery of healthcare and welfare services, varied bureaucracy, and overall increased management costs.

122. The mutual system allowed a good healthcare delivery during its period, especially in those Regions where there were a larger number of contributors. How- ever, one of its strong limits was the inability to answer to the constitutional principle embedded in Article 32 that refers to ‘equal and uniform’ protection of health. In fact, depending on the mutual system or on the geographical location (areas with larger numbers of contributors), disparities could even be seen within individual mutual systems.

62 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 123–125

123. Against this bedrock, during the seventies of the last century, the mutual system was dismantled piece by piece. The first reform came by way of reforming the organization of hospitals (Law 132/1968 transforming the ‘opere pie’ and the hospital establishments into points of service delivery characterized by their own economic independence) and followed by Law 29 June 1977, no. 349 establishing the decentralization of administrative and healthcare services defined by the Regions. This latter statute established the smaller administrations called ‘Strutture Amministrative Unificate di Base’ (S.A.U.B.) which were subsequently transformed into Local Health Units (‘Unità Sanitarie Locali’ – U.S.L.) by the Health Care Reform of 1978 (Law 23 December 1978, no. 833) and much later into the ‘aziende sanitarie locali’ (ASLs; see 63).

III. From the Institution of the NHS to Date

124. The healthcare reform of 1978 represents a milestone change substituting the mutual system with a National Health System (NHS). This is considered an important social conquest since it came to cover the deﬁcit left by the mutual system concerning the quality of the service and disparities in treatment when it came to the needy. In this sense, Law 833/1978 foresaw a deep renewal with the passage from the mutual-hospital system – based on a multiplicity of bodies and institutions – to a single national healthcare system in the name of larger homogeneity, equity and efficiency. Before this statute, institutions dealing with health and healthcare were not only different in their nature (public or private) but also in their territorial location and ability to offer treatments. They differed in their organization, aims and management. Each category of citizens (artisans, traders, professionals, civil servants, etc.) paid to the respective mutual institutions a different amount of money and received different baskets of services both in terms of quality and quantity. In the same years, profound changes were occurring in relation to the traditional medical setting and its socio-legal perception. During the 1970s, debates (and later reforms) revolved around patient autonomy and the importance of the informed consent process in selecting the treatment on the one hand, and on the other, treatment standards concerning mental patients (see infra 926ff), a debate that essentially paved the way to the Healthcare Reform. The constitutional principles that guided the reform can be found in Articles 3,40 32 (see supra 36) and 38 of the Con- stitution, indicating universality, uniqueness, equality and uniformity as general principles for healthcare delivery.

125. The idea of universality is based on the insurance-welfare coverage for citizens, regardless of their legal and social status. Uniqueness is represented by the normative indication that the system should be concentrated in a single institutional

40. Article 3 ‘All citizens have equal social dignity and are equal before the law, without distinction of sex, race, language, religion, political opinion, personal and social conditions. It is the duty of the Republic to remove those obstacles of an economic or social nature which constrain the freedom and equality of citizens, thereby impeding the full development of the human person and the effective participation of all workers in the political, economic and social organization of the country.’

Medical Law – Suppl. 119 (2020) Italy – 63 126–129 General Introduction, Ch. 3, The Healthcare System body – the NHS with its territorial articulations – and the management of healthcare services. The reform aimed at substantial equality understood as attributing to each person the subjective public right to take advantage of public health actions, without any sort of distinction across the country. It is clear that attention was given to the NHS of the United Kingdom; a model based on a national system of public structures with the duty to deliver prevention, treatment and rehabilitation services, collectively ﬁnanced either through contribution or through general taxation. In this sense, the implementation of the NHS in Italy represents a turning point towards a public healthcare system that indicated a public backbone in relation to the delivery of its services. In this way, private offer was abandoned as a primary tool. This state of affairs was destined to change in the nineties.

126. With the introduction of the NHS, the legislator recognized a normative nature – not just simply a programmatic one – in relation to the provisions of Article 32 of the Constitution. Accordingly, it introduced a healthcare system grounded on Article 32 as opposed to the welfare character grounded in Article 38 of the Con- stitution. The reform aimed to substitute the mutual system, pointing to the citizen – not to the worker – as the holder of the right to health. Indeed, in spite of previous efforts to create an autonomous health administration, the High Commissioner for Hygiene and Public Health endured the fragmentation of the decisional powers based on a rigid division between the protection of collective interests (public hygiene and health) and the protection provided to individuals exercised through welfare and hospital entities (health and hospital assistance).

127. Today, the overall structure of the NHS can be viewed as a multilevel one. At the ﬁrst and central level is the State. The ‘intermediate’ level coincides with the Regions, and the ‘local’ one refers to local territorial entities such as cities and provinces (Comuni e Provincie). Each of them plays an important role that has changed over time.

128. The State, according to Articles 3, 4, 5 and 6 (of Law 833/1978) deﬁnes the collective interest sphere, the general directions of the system and establishes, with the participation of the Regions, the goals of the National Health Plan (‘Piano Sanitario Nazionale’ – NHP). It co-determines the minimal basket of services to be assured to all citizens; it establishes the rules to guarantee uniform health conditions for the national territory and the correspondent criminal sanctions. It is up to the State to coordinate the regional administrative activities, to fulﬁl administrative functions of general character and to draw up the National Health Plan.

129. Increasingly, the Regions represent the key actors in healthcare. Their tasks originally focused on bridging the central State directives and local institutions called upon to apply them. Regions legislate (according to Articles 7, 10 and 11) on assistance and hospital care, respecting the fundamental principles established by State laws. They administer powers entrusted by national and regional laws and transpose, adapting to the speciﬁc reality, the indications of the NHP (National Healthcare Plan), by way of Regional Healthcare Plans that are drawn up every three years by way of broad democratic participation of territorial administrations

64 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 130–133 and universities, of representative of social organizations and health operators present in the Region including military health institutions operating in parallel.

130. Regions are the actual arbiters of the territorial articulation and management of the healthcare system in their territory. They regulate the local points of delivery (articulation, organization, management, operation and accounting) and establish the criteria for the allocation of their healthcare budget (‘fondo sanitario regionale’) among the various territorial articulations.

131. Originally, Articles 12 and 13 of Law 833/1978 provided a role for local territorial articulations even in the control and management of healthcare local units. After law 56/2014, the provinces are particularly charged with responsibility for environmental and preventative measures in their territories, municipalities maintain their role in administrative functions, and Mayors remain the local healthcare authority for public safety and eventually declare emergency orders and measures. See supra 87.

132. The end of the mutual system and the creation of the NHS required a new structure in the financing of the system. Accordingly, the National Health Fund (‘Fondo Sanitario Nazionale’) was set up. It was financed through the allocation of an annually defined sum in the State’s budget, by individual contributions to mandatory insurance, by proceeds originating from the divided assets after the break-up of the mutual system, and by the amount that regions, provinces and municipalities assign to social-health assistance. The Fund, financially defined in this way, was distributed among all the Regions that in turn are charged with establishing regional health funds. Following constitutional reforms in the 2000s, the National Health Fund was abolished (see infra also 176, 184).

133. Several factors instigated deep reform of the system in the 1990s. The necessity of cost containment and the importance of enhancing the qualitative level of healthcare services in addition to rebalancing the differences inherited from the mutual system constitute the inspiring aims of Legislative Decree of 30 December 1992, no. 502, modified by Legislative Decree of 7 December 1993, no. 517, regarding the rationalization and review of the healthcare system. This reform fostered the ‘regionalization’ of healthcare; changed the USL’s legal status transforming them into public companies (ASL – Aziende Sanitarie Locale) with public legal personality and with entrepreneurial autonomy; gave a similar status and entrepreneurial autonomy to large hospitals (‘aziende ospedaliere autonome’, AO); reformed the financing system; modified the organization of services delivery introducing competitive elements between private and public structures through the accreditation system (‘accreditamento’). In countries where it is historically adopted, accreditation is an evaluation mechanism concerning hospitals or healthcare institutions that apply for it, usually done for specific terms by independent and anonymous societies. This is the scenario present, for instance, in the United States, Australia and Canada.

Medical Law – Suppl. 119 (2020) Italy – 65 134–136 General Introduction, Ch. 3, The Healthcare System

134. In Italy, accreditation is an activity that promotes and verifies the level of excellence in consideration not only of the minimum requirements stipulated in national laws but also in consideration of the services provided. The accreditation process of private structures, characterized by a sense of finality, should allow the patient free access while protecting her right to choose based on a certification of the institution’s quality. The entire accreditation system and its specific modalities of accomplishment is a competence of the regions; the central level is responsible for delineating the general guidelines aimed at achieving a uniform behaviour in the national territory in order to avoid divergences in quality standards. The Italian Con- stitutional Court, with the decision no. 416/1995, defines accreditation as an ‘operation through which an authority recognizes a subject’s or body’s possession of the prescribed, specific requirements (qualification standards) resulting in their inscription in a list, from which other parties (end-users of healthcare assistance or other players) can draw from’.

135. The reform overall aimed to expand citizens’ freedom of choice concerning both physicians and place of treatment. Nevertheless, this reform left several legal issues to be tackled, including closer regional control over funding and better coordination of the regional models of healthcare.

136. While the mentioned reforms in the early 1990s aimed at gaining more efficiency and containing healthcare spending, the late 1990s reforms (Law of 30 November 1998, no. 419 and the Legislative Decree 229/1999) and the 2012 reform (DL 13 September 2012 as modified by Law 189/2012, so-called Balduzzi Law), focused on the reorganization of the NHS, further emphasizing its role as an instrument guaranteeing effective health provision. These last-mentioned reforms indeed affected the area of healthcare but were stifled by the reforms instigated by Law 15 March 1997, no. 59 (known as ‘riforma Bassanini’), reforms that specifically touched upon the public administrations including the administration of healthcare. They moved along the lines drafted in the original 1978 (a universal National healthcare system) and 1992 legislation (devolving to the Regions a larger normative, financial and organizational role along with the corporatization of local healthcare delivery units) aiming to better integrate all levels of governance and the delivery of services reinforcing the role and autonomy of the Regions. This wave of reform was completed by Legislative Decree 18 February 2000, no. 56, concerning the fiscal federalism that created a sort of continuity regarding the decentralization programme also on a fiscal base, through the attribution to the Regions of financing and spending. The 2012 so-called Law Balduzzi (DL 13 September 2012 as modified by law 189/2012) has revised certain sections of Law 502/1992 (has ordered the introduction of the letter a) Article 8, paragraph 1, the introduction of bbis)to b-f) Article 8, paragraph 1, the repeal of the letter e) of Article 8, paragraph 1, the repeal of the letter f) of Article 8, paragraph 1, the introduction of the letter fbis) Article 8, paragraph 1 and the amendment of Article 8, paragraph 1, letter h) and the introduction of the letters a-h) and hter) Article 8, paragraph 1 and the amendment of Article 8, paragraph 1, letter i), the introduction of the letter mter) Article 8, paragraph 1). Afterwards, D. Lgs. n. 171/2016 has ruled the nomination system

66 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 137–140 for the General Managers for healthcare institutions belonging to the NHS providing for general rules and criteria to establish a national list of potential nominees.

§2. THE ACTUAL ORGANIZATION OF THE HEALTHCARE SYSTEM AND ITS PLANNING

137. One way of describing the actual status of the NHS is through the underlining idea of its multilevel planning. Theoretically, planning is the main organizational tool for the Italian healthcare system to fulﬁl its goals in line with the Constitution and the statutory framework. Accordingly, planning has been a complex shared competence between the central and regional levels since 1978. Through the years and with the decentralization process that ensued the 1990s, the regional role has been steadily increasing effectively transforming the Italian model into a decentralized and market-oriented system according to which regional planning has become even more central.

138. However, since the beginning of the NHS, unfortunately, one of the main concerns of planning has been cost containment and cost-cutting to be considered at every level.

139. National planning is hence increasingly taking on a role of stewardship, a term not yet accurately translated into Italian but meaning a new model of governance, promoted in Tallinn by WHO and adopted by other European countries, in which meetings and inter-institutional collaborations are privileged, and eventually include the interest-holders, for the development of shared goals and strategies, with levels of responsibility consistent with decision-making powers, promoting autonomy, and respecting the principle of subsidiarity. The authority that derives from a rigid hierarchical approach at the various levels of the system is replaced by an authoritativeness that comes from an organic and structured knowledge of data and of the information needed to deﬁne the policies and tools and conditions for their practical implementation, and their evaluation for the detection of possible improvements. The various levels of government, becoming nodes in a network in a polycentric system in both the vertical and horizontal senses, also take actions of stewardship in relation to the other subjects involved. The identiﬁcation of the different players with the agreed objectives leads to a greater responsibility on themselves to improve the effectiveness and efficiency of the system.

140. Constant and timely monitoring, implemented at national level through the use also of the new healthcare information system, of processes, of achievement of objectives and of trends in economic performance, allows the feedback required for the development and implementation of necessary corrective actions so as to ensure effective delivery of the LEA in line with the observance of the constitutional right to health and economic objectives established.41

41. Ministero della Salute Direzione Generale del Sistema Informativo e Statistico Sanitario, Report on the Health Status of Country, 2011, 23 (2012).

Medical Law – Suppl. 119 (2020) Italy – 67 141–146 General Introduction, Ch. 3, The Healthcare System

141. Bearing these premises in mind, we can further describe the Italian multilevel healthcare system.

I. The National Level

142. The National Health Plan should define objectives, targets and activities along the lines of the proposals set out by the regional health departments. The National Health Plan (NHP) sets out general and specific targets to be reached by Regions (that are then specified in the Regional Health Plans), and it also defines the basic benefit package guaranteed to every citizen (the essential levels of benefits – LEPs formerly called LEA – according to the new Article 117 lett. m) of the Con- stitution). As anticipated, the National Health Plan for 1998–2000 set the normative principles called to drive the decision-making process for setting the LEPs: human dignity; need; burden of disease and equity; effectiveness, appropriateness and economic efficiency. See 35, 42, 57f.

143. Even with the current, deeply ‘federal’ healthcare system, the national Min- istry of Health maintains ample responsibilities for supporting, monitoring and assessing the implementation of the NHP. The structure of the system is somehow circular. Regions predispose proposals according to the needs of their population (assessed in cooperation with ASLs and AOs). Those proposals are taken into account at the national level to establish general objectives and deﬁne targets to be reached by Regions whose performance is then monitored centrally.

144. In addition, whenever the NHP promotes speciﬁc priorities, it is the Min- istry of Health who is called upon to adequately fund them with earmarked resources. The overall activity is agreed upon at the Standing Conference on Rela- tions between the State, the Regions and the Autonomous Provinces.

145. Since the late 1990s, the tendency has been to progressively reduce the role of the national level in governing healthcare at a micro level while reinforcing its coordinating and regulating powers. Regional accountability for management and expenditure has been increased by clear distinctions in relation to responsibilities and speciﬁcally on who is called to provide the basic beneﬁt basket (LEP) under a balanced budget (the Regions) and who is called on to oversee and remedy inequalities among the Regions (the State). See 183.

146. Accordingly, it is for the State to promote strategic planning, regulate competition among public and private providers, assess the quality of care, and promote cooperation across levels of care and healthcare companies.

68 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 147–153

II. The Regional Levels

147. The national political agenda on healthcare is to be accorded to the regional one. The above-described (supra 143) circular mechanism of collaboration is translated at the regional level into the Regional Health Plan in which general objectives and speciﬁc targets match with actual organizational directives and funding allocation. The Standing Conference on Relations between the State, the Regions and the Autonomous Provinces monitors the implementation of the regional healthcare plan. The aim is to guarantee effective coherence between regional health plans and their execution and the National Healthcare Plan with its need to ensure that national healthcare targets are achieved and differences among Regions in providing healthcare are progressively levelled.

148. What is referred to supra (see 147) holds true even if the federalization pressure of the last years entailed the risks of increasing interregional differences in both the quantity and quality of healthcare services.

149. It is also a task of the Regions to draw the boundaries of local healthcare units (ASLs and health districts) and to oversee them.

150. Reforms in the early 1990s attempted to mimic the English way towards a larger market orientation of the system. In this attempt, Regions gained a larger role in managing and regulating the internal market by appointing the General Manag- ers of both ASLs and AOs and controlling their overall activity since it is the Region which redistributes to local healthcare units public healthcare funds obtained from the weighted capitation budget provided by the State. See 63, 214f.

III. The Local Structure

151. The ASLs and AOs are called to maintain a balance between resources allocated by Regions (or elsewhere) and their actual expenses for services. Theoreti- cally, they have signiﬁcant managerial autonomy, which is formally translated in the Atto di indirizzo (Programme of Governance see 63 supra). In a competitive market system, however, they somehow assume both purchase and supply functions. See 193–788.

152. At the point of delivery, patients have a free choice over their preferred providers, although ASLs continue to directly provide most hospital care by their directly controlled structures. See also 650–655, 939, 964.

§3. ELIGIBILITY,COVERED BENEFITS AND ACTUAL ACCESS

153. The National Health Plan for 1998–2000 set the main categories of care that the NHS must provide to all: ‘public health services in working and living environments’, ‘community healthcare’ and ‘hospital healthcare’. The former, which is

Medical Law – Suppl. 119 (2020) Italy – 69 154–157 General Introduction, Ch. 3, The Healthcare System basically provided at the district level, is chieﬂy related to disease prevention (including vaccinations), occupational health, veterinary medicine and food hygiene (including controls on food processing plants, and shop and restaurant inspections) and environmental pollution. In the category of hospital healthcare falls acute patient care (both emergency and scheduled) and post-acute patient care (including rehabilitation and long-term care).

154. Last but not least, community healthcare includes a very large array of services mainly managed directly or indirectly by ASLs. It includes primary care by general practitioners and paediatricians (including referrals for specialist ambulatory services, diagnostic procedures and hospital treatment), the corresponding specialist visits, diagnostic procedures and therapeutic treatments, pharmaceutical delivery, home care, residential and semi-residential care (including psychiatric care, rehabilitation, hydrothermal treatments, prostheses and drug addiction care).

155. Eligibility for these services is non-discriminatory according to the grounds of discrimination identified by the International Covenant on Economic, Social and Cultural Rights (Article 2 (2)) and the Convention on the Rights of the Child (Article 2 (1)).42 Consequently, all citizens and regular immigrant residents are equally entitled to access the healthcare system for primary care, ambulatory care, hospital care, rehabilitation and emergency care. Also included are asylum-seekers (temporarily inscribed) and those who have obtained a status that confers access according to citizens’ rights. Prisoners equally enjoy the whole package of benefits as long as they are in prison as do military personnel and their families, although military personnel can use military hospitals and facilities directly financed by the Ministry of Defence. See infra 168.

156. The EU citizens have equal access as citizens and were required to pay co-payments. Today, however, Directive 2011/24/EU determines the applicable regime in more detail.

157. The status of illegal immigrants is rather complicated. They can access the healthcare system as foreigners temporarily present (Stranieri temporaneamente presenti – STP). The STPs only have access to emergency care, maternal and child healthcare, healthcare for people under 18 years of age, vaccinations and international preventive treatments, prophylactic services, diagnosis and care for infectious diseases, as well as ambulatory and hospital care. Law expressly defines preventive, necessary and urgent treatments in defining the LEA. From the basket of benefits for STPs, the interplay between individual rights and health as a collective interest is again self-evident and clearly sustains the individual rights as long as they are functional in relation to the collective interest and international commitments.

42. Race, colour, sex, language, religion, political or other opinion, national or social origin, property, disability, birth or other status. According to the Committee on Economic, Social and Cultural Rights, ‘other status’ may include health status (e.g., HIV/AIDS) or sexual orientation.

70 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 158–161

158. In Italy, under Article 34 of the National Migration Act of 1998, foreigners have the obligation to register with the National Healthcare Service. Once lawfully registered, they are granted equal treatment and have the same rights and duties as any Italian citizen. Therefore, their children are entitled from birth to the same treatment conferred on any minor of Italian nationality. The same assistance is also granted to dependent minors living in Italy, regardless of legal status. Bilateral treaties normally regulate the delivery of healthcare services for non-EU citizens.

159. The boundaries of eligibility are somehow in evolution also due to judicial intervention. For instance, the Regional Administrative Court of Venice declared as illegitimate the denial of a residence permit – because of her irregular status and a previous expulsion – to a Nigerian woman suffering from chronic renal insuffi- ciency while she was undergoing regular life-sustaining treatment (TAR Venezia 2008).

160. The issue of eligibility is strictly connected to actual access. Indeed, eligibility and actual access are the two sides of the same coin. Equitable access does not necessarily depend on education, income, migrant status, ethnicity or geographical distance, for example. Even eligible individuals might not enjoy equitable access (think of insufficient services in rural areas or the decreasing number of general practitioners in mountainous areas of the country), and the problem is difficult to spot because access itself is difficult to measure. This is one reason why every international body implementing conventions somehow related to health seek disaggre- gated data. It is also for this reason that several monitoring systems have been put in place.

161. Against this backdrop, however, actual use of the healthcare system can be affected by various factors including health and socioeconomic status, self- perceived needs, health beliefs, health-seeking behaviours, language barriers, cultural differences, trauma, stigma perception, and perception as a minority. With respect to these, and taking as an example migrants, the ‘Amsterdam Declaration towards Migrant-Friendly Hospitals in an ethno-culturally diverse Europe’ recognized the need to render healthcare more culturally responsive recognizing the ensuing challenges to healthcare practitioners. These concerns are more frequently considered in codes of ethics and by regional legislation as mentioned. Yet, it is not just a problem of immigration from non-EU countries. Within an increasingly mobile EU, concerns related to language or cultural barriers affect full and effective access to, and eligibility for, MS healthcare systems. This affects not only potential patients but also the system itself in its provision of services. Indeed, barriers to access can come from both the supply and the demand side of the healthcare market: doctors and nurses migrate as well within the EU in which there are 23 official languages, 60 regional languages and around 175 languages spoken by migrants.43

43. Euranet (2010) Préserver la diversité linguistique de l’union européenne (http://www.euranet.eu/fre /Dossiers/Dialogue-interculturel/Preserver-la-diversite-linguistique-de-l-Union-europeenne, accessed 1 Jun. 2011).

Medical Law – Suppl. 119 (2020) Italy – 71 162–165 General Introduction, Ch. 3, The Healthcare System

Finally, we can note that communication barriers can be linked, regardless of language, to skills not taught to healthcare providers (see infra 237).

162. Last but not least, effective access in Italy is still limited by the presence of long waiting lists. Despite regionals programmes aimed at prioritizing the delivery of care on the basis of clinical appropriateness of the services prescribed and severity of illness, it remains a problem emphasized by cross-regional and international patient mobility which is now tackled by Directive 2011/24/EU and Regulation (EC) no. 883/2004 or Council Regulation (EEC) no. 1408/71 of 14 June 1971.

I. Essential Levels of Assistance

163. In adherence with the previous analysis, the Constitution entrusts to the State the definition of essential levels of health services LEA (Essential Levels of Assistance) now called Livelli Essenziali di Prestazioni – LEP) while, according to the principle of subsidiarity, to the Regions the responsibility for their full implementation. Defining the ‘health-baskets’ of the Regions and the State, however, is done within the boundaries of financial constraints. The constitutional allocation of powers among the different levels of government has been enriched by way of the constitutional reform under the Law of 5 May 2009, no. 42 ‘Government Delega- tion on fiscal federalism, in implementation of Article 119 of the Constitution’44 which has paved the way for a ‘multi-level governance’ according to which the State is the guarantor of constitutional rights, while regional and local levels are both called upon to cooperate in the decision-making process and to ultimately implement the decisions.

II. Rationing Instruments

164. A structure of out-of-pocket expenses as co-payment (so-called tickets) for diagnostic procedures, drugs and specialist visits operates as a sort of rationing system. Similar aims animate the choice to not ﬁnance several over-the-counter drugs (OTC) or to require co-payments for most drugs. See 167, 172, 177, 186, 187. Gen- eral practitioners are involved in the rationing as well. See 200, 201, 327.

165. Another rationing instrument consists in the direct dispensation of drugs by hospitals and ASL. See 228.

44. See D.Lgs. no. 68, 6 May 2011 ‘Provisions on autonomy of income of the Regions and of the Prov- inces by ordinary statute, as well as the determination of costs and standard requirements in the health sector’; D.Lgs. no. 118, 23 Jun. 2011 ‘Provisions on harmonisation of accounting systems and ﬁnancial statements of the Regions, local entities and their agencies, under articles 1 and 2 of the law of May 5, 2009, no. 42’; D.Lgs. no. 149, 6 Sep. 2011 ‘Reward and sanction mechanisms related to Regions, Provinces and municipalities, under articles 2, 17 and 26 of the law of May 5, 2009, no. 42’.

72 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 166–171

166. Last but not least, the evolving structure of DRG-based payments to providers incentivize outpatients’ services if in line with the principles of effective treatment and appropriateness. See supra 35.

§4. THE FINANCING OF HEALTHCARE

167. Expenditures on healthcare have been increasing over time for several reasons, including an ageing Italian population and improvements in medical science and its corresponding costs. Over the years, the debate concerning health organization and ﬁnancing has often revolved around the dichotomies of ‘private’ and ‘public’ sources, ‘State taxes’ and ‘market forces’. The Italian system attempts to follow both prongs of these dichotomies although ﬁnancial constraints are steadily increasing the role of co-payments (so-called tickets) and private points of delivery.

168. Up until the establishment of the NHS in 1978, 7% of the population were not covered by the many insurance funds then existing. Upon reform, solidarity within categories was substituted by solidarity among citizens and generations sustaining free universal access. Since 1998, immigrants are covered as well. Although legal immigrants receive the same services as citizens, illegal immigrants have access to a more limited basket including urgent treatment (both speciality and in hospitals) following accidents or illnesses, treatment for minors and babies, and for pregnant women. Everyone has access to vaccination programmes and treatments for infectious diseases. See supra 155.

169. As in all countries, the definition of the financing sources and the definition of the basket of services offered are strictly interrelated. They have to take into account goals, which sometimes are contradictory, including solidarity, free access, economic efficiency, social justice and sustainability.

170. The shift to the NHS offered more horizontal equity than the mutual system by way of introducing the notion of a common package for everyone irrespective of sex, age, social or working condition or income. Every three years, the National Health Plan (NHP) and Regional Healthcare Plans in accordance with the LEP established at the Standing Conference on the Relations between the State, the Regions and the Autonomous Provinces receive the task of deﬁning the basic and the (regional) additional package of services received by residents. Governors of each Region and Autonomous Provinces are members of the Standing Conference.

171. Yet, the first NHP was produced only in 1994, and it was only in 2001 that the first list of Essential Levels of Assistance (LEA as they were called before the reform of Article 117 Cost.) was established defining the common basket for all residents in all Regions. The most recent update has been delivered by d.p.c.m. of 12 January 2017, n. 17 establishing the new list of Essential Levels of Assistance in force.

Medical Law – Suppl. 119 (2020) Italy – 73 172–176 General Introduction, Ch. 3, The Healthcare System

172. Due to near-universal coverage, voluntary health insurance (VHI) does not play a signiﬁcant role in funding healthcare in Italy, although recent reforms have urged a larger role for VHI. Those existing insurance policies are usually complementary ones devoted to cover co-payments, non-reimbursed services, per diem for private rooms in healthcare facilities and similar services.

173. Technically, since D. Lgs. n. 229/1999 (reforming Article 9 of Law 502/ 1992), it is possible to have supplementary funds of the NHS. These aim to enhance the delivery of treatments and services not included in the LEP. These supplementary funds can, according to Article 9 paragraph 4, pertain to:

(a) additional services not included in the basic levels and uniform support but that are in some way integrated with these and provided by professionals and accredited facilities; (b) the services provided by the NHS including uniform and essential levels of assistance – only comprising the amount charged to the assisted – including charges for access to the beneﬁts provided under the freelance intramural profession and for the use of accommodation services [servizi alberghieri]atthe request of the assisted referred to in Article 1, paragraph 15 of the Law of 23 December 1996, 662; (c) health and social services provided in residential and non-residential accredited facilities or in a housed form, for the amount charged to the resident.

The beneﬁts referred to in paragraph 4, let. a) (supra 173), include:

(a) the performance of non-conventional medicine, even that provided by non- accredited facilities; (b) thermal treatments, limited to beneﬁts paid by the National Health Service; (c) dental care, limited to beneﬁts paid by the National Health Service and in any case with the exclusion of programmes for the protection of dental health in childhood and care, and dental prosthetic to certain categories of subjects considered particularly vulnerable.

174. Supplementary insurance should allow a wider choice of (private) providers for patients.

175. Against this background description, the funding of the system(s) can be better understood following its historical evolution.

I. Historical Evolution and …

176. The ﬁnancing approach during the regime of the mutual system was understood as a means of funding social security (‘previdenza sociale’) by way of mandatory insurance against the risks of illness. Hence, the mutual system offered to the insured both (a) economic assistance in case of illness or maternity and (b) healthcare services according to one’s own subscribed mutual fund. As mentioned, the

74 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 177–179 main limits of this system were the binding connection between work and access to health protection and an unequal access among the different kinds and levels of workers and their labour institutions. During the shift from the mutual system to the national NHS, several statutes45 paved the way to Law no. 833/78, which entrusted the ﬁnancing regulation, according to Article 51, to the National Health Fund. The NHS was concretely realized through centralizing funds from the State, from the public tax system, and from resources assigned to social-health assistance by regions, provinces and municipalities and merging them into the same budget. The overall budget was then allocated among the Regions and, from those, distributed to the local healthcare units by way of establishing regional healthcare funds. See also 132, 184.

177. In short, between 1978 and the reforms of the late 1990s, the main sources of financing were (1) social insurance contributions paid for by public/private employers and self-employed people with a regressive structure and different rates among them; (2) co-payments paid to the local healthcare units by users of diagnostic procedures, specialist visits and drugs (the so-called ticket system); (3) contributions by special status Regions which fully financed their health systems (Sicily and Sardinia, for example, were only partially financed).

178. Indeed, the result of this decentralization process was open to criticism based on a lack of financial responsibilities by regional and local governments while they retained rights to autonomously decide expenditure levels. This mismatch caused frequent and marked deviations from the agreed allocated budgets resulting in financial deficits that had to be covered ex-post by the central government, without imposing any credible sanction on the overspending actors. This situation brought about two main consequences. First, in contrast with the declared aim of the NHS, the already existing interregional disparities in the quality and efficiency of healthcare provision widened, especially between the more developed northern and the less developed southern regions. Second, public health expenditure went out of control.

II. … and the State of the Art

179. Subsequently, D.L. 18 February 2000, no. 56 establishing fiscal federalism, changed the financial model of the NHS. The determination of the quotas to be assigned to each Region of ordinary statute was to be conducted by the Treasury (Ministero del Tesoro) according to specific indications: the resident population, fiscal capacity, healthcare needs, and the geographical dimension of each Region

45. The laws that indicated the functional and administrative regional decentralism (l. 16 May 1970, n. 281) and the transfer of the administrative attributions related to healthcare and hospital assistance to the Regions (d.p.r. 14 Jan. 1972, n. 4). The following Decree n. 264, of 8 Jul. 1974, concerning the ‘Norme per l’estinzione dei debiti degli enti mutualistici nei confronti degli enti ospedalieri, il ﬁnanziamento della spesa ospedaliera e l’avvio della riforma sanitaria’.

Medical Law – Suppl. 119 (2020) Italy – 75 180–184 General Introduction, Ch. 3, The Healthcare System

(Article 7, paragraph 2). Where a Region defaults in relation to the established measures, the Government, following a proposal of the Department of Health, determines the progressive reduction of the equalization transfers and partnerships (‘trasferimenti perequativi e delle compartecipazioni’).

180. On 8 August 2001, Government and Regions signed the so-called stability pact (patto di stabilità), an agreement on healthcare matters incorporated and enforced by Law no. 405, of 16 November 2001. The stability pact improves the autonomy and responsibility of the Regions in a federal like direction emphasizing measures for the control of healthcare expenditure.

181. The architecture of the system was further restructured by Constitutional Law no. 3, of 18 October 2001 modifying nine articles and abrogating six of Title V, Part II of the Constitutional Chart redistributing central and peripheral powers essentially impacting competences in relation to healthcare. The result was that competences expanded for Regions and other non-State levels of administration. It reaffirmed that Regions and local entities maintained ﬁnancial autonomy and the need to fund their activities using their own resources. These reforms provided for the creation of an equalizing fund (‘fondo perequativo’) aimed at redistribution to territories with less ﬁscal capacity.

182. The State maintained its exclusive competence regarding the ‘determination of the basic level of beneﬁts relating to civil and social entitlements to be guaranteed throughout the national territory’ (LEP),46 and left to the Regions a legislative concurrent competence regarding the ‘protection of health’. See 137, 834.

183. Accordingly, the late 1990s/early 2000s reforms attempted to tackle the problems with an important breakthrough in ﬁnancial autonomy for the Regions reached via several instruments: (1) substituting social insurance contributions with a regional tax imposed on productive activities (Imposta Regionale sulla Attivatà Produttive, IRAP) applied to corporations, partnerships and self-employed workers as well as to salaries paid to the public sector; (2) introducing a regional tax calculated on top of the national personal income tax (which is the Imposta sui Redditi delle Persone Fisiche (IRPEF); (3) devoting a nationally ﬁxed percentage of petrol excise duty that can further be increased by a maximum amount by the Regions; (4) assigning responsibility for revenue generated by motor vehicle tax and other taxes to Regions.

184. The National Health Fund was formally abolished in 2000 (D.L. 56/2000 on ﬁscal federalism). As a consequence, regional funds are now derived from a portion of central personal income taxes (Imposta Personale sul Reddito, IRPEF) and regionally collected taxes on ﬁrms’ value added (Imposta Regionale sulle Attività Produttive, IRAP). See also 132, 176.

46. Article 117, m, Italian Constitution (available online at: http://www.senato.it/documenti/repository/ istituzione/costituzione_inglese.pdf).

76 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 185–190

185. A fiscal horizontal equalization mechanism (Fondo di Perequazione Nazio- nale, FPN), financed by a fixed proportion of the national VAT revenues, had to be developed to transfer funds to those Regions unable to raise sufficient resources to meet the healthcare needs of the population. Since then, there have been many changes in the allocation formulas to both Regional Health Authorities and ASL. The tendency has been to reconcile equity and efficiency objectives, by taking account of both population needs and fiscal capacity indicators.

186. The above-described system is paralleled by a structure of out-of-pocket expenses that revolves around co-payment for diagnostic procedures, drugs and specialist visits (the already mentioned ‘ticket’ system). Therefore, there remains the possibility (widely used) for users to purchase private healthcare services and over- the-counter drugs (OTC). Co-payments for most drugs are today considered by Regions as a measure to contain pharmaceutical expenditures.

187. The ‘ticket’ co-payment structure is difficult to explain. It has changed several times, moving from ﬂat co-payment of diagnostic procedures and drugs (e.g., 50% in 1991) to a maximum charge per prescription (where a prescription cannot apply to more than eight procedures related to the same medical ailment or to more than two different medications). Recent reforms have related the level of co-payment to levels of income. There are four ranges of family gross income that lead to different ﬁxed co-payments for those procedures/drugs which require a co-payment: from 0 to EUR 36,152, from EUR 36,153 to EUR 70,000, from EUR 70,001 to EUR 100,000, and above EUR 100,000. Regions decide the amount of co-payments provided under each category.

188. Exemptions from co-payments apply to users according to speciﬁc mixes of family income and age or for speciﬁc diseases. For instance, a co-payment (EUR 25) on non-urgent visits to all emergency departments does not apply to children under 6; users with chronic diseases listed in Article 8 d.p.c.m. 12/ 2017 or to those who are in special conditions needing medical devices (e.g., absorbent products for urinary incontinence, stoma bags, prostheses, wheelchairs and catheters). Income exemptions are continuously changed.47 These categories are exempt for visits, drugs, and medical devices that are essential in the treatment of those diseases or conditions. Note that medical devices listed in national formularies established by law under the above situations are free of charge upon specialist diagnosis and ASL approval for delivery.

189. Inpatient care and primary care are free at the point of use although over time several attempts to introduce co-payments (e.g., for a visit to general practitioners) have been rolled out.

190. A weighted capitation helps the Ministry of Health to propose the resources to be allocated to each Region. This capitated amount in principle should cover the

47. See http://www.salute.gov.it/portale/esenzioni/dettaglioContenutiEsenzioni.jsp?lingua=italiano&id= 1019&area=esenzioni&menu=vuoto.

Medical Law – Suppl. 119 (2020) Italy – 77 191–195 General Introduction, Ch. 3, The Healthcare System basket of LEPs. Once approved by the Standing Conference on the Relations between the State, the Regions and the Autonomous Provinces, the resources have to be distributed in the following three areas, within which Regions have autonomy of allocation:

(1) Public health services in working and living environments (5%). (2) Community healthcare (50%). (3) Hospital healthcare (45%).

191. Setting criteria in relation to the transfer of funds from Regions to ASLs remains a regional power. Nevertheless, most Regions make it per capitation, possibly reserving some extraordinary funds for special projects, while several others use additional criteria to change the historical spending mode of transfer to more performing results and to reduce progressively territorial quality and quantitative imbalances. Note, however, that Regions remain accountable for their own healthcare deﬁcits that should be covered eventually either by raising additional regional taxes or by increasing co-payments.

192. Finally, as anticipated, part of the national tax revenue constitutes a National Solidarity Fund to redistribute funds to Regions that are unable to raise sufficient resources.

III. Financing and Purchasing Services

193. There is an important interplay between funding and spending in the healthcare system. The main sector-speciﬁc regulation on the matter comes from Law 229/1999 which determines that the selection of both public and private providers on behalf of the NHS must be inspired by a comparative evaluation of quality and costs. This norm introduced competition in the system in an attempt to balance the solidarity principle and the improvement of quality with efficiency and cost containment concerns.

194. Inpatient and outpatient care providers are selected in a four-step procedure. First of all, municipalities, after agreement with the regional health-planning unit, have the power to authorize the establishment or the modiﬁcation of existing healthcare facilities. It is for the regional health departments to authorize delivering healthcare services by healthcare organizations which satisfy a minimum set of structural, technological and organizational requirements.

195. Regional authorities following national guidelines deﬁned by the National Commission are supposed to grant institutional accreditation for Accreditation and Quality of Care. Accreditation is conditional to regular assessment of the quality of the organizational, managerial and technological infrastructure of healthcare providers and of the skills and practices of health professionals. It is also conditional to the evaluation of the value added by each newly accredited provider, considering the existing regional health services and the beneﬁt package to be delivered. Often

78 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 196–200 regional departments set additional conditions such as formal acceptance of the ﬁnancing scheme, formal acceptance of the external system for auditing quality of care, adoption of ‘health service charts’, and acceptance of control based on clinical results.

196. All these steps are preliminary to any right to deliver healthcare services funded by the NHS. In fact, only contractual agreements with regional and local authorities on a comparative evaluation of quality and cost (value-for-money basis) can confer such a right (and only) to providers accredited by the NHS.

§5. INTEGRATING PUBLIC HEALTHCARE COVERAGE INSURANCE

197. Fiscal incentives and tax breaks to foster private-sector insurance have been established, but without great success. In this framework of universal coverage and with the possibility to opt out, it is of no surprise that voluntary health insurance is not significantly developed. Both mutual (non-profit) and for-profit insurances offer voluntary healthcare insurance. High-earning and highly educated people mainly buy policies. Demands vary from area to area of the country even though the northern part of Italy has a more developed demand. Mostly, medium- low income people purchase mutual insurance products. However, the reduced number of players on the market has experienced an even larger concentration of offer.

198. It can be said that the largest integration of public healthcare coverage comes in the form of the co-payments we mentioned earlier and might, although not technically, be called self-insurance. See 186ff.

§6. TERRITORIAL SERVICES AND HEALTHCARE PROTECTION

I. Delivery of Services (Persons)

199. The personnel of the healthcare system are paid in two different ways. Gen- eral practitioners and paediatricians engaged in the delivery of primary care, and preventive medicine are remunerated via the capitation method (multiplying the per capita for the number of patients enrolled in the physician’s list). Personnel delivering secondary care and working in hospitals and administration are paid a monthly salary.

200. General practitioners (GPs) and paediatricians (Ps) can also provide a for- fee service treating patients privately, provided that the time they devote to private treatment does not interfere with the regular provision of primary care services for NHS patients. The capitation payments are set down by a collective agreement negotiated every three years between their trade unions and the national government.

Medical Law – Suppl. 119 (2020) Italy – 79 201–202 General Introduction, Ch. 3, The Healthcare System

201. The salary of general practitioners and paediatricians can be increased where variables occur or where there is an additional per capita sum, which increases the fixed per capita amount. The variable part is linked to joint medical practice with additional payments for specific activities (e.g., minor surgery, preventive activities, therapies and post-surgery follow-up) and for services rendered exclusively for the NHS. The additional part is basically linked to cost containment as a proportion of the positive difference between expected and actual expenditures for pharmaceuticals, laboratory tests and the therapeutic treatments they prescribe (see supra). This last part of their income is agreed upon at regional level. It is important to note that after several attempts over the years to settle the interplay between primary care and emergency care (offered by first aid physicians), the Balduzzi reform modified Law 502/1992 and has structurally begun to tackle the issue. It introduced Article 8 lett. bbis pursuant to which the National Convention between general practitioners (including paediatrician) and the Regions must ensure that healthcare provisions cover:

the entire day and all days of the week, as well as an integrated offer of services provided freely by general practitioners, paediatricians of free choice, physicians of urgent care, physicians of medicina dei servizi, outpatient specialists, adopting single-profession organizational forms, functional territorial aggregations, which share, in a structured format, aims and care pathways, quality of care assessment tools, guidelines, audit and similar tools, as well as multidisciplinary organizational forms, so-called complex primary care units, which provide welfare beneﬁts through the coordination and integration of professionals in primary care and in social services of healthcare relevance taking into account the peculiarities of the territorial areas such as metropolitan areas, in sparsely populated areas and smaller islands.

Thus, the Regions shall regulate complex units of primary care with an emphasis on regional networks of health centres equipped with basic instruments, open to the public throughout the day, including the day before and the day of holidays with suitable shifts, working in coordination and in telematic connection with the hospitals. See also 322–325.

202. The radical reforms of the early 1990s have reorganized hospital physicians into two levels differentiated according to seniority and duties reducing hierarchical vertical relationships. First-level physicians (dirigente medico di primo livello) are newly employed physicians that provide support and cooperate in relation to clinical duties according to arrangements set by the physician in charge of the hospital unit. Second-level physicians (dirigente medico di secondo livello) assist in the selection of the most appropriate therapeutic, diagnostic and preventive treatments for patients and fulﬁl additional duties also in relation to management and organization in their hospital unit. In 1999, this structure was substituted with just one level of medical management (dirigenza medica) linking the salary to actual fulﬁlled tasks and responsibilities and reserving directive positions to those

80 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 203–205 physicians working exclusively for the NHS. At the same time, a system of incentives (progression in career) and disincentives (both economic and in career progression to top-level positions) has been put in place. In principle, physicians choosing to treat patients in private facilities, in addition to their role in the public system, cannot reach top management positions. Yet, in reality most hospitals were unable to offer sufficient room for physicians willing to provide services for fees in their spare time at public facilities (so-called intramoenia) and were ‘temporarily’ (since 1992 with variations over the years) authorized to do so at private facilities. Indeed, since 1992 all physicians are permitted to conduct private practice in public facilities paying a percentage of their extra income to their hospital. The so-called Balduzzi Law (Article 1 and Article 4 lett. m DL 13 September 2012 as modiﬁed by Law 189/2012) basically requires to force all physicians involved with the NHS that are willing to provide services for a fee beyond their scheduled office hours to either opt out from exclusivity or to perform only intramoenia at public healthcare facilities. The system was supposed to be fully operational by the end of 2014 but the implementation is running behind. See also 252.

203. In recent years, nurses have become integrated as healthcare professionals whose professionalism is fully acknowledged by the system. They are the only actors responsible for nursing care and perform, in full professional autonomy, activities for prevention, treatment and protection of individual and collective health according to speciﬁc statutory and deontological provisions (the most recent deontological code was delineated in 2019). Today, nurses must possess a bachelor university degree after studying for three years. For private practice, their formal inscription in a relevant register maintained by every province is required.

204. The position of nurse coordinator has become a highly specialization one. According to Law 17 February 2006, no. 43, the three-year university degree required for all nurses is insufficient for this post. Now, the Law demands a master’s in Management focusing on coordination of their ﬁeld of specialization and at least three years of actual experience in the same ﬁeld. Mostly, nurses work in hospitals.

205. While in the recent past the numbers of healthcare professionals has been increasing with the only exception of nurses, the actual trend forecast a diminution of medical doctors and a real shortage of some specialities and even of general practitioners in some areas of the countries (mainly mountainous and hilly ones). Short- age of physicians appeared also in hospitals and emergency rooms. Since 2017 several Regions have either recalled retired physicians or allowed trainees to work in hospitals as physicians in training to cover the shifts.

Medical Law – Suppl. 119 (2020) Italy – 81 206–211 General Introduction, Ch. 3, The Healthcare System

II. Delivery of Services (Structures)

A. Main Services and Organization

206. While general practitioners and paediatricians provide basic primary healthcare, it is the ASLs that provide a large range of services for health promotion and prevention activities, food safety, occupational diseases and accidents, and veterinary medicine (apparently Italy is the only country with veterinary services included in the NHS). In addition, ASLs cover specialist visits and diagnostic activities. These services can also be delivered by accredited private facilities following speciﬁc contractual agreements with ASLs (see 194 and 195). Access goes through a central booking number, but by way of a prescription by a general practitioner.

207. Hospitals have been reorganized in relation to the 1990 reforms distinguishing between public hospitals without company status (on the one hand university hospitals and highly specialized and nationally relevant hospitals and on the other hand AOs azienda ospedaliera). The latter were given the status of ‘hospital companies’ (AO) formally separated from ASLs, with financial autonomy and full responsibility for their budgets, financing, management and technical functioning. Non-AO public hospitals are still controlled by ASLs with rather limited economic and financial autonomy and a separate accounting system for auditing and control purposes. Private facilities (clinics and religious hospitals) maintain their original organization and must be accredited for entering contractual agreements with the NHS.

208. In short, healthcare structures providing primary and secondary care in the territory can be distinguished into local health public companies (ASLs), public hospital companies (AOs), National Institutes for Scientiﬁc Research (Istituto Di Ricov- ero e Cura a Carattere Scientiﬁco IRCCS), and private accredited providers.

209. The latter supply services ﬁnanced by the NHS along the entire chain: ambulatory care, hospital treatment and/or diagnostic services.

210. The IRCCS are research-oriented hospitals that have been recently (by D. Lgs. n. 288/2003) either transformed into foundations or reorganized to better their participation in a national network of centres of excellence. They constitute a network of hospitals producing basic and transnational biomedical research while delivering high-quality healthcare. A Board of Trustees nominates their general director while the Ministry of Health nominates the scientific director. The IRCCS receive research funding for scientific research by the Ministry of Health that also authorizes hospitals as IRCCS and monitors their scientific activity. In relation to their hospital activity, Regions pay IRCCS services on a fee-for-service basis. They enjoy a special exception for processing their clinical data for research purposes (Article 110-bis, paragraph 4, DPA).

211. Public hospitals, established as public companies (AOs) by 1992, provide highly specialized tertiary hospital care (inpatient and outpatient). Among them, we

82 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 212–213

find teaching hospitals that deliver healthcare services while performing research and clinical training. Indeed, they are connected with the university system (in these cases they take the name of Azienda Ospedaliera Universitaria – AOU)/University Hospital Company) and corresponding universities participate in nominating directors and appointing physicians. Overall, AOs or AOUs must have a national, or at least an interregional, catchment population, and they enjoy financial and technical autonomy. At least one Region (Lombardy) has conferred the status of AO to all public hospitals. To obtain such a status there are conditions to be met including: a divisional organizational structure; the existence of at least three ‘highly specialized’ clinical units as determined by D. Lgs. n. 502/1992; and a complete accident and emergency department with an intensive care unit. The healthcare activities of AO(U)s are financed on a fee-for-service basis by Regions.

212. The ASLs are geographically based organizations responsible for assessing needs and providing comprehensive care to the population in their catchment area. They have the largest territorial role. Their organization and dimension is established by the Regions, which are responsible also for monitoring and funding them. The ASLs provide care either directly and through directly controlled hospitals or through agreements with AOs, IRCCS and accredited private providers. Private providers include acute and long-term hospitals, diagnostic laboratories, nursing homes, outpatient specialists and general practitioners.

213. Usually the actual facilities of the ASLs are organized under a typical divisional model covering three different areas of the healthcare system. Health promotion divisions inherited most of the public policy issues originally constituting the core of the national healthcare system. Among the various responsibilities, we ﬁnd: prevention of infectious or other diseases and occupational injuries; prevention and control of the production, distribution and consumption of food and beverages; the monitoring of environmental hazards; along with the general responsibility for health promotion, community care and the enhancement of quality of life. The second kind of division (presidi ospedalieri) operates directly managed acute-care and rehabilitation hospitals offering secondary care. They treat hospital-based acute inpatient and outpatient and provide rehabilitation care. Physicians in these hospitals are direct employees of the ASL. The last kind of department is the health district. These geographical units coordinate and provide primary care, non-hospital- based specialist medicine and residential and semi-residential care to their assigned populations. General practitioners and paediatricians operate within the health districts as independent contractors. Note that size and organization of these departments depend on the demography of the territory. Similar to the peculiar organization noted in Lombardy, it is in Tuscany where ASLs are organized in three superstructures (only three structures for the entire Region joined by four AOU linked to the Universities) so as to better manage speciﬁc administrative processes (e.g., purchasing of goods and services, health technologies, and technology assessment and management) aiming at higher economies of scale. Aiming at the same goals, Sardinia has successfully collapsed its seven ASLs in only one with eight social and health areas on the territory.

Medical Law – Suppl. 119 (2020) Italy – 83 214–218 General Introduction, Ch. 3, The Healthcare System

214. The relevant autonomy of ASLs is evidenced as well by (at least formal) autonomy of their General Manager (Direttore Generale or GM). The GM is appointed by the Region with a contract of five years on the basis of professional qualifications and technical skills. Their autonomy has been strengthened by case law asserting that they can be dismissed only (according to law) if their mid-term targets results (assessed every eighteen months) are not met. The GMs have substantial autonomy in managing human, financial and technological resources to reach sound financial performance of the ASL and the fulfilling of the objectives laid out by the regional health plan and by the local planning process. Case law has stressed the importance and nature of the three-year strategic plan (atto di indirizzo/ programme of governance) in which the GM defines the organization’s mission and goals. The selection of the administrative manager (direttore amministrativo) and the medical director (direttore sanitario) is in the hands of the GM. See also 63 and 150.

215. It must be emphasized that the targets, precision and quality of the Regional Healthcare Plans and the corresponding targets vary widely among the Regions.

216. Patients, according to EU rules (after Directive 2011/24/EU and Regula- tion (EC) no. 883/2004 or Council Regulation (EEC) no. 1408/71 of 14 June 1971) and the national character of the Italian healthcare system, can seek services in their own ASL/AO/AOU or through providers located elsewhere. If they choose the latter, their ASL must pay directly the provider according to the relevant DRG for inpatients and on a fee-for-service basis for outpatient care. The system has led to an increased circulation of patients with deﬁnite ﬂuxes of outward and inward mobility.

B. Speciﬁc Services and Related Strategies

217. As anticipated, the structure of points of delivery of service has been under constant evolution and reorganization. Today their structure is regionally based in relation to deﬁning the relative catchment area. The number of local health authorities has been decreasing rather constantly, even though at a different pace in each Region. One of the sharpest overall reductions in numbers followed the original implementation of D. Lgs. n. 502/1992 (roughly 65%) while in more recent years there has been an overall increase (in 2011, 145 in all). A different pattern, with aggregations and reduction, has emerged for Hospital Companies (Aziende ospedaliere, AOs), especially in those Regions engaged in the Realignment Plan, reducing their overall number. The only Region that has promoted all hospitals to AOs is Lombardy.

218. At a more local level, districts have been decreasing in number with a rather stable average population, mostly exceeding the legislative regulation of a

84 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 219–221 minimum population of reference by district of 60,000 inhabitants. Territorial differences related to economic and geomorphological characteristics (e.g., mountainous areas and rural ones) are apparent.48

219. New changes will ensue due to factors such as ageing population, foreign immigration and the increasing relevance of chronic diseases requiring further reorganization. In this line, both at regional level and as a result of recent reforms (the Balduzzi Law reformed Article 8 Law 502/1992) we notice a trend in reorganizing territorial care strengthening the role (and organization based on professional integration and participation of patients and families) of primary care providers as a more advanced interface for increasingly specialized and technologically equipped hospitals. The two challenges of expanding advanced intensive technology treatment requests and of the need for long-term treatment (due also to increased quality of life and increased rates of chronic diseases causing loss of autonomy) is moving the systemic approach from a disease-focused one to a person focused one with a coherent expansion of the role for socio-healthcare (including prevention and health education) and of the network of long-term care.49

220. Coherently, the Balduzzi reform (Article 1) has basically endorsed the evolutionary lines established recently by collective agreements.50 Accordingly, while it strengthens the role of districts, the reorganization of primary care presses for organizing the practice of general medicine in a more integrated way that has been experimented in various Regions. For instance, the Functional Territorial Groupings integrate the activities of several general practitioner and – along with the Complex Primary Care Units (Unità Complesse delle Cure Primarie, UCCPs) – realize the continuity of care twenty-four hours a day seven days a week in expanding integration with hospital structures.

221. Models implemented at regional level vary. Among the most used ones are the Houses of Health and the Territorial Units for Primary Care (Unità Territoriali di Assistenza Primaria, UTAPs) which were adopted originally in Tuscany and are a multipurpose facility delivering socio-health service according to the same premises; the Nuclei of Primary Care (Nuclei di Cure Primarie, NCPs) originally designed in Veneto integrates, in the same structure, multidisciplinary professionals; the Community Hospital (Ospedale di Comunità, OC) model was set up as a district health facility called to treat that portion of the population traditionally requiring residential or semi-residential hospital stays. All Regions adopted several forms of 24-Hour Models of assistance especially aiming to reduce improper uses of emergency structures. In addition, the Centre-North Regions have been experi- menting with several other forms of integration aimed at both continuity of care and the enhancing of sharing of pathways.

48. Article 3-quater of Legislative Decree no. 229/1999. 49. See, for instance, National Health Plan (Piano Sanitario Nazionale, PSN) 2006–2008 and proposed PSN 2011–2013. 50. See, for instance, those provided for by the National Collective Agreements of General Medicine (ACN 29 Jul. 2009 and ACN 8 Jul. 2010.

Medical Law – Suppl. 119 (2020) Italy – 85 222–226 General Introduction, Ch. 3, The Healthcare System

222. These efforts are coupled with a significant diversification among Regions both with regard to residential and semi-residential structures and to Integrated Home Care (Assistenza domiciliare integrata, ADI). As emerges from our discussions, models of organization on the territory, beyond the basic description, are rather diversified. However, they all tend to achieve forms of better (effective, effi- cient, continuous and appropriate) integration between the services (both health and social) delivered by aggregating these services in more or less structured networks of assistance for which the districts play a key strategic role confirmed by the recent reforms.

223. The proper use of facilities is at the core of the system and its evolution. One area of intervention aims at reducing improper use of emergency-urgency units strengthening, among other things, primary care, and enabling a fast response to the needs of citizens at least for the management of codes of emergency of lesser severity (white and green). Again, various models have been implemented with this goal in mind, including the establishment of clinics for outpatients run by Continual Assistance physicians and Centres of Early Intervention (Presidi di Primo Inter- vento, PPIs) for geographically problematic areas.

224. All these changes came along with a revision of the hospital networks in the name of clinical and organizational appropriateness. According to the most recent data on the allocation of hospital beds,51 there are 0.7 beds per 1,000 inhabitants, including 251,701 beds, equal to 512 per 100,000 inhabitants for rehabilitation and long-term care with the aim of reducing this number even further with a view to promoting day care and home and residential care.52

225. As a result:

The NHS used 1,326 public residential health institutions for inpatient care in 2017, to which it should be added 974 semi-residential ones. The private ones were respectively 69 and 9. The number of medium-sized hospitals (between 121 and 400 beds) reduced by 5% circa (–12 institutions in 2011 with respect to 2009).53

226. With reference to the emergency/urgency network, the last available data indicate (in the year 2017), ﬁrst aid is present in 79.9% of hospitals. Paediatric emergency room is present in 17.4% of hospitals.54

51. See The Pact for Health 2010–2012. 52. Ministero della Salute, Annuario Statistico del Servizio Sanitario NazionaleAssetto organizzativo, attività e fattori produttivi del SSN Anno 2017. 53. Ibid. 54. Ibid.

86 – Italy Medical Law – Suppl. 119 (2020) General Introduction, Ch. 3, The Healthcare System 227–230

C. Pharmacies

227. Pharmacies have always played an important role in the delivery of healthcare. Nevertheless, their role has been changing sharply in recent times both in structural terms (expanding their business well beyond over-the-counter drugs) and in regulatory terms embedding them even more deeply in the national and regional healthcare systems. The recent legislation (D.L. 153/2009, adopted pursuant to Law 69/2009, and subsequent decrees of the Ministry of Health 16 December 2010), expanded the role of pharmacies according them new functions bearing in mind the goals of transforming them into:

– general points of access for patients (providing also protected environments to the most vulnerable to perform, for instance, easy clinical tests); – a tool for the customization of care and the reduction of errors in the use of services (for instance, providing nursing assistance to an old person for running a glycaemic test and interpreting the results).

228. In this direction and within the NHS, pharmacies (Article 1 Law 53/2009) collaborate in integrated home care and deliver support at the request of general practitioners or paediatricians. This support includes delivery of medicines and medical devices to the home, the preparation and dispensing to the home of blends for artiﬁcial nutrition and pain medication, dispensing of medicines of direct distribution, the making available of socio-health workers, nurses and physiotherapists for the performance of speciﬁc professional practices in the home. They can also help by ensuring the proper use of prescribed medications, monitoring the consumption of them, and they also have a role to play in relation to pharmacovigilance programmes.

229. According to these new rules, pharmacies provide first-level services for the implementation of health education programmes and campaigns for the prevention of major diseases with a high social impact. In being a first point of contact for many patients, they also ‘provide second-level services aimed at individual persons being assisted in line with the guidelines and diagnostic/therapeutic pathways provided for specific diseases, on the order of the MMGs [medico medicina generale] or PLSs [pediatra di libera scelta], with the assistance of nursing staff, providing also for the inclusion of pharmacies as places equipped with semi-automatic defibrillators’ (Article 1 lett. d). At pharmacies, patients can also obtain ‘on a physician’s request, first-level analytical procedures which are of the self-care type’ (Article 1 lett. e); book specialist outpatient care and provide for the payment of their share of the costs, and collect reports relating to services of specialist care (Article 1 lett. f).

230. All the above tasks are regulated at regional level since pharmacies are integrated into the regional healthcare system. From 2014, the full implementation of the pharmacy services has been facilitated by an agreement signed at the State- Regions Conference. Among the ﬁnanced project lines, there is also that relating to ‘Interventions for the organizational and structural reorganization of the network of

Medical Law – Suppl. 119 (2020) Italy – 87 231–232 General Introduction, Ch. 3, The Healthcare System hospital and territorial care services – Pharmacy of services.’ Article 5 of the Pact for Health 2014–2016 provided that the Regions should deﬁne with speciﬁc acts of guidance the promotion of ‘initiative medicine’ and ‘pharmacy services’, as a welfare model oriented to the active promotion of health, including through the education of the population to the correct lifestyles, as well as the assumption of the need for health before the onset of the disease or before it occurs or worsens, including through active management of chronicity.

231. Pharmacies are not involved in cost containment, although pharmaceutical expenditures for the NHS have been increasing sharply and constantly in relation to direct and ‘on behalf of’ distribution, a problem that has been at the centre of various manoeuvres. Nevertheless, Law 405/2001 has introduced an alternative channel to pharmacies open to the public. Public structures, by tender procedures, can purchase in bulk medicines of high consumption, obtaining a lower price than the one channelled by pharmacies. They can then distribute the pharmaceuticals directly to patients discharged from hospital or to those that require periodic checks or after a specialist outpatient visit. Alternatively, the same drugs can be distributed by the pharmacies (following speciﬁc agreements) ‘on behalf of’ the local health authorities to chronic patients requiring continuous pharmaceutical assistance.

232. Along with active pharmacies in Italy, in 2011 there were 12,603 commercial enterprises (according to the Ministry of Health, while other sources indicate a smaller number: 6,168 which is still double than what it was in 2013), so-called para-pharmacies, carrying out the sale of medicinal products.

88 – Italy Medical Law – Suppl. 119 (2020) 233–234 Part I. The Medical Profession(s) and the Healthcare System

Chapter 1. Access to the Medical Profession

§1. MEDICAL EDUCATION

I. Historical Note and Overview

233. It was only with the birth of universities in the eleventh century that the training of physicians became institutionalized and the title of doctor medicinae gave rise to the distinction between physicians trained at university and other heal- ers or health professionals.55 Embedding medical training in the university system was a milestone. It gave way to discussions and teachings of a scientific and secular character. Accordingly, during the middles ages, innovative healing practices were introduced. For example, ever since the first dissection of a corpse in 1315 in Bolo- gna, the practice spread breaking what was once a taboo and further leading to the use of the human body in scientific research during the renaissance era. In this way, the path to university and scientific training opened to the actual provision of healthcare services. Indeed, ever since the creation of university institutions, the basic education of medical doctors has been strictly connected with the organization of the healthcare system, especially in the delivery of hospital care and research.

234. Research institutions, hospitals and university teaching are all strictly embedded in the healthcare system (see above in relation to AOUs and National Institutes for Scientific Research IRCSS). For instance, since the nineteenth century, statutory provisions have granted access for university students to both private and charitable hospitals (Article 98, l. 17 July 1890 no. 6972) so long as the ensuing extra costs were covered. The principle, according to which clinical education and availability of clinical data for research are strictly connected, dates back at least to the establishment of the first University-Hospital (the Policlinico Umberto I in Rome) early in the last century. To date, this exigency has led to the sharing of costs between hospitals and the university system and remains a key feature influ- encing the procedures related to the nomination of physicians and administrators in the actual healthcare system. The need to reconcile research and teaching needs with healthcare delivery has been formalized in various legislation enacted over the years

55. See Reference 2 at the end of Part I, Chapter 1.

Medical Law – Suppl. 119 (2020) Italy – 89 235–239 Part I, Ch. 1, Access to the Medical Profession with a view to reforming the Italian healthcare system (e.g., Article 26, paragraph 1, lett. a), Law 12 February 1969, no. 132).

235. It goes without saying that it is in the best interest of the healthcare system to properly train new medical doctors. Therefore, the system is called upon to share the costs of the ﬁnal (vocational primary) training of medical students and to provide a training ﬁeld for them. The interplay between university hospitals and universities is regulated by cooperation agreements routinely negotiated between paritetic institutions.

236. Since university professors are included in the functioning of the university-hospital to which they are affiliated, their salary is based on the healthcare system rules, and the NHS supplements their university salary.56 The overall interplay between the NHS and the universities is today ruled mostly by speciﬁc organic legislation.57 The AOUs enjoy independent legal personality and corporate autonomy (see 211, 253), albeit within the limits of regional and national programming in the healthcare sector.58

237. That being said, the education system is not well connected to modern exi- gencies and required reorganization for reasons linked, for instance, to phenomena emerging from an ageing population. Accordingly and for instance, there is almost no connection between medical training and home care. To put it bluntly, there is too much hospital training in comparison to training related to territorial care. Indeed, although considered in the curriculum of medical science, neither the university degree for MD nor the Bachelor of Science in Nursing devote much time to the teaching of skills related to territorial and primary care nor to the so-called non- technical skills such as in communication or in Root-cause-analysis. Similarly, with regards to the university degree, very little attention (contrary to other European systems and that of the USA) is paid to primary care (family medicine). A similar conclusion can be made in relation to the university degree in Nursing.

238. Against this background information, we can summarize that physicians’ education is organized around three stages: university education, postgraduate education and continuing professional education. Both private and public universities educate undergraduates. The programme lasts six years, during or after which students must work in a hospital ward for at least six months. Once completed this training, medical students must pass a state examination (abilitazione) allowing them to register as practising physicians.

239. Postgraduate specialization is basically required to enter both main career paths: general practitioner (or paediatrician which are ‘freely’ chosen by patients

56. Article 2, L. 5 Feb. 1968, n. 82, L. 25 Mar. 1974, n. 200. Art. 3, l. 5 Feb. 1968, n. 82. 57. Article 6 L. 30 Nov. 1998, n. 419. 58. Article 2, comma 1, D.Lgs. 21 Dec. 1999, n. 517. For instance, it belongs to the Regions the establishing of criteria and parameters for management and general criteria for the adoption of the company act by the General Manager (Art. 1, D.Lgs. 21 Dec. 1999, n. 517).

90 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 240–243 from official lists detailing those available; see 273) or outpatient/hospital specialist. While originally no specific training (other than a specialization) was required to become a general practitioner, as of 1 January 1995 successful participation in a two-year general practitioner training course is required to enrol in the national list. D.L. no. 256/1991, which implemented Council Directive 86/457/EEC of 15 Sep- tember 1986 on specific training in general medical practice, that made participation in this two-year course compulsory with regard to the practice of family medicine. Moreover, in accordance with D. Lgs. n. 256/1991 and 368/1999, general practitioner certificates issued by other EU Member States are considered equivalent to those issued in Italy and are therefore valid for practice in Italy.

240. If physicians wish to become hospital/outpatient physicians and outpatient specialists, they must attend a medical specialist school at a university attending courses in programmes lasting between three and ﬁve years (since 2015). This gives them the clinical specialization required. Both undergraduate and specialization courses operate in a numerus-clausus context essentially meaning that a competitive examination must be passed granting access to university and specialization courses. In line with EU regulations, specializing students can beneﬁt from a grant (scholarship) to attend medical school acting as physicians in their specializing hospitals during the training.

241. The continuing education requirements, governed under the National Con- tinuing Education in Medicine Programme by the Ministry of Health, constitute the third step related to physician education. See infra 263ff.

II. Constitutional Competence

242. The competence to regulate health and the health professions is shared between the State and Regions. Accordingly, any change to the list of twenty-two professions, provided for by Article 6 paragraph 3 of D.L. 30 December 1992 no. 502, should be agreed upon and can no longer be regulated by the simple use of ministerial decrees. The State is called to establish fundamental principles and the rules needed for the shared indivisible interests (e.g., to establish new health professions). Regions can diversify the Regulation within the national legal framework.

243. Following the reform of Title V of the Constitution, the Memoranda of Understanding – signed between the different regions and universities operating in the healthcare ﬁeld – is formulated in accordance with regional guidelines (DPCM 24 May 2001, but see Cost. 4 November 2003, n. 329 excluding the competence of the State), since this is a shared competence in the ﬁeld of health protection. These memoranda rule the interplay between each university and the regional healthcare system.

Medical Law – Suppl. 119 (2020) Italy – 91 244–246 Part I, Ch. 1, Access to the Medical Profession

III. Undergraduate Medical Education

244. After six years of medical education, graduates of university degree courses in medicine and surgery must have acquired the scientiﬁc basis and the theoretical and vocational training required under Directive 75/363/EEC enabling them to practise medicine in conformity with proper methodology and according to the correct medical culture necessary for embarking in the practice of lifelong learning. Gradu- ates are supposed to have obtained a sufficient level of professional autonomy, decision-making and operational ability. Their training path should be characterized by a holistic approach to health issues for both healthy and sick individuals in relation to their chemical, physical, biological and social environment.

245. With this aim in mind, the training programme provides a total of 360 university credits (hereinafter ‘CFU’), apportioned over six years of study. At least sixty CFU must be acquired in educational activities oriented to the maturation of:

– specific professional skills; – fundamental theoretical knowledge derived from basic sciences with a view to subsequent professional application; – the ability to detect and evaluate critically from a clinical point of view data on health status and any disease manifested by individuals, interpreting them in a unified way mindful of the socio-cultural and the gender dimension and in line with the scientific knowledge base of pathophysiology and pathology of organs and the bodily systems; – skills and experience, together with the ability to self-assess, to address and responsibly resolve urgent health problems in terms of prevention, diagnosis, prognosis, treatment and rehabilitation; – knowledge of the historical, epistemological and ethical dimensions of medical issues; – the ability to communicate clearly and humanely with the patient and his/her family; – the ability to work with different professionals regarding diverse health activities performed in group scenarios; – the ability to apply, in relation to medical decisions, principles of health econom- ics; – the ability to recognize the health problems of the community and to act in a competent manner.59

246. The overall goal of the degree (as demonstrated by the involute example provided by the University of Perugia) is the:

education of a physician at her initial professional level with a biomedical, psychological, and social culture; possessing a multidisciplinary and integrated

59. The text is taken from the description of the relevant degree of the University of Perugia. Yet the description is largely similar in all universities. The italic is added and highlights areas in which de facto very few credits are used to offer these fundamental non-technical skills.

92 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 247–250

vision of the common problems of health and disease, with an education oriented to the community, to the territory and ultimately to the prevention of disease and promotion of health; with a humanistic culture in relation to the implications of medical interest, this speciﬁc mission responds more adequately to the new demands of healthcare and, being not only centred on the disease but also on the sick individual considering the soma and the psyche in a social context.60

Clearly enough the language used in describing the goals of the university programme for medical students evokes the language of Council Directive of 16 June 1975 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of activities of doctors (75/363/EEC).

247. A certain number of CFU are reserved for the ﬁnal thesis, written by the graduate candidate and defended at graduation.

IV. Graduate Medical Education

248. Since the 1970s, European Directives have aimed to harmonize rules for training young physicians. In this regard, Directive 82/76/EEC that enacted mandatory training for physicians in the form of continuous clinical activity and the recognition of a suitable remuneration for them has been fundamental. Italy transposed this Directive (via D. Lgs. n. 257/1991) not only late – after having been condemned by a decision of the EUCJ – but also incorrectly. This tempestuous implementation has resulted in ongoing litigation in Italy on the substance of the legislation.

249. Until 1991, attendance of medical graduate schools was self-regulated by each school, de facto limiting trainees’ duties to lessons prescribed by each school. Since the early 1990s, the national legislator has restricted the recruitment of physicians in the NHS to those possessing specialization in the discipline requested in the competition announcing the post, or an equivalent specialization as declared by speciﬁc ministerial decrees. The result was the forcing of all physicians to get a specialization in the hope to enter the NHS and therefore a standardization of prescribed learning units.

250. The actual regulation of medical specialists is mainly related to the enactment of D. Lgs. n. 368/99 (implementing EU Directive 93/16/EEC and revised by D. Lgs. 8 July 2003, n. 277), which instituted an annual renewable training contract aimed exclusively at the acquisition of skills related to the title of ‘specialist’. The trainee enters into a contract with the University running the Graduate School and with the regional office of the teaching hospital. Such a contract, however, does not necessarily give the right to a permanent position within the NHS or the University.

60. Our translation.

Medical Law – Suppl. 119 (2020) Italy – 93 251–255 Part I, Ch. 1, Access to the Medical Profession

The trainee must commit to work in the NHS full-time for the duration of the contract for ﬁfty-eight hours a week although it would seem that trainees in fact provide more extensive services.

251. According to existent rules, physicians in specialist training shall be paid an annual all-inclusive salary of EUR 25,000 (as deﬁned by Law no. 266 of 2005) for the ﬁrst two years of specialization and EUR 26,000 for the remainder of the legal duration of the course. This sum is exempt from personal income tax and is paid on a monthly basis in arrears. With regard to social security rights, the physician undertaking specialist training is included in the separate management of the self-employed regulated by the INPS (Istituto Nazionale Previdenza Sociale). The named contract provides for the protection of motherhood in accordance with the provisions relating to the protection of pregnancy pursuant to Law 151/2001 and their liability insurance is provided for by the teaching hospital in which they are enrolled.

252. For the duration of the specialist training, trainees are forbidden to exercise freelance activities outside the care facilities where the training is carried out. That being said, their work is equal to that provided by the medical staff of the NHS full- time professionals meaning that they can, according to the correct exercise of the profession, carry out the intramural activities referred to in Article 19 paragraph 11 of Law 28/12/2001 no. 448 (i.e., they can only work as ﬁrst aid physicians in touristic areas and can stand in for ﬁxed-term general practitioners affiliated with the NHS). The contract provides also the possibility of exercising the profession in-house (so-called intramoenia activity), but in fact the Memoranda of Understand- ing between the Regions and Universities has not yet delineated those intramoenia activities that can be performed. See 202.

253. Specializing physicians assume the status of workers. They are guaranteed certain fundamental rights including maternity leave, sick-pay insurance and insurance coverage for occupational hazards. Accidents and civil liability against third parties are guaranteed by the AOU, which also pays retirement contributions.

254. Furthermore, the law prohibits the substitution of full-time employed personnel of the teaching hospital with medical trainees. Nevertheless, and despite the clarity of the law on the activities of postgraduate training in clinical practice, dis- tortions have been reported including trainees independently undertaking specialist services in clinics and wards acting as day and/or night watchkeepers without the presence of permanent personnel. In addition, reports conﬁrm that trainees are known to perform medico-legal bureaucratic activities including the compilation of medical records and the reporting of examinations. Also, as mentioned, for the existing shortage of physicians, some regions are employing specializing physicians.

255. The training of physicians requires their tutored participation in all medical activities of the pursued speciality, their gradual involvement in clinical care and the execution of services under binding directions from their mentor. The overall goal is to permit the gradual evolution of skills with a parallel undertaking to increase

94 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 256–257 autonomy and accountability. However, the legislation does not specify the criteria to be fulﬁlled in achieving autonomy and operational decision-making. In addition, case law (Cass. no. 2453/99) has clariﬁed that even if acting under the direction of the mentor, medical acts performed by trainees incur their direct professional liability. This stands because even within bound autonomy, medical practice is not relieved from personal liability (at least under criminal law): the inexperience of young physicians does not constitute an excuse but rather an aggravating circumstance because the trainee, like all professionals, must be able to assess the complexity of each situation and if s/he is not up to the task it should be delegated to a more experienced physician. See 505ff.

256. Moving on to the detailed regulation of the training path, the reorganization of medical postgraduate schools has been provided for by a Decree of the Min- istry of University and Research dated 1 August 2005 and a later decree that deﬁned the Standards and Minimum Requirements of Postgraduate Schools (issued by the Ministry of Education in agreement with Ministry of Health dated 8 May 2006). In the decree of the Minister of Education, Universities and Research, in agreement with the Minister of Health, of 4 February 2015, n 68 2015, the specialization schools have been reformed reducing their duration and revising the criteria for accrediting the School of Specialization (a further interministerial decree in 2017 has complemented the Regulation: 402/2017).

257. The 2015 – 2017 Decrees deﬁne the postgraduate schools of specialization, the proﬁle of the specialist they should train, their educational objectives and the related learning paths dividing them into areas and classes. Accordingly, the postgraduate programmes are divided into three areas with internal sub-areas that provide for classes:

(a) Medical Area: – Class of General and Specialty Medicine. – Class of General and Specialistic Clinical Medicine. – Class of Neurosciences and Behavioural Sciences. – Class of Developing Age Medicine. (b) Surgical Area: – Class of General and Specialty Surgery. – Class of Head and Neck Surgery. – Class of Cardiothoracic Vascular Surgery. (c) Clinical Services Area: – Class of Diagnostic Medicine and Laboratory. – Class of Medical Imaging and Radiotherapy. – Class of Clinical Specialty Services. – Class of Biomedical Clinical Services. – Class of Public Health. – Class of Odontoiatry. – Class of Pharmacy. – Class of Medical Physics.

Medical Law – Suppl. 119 (2020) Italy – 95 258–263 Part I, Ch. 1, Access to the Medical Profession

258. To take an example, the Class of Neurosciences and Behavioural Sciences is further divided into Neurology, Child neuropsychiatry, Psychiatry, while the Class of General and Specialty Medicine unfolds in eighteen specialities.

259. Postgraduate schools of specialization programmes form part of the Medi- cal Schools that are permitted to activate a maximum of one Residency Programme for each speciality with a mandated minimum number of seats to be made available. The actual training activities are deﬁned in broad terms by the mentioned decrees dividing them into basic and general teachings, those necessary for the speciality, those characterizing the educational path, common teachings, and similar, integrative, and interdisciplinary teachings.

260. The schools of specialization must be accredited. Accordingly, Medical Schools must possess the detailed requirements provided for by the law. Legislation goes so far as to specify the minimum number of computers available to the personnel.

261. Faculty members must be comprised of only full, associate and assistant professors with a maximum of 30% of non-University personnel involved in the teaching.

262. The same Ministerial Decree, as reformed, establishes both the typology and the minimum duration of required activities for each speciality, apportioning them in homogeneous areas of knowledge, identiﬁed by scientiﬁc areas as follows:

(a) basic tasks to which 5 CFU are assigned; (b) activities specific to the speciality to which at least 210 CFU are assigned for schools articulating their course in three years and 370 CFU for those with a five-year programme; (c) electives specific to the speciality to which each school assigns a certain number of credits; (d) related, integrative and interdisciplinary activities to which 5 CFU are assigned; (e) activities linked to the final test (a thesis to be defended) to which 15 CFU are assigned; (f) other activities to which 5 CFU are assigned.

V. Continuous Education in Medical Science

263. The regulation of continuing education for physicians (CEM Continuing Education in Medicine) is not that long established in Italy. It was launched at the national level on 5 July 2000 with the so-called National Programme on Continuing Education in Medicine (NPCEM). There is no distinction between private or public practitioners since all health professionals are today required to successfully follow continuous education training programmes obtaining 150 continuing education training credits in ﬁve years in order to be accredited (i.e., to maintain accreditation).

96 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 264–266

264. Since 2002, the year in which the National Programme of CEM became fully operational, healthcare personnel who attend, in Italy or abroad, post-basic training similar to the following are exempted from CEM requirements. In detail:

– Those who attend postgraduate, doctoral, or master’s degree courses in advanced scientific and specialist areas planned and governed by the Decree of the MURST of 3 November 1999, no. 509. – Physicians undergoing specific training in general medicine, according to Legis- lative Decree 17 August 1999, no. 368 implementing Directive 93/16/EEC on the free movement of physicians and the mutual recognition of their diplomas, certificates and other degrees. – Attendees of complementary trainings, such as the ones envisaged by Article 66 ‘enabling one to operate in emergency cases’ by the Decree of the President of the Republic 28 July 2000 no. 270, as provided for in the national collective agreement regulating relationships between the NHS and general practitioners. – Attendees of training courses and refresher courses conducted pursuant to Article 1, paragraph 1, let. d) ‘Plan of interventions against AIDS’ according to Law of 5 June 1990 no. 135, published in G.U. n. 132 of 8 June 1990) for the entire year of attendance. – Other exemptions from the CEM obligation include those who make use of the provisions relating to the protection of pregnancy under Law 30 December 1971, no. 1204 and subsequent amendments, as well as performance of military service as per the Law of 24 December 1986, no. 958, as amended. They are exempt for the entire year in which they are subject to the above provisions.

265. All CEM courses are supposed to fulfil the strategic objectives of the NHS. The educational objectives established at national level constitute the tools used to guide the continuing education programmes in order to prioritize the interests of NHS. The identification and allocation between levels of government (national, regional, healthcare units) of the educational objectives constitute a point of reference and an instrument for balancing their powers and responsibilities as these goals are articulated in the training of the individual professionals (individual file) and/or team (file group) (see Rules of application of objective criteria for the State- Regions Agreement of 5 November 2009 – page 8). Training courses aim to fulfil the ‘learning outcomes’ stipulated in the State-Regions Agreement of 2009 (still in force). Today, in paragraph 10 of Article 1 of Law 291/2017, it is added that: ‘ The initial and continuous training of doctors and other health professionals includes training in the areas of patient relations and communication, pain therapy and palliative care.’ Also, from 1 January 2019, the new National Manual for accreditation of CME courses entered into force reforming the criteria for assigning credits to each course.

266. The National Commission on Continuing Education in Medicine (CNFC Commissione Nazionale per la Formazione Continua). These objectives must be related to the healthcare and social care needs encompassed by the LEA (Essential Levels of Care). The Regions and local healthcare authorities themselves, taking into account regional health plans and the speciﬁc missions of ASL and AO/AOU,

Medical Law – Suppl. 119 (2020) Italy – 97 267–267 Part I, Ch. 1, Access to the Medical Profession deﬁne the educational objectives of regional importance and those of speciﬁc importance to the ASLs. They are designed to ensure effectiveness, appropriateness and efficiency of the healthcare services according to local and organizational peculiarities and according to the epidemiological characteristics and socio-territorial health structures at the territorial level (see State-Regions Agreement of 5 November 2009 – p. 8–9).

267. The educational objectives of national interest established by the Perma- nent Conference for Relations between the State, Regions and Autonomous Prov- inces are as follows:61

(1) Application in daily practice of the principles and procedures of Evidence- Based Practice (EBM – EBN – EBP). (2) Guidelines, protocols, procedures, and clinical documentation. (3) Clinical-diagnostic and rehabilitative care, service profiles, and profiles of care. (4) Appropriateness of health services in the LEA including the evaluation of systems, testing and improving efficiency and effectiveness. (5) Principles, procedures and tools for the clinical management of health activities. (6) Patient safety. (7) Effective communication, privacy and informed consent. (8) Integrating inter-professionalism and multi-professionalism in inter- institutional settings. (9) Integration between hospital and community care. (10) Epidemiology, prevention and health promotion. (11) Healthcare Management: Management innovation and experimentation with organizational and management models. (12) Relational aspects (internal communication and communication with the patient) of care and humanization. (13) Methodology and techniques of social communication for the development of national and regional programmes of primary prevention and health promotion. (14) Accreditation of health facilities and professionals. The culture of quality in services delivery. (15) Multiculturalism and well-being culture in healthcare. (16) Ethics and bioethics. (17) General topics including computer science; English at advanced levels; health law; and the ethical and civic principles of the NHS. (18) Technical-professional contents (knowledge and skills) that are specific to each profession and/or specialization. (19) Non-conventional medicine: evaluation of the effectiveness on the basis of the outcomes and areas of complementarity.

61. http://www.salute.gov.it/ecm/paginaInternaEcm.jsp?id=1&menu=obiettivi.

98 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 268–271

(20) Special issues of the NHS and SSR (Servizio Sanitario Regionale/Regional Healthcare Service) and those urgent and/or extraordinary as identified by the National Commission on Continuing Education in Medicine to meet specific public health emergencies. (21) Treatment of acute and chronic pain, palliative care. (22) Vulnerable individuals (children, elderly, drug addicts, individuals with mental health problems): welfare aspects and social care. (23) Food safety and/or related conditions. (24) Veterinary health. (25) Pharmacoepidemiology, pharmacoeconomics, pharmacovigilance. (26) Environmental safety and/or related conditions. (27) Safety in the workplace and/or related conditions. (28) Implementation of a safety culture in the field of donation-transplantation. (29) Technological innovation: evaluation, process improvement management of biomedical technologies and medical devices. Technology assessment.

268. The National Commission on Continuing Education in Medicine has established a national database providing information on the speciﬁc credits earned by individual health professionals. However, the database needs to be improved especially since the rules for accrediting providers have recently been changed.

§2. LICENSING OF GENERAL PRACTITIONERS AND MEDICAL SPECIALISTS: POSTGRADUATE MEDICAL EDUCATION

269. General practitioners are licensed. More in general, all physicians must be licensed (as all professionals according to Article 1 Law 1378 of 8/12/1956) to practise their profession (abilitazione/qualiﬁed). Practice licences are obtained after successfully passing a State examination. To enlist for the State examination, physicians must have been awarded a degree according to the pre-reform regime mentioned in Article 17, paragraph 95 of Law 15 May 1997, no. 127 and subsequent amendments, or a bachelor’s degree within the class 46/S or a university diploma or degree relating to the class LM-41 (both programmes being of a six years duration).

270. The State examination granting a licence to practise consists of a practical internship and a written test. The internship is a vocational training test, on a continuous basis, for a period of three months realized, after graduating, at university hospitals, hospitals, local health centres offering outpatient emergency services (‘guardia medica’) or, if incorporated, AO, as well as at the clinic of a general practitioner pursuant to the national agreement with the NHS.

271. Vocational training must be carried out for one month at local health centres offering outpatient emergency services (‘guardia medica’), another month in a surgical department and for the ﬁnal month at a general practitioner’s clinic. The

Medical Law – Suppl. 119 (2020) Italy – 99 272–276 Part I, Ch. 1, Access to the Medical Profession aim is to integrate the vocational training provided by the bachelor degree of class 46/S of the Ministerial Decree of 28 November 2000. The training period and exams dates are set nationally.

272. Actual exercise of the profession without such qualification/professional training (leading to licence) is a crime according to Article 348 cp as amended by Law 3/2018: ‘Anyone who abusively practices a profession for which a special State authorisation is required shall be punished by imprisonment from six months to three years and a fine from 10,000 to 50,000 euros. The conviction involves the publication of the judgement and the confiscation of the things that served or were destined to commit the crime and, in the case in which the subject who has committed the crime regularly exercises a profession or activity, the transmission of the same judgement to the competent Order, roll or register for the purposes of the application of the disqualification from one to three years from the profession or activity regularly exercised. The penalty is imprisonment of from one to five years and a fine of from 15,000 to 75,000 euros for the practitioner who has determined others to commit the offence referred to in the first paragraph or has directed the activity of the persons involved in the offence itself.’

273. The qualifications and licence relating to the functions of general practitioners of the NHS are based on the parameters defined in the context of regional agreements granting access to the system for those who qualified both before and after the 1995 reforms and who hold a certificate of training in general medicine or a diploma of specific training in general medical practice or an equivalent qualification (Article 21, D.L. 17 August 1999, no. 368). Position on the list of general practitioner by contract with the Regional Hospital depends on several factors, among which is the successful attendance of the specific training for general practitioners that opens access for new positions. See 239.

274. Physicians wishing to become a general practitioner undergo appropriate training and are registered on a national registry. A policy of mutual recognition of general practitioner qualiﬁcations gained in other EU Member States for the purposes of practising in Italy is adhered to (see infra 299ff, 311ff).

275. Physicians must also attend Continuing Medical Education programmes that, somehow, although not coinciding with, can be deemed equivalent to a ‘re- accreditation system’ carried out annually.

§3. MANPOWER PLANNING:FREEDOM OF ESTABLISHMENT

276. To practise medicine in Italy, it is compulsory to ﬁrst enrol in the single- cycle Degree in Medicine and Surgery, the duration of which is six years (see 244ff). A similar situation exists for dentistry in that it is currently necessary to enrol for a period of six years. For both courses, registration is only possible after passing an admission exam since these courses are limited (numerous clausus). After graduating and after a compulsory internship of three months (one month in a surgical

100 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 277–279 emergency care unit, one month in a medical emergency care unit and a month at the clinic of a primary care physician), graduate physicians must take a State exam with a view to obtaining their professional qualiﬁcation. Once passed, it is possible to register with the Register of Provincial Physicians and Dentists, a list maintained by the Provincial Order of Physicians and Dentists in each province. See 313.

277. In addition to the numerous clausus in relation to the basic training, a numerous clausus is also set nationally (specialist medical training contracts for 2018/2019 have increased: the total is 8,776) for specialization schools to which access is granted after passing a specific admission exam. Schools of specialization in medical or surgical treatment vary in duration (three to five years, depending on the type of specialization: specialization in general surgery and neurosurgery last five years, while others last for three to four years).

278. Specialization in general practice differs to some extent in that it lasts three years and aims to train family physicians. Access numbers are set on the basis of the needs of the Region but are limited to a predeﬁned number of enrolled individuals. This system is, somehow, a form of manpower planning.

279. An exception to the above is the exercise of the freedoms of movement and establishment grated to EU citizens. See 293ff.

Medical Law – Suppl. 119 (2020) Italy – 101 279–279 Part I, Ch. 1, Access to the Medical Profession

Reference 2

In addition to sources previously quoted please see also for this Part: J. Agrimi, Le professioni mediche, in Storia della Scienza, IV, Roma, Istituto della Enciclopedia Italiana, 2001, 485–493. Ascone & D’Alessandro, La giurisprudenza della commissione centrale per gli esercenti le professioni sanitarie, 1951 –1985 (Federazione Nazionale degli Ordini dei Medici-Chirurghi e Degli Odontoiatria). Balduzzi R. – Carpani G., Manuale di diritto sanitario, il Mulino, Bologna, 2013. M. Barni, Diritti – doveri – responsabilità del medico, Milano, Giuffrè, 1999. M. Barni, L’atto medico, convenzionale o non, nell’intervento della Corte Costi- tuzionale, in portale.fnomceo.it. L. Benci, Aspetti giuridici della professione infermieristica, Milano, McGraw-Hill, 2008. R. Bertolino, L’obiezione di coscienza moderna. Per una fondazione costituzionale del diritto di obiezione, Torino, Giappichelli, 1994. L.M. Borgia, Guida per i Comitati di bioetica alla sperimentazione clinica. Modelli di procedure operative e riferimenti normativi, Roma, Il pensiero scientifico editore, 2001. C. Bottari, Tutela della Salute ed Organizzazione Sanitaria. Giappichelli, Torino, 2009. B. Cavarra, Scienze della vita e medicina nell’Europa latina, in Storia della Sci- enza, IV, Roma, Istituto della ‘Enciclopedia Italiana, 2001, 191–204. Consiglio Nazionale Fnomceo, Linee guida su medicine e pratiche non convenzionali, Terni, 18 maggio 2002. Consiglio Nazionale Fnomceo, Linee guida per la formazione nelle medicine e pratiche non convenzionali, 12 dicembre 2009. G. Cosmacini, Storia della medicina e della sanità in Italia, Bari, Laterza, 2005. G. Cilione, Diritto Sanitario, Maggioli Editore, 2005. G. De Cesare, Enciclopedia del Diritto, XLI, Voce Sanità. Giuffrè, 1989. R. Ciliberti, Medicina, etica e diritto nella rivoluzione biotecnologica. Torino, C.G. Edizioni Medico Scientifiche, 2001. G. Corbellini, Breve storia delle idee di salute e malattia, Roma, Carocci, 2004. G. Cosmacini, La qualità del tuo medico. Per una filosofia della medicina, Bari- Roma, Laterza, 1995. V. Crupi-M. Motterlini, Decisioni mediche: Un punto di vista cognitivo, Milano, Raffaello Cortina Editore, 2005. J. Gilardi – R. Latocca, Postgraduate medical trainees in Italy and development of legislation: a pathway in agreement with the international scene?, in Journal of Medicine and The Person, December 2008, vol. 6, number 4: 147–151. M. Greco & G Morrocchesi, Il potere disciplinare nell’ordine professionale (CGEMS 2006). L. Nocco, Diritti fondamentali e tecniche di tutela degli incapaci: le esperienze USA e italiana a confronto sul ruolo dei comitati etici, Rivista Italiana Di Medicina Legale; N. 26; 1103:1160 (2004). G. Montanari Vergallo, Il rapporto medico-paziente, Milano, Giuffrè, 2008.

102 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 1, Access to the Medical Profession 279–279

F.C. Palazzo, voce ‘Obiezione di coscienza’, in Enciclopedia del Diritto, XXIX, Milano, Giuffrè, 1979, 539ff. M. Trabucchi, L’ammalato e il suo medico: successi e limiti di una relazione, il Mulino, Bologna, 2009. F. Raimondi & L Raimondi, Il Procedimento Disciplinare Nelle Professioni Sani- tarie (Giuffrè 2006). M. Tavani-M. Picozzi-G. Salvati, Manuale di deontologia medica, Milano, Giuffrè, 2007. See also individual contributions in the following collective works: M. Barni (a cura di), Bioetica, deontologia e diritto per un nuovo codice professionale del medico, Milano, Giuffrè, 1995. M. Barni-A. Santosuosso (a cura di), Medicina e diritto. Milano, Giuffrè, 1995. FNOMCEO, Cento anni di professione al servizio del Paese, 2010. S. Rodotà-M. Tallacchini (a cura di), Ambito e fonti del Biodiritto, in Trattato di Biodiritto, diretto da S. Rodotà-P. Zatti, Milano, Giuffrè, 2010. M. Ferrari-P. Mazzarello (a cura di), Formare alle professioni, ﬁgure della sanità, Milano, Franco Angeli, 2010, 7–13. R. Sangiuliano (ed.), Diritto Sanitario e Servizio Sanitario Nazionale (20th ed., Edizioni Giuridiche 2010).

Medical Law – Suppl. 119 (2020) Italy – 103 280–282

Chapter 2. Practice of Medicine

§1. LEGAL CONDITIONS FOR THE PRACTICE OF MEDICINE

I. Historical Note (and Interplay with Other Healthcare Professions)

280. Pursuant to Article 33 of the Constitution, a State examination for a certi- ﬁcation to practise is prescribed for qualiﬁcation to exercise a profession. Article 2229 of the Civil Code states:

the law establishes those intellectual professions for which registration is required in special registers and lists in order to practice. The assessment of the requirements for registration, keeping of registration and disciplinary authority over members are issues delegated to professional associations, under the supervision of the State.

Intellectual professions are those that involve carrying out activities that are mainly intellectual in nature and relate to speciﬁc ﬁelds.

281. Up until the enactment of Law 42/1999, the healthcare consolidated laws (TULLS 1265/1934) placed health professions within a hierarchical structure placing physicians at the top and all other recognized professions as auxiliary ones. The medical profession was the only profession that did not have a detailed (nor generic in reality) description of permitted/reserved activities (so-called mansionario). On the contrary, detailed lists provided in speciﬁc laws inventorying their reserved activities governed all the other health professions. Hence, for instance, Article 2 of Law 225/1974 reserved, among other things, to professional nurses:

capillary and venous blood withdrawal; hypodermic injections; intramuscular and allergic diagnostic testing; hypodermoclysis; orally, intramuscularly and percutaneous vaccinations; enemas; burn wound care, massages, medical gym- nastics; electrical applications of simpler execution like ECG, EEG, and similar; wound dressings and bandages; medicinal and nutritional enemas; vaginal washes; catheterization in women; catheterization in men with soft catheters, gastric and duodenal survey for diagnostic purposes; gastric lavage; therapeutic baths and medicated ones; removal of secretions and excretions for diagnostic purposes; and removal of sanitary tampons.

Other activities could be performed but only in hospitals and/or under direct medical control (for instance, intravenous injections).

282. Law 42/1999 in abolishing all job descriptions (Article 1) has eliminated any reference to the notion of auxiliary health professions with regard to physicians. In addition, the reform of the education system has deﬁned and upgraded the training for most of the non-medical health professions to university level. See also 288ff, 315ff, 320ff.

104 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 283–286

283. Moreover, since 1994 ministerial decrees have defined the professional profile of twenty-two health professions altogether describing their activities in more general terms and avoiding detailed lists. Indeed Article 2 paragraph 2 of Law 42/1999 clarifies that:

The proper domain of activities and responsibilities of the health professions … is determined by the contents of the ministerial decrees establishing their relative professional profiles and teaching regulations of the respective university diploma courses and post-basic training as well as of their specific codes of ethics, subject to the skills required for the medical profession and other professions in the health role, access to which is required to hold the diploma degree in mutual respect of specific professional skills.

284. Medical doctors constitute the only profession remaining without a legal norm that deﬁnes their reserved acts and activities beyond the generic description contained in the ruling of the requirements of their bachelor or specialist university degrees. In 2015 several attempts to produce a legislative deﬁnition of a medical act failed.

II. Healing Arts and Medicine

285. The art of healing has not been always a business reserved for physicians. In other words, often physicians have not been the sole healer recognized in society. On the contrary, the differentiation in healing between sacral roles and scien- tiﬁc ones is a rather recent phenomenon and can be related to the establishment of secular hospitals and the linkage of medical training to universities. Therefore, it comes as no surprise that in the last decades, various treatments, remedies and spiritual/religious philosophies, often deﬁned as unconventional, alternative, complementary and integrative, have been adopted in Italy as cures for several health problems. Some of them have even been integrated into the healthcare system (see 173ff). Scepticism over these practices, perceived as outsiders in relation to the evidence-based model, has been overcome in various instances leading to an understanding of complementary and alternative medicines as additional disciplines for which there is still not enough sufficient evidence upon which their assimilation into the EBM model could be based. This approach permits the maintenance of a rigorous evidence-based approach in treating patients while meeting an increasing demand for treatment and an actual lack of sufficient data on several procedures.

286. Against this backdrop of insufficient or inexistent regulation (often dealt with by way of emergency ordinances; see 87ff) these complementary or alternative medicines are not normally included in the basket of beneﬁts offered/reimbursed by the NHS. Nevertheless, some regions add some of them to their speciﬁc basket in some form. The same statute (Legislative Decree no. 299/1999) that excluded their reimbursement as a default rule, in principle admits their potential complementarity to the healthcare system. See 173ff.

Medical Law – Suppl. 119 (2020) Italy – 105 287–290 Part I, Ch. 2, Practice of Medicine

III. Legal Monopoly of Physicians

287. Article 5 paragraph 2 of D.L. C.P.S 13 September 1946, n° 233 (as amended by Article 4 law 3/2018) requires enrolment in the Register of the Order before medical practice can be undertaken. In addition, Article 13 no. 221 (Article 5 D.P.R. 5 April 1950) provides that enrolment in the Register entitles free exercise of the profession in the province to which the Register (Albo) refers and on the whole territory of the Republic. In addition, as previously mentioned, carrying out medical activities without having lawfully obtained the corresponding legal diploma, along with the ‘abilitazione’ and inscription in the provincial professional association can amount to a crime (see infra 353ff and supra 272). However, within this formal legal monopoly, the actual situation is more ﬂuid since there is no clear deﬁnition of what constitutes a medical act (see supra 233ff).

288. Of course, the lines that once provided the framework for this ‘physicians’ monopoly’ have become blurred since the elimination of the hierarchical distribution among health professionals making it legal for other health professionals to ful- ﬁl several tasks, tasks which they have already been practising but were not included in their job descriptions (mansionari)(see supra 281, see infra 362).

A. Legal Conditions for the Practice of Medicine

1. Legal Diploma

289. According to Italian law, a legal diploma in medicine is required to enter specialization schools and general practitioner training courses, in line with EU regulations. Furthermore, since the NHS cannot hire physicians without a specialization in the required field (or in one assumed by law equivalent to it) and both the Code of Ethics (Article 56, also as amended in 2016) and specific legislation (Article 348 cp) forbids physicians to present themselves as having a specialization without holding the correspondent diploma, it is rather clear that both a university degree in medicine obtained after six years of course study and a specialization title (obtained after three or five years) or general practitioner qualification is a prerequisite to practise. a. Exemption from the Legal Diploma 290. Since the law requires evidence of proper training (and the equivalent for foreigners), it appears that no exemption can be obtained from the legal diploma requirement. That being said, there is one exception that applies to nurses who were already employed by private or public entities before the reform – providing for specific university training – was implemented.

106 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 291–297 i. Mutual Recognition 291. In accordance with D. Lgs. n. 256/1991 and 368/1999, certiﬁcates issued by other EU Member States granting general practitioner licences are equivalent to those issued in Italy and therefore are valid in Italy.

292. This is also the case in relation to all EU University diplomas deemed equal according to EU and national rules. b. The Recognition of Professional Activities i. General Overview 293. Article 45 of the Treaty of the Functioning of the EU (ex Article 39 EC Treaty) refers to the possibility for Member State citizens to pursue labour activities in the territory of any Member State. The aim is totally political, economic and social integration among the Member States via free professional movement.

294. The general system of professional recognition was created by Directive 89/48/EEC and was integrated by Directive 92/51/EEC. It is directed to professionals of different areas interested in pursuing their activities in a country other than the one where they acquired their professional qualification. ii. Recognition of Professional Activities in Italy 295. Anyone who has obtained a professional qualification in any of the Mem- ber States can, based on the freedom of establishment, request official recognition of professional certificates if s/he intends to practise in Italy. For health professionals, the procedure can change according to the occupation. For some professions, such as surgical, veterinary, pharmacy, dentistry, nursing and obstetrics, the communitarian normative established rules of harmonization indicate that the recognition of professional titles should be conducted via simple verification of the documents presented.

296. D.L. 9 November 2007, no. 206 (implementing Directive 2005/36/EC on the recognition of professional qualifications and Directive 2006/100/EC adapting certain Directives in the field of freedom of movement of persons, by reason of the accession of Bulgaria and Romania) contains the rules concerning the recognition process. It clarifies that, without prejudice to the requirements for the exercise of the profession, those benefiting from the recognition of professional qualifications should possess the necessary language skills to perform their duties.

297. Article 9, as amended by Legislative Decree no. 15 of 28 January 2016, provides for the freedom to provide services and to provide occasional and temporary services. In the case where the service provider moves to the Italian territory to pursue, on a temporary or occasional basis, her profession, the law forbids any restriction of her freedom of movement for any reason relating to professional quali- ﬁcations on the condition that (a) the service provider, in pursuing the same profession, is legally established in another Member State; and (b) if in the Member

Medical Law – Suppl. 119 (2020) Italy – 107 298–299 Part I, Ch. 2, Practice of Medicine

State of establishment the profession is not regulated, the provider has practised the profession for at least one year during the ten years preceding the provision of services.

298. Pursuant to law, the qualiﬁcations eligible for recognition are as follows:

(1) Pharmacist (2) Surgeon (3) Medical Specialist (4) General practitioner (5) Dentist (6) Veterinarian (7) Psychologist (8) Psychotherapist (9) Health Assistant (10) Dietician (11) Educator (12) Physiotherapist (13) Dental Hygienist (14) Nurse (15) Paediatric Nurse (16) Speech Therapist (17) Masseur/lifesaver (18) Dental technicians (19) Community/social-health worker (20) Orthoptist/Ophthalmic Assistant (21) Midwife (22) Opticians (23) Podiatrist (24) Paediatric nurse (25) Technical audiometrist (26) Hearing healthcare professional (27) Expert in technical pathophysiology of cardiovascular and vascular perfusion (28) Technicians concerned with the workplace environment and protection of it (29) Expert on technical psychiatric rehabilitation (30) Expert in technical neurophysiopathology (31) Orthoptist (32) Sanitary technician in a biomedical laboratory (33) Technical and medical radiology (34) Therapist of neuro-psychomotor system of developmental age (35) Occupational therapist. iii. Recognition of Professional Certificates Obtained in Italy and the EU 299. Italian citizens qualified in Italy intending to practise their profession in another Member State of the European Union have to make a recognition request to the concerned authority of the chosen country. The concerned authority must first of

108 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 300–305 all compare the professional education in each country (the one of origin and the one chosen for practice). In case of differences concerning the professional education (e.g., length or characteristics), the authority can submit the applicant to fulﬁl certain complementary requirements as a measure of compensation with a view to closing possible gaps related to the differences in professional education.

300. In the ﬁeld of health, the concerned authority may request a conformity cer- tiﬁcate issued by the Italian Ministry of Health.

301. Pursuant to Article 31 (the principle of automatic recognition), professional titles in relation to medical doctors with basic training, medical specialists, general nurses, dentists, dental surgeons, veterinary surgeons and pharmacists are automatically recognized by the Ministry of Health with the same effects as titles issued in Italy for the same professions upon veriﬁcation of two conditions. The ﬁrst condition is that they must be in accordance with the minimum training conditions set out respectively in Articles 33, 34, 38, 41, 42, 44, 50 and 52 D.L. 206/2007 and the second is that they must be issued to EU citizens by other Member States. The reform extends the law also to Italian nationals who have completed a professional traineeship outside the national territory.

302. Articles 33–51 of D.L. 206/2007 define the specific training requirements for each profession and/or specialization in a rather detailed way. In case such requirements are not fulfilled (because of differences in the training requirements in the MS of origin), recognition can be subject to completion of an adaptation period not exceeding three years or an aptitude test, at the option of the applicant. Some- times specific rules are set down, for example, with regards to specializations obtained in certain MS countries (see, for example, Article 35 in relation to Spain). iv. Recognition of Study Certificates Obtained in Extra-Communitarian Countries 303. In order to obtain authorization to exercise a profession in Italy, all Italian and EU citizens that have obtained their qualifications in a non-EU country must submit an application for recognition of the title. This stands even if the title has already been approved in another country of the European Union. However, the Ministry of Health will take into account any additional training and professional activities carried out in another EU country.

304. For citizens that do not belong to the European Union, professional practice is conditioned by the rules related to their legal immigration status in the Italian territory.

305. D.M. 18 June 2002, integrated and amended by D.M. 2 August 2002 and D.M. 27 November 2002, authorizes Italian Regions to carry out the acts related to the recognition of certiﬁcates obtained in extra-communitarian countries regarding some health professions. The Decree indicates the procedural instructions to be

Medical Law – Suppl. 119 (2020) Italy – 109 306–309 Part I, Ch. 2, Practice of Medicine undertaken in recognizing foreign certiﬁcates. In particular, it stressed that the Min- istry of Health, which receives a copy of the request, has to verify the documents (Article 11 D.Lgs 206/2007). The formal recognition of the certiﬁcate has to be transmitted to the interested parties and to the institution that initiated the formal procedure.

306. In Italy, the Ministry of Health, on a case-by-case basis, also allows the pursuit of health professions to those who have obtained their expected qualifications abroad. In addition, the Ministry of Health must, at the request of an interested party, issue a conformity certification specifying that the training received meets the requirements set by the relevant Community directives. This generally applies to those who have acquired a professional qualification in Italy in the health area and plan to practise their profession abroad.

B. Visa

307. Non-EU citizens wishing to pursue their health profession in Italy must comply with immigration rules by obtaining the prescribed immigration visa.

308. All physicians (including national ones) must be enrolled in the provincial order of residence. The EU citizen professionals willing to provide their services on a temporary and occasional basis can even enrol upon previous notification to the Ministry of Health without the need to obtain an immigration visa (D.L. 206/2007). However, the Ministry of Health sporadically assesses the temporary and occasional nature of the service considering the nature of the service, the duration of the service itself, its frequency, its regularity and its continuity. When moving, the service provider is subject to the rules governing the exercise of the affiliated profession including the definition of the profession and the use of titles and professional liability linked directly and specifically to the protection and safety of consumers. In addition, the service provider is subject to the disciplinary provisions applicable to professionals who, on Italian territory, are members of the corresponding profession.

309. Any service provider that, according to Article 9 D.L. 206/2007, as amended by D. Lgs. n. 15/2016, moves for the first time to Italy with a view to providing services must notify the authorities – referred to in Article 5 – thirty days in advance (except in cases of urgency). They must provide a statement in writing fur- nishing information on the services they intend to carry out, as well as information on their insurance coverage or other means of personal or collective protection against professional liability. This statement remains valid until the end of the year in question but must then be renewed if the service provider wishes to continue to render temporary or occasional services in Italy. The service provider can supply the declaration by any suitable means of communication. The declaration must be substantiated by (a) a certificate or copy of a document certifying the nationality of the provider; (b) a certification from the relevant authority stating that the holder is legally established in the Member State in which activities are to be carried out and

110 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 310–314 that there is no practice prohibition, not even a temporary one, in place at the time of the declaration; (c) a document providing evidence of qualiﬁcations. Further- more, if at any time the situation of the service provider changes, the declaration referred to must be updated before practice can resume.

310. A copy of the declaration and accompanying documents is forwarded to the relevant provincial professional board for temporary automatic registration in a special list (Article 11). No person can exercise his/her medical profession (or any other health profession for that matter) if not duly enrolled in the relevant list at the Pro- vincial Council (but see infra 311).

1. Exemption from the Visa

311. Physicians, wishing to exercise their profession, who are citizens of another MS and are established in Italy, shall be subject to the disciplinary authority of the order of their registration. Those present in Italy to perform occasional services are not obliged to register with the provincial order. However, they are still subject to the obligations and disciplinary measures envisaged in relation to Italian professionals, and disciplinary action rests with the order connected to the jurisdiction in which the service is provided. See 308 supra 308–310.

2. Withdrawal of the Visa

312. Since health professionals are subject to the rules speciﬁc to their profession, their permit can be withdrawn according to the same rules established for Ital- ian members of the corresponding profession. See infra and see 505ff.

C. Inscription on the List of the Order of Physicians

313. In order to practise medicine, along with the proper training legally required, all EU citizen physicians must be registered at the competent territorial provincial order (Article 5 paragraph 2 D.L. CPS 23/1946, after the amendments of law 3/2018) even if they practice for a temporary period (see supra 308 and 311). See also 387–389.

§2. THE PRACTICE OF MEDICINE AND HEALTH-RELATED PROFESSIONS

I. General Introduction and Discipline

314. As anticipated (see 281ff), Article 99 of the Consolidated Text of Health Laws, approved by the R.D. 1265 of 27 July 1934, divided health workers in three categories:

Medical Law – Suppl. 119 (2020) Italy – 111 315–317 Part I, Ch. 2, Practice of Medicine

(1) Health professionals, (2) Auxiliary health professionals, and (3) Auxiliary skills of health professions.

315. This distinction lasted more than sixty years, until the legislator, at the end of the 1990s, instigated modiﬁcations eliminating all hierarchical structures among health professions. Law n. 42, of 26 February 1999, collates the categories outlined above into one denomination called ‘professioni sanitarie’, health professions. Later, Law n. 251, of 10 August 2000, sought to regulate nurses, obstetric, technical, rehabilitation and preventive health professions, by qualifying their university education and entrusting to the State and Regions the responsibility of promoting the development and valorization of these professions. The goals for these new professions included contributing to citizens’ right to health, transforming healthcare units into business units and improving the organizational and professional qualities within the NHS. The overall aim was the integration and harmonization of Euro- pean health orders in this area. As per the reform produced with law 3/2018 (Article 6), the deﬁnition of the functions characterizing the new health professions is done avoiding fragmentations and overlaps with the professions already recognized or with their specialization paths. This reform institutionalizes (Article 5) the area of social and health professions (paragraph 1) and provides for the possibility of identifying new socio-sanitary professions.

316. Subsequently, with Law n. 43, of 1 February 2006, the legislator established ﬁve groups of health professions and:

(a) conﬁrmed that nurses, obstetric, technical, rehabilitation and preventive health professions must be considered as those indicated in the cited Law n. 251, of 10 August 2000 (and of D.M. 29 March 2001); (b) pointed out that the exercise of such activities is subject to obtaining a university degree that must be valid on the national territory so as to be in line with the European normative framework concerning free professional movement; (c) gave the Government the power to adopt a legislative decree the aim of which was to institute, for the areas of nurses, obstetric, technical, rehabilitation, and preventive health professions, the related professional associations and the possibility of planning the organizational levels of these Orders in national, regional and provincial levels; (d) gave the Government the power to adopt a legislative decree the aim of which was to update the deﬁnition of professionals with a view to their inclusion in the categories of nurses, obstetric, technical, rehabilitation and preventive health professions.

317. In addition, changes in the evolution of healthcare organization and treatments have had an impact on medical professions, along with the acknowledgement of several ‘new’ professions related to health and healthcare. Indeed, a clear fram- ing of the (reserved and characterizing) activities and acts of physicians is progressively difficult considering the inﬂuence of several factors. For instance, medical activities are subject to increasing social and organizational constraints. Among the

112 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 318–319 former, medical autonomy is increasingly subject to socially accepted acts (e.g., the expanding role of informed consent). Among the organizational constraints, medical acts are indirectly shaped and deﬁned by both their interplay with other health professions (those that have been relieved of the hierarchical structure) and by the organizational structure of the healthcare system. For instance, medical doctors working in or for the healthcare system are called upon, by contract, to contribute to the pursuit of the goals of the facility in which they operate: in terms of cost containment, for example.

318. The absence of a shared deﬁnition in relation to the activities reserved to physicians is therefore problematic. Although useful in descriptive terms, even the deﬁnition offered at the European level by the Munich-Budapest (2005–2006) declaration of the European Union of Medical Specialists does not help much in practice. It states that:

The medical act encompasses all professional actions, for example scientiﬁc, teaching, training and educational, clinical and medico-technical steps, performed to promote health and functioning, prevent diseases, provide diagnostic or therapeutic and rehabilitative care to patients, individuals, groups or communities in the framework of the respect of ethical and deontological value. Conducting medical acts is the responsibility of, and must always be performed by, a registered medical doctor/physician or under his or her direct supervision and/or prescription.

319. Indeed, this is too broad and encompasses activities that are, to the contrary, clearly reserved to other health professions in Italy or activities that refer to several health professions. Although traditionally, diagnosis and proposed therapy were duties attributed to physicians, today these same duties are also claimed by nurses. After all, the Code of Ethics for physicians does not reserve diagnosis and therapy to physicians but actually uses a rather different language. Article 13 paragraphs 1 and 2 state:

The prescription of a diagnostic assessment and/or therapy engages the direct professional and ethical responsibility of the physician and can only be the result of a detailed diagnosis, or at least a diagnosis based on reasonable suspicion. Of course, any prescription should be based on available scientiﬁc evidence, optimal use of resources and respect for the principles of clinical effectiveness, safety and appropriateness.

On this basis the physician is accorded autonomy in programming, the selection and application of each diagnostic and therapeutic instrument, even on an inpatient basis, subject to the patient’s freedom to reject them and to assume the responsibility of the refusal.

Medical Law – Suppl. 119 (2020) Italy – 113 320–324 Part I, Ch. 2, Practice of Medicine

320. There are no general lists of reserved activities and even the Code of Eth- ics uses general expressions, ‘engaging’ the physicians in prescribing and administering treatments without expressly referring to reserved activities. This is likely due to the fact that the reform of the health professions has overcome a hierarchical and somehow anachronistic differentiation that existed among the various health professions according to which physicians were placed in a superior hierarchical position.

321. As a consequence of the above, there is no clear definition of what constitutes the practice of medicine and of the activities reserved to physicians. An idea can be grasped only upon description of the integration of the practice of medicine in the healthcare system and from some norms on specific activities or fields. See also 287, 288, 329ff, 339ff.

II. The Practice of Medicine and the NHS

A. Primary Care

322. Since the establishment of the NHS, general practitioners, paediatricians and physicians have provided primary care in both a self-employed and NHS contract capacity. These professionals are paid a capitation fee based on the number of people (adults or children) on their patient list (see supra 199ff). In recent years and according to the most recent legislation, primary care physicians are given ﬁnancial incentives to share clinic premises with their colleagues and contribute to emergency primary care. In order to become a primary care physician and potentially work in the NHS, physicians must successfully complete a two-year specialization course in general medicine and acquire clinical experience by acting as temporary staff members in NHS facilities. General practitioners and paediatricians are expected to provide most primary care and to act as gatekeepers for access to secondary services and pharmaceutical prescriptions (with incentives for reducing costs). They are supposed to visit patients at home if necessary, as well as vaccinate patients against inﬂuenza during the vaccination campaign period.

323. Individuals have a right to choose and change their general practitioner or paediatrician at any time, provided that the desired physician’s list has not reached the maximum number of patients allowed (1,500 for general practitioners and 800 for paediatricians). See 650.

324. As anticipated, the 1999 reforms, particularly the economic incentives enshrined therein, have led to an increase in group practice and the promotion of integration between primary care physicians and district services such as social care, home care, health education and environmental health. The legal structures of various resulting cooperations are different, but they generally all relate to teamwork. In base group practice (Medicina in associazione), three to ten general practitioners, while retaining their own offices, share clinical experiences, adopt common

114 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 325–327 guidelines and organize workshops aimed to assess the quality and the appropriateness of certain prescriptions. Network group practice (Medicina in rete) adds to the characteristics of base group practice by way of setting up a network through which the electronic health records of patients can be shared. According to the most integrated form of cooperation, so-called advanced group practice (Medicina di gruppo), three to eight general practitioners not only share the same office and electronic health records but they also provide primary care to patients that do not even belong to their particular catchment area. The Balduzzi reform has strengthened these practices: see 220.

B. Ambulatory Care

325. The ASLs or accredited public and private facilities with which ASLs have agreements and contracts provide specialist ambulatory services listed in speciﬁc formularies that vary among regions. People are allowed to access outpatient specialist visits, diagnostic and curative activities either directly or indirectly. Their general practitioner can refer them for a visit or procedure, and they are free to choose their provider among those accredited by the NHS. Alternatively, patients can obtain an appointment themselves through what is known as the central booking point (centro unico di prenotazione (CUP)) for the following health services: gynaecology, dental care, paediatrics (for those who have decided not to register their children with a designated paediatrician), optometric services and psychiatric services for children. Note that if patients select public ambulatory services, they must arrange visits via the CUP. In cases of emergency, the service is characterized by direct access to all health services.

326. Specialist ambulatory care suffers from long waiting lists and imbalances in terms of quality. For this reason, patients often opt to access services in private practice and sometimes even outside their own regions.

327. As anticipated, general practitioners are charged with a gatekeeping function in terms of their patients’ pathway to health, and their role is influenced accordingly. The first step to access specialist ambulatory care begins with a free visit to the general practitioner with whom the patient is registered. The general practitioner will then refer the patient to a specific hospital department. Once an outpatient hospital appointment has been secured, a specialist examines the patient. Depend- ing on the result of this, inpatient admission, surgery, primary rehabilitation and home care (home nurse and/or home assistance) will be considered. It might also occur that, if the patient needs post-acute care, the discharging hospital may refer him/her to a specific hospital for rehabilitative care. See supra 166.

Medical Law – Suppl. 119 (2020) Italy – 115 328–331 Part I, Ch. 2, Practice of Medicine

C. Secondary/Inpatient Care

328. Secondary inpatient care is provided by public and private entities. Those services encompass rehabilitation, intermediate care and long-term care. Rehabili- tation in the form of intensive care, for the post-acute phase of a disease when it is possible to positively inﬂuence the disablement, is carried out in AOs, and public or private hospitals. Intermediate care that encompasses those non-intensive interventions is carried out in long-term hospitals, outpatient settings, nursing homes and residential and semi-residential homes. For instance, elderly and disabled people in Italy can be treated both in residential or semi-residential facilities (residenze sanitarie assistenziali (RSA)) and in community home care facilities (case protette). The RSAs are normally used for patients whose health status requires intensive use of healthcare resources, while community home care is often utilized when patients do not have critical health conditions.

III. Speciﬁc Medical Activities

329. Only in a very limited number of instances does the law contain detailed rules regarding the medical (and non-medical) activities reserved to physicians (see, for instance, infra and 857). In addition, from these vague rules, it is difficult to decipher a meaningful deﬁnition of the practice of medicine or of what exactly constitutes a medical act. Nevertheless, some of the provisions offer useful indications to which we will refer (for detailed illustrations see infra 339ff; see also supra 317–321).

330. Law 29 December 1993, no. 578 (on the Standards for the Assessment and Certiﬁcation of Death), after deﬁning death as ‘the irreversible cessation of all brain functions’ (Article 1) establishes that:

the death of a patient with encephalic lesions who has been subjected to resus- citative measures must be ascertained by a medical board appointed by the health department, consisting of a medical examiner or, failing that, a medical doctor of the health department or by a pathologist, a medical specialist in anaesthesia and intensive care and a medical neurophysiopathologist or, failing that, by a neurologist or a neurosurgeon experienced in electroencephalogra- phy. The members of the medical board must be employees of public health facilities (Article 2).

The law also establishes that the participation of such boards in ascertaining death is compulsory. Not only this, physicians have a duty to call for such board intervention when in their opinion, the clinical conditions speciﬁed by law materialize (Article 3). See 1085ff.

331. Organ and tissue removal from corpses is regulated by Law 1 April 1999, no. 91 (Provisions for the Removal and Transplant of Organs and Tissues) and Law 12 August 1993 no. 301 (Rules on Removal and Grafts of Cornea). The former

116 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 332–335 reserves to physicians the role of providing information concerning the benefits of transplants, in particular in relation to potential donees (Article 3). Article 13 of the statute entrusts coordination functions concerning the structures in place for organ removal to a physician of the healthcare institution with territorial jurisdiction. The physician must have experience in the field of transplantation. Article 18 clarifies that ‘The physicians performing the removal and transplant must be different from those charged with finally ending the life of the patient. Medical and administrative personnel involved in sampling activities and transplantation are required to guarantee the anonymity of the data relating to the donor and the recipient.’ See also 1080ff.

332. Law 301/1993 reserves the ascertainment of death and the removal operations, to physicians (Articles 2–3). See infra 1056ff.

333. Organ removal from living persons is regulated by Law 483/1999 (on (partial) liver donation) the rules of which are also extended to Law 458/1967 on kidney transplant between living persons. It provides that ‘by way of derogation from the prohibition laid down in Article 5 of the Civil Code, kidney donation between living persons is permitted’ (Article 1).62 Clinical and surgical activities pertaining to these procedures are reserved for physicians. See infra 1042 and 1054ff.

334. The statute on medically assisted procreation (Law 40/2004) reserves to physicians a signiﬁcant role in certifying the medical conditions permitting access to the procedures (Article 4) and in informing the couple ‘on methods, on bioethical issues and possible psychological and physical side-effects resulting from the application of the techniques themselves, the chances of success and the risks of the procedure, as well as the legal consequences for the woman, the man and the unborn’ (Article 6). Strangely enough, the same physician is called upon to illustrate the possibility of recourse to procedures for adoption or foster care according to existing law. The statute (Article 16) also regulates moral objection in order to ‘exempt health personnel and auxiliary health operators from procedures and activities spe- ciﬁcally and necessarily designed to determine the involvement of medically assisted procreation but not from care antecedent and consequent to the procedure’. See also 100ff, 330ff, 1014ff.

335. Similar provisions on moral objections are contained in Law 22 May 1978, n. 194 which sets down the rules in relation to the social protection of motherhood and on abortion (Article 9). The statute speciﬁes the physician’s role in prescribing treatments for contraception (Article 2), in certifying the health status of the patient in granting access to abortion, in assisting the pregnant woman in her choice, and in certifying the speciﬁc cases according to which abortion is permitted beyond the

62. The provision continues setting that ‘The exemption is allowed to the parents, children, siblings or non-siblings to the patient that are of majority age, provided they comply with the provisions of that law. Only in the event that the patient does not have blood relatives mentioned in the preceding paragraph or none of them is appropriate or available, the derogation may be permitted for other relatives and unrelated donors.’

Medical Law – Suppl. 119 (2020) Italy – 117 336–339 Part I, Ch. 2, Practice of Medicine ninetieth day of pregnancy (Articles 6–7). In relation to the performance of abortion procedures, the statute makes reference to particular physicians employed at designated hospital facilities equipped to carry out the procedure (Article 8).

336. D. Lgs. 24 June 2003, n. 211 (implementing Directive 2001/20/EC on Good Clinical Practice (GCP) in clinical trials of drugs for clinical use), deﬁnes (in Article 2) the investigator for clinical trials as ‘a physician or dentist qualiﬁed for the purposes of experimentation, responsible for the execution of the clinical trial at a particular centre’ and reserves such practice to such individuals (Article 3).

337. The Regulation for the simpliﬁcation of procedures for the assessment and control of new systems and experimental treatment protocols (Decree of the Presi- dent of the Republic 21 September 2001, no. 439) offers insights in relation to medical activities in the ﬁeld of experimental treatment and, in addition, experiments with animals.

338. Decree-Law no. 26 of 4 March 2014 (implementing Directive 2010/63/EU on the protection of animals used for scientiﬁc purposes) repealed D. Lgs. 27 Janu- ary 1992, n. 116 that provided (Article 4): ‘The experiments must be carried out directly, or under their direct responsibility, by graduates in medicine and surgery, veterinary medicine, biology, natural sciences or by persons possessing any other qualiﬁcation recognized as suitable and equivalent.’ Today, Article 24 law 26/2014 states:

Each breeder, supplier or user [] of animals for experiments must have a designated veterinary surgeon, expert in laboratory animal medicine, with experience and speciﬁc training requirements, who prescribes the modalities for the welfare and therapeutic treatment of animals.

Law no. 12 October 1993. 413 (containing the regulations on moral objections to animal testing) provides that (Article 2):

Physicians, researchers and healthcare professionals who have assumed the role of graduate professionals, technicians and nursing staff, as well as interested university students, who have declared their moral objections, are not required to take part directly in the activities and interventions speciﬁcally and necessarily involving animal testing.

A. Preventive Medicine

339. In the absence of a general list of reserved medical activities, it is assumed that acts aimed at the prevention of diseases are not abusive exercises of the profession as such. Nevertheless, several preventive activities, such as vaccinations, are either reserved to or must be held at healthcare facilities and by health professionals. This is the case, for example, in relation to the administration of vaccinations within the framework of preventive campaigns.

118 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 340–342

B. Self-care

340. By deﬁnition, self-care cannot be considered an illegal practice of medicine. In triggering criminal sanction, the activity in question must be addressed to third parties (see 361). In addition, several legal provisions in relation to the overall structure of healthcare delivery and access to drugs (for instance, over-the-counter and self-medication) presuppose a large discretion for individuals in the area of self- care. For instance, blood pressure and other simple tests can be undertaken by patients themselves and several pharmacies are enabled to offer help in their interpretation. See infra 345 and supra 229 and 231.

C. Taking of Blood: Venepunctures

341. See also 281 and 1071. The collection and use of human blood for transfusion is part of the process of treating pathologies. Law no. 107 of 4 May 1990, ﬁrst regulated this activity. It is now regulated by Law no. 219, of 21 October 2005 on the domestic production and transfusion of blood and blood products. The statute regulates (Article 2):

transfusion activities or activities relating to the promotion of blood donation, the collection of whole blood, blood components and autologous hematopoietic, homologous and cord stem cells; fractionation by simple physical means; validation, storage, and distribution of human blood and its components, as well as the activities of medical transfusion and the manufacturing of drug blood products.

These activities are directly or indirectly the responsibility of physicians. The notion of blood transfusion itself in fact infers a certain aspect of advertising or promotion.

342. The drawing of blood is not a medical act as such, but it has to be performed under medical supervision. For instance, in relation to the blood sample that must be drawn following a road traffic accident so as to check blood-alcohol levels, pursuant to the old version of Article 186 paragraph 5 of D.L. 30 April 1992 n. 285, it was required that ‘the sampling shall be performed under the direct supervision of a physician of the hospital to which the subject has been admitted for treatment as a result of the road accident in which s/he was involved’. However, the actual version in force has been modiﬁed, and it is now unclear whether supervision is still requested: ‘the veriﬁcation of the alcohol level is carried out, … , by the basic health structures or by those accredited or in any case for such purposes treated as such’.

Medical Law – Suppl. 119 (2020) Italy – 119 343–346 Part I, Ch. 2, Practice of Medicine

D. Radiographies

343. Radiation protection is a highly regulated area from which indications on reserved activities for physicians can be derived. For instance, D.L. of 17 March 1995, no. 230 (implementing Directives 80/836, 84/467, 84/466, 89/618, 90/641 and 92/3) concerning the ﬁeld of ionizing radiation sets down the role of physicians in monitoring the phenomena and accessing collected data. D.L. of 26 March 2001, no. 151 (consolidated text of the laws on the protection and support of motherhood and fatherhood) excludes pregnant women from medical activities that would expose them to radiation risks. Law 39/2002, implementing several Euratom directives, delineates the role of ethical committees in biomedical research programmes.

344. However, with regard to the practice of radiography, technicians must take the X-rays but only a physician can produce a medical report or a diagnosis on their basis. It is the role of technical medical radiologists, as per D.M. 14 September 1994 n. 746, to perform – on medical prescription – autonomously, or in collaboration with other health professionals, all operations that require the use of ionizing radiation, both artiﬁcial and natural, of thermal, ultrasonic, or nuclear magnetic energy not to mention those interventions dealing with physical and dosimetric protection. In order to act as a radiographer, a bachelor’s degree is required and obtained after attending a ﬁrst-level university course in Techniques of Medical Radiology or Imaging and Radiotherapy at the faculties of medicine and surgery.

E. Blood Pressure Measuring and the Use of Other Simple Measuring Appliances

345. As mentioned elsewhere (see 340), blood pressure and other simple tests can be self-executed by patients, and several pharmacies are enabled to offer help with regard to their interpretation. Of course, this does not mean that a diagnosis can be made from the results. Such testing is routinely used rather for monitoring chronic disease or sudden situations. Pharmacists have to refer to medical advice if the results are beyond the natural parameters or if other factors suggest this course of action.

F. Eye Examination and the Measuring of Eye Deviations

346. Optometrists offer one exception. A judgment of the Supreme Court (Pub- lic hearing of 11 April 2001, n. 42895/2001 general role; judgment number 595) has ruled that the optometry profession in Italy is not prohibited from carrying out eye examinations or from measuring eye deviations. Indeed, it is considered a free profession. This judgment essentially distinguished ophthalmology from the medical profession. Nevertheless, an optometrist cannot carry out the functions of medical ophthalmology, manage diseases, prescribe therapies or advise the client on the medical disorders s/he presents with. The activity of the optometrist responds to the regulations in relation to the production of medical devices [D.L. 24 February 1997,

120 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 2, Practice of Medicine 347–350 no. 46 implementing Directive 93/42/EEC]. The optometrist is qualiﬁed therein as a manufacturer of tailored medical devices, ‘and not as a mere assembler’. With the exception of protective glasses and the correction of simple defects relating to myo- pia and presbyopia, optometrists can pack, prepare and sell glasses and lenses only when directed by a physician’s prescription. To the contrary, corrections of hyper- metropia, astigmatism and aphakia are excluded by statute from the span of their activities (Article 12 of R.D. 1334/1928).

G. Psychoanalysis and Psychotherapy

347. It is beyond doubt that psychoanalysis and psychotherapy are activities to be carried out by health professionals. According to law, the exercise of psychotherapy is subject to a speciﬁc vocational training, to be obtained by following a degree course in psychology or in medicine and surgery that included at least four years of specialization courses (Article 3 Law 18 February 1989, no. 56). Non- medical psychotherapists are forbidden to carry out any activity that is the sole responsibility of the medical profession. In other words, they are forbidden from performing any medical actions that go beyond the limits of psychotherapy.

348. All psychotherapists must be enrolled in the Register of Psychologists and are bound – as all professionals – by a duty of conﬁdentiality sanctioned by Article 622 cp. Their provincial council deals with the enrolment of psychotherapists. It possesses all disciplinary powers in cases where the enrollee is found guilty of abuses or failures in exercising the profession or where s/he has behaved in a manner inconsistent with dignity or professional decorum.

H. Group Therapy

349. The status of psychotherapy with reference to the notion of medical acts was rather unclear. However, once it was acknowledged by law that psychotherapy must be performed by a specialist in possession of a basic degree in psychology or medicine, all therapies scientifically recognized were included among those reserved to these health specialists. All abuses including performance in the field by individuals not duly trained and enrolled in the pertinent Register constitute a crime. Yet, we should distinguish those group therapies scientifically recognized and used by psychologists and the side effect that procedures, such as mediation, can have in overcoming the psychological problems of individuals and their mutual rapport.

I. Acupuncture

350. According to case law (Cass, Criminal Section VI, judgment 21 May 2003 no. 22528) acupuncture – like other therapies such as ‘homeopathy’, ‘homotoxicol- ogy’, ‘physiotherapy’ and other homologous therapies – is considered among the

Medical Law – Suppl. 119 (2020) Italy – 121 351–352 Part I, Ch. 2, Practice of Medicine

‘unconventional’ therapeutic practices requiring specific knowledge of medical science. These therapies revolve around the materialization of a significant medical act consisting of the diagnosis of an organic or a functional disorder of the body or mind and the identification of corresponding remedies and their administration by the physician making the diagnosis or by paramedical staff under the direct supervision of a medical doctor. Accordingly, a person, who exercises acupuncture without having a degree in medicine, commits the crime of unauthorized practice of the medical profession pursuant to Article 348 cp.

351. Indeed, according to the Supreme Court, acupuncture is an invasive therapy that, in addition to the typical hypnotic and anaesthetic effects it causes to the patient, is exposed to all the risks associated with treatments of this nature. These include risks of serious injury caused by inappropriate invasions of parts of the human body, not to mention the risk of infection related to the use of unsterilized needles in accordance with the standards currently stipulated and regularly monitored by healthcare services. Indeed, several Regions have begun to directly provide acupuncture on a fee-for-service or co-payment basis. See supra 173.

J. Written and Oral Advice and Recommendations

352. As mentioned above, there is no clear-cut deﬁnition of medical activities that trigger the abusive exercise of the profession. Accordingly, generic written or oral advices and recommendations do not as such automatically amount to the illegal practice of medicine unless they lead to an actual diagnosis or the treatment of diseases.

122 – Italy Medical Law – Suppl. 119 (2020) 353–358

Chapter 3. Illegal Practice of Medicine

§1. LEGAL DEFINITION OF THE OFFENCE

353. The practice of medicine without proper training, demonstrated by passing the state examination and enrolment in the Register of the pertinent Provincial Order, amounts to a crime pursuant to Article 348 cp. The situations covered by Article 348 of the Criminal Code protect the interest of the public administration by providing for a complex organizational set of norms that regulate the professions with a view to reserving their exercise only to persons in possession of special quali- ﬁcations (see 272).

354. Article 348 cp regulates the abusive exercise of a profession providing that ‘Any person who abusively exercises a profession, for which a special certiﬁcation of the State is required, shall be punished with imprisonment from six months to three years and a ﬁne from 10,000 to 50,000 euros.’ See also 336.

355. The special certification required by law for several professions of high social relevance presumptively guarantees both professional and moral requirements in an attempt to avoid citizens running into inexperienced subjects exercising a profession, or into those who exercise it in an unworthy manner. The provision, first introduced in the new Criminal Code, is not a corporative protection but rather a rule aimed at the protection of the general interest. Such an interpretation is confirmed by the fact that courts construe the rule for physicians and other health professionals in a very stringent manner since the fundamental right to health is at stake.

356. It is noteworthy that case law, especially that in relation to physicians, does not require habitual abusive practice of the profession but rather one single activity can trigger the crime. In addition, the abusive exercise is punished as such (as a so-called crime of danger) without requiring an actual harm to health.

§2. WHO ISANUNAUTHORIZED PERSON (CRIMINAL AND CIVIL CONSEQUENCES)

357. An unauthorized person is any individual who does not have or no longer has one of the requirements to be considered part of the profession (see 289ff). Accordingly, an active subject is a person pursuing a profession either without the required qualification, without the formalities prescribed or a person who has been disbarred or perpetually or temporarily disqualified or suspended. The lack of special qualification is often equated with fraudulent registration made through the sub- mission of fictitious documentation.

358. It is not essential that the abuse in question be continual or publicly conducted. Essentially, what is condemned is the de facto exercise of the profession.

Medical Law – Suppl. 119 (2020) Italy – 123 359–361 Part I, Ch. 3, Illegal Practice of Medicine

359. From a private law point of view, the intellectual service provided by individuals not enlisted in the relevant professional register, simply infers the invalidity of the contract between them and the client. As a consequence, the professional not enlisted loses the right to remuneration and the possibility to exercise action for payment. Actually, the client would even have the right to request reimbursement of any amounts already paid. Indeed, Article 2231 of the Civil Code states that ‘non- payment for services performed by those not enlisted in the registers is not actionable’.

360. Nevertheless, it would follow from such an interpretation that ‘suspended’ or ‘disbarred’ professionals could continue to practise without actually being criminally penalized since they in any case possess the qualifying title. This obviously would defeat the very purpose of the professional requirement to register and would render meaningless the very aims the legislature had in mind in establishing the Pro- fessional Orders. Instead, a disqualiﬁcation order or a suspension order imposed by criminal court judgments, ancillary to the main criminal sanctions, would have a different result. In such instances, case law clearly states that disobeying the Order would give rise to an offence punishable pursuant to Article 348 cp. However, the majoritarian view is that anyone carrying out an occupation that a provision of law expressly reserves to persons appropriately registered is deemed, in the absence of such registration, to be acting in an unauthorized manner. Yet, it is disputed among scholars and in case law whether or not Article 348 cp. also applies to cases concerning non-registration in the provincial order where this is required as a necessary condition for pursuing the profession. Indeed, the typical function of the Registers is essentially to ensure presumptive certainty for the protection of public faith on the technical preparation and the moral seriousness of the registered members. As speciﬁed by courts (Cass. Criminal Section, 17 October 2001, in CED Cass., RV. 220186): ‘current enrolment attests – in the general interest – [that professionals] meet the requirements of integrity and technical competence necessary for the exercise of the profession’. In literal terms, the abusive character mentioned by Article 348 refers to all of the requirements for the exercise of a profession. Therefore, it would be legitimate to equate non-registration to the lack of authorization where the professional laws also require such an additional requirement for the performance of professional duties. See also 272.

§3. THE CONDUCT

361. One requirement for the realization of the crime is that the activity is carried out on third parties, regardless of whether or not it is done for proﬁt. Further- more, individual acts, in order to assume criminal relevance, must, in themselves, produce the criminal result prescribed by the norm. The role of individual actions for the purposes of constituting a crime under Article 348 cp. is strictly connected to the legally protected values exposed to danger by the abusive exercise of the profession actually performed. In the absence of a clear description of the activity of the profession, some courts have drawn a distinction between acts ‘typical or reserved’ to a profession, the realization of which sets off the crime related to Article

124 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 3, Illegal Practice of Medicine 362–365

348 cp. Accordingly, acts ‘characteristic’ of the profession, that although ‘relatively free’, if carried out in a repeated way, become signiﬁcant in criminal terms (Court of Taranto, 25 January 1989, in Riv. Pen., 1989, 1121, Cass. Criminal Section, 8 October 2002, in Cass. Criminal Section, 2004, 849). These decisions consider that not only those acts normally attributed to the profession but also acts instrumentally connected to the characteristic acts mentioned amount to a crime as per Article 348 cp. provided that they are made on an ongoing and professional way. This solution, however, has not been unanimously accepted in case law for reasons related to concerns not to interfere with the stringent nature of criminal provisions.

362. Indeed, there are particular acts reserved to each profession, and acts, which, although characteristic of professional performance, can be made by anyone. However, after the elimination of ‘mansionari’ (job descriptions for health professions), the area of uncertainty between lawful and unlawful acts is left to the discretion of the judge who makes a value judgment on the concept of exclusive or reserved acts to the profession.

363. A different legal situation is triggered when an individual publicly declares that s/he has obtained speciﬁc training or specialization. This constitutes a different crime (usurpating titles or honours) punishable by Article 498 cp. that criminalizes the public adornment of the distinguishing signs of a profession for which special state authorization is required.

364. Speciﬁc laws and the code of professional ethics (see Article 56 CME) sanction public declarations of holding title(s) and specialization(s). On these matters, the Supreme Court (Civil Section III, no. 3717/2012) considered that, with a view to applying the disciplinary sanctions, the Order has the power of veriﬁcation on the advertising for its transparency and truthfulness based on the Code of Ethics and on objective parameters.

§4. SANCTIONS

365. The sanctions have been modiﬁed (aggravated) by law 3/2018. See 272.

Medical Law – Suppl. 119 (2020) Italy – 125 366–371

Chapter 4. Control over the Practice of Medicine

§1. THE ORDER OF PHYSICIANS

366. Health professions are those the Italian State recognizes and that, pursuant to a qualifying title, engage in prevention, diagnosis, treatment and rehabilitation. Some healthcare professions are constituted in Orders or Colleges with offices in each of the provinces of the country.

367. Currently, we can ﬁnd: provincial orders of surgeons and dentists; veterinarians provincial orders; provincial orders of pharmacists; provincial colleges of midwives; provincial colleges of nurses, healthcare assistants and childcare professionals (Infermieri Professionali, Assistenti Sanitari e Vigilatrici di Infanzia IPASVI); and the provincial colleges of sanitary technicians in medical radiology (radiographers). In relation to disciplinary matters, matters concerning the maintenance of the official registration list and on election of the governing bodies, appeals may be lodged to the Central Commission for Healthcare Professionals (Commis- sione centrale per gli esercenti le professioni sanitarie, hereinafter ‘CCEPS’). See infra 393ff and 436ff.

368. The provincial orders governing physicians are public institutions established again by D.L. CPS 13 September 1946, no. 233 as modiﬁed in its Chapters I-III by law 3/2018.

I. Historical Note

369. Historically in Italy, the Orders of physicians were established for the first time by a law enacted on 19 July 1910. This law established that the Provincial Council of the Order, composed of five or seven members, ought to be elected by a majority vote. It had the duty to ‘ensure the preservation of the decorum and independence of the Order’, ‘to repress disciplinary abuses and deficiencies of which physicians are found guilty’ and ‘to intervene, if required, in disputes between or among physicians themselves and physicians and clients, in matters relating to costs, fees or other matters relating to the exercise of the profession, providing the conciliation of the dispute and, in the event of a failed agreement, giving their views on the same dispute’ (Article 8). The Orders were, however, prohibited from interfering in the relationship between physicians and municipalities, which at that time were the cause of most of the litigation, based either on the allocation of public medical offices or on the application of the sanitary laws.

370. Women could be enlisted if they had enjoyed civil rights and the related professional degree that gave the right to practise the profession in the Italian King- dom, its colonies and protectorates.

371. The provincial orders and the national federation were weakened and eventually cancelled and replaced by fascist unions during the fascist era.

126 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 372–378

II. Registration on the List of the Order

372. Pursuant to Article 5 paragraph 3 D.L. C.P.S 13 September 1946, no. 233, as modiﬁed by Article 4 law 3/2018 in order to be registered, it is necessary to: a) have full enjoyment of civil rights; b) possess the prescribed title and be qualiﬁed to practise professionally in Italy; c) have a residence or domicile or practise one’s profession in the district of the Order.

373. With reference to non-Italian physicians, Article 5, paragraph 4 clariﬁes that ‘Without prejudice to the provisions of Legislative Decree no. 206 of 9 Novem- ber 2007 on the recognition of professional qualiﬁcations, foreigners may be entered in the register if they meet the requirements of paragraph 3 (see 372), and are in compliance with the rules on entry and residence in Italy’ (see also supra 291ff for exceptions for EU nationals).

374. In order to obtain registration, the physician must attach to one’s own application a series of documents. Physicians working full-time for public administrations are exempt from this requirement (Article 5 D.P.R. 5 April 1950, n. 221).

A. Obligation to Register on the List

375. As mentioned, Article 5 D.L. C.P.S 13 September 1946, no. 233, as modi- ﬁed by law 3/2018, requires enrolment in the Register of the Order for medical practice. In addition, Article 13 (Article 5 D.P.R. 5 April 1950, n. 221) provides that enrolment in the Register entitles free exercise of the profession in the province where the Register is located and on the whole territory of the Republic.

376. Registration is denied in cases pursuant to Articles 42, 43 and 50 of D.P.R. 5 April 1950, no. 221 (statutory debarment or suspension).

377. Statutory debarment is provided for in Article 42 in cases of:

– a judgment for an offence under the Criminal Code according to Articles 446 (fraudulent or clandestine trade of drugs), and for any other intentional crime for which the law imposes a term of imprisonment not less than a minimum of two years or a maximum of five years; – disqualification from holding public office either for good or for a term exceeding three years and the interdiction by profession for the same duration; – hospitalization in a mental judicial hospital [closed by of D. Lgs. 22 December 2011, n. 211] in the cases specified in Article 222, second paragraph, of the Criminal Code (see infra 968); – the application of preventive security measures.

378. Statutory suspension is provided for in Article 43 in cases concerning:

– the issuance of a warrant or an arrest warrant;

Medical Law – Suppl. 119 (2020) Italy – 127 379–382 Part I, Ch. 4, Control over the Practice of Medicine

– the provisional application of a corollary punishment or a security measure ordered by the court, pursuant to Articles 140 and 206 of the Criminal Code; – disqualiﬁcation from public office for a period not exceeding three years; – the application of security measures predicted by Article 215 of the Criminal Code, Section two (admission to a nursing home and care or hospitalization in a mental hospital); – the application of a non-custodial security measure anticipated in the cited Article 215 of the Criminal Code, third paragraph, nos. 1, 2, 3 and 4 (probation – prohibiting residence in one or more municipalities or in one or more provinces – a prohibition from entering taverns and licensed public premises – expulsion of a foreigner from the national territory).

379. The Council declares both debarment and suspension. In addition, the Council may impose, after hearing the professional, his/her suspension if warned by the public security authorities or if a warrant or subpoena has been issued against him/her without prejudice to the subsequent sanctions.

B. Exceptions

1. Nationals of EC Member States

380. As mentioned supra (see 309) EU nationals who are established physicians can provide medical services upon producing a prior declaration that is sent in copy to the relevant provincial Order of Physicians with jurisdiction for temporary enrolment in the Register. In case of urgent matters, the declaration can be made later, but it should be made as soon as is possible. In any case, the physicians are subject to all the rules and obligations (including disciplinary and deontological ones) regulating Italian physicians.

2. Military Doctors and Physicians Working Exclusively for the NHS

381. Provisions of Article 5 D.L. C.P.S 13 September 1946, no. 233, as modi- ﬁed by law 3/2018, and Article 5 D.P.R. 5 April 1950, no. 221 are unclear as to whether physicians practising exclusively within an employment relationship – or by exclusive agreements – such as military doctors or doctors within the NHS are required to register at the Provincial Order of their residence. All other relevant legal provisions make reference to the freelance exercise of the profession. A ﬁrst line of cases in court, still followed by FNOMCEO, sustains the duty for all graduated medical doctors to register in the list of the Provincial Order of their residence.

382. In 2004, the Council of State resolved the issue of mandatory enrolment for healthcare professionals employed by the Government stating that the obligation of enrolment applies only to professionals, not to health professionals who are exclusively civil servants, unless they are also permitted to exercise in private practice as freelancers. The opinion expressed in 2004 (Consiglio di Stato, sez. I, 17 March

128 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 383–385

2004, n. 133) is in line with the Court of Cassation Decision of 2003 (section VI, judgment no. 28306, conﬁrmed by Cass.civ.sez.III, n. 13004/2006) and essentially sets aside the rules providing for the requirement of inscription for access to the roles of health professionals in the NHS (DPR 483/1997 and Presidential Decree 220/2001). Article 2 paragraph 3 of Law 43/2006 prescribes for health professionals (but it does not mention physicians expressly) the registration in the list of their relevant Provincial Order, also for professionals who are exclusively civil servants, as compulsory. Subsequently, the Supreme Court speciﬁed (Court of Cassation no. 7776/2015) the general principle that if the exercise of the profession is carried out in the exclusive interest of the employer, the payment of the registration fee of the employee entered in the Register is to be borne by the employer, is part of the costs for the performance of activities that must be borne by the institution itself, and if such payment is advanced by the employee must be reimbursed by the institution itself.

383. Nevertheless, Article 68 of the Code of Ethics provides that ‘Physicians who provide their services throughout a relationship of employment or agreement as part of public or private health facilities are subject to the disciplinary authority of the Order also in respect of obligations connected with the employment or convention.’ It is our opinion that Article 68 rightly provides a guarantee to the public concerning medical professionalism. Moreover, the Italian legal system already provides that EU physicians authorized to practise in Italy are enrolled in the Register of the Provincial Order and are subject to all rules (including disciplinary powers) that Italian physicians are subject to (see 308 supra, 309 supra, 310 supra). There- fore, even if not enrolled in the pertinent register, all physicians are in any event subject to both deontological rules and disciplinary authority in cases of violation.

C. The Obligation to Register and the Freedom of Association

384. Since the early 1960s, the Constitutional Court has repeatedly conﬁrmed the constitutional legitimacy of the obligation of enrolment in professional bodies (Cost. no. 69 of 1962, and no. 11 and 98 of 1968). Article 18 of the Constitution guarantees the freedom of association as positive freedom and as negative liberty (the freedom not to associate). However, in the latter case, the Constitutional Court has made clear that it does not impair the power of the State to create institutions of associative structures for the achievement and the protection of public purposes. Hence, the requirement of enrolment in such institutions poses a limit to the freedom not to associate, a limit permitted for the protection of other interests constitutionally guaranteed.

385. The legal recognition of associations of those freely exercising an art or profession aims to protect both the individuals who use the services of professionals and the professionals themselves. The legal regulation of the professions is based on enrolment in the Registers, which implies the existence of certain guarantees and other requirements, the use of disciplinary powers against members, and the safeguarding of the interests of the corporation.

Medical Law – Suppl. 119 (2020) Italy – 129 386–394 Part I, Ch. 4, Control over the Practice of Medicine

D. Competent Provincial Council

386. The competent provincial council concerned with registration, disciplinary and all other matters, is that in which the professional is enrolled. Physicians must enrol in the Register kept by the Order of the province in which they have their residence (D.P.R. 5 April 1950, n. 221).

387. The application for registration must ensure the following requirements are met: a) to have full enjoyment of civil rights; b) to possess the prescribed title and to be qualiﬁed to practise professionally in Italy; c) to have a residence or domicile or to practise one’s profession in the district of the Order.

388. Pursuant to Article 5 paragraph 4, of D. Lgs. 13 September 1946, n. 233 as modiﬁed by law 3/2018, foreign physicians must submit their application following the same rules as Italians, demonstrating they can fulﬁl the same requirements and are in compliance with the rules on entry and residence in Italy.

389. The old requirement of a certiﬁcate of good standing issued by the Mayor of the place of residence for those residing in Italy since less than three months has been de facto suppressed by the new Article 5 paragraph 4 of D. Lgs. 13 September 1946, n. 233.

E. Refusal or Delay of Registration

390. Pursuant to Article 3 of D. Lgs. 13 September 1946, n. 233, the Council must decide on the application for registration. Pursuant to the reform, the following procedural rules are not provided for by law but remain in practice. The decision must be motivated in each case.

391. News of the performed registration or rejection of the application is con- veyed to the person concerned.

392. The registration is carried out after the person concerned has furnished proof of actual payment of the required tax on government concessions.

393. Still Article 3, paragraph 4 provides that the applicant may appeal to the Central Commission for Health Care Professionals (CCEPS) against the resolution stipulating rejection of the enrolment application. The Commission shall decide on the enrolment.

F. Registration after Being Struck Off the Register

394. Article 50 D.P.R. 5 April 1950, no. 221 provides for re-registration after debarment. The debarred physician may be enrolled again after ﬁve years have

130 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 395–398 elapsed since debarment. If debarment resulted from a criminal conviction, the physician must be rehabilitated. In any case, it must be clear that the debarred, after being discharged, has maintained irreproachable conduct (see CCEPS nos. 30/2010 and 40/2010).

395. The Council is responsible for re-entry after debarment observing the provisions that regulate initial enrolment.

G. Removal from the List

396. Removal from the list can be the result of debarment, temporary suspension, ex officio in cases of death (although this is not speciﬁcally provided for and stems from the duty to revise and update the list by December of every year (ex Article 1 D.P.R. 5 April 1950, no. 221) or of the free choice of the physician.

397. Statutory debarment is commanded in the hypotheticals provided for in Article 42 that is in the case of:

– a judgment for an offence of any intentional crime for which the law imposes a term of imprisonment not less than a minimum of two years or a maximum of five years; – disqualification from holding public office either for good or for a term exceeding three years and the interdiction by the profession for the same duration; – hospitalization in a mental judicial hospital in the cases specified in Article 222, paragraph 2, of the Criminal Code (but see 968); – the application of preventive security measures.

Physicians are temporarily removed from the list (suspended) by default (Article 43) in case of:

– issuance of a warrant or an arrest warrant; – provisional application of a corollary punishment or a security measure ordered by the court, pursuant to Articles 140 and 206 of the Criminal Code; – disqualiﬁcation from public office for a period not exceeding three years; – application of security measures predicated by Article 215 of the Criminal Code, section two, nos. 2 and 3 (admission to a nursing home and care or hospitalization in a mental hospital); – the application of non-custodial security measures anticipated in the cited Article 215 of the Criminal Code, paragraph three nos. 1, 2, 3 and 4 (probation – prohibiting residence in one or more municipalities or in one or more provinces – a prohibition from entering taverns and licensed public premises – expulsion of a foreigner from the national territory).

398. Any member who, by her conduct, has seriously damaged her reputation and dignity or that of the entire class of medical physicians can be debarred (Article 41). See infra 402.

Medical Law – Suppl. 119 (2020) Italy – 131 399–402 Part I, Ch. 4, Control over the Practice of Medicine

III. Disciplinary Competence of the Order of Physicians

A. Control over the Observance of the Rules of Professional Ethics

1. General Description of the Disciplinary Competence

399. The most relevant norms ruling disciplinary powers are the following:

– Article 2 Code of Ethics ‘Powers and disciplinary sanctions’. – Article 67 Code of Ethics ‘Abusive exercise of the profession false imperson- ation’ Article 3 lett. f; see also DLCPS 09/13/46 no. 233). – Articles 38–52 DPR 05/04/50 no. 221. – Chapter IV ‘Of the disciplinary sanctions and the related procedure’. – Article 6 of Law no. 409, 24 June 1985. – Section 8 of Law no. 175, 2 May 1992. – Judgments of CCEPS (accessible online: http://www.salute.gov.it/cceps/ homeCceps.jsp).

400. Provincial Councils have competence over their registered members (Article 38 of P.D. 5 April 1950 no. 221) in relation to abuses or deﬁciencies in the profession and for discreditable facts of professional decorum. The same competence arises for medical doctors, regardless of their registration in the list, who commit actions/omissions subject to disciplinary proceedings in the territory of the Provincial Order. The disciplinary procedure is initiated ex officio or at the request of the Prefect or the Public Prosecutor.

401. Law 409/1985, establishing the profession of dentistry, has conferred the Provincial Council jurisdiction on the Commission to regulate the Members of the Order of Physicians and Surgeons and on the Committee for Members of the Order of Dentists, conferring competence, in relation to the recognition of qualiﬁcations, to the territorial jurisdiction. When the fact that led to the disciplinary proceedings is not relevant to one of the two speciﬁc professions but relates in general terms to the professional activity, and in the case of double registration of the professional, both Commissions have jurisdiction.

402. The non-observance of the precepts, obligations and prohibitions laid down in the rules of professional ethics (code of professional ethics) and any act or omission that harms the decorum or the proper exercise of the profession are punishable by disciplinary committees with the penalties provided for by law. The sanctions, under the disciplinary jurisdiction, must be commensurate with the seriousness of the acts/omissions complained of. Of course, such an open clause is difficult to inter- pret and apply. Consider also that sanctions should be commensurate to the seriousness of the ‘offence’. However, formally at least, there is no minimum level of violation required.

132 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 403–408

403. Registered physicians (and in general medical doctors) are obliged to observe the rules of ethics (professional ethics) independently developed by the body of the profession and collected in a special code that establishes the duties proper to that of the profession.

404. Accordingly, the Councils are responsible for disciplining any misconduct by their registered members (or in any event committed in their territory by medical doctors), be it or not within the scope of their professional activity insofar as it is considered harmful to professional decorum or proper exercise of it. For this reason, disciplinary measures are laid down in statutory provisions (see Article 40 D.P.R. 5 April 1950, n. 221) for the more serious instances of misconduct.

405. Physicians must report any initiative giving rise to non-compliant behaviour in professional ethics, from whatever source it may come, to the Order (Article 2 Code of Ethics).

406. General competence lies with the disciplinary committees established at every provincial council according to the distinction between medical doctors and dentists (see supra 401 and 404).

2. Rules of Professional Ethics and Standards of Discretion, Probity and Dignity a. The Code of Professional Ethics 407. It is one of the primary roles of the National Council of the National Fed- eration (FNOMCEO) that reunites all Provincial Orders of Physicians (OMCEO) (see 470) to deﬁne the principles and rules that the physician-surgeon and the dentist must observe in exercising the profession and towards which they shall orien- tate their behaviour even beyond the actual exercise of their profession. At all times, the CME ‘engages the doctor in the protection of individual and collective health by monitoring the dignity, decorum, independence and quality of the profession … . The doctor must know and respect the Code and the attached application addresses’ (Article 1 of the Code of Medical Ethics-CME).

408. The CME deals with the general duties of medical doctors (freedom, independence and dignity of the profession), emergency services, professional secrecy, conﬁdentiality of personal data and the processing of sensitive data. The CME provides guidance on controversial issues related to diagnostic tests and therapeutic treatments including non-conventional practices, therapeutic and diagnostic obstinacy, euthanasia, informed consent, all treatments that affect physical and psychological integrity, and experimentation. It imposes obligations for updating and continuing vocational training and disciplines the relationship between physicians and patients in relation to most issues of healthcare delivery. It also provides guidance on relationships between colleagues.

Medical Law – Suppl. 119 (2020) Italy – 133 409–411 Part I, Ch. 4, Control over the Practice of Medicine

409. On 18 May 2014, the new Code of Medical Deontology approved by the National Federation of Associations of Surgeons and Dentists (FNOMCEO) was published. It comprises 79 articles divided in XVIII titles (and eliminating the previous subdivision in chapters). They are divided as follows. Title I illustrates the contents and purpose of the Code along with issues concerning authority and disciplinary sanctions. The 2014 reform significantly changed the label of Title II to ‘medical competences and obligations’ while still dealing with the general duties of the physician in Article 3. Article 4 is devoted to freedom, independence and dignity of the profession, adding in the rubric reference to ‘autonomy and responsibility of the physician’. Articles 5–7 deal with the promotion of health, environment and global health; professional and managerial quality and in general the status of the doctor by making him/her accountable on these issues. Articles 8 and 9 regulate performance in emergency and disaster relief. The remainder of the Title is dedicated to professional secrecy (Article 10), the confidentiality of personal data (Article 11) and the processing of sensitive data (Article 12). Article 13 is significantly entitled ‘Prescription for prevention, diagnosis, treatment and rehabilitation purposes’, while Article 14 deals with, among other things, patient safety and risk prevention in clinical practices. Article (15) is devoted to unconventional remedies. The rubric of Article 16 has been changed from ‘therapeutic and diagnostic obstinacy’ to ‘Non-proportionate diagnostic procedures and therapeutic interventions’. Without changing the content, the rubric of Article 17 changed from ‘euthanasia’ to ‘Acts aimed at causing death’. Article 18 deals with treatments that affect physical or mental integrity. Article 19 sets down the requirements in relation to ongoing professional training and vocational training.

410. Title III (now titled ‘relations with the person assisted’) sets down general rules of behaviour (Article 20) basing them on the respect for the rights of the person, on professional competence (Article 21), autonomy and diagnostic-therapeutic responsibility (Article 22). The Code provides for continuity of care (Article 23) and certification duties (Article 24) along with guidance in dealing with medical documentation (Article 25) and clinical records (Article 26). The old Chapter II (Articles 27–31) governs the duties of the physician and the rights of the citizen. Article 32 deals with the protection of vulnerable subjects (defined as ‘a minor, a victim of any abuse or violence and a person in a vulnerable or fragile physical, mental, social or civil situation’), confirming all the reporting obligations provided for by the law and engaging the physician to act in a particular way with these individuals.

411. The old Chapter IV is now Title IV that deals with information and communication; consent and dissent. Its different articles deal with Information and communication with the person assisted (Article 33) and with third parties (Article 34). Similarly, Articles 36 and 37 deal respectively with the consent or dissent of the patient and of their legal representative, while a speciﬁc article regulates physicians’ involvement with advance directives. Article 39 is dedicated to terminally ill patients. Chapters VI is now Title V dedicated to the transplantation of organs, tissues and cells (Articles 40–41). Title VI is devoted to sexuality (Article 42),

134 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 412–416 reproduction (Article 44), voluntary termination of pregnancy (Article 43). Genet- ics and Predictive testing are dealt with in Arts 45 and 46. Title VII is devoted to research and experimentation (scientiﬁc, human, clinical and animal: Arts 47–50).

412. Title VIII (entitled Medical Treatment and Personal Liberty) sets down rules governing the behaviour of physicians. It strictly forbids any form of participation or assistance to torture and inhuman treatment and imposes respect for the conscious refusal to eat. Title IX deals with professional fees and health information and advertising. Article 55, in particular, has been deeply reformed after the Competition Authority ﬁned the FNMCEO for preventing promotional and comparative advertising. Title X sets down the ethical and professional rules to be adhered to in conducting relationships with colleagues (Articles 58–59), counselling and consultation (Article 60), substitutions between physicians (Article 61). Title XI rules medical- legal activities, while Title XII is devoted to intra- and inter-professional relations. It establishes as well the duty to cooperate with the Professional Council (Article 64). It also regulates the manner and form of the profession in relation to its possible organized forms (Article 65) and in relation to other health professions (Article 66) and the duty to report any abusive exercise of the profession (Article 67).

413. Title XIII (Articles 68–70) sets the professional rules for dealing with the NHS and other private or public entities. It deals with the ethical obligations of the physician both when in employment with the NHS or simply bound by contract to it. Title XIV regulates sports medicine, while Title XV on the protection of collective health addresses also rules on mandatory medical treatment; duty to report to the authority; prevention, care and treatment of addictive substances. Titles XVI- XVIII are new. Title XVI is dedicated to potentiative and aesthetic medicine, while title XVII is dedicated to military medicine. Last but not least, Title XVIII is devoted to computerization and innovation in healthcare.

414. As mentioned (see 89, 752), the CME has acquired an important role also because of the express reference made to it in the data protection law and in the law reforming healthcare professions. b. Legally Determined Rules of Professional Ethics 415. There are several instances in which rules of professional ethics are determined by the law. The Council, for instance, has no discretion other than acting accordingly when it comes to suspension or debarment imposed by law (statutory debarment; see 376, 377). In addition, however, several professional points of conduct set out in the Code of Ethics amount to either crimes/administrative violations or to civil wrongs leading to contractual or tortious liability.

416. Among the former, we can certainly enlist the following:

– disease-mongering (criminalized by R.D. of 27 July 1934, no. 1265 entitled ‘Consolidated Health Laws’, in Articles 170, 171 and 172, as well as D. Lgs. 24

Medical Law – Suppl. 119 (2020) Italy – 135 417–419 Part I, Ch. 4, Control over the Practice of Medicine

April 2006, n. 219 ‘The Code of Medical products’, Article 147, paragraph 5), that is, unlawful conduct of the physician or veterinarian by way of accepting beneﬁts (or promise thereof) in order to facilitate, with medical prescriptions or in any other way, the spread of medicinal products or any other product in pharmaceutical use. Similarly, the conduct of a pharmacist who receives comparable beneﬁts for facilitating the dissemination of products to the detriment of other products for which s/he has agreed to sell, is unlawful (see Article 31 Code of Ethics); – violation of the rules on the removal of organs and tissues from a cadaver donor for transplantation therapy (see Article 41 Code of Ethics); – violations of the National Collective Agreement For The Discipline Of Relations With general practitioners (pursuant to Article 8 D. Lgs. n. 502/92 as amended by D. Lgs. n. 517/93 and n. 229/99), for instance, with reference to discontinuing treatment/assistance without reason (see Article 23 Code of Ethics); – violations of statutory norms on abortion (see Article 43 Code of Ethics).

417. Among the latter, we may also include violations of the rules on informed consent (see Articles 33–37 Code of Ethics). See 669ff. c. Normative Authority of the Provincial Councils 418. According to the principle of self-governance of the profession, all professional bodies have the power to self-regulate, that is, the power to adopt internal rules of conduct according to which all members are bound. The person enrolled is obliged to comply with these rules of conduct (professional ethics). The disciplinary powers over the members, expressly attributed by law to the Order, implies that it can be exercised not only by way of repression through the imposition of sanctions but also in advance, through the enactment of the ethical rules pertaining to correct behaviours. In addition, the publication of judgments on disciplinary matters offers an opportunity for members to take note of them since these decisions assume normative character as well as provide ethical orientation for the future behaviour of professionals.

419. Article 38 of P.D. 5 April 1950. no. 221 provides for disciplinary offences such as those of healthcare professionals and sanctions ‘abuses or deﬁciencies or conducts harming the professional decorum’. The majoritarian view of scholars, along with case law, stresses that this norm does not fully describe the actions or omissions prohibited, but it sets general clauses, the contents of which must be supplemented by the rules of professional ethics. The enunciation of the latter is left to the autonomy of the Professional Council solely responsible for interpretation and application of the rules of professional ethics in the exercise of the power of self-government in disciplinary proceedings. The public nature of the disciplinary power of the Order implies that the disciplinary measures, by which sanctions are imposed, are also binding externally.

136 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 420–425 d. The Precedent Authority of Disciplinary Decisions 420. Disciplinary decisions concur in deﬁning the deontological duties for members. This is one important reason for which the law provides for their mandatory publication. However, a precedential role is attributed only to decisions rendered by the CCELPS (Commissione Centrale per gli Esercenti le Professioni Sanitarie/ Central Commission for Health Care Professionals). e. Advice of the Provincial Councils 421. In their collaboration with local authorities in the study and implementation of measures that may be of interest for the Orders, the Provincial Councils do offer advisory opinions on the interpretation, for instance, of the CME. Yet, their advisory powers and actual inﬂuence is much less than that of the National Council. f. Advice of the National Council 422. Indeed, in addition to collaborating with similar studies at the national level, the National Council produces guidelines on issues related to the interests of the profession and in the application of the Code of Ethics. Pursuant to Article 1 of the new CME, ‘The physician must be familiar with and comply with the Code and the attached application guidelines.’ Therefore these guidelines have somehow more than an advisory role for the professionals and somehow concur in determining the normative content of the CME provisions they are illustrating.

3. Limitations to the Disciplinary Power of the Provincial Councils a. Non-interference in Fundamental Freedoms 423. The disciplinary powers of the Provincial Councils and the National Coun- cil are subject to all constraints directly or indirectly provided for by law and the Constitution. Accordingly, no disciplinary sanction or regulation can be based on discrimination grounds or can run against the constitutional principles.

424. Moreover, regulations or decisions amounting to an infringement of the EU fundamental freedoms are not permissible according to EU law whose supremacy in matters of EU competence is guaranteed by the Italian Constitution (Article 117). b. Duty to Motivate Decisions 425. Pursuant to Article 47 D.P.R. 5 April 1950, no. 221:

The decision must, under penalty of nullity, contain the indication of the date on which it is adopted, the facts alleged and the evidence gathered, and the exposure of the reasons underlying the ruling. All members participate and the Council signs it. The publication of the decision coincides with the deposit of the original in the competent offices; secretarial staff shall notify the person concerned. Motivation must compare the results of the investigations with the

Medical Law – Suppl. 119 (2020) Italy – 137 426–431 Part I, Ch. 4, Control over the Practice of Medicine

statements offered by the person on trial, so that the holding is consistent with the legal arguments in substantiating the judgment of guilt of the physician indicted.

426. These rules are observed, as applicable, to the provisions of debarment or suspension from professional practice.

427. Case law has established that disciplinary proceedings are administrative rather than jurisdictional in nature (Court of Appeal, Civil Section, III, no. 10389/ 2001) with the consequence that it is possible to continue the proceedings in absen- tia but not in cases where only the attorney delegated to represent the physician is present at the proceeding.

4. Disciplinary Sanctions a. Possible Disciplinary Sanctions 428. In case the Council ﬁnds the behaviour worthy of sanction, it can apply one of the disciplinary sanctions enumerated by law as recalled by Article 40 D.P.R. 5 April 1950, no. 221:

(1) a warning advising the culprit not to behave in a similar fashion again; (2) condemnation, that is, the issuance of a censure motion; (3) suspension from the exercise of the profession for a period of one to six months or according to statutory suspensions in line with Article 43; (4) debarment from the Register.

429. The law provides for both statutory suspension and statutory debarment (see Articles 42 and 43).

430. In addition to cases of statutory debarment and unless the physician submitted to criminal prosecution has been acquitted on grounds of the non-existence of the fact or not having committed it, the professional is indicted for disciplinary reasons for the same facts for which she is under criminal prosecution. In addition to statutory suspension (supra 378 Article 42), those physicians submitted to a detention, police arrest or warning are submitted to disciplinary proceedings as well.

431. The automatic application of statutory debarment/suspension is considered contrary to the principles of disciplinary proceedings. For this reason, these provisions are not applied without due independent analysis by the Council. In addition, case law has set speciﬁc guidelines for disciplinary sentencing (Court of Cassation Civil Section no. 834/2007).

138 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 432–438 b. Consequences of a Disciplinary Sanction 432. From the moment the disciplinary procedure is opened, the physician concerned cannot move the registration to another Order until the end of the proceedings (Article 10 paragraph 2 of P.D. 221/50).

433. According to the disciplinary sanction inﬂicted, physicians may be temporarily or permanently prevented to exercise their profession. c. Regarding the Right to Vote and to Be Elected 434. Pursuant to Article 2 DPLCS 233/1946, only registered members can vote and be elected as members of the Council. As a consequence, those physicians either suspended or debarred temporarily or permanently lose their rights to vote and to be elected. d. Regarding the Right to Practise Medicine 435. Since continuous registration is a necessary requirement for practising, any exercise of the practice of medicine during suspension or after debarment is abusive (see however supra 360).

5. The Disciplinary Procedure and Article 6 of the European Convention on Human Rights a. The Applicability of Article 6 of the European Convention on Human Rights in Disciplinary Proceedings 436. Some parts of the disciplinary procedures before the Provincial Council and The National Federation and the CCEPS might seem in contradiction with the ECHR jurisprudence (Albert e Le Compte v. Belgium, Application no. 7299/75; 7496/76; Le Compte, Van Lauten and De Meyere v. Belgium, Application no. 6878/ 75; 7238/75) on several accounts among which we can make reference to the public character of the disciplinary proceedings that is excluded by law.

437. The mentioned decisions of the ECHR clearly make the Convention (and Article 6 in particular) applicable to disciplinary proceedings. See also 441. b. The Public Character of Disciplinary Proceedings 438. Meetings and hearings of the Council are not public (Article 46 D.P.R. 5 April 1950, no. 221 and Court of Cassation Civil Section III, no. 11275/2004). Nev- ertheless, for each meeting\hearing, minutes are prepared and must indicate:

(a) the day, month and year; (b) the names of the Council members present at the meeting; (c) the proceedings examined and the issues addressed; (d) the measures taken in respect of each proceeding.

Medical Law – Suppl. 119 (2020) Italy – 139 439–445 Part I, Ch. 4, Control over the Practice of Medicine

439. The rulings of the decisions are recorded in the minutes.

440. This level of publicity, along with the guarantees provided in terms of appeal and technical assistance by an attorney, thanks to the disapplication of those provisions precluding it should offer a sufficient level of compliance to the ECHR. c. Hearing within a Reasonable Time 441. The hearing of the professional (as governed by Article 39 D.P.R. 5/04/50 no. 221) before beginning the disciplinary proceedings is a necessary step and constitutes a necessary ‘procedural requirement’ for the validity of the disciplinary proceedings themselves. Further to what was said during the hearing, the physician can then submit a written response to the questions. The Council of State (of 2 Septem- ber 2005) granted the right to access to the documents of the proceedings pertaining to this phase of disciplinary proceedings. Since a reasonable timeframe is granted to the physician and it is mandatory to hear her/his explanations, it seems that potential violations of Article 6 ECHR are precluded. d. Right to Challenge the Members of Councils 442. The members of the Commissions of the Register may be challenged only on the grounds established by the Code of Civil Procedure – that is when they have a personal and direct interest in the decision (see Article 51.1 Code of Civil Pro- cedure: compulsory abstention and Article 51, Code of Civil Procedure paragraph 2: optional abstention for serious reasons of convenience).

443. No challenge can be made in respect of the collegial body as a whole, as the abstention and recusal are possible only on grounds related directly or indirectly to the judge as an individual (Court of Cassation Civil Section III, no. 4657/2006). The same committee decides on the request for recusal since there is no higher court jurisdiction for such issues (CCEPS no. 55/2002).

6. Disciplinary Procedure Before the Provincial Councils and the Appeals Councils

444. The power to begin the proceedings is entrusted to the President of the Order (the President of the Committee for Members of the Order of Physicians), the Chairman of the Committee for Members of the Order of Dentists, the Prosecutor of the Republic, the Minister of Health, by CCEPS towards its professional components and members of the Central Committee of FNOMCEO (Federazione Nazionale degli Ordini dei Medici Chirurghi e degli Odontoiatri)(Article 18, lett. b, D.L. C.p.S. 13.09.1946, no. 233).

445. When there are facts that can lead to disciplinary proceedings, the Presi- dent, once such circumstances are summarily conﬁrmed, obtains the appropriate

140 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 446–450 information (directly or with the help of an investigating agency, see Court of Cas- sation Civil Section III, no. 743/2002) and, after hearing the indicted physician, reports to the Council (i.e., today the relevant Commissions of the Register) for the necessary decision (Article 39 supra). The Commission may (1) decide to open the disciplinary proceedings and appoint a rapporteur for the proceedings; (2) decide to close the proceedings; (3) authorize the Chairman to conduct further investigative activities.

446. The President sets the date for the hearing, designates a rapporteur and noti- ﬁes the following to the person concerned: (a) a detailed statement of charges; (b) the term of not less than twenty days that may be renewed on request, within which the physician can access the facts concerning her disciplinary proceedings and produce his/her own counterarguments in writing; (c) the place, day and time of the disciplinary proceedings; (d) the express warning that, if not present at the proceedings, the Council shall proceed to trial in his/her absence; (e) that within the period referred to in subparagraph (b) the person concerned may request to be heard.

447. At the hearing, after the reporter for the case has illustrated the facts and the results of the investigation, the indicted physician is heard. Technically, the law excludes the presence of an attorney or other consultant acting on behalf of the physician under judgment unless otherwise stipulated by the Council. Nevertheless, case law (Court of Cassation, United Section no. 3195 of 4 July 1989; see also CCEPS no. 34/1999) has considered this provision as illegitimate.

448. Once the indicted physician leaves the hearing, the Council immediately debates the case and decides on its merit (Article 45). In cases where it is necessary to carry out the disciplinary proceedings in more than one session, it is forbidden to change the composition of the members. The decision is considered valid only if made by the collegial body composed by the same members present at all stages of the proceedings (CCEPS decision no. 12 of 3 December 1991 and Court of Cas- sation, Civil Section III, no. 5819/1999).

449. When the Council fails to initiate the disciplinary proceedings at the request of the Prefect or the Public Prosecutor, or during the proceedings neglects to issue its decisions, the Prefect shall, after consulting the Provincial Health Coun- cil (Consiglio provinciale di sanità), proceed with the procedure laid down in Article 75, paragraph 1, of the Consolidated Health Laws, approved by R.D. of 27 July 1934 no. 1265. The order of the Prefect must be justiﬁed. These rules also apply in cases of statutory debarment or suspension pursuant to Articles 42 and 43 D.P.R. 5 April 1950, no. 221.

450. The disciplinary action must be prescribed in ﬁve years (Article 51). The ﬁve-year limitation period, in relation to breach of a rule of professional ethics, begins from the date on which the Order has become aware of the violation (if the violation is continuous in time, the limitation period shall run from the moment in which the last act, essentially triggering the procedure, was conducted). In relation

Medical Law – Suppl. 119 (2020) Italy – 141 451–455 Part I, Ch. 4, Control over the Practice of Medicine to acts of criminal signiﬁcance, the limitation period is frozen until the criminal proceedings have been heard and a ﬁnal judgment is given.

451. The President must disclose immediately to the Prefect and to the Public Prosecutor with jurisdiction for the Register the instigation and outcome of all disciplinary proceedings, as well as to those authorities affiliated to the jurisdiction that has promoted the proceedings.

452. The measures of suspension from the profession and disbarment, once they have become ﬁnal, are sent to all provincial orders and to the authorities and bodies to which it should according to law.

453. In disciplinary proceedings before the Central Committee and in those before the CCEPS, the same rules of procedure with regard to disciplinary proceedings against registered physicians and the rules concerning notification to relevant authorities must be observed. Appeals to the Central Commission for Health Pro- fessions Practitioners (CCEPS) against measures decided by the Associations or Colleges of Health Professions must be notified, pursuant to Article 54 of Presiden- tial Decree no. 221 of 5 April 1950, and in accordance with the procedures set out in the Code of Civil Procedure, to the Order or Board that issued the measure; Procurator of the Republic territorially competent (where the Council of the Order or College has its seat); Minister of Health at the Attorney General of the State (see Court of Cassation, Section Un. 26 May 1998, n. 5237 and Court of Cassation Civ., Section III, 27 August 1999, n. 8995). The indicted physician can be heard in the preliminary stages of the procedure by letters rogatory. Note that it is only in electoral appeals (see Court of Cassation no. 5743 of 24 October 1988) that the notification of the appeal against the election of a member of the Governing Council, not made to the other party concerned, is carried out in breach of the principle of the right to be heard and is a ground for invalidity of the resulting decision. Con- sequently, such appeals must be notified to all the members of the body of the Order or College against whose election there is a recurrence.

454. The CCEPS for healthcare professionals is established at the Ministry of Health and is appointed by decree of the President of the Republic. A Councillor of State chairs it. It is composed of one member of the Superior Health Council (Con- siglio Superiore di Sanità), a deputy from the Ministry of the Interior, and professionals appointed by the Central Committee of the National Federation.

455. The Constitutional Court has established (Constitutional Court. no. 284/ 1986) that the jurisdiction of the CCEPS does not run contrary to the ban on special jurisdictions provided for in Article 102 Const. (‘Extraordinary or special judges may not be established.’) provided that it does not infringe the principles of Article 24 (‘Defense is an inviolable right at every stage and instance of legal proceedings’), Article 25 (‘No case may be removed from the court seized with it as established by law’), and Article 108 (‘The law ensures the independence of judges of special courts, of state prosecutors of those courts, and of other persons participating in the administration of justice’).

142 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 456–460

456. The CCEPS has competence in the following matters: the exercise of disciplinary powers against members of health professions and members of the Cen- tral Committees of FNOMCEO, including proposed appeals against provincial decisions, and in particular, those in disciplinary matters concerning members enlisted in the provincial orders and members of the Provincial Councils of each Order.

457. Both the person concerned (if the proceedings in the Council of the Order has ended in sentencing) and the Public Prosecutor are entitled to appeal. Appeal from the person concerned shall have a suspensive effect on the disciplinary measure with the exception of statutory suspension and disbarment. The deadline for ﬁl- ing the appeal is thirty days from the communication or the notiﬁcation of the decision. The meetings of the CCEPS are not public and decisions are taken in the absence of the concerned parties.

458. The decisions of the CCEPS may be challenged to the Supreme Court (Article 19 Law D.L.C.p.S. 13.09.1946, no. 233) (see Court of Cassation Civil Sec- tion III, no. 835/2007, no. 1487/2004; Cass. 2542/1986) in the United Sections chamber if the challenge concerns jurisdiction (Article 362 CPC) or in the regular Section if the issue relates to a violation of the law (Article 111 Cost.).

459. The appeal must be lodged within sixty days (with disapplication of the above-mentioned thirty-day deadline Article 68, paragraph 2) and must be ﬁled within twenty days from the last notiﬁcation (Article 369 CPC).

460. The proposition of the appeal does not suspend the execution of the decision of the CCEPS (Court of Cassation Civil Section no. 13427/2004). By judgment no. 193/2014, the Constitutional Court declared the constitutional illegality of Article 17(1) and (2)(c) of D.L.C.p.S. 13.09.1946, no. 233 in so far as it does not provide for the appointment of substitute members of the Central Com- mission for the examination of questions concerning the profession of pharmacists, allowing for the establishment, by number and category, of a formation of a different composition of the judging panel from that which issued an annulled decision referred back by the Court of Cassation ‘and, as a consequence, … ’ the constitutional illegitimacy of Article 17(1) and (2)(a), (b), (d) and (e) of Legislative Decree no. 233 of 1946, in so far as it does not provide for the same appointment examination of questions concerning the professions of doctors, surgeons, veterinarians, midwives and dentists.

Medical Law – Suppl. 119 (2020) Italy – 143 461–466 Part I, Ch. 4, Control over the Practice of Medicine

IV. Organs of the Order of Physicians and Their Function

A. Provincial Councils

1. Composition

461. There are 110 provincial orders of physicians that have been reinstituted after WWII:

462. Normally every three years, in the month of November in the year in which the Governing Council expires, the President of the Order shall convene the meeting of members (Assembly) for the election of the new Governing Council. The Governing Council is composed of seven members if the number of registered members does not 500; nine, if they exceed 500 and are less than 1,500; and fifteen if in excess of 1,500 (Article 2 lett. a D.L. 13 September 1946, no. 233, as modified by law 3/2018). Ministerial Decree of 15 October 2018 provides for specific electoral rules to be implemented by each Order.

463. Pursuant to D.P.R. 5 April 1950, no. 221, the provincial orders are based in the capital of the province in which they are established. If the Order or the Council has jurisdiction in two or more provinces, the seat must be in the capital of one of them. The National Federation (FNOMCEO) has its headquarters in Rome (Article 28).

464. The Presidents of the provincial orders and of the National Federation oversee the execution of the resolutions of their respective governing bodies and direct the work of the offices (Article 29). The meetings of the Council and the Central Committee are invalid unless the majority of members participate in them. Reso- lutions are passed by a majority of votes. In the event of a tie, the vote of the Presi- dent prevails (Article 30).

465. The Secretary is responsible for regular office (Article 31). His/her responsibilities include the archives, the minutes of meetings of the Assembly and the Council, records of deliberations, the Register for actions undertaken in the conciliation pursuant to Article 3 e) of D. Lgs. 13 September 1946, n. 233, as revised, the Register of the opinions expressed by the Council, and such other records as prescribed by the Council. It is up to the Secretary to legally certify copies of resolutions and other acts to be issued to public offices or, where permitted, to interested individuals. In cases of absence or impediment, the less senior counsellor, so long as s/he is not the Treasurer, replaces the Secretary. The Treasurer is responsible for any cash funds and other property of the Order (Article 32).

466. The supreme organ of the Provincial Order remains its Assembly.

144 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 467–467

2. Functions

467. Pursuant to D. Lgs. C.P.S. 13 September 1946 n. 233 (on the reconstitution of the Orders of the health professions and the definition of the professions) ratified by Law 17 April 1956, no. 561 and modified by law 3/2018, provincial orders are charged with the following responsibilities (Article 1):

(a) To promote and ensure the independence, autonomy and responsibility of the professions and professional practice; the technical and professional quality; the enhancement of the social function; the protection of human rights and ethical principles of professional practice indicated in their respective codes of conduct, in order to ensure the protection of individual and collective health; (b) To verify the possession of qualifications enabling professional practice; (c) To take care of the keeping of the professional register, including an electronic version, and of its publication also in electronic forms, and, where required, specific lists of members; (d) To ensure an adequate system of information on the activity carried out, in order to ensure accessibility and transparency to their action, in accordance with the principles of D.L.gs. 33/2013; (e) To participate in the procedures relating to the planning of the needs of professionals, training activities and the examination of qualification for professional practice; (f) To render their compulsory opinion on the rules for the examination of qualification for the professional practice, and in other cases provided for by legal the rules in force; (g) To concur with local and central authorities in the study and implementation of measures that may affect the Order and contribute with public and private health and education institutions to the promotion, organization and evaluation of training activities; (h) To promote the continuous professional development of all registered members, fostering the maintenance of professional requirements also through training credits acquired in the country or abroad; (i) To supervise their enrolled members, in whatever legal form they carry out their professional activity, including that of the company, imposing disciplinary sanctions according to a scale related to the voluntariness of the conduct, seriousness and repetition of the offence, taking into account the obligations of the members.

Please note that they cannot perform trade union representation roles. In addition, in the exercise of the disciplinary function, orders must keep the investigative function separate from the judging one, in order to guarantee the right of defence, autonomy and impartiality of the disciplinary judgment. For this reason, in each Region there are investigation offices, composed of a number between ﬁve and eleven members drawn from among the members of the disciplinary commissions of the corresponding profession, ensuring the representation of all orders, and a representative from outside the profession appointed by the Ministry of Health.

Medical Law – Suppl. 119 (2020) Italy – 145 468–475 Part I, Ch. 4, Control over the Practice of Medicine

468. The Regulations provide that the operational guidelines applicable to the Orders are contained in the P.D. of 5 April 1950 no. 221.

469. The Council shall ensure the administration of goods pertaining to the Order and proposes the approval of the budget and the final account. The Council shall, within limits strictly necessary to cover the costs of the Order, establishes an annual fee, a fee for the enrolment, as well as a fee for the issuance of certificates and of opinions for the settlement of professional fees. Their provisions may be challenged during meetings of the members, convened in a general assembly, which decides definitively on matters concerning fees. Against measures for the subjects listed in numbers (1) and (6) above, appeals may be submitted to the CCEPS.

B. The National Council

1. Composition

470. Pursuant to the renewed Article 7 D.L. C.P.S 13 September 1946, no. 233, the Provincial Orders (OMCEO) have been collated into the National Federation (FNOMCEO) with headquarters in Rome. A Central Committee composed of thir- teen members directs the Federation.

471. The Central Committee elects a President, a Vice President, a Treasurer and a Secretary. The President represents the Federation and s/he convenes and chairs the Central Committee and the National Council. The Vice President substitutes the President in cases of absence or impediment and exercises the functions delegated to him/her by the President (see renewed Article 8).

472. In the year following the election of the Presidents and Councils of Orders, the Presidents of the Orders elect the Central Committee choosing from those enrolled in the Registers that have won a relative majority of votes by secret ballot.

473. In accordance to Article 8 paragraph 9 of D.L. C.P.S 233/1946, each Presi- dent has one vote for every ﬁve hundred registered and a fraction of at least two hundred and ﬁfty registered members of the respective register.

2. Functions

474. Pursuant to Article 11 of D. Lgs. C.P.S. 13 September 1946 n. 233 in its new formulation, the National Council is composed of the Presidents of the Orders. The National Council has the power to approve the budget and the ﬁnal accounts of the Federation on the proposal of the Central Committee.

475. The responsibilities of the Central Committee of the Federation are the following (see Article 8 paragraph 15):

146 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 476–478

(a) monitoring, at the national level, the preservation of the dignity and independence of the profession; (b) coordinating and promoting the activities of the provincial orders; (c) promoting and facilitating, at the national level, all the initiatives designed to facilitate the cultural advancement of members; (d) appointing representatives from the Federation to participate in commissions, agencies or organizations of national or interprovincial character; (e) cooperating with the central authorities in relation to the study and implementation of measures that may be of interest to the Orders; (f) providing general direction for the resolution of disputes between professionals or between professionals and patients or between professionals and institutions for reasons of expenses, fees and other matters relating to the practice of medicine; (g) exercising disciplinary authority over the members of the Executive Councils of the provincial orders.

476. The disciplinary function is now carried out, however, by the Commissions of the Register. The Commissions of each Federation have the following powers: a) to assist the central authorities in the study and implementation of measures that may affect the profession; b) to exercise disciplinary power; c) in Federations with more registers, exercise the functions referred to in letters d), e) and f) of paragraph 15, except in cases where the designations referred to in paragraph e) concern one or more representatives of the entire Federation. It is possible, however, to appeal to the Central Commission for Health Professions against the measures adopted pursuant to paragraph 16, letter b) and paragraph 18.

477. The National Council, on the proposal of the Central Committee, shall determine the annual contribution that each Order must pay towards the operating expenses of the Federation considering how many members are enrolled (Article 8 paragraph 13 in the new version of D.L. C.P.S 233/1946).

478. The Central Committee has the administration of assets belonging to the Federation (Article 9 paragraph 14). It also has the power to dissolve provincial orders and Commissions of the Register (Article 4 law 3/2018), when they are not able to function properly or when there are serious violations of the regulations in force. The dissolution is ordered by a decree of the Minister of Health, after consultation with the respective National Federations. The same decree appoints an extraordinary committee of three members, of which no more than two are registered in the professional registers of the category and one is identiﬁed by the Min- ister of Health. The Committee shall have all the powers of the Council or of the dissolved committee.

Medical Law – Suppl. 119 (2020) Italy – 147 479–482 Part I, Ch. 4, Control over the Practice of Medicine

§2. MEDICAL ETHICS COMMITTEES

I. General Remarks

479. The National Federation of the ethics committee offers a definition of what constitutes an ethical committee in its institutive charter. Article 2 states that an ethics committee is ‘an independent body or an expression of an institutional facility for healthcare or for scientific research consisting of medical and non-medical doctors whose task is to ensure that the security, integrity and the rights of the individual are safeguarded. It must also provide opinions and create educational opportunities on the ethical aspects of practice and research in the biomedical sciences thus providing public assurance. It also provides assurance by way of relating with the relevant professional bodies in relation to deontological aspects’. The definition includes ethical committees for research on animals that serve to protect the quality of life and death of the animals, posing them as a third party between the sponsor/investigator and the subject of the experiment. It includes also technical committees that have similar overlapping functions, purposes and compositions.

480. D. Lgs. 24 June 2003, n. 211 (implementing Directive 2001/20/EC on the implementation of GCP in clinical trials of drugs for clinical use) provides (Article 2 lett. m) another deﬁnition of ethics committees. It states that an ethics committee is:

an independent body, composed of medical and non-medical personnel, who has the responsibility to ensure the protection of the rights, safety and well- being of human subjects in trial and to provide public assurance of that protection, expressing, for example, an opinion on the trial protocol, the suitability of the investigators, the adequacy of the structures and methods and documents that will be used to inform the subjects and obtain their informed consent.

481. Differences in the two deﬁnitions fully capture ethics committees’ role in offering an answer to the ‘physician’s solitude in facing choices that require explicitly pursuing one path over another in cases where ethical positions are not shared by all’.63 In other words, this includes situations where there is tension between clinical answers on the one hand and rigid rules based on protocols on the other.

482. The ﬁrst Italian regulation on ethical committees dates back to the M.D. 18 March 1998 issuing ‘Guidelines of reference for the establishment and functioning of ethics committees’. However, this regulation (like all ensuing regulations) is

63. L. Nocco, Diritti fondamentali e tecniche di tutela degli incapaci: le esperienze USA e italiana a confronto sul ruolo dei comitati etici, in Rivista Italiana Di Medicina Legale; N. 26; 1103:1160 (2004) at 1103.

148 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 483–485 mainly devoted to ethics committees in experimentation. Indeed, Directive 2001/ 20/EC on GCP in clinical trials of drugs for clinical use only indicates relevant legislation on these matters.

483. Today, the general legislation regulating ethics committees is Regulation (EU) no. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/ 20/EC.

484. Originally the healthcare reform in 1999 (Law no. 229 Article 12bis) allocated to the Regions and Autonomous Provinces of Trento and Bolzano the power to regulate the organization and functioning of ethics committees established at each local health authority in accordance with M.D. 15 July 1997 and 18 March 1998, taking into account the guidelines and minimum requirements referred to in these decrees and establishing a register of ethics committees operating in their territories. This law entrusted to the Ministry of Health the establishment of the National Ethics Committee for Research and Clinical Trials. These reforms seem to establish the general principles that allocate competencies between central and local territorial authorities since the same criteria have persisted after the constitutional reform of Title V of the Constitution by D.L. 211/203 and by Decree of 12/05/2006, establishing the minimum requirements for the establishment, organization and functioning of ethics committees for clinical trials of medicines. Yet, Article 2 of Law 3/2018 reorganized the territorial ethics committees (they cannot exceed forty), specifying their powers according to the following general directives implemented by a decree of the Ministry of Health: a) the presence of at least one ethics committee for each Region; b) the reorganization of the ethics committees, provided for in Article 12, paragraphs 10 and 11, of Decree-Law 13 September 2012, n. 158, converted, with amendments, by law no. 189 of 8 November 2012, within the terms provided for by the above legislation; c) the number of trials evaluated as a coordinating centre during the year 2016. The appointment of the members of each territorial ethics committee is a regional competence, guaranteeing in any case the independence of each committee and the absence of hierarchical relationships between different committees. At the national level, three ethical committees are established, one of which is reserved for paediatric trials. The territorial ethics committees shall be responsible for the evaluation of clinical trials on medical devices and phase I, II, III and IV medicinal products for human use for the aspects included in Part II of the assessment report, as referred to in Article 7 of Regulation (EU) no. 536/2014.

485. The Comitato Nazionale Italiano di Bioetica (National Committee on Bio- ethics (NCB) has produced several interventions on ethical committees. In its opinion entitled ‘Guidelines for Ethics Committees in Italy’ – dated 13 July 2001 and complemented by its Opinion of 31 March 2017 on ‘Ethics committees in the clinic’ – it offered ‘a theoretical and systematic reﬂection on the nature and signiﬁcance of the local and regional ethics committees, which in general organise and supply healthcare, or carry out research activities or clinical or pharmacological trials on human beings’. The same document ‘highlights some problematic issues about the

Medical Law – Suppl. 119 (2020) Italy – 149 486–488 Part I, Ch. 4, Control over the Practice of Medicine existence of ethics committees, like the risk of bureaucratization; difficulties in punctually carrying out their broad range of duties; uncertainties about the relationship with the institutions of reference and legal ambiguity in the nature of such relationships; the value and efficacy of the opinion expressed by the ethics committees and the associated issue concerning responsibility of members’. It also analyses ‘the distinction between the role of the Institutional Review Board for clinical trials and the other roles that an ethics committee can have in healthcare structures and in research centres’. Last but not least, it urged the legislator ‘to clearly define the responsibilities of the members of ethics committees for clinical trials, with the activation, by the structures of reference, of a suitable insurance cover; [to provide them] with an appropriate scientific secretariat and a technical-administrative secretariat, with functional autonomy, composed of qualified personnel’.

486. The NCB also clearly stated that ‘Regional and national committees have no hierarchical higher power and cannot limit or bind the activity of local ethics committees.’

487. Since 1992 (opinion of 27 February), the NCB has suggested that the legislator reorganizes the ethics committees into two types. It proposed to have one type at a local level and another at a regional level allocating different functions to each type. The local committees should have been called upon as a consulting body on the definition of biomedical research protocols, including clinical trials on humans, and should be flexible in their composition according to the needs of the healthcare centre and local community. The regional committees should, however, work as consultancy organs for the city and regional councils, for all the healthcare initiatives of the Region, the regional legislative activity and the administration in the field of assistance and medical research. However, as mentioned the reorganization followed different lines. Note also that a new institution has been established by Article 2 law 3/2018 at the National Agency for Pharmaceuticals (AIFA), the National Coordination Centre for Territorial Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices, with the function of coordinating, guiding and monitoring activities for the evaluation of ethical aspects related to clinical trials on medicinal products for human use delegated to territorial ethics committees. Its functions, powers and composition are specified in paragraphs 1–6 of the same article.

II. Ethics Committees in Hospitals

488. It is a task of ethical committees to approve any experimentation. There- fore, all healthcare institutions that want to run experiments or clinical trials (but only those that choose to do so) are obliged to institute ethics committees according

150 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 489–491 to the Decree of the Ministry of Health of 15 July 1997 (Transposition of the Euro- pean Union guidelines of GCP in the conduct of clinical trials of medicinal products) and to the Decree of the Ministry of Health 12 May 2006 (providing minimum requirements for the establishment, organization and functioning of ethics committees for clinical trials of medicines).

489. Article 3 of M.D. 5 December 2006 provided that their autonomy must be guaranteed at least by (a) the avoidance of hierarchical subordination of the ethics committee in relation to the institution within which it operates; (b) the presence of personnel not employed by the same institution where the ethics committee operates; (c) protection from the peculiar nature of the experiment at issue and conﬂicts of interest between voters in this regard; (d) by the absence of economic co-interests between committee members and companies in the pharmaceutical sector.

490. Therefore, in relation to the appointment of the members of the ethics committee, the administrators shall refrain from designating employees of pharmaceutical companies or individuals interested in the economic activities of the same. It is also suggested that the members of the ethics committee must annually sign a statement that obliges them to remain silent in relation to experiments involving possible conﬂicts of interest, either direct or indirect, including involvement in the design, conduct or management of the trial, relationship of dependency by the experimenter, and consulting relationships with the company that manufactures the drug.

A. Composition of the Committee

491. Pursuant to Article 2 of Decree of 12 May 2006, the composition of ethics committees must ensure the qualiﬁcations and experience necessary to evaluate the ethical, scientiﬁc and methodological elements of the proposed studies. All its members must have documented knowledge of and/or experience in clinical trials of medicines and other subject matters considered as competences of the ethics committee. Accordingly, ethics committees must include:

a) two clinicians; b) a general practitioner and/or a paediatrician of free choice; c) a biostatistician; d) a pharmacologist; e) a pharmacist (ex offıcio) of the pharmaceutical service of the healthcare facility or hospital that is to host the pharmaceutical clinical trial, or [if they are instituted at the Regional level] a pharmacist of the regional health service; f) the healthcare director (ex offıcio) and, where applicable, as in the case of institutions for hospitalization and care of a scientiﬁc nature [IRCSS], the Scientiﬁc Director (ex offıcio) of the institution hosting the trials or [if they are instituted at the Regional level], an officer belonging to the healthcare department of the Region or of the Autono- mous Provinces; g) an expert in legal and insurance matters or forensic scientist; h) an expert on bioethics; i) a representative of the nursing sector; l) a representative of volunteers and/or associations for the protection of patients.

Medical Law – Suppl. 119 (2020) Italy – 151 492–496 Part I, Ch. 4, Control over the Practice of Medicine

492. The DM also imposes that at least half of the total components must not be employees, in any form, of the institution establishing the ethics committee. This percentage decreases to no less than one-third if the ethics committee belongs to more than one institution or is established at the regional level.

493. The members of the ethics committee shall be appointed for a term of three years. The mandate cannot be renewed consecutively more than once, except for ex officio members, who, however, cannot hold the office of President for more than two consecutive terms.

494. The ethics committee shall elect a chairman and another member to replace him/her. The members of the ethics committees may not delegate others in their place. However, the ethics committee may call for advice experts with experience in speciﬁc areas, not covered by the members of the ethics committee.

B. The Competences of the Committee

495. Pursuant to D. Lgs. 24 June 2003, n. 211 (implementing Directive 2001/ 20/EC on the implementation of GCP in clinical trials of drugs for clinical use) and D.M. 5 December 2006, the main tasks of ethics committees are devoted to experimentation and assistance.

496. As per the former, the instructions described (see 491 supra) are compulsory. In addition, the opinions of the ethics committees are a necessary requirement for any trial. They must be acquired before the trial and they are binding (Article 3 paragraph 1 lett. a and Article 6 paragraph 1 D.L. 211/2003). In deﬁning the parameters for the opinions in clinical trials, Article 6 D.L. 211/2003 deﬁnes, in more detail, the competences of such ethics committees. Indeed, the Committee shall particularly consider:

(a) the relevance and importance of clinical trials and study design; (b) whether or not the evaluation of the expected benefits and risks for the subject are justified considering actual and future patients. In fact, a clinical trial may be initiated only if the ethics committee and, where applicable, the competent authorities have come to the conclusion that the expected benefits, both therapeutic and those relating to public health, justify the risks; (c) the protocol; (d) the suitability of the investigator and supporting staff; (e) the investigator’s files; (f) the adequacy of the healthcare facility; (g) the adequacy and completeness of the written information available to the subjects admitted to the trial and the procedure that needs to be followed in relation to acquiring informed consent. A sound justification for conducting the research on those who are not able to give their informed consent must be provided out- lining the nature, significance, implications and risks of the clinical trial;

152 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 4, Control over the Practice of Medicine 497–501

(h) the provisions relating to compensation in case of injury or death attributable to a clinical trial; (i) the provisions relating to insurance covering compensation for damage caused to individuals by the activity of experimentation, to cover investigators’ and sponsors’ liability; (j) the amounts and the methods of remuneration or compensation or emoluments to be paid in favour of the investigators and the eventual beneﬁts of the subjects included in the trial and the relevant parts of the contract between the sponsor and the test centre; (k) the procedures for recruitment of subjects and the information procedures in place to disseminate information relating to the trial in compliance with the relevant provisions of the standards of GCP and in compliance with applicable regulations.

497. In addition, once established for clinical trials, and where not already assigned to speciﬁc agencies, ethics committees can also play an advisory role in relation to ethical issues associated with scientiﬁc activities and welfare services so as to protect and promote the values of the human being. The ethics committee may also propose initiatives in view of training health professionals in relation to bioethical issues.

498. Taking into account this ‘residual’ competence, healthcare institutions often have only one ethics committee. Their opinions on healthcare assistance are advisory in nature (in fact as a default rule, opinions are advisory).

III. The National Committee on Bioethics

A. Composition of the Council

499. The National Bioethics Committee (NBC) was established by Decree of the President of the Council of Ministers of 28 March 1990. It has been renewed with Decree of the President of the Council of Ministers of 23 March 2018. It is charged with expressing opinions and, for the purpose of preparing legislative acts, addressing the ethical and legal problems that may arise as a result of progress in scientiﬁc research and technology on life.

500. The Committee formulates opinions and motions which are published on the website following approval. The NBC establishes and maintains relations at European and International levels.

501. The Committee is elected every four years. At the end of the term, the President of the Council of Ministers is responsible for appointing a new President and Vice President of the Committee. The only members expressly provided for by statutory regulation (Article 2 DPCM quoted 499 supra) are the Presidents of the National Council of Research, the National Health Council, Superior Institute of

Medical Law – Suppl. 119 (2020) Italy – 153 502–504 Part I, Ch. 4, Control over the Practice of Medicine

Health, and the National Federation of the Associations of Physicians (FNOM- CEO). In addition to these statutory members of the NBC, the Committee is comprised of experts in legal, philosophical, biological, medical, medical-legal, psychological and sociological matters. Accordingly, the composition of the Com- mittee is characterized by the interdisciplinary nature of the expertise and the plu- ralist representation of the theories, achieved through the appointment of members from different cultural backgrounds and from diverse scientiﬁc, political, religious and philosophical points of view. Meetings are normally held in private.

502. Pursuant to its Internal Regulation issued in accordance with Article 5 DPCM. 28 March 1990 and approved by the plenary committee on 28 November 2008, the National Committee for Bioethics comprises the following organs: (a) President, (b) Vice Presidents, (c) Council of the Presidency, and d) Assembly.

503. The same Regulation (Article 4 paragraph 3) provides that each member may request the inclusion, in the notes to the documents approved by the Commit- tee, of their individual opinion for clariﬁcation of their attitude about speciﬁc matters. Each of the members of the Committee may submit a report on such matters supplementing or dissenting the overall opinion. The report must be attached to the document approved by the Committee and be published together with the document itself.

B. The Competences of the Council

504. Pursuant to Article 1 of the Decree of the President of the Council of Min- isters of 28 March 1990 [1], the tasks of the National Bioethics Committee are:

(1) to elaborate, availing itself of the right to access the necessary information at the existing centres operating at the national level and in liaison with similar committees set up by other countries as well as other international organizations working in the ﬁeld, a summary of programmes, objectives and results of research and experimentation in the ﬁeld of life sciences and human health; (2) to express opinions and put forward solutions in relation to the preparation of legislation addressing ethical and legal problems that may arise with the progress of research and with the emergence of new possible applications of clinical interest having regard to the protection of fundamental rights and human dignity and other values expressed in the Constitution and international instruments which Italy has endorsed; (3) to propose solutions for the control functions towards both human and environmental protection in the production of biological materials and the protection from risks to patients treated with genetically engineered products or those posed by gene therapy; (4) to promote the drawing up of codes of ethics for operators in the relevant sectors and foster the availability of accurate information made available to the public.

154 – Italy Medical Law – Suppl. 119 (2020) 505–508

Chapter 5. Medical-Related Accidents and Compensation64

§1. THE MEDICAL ACT AND ITS LEGITIMACY

505. See also 688, 705. The legitimacy of medical interventions should be cast within the framework of the modern delivery of healthcare services. Such delivery is becoming increasingly complex due to scientific advances. Over the years, scientific and technological advances have necessitated a reframing process according to which individual acts carried out within an organizational infrastructure are characterized by a desire to both fully exploit the benefits of science and technology and to obtain benefits provided by public institutions. This is true for each and every medical act, even the simplest one such as a general practitioner prescribing a drug referred to by a specialist physician (see 1165, 1166). This state of affairs has switched attention from the medical act itself (on which see in general supra 233ff, 281, 317–321, 362) to the actual delivery of healthcare, a change that carries with it obvious legal implications (see, for instance, 520 and 523). Chiefly, and with reference to liability, instead of ascertaining professional misconduct with a view to linking damages liability to the healthcare institution, today case law is moving in the direction (see infra 522f and 574) of contractual liability of the healthcare facility (pursuant to Article 1218 and 1228 cc) thereby eventually only requiring joint and several liability of the physician. Indeed, the Supreme Court seems ready to accept a liability model according to which liability is attached to a defective service (see section 4:202 Principles of European Tort Law) regardless of its causal connection to a medical act. See 623.

506. Yet, the mentioned switch maintains patients and their rights (among else) as the focal point with regards to ‘the provision of public services according to quality standards and efficiency’ (Article 2 D.L. 2005, no. 206, the so-called consumer code). For instance, it is true that a legitimate medical intervention must necessarily be sustained by the lawfully provided informed consent of the patient. However, most of the actual modalities, timing, format, etc. for acquiring it are designed by the physician institution and the general legal framework resulting from both statutory rules and case law.

507. In addition, the deﬁnition of the medical act is neither easily settled nor shared across borders and within any given legal system. Italy is no exception in this regard. See supra 233ff, 281, 317–321, 362.

508. Certainly, with regard to the aims of liability, the notion of the medical act tends to be enlarged more than its technical definition. Indeed, it includes certifications and formal actions, as well as personal data processing. From the point of view of private law, the notion of the medical act and its legitimacy is intertwined strictly with the very notion of civil liability and the definition of its scope.

64. See Reference 3 at the end of Part I, Chapter 5.

Medical Law – Suppl. 119 (2020) Italy – 155 509–513 Part I, Ch. 5, Medical-Related Accidents and Compensation

509. Historically (between the 1950s and the early 1970s), medical acts have been considered licit by virtue of their social aims (even when leading to a fatal result), for the absence of intention to harm, or because of the role played by spe- ciﬁc exonerations rules (necessity Article 54 cp, fulﬁlment of a duty Article 51 cp, consent of the victim Article 50 cp).

510. However, the theory dominating today also in case law relies on patient consent to legitimize medical acts (with some exceptions, see 720ff); a reading that has been confirmed by law 219/2017 (see 525, 550, 657). Any medical act carried out without obtaining the consent of the patient would run against Articles 32 and 13 of the Constitution and against Article 33 Law 833/1978. Case law is rather clear in admitting that medical acts find their legitimacy in their aim to protect the fundamental right to health pursuant to Article 32 Cost. Indeed, courts have provided clarification that patient consent is the unfailing precondition of any medical act but for the exceptional cases of necessity and inability to express consent and those instances of compulsory treatment provided for by law (see 720ff, 871ff). It is a result of a long process led by constitutional principles and aided by international documents and norms (see, for instance, 16, 40, 60, 64, 84, 86, 159, 161, 672). This concept was fully incorporated in the CME already in its 1998 version (and confirmed in the last one) and has been expressly stated by the Supreme Court (criminal chamber) in the famous Massimo case (Cass. Pen., 21 April 1992) whereby a surgeon was condemned for a voluntary personal injury (Article 584 cp) causing death for having performed a different treatment than the one consented to by the patient outside a situation of unforeseeable necessity and emergency. The case stated that the physician, before obtaining valid consent, must inform the patient on the nature, scope and extent of its results, the possibilities and probabilities of the attainable results, the risks that it entails and available alternatives. See also 701.

511. According to the situation, consent can also have an impact on other elements of liability. For instance, it can impact on ‘fault’ where the medical equipe is using an innovative therapeutic technique to follow the wishes of the patients (in line with ethical and legal rules, see 1154ff).

512. It ensures that the physician must demonstrate that proper informed consent has been obtained. However, it is up to patients, in claiming that consent was not given or, when given (see 505), not informed, to show the impact the information would have had had she been fully informed. See also 521–524.

I. Consent to Contract Versus Consent to Medical Treatment

513. Scholars have doubted the potential role of consent in instances in which one party is ‘forced’ to contract as in the case of healthcare services in which most of the content of the service provided is determined by law (see Article 14 and 8 of Law 502/1992), and accredited public (and private) healthcare facilities cannot refuse to contract when it comes to providing the required LEP services that fall within the limits agreed with the Regions (Article 8 quinquies of Law 502/1992)

156 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 514–518 respecting ‘accessibility, clinical and organizational appropriateness, waiting time and continuity of care’ (Article 8 quinquies lett. c).

514. The contract for healthcare between healthcare facilities and patients is an expression of their freedom of contract and is a way in which patients exercise their right of ‘free choice of place of care, and choice of professional from those accredited with whom appropriate contractual agreements have been deﬁned’ (Article 8bis Law 502/1992). See also 650ff.

515. Consent to treatment has nothing to do with consent to the contract for healthcare services; consent to medical treatment is the necessary legitimizing element of medical interventions on a patient.

II. Legitimate Medical Intervention and the Limits of Consent: Damages for Lack of Consent

516. Informed consent, as a conscious adhesion to the medical treatment proposed by the physician, is a fundamental right grounded on the protection of health (Article 32 Cost) in conjunction with the principio personalistico (personalist principle; see 678) (Article 2 Cost.) and the protection of individual liberty (Article 13 Cost) (see also the Constitutional Court decision, 14 December 438/2008). Accord- ingly, and with the exception of statutory provided mandatory treatments, any intervention on individual health (considered broadly as illustrated, see 505ff) without patient consent might lead to criminal and civil liability.

517. Even in the case in which the treatment has not caused any personal injury (and even when it has actually improved health or saved the life of the patient) courts awards non-economic damages for the violation of the right to consent to healthcare treatments. This is, for instance, the case of Jehovah witnesses unlaw- fully forced to undergo a blood transfusion. However, compensation is limited to non-economic damages for the violation of consent and extension to any permanent impairment eventually ensuing as an adverse event of the medical treatment is only considered where the patient can demonstrate in court that she would not have undergone the treatment if fully informed of the risk of adverse event that actually materialized. See 532.

§2. PROFESSIONAL LIABILITY

I. Introduction and History

518. Both criminal and civil liabilities of physicians have gone through several periods of change. Case law oscillated between an age of both indulgence and severity in relation to the physician before arriving at a historical moment according to which the evolution of medical science rendered the role of the sole practitioner almost non-existent.

Medical Law – Suppl. 119 (2020) Italy – 157 519–522 Part I, Ch. 5, Medical-Related Accidents and Compensation

519. In criminal law, the current complex mode of healthcare delivery collides with the constitutional principle (Article 27 paragraph 1) for which criminal liability is personal with the result of a progressive reduction of its scope in the medical profession. In civil liability matters, the organizational changes in the delivery of healthcare (see 521), coupled with the evolutions in terms of both medical science (see 520) and the expanded role of informed consent (see 669ff) has led to a profound revision of the criteria for allocating damages liability (see 545ff, 554). Such a progressive expansion of the scope of civil liability can be easily described with the lexical changes in the language used when referring to liability for damages resulting from the provision of healthcare services. Scholars and case law originally used the expression ‘responsabilità del medico’ (physician’s liability) signalling individual (at ﬁrst only contractual) professional liability and making it rather easy for physicians to escape liability. Later, since the 1950s, once the complexity of healthcare delivery began to emerge clearly the most utilized expression was ‘responsabilità medica’ (medical liability) referring to those instances in which individual contribution to the harm was not easy to ascertain since intervention was characterized by teamwork in equipe, for instance, in a surgical operation. Today, the most utilized expression is ‘responsabilità sanitaria’ (liability in healthcare delivery) mostly referring to the liability (direct or vicarious) of the healthcare facility involved in causing the harm (see 574ff).

520. The last thirty years between the late twentieth and early twenty-first century have witnessed a growth of healthcare liability and attention on it. During this period, several changes in the legal rules and in the perception of the responsibility involved in incomplete healing were effectuated. As it is known, the exponential growth of treatment options due to scientific and technological innovation has, even since before the 1990s, increased the chances of survival for sick and injured persons. This positive result has amplified the social perception that healthcare can increasingly not only cure but also heal. From this perception, it does not take much to go from a duty to care to a legal obligation to heal – even if this step is wrong.

521. At the same time, the liability rules for healthcare services have undergone profound metamorphosis intended to make the burden of proof less burdensome for the claimants when attempting to obtain compensation for the impairment of their health. The gradual widening of the possibilities of compensation for personal injury related to medical activities did somehow echo the increased role of the compensable head of damages, intertwining further the parallel stories of medical liability on the one hand and the explosion of personal injury damages on the other.

522. Healthcare reforms have become entangled with the evolution of physician liability, assisting in promoting medical liability at ﬁrst followed by liability for healthcare services. In Italy, since the 1970s, the organization of healthcare focused its attention on the right to health of the citizens, spreading and implementing the ability to demand treatment from the State provided for in Articles 32 and 38 Cost. In the 1980s, 1990s and later, the consolidation of the elements of a personal injury claim corresponded to an increasingly easier recoverability of damages through more lenient interpretations of the building blocks of civil liability (both in contract

158 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 523–526 and tort) and the allocation of the burden of proof between healthcare giver- defendant and patient-plaintiff progressively in favour of the latter. See 39.

523. The reversal of the burden of proof in conjunction with the distinction between difficult and not so difficult medical interventions in addition to a progressively probabilistic reading of the causal link (see 540ff) all aimed to facilitate the attribution of liability to the physician and, above all, to the healthcare facility as the last instance payer. From this process, we eventually saw a shift from physician liability to the liability of the healthcare facility.

524. The process reversing the burden of proof culminated in the affirmation of the principle of proximity of proof and in the comprehensive anchoring of civil liability of staff and of the healthcare facility to rules of contractual liability in general and not on the contract for delivery of professional services. See 526.

525. Indeed, healthcare systems are defined by the Ministry of Health (Rap- porto sulla 1° rilevazione nazionale relativa agli ‘aspetti assicurativi in ambito di gestione aziendale del rischio clinico’, September 2006 pg. 4) as ‘highly complex systems characterized by the presence of multiple factors, among which and particularly relevant are the specificity of individual patients, the high specialization levels of diagnostic and therapeutic interventions, the coexistence of multi- professional experiences and the presence of different National and management models’. This definition and the actual citizens’ perception of the mechanisms of healthcare delivery, encompassing a plurality of factors involved in it along with the potential harmful effects that can arise from such provision of services required the establishment of a liability system that goes beyond the mere search for individual liability and blame. And indeed, these characteristics of modern healthcare delivery remain at the core of the actual set of rules and principles of civil liability for both healthcare professionals and healthcare institutions. Finally, in 2017 the legislator was able to pass a legislative reform of healthcare providers’ liability (law 24/2017) largely following established case law at that time. In the same year, a statute on informed consent and advance directives was passed as well (law 219/2017). While several governmental decrees to fully implement the statutes are still missing, on 11 November 2019 a series of decisions issued by the Supreme Court clarified several issues left open by law 24/2017 on the nature of healthcare providers’ liability, suc- cession of laws in time, informed consent (see 535, 549, 571, 572).

II. Civil Liability

A. Classiﬁcation of Physician Liability

526. For a long time, physician liability with regard to the patient has been construed according to the typical professional service contract. However, in more recent times, the Supreme Court (since Cass. 22 January 1999, no. 589) has recast

Medical Law – Suppl. 119 (2020) Italy – 159 527–529 Part I, Ch. 5, Medical-Related Accidents and Compensation the patient-physician relationship, and the corresponding liability, in terms of contractual liability, eventually founded on social contact in cases where no pre- existing contractual relationship or relationship of trust between physician and patient could be established (Cass. 29 September 2004, no. 19564; Cass. 21 June 2004, no. 11488; Cass. 21 July 2003, no. 11316; Cass. no. 6318 of 2000; Cass. 11 March 2002, no. 3492; Cass. no. 19133 of 2004; Cass. no. 10297 of 2004; Cass. no. 9085 of 2006). This issue was affected by Law 24/2017, which provides, in Article 7, that the liability of the public or private healthcare facility is contractual, while that of the healthcare professional is non-contractual, unless she acted in the performance of a contractual obligation assumed with the patient (paragraphs 1 and 3: ‘The public or private health or social care facility that, in the fulﬁlment of its obligation, avails itself of the work of health professionals, even if chosen by the patient and even if not employee of the facility itself, is liable, pursuant to Articles 1218 and 1228 of the Civil Code, for their intentional or negligent conduct. 2. The provision referred to in paragraph 1 shall also apply to health care services provided under the intramural freedom of establishment [ … ] 3. The healthcare professional referred to in paragraphs 1 and 2 is liable for his actions pursuant to Article 2043 of the Italian Civil Code, unless he has acted in the performance of a contractual obligation assumed with the patient.’).

527. However, even in those cases in which liability would ensue from a violation of a statutory duty (to provide information, for instance) or from a wrongful act, courts would have applied rules of contractual liability as far as the burden of proof is concerned (principio di vicinanza della prova; see 524, 537).

B. Contents of the Physician’s Duty

528. The content of the physician duty had already been reshaped to fit within the framework of the (organizational) contractual breach of the healthcare institution with which the physician is affiliated (for case law it was irrelevant whether this is in an employee or third-party contractor capacity). The result of this re-shaping process is quite beneficial to the injured party in that the limitation period has been increased from five to ten years, and it also mitigated the burden of proof for the patient pursuant to the application of the contractual liability regime. The legislator in 2017 just adopted it as a statutory rule. As anticipated, over the years, case law has intensified the burden of proof imposed on professionals and the healthcare facility with a view to enabling better patient protection. Accordingly, the physician/ employee must show not only that she has performed her service well but also the unforeseeability and exceptional nature of any harm caused to the patient resulting from her intervention (or the worsening of the health condition of the patient; see for all Cass. 577/2008).

529. The physician’s duty to act is strictly connected to her activity. However, a speciﬁc duty arises only once a contact has been established with a given patient after which the physician has a duty to act accordingly (following proper leges artis) so as to avoid any potential harm that arises related to the illness.

160 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 530–534

530. Under criminal law, the extent of this duty may vary depending on whether the physician is a general practitioner, paediatrician or the director of the hospital/ department (see 581ff). It may be the case that their duties do not create a so-called posizione di garanzia (position of guarantee) with a speciﬁc duty to (by taking all possible precautionary measures) avoid the harmful event. Case law follows two possible ways of giving content to the duty (the deﬁnition of the rule that should have been followed): requiring that the physician must adhere to either ‘best science and experience available at the given moment in time’ or the model agent (homo eiusdem condicionis et professionis).

531. The obligation for the physician is typically an obligation of means and not of result (Cass. no. 23918 of 2006, Cass. N. 4400 2004).

532. Case law has given a coordinated reading of Articles 1176 and 2236, considering them as an expression of the unitary concept according to which the degree of care required must be assessed with regard to the difficulty of the services rendered (Cass. no. 23918 of 2006). In addition, case law has developed over time a distinction between routine surgery and that considered more complex to perform. In relation to the latter, the difficulty of execution must be objectively assessed. We can consider ‘difficult’ interventions those that transcend average ability or those not yet sufficiently studied by medical science. Consequently, for some time now, in cases where the planned surgery was considered easy to perform in that it did not require any particular skill on the part of the physician and it presented a minimal risk of a negative outcome including the worsening of the patient’s condition (so- called routine interventions), the patient was required to describe the intervention and to prove that it fell fully within the scope of technical knowledge acquired by the scientiﬁc community where a negative outcome in fact did arise leading to an action for damages.

533. Failure of the surgery gave rise to a presumption of physician negligence resulting in an exoneration of the burden of proof on the patient. It was then the physician, in cases concerning failed medical interventions, that was charged with proving that the failure did not depend on her negligence. On the contrary, when a medical treatment considered ‘difficult’ was carried out, it was up to the patient to prove the unsuitability and inappropriateness of the methods used in the performance. Instead, the physician had to prove that the treatment involved speciﬁc technical problems transcending the average knowledge. The special difficulty was, however, ascertained by reference to the case at hand in all its particularity, and not by taking into account the intervention abstractly considered.

534. Case law has further clariﬁed that the limitation of liability to cases of intent and gross negligence pursuant to Article 2236, paragraph 2. cc (in reference to cases involving the resolution of technical problems of particular difficulty, see Cass. no. 9085 of 2006) does not apply with reference to damages caused to the patient due to negligence or recklessness, but only to cases related to malpractice. Indeed, medical surgeons in the fulﬁlment of contractual obligations related to their professional activity are held to a standard above the average diligence of a good

Medical Law – Suppl. 119 (2020) Italy – 161 535–537 Part I, Ch. 5, Medical-Related Accidents and Compensation family man (ex Article 1176 first paragraph cc). It equates to the specific standard applied to that of debtors as qualified and prescribed by Article 1176, second paragraph, cc. Such required diligence shall include compliance with all the rules and precautions that as a whole constitute the knowledge of the medical profession, including the monitoring obligation on the health of the patient also in the post- surgery phase (Cass. no. 23918/2006, Cass. no. 19133/2004, Cass. no. 4400/2004 and Cass. no. 3492/2002).

535. Since 2004 (Cass. 21 June 2004, no. 11488), the Supreme Court has settled the rule as follows: in the area of professional liability of the physician-surgeon and of the healthcare facility, subsisting a contractual relationship (even if based only on social contacts), according to the rule pursuant to Article 1218 cc., the patient is charged with the burden of proof in establishing the inaccuracy that essentially caused the failure. He does not have to prove fault or, even less, the severity of it. Thus the rule provided for by Article 7 law 24/2017 remains in line with case law but makes useless to dispute the nature of liability in all these instances. However, the Supreme Court has recently stated that the substantial provisions contained in law 24/2017 do not apply to facts or cases already materialized on 1 April 2017, date of its entering into force (Cass. n. 28990/2019).

536. Proof of the absence of fault and its assessment in terms of severity (in the case pursuant to Article 2236 cc) is left in the hands of the physician or the healthcare facility. The evidence presented demonstrating that no negligent breach (i.e., the positive evidence of the impossibility of performance due to causes not attributable to the debtor) and/or lack of professional diligence occurred must always refer to the sphere of action of the debtor. This is even more so when the performance of the service consists in the application of technical rules, unknown to the creditor/patient, considered to be foreign to the baggage of common experience and speciﬁcally pertaining to that of the debtor/physician.

537. In practice, therefore, the patient should show the title of her claim and attach the breach of duty, consisting of either aggravation of their pathological situation, or the onset of new diseases, or the failure to achieve a reasonably expected improved health status (e.g., an increase in respiratory capacity in case of rhino- septum-plastic). In any case, proof of the contents of the medical service received remains the responsibility of the physician/healthcare facility, as evidence of the proper fulﬁlment, whether considered normal or difficult in terms of performance level. In fact, the professional (or the healthcare facility) in order to provide evidence of the facts extinguishing the claim will have to prove that the service was performed in a diligent manner and that the worsening outcomes or the aggravation of the pathological situation or the development of a new disease were determined by an unforeseen and unpredictable event (see ex multis Cass. no. 9085 of 2006). This principle of evidence (also called the principle of proximity to the evidence) applies to obligations consisting in conducting an activity and in which the breach coincides with the lack of diligence. In these cases, the evidence is ‘closer’ (hence considered easier to prove) to whoever performed the service, especially when an

162 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 538–541 obligation is borne by a professional. In such a situation, the lack of diligence constitutes the violation of the technical rules governing her activity. As a consequence, the distinction between different levels of interventions is today irrelevant, given the application of a general rule of basically uniform evidence. See also 527.

C. The Basis of Liability and Burden of Proof

1. Fault

538. A negligent behaviour ensues from the violation of the precautionary measure that should have been followed.

539. Both the physician and the healthcare institution are contractually committed to the result due (see Cass. SSUU 11 January 2008, no. 577, Cass., 19 May 2004, no. 9471) which is usually delineated according to the criteria of ‘normal outcome’ to be appreciated in relation to the patient’s condition, the technical skill of the physician and the technical and organizational capacity of the institution (see Cass., 13 April 2007, no. 8826, Cass., 22 December 1999, no. 589 Cass., no. 2750/ 98; and Cass., 8 January 1999, no. 103). Consistently, the regular outcome of the performance depends on a number of factors, including the kind of pathology, the patient’s general conditions, the current state of technical and scientiﬁc knowledge (state of the art), and the organization of appropriate means to achieve the healthcare objectives under normal conditions. Note, however, that after law 24/2017, patients satisfy the burden of proving fault in different ways for healthcare institutions and doctors collaborating with them. For the former, fault is presumed by establishing the non-fulﬁlment of the obligations in the contract, while physicians’ fault must be positively established by the patient unless the physician has ‘acted in the performance of a contractual obligation entered into with the patient’.

2. Causation

540. The trial judge must ﬁrst identify separately the existence of a causal link between the unlawful conduct and the event of damage and then determine whether that conduct was negligent or wilful (Court of Cassation 26 June 2007 no. 14759).

541. Only after ﬁnding a causative link must the existence of negligence and the consequent burden of proof be addressed. Note that the causal link between the failure to act on the part of the physician and the injury suffered by the patient should be conﬁgured through a necessarily probabilistic criterion if it is deemed that the work of the physician, if properly and promptly provided, would have offered a serious and considerable opportunity to avoid the damage that has occurred (Cass. 4 March 2004, no. 4400, Cass. 23 September 2004, no. 19133, Cass. 11 November 2005, no. 22894, Cass. 21 January 2000, no. 632).

Medical Law – Suppl. 119 (2020) Italy – 163 542–547 Part I, Ch. 5, Medical-Related Accidents and Compensation

542. While under criminal law (Cass. SSUU crim. 11 September 2002 the so-called Franzese case) the causation criteria requires certainty at trial beyond any reasonable doubt, under civil liability (Cass., 16 October 2007 no. 21619) the criteria for ascertaining causation is that it should be ‘more probable than not’ that the facts caused the harm.

543. Following the 2002 ‘revirement’ in criminal case law (supra 542), the mentioned rule of evidence in establishing causation was extended to the civil divisions by the decision of the Court of Cassation dated 4 March 2004, no. 4400. This adoption of a basically high probability standard – which would have reduced the recoverability of damages in civil law matters – forced the civil division of the Italian Supreme Court to adopt the criterion of loss of a chance of survival or recovery, in order not to over-reduce compensation. See infra 545, 572.

544. In short, the civil division of the Italian Supreme Court accepted the recoverability of damages deriving from the loss of a chance of survival, considering the chance of survival as an interest to be protected as such. Damages were awarded in proportion to the loss of a chance of survival (or recovery) that a physician had ‘caused’ to the patient through her malpractice. Loss of chance operates in a very similar way to proportional liability, albeit, as will be illustrated below, in a non- convincing and probably theoretically and technically incorrect way.

545. Some decisions of the civil divisions of the Court of Cassation (Cass. 18 April 2005, no. 7997, in Corriere giuridico, 2006, 257, commented on by F. Rolﬁ, Il nesso di causalità nell’illecito civile: la cassazione alla ricerca di un modello uni- tario and Cass. 19 May 2006, no. 11755, in Danno e responsabilità, 2006, 1238ff, commented on by L. Nocco, Causalità: dalla probabilità logica (nuovamente) alla probabilità statistica: la Cassazione civile fa retromarcia), on the contrary, have initiated a process of deviation from the principles previously outlined regarding the assessment of causation and loss of a chance. Particularly, Cass. 19 May 2006, no. 11755 closed the gap between the understanding of causation in criminal and civil matters, claiming that the assessment of causation in the mentioned decision of 11 September 2002, no. 30328 (where the principle requiring to prove causation beyond any reasonable doubt is stipulated), explored a different area of law, i.e., criminal law and could therefore not be applied to civil cases (sic). But see now 576.

546. Following the decision of 2006, the Italian Supreme Court case no. 21619 conﬁrmed the existence of a clear distinction in the assessment of causation between civil and criminal proceedings.

547. Furthermore, in civil liability cases, courts require a comparison of statistical data with all the relevant elements of the facts under judgment (Cass. 3 Octo- ber 2007 no. 36162). In addition, individual causation – meaning causation in the given individual case – must be ascertained. In other words, the relative probability of the general law of causation must produce the expected result in the given individual case (Cass. SSUU 1 November 2008 no. 584) according to a judgment based

164 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 548–551 on logic probability sustained by a ‘preponderance of the evidence’ and the criterion of ‘more probable than not’ (see among several, Cass. 584/2008).

548. The switch from an era in which medical liability was based on tort – and institutional liability was dependant on it – to an era in which both healthcare institutions and medical liability are grounded in contract as liability for breach of the agreement to provide healthcare with the quality prescribed by law (see Law 502/ 1992) left to causation a speciﬁc role in deﬁning the scope and amount of damages attributable to the breach. It still plays an important role in situations in which a variety of factors (e.g., natural evolution of the pathology, pre-existing state of health, etc.) play an important causal role in the resulting harm to health (potentially concurring or even excluding causations and consequently liability for the breach). Therefore, its role is better understood through a delineation of issues related to damages.

549. In those cases where a discussion arose as to whether the harm could be sourced in the alleged medical malpractice, courts have requested that the patient (in line with the general principles on the burden of proof contained in Article 2697 cc) shows the casual link between malpractice and the suffered harm (see, for instance, Cass. 10743/2009). This line of reasoning has been strengthened over the years and finally confirmed by Cass. 28991/2019. According to this decision, it is the responsibility of the creditor (patient) to prove the causal link between the conduct of the professional and the damaging event also in the context of contractual liability. It is the responsibility of the debtor (medical doctor or healthcare facility) to prove an unforeseeable and unavoidable cause, not attributable to the creditor that has made impossible the correct execution of the service. Therefore, the Court of Cassation (28992 /2019) clarifies that when the contractual liability of the healthcare professional is deducted, for failure to comply with and infringement of the right to health, it is the responsibility of the injured party to prove – even by way of presumption – the causal link between the worsening of the pathological situation and the conduct of the healthcare professional.

550. Accordingly, patients are not only requested to assert the breach but are also asked to prove both that damage has ensued and the material causal link between the medical act and the harm suffered.

551. Yet, courts presume liability with a reversal of the burden of proof in instances where:

– the medical act presented a high potential for positive results but only partially reached them (see Cass. 26 June 2007 no. 14759; Cass. 13 April 2007 no. 8826); – the intervention is thought to be easy but results in an adverse outcome (Cass., 14 February 2008 no. 3520); – the medical intervention did not reach the positive outcome that would be expected based on consideration of the patient’s conditions, the technical ability of the physician and the organizational capability of the healthcare institution (Cass. 13 April 2007 no. 8826; Cass. 8 October 2008 no. 24791).

Medical Law – Suppl. 119 (2020) Italy – 165 552–556 Part I, Ch. 5, Medical-Related Accidents and Compensation

552. When issues arise dealing with a breach of duties on the part of the healthcare institution (regardless of whether they are considered contractual breaches or breaches of legally imposed obligations), courts require the healthcare institution to demonstrate that an actual unforeseeable exceptional event caused the harm. Mostly, these cases have dealt with damages resulting from infected blood transfusions or the administration of blood products (Cass. 577/2008; see infra 611 and 604ff) and incorrect diagnosis due to false positives in clinical examinations. In these cases, defects and failures related to the correct maintenance of medical records triggered the liability of the institution autonomous from the ascertainment of speciﬁc malpractice attributable to one of the employees. Similarly, in cases concerning nosocomial infections (see Trib. Bari 10 March 2009 and Cass. 11 May 2009 no. 10743) structural and organizational defects were held to constitute direct exclusive liability of the healthcare institutions requiring the defendant to show the actual unforeseeable exceptional event as the cause of the harm.

553. A ﬁnal set of cases in which causation issues have been of signiﬁcant importance are those in which late or wrong diagnosis by the physician reduced the possibility of avoiding the harm (death or permanent injury) while concurring with other natural (e.g., the pathology) or organizational factors (e.g., a nosocomial infection – Healthcare-Associated Infections (HCAI) – worsening the patient’s health and quality of life; see also 636ff). In these instances, courts have argued in terms of loss of chances sometimes within the framework of material causation and sometimes within the framework of legal causation and compensable losses. See also 572. As mentioned, after the decisions issued on 11 November 2019, these cases must be considered as actual damages (i.e. anticipated time of death).

3. Damages

554. Contractual liability is regulated by Article 1218 cc and does not contain a distinction between economic and non-economic damages.

555. Since the original frame of the Code considers tort liability as a special kind of liability, Article 1223 cc, encompassed in the contract section of the Code, also applies to tort liability (see Article 2056 cc). It expressly provides that damages must include both the loss which is actually sustained and lost proﬁts. This explains why Article 2056 cc on the evaluation of damages merely states that ‘damages to the victim must be calculated according to Articles 1223, 1226, 1227’ regulating damages for breach of contract.

556. The general principle on recoverable damages is that the actual amount of damages must be established. However, if this is not possible, they are ‘awarded by the judge through his/her equitable evaluation’ (Article 1226 cc invoked by Article 2056 cc). In any event, ‘lost proﬁt is appreciated by the judge through an equitable consideration of the circumstances of the case’ (Article 2056 cc, section 2).

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557. Need we say that it is de facto impossible to establish the actual amount of non-pecuniary damages. On the contrary, the costs proven for medical and care expenses are recoverable losses. The same is also true for loss of earnings due to temporary and/or permanent disability.

558. The architecture of the civil liability system (in tort especially) rests upon two norms: the general rule for liability under a fault-based rule (Article 2043 cc) and the speciﬁc rule for limiting the scope of non-pecuniary damages: Article 2059 cc. This latter norm was originally read as having a predominantly ‘punitive’ aim because it limits non-economic damages (non-economic losses) only awarding them in the hypotheses provided for by the law. For a long time, scholars and judges have perceived the rule as limiting compensation for moral damages merely to cases in which the tort also constitutes a crime, pursuant to Article 185 cp, or to the other few instances in which the legislator mentions the compensation of non-pecuniary damages. However, a long-lasting scholarly and judicial debate produced a ﬁrst fundamental revolution through the judicial introduction of damage to health (danno alla salute) in the 1970s as an autonomous type of recoverable loss, and a second revolution in 2003, when the Supreme Court reaffirmed the original revolutionary jurisprudence on danno alla salute but expanded the scope of non-pecuniary damages in the legal system. To date, the general rule for compensation of non- economic damages encompasses all cases of violations of fundamental rights according to the rules settled by Cass. SSUU 26972/2008 as revised by the III Chamber in its decisions of 2018/2019 (see 535, 549).

559. Finally, as a preliminary remark, we must notice that one article explicitly deals with personal injury damages. Article 2057 cc provides that ‘when damage to persons is permanent, awards of damages can be made by the judge, taking the conditions of the parties involved and the nature of damages into account, as a life annuity’. However, this rule is constantly ignored by predominant case law and decisions applying it are quite rare even upon request of the parties.

560. See also 687. Economic

561. As anticipated economic damages include out-of-pocket expenses and loss of earnings (both actual and future). However, medical treatment costs are paid upfront mostly by the social security system and the victim usually only has to pay a so-called ticket (a co-payment related to the cost of the treatment). This even occurs when expenses are relatively small in comparison to actual costs and should be reimbursed to the victim by the tortfeasor. Nevertheless, several cases award damages for future surgical operations (even cosmetic ones).

562. As far as lost earnings are concerned, employers pay these to employees who never actually ‘lost’ anything. A victim who is reimbursed by her employer could seek personal injury damages in connection with temporary impairment, but one cannot seek double recovery for lost wages just because the victim did not lose

Medical Law – Suppl. 119 (2020) Italy – 167 563–566 Part I, Ch. 5, Medical-Related Accidents and Compensation anything. In turn, the employer can recover the wages paid to the employee from the wrongdoer since she has sustained damage due to the missed professional services. Italian courts have substantiated this possibility in many cases, particularly conﬁrming it in a 1988 decision, in which it was acknowledged that the employer has a right to indemniﬁcation from the wrongdoer who was responsible for the employee’s accident, and also for the amount of social security contributions paid during the injured employee’s absence (Cass., United Sections, 12 November 1988, no. 6132, [1989] Foro italiano I, 748). Therefore, the employee can claim compensation for personal injury from the social security agency (INAIL – National Insti- tute for Insurance against Industrial Accidents) for any economic loss. The social security agency has recourse against the wrongdoer. The Court of Cassation used to distinguish between permanent and temporary injuries: in the latter case if temporary injuries allow the worker to work, she could recover damages for difficulties in rendering these services (see Cass. 15 April 1993, no. 4475, in Foro it. Rep., 1993, voce Danni Civili, no. 30). Note that this understanding must be interpreted in light of the theory of ‘danno alla salute’.

563. In the case of self-employed persons, as professionals they must show actual loss of earnings in order to recover lost profits. In relation to road traffic accidents, these are calculated according to the highest declared fiscal net profits over the previous three years. In any event, annual profits to be taken into account cannot be lower than three times the annual value of the social pension (see Article 137, section 4 of the so-called insurance code: Law no. 209 enacted on 7 September 2005). Sometimes, when actual lost profits cannot be established, as in the case of students, courts award damages by considering the ways in which the permanent impairment can reduce the victim’s ability to work according to completed studies and other experiences, together with damage to health. When those parameters for equitable evaluation are missing – some courts say – the specified criterion of Article 137 applies.

564. An impediment to advancement in one’s profession is not a separate head of damage. Courts however when awarding future lost earnings do consider it.

565. The inability to run a household as such is taken into account as damnum emergens in the case of housekeepers and housewives who suffer permanent/ temporary impairment. Damages are calculated according to the market value of the lost work. Note that since 1999 a ﬁrst-party insurance scheme (mostly State- funded) was created in order to also compensate the victims of household accidents when the disability is particularly severe.

566. Along with increased expenses, any damnum emergens directly linked to the personal injury suffered can be awarded. This is the case in relation to reasonable costs to adapt the house for an impaired victim. As far as indirect losses are concerned, there were some cases dealing with these losses but usually courts qualify them as indirect consequences irrecoverable under Article 1223 cc. This was the case, for example, concerning damages for a spouse’s lost wages due to the

168 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 567–569 assistance offered to the injured marital partner (Cass. civ., sez. III, 16 April 1996, no. 3564, in Riv. giur. circ. trasp., 1996, 625). Non-economic

567. The key damages for personal injuries and death are non-economic ones. Italian case law has developed a distinction in the non-pecuniary damage category most comprehensively, by establishing an independent category of damages to the person (‘danno alla salute’), which has gained a primary and crucial role in personal injury. In fact, the Constitutional Court has stated that danno alla salute is ‘a ﬁrst, essential, priority compensation that conditions every other one’. See, e.g., Cost., 14 July 1986, no. 184, Foro It. I 1986, 2053 (arguing that lost earnings and out-of-pocket expenses may not accrue in an actual case, but danno alla salute must always be compensated). This new title of damages absorbed various other titles for non-pecuniary damages, bringing disparate case law under a uniﬁed theory.

568. This new trend sprung from a constitutional approach to personal injury damages: everyone is entitled to health which is a right constitutionally protected by Article 32 of the Constitution. According to the Supreme Court, the principle to which courts should be bound is that damages coming from the infringement of the right to health must be compensated even though it does not impair the ability to generate earnings. This stands regardless of the ability to earn impairment of which should be independently compensated.

569. The Italian Supreme Court identified the need for an equitable evaluation that must be coherent with the kind of loss involved for this fundamental title of damages (Cass., Civil Section., 13 January 1993, no. 357). This quest for coherence led to the search for a formula that had a double means of assessing damages, which would primarily base uniformity on a medical evaluation of the psychophysical disability and on the possibility of extrapolating homogeneous monetary guidelines from prior awards. In practical terms, a medical evaluation gauges permanent disability, through assigning to it a percentage according to specific scientific parameters commonly available in reputed scientific and practitioner publications. Following this expert medical evaluation, which yields a verifiable medical condition element, judges assign a monetary value to the percentage point and multiply it by the number ascertained, which represents the victim’s disability. In addition, the system safeguards that the judgment is equitable, because it is for the court to define the monetary value of each point according to previous awards, and it is also for the court to ascertain the disability and its correspondence to a severity percentage, according to the medical evidence given by expert medical witnesses. Finally, the court adapts the scheduled result obtained for the case under consideration by multiplying the selected monetary point value by the ascertained percentage (Cass., Section. III, 14 April 1995, no. 4255, in 60 RESPONSABILITÀ CIVILE E PREVIDENZA 519 (1995) (with commentary by G. Ponzanelli, La Corte di Cassazione ed il cri- terio equitativo nella valutazione del danna alla salute, confirming the criteria summarized in the text and referring to them as ‘the results reached by the most sagacious courts of merits’).

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570. Indeed, the Italian Constitutional Court expressly fostered ‘a criterion fulfilling both the need for basic monetary uniformity and [the need] for elasticity and flexibility to adjust awards to reflect the actual effects of the ascertained disablement on activities of daily life’ (Cost., 14 July 1986, no. 184, Foro It. 1986, I, 2067).

571. Finally, it is also worth remembering that the use of monetary tables or medical barème is not compulsory outside the domain of road traffic accidents (D.lgls. 209/2005 artt. 138 and 139) and healthcare providers’ liability (Article 7 paragraph 4 extends the monetary tables of Articles 138 and 139 D. Lgs 209/2005 to healthcare providers’ liability). They are followed because of their scientiﬁc authority and/or because they constitute shared information among the players in the personal injury compensation arena. However, the Supreme Court (Cass. no. 12408/2011 and 14402/2011) has declared that, absent a legislative intervention, it will consider as a point of reference the monetary tables developed by the Tribu- nale of Milano. In any event, it is worth noticing that the Italian Court of Appeals and the Italian Supreme Court will not question the amount of damages awarded by trial courts if the criteria used for calculation and the ratio decidendi are consistent. Therefore, when the reasoning of judges is logically consistent and coherent with the evidence, a Court of Appeal would not question the amount or the criterion adopted for awarding personal injury damages. Note that the Supreme Court con- ﬁrmed the (compulsory) applicability of the monetary tables to proceedings and facts already occurred before 1 April 2017 (Cass. n. 28990/2019), while it has excluded the retroactivity of the substantial rules differentiating liability for doctors and institutions (Cass. n. 28994/2019). Damages for Loss of Chance

572. ‘Loss of a chance’ is a theory oriented towards sustaining and expanding compensation. The limits it faces in this perspective and in the context of medical liability are basically conceptual ones. Case law has pointed out that, when dealing with the loss of the possibility to win in a competitive examination, courts examine the possible evolution of a future condition. On the contrary, in medical liability cases, ‘medical conduct interferes in a causal chain in progress, precluding the possibility of reaching the result of care or survivorship’ (see Tribunale Venezia 25 July 2007, in Danno e responsabilità, 2008, 43, commented on by R. Pucella, Causalità civile e probabilità: spunti per una riﬂessione). Yet, in such cases, the loss of a chance of success was awarded by courts. Everything seems to have changed with a decision of the III Chamber of the Supreme Court on 11 November 2019. Cass. n. 28993/2019, published with other decisions ‘rewriting’ liability for damages ensuing from the delivery of healthcare services, has forced a different reading of the loss of chance (especially with reference to the expectations to survive). Following this judgment, the notion of chance is to be understood as the appreciable, serious and consistent loss of the possibility of a hoped-for result (lost possibility of a better and only possible result), whereby it differs from the hypotheses in which the damage coincides with the hoped-for lost opportunity. The decision clariﬁes that, from a functional point of view, patrimonial and non-patrimonial

170 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 573–574 chances share the same nature. The morphological difference between patrimonial and non-patrimonial chances in healthcare liability is to be found in the diversity of the pre-existing situation: negative pre-existence (non-patrimonial chance); positive pre-existence (patrimonial chance). Such pre-existence postulates, in the patrimonial chance, a positive situation (professional qualifications, curricula, previous experiences, specific attitudes, etc.), in the non-patrimonial one, a pathological (already) health situation (i.e. negative). Therefore, ‘in cases where the damage event is not a possibility – synonymous with uncertainty of the expected result – but from the (missed) result itself’, we must not speak of loss of chance but of another damage event. In these cases, the loss of the chance to survive is configured as damage from anticipated loss of life (a real damage and not the loss of a possibility) as well as the demonstration of not having been able to live in different and better conditions the time of remaining life, if demonstrated, is configured as a real loss. It is too early to assess if trial courts will follow the new direction opened by the Supreme Court’s decision n. 28993/2019 (see also 544).

D. Aspects of Vicarious Liability

1. Liability of Hospitals and ASL for the Acts of Their Medical Staff

573. According to long-standing case law, the patient and the healthcare facility are bound by a contractual relationship the breach of which results in civil liability of the healthcare facility (see ex multis Cass. 24 March 1979, no. 1716, Cass. 03 January 1988, no. 2144, Cass. 27 May 1993, no. 5939, Cass. 27 July 1998, no. 7336, Cass. 1 September 1999, no. 9198, Cass. 8 January 1999, no. 103; Cass. 8 May 2001, no. 6386, Cass. 11 March 2002, no. 3492, Cass. 4 March 2004, no. 4400, Cass. 29 July 2004, no. 14488, Cass. 14 July 2004, no. 13066, Cass. 28 May 2004, no. 10297, Cass. no. 19133/2004, Cass. no. 9085/2006, and Cass. 3 February 2012, n. 1620 and Cass. 20 March 2015, n. 5590). This long-lasting line of cases has been fully conﬁrmed by Article 7 law 24/2017 that clearly refers to articles 1218 and 1228 of the Civil Code.

574. For a long time, such a contractual relationship was construed and governed by an analogous application of the rules related to contracts concerning intellectual services connected to the doctor-patient relationship. It followed that the basis for the assertion of contractual liability of the facility was a finding of wrongful conduct of the physician working at the same facility. However, case law has reconsidered this relationship, independently of the doctor-patient relationship, and classified it according to autonomous and atypical contracts for healthcare services, sometimes referred to as a ‘hospitalization contract’ (‘contratto di spedalità’), which is governed by the ordinary rules on non-performance laid down by Article 1218 cc. From this follows the possibility of independent liability of the facility, independent from any finding related to the negligent conduct of individual operators, and instead based on the non-fulfilment of the obligations directly related to the facility (Cass. SU 1 July 2002 no. 9556 and later confirmed by Cass 577/2008). See 526.

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575. The contractual relationship between patient and facility is a complex atypical one. It goes far beyond the provision of inpatient accommodation services (so-called hotel services) and includes the provision of auxiliary medical personnel, paramedics, the provision of medicinal products including all the necessary equipment that may be required where complications arise. The facility must then provide the patient with a highly articulated performance, defined generically as ‘healthcare’, which incorporates, in addition to the main medical benefits, a series of obligations. For instance: the requirement to have suitable premises, in terms of both dimension and hygiene; the obligation to have modern equipment, suitable and functioning; the obligation to have qualified, adequate and present staff both at medical, paramedical and auxiliary levels; the obligation to have medicines and therapeutic facilities considered effective and currently valid; and the obligation to provide adequate ancillary services. As a result, the civil liability of the healthcare facility, in terms of organizational inadequacy has been deemed configurable (this was held the case, for example, when the medical record was incomplete or missing or otherwise insufficient for an adequate reconstruction of the facts and for an assessment of whether or not the fault could be attributed to the physician see Cass. 21 July 2003, no. 11316, Cass. 23 September 2004, no. 19133). See also 519, 522, 525.

576. This reconstruction of the healthcare facility-patient relationship gives rise to major consequences. In terms of liability, where it is considered as subsisting the contract (‘contratto di spedalità’) between the healthcare institution and the patient, the liability of the institution is rendered independent of the liability – or lack thereof – of the physician for the ominous outcome of an intervention or for an injury that has no direct connection with the outcome of a surgery. In other words, the establishment of the liability of the defendants is moving along levels completely independent from each other.

577. Yet, pursuant to Article 1228 cc, if the physician is an employee of the healthcare facility, contractual liability of the facility will be established where the facility has entered into a contract with the patient to perform any healthcare intervention that has been requested or proposed by a physician on the basis of an assessment of the clinical condition of the patient. Similarly, a facility will still be liable by virtue of the principle of social contact in the event that a relationship between a patient and a physician has arisen directly as a result of advice from a trusted professional – and on the basis of this a medical intervention at a private facility to which the patient is directed is carried out on the basis of this advice. Such a line of reasoning has been endorsed by law 24/2017.

578. Only in the case in which the contract is concluded directly with the professional and the latter has contacted the nursing home, for the rental of the equipment or rental of the rooms, can it be concluded that the healthcare facility is only liable for the ancillary performances agreed upon with the patient (e.g., nursing care operating theatre, medications, etc.) but not for the malpractice of the physician. Nevertheless, law 24/2017 has intervened on these matters in various ways. Article 7, paragraph 1, makes the public or private health or social-health facility that avails

172 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 579–582 itself of the services of health professionals, even if chosen by the patient and even if not an employee of the facility itself, liable, pursuant to articles 1218 and 1228 of the Civil Code, for their intentional or negligent conduct. Note, however, Article 10 requires professionals ‘who avails himself of it in the performance of his contractual obligation entered into with the patient pursuant to Article 7(3)’ to insure against damage to third parties. Scholars and judges are having hard times in rec- onciling the two norms.

579. Of course, an eventual tort (according to the general rules of liability contained in Article 2043 cc or contractual liability ex Article 1218 cc) of the physician and contractual liability of the healthcare institution employing her can concur, but the quoted statutory rules have put into question the pre-existing settled case law.

580. The distinction between public and private healthcare facility was already irrelevant to civil liability towards the patient (Cass. 25 February 2005, no. 4058; Cass. 8 January 1999, no. 103; Cass. 11 March 1998, no. 2678) since the obligations of the two kinds of facilities towards the user of their services are substantially equivalent at the normative level. Case law revealed that in relation to the rules of civil liability, private facilities are fully equivalent to public facilities, even in view of the fact that their violations affect health as a fundamental right protected by the Constitution, without the possibility of any limitation of liability or differences for damages according to the different nature of the healthcare facility. Once again law 24/2017 endorsed the settled case law.

III. Criminal Liability

581. Criminal law experts and courts have profoundly examined the issue of medical criminal liability searching for justifications of an activity that perfectly correspond to the archetypical figures of intentional personal injuries or homicide as described in the Criminal Code when these events materialize in the course of medical treatment. The search for justification has fed a debate –at times self- referential – that examines traditional de-criminalization justifications (e.g., consent of the victim ex Article 50 cp) or looks to the self-legitimizing role of performing an activity (treating illnesses) organized directly by the State, the social utility of which was not disputed. In more recent times, criminal law experts and courts have moved towards patient consent as the (sole) legitimizing basis of medical acts even in cases of criminal relevance (see 505ff).

582. It is worth mentioning that the 2008 decision of the Court of Cassation (Criminal Section 18 December 2008 no. 2437, so-called Giuliani case) has basically adopted the analysis of the Enghelaro case (Cass. 21748/2007; see 914ff) and the Constitutional Court (428/2008) has linked the fundamental right to provide consent to treatment not only to Article 32 paragraph 2 but also to Articles 2 and 13 of the Constitution. The combined result of these last-mentioned judgments has led to the establishment of a set of rules.

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583. In line with Article 32 Cost., Article 2 EU Charter of Fundamental Rights, Article 5 of the Oviedo Convention (although the latter is technically not binding nor applicable in Italy see 1005) and Article 33 Law 1978/833, the general legitimizing rule is informed consent of the patient capable of self-determination (with discernment).

584. A second rule, relating to those having legally lost their mental capacity and are therefore debarred, is consent of the legal representative (see supra 882). Excep- tions to these rules are (which in fact constitute a third rule in the end) treatment of the mentally ill (see supra 926) for which medical action is legitimized by Article 33ff Law 833/1978 with all the guarantees provided for in the Constitution, and for emergency situations (see also Articles 7 and 8 respectively of the Oviedo Conven- tion; see 1147).

585. If we set aside arbitrary treatment (i.e., without consent), today wilful or malicious conducts amounting to crimes remain rather residual in healthcare delivery, although they do exist and can be committed by physicians. We have already dealt with most of them: Article 348 cp (abusive exercise of a profession), and comparaggio (Articles 170 and 171 TULS and Articles 30–31 CME). See 868.

586. In addition, Article 480 cp punishes ideological falsehood committed by public officials in certificates or administrative permissions. Article 481 cp expressly punishes with imprisonment of up to one year or a fine ranging from EUR 51 to EUR 516 ‘anyone who, in the exercise of a health profession or forensic or other necessary public service, falsely attests, in a certificate, to facts intended to prove the truth’. See 854ff.

587. Potentially at least, the larger area of intervention for criminal sanctions is in negligence cases resulting in personal injuries or death. Among applicable crimes based on criminal negligence, in general, we can distinguish the hypothetical of an illegitimate medical act, not grounded on the legitimizing rules and the hypotheticals in which the physician is accused of having caused death or personal injuries or to have failed to prevent either death or further injuries to a patient’s health (by not respecting the rules of her profession).

588. In these sets of cases, and without regarding any medical malpractice, the main criminal rules potentially operating are those referring to:

(1) homicide (involuntary manslaughter Article 584 cp) and personal injury crimes (Articles 582, 583, 590 cp; see 589); or (2) crimes against individual freedom (Articles 610, 605, 613 cp). See 592ff.

Moreover, Law 3/2018 added a general aggravating circumstance to Article 61 of the Criminal Code: ‘1-sexies) having, in unintentional crimes, committed to the detriment of persons admitted to health care facilities or residential or semi-residential social and health care facilities, public or private, or to social and educational facilities’.

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Law 24/2017 (Article 6) introduced Article 590-sexies of the Italian Criminal Code, which establishes: ‘If the facts referred to in articles 589 and 590 are committed in the exercise of the healthcare profession, the punishments provided for therein are applied, subject to the provisions of the second paragraph. If the event occurred due to inexperience, the punishment is excluded when the recommendations provided by the guidelines as deﬁned and published pursuant to law are respected or, in the absence of these, good clinical and welfare practices, provided that the recommendations provided by these guidelines are appropriate to the speci- ﬁcities of the case.’ This rule has been implemented with reference to the public register of guidelines, but to date only very few guidelines have been published.

A. Medical Acts Resulting in Personal Injury or Death (Crimes)

589. Case law has moved from the position established by the so-called cases Massimo and Firenzani (Cass. crim. 21 April 1992 and Cass. Crim., 11 July 2001) to that espoused by the so-called Barese and Volterrani cases according to which, absent patient consent, medical crimes were attributed to physicians when all their constitutive elements unless contrary evidence was shown (Cass. 9 March 2001 and Cass. Crim. 29 May 2002). These contrasting positions were partially dealt with by the Court of Cassation by the joint chambers (SSUU, 18 December 2008 no. 2437) which held that medical procedures performed leges artis but without the patient’s consent cannot amount to a punishable personal injury crime if they produce an improvement in the patient’s health (a positive outcome), and there is no explicit dissent to treatment. The Court excluded also that the mere anatomical lesion caused as a result of having to undergo surgery constitutes in itself an illness. It stated that a favourable outcome ‘should be understood only by way of a positive assessment on the appreciable improvement of the health conditions of the patient, with reference not only to the rules of medical science, but also to the possible alternatives, and it must include the manifestations of will positively or indirectly expressed by patient’.

590. In the case of a negative outcome, it seems that the materialization of the crime under no. 1 (supra 588) is excluded for lack of malice (dolo) while negligent inﬂiction of personal injury will depend on the ascertainment of a violation of leges artis. Scholars have highlighted the many technical problems which remain open with this solution, of course subject to the applicability of the new Article 590- sexies. See also 584 and 686.

591. Voluntary active euthanasia is comparable to murder (Article 575 of the Criminal Code). In case where the consent of the patient can be demonstrated, the penalties are provided for in Article 579 Criminal Code (murder of the consenting), ranging from six to ﬁfteen years of imprisonment. Also, assisted suicide is considered a crime under Article 580 cp.

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B. Medical Acts Resulting in Crimes Against Individual Freedoms

592. It is obvious that crimes against individual freedoms (mainly under Articles 610, 605, 613 cp) can coexist with the personal injury crimes discussed supra (see 589ff).

1. Private Violence and Procured Incapacity

593. Article 610 cp punishes ‘Whoever, through violence or threat, forces others to do, tolerate, or omit anything’ with imprisonment of up to four years. This is probably the most recurrent crime evocated in the medical context, particularly in consideration of a failure to get full consent.

594. Indeed, physical or pharmacological restraint constitutes the normative elements of violence with which a physician ‘forces’ a patient to ‘tolerate’ the treatment.

595. Those cases in which no physical or pharmacological restraint is used, but rather the physician deviates from the planned treatment (for instance, while the patient is anesthetized in the surgery room) remain problematic. In these cases, there is no actual conﬂict of wills (unless the patient has expressly denied consent as occurs, for instance, in cases concerning Jehovah’s Witnesses).

596. Article 613 cp punishes (the so-called state of incapacity procured through violence) with imprisonment of up to one year ‘anyone who, either inﬂuences through hypnotic or conscious suggestion, or by administration of alcoholic substances or drugs, or by any other means, places a person, without her consent, in a state of inability to understand or desire’. The application of this provision remains problematic in cases where the patient has actually consented to anaesthesia but is unaware that she is about to receive an unwanted different medical treatment.

2. Kidnapping

597. Article 605 cp punishes a person who kidnaps, i.e. ‘anyone who deprives someone else of their personal freedom’ with imprisonment from six months to eight years. Case law applying this provision to medical actions is rare and really only materializes if the deprivation of freedom constituted a signiﬁcant period, for instance, longer than the necessary time for a surgical intervention. Yet, and although extremely rare, case law can be found and it seems it is more common in cases of psychiatric patients or individuals suffering from senile dementia. In this scenario, individual freedom is limited either for therapeutic or custodial reasons in the absence of the requirements provided for by law (see 910ff and 926ff).

176 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 598–602

3. Professional Medical Negligence

598. There are no speciﬁc rules dealing with medical negligence in criminal law. Rather the general rule contained in Article 43 cp, which stipulates that negligence arises when the event, although expected, is not wanted by the agent and occurs due to negligence or carelessness or inexperience, or for failure to comply with laws, regulations, orders or disciplines.

599. Reference to all professional liabilities is also contained in Article 2236 cc pursuant to which ‘if performance involves solving technical problems of special difficulty, the professional undertaking the work is not liable for damages, except in cases of wilful misconduct or gross negligence’. Case law has interpreted the notion of fault in Article 2236 cc as referring only to inexperience. See also 532, 534, 536.

600. Beyond any doubt, medical activity (diagnostic, therapeutic or surgical) often operates under different grades of uncertainty related to its expected results. In addition, it offers the occasion to decline the required cognitive and operational standards of the homo eiusdem condicionis et professionis in a differentiated manner on the vertical (different levels of competences in medical specialities) and transversal (across various specializations) plane.

§3. SPECIAL INDEMNIZATION PROGRAMMES

I. Compensation for Victims of Vaccinations

A. History

601. Damages caused by vaccination do materialize, although rarely. The solidarity principle and the actual interpretation of Article 32 of the Constitution require that such damages are compensated. Following these principles, the Constitutional Court (307/1990) has declared unconstitutional the Law of 4 February 1966 no. 51 (mandatory polio vaccination) insofar as it does not provide for fair compensation by the State in the event of a harm that arises and goes beyond the hypothetical contained in Article 2043 cc. This covers harm arising as a result of contagion or any other disease considered causally attributable to the mandatory polio vaccination, reported by the vaccinated child or transmitted to another person by way of personal care given directly to the former. In the case at hand, the mother, while taking care of her vaccinated child, contracted polio which resulted in serious personal injuries. The case led to the approval of Law 210/1992 (concerning compensation for those harmed by irreversible complications as a result of mandatory vaccinations, blood transfusions and blood products). See for the general principles 679ff.

602. The law clearly provides a social security tool, which does not exclude the operability of general tort law rules.

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603. The ‘timely’ response of the Italian legislator in this situation, by way of expanding the solution to all mandatory vaccinations and to harm caused by blood transfusions and blood products, has opened a long litigation on several issues. The actual discipline is the result of several legislative reforms and Constitutional Court interventions whose results we summarize below. See 604ff.

B. Discipline

604. Pursuant to Article 1 Law 210/1992 an indemnity by the State can be obtained by:

605. ‘whoever has received, as a result of vaccinations required by law or by order of an Italian health authority, injury or illness, from which a permanent physical-psychological impairment is derived’. The Constitutional Court, with judgment of 16 April 2012, no. 107 declared the constitutional illegitimacy of Article. 1, paragraph 1 extending the compensation to vaccinations not mandatory but recommended.

606. The same allowance is also payable:

– ‘to individuals infected with HIV as a result of the administration of blood and blood-derived products, as well as; – to health professionals who, during and while in-service, have suffered permanent damage to their physical-psychological integrity resulting from an infection contracted by contact with blood and blood products originating from patients with HIV infection’; – ‘to those who present with irreversible damages from post-transfusion hepatitis’; ‘to unvaccinated persons who have suffered, as a result, and as a consequence of contact with a vaccinated person, the damage referred to in paragraph 1’ (supra 605); – ‘to persons who, for reasons related to work or assignment of their duties or to gain access to a foreign country, were subject to vaccinations that, although not mandatory, are considered necessary’; – ‘to those at risk working in healthcare facilities who have undergone non- obligatory vaccination’; – ‘to the heirs of the above mentioned victims’.

607. The beneﬁts are extended also to cases in which the medical treatment (vaccination) was not mandatory but rather highly recommended so as to avoid dis- parity among individuals exposing themselves to risks (also) for the beneﬁt of protecting the community at large.

608. Pursuant to constant case law, the benefits allowed are considered a social security benefit according to law and are independent of any requirement to demonstrate fault. Therefore, a victim remains free to seek full compensation in tort law. This possibility has been recently confirmed by Law 229/2005. However, scholars

178 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 609–615 and trial case law (although not unanimously) have proposed various solutions to avoid the simple cumulating of tort compensation and indemnity to elude risks of overcompensation. Recently the Supreme Court has opted for deducting this social security allowance from the compensation for damages (Cass. 584/2008).

609. Compensation is given to those who can provide evidence of a causal link between vaccination, transfusion, administration of blood products, contact with blood and blood products during activities of service and suffered the permanent damage.

610. The causal link is established by means of a medical judgment for which a special medical committee (the ‘Commissione Medico-Ospedaliera’ established pursuant to Article 165 of DPR 29 September 1973, no. 1092) has jurisdiction under Article 4 of Law no. 210 of 1992.

II. Compensation for Victims of Blood Transfusions

A. History

611. See 601.

B. Discipline

612. Beneﬁts (see supra 604–610) for victims of blood transfusions extend also to those who have contracted diseases due to the administration of blood derivative products. It is absolutely irrelevant whether the blood transfusion (or administration of derivative products) corresponds to continuative needs (such as for haemophili- acs and those suffering from thalassemia) or it is occasional.

613. The beneﬁts also extend to partners claiming to have been infected by their infected partners and to children infected in the womb.

III. Other

614. As mentioned, compensation plans for damages caused by vaccinations, blood transfusions and blood products do not preclude actions in tort according to the general rules. Therefore, at least in principle, patients who claim to have been harmed by these medicinal products can sue the producer or the physician/facility administering them.

615. There are some statutory arguments that can be used for supporting that the transfusion activities, even if carried out within public facilities, may be included

Medical Law – Suppl. 119 (2020) Italy – 179 616–618 Part I, Ch. 5, Medical-Related Accidents and Compensation among dangerous activities pursuant to Article 2050 cc, which requires that the supposed tortfeasor provide positive evidence proving that she has adopted all the measures that may be recommended by diligence, skill and above all prudence: ‘Anyone who causes damage to another in the performance of a dangerous activity, by its nature or the nature of the means used, is liable to pay, if she does not proof to have taken all appropriate measures to avoid the damage’ (Article 2050 cc).

616. Legal action under Article 2043 cc would require proof of at least a negligent behaviour causing the harm complained of and the ensuing damages. Produc- ers could be sued also pursuant to products liability law although case law in this ﬁeld has mostly dealt with medicinal products liability for dangerous activities. Hence, producers’ liability for damages caused by vaccines and blood products can be claimed also pursuant to Article 2050 cc (see among several Cass. no. 1138/ 1995, no. 6241/1987, 8069/1993, no. 814/1997).

617. Note also that design and manufacturing defects are rarely invoked and almost impossible to prove since the product is consumed and further tests aiming to prove defects are impossible. Nevertheless, in recent cases, such as for the vaccination against H1N1, special agreements have burdened producers only of those damages related to the manufacturing while the Ministry of Health was held to be under a duty to shield producers’ liability for any other damage caused to third parties (i.e., patients). See Decision of the ‘Corte dei Conti’ no/ 16/2009/P.

618. Patients could also sue the Ministry of health for omitting to carry out control pursuant to Articles 40 cp and 2043 cc (the general liability rule for fault: ‘Any malicious or negligent fact, which causes wrongful damage to others, obliges the one who committed the act to compensate the damage’) as it has already happened for blood products (see Cass. 576–585/ 2008).

180 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 5, Medical-Related Accidents and Compensation 618–618

Reference 3

In addition to sources previously quoted please see also for Chapters 5–6 of Part I: R Balduzzi (a cura di), La responsabilità professionale in ambito sanitario, il Mulino, Balogna, 2010. M. Bargagna & F. D. Busnelli, eds., Rapporto Sullo Stato Della Giurisprudenza in Materia di Danno Alla Salute, 1996. M. Bargagna & F. D. Busnelli, eds., La Valutazione del Danno Alla Salute, 1995. M. Barni. Il rapport di causalità in medicina legale, Milano, Giuffrè, 1995. M. Barni, Consulenza medico-legale e responsabilità medica, Milano, Giuffrè, 2001. Belvedere A. – Riondato S. (edts), Le responsabilità in medicina,inTrattato di Biodiritto diretto da S. Rodotà E P. Zatti, Giuffrè, Milano, 2011. L. Benci, Aspetti giuridici della professione infermieristica, Milano, McGraw-Hill, 2008. M. Bilancetti, La responsabilità penale e civile del medico, Padova, Cedam, 2006, VI ed. F.D. Busnelli – S. Patti, Danno e responsabilità civile, Giappichelli, Torino, 1997. F. D. Busnelli, Il danno biologico: dal diritto vivente al diritto vigente, Giappich- elli, Torino, 2001. F. D. Busnelli – G. Comandé, Compensation for personal injury in Italy, in Com- pensation for Personal Injury in a Comparative perspective, in B. A. Koch, H. Koziol, eds., Springer, Wien-New York, 2003. F. D. Busnelli – G. Comandé, Damages in the Italian Legal System,inUniﬁcation of tort law: damages, U. Magnus, ed., Kluwer Int., The Hague, 2001, pp. 117ff. F. D. Busnelli – G. Comandé, Non-Pecuniary Loss under Italian Law,inDamages for Non-Pecuniary Loss in a Comparative Perspective, W. H. Rogers, ed., Springer, Wien-New York, 2001, 135ff. S. Canestrari-F. Giunta-R. Guerrini-T. Padovani (a cura di), Medicina e diritto penale, Pisa, ETS, 2009. M. Capecchi, Il nesso di causalità. Da elemento della fattispeciee fatto illecito a cri- terio di limitazione del risarcimento del danno, Padova. Cedam, 2005. C. Castronovo, Ritorno all’obbligazione senza prestazione,inEur. dir. priv., 2009, 3, 679ff. G. Comandè, Towards a Global Model for Adjudicating Personal Injury Damages: Bridging Europe and the United States,19Temple Int’l & Comp. Law Jour., n. 2, 2005, 241–369. G. Comandè, Risarcimento del Danno alla Persona e Alternative Istituzionali, Torino, Giappichelli, 1999. G. Comandè, Product Liability in Italy in European Product Liability. An Analysis of the State of the Art in the Era of New Technologies, Piotr Machnikowski Piotr Machnikowski (ed.),, Intersentia Ltd, 2016, G. Comandé-G. Turchetti (a cura di), La responsabilità sanitaria, Padova, Cedam, 2004.

Medical Law – Suppl. 119 (2020) Italy – 181 618–618 Part I, Ch. 5, Medical-Related Accidents and Compensation

G. Comandé, ‘La Riforma della Responsabilità Sanitaria al Bivio tra Conferma, Sovversione, Confusione E … No – Blame Giurisprudenziale’’ in Editoriale – Rivista Italiana di Medicina Legale, anno XXXVIII, 01/2016, Giuffrè ed., pp 1–28. Corte suprema di Cassazione (a cura di Marco Rossetti), Quaderni del Massimario, Responsabilità sanitaria e tutela della salute, 2011. G. Cricenti, Il problema della colpa omissiva, Padova, Cedam, 2002. R. De Matteis, Responsabilità e servizi sanitari: modelli e funzioni, in Trattato Gal- gano, XLVI, Padova, Cedam, 2007. A. Fiori, Medicina legale della responsabilità medica, Milano, Giuffrè, 2009. G. Forti, M. Catino, F. D’Alessandro, C. Mazzucato, G. Varraso, Il problema della medicina difensiva, Pisa ETS, 2010. L. Nocco, Il sincretismo causale e la politica del diritto: spunti dalla responsabilità sanitaria, Giappichelli, 2010. F. Peccenini, La responsabilità sanitaria, Bologna, Zanichelli, 2007. P. Pucella, Autodeterminazione e responsabilità nella relazione di cura, Milano, Giuffrè, 2010 ed. agg. P. Pucella, La causalità ‘incerta’, Torino, Giappichelli, 2007. P. Stanzione-V. Zambrano, Attività sanitaria e responsabilità civile, Milano, Giuf- frè, 1998. F. Stella, Leggi scientiﬁche e spiegazione causale nel diritto penale. Milano. Giuf- frè, 2000. II ed. M. Zana, Responsabilità medica e tutela del paziente, Milano, Giuffrè, 1993. V. Zeno-Zencovich, La sorte del paziente. La responsabilità del medico per l’errore diagnostico, Padova, Cedam, 1994.

182 – Italy Medical Law – Suppl. 119 (2020) 619–623

Chapter 6. Quality Assurance and Risk Management

§1. QUALITY ASSURANCE AND RISK MANAGEMENT:INTRODUCTION

619. At least in principle, the reference point in deﬁning quality is the WHO document ‘The Principles of Quality Assurance’ (1983). Yet, since 1999, the concept has been dealt with in statutory provisions expanding the notion of quality control already incorporated in healthcare management (see infra). Indeed, Article 15 D. Lgs. n. 229/1999, reforming Article 17 D. Lgs. n. 502/1992, introduced a new governing body for ASL/AO, namely the Collegio di Direzione (Board of Direc- tors) entrusting clinical governance to it. It contributes to the organizational development of and management of ASL/AO, with particular reference to the identiﬁcation of performance indicators for clinical care and efficiency, as well as for the requirements of appropriateness and quality of performances. The Board ‘must be consulted by the General Manager on all matters relating to the government of clinical activities’.

620. Article 3bis of DL 158/2012 as modiﬁed by Law 189/2012 (devoted to the management and monitoring of health risks), ruled that ‘in order to reduce the costs associated with all the risks related to their business, healthcare organizations, as part of their organization and with no new or additional costs charged to public ﬁnances, must take care of their analysis and study and take the necessary steps for the management of risks in view of the prevention of litigation and the reduction of insurance costs’. Article 3 bis explicitly entrusts the Ministry of Health and the Regions monitoring functions, at both national and regional levels, in relation to the data pertaining to clinical risk.

621. It clearly emerges that what is termed in Italian as ‘governo clinico’ incorporates a concept which is different from the universally accepted notion of clinical governance primarily because it is aimed at the reduction of litigation and insurance costs without the proper multidisciplinary approach.

622. Other rules on quality assurance offer a different approach. For instance, Articles 10 and 14 D.L. 502/1992 and subsequent modifications stipulate rules in relation to quality controls and citizen rights. It states that: in order to ensure quality of services to citizens in general, methods related to the verification and review of the quality and quantity of performances shall be adopted, as well methods related to analysing cost, the development of which must be functional considering the organizational models and information flows [ … within] the National Health Service.

623. Article 10 paragraph 2 requires that the ‘Regions verify compliance with the provisions on minimum requirements and classiﬁcation of supply structures, particularly with regard to the introduction and use of surveillance systems and tools and methodologies in place for the veriﬁcation of the quality of services and performances.’

Medical Law – Suppl. 119 (2020) Italy – 183 624–626 Part I, Ch. 6, Quality Assurance and Risk Management

Article 14 charges the Minister of Health with defining ‘in consultation with the Permanent Conference for relations between the State, the regions and the autonomous provinces, the content and methods of use of quality indicators related to services and health benefits in relation to personalization and humanization of care, the right to information, hotel [hospital] services, as well as the progress of activities of disease prevention’. The Regions use this ‘system of indicators for verification, also in consideration of the sociological angle related to the implementation of the rights of citizens in view of regional planning and in delineating human investment in addition to technical and financial resources’ (paragraph 2). The ASLs need to establish procedures for the collection and analysis of elements signalling poor service, in collaboration with organizations representing the public, charitable organizations and of protection of rights (paragraph 4). Healthcare Directors (Direttore Sanitario) and the heads of the health services, at the request of patients, are required to take the necessary steps to remove the inefficiencies that affect the quality of care (paragraph 5).

624. Among the rules related to quality assurance and risk management, we ﬁnd several secondary level legislative acts devoted to a variety of issues. DM 30 June 2004, establishing the national system for guidelines in healthcare, views the ‘guidelines as an effective tool of clinical governance and the organization of the National Health Service’. The system of guidelines stipulated therein is continuously implemented.

625. Explicit reference is made to Clinical Governance in the National Health Plan (NHP) 2006–2008 which deﬁnes it as:

a tool for improving the quality of care for patients and for the development of overall capabilities and capital of the NHS, which aims to maintain high standards and improve the professional performance of staff, by way of supporting the development of clinical excellence and developing reﬂections on the issue of quality which many organizations have been working on for years, including the World Health Organization (The Principles of Quality Assurance, 1983).

It considers the protection and safety of patients and staff to be a fundamental aspect of clinical risk management (paragraph 4.4. page 54 and 55 NHP 2006–2008).

§2. THE NOTION OF RISK MANAGEMENT

626. The fundamental objective of quality assurance programmes is that each patient receives treatment which produces the best possible outcome on the basis of available knowledge and which poses the lowest risk, consumes the least amount of resources, and is to the utmost satisfaction of the patient. These aims require a systemic approach that must consider:

184 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 6, Quality Assurance and Risk Management 627–629

continuing education, clinical risk management, auditing, evidence-based medicine (EBM and EBHC), clinical guidelines and care pathways, the management of complaints and litigation, communication and management of documentation, research and development, evaluation of outcomes, multidisciplinary collaboration, the involvement of patients, the correct and transparent management of information and of personnel management (NHP 2006–2008 page 55).

Accordingly, the notion of (clinical) risk management incorporated in the NHP (page 57) ‘is the probability that a patient suffers an adverse event, that is she suffers any damage or inconvenience caused, even if unintentionally, by the provision of medical treatment, which causes a deterioration of health or death’. Such a deﬁ- nition assumes that all personnel are aware of the problem, for encouraging the reporting of events and that consideration be given to complaints and the point of view of patients. All this should be conducted, where possible, ‘with a pro-active, multi-disciplinary, systemic approach, that must include training and monitoring of adverse events’.

§3. REGIONAL AND NATIONAL INTERPLAY

627. As emerges (see 619ff), the all-encompassing system of quality assurance and risk management is articulated primarily at the three main levels of the NHS. State competences (via the Ministry of Health) are exercised in concert with Regions (mainly via the National Conference of Regions and Autonomous Prov- inces) deﬁning national principles and guidelines. In this role, the Ministry has established a number of national technical committees (for instance, those related to clinical risks and patient safety).

628. Regions have developed a variety of systemic approaches implemented at the local level by AS /AO.

§4. RISK MANAGEMENT,INSURANCE AND LIABILITY

629. Following the assumption of a signiﬁcantly farsighted approach to the interplay of risk management in the early 2000s, the insurance market, responded to the growth of civil liability in healthcare, ﬁrst, by escaping the competitive sector paving the way for non-national companies to access the market in an economic position considered less encumbered by onerous past situations and second, by increasing insurance premiums to cover the cost of increased litigation. Subse- quently, the market reacted adapting to the logic of aggregate deductibles and then, in the case of multiple claims, to a maximum annual deduction often reserving for management all the adverse events leading to litigation. This last fact prevents Regions from producing a complete analysis of the incident for the purpose of its elimination in the future.

Medical Law – Suppl. 119 (2020) Italy – 185 630–632 Part I, Ch. 6, Quality Assurance and Risk Management

630. The phenomenon – in itself inevitable – however, turns into a vicious circle whereby the insurer does not make available to the healthcare industry its entire expertise. Rather, it merely guarantees insurance coverage beyond a threshold of high deductibles, creating perverse incentives between the insurer and the insured in responding to the injured. For the former, more modest harms, covered by the deductible becomes, paradoxically, more ‘easy’ to indemnify because – in the end – it is paid by the insured; for the insured healthcare provider, it creates the incen- tive to close quickly and without fanfare the most signiﬁcant cases in the face of resistance of the insurer with the result of deferring compensation and an increase in hype about individual cases (sic). In the end, the ‘cake’ of compensation is not allocated according to the logic of either efficiency or justice. This is because the players involved are set in an antagonistic logic: physician v. patient, patient v. healthcare facility, injured v. insurer.

631. Article 3 paragraph 5 lett. (e) of DL 138/2011 and Article 9 DL 24 January 2012 impose that all professionals (including physicians) carry liability insurance. Those who work exclusively for the NHS and do not practise in any other capacity are not required to carry a liability insurance policy. The national collective contract for physicians (Article 16) requires the AS/AO to give physicians all pertinent information, in a complete and timely fashion, on the terms and conditions of the insurance coverage and legal assistance, ensuring the maximum information and transparency, including through periodic communications suitable for providing constant updating of the physicians on the active insurance guarantees.

632. Also, it is worth mentioning that, pursuant to Law 211/2003 implementing Directive 2001/20/EC, the promoter (the healthcare facility) pursuing experimentation must carry proper insurance coverage (see 1133). Law 24/2017 has also reformed the insurance rules related to healthcare liability and risk management. In its Article 1 (paragraph 2) expresses the general principle that ‘The safety of care is also achieved through the set of all activities aimed at preventing and managing the risk associated with the provision of health care and the appropriate use of structural, technological and organizational resources.’ Also, it calls ‘all staff, including members of the professions who operate there under an agreement with the National Health Service’ to contribute to prevention activities. It provides for the establishment of regional centres for health risk management and patient safety (Article 2). Article 10 of law 24/2017 is dedicated to insurance obligations. It conﬁrms the obligation for public and private health and social care facilities to be covered by insurance or other similar measures for civil liability towards third parties and for civil liability towards service providers. The obligation was already provided for by Article 27, paragraph 1-bis, of Decree-Law no. 90 of 24 June 2014, converted, with amendments, by Law no. 114 of 11 August 2014. The coverage must also extend to damage caused by staff in any capacity operating in public and private health or social care facilities, including those who carry out training, refresher courses and clinical research and testing or healthcare services carried out under the regime of intramural freelance profession. The regulation also applies to activities carried out in agreement with the National Health Service as well as through telemedicine.

186 – Italy Medical Law – Suppl. 119 (2020) Part I, Ch. 6, Quality Assurance and Risk Management 633–636

A similar mechanism (insurance policies or other similar measures) must be provided for the coverage of third-party liability of health professionals also pursuant to and in accordance with the provisions of paragraph 3 of Article 7 (tort liability of healthcare professionals). Paragraph 2 of the same article also conﬁrms the insurance obligation for the health professionals who carry out their activity outside one of the structures referred to in Article 10 paragraph 1 or who work within the same under the free professional regime or who use the same in the performance of his contractual obligation assumed with the patient. Finally, it imposes (paragraph 3) the obligation to insure against recourse for gross negligence.

§5. QUALITY ASSURANCE AND THE ROLE OF ORDER OF PHYSICIANS

633. The Order of Physicians is not directly involved in the process of quality assurance and risk management. Nevertheless, Article 10.3 D. Lgs. n. 502/1992 prescribes that the Ministry of Health must establish the ‘content and how to use the indicators of efficiency and quality’ in accord with (among others) the ‘National Federation of the Orders of Physicians and Dentists and other relevant Orders and Colleges’.

§6. QUALITY ASSURANCE AND INTERNAL MANAGING CONTROLS

634. There are several rules and mechanisms established at national, regional and local level to monitor the system. For instance, sentinel events are the target of speciﬁc shared protocols for their monitoring and management.

635. The lack of a systemic approach also in legal terms makes it difficult to implement most methods of quality assurance. For instance, as a public official or someone charged with public service the clinical risk manager, in receipt of incident (e.g., complaints or audits, information gained during patient safety ‘walk- rounds’) must report those cases of crimes actionable ex officio to the judicial authorities (pursuant to Articles 361 and 362 cp and 331 cpp, see also 405, 414, 635, 826ff). She is not required to report personal injury damages unless they are serious ones produced in violation of specific norms (Article 590 cp paragraph 5). Never- theless, the absence of specific rules relating to confidentiality and failure to report incidents to judicial authorities deterred effective incident reporting. To answer this unpleasant situation, article 16 of Law 24/2017 amended Law 208 of 28 December 2015, establishing that ‘the minutes and documents resulting from the activity of clinical risk management may not be acquired or used in judicial proceedings’.

§7. HEALTHCARE-ASSOCIATED INFECTIONS (HCAI)

636. The HCAI have been a major issue for many years in public health in terms of the quality of care, cost of hospitalization and the damage that these infections

Medical Law – Suppl. 119 (2020) Italy – 187 637–637 Part I, Ch. 6, Quality Assurance and Risk Management can lead to in terms of increased patient morbidity and mortality. Both national and regional interventions on the issue aim to tackle this issue. This is evidenced by the Regional Prevention Plan and the establishment of the National Observatory for the Monitoring of Sentinel Events (Osservatorio Nazionale di Monitoraggio degli Eventi Sentinella, OsMES) at the Ministry of Health (State-Regions Understanding of 20 March 2008) which delineated a speciﬁcally designed reporting system (Infor- mation System for the Monitoring of Adverse Events: Sistema Informativo per il Monitoraggio degli Eventi Avversi, SIMES).

637. According to the ﬁrst available report (data refer to September 2005/ December 2010), the specialities most affected by events were obstetrics and gynaecology, general medicine, general surgery and orthopaedics and trauma. The most common contributing factors were health technologies, drugs, guidelines and barriers to adequate care.

188 – Italy Medical Law – Suppl. 119 (2020) 638–640 Part II. The Physician-Patient Relationship Within and Outside the Healthcare System

Chapter 1. General Description

§1. RIGHTS AND DUTIES OF PATIENTS AND PHYSICIANS

I. The Rights of Patients

638. In Italy, there is no statutory deﬁnition of ‘patient’. Rather, the notion and indeed the main source of patient rights can be inferred from the constitutional protection accorded to the human being (see supra 36–53). Nevertheless, the Code of Ethics of Physicians and most of the other codes of ethics that relate to other healthcare professionals65 refer to human beings and citizens in terms of ‘patients’. Simi- larly, statutory provisions more recently refer to citizens, sick persons or healthcare clients more than to patients, mostly to avoid the paternalistic allure that has covered the physician-patient relationship in the past. Indeed, statutory provisions regulating the delivery of healthcare services or experimentation on human beings contribute to deﬁning and regulating the rights of patients (see 646ff), often referring to patients as ‘clients’ in terms of the delivery of healthcare-related services.

639. Nevertheless, several other statutory provisions contain explicit deﬁnitions of who exactly a ‘patient’ is.

640. The general principle of respect for patients’ rights found in the Italian Con- stitution, corresponds to the respect for ‘human dignity, human rights and fundamental freedoms’ envisaged in Article 3 of the Universal Declaration on Bioethics and Human Rights of 19 October 2005, adopted by the 33rd Session of the General Conference of UNESCO (hereinafter referred to as the ‘Declaration’). According to this document, ‘the interests and welfare of the individual should have priority over the sole interest of science or society’. These principles closely reﬂect Article 32 paragraph 2 of the Italian Constitution (see 40ff) and the idea of sustaining the ‘full development of the human person’ (Article 3 Cost.).

65. See Reference 4 at the end of Part II, Chapter 1.

Medical Law – Suppl. 119 (2020) Italy – 189 641–645 Part II, Ch. 1, General Description

641. The backdrop for these provisions clearly rests on the fear of medicine being unconnected to respect for individual freedom and dignity. After all, among the ﬁrst documents of reference is the so-called Nuremberg code on ‘Permissible Medical Experiments’ (American military tribunal in the case of the USA v. Karl Brandt et al.) condemning Nazi crimes committed in the name of clinical trials; the subsequent Helsinki Declaration of 1964 on Ethical Principles for Medical Research Involving Human Subjects; and the United Nations International Covenant On Civil And Political Rights of 1976.66 See 669ff.

642. The right to protection of privacy in relation to health data is guaranteed by subjecting the processing of individual personal data to the rules of the GDPR. The GDPR and the DPA (Law 196/2003 –DPA as reformed by law 101/2018) govern the modalities according to which information should be stored, the eventual consent of the parties concerned, and the particular rules for the processing of genetic data, particularly in terms of conﬁdentiality. See 732ff and 748ff.

A. The Duty of the Patient to Cooperate

643. There is no duty to accept treatment because every diagnostic or therapeutic act is subject to the actual and informed consent of the patient (see 669ff). Yet, since health is not only a fundamental right but also a public interest, the Consti- tutional Court has clariﬁed there is a ‘duty of individuals to avoid damaging or endangering, as a result of their behaviour, the health of others according to the principle that the protection of one’s right is mutually recognizable and is limited by the equal protection afforded to the rights of others’ (C. Cost. 218/1994).

644. The content of this duty is difficult to deﬁne in positive terms. Neverthe- less, we can certainly detect from it an element of concurrent negligence, for instance, in a case concerning a failure, on behalf of the patient, to give crucial information to the physician and might even lead to compulsory treatment in spe- ciﬁc cases (see 720). In addition, compulsory vaccination can be interpreted as a duty to cooperate together with other instances of mandatory healthcare treatments.

645. There is no provision in Italian law that requires the individual to undergo what are considered necessary medical treatments in terms of his/her physical safety where to do so would go against the will of the patient. This stands so long as the effects of the refusal do not adversely affect any third party (see on informed consent 669ff).

66. Article 7: ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientiﬁc experimentation.’

190 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 646–650

B. The Right to Quality Care

646. The right to quality of care emerges from several statutes dealing with spe- ciﬁc services and in the CME (see infra).

647. D. Lgs. n. 502/1992 explicitly deals with the quality of assistance and treatments apportioning the tasks of ensuring and monitoring them between the State and the Regions. Quality assurance and risk prevention in healthcare delivery are mutually related as is stressed by D.L. 158/2012 (Article 3bis) which requires healthcare facilities to analyse clinical risks, envisaging and putting in place solutions necessary for their management, bearing in mind dispute prevention and reduction of insurance costs.

648. The contours of the quality of care are deﬁned by the CME in several norms, in terms of continuity of care (Article 23), professional quality (Articles 6 and 22), and patient safety and clinical risk management (Article 14). Article 70 CME is speciﬁcally devoted to quality and fairness of services and provides that:

The physician shall not make any professional commitment which would result in an excess of services such as to jeopardise the quality of his work and the safety of the person cared for. The doctor must demand from the structure in which he operates all guarantees so that the methods of his commitment and the requirements of the working environment do not adversely affect the quality and safety of his work and the fairness of services.

This applies to both physicians employed by the NHS and those holding a service contract with it or with private institutions.

649. Finally, yet importantly, quality of care and clinical risk management are increasingly at the centre of the informed consent (to treatment) process in relation to healthcare organization and delivery. See 621ff.

C. The Right to Free Choice

650. Among the rights that patients enjoy according to both the law (833/1978) and the Code of Ethics of Physicians (Article 27) is the right to (a) freely choose a physician, and (b) to freely choose among the proposed treatments (so-called informed consent; see 669ff. In particular, Article 27 CME provides that:

The free choice of the physician and the place of treatment is a right of the person. Any agreement between physicians aimed at inﬂuencing the free choice of the assisted person is prohibited, although it is permitted to indicate, if appropriate and in its sole interest, consultants or places of care considered suitable for the case. Note that informed consent is now regulated by law 219/ 2017. See paragraphs 525, 550, 657, 690, 693, 695, 706.

Medical Law – Suppl. 119 (2020) Italy – 191 651–653 Part II, Ch. 1, General Description

Article 28 provides the possibility for the physician to withdraw from treatment in circumstances: ‘If the physician considers that the relationship of trust with the assisted person or his or her legal representative has been disrupted, he or she may terminate the treatment relationship with a timely and appropriate notice, continuing his or her work until he or she is replaced by another colleague to whom the information and documentation, useful for the continuity of care, have been transmitted with the prior written consent of the person assisted.’

651. The right of free choice must be exercised within the limits provided for by law, especially those pertaining to the organization of the delivery of healthcare. Individuals have a right to choose and change their general practitioner or paediatrician at any time, provided that their preferred physician’s list has not reached the maximum in terms of the number of patients allowed (1,500 for general practitioners and 800 for paediatricians). The choice is effectively valid for one year and is tacitly renewed. Patients are always free to change their mind.

652. The law, in several ways, guarantees this free choice. For instance, patients may revoke their choice (according to the rules laid down by the conventional regime dealing with patient lists for general practitioner and paediatrician). More- over, the physician or paediatrician cannot object to the patient’s choice if not for outstanding and ascertained reasons of incompatibility. The right to choose one’s general practitioner and paediatrician is very important since they provide a number of services (e.g., outpatient visits, home care, prescription of drugs and/or diagnostic tests, certifications, etc.) and the relationship often constitutes a point of access for clients to the NHS. The fundament of the choice is the fiduciary relationship between the parties, which, once broken, may result in the revocation of choice on the part of the patient or the disqualification of the physician when it creates an exceptional and verified situation of incompatibility. Pursuant to Article 23 of the CME, ‘The physician guarantees continuity of care and, in the event of unavailability, impediment or loss of trust, ensures his replacement by informing the person assisted. If a physician is faced with clinical situations that she is not able to deal with effectively, she or he shall indicate to the patient the specific skills required for the case under examination.’

653. The right to free choice allows patients to choose to either receive treatment within the ASL structures to which they belong (i.e., the structures associated to their place of residence) or to choose a provider in another ASL (be that in the same Region or in another Region: Article 8ter and following D.L. no. 502/1992). If the patient opts for the latter, i.e., to ‘migrate’ (outward mobility), their ASL must organize payment for any treatment provided by structures located in other regions or ASLs. The same principle, of course applies in cases of inward mobility. As stated by Article 2.1 lett. d) Law no. 419/1998; these choices must be assured to the patient with ‘respect to the facilities and accredited professionals with whom the NHS have established speciﬁc relationships’. Clearly, these rights should respect the organizational rights of each ASL and should, in addition, be mindful of availability constraints in healthcare facilities. Directive 2011/24/EU ensures the same rights to

192 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 654–657 all EU citizens and expands the ability of Italian patients to search treatments beyond the limits already set by EU regulations.

654. Trust is not the only key factor in relation to the choice of patients although the law does take it into account. Article 14. 6, of D.L. 30 December 1992, no. 502 prescribes that, in order to facilitate the exercise of the right of free choice of physicians and healthcare facilities, the Ministry of Health shall publish the list of all public and private institutions that provide high-performance medical specialities, indicating the availability of high-tech equipment as well as the prices for the most relevant services. The same Article provides an articulate system of indicators to be made available to the public for their information and consequent choices. Similar information is required by Directive 2011/24/EU.

655. The 1978 healthcare reform implemented for the first time the principle of free choice, subsequent to which patients were allowed to choose their healthcare provider(s). Originally, this did not constitute a serious issue for the Regions because of their limited responsibility in terms of expenditure. However, once the 1992–1993 reforms introduced a prospective payment system and increased the fiscal responsibility of the regions, cross-boundary flows were seen as a tool for com- pensating for an uneven distribution of providers across regions and for reducing the effects of different levels of per capita healthcare spending in Italian Regions. It was and still is a competition factor included in the system. Since Regions are responsible for the deficits that might arise (in case of imbalances between outward and inward mobility) and cannot rely on State intervention, the results of the migration flows actually incentivize regional healthcare planners to improve healthcare services so as to keep residents within their regional boundaries and to attract patients from other regions. The system will become even more pro-competition following the entry into force of Directive 2011/24/EU. Indeed, D. Lgs. n. 502/ 1992 and 517/1993 have already aimed to promote efficiency by introducing a limited form of competition between hospital care providers. For the same reasons, patients were given the choice of opting for private, contracted-out hospitals, accredited by the Government. See also 514.

D. Rights Related to Information about the State of Health

1. The Right to Information about One’s State of Health

656. The patient has the right to be informed of the precise type of treatment s/he is about to undergo, including the method of execution as well as any related risks.

657. Today, Article 1, paragraph 3 of Law 219/2017 states that: ‘Every person has the right to know his or her state of health and to be fully informed, updated and in a comprehensible way about the diagnosis, prognosis, beneﬁts and risks of the diagnostic tests and health treatments referred to, as well as about the possible alternatives and consequences of any refusal of health treatment and diagnostic assessment or renunciation thereof. Every person may refuse to receive all or part

Medical Law – Suppl. 119 (2020) Italy – 193 658–660 Part II, Ch. 1, General Description of the information, or may indicate the family members or a person of his or her trust entrusted with the task of receiving it and expressing his or her consent on his or her behalf if the patient so wishes. The refusal or renunciation of information and the possible indication of a person in charge are recorded in the medical record and in the electronic medical record.’ This right is rooted in the constitutional provisions regarding the right to physical integrity and the prohibition of being subjected to forced treatment (Articles 13 and 32. Cost.). Article 33 of Law 833/1978 already provided a statutory link to informed consent establishing that ‘health examinations and treatments are normally voluntary’ and that ‘mandatory health examinations and treatments [ … ] must be accompanied by initiatives aimed at ensuring the consent and participation on the part of those who are obliged to undergo them’. The underlining reasoning is that there is a right to be informed about the scope of health services and their consequences, thus giving rise to freedom of choice for the individual. See also 669ff.

658. Relying upon constitutional and international sources and on these legal provisions, courts have developed autonomously the notion of informed consent without which the medical act is illegal and leads to damages compensation (see 505ff). Courts acknowledge compensation also in cases of simple failure to acquire actual informed consent even if the service was provided correctly (i.e., without any fault and with due diligence). See 518ff.

659. The CME (Article 33) expressly deals with the right to information, linking it to informed consent. It obliges the physician to provide the patient with ‘comprehensible and comprehensive information on prevention, the diagnostic route, diagnosis, prognosis, treatment and any diagnostic-therapeutic alternatives, foreseeable risks and complications, as well as on the behaviour that the patient will have to observe in the treatment process’. In communicating with the patient ‘the doctor shall adapt the communication to the capacity of understanding of the person assisted or his/her legal representative, answering any request for clariﬁcation, taking into account their sensitivity and emotional reactivity’. Medical doctors are not fully in control of the ﬂow of information and should satisfy ‘any further request for information from the patient’ and requests for information from citizens with regard to the prevention of diseases.

660. ‘Information regarding a serious or ominous prognosis’ is not excluded from the range of information to be provided. However, the CME required that such information be provided ‘with caution, using non-traumatizing terminology and without excluding elements of hope’. The CME (Article 34) clariﬁes that providing information to third parties requires the patient’s express consent unless there is a ‘serious danger to the health or life of the patient him/herself or to others’. In consideration of good ethics and good practice ‘the physician should collect the names of anybody who has been previously indicated as a potential receiver of sensitive data’ in the case of hospitalization. However, see today law 219/2017. See paragraphs 525, 550, 657, 690, 693, 695, 706.

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661. The violation of the right to be informed is related to the right to self- determination with reference to one’s own health. It leads to compensation (for the violation of this right) even in the absence of damage to health (see. Court of Cas- sation 2847/2010) if ‘only in the case in which both it is exceeded the level of tol- erability and the injury is not futile’ (recalling Court of Cassation United Section 26972/2008). And yet already Cass. 10414/2016 declared that if informed consent is not obtained, the person concerned is entitled to compensation even if the intervention was necessary. Lately Cass n. 28985/2019 has established that there is a right to compensation for damage sustained as a result of infringement of the right of self-determination, which has arisen as a result of the unforeseeable consequences of a therapeutic act, but which is nevertheless carried out without the patient being informed in advance of its possible harmful effects and therefore without the consent of the patient being given. Compensation should occur even if the treatment is necessary and even if it is carried out secundum legem artis. In these cases, if the plaintiff shows she would have not consented having known the consequences, compensation is due both for any danno biologico and for the (separated) damages to self-determination.

2. The Right Not to Know about One’s State of Health

662. Alongside the right to information about one’s state of health, we ﬁnd the rather paradoxical right not to know the same. The CME deals explicitly with this (Article 33 CME) in stating the following: ‘The doctor respects the necessary con- ﬁdentiality of the information and the willingness of the assisted person not to be informed or to delegate the information to another person, reporting it in the health records.’ We assume that the need to actually document the wish not to be informed acts as a legal safeguard for the physician considering the potential legal risks in terms of liability for physicians.

663. In practice, there are two different orders of issues to be dealt with. On the one hand, the need to ensure that patients, who do not wish to know about their actual or potential state of health, are respected. On the other hand, the right not to know respects those individuals, perhaps more vulnerable, for instance, due to their age or state of health, by not informing them assuming that they ‘do not want to know or are not able to process the information correctly’. While we deal with the issue in more detail in the chapters on informed consent (see infra the relevant sections of Chapters 2–3), it is worth mentioning here issues related to the request to not know the results of genetic predictions.

664. Medical development itself opened this window, especially in the ﬁeld of genetics. The increased predictive power of genetic tests increases the number of people that come to know that they are at risk from a serious disease with no real chance of reducing that risk or of undergoing effective treatment.

Medical Law – Suppl. 119 (2020) Italy – 195 665–666 Part II, Ch. 1, General Description

665. The right not to know has been explicitly recognized by various ethical and legal instruments at both supranational and national level. Here, we indicate some of them and their speciﬁc features:

– The Council of Europe: Convention on Human Rights and Biomedicine (Oviedo Convention), 1997 (Article 10.2).67 – UNESCO: Universal Declaration on the Human Genome and Human Rights, 1997 (Article 5.c).68 – UNESCO: International Declaration Human Genetic Data, 2003 (Article 10).69 – World Medical Association: Declaration on the Rights of the Patient, 1981/1995 (Article 7.d).70 – WHO: Guidelines on Ethical Issues in Medical Genetics and the Provision of Genetic Services, 1997 (Table 7).71

666. The right not to know is also present in domestic laws, for example:

– France: Law on Patients’ Rights, 2002. Loi sur les droits des patients (Article 1111–2, Code de la Santé Publique) – The wish of an individual not to be informed about a diagnosis or prognosis should be respected, unless third persons are exposed to a risk of transmission.72 – Spain: Law on Patient Autonomy, 2002. Article 9.1 – Withdrawal from the right to receive information can be limited to protect the health of the patient, of third persons, of the community, and in conformity with the therapeutic requirements of the case. When patients explicitly express their wish not to be informed, such a wish must be respected.73 – Switzerland: Federal Law on Human Genetic Testing (2004) Article 6 – Every person has the right to refuse to be informed about his/her genetic status, except

67. Article 10.2: Everyone is entitled to know any information collected about his or her health. How- ever, the wishes of individuals not to be so informed shall be observed. 68. Article 5.c: The right of each individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected. 69. Article 10: The right to decide whether or not to be informed about research results – When human genetic data, human proteomic data or biological samples are collected for medical and scientific research purposes, the information provided at the time of consent should indicate that the person concerned has the right to decide whether or not to be informed of the results. This does not apply to research on data irretrievably unlinked to identifiable persons or to data that do not lead to individual findings concerning the persons who have participated in such a research. Where appropriate, the right not to be informed should be extended to identified relatives who may be affected by the results. 70. Article 7.d: The patient has the right not to be informed on his/her explicit request, unless required for the protection of another person’s life. 71. The wish of individuals and families not to know genetic information, including tests results, should be respected, except in testing of newborn babies or children for treatable conditions (Table 7). 72. ‘La volonté d’une personne d’être tenue dans l’ignorance d’un diagnostic ou d’un pronostic doit être respectée, sauf lorsque des tiers sont exposés à un risque de transmission’. 73. Artículo 9. Límites del consentimiento informado y consentimiento por representación. 1. ‘La renuncia del paciente a recibir información está limitada por el interés de la salud del propio paciente, de terceros, de la colectividad y por las exigencias terapéuticas del caso. Cuando el paciente manifieste expresamente su deseo de no ser informado, se respetará su voluntad haciendo constar su renuncia documentalmente, sin perjuicio de la obtención de su con sentimiento previo para la intervención’.

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in the situation referred to in Article 18.2, according to which the physician must immediately disclose the results of the test to the individual in cases where there is an imminent physical danger to himself/herself, to the embryo or the foetus, which could be avoided. – Germany: Law on Genetic Diagnosis, 2009 (Gendiagnostikgesetz) Article 11.4 – The results of a genetic test should not be disclosed to the concerned person if he/she has decided that they should be destroyed, or if he/she has withdrawn his/ her consent to the test.74 – Italy: There are no legal provisions on genetic testing, but speciﬁc governmental guidelines on medical genetics were approved in 2004 (Linee-guida per le attiv- ità di genetica medica G.U. no. 224 – 23/9/2004). They state ‘Anyone who has been submitted to a genetic test should, after having given his/her informed consent, be free to not know the results, even if the test has already been carried out’ (Article 7 paragraph 2).75 Today, Article 1, paragraph 3, of Law 219/2017 explicitly recognizes this right: any person ‘may refuse in whole or in part to receive the information or indicate the family members or a person of his or her trust in charge of receiving and expressing consent on her or his behalf if the patient so wishes. The refusal or renunciation of information and the possible indication of a person in charge are recorded in the medical record and in the electronic medical record’.

3. Relinquishing the Right to Information

667. Article 33 CME prescribes to physicians that:

The physician shall provide the assisted person or his/her legal representative with comprehensible and exhaustive information on prevention, the diagnostic path, diagnosis, prognosis, therapy and possible diagnostic-therapeutic alternatives, foreseeable risks and complications, as well as on the behaviour that the patient must observe in the treatment process. The physician shall adapt the communication to the capacity of understanding of the assisted person or his/ her legal representative, answering any request for clariﬁcation, taking into account their sensitivity and emotional reactivity, particularly in the case of serious or unfavourable prognosis, without excluding elements of hope. The physician shall respect the necessary conﬁdentiality of the information and the willingness of the assisted person not to be informed or to delegate the information to another person, and shall include it in the health documentation. The physician guarantees the minor elements of information useful for him or her

74. ‘Das Ergebnis der genetischen Untersuchung darf der betroffenen Person nicht mitgeteilt werden, soweit diese Person nach § 8 Abs. 1 Satz 1 in Verbindung mit Satz 2 entschieden hat, dass das Ergeb- nis der genetischen Untersuchung zu vernichten ist oder diese Person nach § 8 Abs. 2 ihre Einwil- ligung widerrufen hat’. 75. See Art. 10, para. 2 Oviedo Convention.

Medical Law – Suppl. 119 (2020) Italy – 197 668–670 Part II, Ch. 1, General Description

to understand his or her state of health and the planned diagnostic and therapeutic interventions, in order to involve him or her in the decision-making process.

This provision regulates in positive terms the right to relinquish the right to information. As mentioned (see 653, 655), today the right not to be informed is governed by Article 1 paragraph 3 of law 219/2017.

4. Not Informing Based on the Physician’s Initiative (the Therapeutic Exception)

668. The constitutional protection afforded to the right to health and to consent to treatment does not leave any room to the physician for not informing the patient based on his/her own initiative. Such a therapeutic exception does not exist, and it cannot be inferred from provisions of the CME. Indeed, while Article 33 provides ‘The doctor shall adapt the communication to the capacity of understanding of the person assisted or his/her legal representative, corresponding to any request for clariﬁcation, taking into account the sensitivity and emotional reactivity of the same, particularly in the case of serious or unfavourable prognosis, without excluding elements of hope.’ It does not permit intentional refusal to impart the information. In fact, but for the state of necessity exception according to which it is impossible to acquire patient’s informed consent (e.g., in emergency cases), informed consent is a necessary prerequisite to be satisﬁed in legitimating diagnostic and/or therapeutic activity. See infra and 507ff.

E. The Right to Give Consent

669. The NCB placed the dignity of patients at the centre of the notion of informed consent, deﬁned by the Constitutional Court (Cost. 438/2009) as an ‘expression of the conscious adherence to medical treatment proposed by the physician’.

670. The NCB further clarified that, in overcoming the strictly paternalistic interpretation of the doctor-patient relationship, the criteria of the ‘patient’s best interest’ is articulated on a double level: that is, it becomes important not only as an objective and knowable fact (entrusted to the physician), but also as a subjective fact (the ‘knowing in himself’ of the patient, starting with his/her awareness of the illness and related pain as part of his/her own life story). Therefore, taking for granted the undisputed centrality of the medico-clinical evaluation, founded on science and the physician’s experience, the expression of the patient’s will, through informed consent, satisfies the ‘best interest’ approach. An interest that can therefore be said to constitute the ‘best’ exactly because it results from the joint contribution of the medico-scientific knowledge on the one hand, and of the patient’s personal experience on the other. If the physician acts in the absence of or against the patient’s will, he exposes himself to serious legal consequences (since it can be considered a

198 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 671–672 crime of private violence, ex Article 610 of the Penal Code); however, the same obligation of care exists and extends to the limit of the opposition advanced by the patient (Opinion of 24 October 2008 on Refusal and Conscious Renunciation of Health Treatments in the Patient – Doctor Relationship). Today, the law clearly establishes the right to refuse treatment, any treatment, as also life-preserving ones.

671. From a private law point of view, preliminary to any legitimate diagnostic or healing treatment the free, informed and actual consent of the individual, grounded on Articles 32 paragraph 2, 13, 2 and 3 Cost, must be obtained. In this ﬁeld and particularly concerning the infringement of the consent requirement, a large number of decisions have awarded damages (see 507ff) and the recent interventions of the Supreme Court have stressed the right to compensation for violation of informed consent (see 535, 549, 571–72). More generally, the right to give informed consent to any diagnostic or therapeutic treatment up to the point of refusing life-sustaining/life-saving treatments found ground in a large number of legal and non-legal norms and has today its main operational basis in a speciﬁc legislation. Law 219 of 2017 acknowledges the patient’s consent with a series of provisions, including Article 1, paragraphs 1 and 2, in compliance with the principles set out in Articles 2, 13 and 32 of the Constitution and Articles 1, 2 and 3 of the Char- ter of Fundamental Rights of the European Union. It protects the right to life, health, dignity and self-determination of the person and establishes that no medical treatment may be initiated or continued without the free and informed consent of the person concerned, except in cases expressly provided for by law (as already stated in law 833/1978). The law promotes and valorizes the relationship of care and trust between patient and physician, which is based on informed consent in which the decision-making autonomy of the patient and the competence, professional autonomy and responsibility of the physician meet, thus reaffirming the margins of professional autonomy of the physician. If the patient so desires, his family members or the part of the civil union or the cohabiting partner, or a person trusted by the patient himself, may also be involved in the care relationship.

672. Scholars and case law focused expressly on several articles of the Consti- tution: Article 13 in stating that ‘personal liberty is inviolable’ speciﬁes that ‘nobody may be detained, inspected, searched or otherwise subjected to any restriction of personal liberty except by reasoned order of the Judiciary and only in such cases and in such a manner as is provided by the law’ (see also Cost. Court no. 238 of 1996 and no. 471 of 1990); Article 32 section 2 asserts that ‘nobody may be obliged to undergo any health treatment except in situations prescribed by provisions of the law’, further clarifying that even ‘the law may not under any circumstances violate the limits imposed by respect for the human person’; Article 2 ‘recognises and guarantees the inviolable rights of the person’ among which we ﬁnd the inclusion of, according to case law, self-determination with reference to health treatments and control over one’s own body (see also Cost. 22 October 1990 n. 471).

Medical Law – Suppl. 119 (2020) Italy – 199 673–677 Part II, Ch. 1, General Description

673. Today, express reference is also made to Article 3 of the Charter of Fun- damental Rights of the European Union as incorporated by the Lisbon Treaty. It provides for ‘the right to respect for … physical and mental integrity’.

674. The so-called Oviedo Convention of 1997 entitled the Convention on Human Rights and Biomedicine – ratiﬁed in Italy by Law 28 March 2001 no. 145 – provides, according to Article 5, the general principle for which ‘an intervention in the health ﬁeld may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time’.

675. Sometimes, although not always in a proper way, reference is also made to Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950. Particular reference is often made to the 2002 ECHR decision Pretty v. the United Kingdom which held that:

[i]n the sphere of medical treatment, the refusal to accept a particular treatment might, inevitably, lead to a fatal outcome, yet the imposition of medical treatment, without the consent of a mentally competent adult patient, would interfere with a person’s physical integrity in a manner capable of engaging the rights protected under Article 8 § 1 of the Convention.

676. Several statutory provisions dealt already with consent (see Law. no. 180 of 1978, health investigations and treatments; Law no. 833 of 1978 establishing the National Health Service; Law no. 211 of 2003, clinical trials; Law no. 40 of 2004, medically assisted procreation; Law no. 219 of 2005, domestic production activities and transfusion of blood products). In particular, Law 180/1978, expressly states that:

health examinations and treatments are voluntary. In the cases referred to in this law and as expressly provided under state laws, compulsory medical examinations and medical treatments can be ordered by health authorities always with respect to personal dignity and civil and political rights guaranteed by the Constitution, including as far as possible the right to freely choose one’s physician and place of treatment (Art.1).

Accordingly, except where provided for by law, medical treatment must be acti- vated upon current, explicit informed consent of the patient provided freely and consciously.

677. The CME (Article 33, already mentioned above, and Article 35) explicitly deals with informed consent. The latter Article prescribes that:

The acquisition of consent or dissent is an act of speciﬁc and exclusive competence of the physician, which cannot be delegated. The physician does not

200 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 678–680

undertake or continue with diagnostic procedures and/or therapeutic interventions without the prior acquisition of informed consent or in the presence of informed dissent. The physician acquires, in written and signed form or by other means of equal effectiveness, the consent or dissent of the patient, in the cases provided for by the law and the Code and in those cases expected to be burdened by a high risk of mortality or by outcomes that permanently affect the psycho-physical integrity. The physician shall take due account of the opinions expressed by the minor in all decision-making processes concerning him/ her.

Today the forms of informed consent are directly prescribed by law permitting also video recording or other electronic means.

678. The Constitutional Court has played a pivotal role in drawing the actual understanding and contours of the right to give informed consent (see 669 and infra) that led to the actual legislation in force. For instance, in its decision no. 238 of 1996 the Court observed that a person could not be compelled to undergo medical intervention in the absence of a provision expressly requiring so. The court made it clear that this right is inviolable and is ‘among the highest values connected to the core of “the individual person”, similar to the adjacent and connected right to life and physical integrity, with which it combines to create the basic matrix of the protected constitutional right of the person’.

679. Judgment no. 307 of 1990 on compulsory vaccination against polio (see 603ff), an issue already touched upon in Article 32 of the Constitution, highlights permissible limits for medical treatments required by law: a. the treatment must be directed not only to improve or preserve the health of those who are subject to it ‘but also to preserve the state of health of others’ because only the protection of health as a collective interest can justify ‘the compression of the self-determination of man that is inherent in the right to health as a fundamental right granted to everyone’; b. ‘medical treatment can only be imposed when it is sure that such imposition will not adversely affect the health of the one that is subject to it, except for those consequences, which, because of their temporary and limited scale, appear normal of each treatment and therefore tolerable’; c. in the event of further damage to the health of the person subjected to compulsory treatment, the constitutional importance of health as a collective interest is not in itself sufficient to justify the treatment because it ‘does not postulate the sacriﬁce of one’s own health for the protection of the health of others’; d. in this case the legal system must recognize an additional protection for the victim of the treatment, in the form of fair compensation for the harm caused.

680. Accordingly, the Constitutional Court decision no. 118 of 1996 summarized the consequences of a health impairment resulting from medical treatments, resulting in:

Medical Law – Suppl. 119 (2020) Italy – 201 681–683 Part II, Ch. 1, General Description a. the right to full compensation of the damage, recognized by Article 2043 cc in the case of guilty behaviour; b. the right to equitable compensation, arising from Article 32 of the Constitution in conjunction with Article 2, where the damage did not involve an unlawful act or has been incurred as a result of the fulﬁlment of a legal obligation; c. in all other cases the right, according to Articles 2 and 38 of the Constitution, to welfare measures were ordered by the legislature in the exercise of its constitutionally legitimate discretionary powers.

681. The court has further clarified that therapeutic practice is placed ‘at the intersection of two fundamental rights of the sick person: to be treated effectively according to the canons of science and the article of medicine, and to be respected as a person in particular in relation to one’s physical and mental integrity’. There- fore, but for the taking of prevalence of ‘other rights or constitutional duties, the legislature is not, as a rule, called to establish, neither directly nor specifically, what the accepted therapeutic practices, subject to what limits and under which conditions, are’. However, just because the practice of the article of medicine is based on scientific findings and continuous evolution, ‘the rule governing this matter is made by the autonomy and responsibility of the physician who, always with the consent of the patient, makes professional choices, based on the state of available knowledge’ (see Cost. 26 26 June 2002, no. 282, in Giur. Cost., 2002, 2012ff; see also Cost. 10 November 2004, no. 338, in Leg. Cost., 2004, 2978). It ensures that the legislature can only ‘prescribe special procedures for the use of risky therapeutic means in order to better ensure, also based on collaboration between different professionals, the appropriateness of treatment choices and compliance with necessary precautions. However, it cannot intervene in the merits of therapeutic choices in relation to their appropriateness’ (in this vein, see Cost. 282/2002).

682. The right to consent to diagnostic or therapeutic treatments becomes more problematic in those instances in which the individual is formally not permitted to express valid consent (the case of minors, for instance) or, while being formally capable of consenting, ﬁnds himself/herself in a more dependent situation as far as his/her ability to understand and act upon the information provided is concerned (for instance, elderly people or mentally ill, see respectively the relevant sections of Chapter 2 873ff and Chapter 3 998ff).

683. Indeed, the whole idea of subjecting each treatment to informed consent is based on the abstract model of rational patients. This model assumes that reasonable individuals of average or high social class, with sufficient education, are able to extricate themselves from the options proposed by physicians and choose ratio- nally because they know perfectly what is good for their health. However, the reality of everyday life illustrates quite different situations in which differences in culture, language skills, the ability to accept or decline a difficult reality, or even hopelessness, are difficult obstacles to overcome for the patient even without considering the speciﬁc cases of minors, the elderly and individuals with psychiatric or psychological problems.

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684. The Italian Constitutional Court has already discussed the issue of minors with reference to regional laws eventually permitting the use of psychotropic drugs thereby crushing two laws that were viewed as not giving enough relevance to the will of the minors (see Cost. 30 July 2009, no. 253 and Cost 23 December 2008, no. 438). See also 872–902.

685. Several cases have dealt with the issue of the will of the elderly tackling it from a physical or pharmacological restraint angle. The need to establish the boundaries and requirements allowing patients’ restraints emerges from the risk of exposing those performing the restraints to the violation of several criminal rules (either by performing or by omitting the restraint; see Articles: 571 cp: abuse of the means of correction or discipline; 572 cp: abuse in the family; 605 cp: kidnapping, 610 cp: private violence; 581 cp: physical violence; 582 cp: personal injury; 586 cp: death or personal injury as a result of another crime; 589 cp: involuntary manslaughter; 591 cp: abandonment of incompetent persons). See also 910. Moreover, Law 3/2018 increased the penalty with reference to the health professional, adding paragraph 3 to Article 589: ‘If the act is committed in the abusive exercise of a profession for which a special qualiﬁcation of the State or of a medical art is required, the punishment is imprisonment from three to ten years.’

686. In general terms, the state of the art for the criminal relevance regarding the lack of informed consent is summarized by a Supreme Court decision, rendered in a plenary session (no. 2437 del 2009), a decision that is arguable from different points of view. The Court ruled on the two most suitable incriminating rules that would apply to the lack or invalidity of consent to treatments (610 cp: private violence; and 582 cp: personal injury). On the former, it excluded the potential of that particular legal provision to encompass the conduct. On the latter, the court ruled that lack (or invalidity) of duly informed consent may lead to criminal sanctions unless there is a ‘favourable outcome’ understood as the appreciable improvement of the health condition of the patient, in relation not only to the typical rules of medical science but also to the possible alternatives considered alongside any manifestation of will either positively or indirectly expressed by the patient. See infra 593ff.

687. In relation to the eventual compensation of damages ensuing from a violation of the right to consent, it is important to distinguish between two hypothetical situations: ﬁrst, where the violation only infringes the right to self-determination with reference to one’s own health and, second, a situation where an actual damage to the health of the patient has been caused (i.e., where an impairment of physical or mental health can be causally linked to the lack of consent). In the former situation, only non-economic damages for such an infringement can be claimed by the patient. In the latter case, if the patient shows that s/he would not have undergone the treatment – upon receiving full information of the risks – and it can be demonstrated that the risks s/he was not informed of actually materialized, s/he can recover full economic and non-economic damages (see Cass. 9 February 2010, no. 2847, in Ragiusan, 2010, 309–310; Cass. n. 28985/2019).

Medical Law – Suppl. 119 (2020) Italy – 203 688–689 Part II, Ch. 1, General Description

688. As the Constitutional Court has emphasized (Cost. no. 438/2009) informed consent has its basis in Articles 2, 13 and 32 of the Constitution. It has a:

function of synthesis of two fundamental human rights: the right of self- determination and the right to health, because if it is true that every individual has the right to be cared for, she has also the right to receive appropriate information on the nature and possible developments in the course of treatment which may be imposed, and of any alternative therapies. This information should be as comprehensive as possible, precisely in order to ensure the free and conscious choice on the part of the patient and, therefore, her own personal freedom, in accordance with Art. 32, para. 2, of the Constitution.

Accordingly, ‘informed consent should be considered a fundamental principle in the ﬁeld of health protection, whose limits are left to state law’. In the end, any medical intervention without lawful informed consent is deﬁnitely illegal, even when it is in the interest of the patient because ‘the practice of free and informed consent is a form of respect for the freedom of the individual and a means to attain her best interests’. Consequently, ‘the appropriateness or otherwise of treatment is not relevant to determining whether the offence for violation of informed consent, which exists for the simple reason that the patient, due to the lack of information has not been put in a position to assent to medical treatment considering all the potential implications’ (Cass. no. 21748/2007). See also 507ff.

1. The Right to Well-informed, Free and Prior Consent

689. Article 5 Law 219/2017, on the ‘shared planning of care’, states that: ‘In the relationship between patient and physician referred to in Article 1, paragraph 2, with regard to the evolution of the consequences of a chronic and disabling disease or characterized by unstoppable evolution with unfavourable prognosis, a planning of care shared between the patient and the physician can be carried out. The physician and the healthcare team are required to comply with this if the patient is in the condition of not being able to express his or her consent or in a condition of incapacity.’ Paragraph 2 of Article 5 provides that ‘the patient and, with his/her consent, his/her family members or part of the civil partnership or cohabiting partner or a person he/she trusts shall be adequately informed, in accordance with Article 1(3), in particular of the possible development of the disease in progress, of what the patient can realistically expect in terms of quality of life, of the clinical possibilities of intervention and of palliative care’. The will to undergo (or not) treatment or to continue (or not) with treatment must have some unfailing characters. It must be personal, conscious (i.e., informed), authentic, not inﬂuenced by irrational reasons, actually attributable to the will of the subject and therefore free from any constraints or suggestions. Nor should it be closely related to speciﬁc personal situations of the patient, it must be effectively expressed in a complete and clear way and not simply inferred from the suffering or

204 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 690–694 the severity of the harm and, above all, it must be current, i.e. standing at the point in time the physician is about to implement the previously expressed will of the patient. See in general law 219/2017.

690. Indeed, information is a key element. The CME (Article 33 see supra, and Article 35) explicitly dealt with informed consent in these terms and well before Law 219 of 2017 stated (Article 1, paragraph 1) that ‘no medical treatment may be initiated or continued without the free and informed consent of the person concerned, except in cases expressly provided for by law’. Yet, as a reaction to the criti- cisms on the time spent to acquire consent, the law (Article 1 paragraphs 8–9) clariﬁes that the time of communication between physician and patient constitutes time of treatment and calls upon each public or private health facility to guarantee, with its own organizational procedures, the full and correct implementation of the principles of the law on informed consent and advance directives, ensuring the necessary information to patients and the appropriate training of staff.

2. Modes of Giving Consent

691. Written consent was only required in a few instances provided for by law (see infra 700).

692. Yet, the CME suggested (Article 13) that ‘written informed consent of the patient’ be required in relation to the prescription of medications ‘both where spe- ciﬁc instructions are not mentioned in the information sheet and for those medicines without permission to trade’. As mentioned, Article 33 CME indicates that ‘in cases where the characteristics of the beneﬁts for diagnostic and/or therapeutic purposes or for the consequences of the same touch on the physical integrity of the patient, appropriate documented manifestation of the will of the person may be required’.

693. According to settled case law, consent must be personal, real, freely revocable, and must be requested at all times during treatment where treatment is divided into several stages (see Court of Cassation, Section III, no. 364/1997). Today, Article 5, paragraph 4 of Law 219/2017 states that the consent of the patient and any indication of a trustee are expressed in writing or, if the physical condition of the patient does not allow it, through video recording or devices that allow the person with disabilities to communicate, and are included in the medical record and the electronic health record.

3. Content of the Information

694. The content of the information to be provided is a key issue, which has led to much litigation since from it depends the possibility of recovering damages compensation. The burden to show that proper information was fully provided is on the

Medical Law – Suppl. 119 (2020) Italy – 205 695–697 Part II, Ch. 1, General Description physician/healthcare institution. However, the patient must demonstrate that s/he would have refused the said treatment if s/he were duly and fully informed about the risks. See 537ff.

695. Only in some instances is the content of the information described by the law, while Article 1 paragraph 3, law 219/2017 expresses a general principle: ‘the right to be informed of one’s state of health in a complete, up-to-date and comprehensible manner about the diagnosis, prognosis, beneﬁts and risks of the diagnostic tests and medical treatments indicated, as well as about the possible alternatives and consequences of any refusal or renunciation of medical treatment and diagnostic investigation’. For instance, Article 14 Law 194/1978 reads:

The physician who performs the termination of pregnancy is required to provide the woman with the information and guidance on the regulation of birth, as well as to let her know of abortive procedures which have to be carried out in order to respect the personal dignity of women.

In the presence of pathological processes, including those related to anomalies or malformations of the future child, the physician who performs the termination of pregnancy must provide the necessary information to women for the prevention of these processes.

696. The law on assisted reproduction is rather detailed with reference to the information that must be given to parents (Law 40/2004). Pursuant to Article 6:

the physician informs in detail [the applicant couple] on methods, on bioethical issues and possible health side-effects, including psychological, that may result from the application of the techniques themselves, and the probability of success and the risks resulting from them, as well as the legal consequences for the women, for the men and for the future baby. The couple should also be given the option to have recourse to procedures for adoption or foster care under Law 4 May 1983 no. 184, and subsequent amendments as an alternative to medically assisted procreation.

This information ‘and those on the degree of invasiveness of the techniques towards women and men must be provided for each of the techniques applied and in such a way as to ensure the formation of a conscious will consciously expressed’. Finally, ‘The economic cost of the whole procedure in the case of authorized private facilities must be clearly outlined to the couple’ (note that the regulations implementing the statute are much more detailed in listing the information to be provided).

697. The physician should communicate with the subject taking into account her ability to understand, in order to promote maximum participation in decision- making and adherence to diagnostic and therapeutic proposals. Any further request for information from the patient must be satisﬁed.

206 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 698–702

698. Information should be communicated and processed so as to suit the actual characteristics of the patient (e.g., considering actual young or old age, education, maturity, social, environmental, linguistic or other weaknesses) (See also 662, 667, 692).

699. As suggested for medical assisted reproduction, where possible, information should be provided in several colloquia and before actual acquisition of consent and the beginning of treatment. We use the term ‘colloquium’ to stress the need of a dialogue and of the ability, on the part of the physician, to listen to and to understand patient needs and requests, beyond the information and technical ones related to the proposed treatment. Mere technical information with just technical jargon does not lead to a valid informed consent.

700. Before law 217/2019, only where prescribed by the law (e.g., in case of HIV virus diagnostic tests, bone marrow donation, organ and tissue donation between living individuals, sampling and the implanting of cornea, electroshock therapy, medically assisted reproduction, abortion), information must be provided (and consent acquired) also in written form.

701. Case law requires the patient to be informed about risks higher than 1% (App. Genova 5 April 1995) but excludes any requirement to inform individual patients about abnormal risks or indeed unforeseeable risks that emerge from linking the existing diagnosis with the patient’s anamnesis. Information must also divulge eventual deﬁciencies of the suggested facility (Cass. 6318/2000).

4. Presumed Consent in Cases of Emergency

702. In emergency cases, case law had settled a rule for which the medical doctor could perform the required treatments despite any manifestation of will by the patient’s relatives. This stemmed from the application of Article 54 cp and 2045 CC according to which one cannot be punished for committing a crime deemed as necessary so as to save oneself or others from imminent danger of serious harm. This danger must be involuntarily caused or otherwise avoidable, provided that the fact is proportionate to the danger. The principle is rather clear. However, it became problematic in those instances in which the state of necessity is predictable and where there has been a previous refusal of speciﬁc treatments. This is the case, for instance, of Jehovah’s Witnesses refusing blood transfusions but ﬁnally reaching a critical condition recovery from which requires such a transfusion. Case law is rather clear in letting the will of the patient prevail as long as the consent (actual refusal of the treatment) is legally valid (see 669ff). Recently, the Court of Cassa- tion (12998/19) adopted some important principles, pointing out that the rejection of hemotransfusion is not only an expression of the right of self-determination but also an objection of religious conscience under Article 19 of the Italian Constitu- tion.

Medical Law – Suppl. 119 (2020) Italy – 207 703–706 Part II, Ch. 1, General Description

703. Concerning the will of Jehovah’s Witnesses, however (see Article 4, D.M. 1 September 1995, that deﬁnes transfusion as a therapeutic practice for which the informed consent of the recipient is required), the case law varies from this general principle of respecting the will of the patient, and in fact, courts almost constantly award non-economic damages compensation even in those cases in which no harm to health actually ensures. Compensation is given for the violation of self- determination. See 903ff.

704. On the contrary, it was already clear in case law that a clear free, conscious, informed patient refusal of treatment does prevail also in case of emergency and necessity making any intervention contrary to patient will illicit. See also 507ff. However, today, paragraph 7 of Article 1 of Law 219/2017 clariﬁes the current rule with reference to these circumstances: ‘In emergency or emergency situations, the physician and the members of the healthcare team shall ensure the necessary care, in compliance with the patient’s wishes where his clinical conditions and circumstances allow it to be implemented.’ Obviously, however, account must also be taken of the substantial discipline of Article 4 of the same law, of which it is worth recalling paragraph 1: ‘Any person of legal age and capable of understanding and wanting, in anticipation of any future inability to self-determine and after having acquired adequate medical information on the consequences of his choices, may, through the Anticipated Treatment Directives, express their willingness in relation to health treatments, as well as consent or refusal with respect to diagnostic tests or therapeutic choices and individual health treatments. S/he also indicates a person of her/his trust, hereinafter referred to as the “trustee”, who acts on her/his behalf and represents her/him in relations with the doctor and health care facilities.’

705. Note that, before law 219/2017, some case law and scholars resorted to the exemption of committing a crime in observance of a duty to act (Article 51 cp) in cases of treatment without patient consent in emergency. Note, however, that the exoneration would apply only for criminal matters.

F. The Right to Refuse or Withdraw Consent

706. At present, as will clearly emerge (see above and below), the right to refuse medical treatment (including life-sustaining treatment) that was left to case law leaving the physician in an unpleasant situation in that s/he must make a decision which will then be examined in court with uncertain outcomes has now changed. Today, paragraph 5, Article 1 of Law 219/2017 solemnly states: ‘Any person capable of acting has the right to refuse, in whole or in part, … , any diagnostic assessment or medical treatment indicated by the doctor for his disease or individual acts of treatment itself. Any person also has the right to revoke at any time, in the same way … , the consent given, even when the revocation involves the interruption of treatment. For the purposes of this law, artiﬁcial nutrition and artiﬁcial hydration are considered health treatments, since they are the administration, on medical prescription, of nutrients through medical devices. If the patient waives or

208 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 707–709 refuses health treatments necessary for his or her survival, the physician shall inform the patient and, if the patient consents, his or her family, of the consequences of such decision.’

707. This state of art emerged already clearly from the Opinion of the National Council of Bioethics in 2008 that stresses the links between Article 13 Cost. and Article 32 paragraph 2 Cost. This link has also been confirmed by statutory law on several occasions (Law. 23 December 1978, no. 833, Article 33; D.L. 24 June 2003, no. 211; Law 19 February 2004, no. 40; Law 21 October 2005, no. 219) as well as by decisions of the Constitutional Court (Cost. 161/1985; Cost. 561/1987; Cost. 471/1990; Cost. 258/1994 and Cost. 238/1996), and of the Supreme Court (Cass. 23676/2008; Cass. 21748/2007; Cass. 5444/2006; Cass. pen. 38852/2005; Cass. pen. 14638/2004; Cass. pen. 26446/2002). In 2012 Cass. n. 20984/2012 clarified that informed consent takes the form, in substance, of a real right of the person ‘which is based on the principles expressed in Article 2 of the Constitution, which protects and promotes fundamental rights, and in Articles 13 and 32 of the Consti- tution, which establish that personal freedom is inviolable and that no one can be obliged to a certain health treatment except by law’. A concept confirmed in 2019. See 535, 549, 571–572.

708. The concept is further conﬁrmed by several articles of the Code of Ethics of Physicians (Articles 35 and 37) that reﬂect international conventions such as the Oviedo Convention of 1997 (Article 5) and the European Charter of Fundamental Rights (Article 3). The right to refuse treatment conceptually related to consent and was dealt with by CNB in its opinion of 20 June 1992. Yet, next to positions favourable to the broad interpretation of the right to conscious:

refusal/renunciation of health treatment, there is a different position in the legal and doctrinal thought which, by stressing the ﬁrst subsection of Art. 32 Cost. in particular, urges a different solution to the balancing of the values that come into play, reducing the possibility to recognize an unconditional and unques- tionable right to refuse/renounce any therapy, no matter what the context might be.

709. Indeed, ‘The issue of the possibility of accepting a conscious refusal/ renunciation of the treatment therefore constitutes a problem of great relevance in healthcare systems heavily dependent on technology.’ The Constitutional Court clearly expressed this point of view already in 1996 (decision no. 238/1996), observing that nobody can be forced to suffer unwanted healthcare in the absence of a law that explicitly imposes it. In addition, it stressed that the right to not be subjected to unwanted medical treatments is an inviolable right, including ‘the inviolable right to personal liberty, considered as a supreme value related to the core of the individual, not unlike the neighbouring and closely connected right to life and physical integrity, which, when combined, take a hierarchical position over all constitutionally protected rights of the person’.

Medical Law – Suppl. 119 (2020) Italy – 209 710–713 Part II, Ch. 1, General Description

710. It ensures that in the absence of the patient’s consent, the physician, although concretely in possession of the professional ability to carry out positive therapeutic procedures, is not fully empowered to cure.

711. From an ethical standpoint, it has been said (Opinion of the National Coun- cil of Bioethics supra 707 at 10) that:

From the point of view of an ethics that believes that human life is an asset in itself, we must distinguish the renunciation to proportionate care from the hypothesis of a renunciation to disproportionate care. The last one, being in effect an acceptance of imminent death, has its place within the area of respect for the value of life, of which it recognises and accepts the intrinsic limit. On the contrary, the renunciation of proportionate care goes against this principle, as it consists of a way of disposing, even if by omission, of one’s life.

712. In light of the above, the CNB distinguished according to the requisites of dependence and competence. The first one occurs when individuals lack ‘the physical autonomy necessary to fulfil his/her intentions, therefore requiring the intervention of a third party, in particular of a physician (or of a medical team)’. According to the latter, a patient is competent if ‘of sound mind and able to express an authentic, informed and present will’. With reference to these instances, the CNB does not have a clear, unified position. There are those that assume withdrawals are ethically and legally possible only in the instances described in Article 16 CME concerning ‘Non-proportionate diagnostic procedures and therapeutic interventions’. Accord- ing to another line of reasoning, however, although Article 32 Cost. protects self- determination, it is understood as acknowledging a right to life and not a right over life. This line of reasoning relates the principle to Article 579 (dedicated to the case of consenting homicide) and Article 5 of the Civil Code (which limits the actions to dispose of the body). A different perspective argues that ‘the possibility to consciously renounce a therapy cannot be limited by reasons beyond the individual: instead it is a subjective, constitutionally guaranteed right, to the concrete realization of which the physician is legitimately called to contribute, as long as he is allowed to abstain’ (Opinion of the National Council of Bioethics supra 707 at 9).

713. ‘Patient’s conscious renunciation or refusal of a particular treatment must not be automatically identified with the final act conducted under the relationship of therapeutic alliance.’ Indeed a patient usually renounces a specific treatment because it is perceived to be insufferable, degrading and intolerable. Accordingly, physicians continue to be called upon to provide their support ‘in’ dying and not in ‘helping to’ die. In these situations, palliative care has an increasingly crucial role (see Articles 3 and 39 CME and the Law of the 8 February 2001 no. 12, concerning regulations to aid the use of analgesic opium drugs in pain therapy). On this way of conceiving the doctor-patient relationship, see today also Article 5 of Law 219/ 2017 on the ‘shared planning of care’. In this vein, the Constitutional Court (242/ 2019) has declared partially unconstitutional Article 580 cp. See also infra 972f and 979ff.

210 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 714–717

714. Of course, and in line with Article 22 CME, physicians may abstain from an action necessary to implement the patient’s right to refuse or withdraw from a speciﬁc treatment (e.g., switching off a life support machine), as long as the patient’s – being legally competent and, although not autonomous, naturally competent – will is fulﬁlled. Again, this right of the patient to abstain does not eliminate the physician’s duty to ‘guarantee assistance to the patient, to provide him/her with palliative care, to share with other health workers all the information on the progression of the illness indispensable for the correct assumption of medical responsibility’ (CNB supra 707 at 16).

715. Accordingly, the CNB (Opinion of the National Council of Bioethics supra 707 at 17) has concluded:

The patient’s conscious refusal of a medical treatment that has not yet started, just as the renunciation of a treatment that has started, cannot ever be uncriti- cally accepted, or passively ‘recorded’, by the physician. Considering the seriousness – and often the irreversibility – of the consequences of a refusal or of a renunciation of care, what becomes necessary is a careful analysis of the patient’s effective competence and of the presence, case-by-case and in concrete, of all the prerequisites and the indicators that allow the consideration of his/her will as certain, conscious and reliable.

716. The explicit recognition of the right to refuse treatment has helped to solve some difficult cases among which we ﬁnd the refusal of treatment for religious reasons, which is actually permissible precisely because of the impossibility to impose treatments that are not justiﬁed by the need to protect the health of others and where the primacy of respect for the human person was a paramount consideration. Simi- larly, the refusal of life-saving or life-sustaining treatment by individuals adequately informed and capable of understanding the consequences (even death) of refusal is permissible. This prevails over the physician’s will to persist with treatment and rather forces them to assist the patient with the regular progression of the illness (see also infra 688, 718ff, 971, 975ff).

717. The Constitutional Court has set limits on the right to refuse treatment. For instance, in the case of challenging mandatory helmet use for minors (considered as healthcare treatment) on scooters and motorcycles, the court clariﬁed that since health is also a collective interest, it is not unreasonable that the legislature in its appreciation prescribes certain behaviours and non-compliance sanctions in order to reduce as much as possible the detrimental consequences, in terms of mortality and disablement, of road accidents. It cannot indeed be doubted that these consequences have an impact in terms of social costs on the society as a whole. The court is of the opinion that it is not even conceivable that an individual, refusing to comply with the procedures laid down by this preventive measure, can simultaneously renounce the support of the public welfare structure and the particulars granted to inﬁrm individuals. Therefore, the compulsory prescription of helmets is constitutionally valid (see Cost. 180/1994).

Medical Law – Suppl. 119 (2020) Italy – 211 718–721 Part II, Ch. 1, General Description

718. The Supreme Court (Cass. no. 21748 of 16 October 2007), however, has clearly ruled that ‘it must be excluded that the patient’s right to therapeutic autonomy encounters limits when its exercise essentially means that life itself will be sacriﬁced’. This is so because ‘informed consent has to be related not only to the right to choose between the various options for medical treatment, but also eventually to the refusal of treatment and consciously deciding to stop it, at all stages of life, even in the terminal phase’.

719. ‘This is consistent with the personalistic principle that animates our Con- stitution [see 678], which sees in the human person an ethical value in itself, bans all instrumentalization thereof for enshrouding heteronomous purposes, conceives of intervention and social solidarity in relation to the person and her development and not vice versa, and looks at the limit of “respect for the human person” referring it to the single individual, at any time of her life and in the totality of her person, in consideration of the bundle of ethical, religious, cultural and philosophical opinions that orient her volitional determinations’ (Cass. no. 21748 of 16 October 2007). In line with this case law, paragraph 6 of article 1 of law 291/2017 states that: ‘The physician is required to respect the patient’s willingness to refuse medical treatment or to waive it and, as a result, is free from civil or criminal liability. The patient may not demand medical treatment that is contrary to the law, professional ethics or good clinical-assistance practices; in the face of such requests, the doctor has no professional obligations.’

G. Compulsory Treatments

720. Permitted compulsory treatments (including diagnostic ones according to Article 33, Law 833/1978) are very limited and are exceptions to the general principle of consent. We should distinguish those cases in which it is difficult to obtain consent from those in which physicians can act without consent. Among the former, we can point to those cases where the patient is suffering from mental illness; the patient is a minor or an elderly person with cognitive problems; the patient enters the penitentiary system in which only the entrance medical visit and some other monitoring visits are compulsory. Among the latter, we can highlight emergency situations and those instances provided for by statute according to the prescription of Article 32 Cost., which balances the individual and collective interest to health. As anticipated, there is no duty to maintain good health. Therefore, the pre- eminence given in healthcare protection to the personal subjective element over the collective interest renders unacceptable the sacriﬁce of individual self- determination except in the presence of (serious) risks to the health of others. Even in these instances, compulsory treatments cannot have negative consequences that go beyond those considered tolerable in consideration of their temporary nature and their extent (Cost. 307/1990). See supra 679–681.

721. The limitation on one’s self-determination should be proportionate to the protection of the health of others. There are also external limits to the legislative

212 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 722–726 powers imposing treatments aimed at avoiding violations of human dignity, including a clear identiﬁcation of the treatment (generic or undetermined deﬁnitions are not permitted without violating Article 32 paragraph 2 Cost.). However, such a requirement remains highly problematic in light of Article 32, Law 833/1978, which provides for the exercise of ‘overriding power’ in case of urgent public necessity in healthcare (see supra 87).

722. Article 33, paragraph 1, Law 833/1978 states that ‘in the cases referred to in this law and as expressly provided under state laws, health authorities can mandate compulsory diagnostic and healing treatments in accordance with Article 32 of the Constitution, respecting the dignity of the person and civil and political rights, including, as far as possible, the right to choose one’s physician and place of care’. See 926ff.

723. Article 34 of the same statute prescribes a speciﬁc guarantee for compulsory mental illness treatment in hospitals. The guarantee consists of judicial authority intervention by a judge, giudice tutelare, who is called upon to validate the decision of the local health authority (the Mayor).

724. In 1978, the legislator enacted a speciﬁc law devoted to the issue: Law 13 May 1978, no. 180 on Mandatory and Voluntary Clinical Tests and Treatments amended again by D.L. 1 September 2011, no. 150. After setting down the general principles in Article 1, the statute mainly deals with compulsory mental illnesses treatments. Article 1 prescribes that health examinations and treatments are voluntary as a rule. In addition, compulsory treatments in cases provided for by laws must respect the dignity of persons and their civil and political rights guaranteed by the Constitution. It further states: ‘during the mandatory medical treatment, the subject has the right to communicate with anyone she considers appropriate. Mandatory medical examinations and treatments of the preceding paragraphs shall be accompanied by initiatives to secure consent and participation on the part of those bound by compulsory treatment.

725. Mandatory medical examinations and treatments are sanctioned by order of the Mayor in her capacity as authority for local health, based on a reasoned proposal by a physician’.

726. In dealing speciﬁcally with mandatory health examinations and treatment for mental illness (Article 2ff), the statute rules that the proposed mandatory medical treatment may provide that care be provided in hospital only: a. if there are mental conditions such as to require urgent therapeutic interventions; b. in cases where they are not accepted by the patient; and c. where appropriate outpatient health facilities cannot deal with the conditions and circumstances at issue.

Medical Law – Suppl. 119 (2020) Italy – 213 727–731 Part II, Ch. 1, General Description

727. In any event, the compulsory treatment must be proposed (with motivation) by a physician, conﬁrmed by a physician from the public healthcare facility and further conﬁrmed within forty-eight hours by a judge.

728. After the abrogation of Law 162/1990 (compulsory medical treatment rehabilitation for drug addicts) the remaining cases of compulsory treatments refer to vaccinations and mental illness treatments (see 926ff) or those related to countering infectious diseases.

729. Statutes distinguish between general vaccinations (usually targeting the elder resident population and those performed during infancy) and special ones related to speciﬁc categories of individuals due to their activity or special circumstances. The former category includes the following vaccinations: diphtheria (Law 891/1939 Law 166/1981), tetanus (Law 419/1968), polio (Law 51/1966), and hepatitis B virus (Law 165/1991). Belonging to the second category, we can highlight tetanus vaccination (Law 292/1963); typhoid vaccination (Law 02/12/1926 – Article 38, P.D. 327/1980), the tuberculosis vaccination (Law 1008/1970), the meningo- coccal vaccine, typhoid, anti-tetanus and anti-diphtheria, and measles-mumps- rubella (Law 1008/1970). Today Decree-Law 7 June 2017, n. 73, urgent provisions on vaccination prevention, as amended by the Conversion Law 31 July 2017, n. 119, provides for the following compulsory vaccinations for minors aged between 0 and 16 years and for unaccompanied foreign minors:

anti-poliomyelitic; anti diphtheria; tetanus-free; anti-hepatitis B; anti-pertussis; anti-Haemophilus; inﬂuenzae type b; anti-morbid; anti-rosolia; anti-parotite; anti-varicella.

The requirement for the last four (anti-morbid, anti-rosolia, anti-parotitis and anti- varicella) is subject to review every three years based on epidemiological data and vaccination coverage achieved (see G. Montanari Vergalo, N. Mario Di Luca and S. Zaami, Childhood immunization: mandate or persuasion? Italian lawmakers have opted for the former. What about European legislators’ European Journal of Health Law, 2018, vol. 25, n 5; 573–586).

730. As mentioned, if damages ensuing from vaccination exceed that considered to be tolerable and temporary, the Constitutional Court has mandated an additional guarantee in terms of compensation (Cost. Court. 307/1990 followed by Law 210/1992 and the subsequent amendments –mainly 238/1997 and 29/1998 – implemented as a result of several other Constitutional Court decisions – e.g., no. 118/ 1996, no. 38/2000, no. 423/2000, and no. 38/2002.) See 603ff.

731. In any event, the duty to inform the patients about the treatment, its risks and the precautions that need to be followed remains for compulsory treatments as well.

214 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 732–737

H. Rights Related to the Patient’s Medical Record

1. The Right to a Medical Record

732. The keeping of medical records is still fragmented among several providers (see infra 807 on EHR). General practitioners and each medical facility visited by patients keep medical records of the diagnosis and treatments offered to the patient. GP must submit many data from their records to the Regions for a number of administrative matters. The patient has a right to a copy of them and to access them.

733. Several pieces of legislation assign to physicians and nurses the duty to maintain medical records in good order. In principle, clinical medical records should be conserved forever. Speciﬁc legislative rules and regulations of each provider describe the content and procedures for making annotations on such medical records. The lack of coordination among the various sets of patient medical records might lead to duplication. In addition, data are collected in different forms (for instance, paper, electronic, and DVD) according to the kind of record (for instance, a TAC) and the internal organization of the facility.

734. The GDPR and the Italian Data Protection Law regulate medical records in some detail retaining the principle of consent (when and if needed), information duties/rights, access, modiﬁcation.

735. In reality, the health record, the clinical record and the electronic health record should be distinguished.

736. The health record is the set of personal data generated by present and past clinical events concerning the person concerned, which are shared between health professionals who assist them in a single healthcare facility (e.g. hospital, private nursing home, etc.). Thus the dossier allows reconstructing the clinical history of a patient with reference to all the health services provided to him/her by a speciﬁc healthcare facility.

737. The clinical record, however, is a tool that describes, according to the standards deﬁned by the Ministry of Health, a single episode of hospitalization of the person concerned. The dossier is accessible to all health professionals of the healthcare facility that owns the dossier and will take care of the person concerned over time. According to data protection law, the interested party has the right to know the subjects who have had access to their health dossier. This has been clearly indicated by the Data Protection Authority in its guidelines on the dossier of 2015 providing that the interested party can request to know the accesses made to their dossier with an indication of the structure/department that has accessed, as well as the date and time of the same. In the domain of health-related data, consent is needed to process data on

Medical Law – Suppl. 119 (2020) Italy – 215 738–740 Part II, Ch. 1, General Description health in the health sector in accordance with Regulation (EU) 2016/679 in the following cases: consultation of the electronic health ﬁle; online report delivery; use of medical apps; customer loyalty; promotional or commercial purposes; electoral purposes.

738. In the event of revocation of consent, the dossier must not be further implemented, the information contained in it must remain available to the professional who drew it up, but must no longer be shared with professionals in other departments who will later take care of the person concerned. In case of incapacity to act of the interested party (data subject in the language of the GDPR), consent must be acquired by the person exercising legal authority over the interested party. In the case of minors, once they have reached the age of majority, the consent of the data subject must be obtained again. It should be noted that the inclusion in the ﬁle of information subject to greater protection by the legal system (such as information relating to acts of sexual violence or paedophilia, HIV infection or the use of alcohol or drugs) must be expressly mentioned in the information and subject to the speciﬁc consent of the data subject. Similarly, he or she may request that certain information on his/her health not be included in the health dossier, obscuring certain health data or documents, which will therefore not be visible and accessible through the dossier. Finally, for the access of administrative staff, this is limited only to the administrative information strictly necessary to carry out the functions for which it is responsible.

739. The CME offers rules on clinical data. It prescribes (Article 25) that physicians put, in the exclusive interest of the patient, the clinical documentation in their possession available in writing so that it is available to patients or their legal representatives and physicians and institutions. The renewed version of Article 25 further clariﬁes that ‘the physician, in cases of enrolment in research protocols, will record the manner and timing of the information and informed consent also with regard to the processing of sensitive data’. Moreover, the medical records of public and private facilities (Article 26) must be written clearly, punctually and diligently, in accordance with the rules of GCP and must contain, in addition to any objective data on the pathological condition and its progression, information on performed diagnostic and therapeutic activities.

740. With reference to informed consent, Article 26 paragraph 3 requires that medical records must record the manner and timing of the information and the terms of the consent of the patient, or of their guardian, and the proposed diagnostic and therapeutic activities. It must also record the patient’s consent to the processing of sensitive data, particularly with regard to cases of enrolment in an experimental protocol.

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2. The Right to Add to the Medical Record

741. At the request of the patient, documents or declarations can be added to the medical records. It is the case, for instance, of express refusal of treatments by the patient. It is again the general rules on data protection that grant the right to access and to update (medical) data. The same rules, however, are also enshrined in previous legal rules governing the maintenance of medical records.

3. The Right to Access

742. While the patient has always a right to access (and to have a copy of) their medical records, Article 92 of the DPA (196/2003) allows (in whole or in part) requests to inspect or obtain a copy of the clinical records and the attached patient discharge form as lodged by entities other than the data subject only if:

it is justiﬁed because of the proven need: (a) to establish or defend a legal claim in pursuance of 9, paragraph 2, lett. f of GDPR, such claim being equal in rank to the data subject’s right or else consisting in a personal right or another fundamental, inviolable right or freedom; (b) to establish a legally relevant claim in pursuance of the legislation concerning access to administrative records, such claim being equal in rank to the data subject’s right or else consisting in a personal right or another fundamental, inviolable right or freedom.

743. The special provision is in line with the general one concerning access to public records.

744. Article 60, Data Disclosing Health and Sex Life which speciﬁes: ‘Where the processing concerns genetic data, data concerning a person’s health, sexual life or sexual orientation, processing shall be permitted if the legally relevant situation to be protected by the request for access to administrative documents is of at least equal rank to the rights of the data subject, or consists of a right relating to personality or another fundamental right or freedom.’

4. The Right to a Copy

745. Article 15 GDPR establishes that the data subject shall have the right to obtain from the controller conﬁrmation as to whether or not personal data concerning him or her are being processed, and, where that is the case, access to the personal data and to the relevant information (see supra 742).

Medical Law – Suppl. 119 (2020) Italy – 217 746–749 Part II, Ch. 1, General Description

5. Access by Next of Kin after the Death of the Patient

746. The right to access the processed data (Article 15 GDPR) is exclusive of the data subject. With reference to the health data of deceased persons, the GDPR, while excluding the application of the legislation to the data of deceased persons, sets out the possibility for Member States to provide for rules concerning the processing of personal data of deceased persons.

747. Accordingly, the Italian legislator with D. Lgs. n. 101/2018 established that the rights relating to personal data of the deceased might be exercised by those who have an interest of their own or act to protect the person concerned, as his or her representative, or for family reasons deserving of protection. From this recognition derives the logical consequence that to the personal data of deceased continue to apply the protections provided by the regulations on data protection. And in fact, Article 2-terdecies DPA provides: ‘1. The rights referred to in Articles 15 to 22 of the GDPR referred to personal data on deceased persons may be exercised by those who have an interest of their own, or act to protect the person concerned, as his/her representative, or for family reasons deserving of protection.’ Among the latter, we can point to the need of relatives to know the cause of death in order to come to terms with the relative’s death or to evaluate grounds for legal actions. Indeed and in addition, the general rules for access to personal data (including medical records) to defend a legal right apply as well (see 742, 743).

I. The Right to Protection of Privacy and Intimacy

748. The GDPR and the Italian Data Protection Code expressly protect privacy and intimacy. Its purpose is to (Article 1 paragraph 2, GDPR) protect ‘fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data’.

749. In the healthcare ﬁeld, the DPA gives medical professionals speciﬁc attention in relation to the information process followed by general practitioners and paediatricians. They must highlight:

in detail, processing operations concerning personal data that may entail specific risks for the data subject’s rights and fundamental freedoms and dignity, in particular if the processing is carried out: (a) for scientific purposes, including scientific research and controlled clinical drug testing, in compliance with laws and regulations, by especially pointing out that the consent, if necessary, is given freely, (b) within the framework of tele-aid or telemedicine services, (c) to supply other goods or services to the data subject via electronic communication networks.

218 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 750–753

750. Pursuant to Articles 77 and 78 DPA, General Practitioners or freely chosen paediatricians must inform the data subject of the processing of personal data, in a clear form and in such a way as to make the elements indicated easily comprehensible (in Articles 13 and 14 of the GDPR).

751. Article 78 DPA requires that the information be provided for the whole processing of personal data necessary for activities (diagnosis, care and treatment) carried out by the doctor or paediatrician to protect the health or physical safety of the data subject, at the request of the data subject or of which the data subject is informed as they are carried out in the interest of the data subject. The information may also concern personal data collected from third parties and is provided pref- erably in writing (the written form is not provided for by the GDPR). The system allows the GP or the paediatrician to inform about the data processing related to their own activity and about the data processing performed by a professional or other subject also identiﬁable on the basis of the performance required, in the following cases if they:

(a) temporarily replace the physician or paediatrician; (b) provide specialist services at the request of the physician and the paediatrician; (c) can lawfully process data in the context of an activity professional service provided in an associated form; (d) provide prescribed medicines; (e) communicate personal data to the physician or paediatrician in accordance with the applicable rules.

752. The processing operations must analytically identify any processing of personal data that presents speciﬁc risks to fundamental rights and freedoms, as well as to the dignity of the person concerned, particularly in the case of processing operations carried out:

(a) for the purposes of scientific research, including clinical trials, in accordance with laws and regulations, in particular highlighting that the consent, where required, is freely manifested; (b) in the field of teleassistance or telemedicine; (c) to provide other goods or services to the person concerned by means of an electronic communication network; (c-bis) for the purposes of implementing the electronic health file; (c-ter) for the purposes of surveillance systems and records of mortality, cancer and other diseases, treatments consisting of transplants of cells and tissues and treatments based on medicines for therapies advanced or tissue-engineered products and prosthetic implants (Article 12, paragraph 10 of Legislative Decree no. 179 of 18 October 2012).

753. Several criminal provisions apply and protect the privacy of individuals. Among these, for instance, we ﬁnd Article 326 cp punishing the revelation and the use of secrets of office by a public official or a person in charge of a public service (as deﬁned by Article 358 cp). If these individuals, in violation of the duties relating

Medical Law – Suppl. 119 (2020) Italy – 219 754–758 Part II, Ch. 1, General Description to the function or service, or otherwise abusing its quality, reveal office information that must be kept secret or in any way facilitate their personal knowledge, they can be punished with six months to two years of reclusion. See also Cost. no. 218/1994. See also 826ff.

J. The Right to Representation in the Event of Incompetence

754. Both the GDPR and the Italian DPA provide instances in which the data subject can be represented by an agent.

755. Furthermore, Article 80 GDPR allows the data subject to mandate a non- proﬁt-making body, organization or association which is duly constituted in accordance with the law of a Member State, whose statutory objectives are in the public interest and which is active in the ﬁeld of the protection of the rights and freedoms of data subjects with regard to the protection of their personal data, to lodge a ‘complaint on its behalf and to exercise on its behalf the rights referred to in Articles 77, 78 and 79 and, where provided for by the law of the Member States, the right to compensation referred to in Article 82’. Of course this does apply also for competent data subjects. A similar rule applies (Article 49 GDPR) in the absence of an adequacy decision of the Commission or of adequate safeguards within the meaning of Article 46, including binding corporate rules, to a transfer or a set of transfers of personal data to a third country or an international organization if ‘f) the transfer is necessary to protect the vital interests of the data subject or of other persons, where the data subject is physically or legally incapable of giving his or her consent’.

756. They mostly refer to the instances in which the data subject can be represented by an agent. There is a life-threatening situation of the subject/third party, and the doctors can intervene postponing information to the data subject if (Article 9 GDPR paragraph 2, (c)) ‘processing is necessary to protect the vital interests of the data subject or of another natural person where the data subject is physically or legally incapable of giving consent’.

757. Article 82 DPA permits to proceed without providing the information requested by Articles 13 and 14 Regulation EU 2016/679 ‘in cases of medical emergency and/or [those] related to public hygiene whenever the competent authority has issued a contingent emergency order pursuant to Section 117 of legislative decree no. 112 of 31 March 1998’. This provides that ‘if the data subject is physically impaired, legally incapable or unable to distinguish right and wrong, and the consent cannot be obtained from the entity legally representing the data subject, or else a next of kin, a family member, a person cohabiting with’.

758. The renewed article 82 of the DPA adds (paragraph 2 and ff) that ‘Such information may also be made available without delay, after performance, in the case of:

220 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 759–761

(a) physical impossibility, inability to act or inability to understand or desire of the person concerned, when it is not possible to provide the information, in the cases provided for, to the person legally representing him/her, or to a close relative, to a family member, to a cohabiting or civilly linked person or to a trustee pursuant to Article 4 of Law no. 219 of 22 December 2017 or, in their absence, to the person in charge of the structure where the person concerned resides; (b) serious, imminent and irreparable risk to his/her health or to that of the person concerned. (c) The information referred to in paragraph 1 may be provided without delay, after the service has been provided, even in the case of medical service that may be affected by their prior release, in terms of timeliness or effectiveness. (d) After reaching the age of majority, the information shall be provided to the person concerned where they have not been previously provided.’

K. The Right to Lodge a Complaint

759. In addition to traditional legal rules protecting privacy and intimacy, the GDPR and the DPA provide for speciﬁc remedies either by way of a complaint in front of the Data Protection Authority or in front of an ordinary court of justice.

760. Data subjects (for our purposes here, patients) may apply to the Data Pro- tection Authority:

(a) to lodge a circumstantial claim in order to point out an infringement of the relevant provisions on the processing of personal data (Article 77 GDPR). (b) to lodge a report in cases where no circumstantial claim as per letter a) Article 141 DPA may be lodged, in order to call upon the Data Protection Authority to check up on the aforementioned provisions.

Article 77 of EU Regulation 2016/679, entitled ‘Right to lodge a complaint with a supervisory authority’, states: ‘1. Without prejudice to any other administrative or judicial remedy, every data subject shall have the right to lodge a complaint with a supervisory authority, in particular in the Member State of his or her habitual residence, place of work or place of the alleged infringement if the data subject considers that the processing of personal data relating to him or her infringes this Regulation.’

761. The Data Protection Authority has extensive powers to block or prohibit the processing of information, in whole or in part, if the latter is found to be unlawful or unfair partly because of the failure to take the necessary or appropriate action to bring the processing into line with the provisions in force. It can also prohibit, in whole or in part, the processing of data concerning individual entities or categories if it is in conﬂict with the substantial public interest. All these remedies can be granted also prior to ﬁnalizing the relevant proceedings (Article 143

Medical Law – Suppl. 119 (2020) Italy – 221 762–766 Part II, Ch. 1, General Description

762. Using these remedies, the Data Protecting Authority can also force compliance with Articles concerning (data subjects) patients’ rights.

763. However, complaints can only be lodged to the Data Protection Authority ‘after a request concerning the same matter has been made to the data controller or processor’.

764. Privacy and confidentiality are also dealt with by the CME. Article 11 expressly regulates confidentiality of personal data. Accordingly, ‘the physician acquires ownership of the processing of personal data with the prior informed consent of the patient or his/her legal representative and is required to respect confidentiality, in particular on data concerning health and sex life. The physician shall ensure the non-identifiability of the subjects involved in the publication or scientific dissemination of data and clinical studies. The physician shall not collaborate in the establishment, management or use of databases relating to persons assisted in the absence of guarantees on the prior acquisition of their informed consent and on the protection of the confidentiality and security of the data’. See also 826ff.

II. Medical Obligations in General

A. The Legal Duty to Help

1. Rules on the Practice of Medicine

765. The renewed article 8 of the CME prescribes a duty of intervention in cases of urgency: ‘In case of emergency, the physician, regardless of his or her usual activity, must provide assistance and in any case take prompt action to ensure appropriate assistance.’ Article 9 requires physicians to be available for the responsible Authority in cases of disaster, calamity or epidemics. Finally, Article 23 imposes to the physician to guarantee citizens the continuity of care. Cases have condemned physicians not intervening (for instance, in case of car accidents: Cass no. 6804/ 2000).

2. Article 593 of the Criminal Code

766. While the CME prescribes (supra 765) a duty to assist on medical doctors, the Criminal Code describes the failure to assist a person as a crime potentially committed by anyone if conditions are satisfied. Article 593 of the Criminal Code punishes with imprisonment of up to one year or a fine of up to EUR 2,500 ‘anyone finding and failing to notify immediately the Authority an abandoned or lost a child less ten years old, or another person unable to provide for themselves, due to illness of mind and body, old age or other cause’.

222 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 767–771

767. The same penalty applies to any person, ﬁnding a human body that is or appears inanimate, or a person injured or otherwise in danger, failing to give assistance as needed or to give immediate notice to the Authority. If, following such conduct, the victim derives a personal injury, the penalty is increased, and if death ensues, the penalty is doubled. It is beyond any doubt that the rule applies to medical doctors once the required conditions are satisﬁed.

3. Article 328 Criminal Code (riﬁuto di atti d’ufficio. Omissione) Refusal to Perform Official Functions: Omission

768. Article 328 cp sanctions with imprisonment from six months to two years ‘A public official or someone responsible for a public service, who unduly refuses an act of her office that, for reasons of Justice or public security, or of public order, or hygiene and health, must be done without delay.’ Accordingly, a physician working for the NHS who refuses her due services to patients is liable (regardless of their working relation with the NHS, e.g., employee or contractor; see Cassa Section VI, no. 28005/11).

769. Pursuant to and by effect of Article 357 cp, public officials are those that (in this case the physicians) have a public legislative, judicial, administrative function, and are governed by public law or authoritative acts and are characterized by the formation and manifestation of the will of the public administration or functioning by means of the powers of authorization or certification. Those acts performed in hospitals by the directors of the operating units, primary care physicians, medical acceptance and first aid physicians are considered public functions. Those who, acting as physicians, in performing the mentioned functions, evade a due act, must respond to the offence according to Article 328, paragraph 1 cp. The latter does not require that the refusal is expressed in a solemn or formal way since it can even materialize from the inertia of the public officer particularly where this continues without justification beyond the terms of respite or forfeiture in cases where it stems from the non-performance of an act within her duties.

770. It emerges clearly that a physician who is not on-duty is not exposed to such criminal liability, although the CME and Article 593 cp would require intervention.

4. Rules on Emergency Medical Care

771. The organization of the services of urgency and emergency is mainly ruled pursuant to Decree of the President of the Republic 27 March 1992 (governing the policy and coordination of the Regions in relation to the determination of levels of emergency healthcare) that organizes and allocates competences and costs among the NHS and Regions and Autonomous Provinces (see 765–767).

Medical Law – Suppl. 119 (2020) Italy – 223 772–776 Part II, Ch. 1, General Description

772. Although the terms ‘emergency’ and ‘urgency’ are often used as syn- onyms, they should be distinguished by the diverse proﬁles of the various care organizations and interventions that underlie them. Emergency refers to an event, unexpected or unforeseen, constituting a serious danger to life, from which emerges the need for immediate and exceptional intervention (concerning one or more persons or sometimes the entire community). Urgency is a concept of a more strictly clinical persuasion. It refers to a condition of serious illness for the individual patient, with potential life-threatening risks or at least a risk of serious harm to her health (disability), from which arises the need for prompt action, decisions and solutions on the part of medical care personnel.

773. The physician is legally and ethically required to intervene promptly and help the person who is in a situation posing danger to the life or health of the patient irrespective of her role in the system. As mentioned (see 765), the CME requires physicians to answer requests of help by authorities and even to ‘offer’ their services in cases of emergency or disaster. However, only in cases concerning the performance of official duty can omissions to help lead to criminal and civil liability.

B. Respect for the Privacy of the Patient

1. General Rule for Processing Personal Medical Data

774. In general, information concerning health in relation to data processing is considered sensitive data and is subject to speciﬁc safeguards by both the GDPR and the DPA. However, the DPA provides for special rules in the ﬁeld of delivery of healthcare services. Note that the GDPR now requires all professionals in healthcare facilities to maintain a record of processing activities under its responsibility (Article 30 GDPR). The appointment of a data protection officer is mandatory for public bodies (e.g. a structure belonging to the NHS) and in the case of ‘large- scale’ treatment (as can be done for hospitals and nursing homes), pursuant to Article 37 GDPR.

775. The general rules for personal data disclosure concerning health forbid their processing. Article 9 GDPR paragraph 1: ‘Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union mem- bership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual orientation.’

776. However, the GDPR (Article 9 paragraph 2) provides for a number of occasions in which data processing is permitted and even without the consent of the data subjecting the domain of healthcare services. These exceptions basically reversed the previous rule for which in general, personal data can be processed by private entities or proﬁt-seeking public bodies only if the data subjects give their express consent.

224 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 777–778

777. The exceptions most relevant for the healthcare professionals are (letters refer to Article 9 GDPR) as follows: (b) processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law in so far as it is authorised by Union or Member State law or a collective agreement pursuant to Member State law providing for appropriate safeguards for the fundamental rights and the interests of the data subject; (c) processing is necessary to protect the vital interests of the data subject or of another natural person where the data subject is physically or legally incapable of giving consent; (d) processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation, association or any other not-for- profit body with a political, philosophical, religious or trade union aim and on condition that the processing relates solely to the members or to former members of the body or to persons who have regular contact with it in connection with its purposes and that the personal data are not disclosed outside that body without the consent of the data subjects; (h) processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3; (i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of healthcare and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy; (j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

778. Access to data disclosing health is permitted also ‘if the legal claim to be defended by means of the request for accessing administrative records is at least equal in rank to the data subject’s rights, or if it consists in a personal right or another fundamental, inviolable right or freedom’ (Article 60 DPA; see also GDPR Article 9 paragraph 2, lett. e).

Medical Law – Suppl. 119 (2020) Italy – 225 779–780 Part II, Ch. 1, General Description

779. However, the DPA sets a special regime for health data in the NHS devoting Title V to the processing of personal data in the healthcare sector (Article 75ff DPA). See infra 780ff.

2. Exceptions

780. The legal rules have been dramatically changed after the entering into force of the GDPR. Article 76 has been repealed. Article 9 of the Regulation, in addition to what has already been said, lays down in paragraphs 3 and 4: ‘Personal data referred to in paragraph 1 may be processed for the purposes referred to in point (h) of paragraph 2 [preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services] when those data are processed by or under the responsibility of a professional subject to the obligation of professional secrecy under Union or Member State law or rules established by national competent bodies or by another person also subject to an obligation of secrecy under Union or Member State law or rules established by national competent bodies. 4. Member States may maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health.’ The Italian legislator has made use of this possibility in Article 2-septies (Guarantee measures for the processing of genetic, biometric and health-related data). According to it, ‘genetic, biometric and health-related data may be processed’ in compliance ‘with the guarantee measures laid down by the DPA, in compliance with the provisions of this article’. Such measures may dictate ‘further conditions on the basis of which the processing of such data is permitted’ and ‘identify security measures, including encryption and pseudonymisation techniques, minimisation measures, speciﬁc procedures for selec- tive access to data and for making information available to data subjects, as well as any other measures necessary to guarantee the rights of data subjects’. The provision establishing these safeguards (adopted at least every two years) must take account of this:

(a) the guidelines, recommendations and best practices published by the European Data Protection Board and best practices on the processing of personal data; (b) scientiﬁc and technological developments in the area covered by the measures; (c) the interest in the free movement of personal data within the territory of the European Union.

Appropriately, given the complexity of the matter, the regulation of detail has been entrusted to the Data Protection Authority, even if further indications of principle would perhaps have been appropriate. However, the prohibition of diffusion of such data remains ﬁrm (Article 2-septies, paragraph 8, of the reformed DPA).

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Article 110, paragraph 1 of the renewed DPA, echoing Article 89 of Regulation 2016/679 with an anodyne formula, excludes the need for consent for the processing of data relating to health, ‘when, due to particular reasons, informing those concerned is impossible or involves a disproportionate effort, or is likely to make it impossible or seriously undermine the achievement of the purposes of the research’. Indeed, the implementation of Article 9(4) and Article 89(1) respectively required the possibility of maintaining or introducing further conditions, including limitations, with regard to the processing of genetic data, biometric data or health data and the adoption of adequate safeguards for the rights and freedoms of the data subject, in accordance with this Regulation. Those safeguards shall ensure that technical and organizational measures are in place, in particular to ensure compliance with the principle of data minimization. Such measures may include pseudonymization, provided that the purposes in question can be achieved in this way. Where they can be achieved by further processing which does not or no longer enable the identiﬁ- cation of the data subject, those purposes shall be achieved in that way. The national legislator, however, seems to add a legitimising basis for the processing of health data, the alignment of which with Article 9 of the Regulation appears problematic despite the fact that Article 110 of the TU 196/2003 requires the data controller to (a) adopt ‘appropriate measures to protect the rights, freedoms and legitimate interests of the person concerned’, (b) obtain ‘reasoned favourable opinion of the competent ethical committee at the territorial level’ for the research programme and (c) the ‘prior consultation of the Data Protection Authority pursuant to Article 36 of the Regulation’.

781. Generally, consent is not required for data processing in healthcare administration (see above 777). The Data Protection Authority has clarified that consent is needed for consultation of the electronic health file; delivery of the online report; use of medical apps; customer trust; promotional or commercial finalities; electoral finalities. Yet, if acquired, it must be after providing the required information using the sim- plified formalities provided for in Article 77ff.

782. Article 77 enables public healthcare bodies, other private healthcare bodies and healthcare professionals, and the services or departments of public bodies working in the sectors of healthcare and/or occupational safety and prevention to use simpliﬁed procedures. The exception (Article 80) applies also to the competent services or facilities of other public entities, other than those indicated above, operating in the ﬁeld of health or social protection and social security.

783. General practitioners and paediatricians constitute the front line when it comes to information about privacy and related rights. Pursuant to Article 78 of the DPA, general practitioners and paediatricians must inform data subjects of the processing of personal data in a clear manner explaining the whole operation surrounding the processing of personal data related to prevention, diagnosis, treatment and rehabilitation as carried out by a General Practitioner or a paediatrician to safeguard the data subject’s health or bodily integrity. The information may also concern personal data collected from third parties.

Medical Law – Suppl. 119 (2020) Italy – 227 784–786 Part II, Ch. 1, General Description

784. These pieces of information are those provided for by Articles 13 and 14 of GDPR. There is no requirement to provide information in writing, although the norm suggests to do so also by means of pocket-sized cards with foldable annexes. See also 748–753.

785. Articles 13 and 14 GDPR, whose rubric read, respectively, ‘Information to be provided if personal data are collected from the data subject’ and ‘Information to be provided if personal data are not obtained from the data subject’ has substituted the repealed Article 13 of the DPA.

786. They require to provide at least the following information: ‘(a) the identity and the contact details of the controller and, where applicable, of the controller’s representative; (b) the contact details of the data protection officer, where applicable; (c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; (d) the categories of personal data concerned; (e) the recipients or categories of recipients of the personal data, if any; (f)where applicable, that the controller intends to transfer personal data to a recipient in a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable safeguards and the means to obtain a copy of them or where they have been made available. 2. In addition to the information referred to in paragraph 1, the controller shall provide the data subject with the following information necessary to ensure fair and transparent processing in respect of the data subject: (a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; (b) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (c) the existence of the right to request from the controller access to and rectifica- tion or erasure of personal data or restriction of processing concerning the data subject and to object to processing as well as the right to data portability; (d) where processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; (e) the right to lodge a complaint with a supervisory authority; (f) from which source the personal data originate, and if applicable, whether it came from publicly accessible sources; (g) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 3. The controller shall provide the information referred to in paragraphs 1 and 2: (a) within a reasonable period after obtaining the personal data, but at the latest within one month, having regard to the specific circumstances in which the personal data are processed; (b) if the personal data are to be used for communication with the data subject, at the latest at the time of the first communication to that data subject; or (c) if a disclosure to another recipient is envisaged, at the latest when the personal data are first disclosed. 4. Where the controller intends to further process the personal data for a purpose other than that for which the personal data were obtained, the controller shall provide the data subject prior

228 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 787–790 to that further processing with information on that other purpose and with any relevant further information as referred to in paragraph 2. 5. Paragraphs 1 to 4 shall not apply where and insofar as: (a) the data subject already has the information; (b) the provision of such information proves impossible or would involve a disproportionate effort, in particular for processing for archiving purposes in the public interest, scientiﬁc or historical research purposes or statistical purposes, subject to the conditions and safeguards referred to in Article 89(1) or in so far as the obligation referred to in paragraph 1 of this Article is likely to render impossible or seriously impair the achievement of the objectives of that processing. In such cases the controller shall take appropriate measures to protect the data subject’s rights and freedoms and legitimate interests, including making the information publicly available; (c) obtaining or disclosure is expressly laid down by Union or Member State law to which the controller is subject and which provides appropriate measures to protect the data subject’s legitimate interests; or (d) where the personal data must remain conﬁdential subject to an obligation of professional secrecy regulated by Union or Member State law, including a statutory obligation of secrecy. 4.5.2016 L 119/42 Official Journal of the European Union’.

787. Normally (unless speciﬁed otherwise by the General Practitioner or paediatrician), the information provided concerns data processing operations that are related to those carried out by the concerned general practitioner or paediatrician, being performed by either a professional or another entity, who should be identiﬁ- able on the basis of the service requested and, according to Article 78, anyone who:

(a) temporarily replaces the General Practitioner or paediatrician in question; (b) provides specialized advice at the General Practitioner’s or paediatrician’s request; (c) may lawfully process the data within the framework of a professional partnership; (d) supplies prescribed drugs; (e) communicates personal data to the General Practitioner or paediatrician in compliance with the applicable regulations.

788. Speciﬁc highlights must be offered if processing operations may entail spe- ciﬁc risks for the data subject’s rights and fundamental freedoms and dignity (see Article 78 paragraph 5 see 821).

789. Articles 79 and 80 DPA provide other similar simpliﬁed forms of information mechanisms respectively for public and private healthcare bodies and for services or departments of public bodies working in the sectors of healthcare and/or occupational safety and prevention.

790. Article 82 of the DPA provides an exception to these simpliﬁed mechanisms allowing compliance with information and consent requirements after the relevant service has been delivered ‘in cases of medical emergency and/or related to public hygiene whenever the competent authority has issued a contingent emergency order pursuant to Section 117 of D. Lgs. n. 112 of 31 March 1998’.

Medical Law – Suppl. 119 (2020) Italy – 229 791–794 Part II, Ch. 1, General Description

791. The law (Article 82 DPA) allows post service delivery compliance of information and consent for data processing in additional two instances:

(1) if the data subject is physically impaired, legally incapable or unable to distinguish right from wrong, and the consent cannot be obtained from the entity legally representing the data subject, or from next of kin, a family member, a person cohabiting with the data subject or, failing these, the manager of the institution where the data subject is hosted; (2) if there exists a serious, impending and irretrievable danger for the data subject’s health or bodily integrity.

3. Guarantees with Respect to the Processing of Personal Health-Related Data

792. The previous regulation provided for minimum safety measure. The switch to a system based on accountability has totally changed the landscape. The principle of accountability has introduced a number of general safeguards including the maintenance of a register, the large need of nominating a data protection officer, the need to predispose evidence of ones’ decisions (see above).

793. It can be said that the main changes in the way personal data protection is regulated with the GDPR provide the largest guarantees for personal health-related data. Chieﬂy the overarching principles of privacy by default and privacy by design (Article 25 GDPR). They are deeply embedded with the principle of data minimization require to take ‘into account the state of the art, the cost of implementation and the nature, scope, context and purposes of processing as well as the risks of varying likelihood and severity for rights and freedoms of natural persons posed by the processing’. In doing this, ‘the controller shall, both at the time of the determination of the means for processing and at the time of the processing itself, implement appropriate technical and organisational measures, such as pseudonymisation, which are designed to implement data-protection principles, such as data minimisation, in an effective manner and to integrate the necessary safeguards into the processing in order to meet the requirements’ of the GDPR and protect the rights of data subjects.

4. Rights of the Data Subject

794. In the new EU regulation, an entire Chapter III, articles 12 to 23, is dedicated to the rights of the data subject. In particular: the rights to information are regulated by Articles 12–13–14, the right of access by Article 15, the right of rec- tiﬁcation by Article 16, the right of cancellation by Article 17. These articles have substituted the corresponding norms of the Italian DPA (see D Lgs. 101/2018). Overall, the data subjects have the right in the GDPR to respect the following rights:

230 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 795–795

(1) right to revoke consent (Article 7(3)); (2) right to receive information (Articles 13 and 14); (3) right of access (Article 15); (4) right to rectiﬁcation (Article 16); (5) right to erasure (‘right to be forgotten’) (Article 17); (6) the right to limitation of treatment (Article 18); (7) right to data portability (Article 20); (8) right of opposition (Article 21); (9) the right not to be subject to automated proﬁling (Article 22).

We will only highlight some of their most important features. According to the GDPR, it is appropriate to arrange easy ways for empowering the data subject to exercise the different rights provided for (recital 59). These facilitating modalities may be, for example, organizational or technological means. Also, GDPR requires that if personal data are processed by electronic means, the data controller must use appropriate forms, for instance, on the site. Also, the GDPR requires that if personal data are processed by electronic means, the data controller must provide the data subject with the means to submit requests electronically. With reference to the time of exercise, the GDPR states that once the data subject requests the exercise of his/her rights, the general rule is that the data controller should respond to the data subject’s requests ‘without undue delay and at the latest within one month’ motivating eventually any intention not to accept such requests (recital 59). Similarly, any refusal to comply with data subjects’ requests must be speciﬁcally justiﬁed.

795. More in details patients have the right to obtain conﬁrmation of:

(a) the identity and the contact details of the controller and, where applicable, of the controller’s representative; (b) the contact details of the data protection officer, where applicable; (c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; (d) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (e) the recipients or categories of recipients of the personal data, if any; (f) where applicable, the fact that the controller intends to transfer personal data to a third country or international organization and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable safeguards and the means by which to obtain a copy of them or where they have been made available.

In addition, the following further information necessary to ensure fair and transparent processing must be provided:

Medical Law – Suppl. 119 (2020) Italy – 231 796–798 Part II, Ch. 1, General Description

(a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; (b) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (c) the existence of the right to request from the controller access to and rectifica- tion or erasure of personal data or restriction of processing concerning the data subject and to object to processing as well as the right to data portability; (d) where processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; (e) the right to lodge a complaint with a supervisory authority; (f) from which source the personal data originate, and if applicable, whether it came from publicly accessible sources; (g) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject.

796. Once aware of any personal data that have been processed, data subjects/ patients enjoy the rights enshrined in the EU regulation (Chapter 3). It must be noted that the GDPR has introduced new data subjects’ rights that can play a role in dealing with health matters. It is certainly the case of the right to portability and to object to solely automated data processing (Article 22). The right to data portability is a new right provided for in the European regulation. It applies only to automated processing based on consent or contractual necessity, and there are specific conditions for its exercise. Pursuant to Article 22 GDPR ‘The data subject shall have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her.’

797. Finally a data subject has the right to object, in whole or in part. The right to object to the processing is one of the instruments of protection currently governed by Regulation 2016/679 (Article 21). It is not a general remedy as it was before in Italy76 but applicable only to speciﬁc hypotheses, substantially united by the fact that the person concerned by the processing to which the data refer has not (had) a say in the processing itself. It is subject to the non-prevalence of ‘legitimate compelling reasons for processing which prevail over the interests, rights and freedoms of the data subject’ or that the processing serves for the establishment, exercise or defence of a right in court.

798. The aforementioned rights can be exercised personally.

76. On this point the ECHR, M.S. c., expressed its opinion). Sweden, No. 20837/92, 27 August 1997; ECHR, Leander v. Sweden, No. 9248/81, 26 March 1987; ECHR, Mosley v. the United Kingdom, No. 48009/08, 10 May 2011.

232 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 799–803

799. The request related to the exercise of the information rights referred to in Article 7(1) and (2) (see 795–797) may also be made verbally. Either a person in charge of the processing or the data processor must write it down in summary fashion.

800. In line with the general rules of private law the patient may grant, in writing, power of attorney or representation to natural persons, bodies, associations or organizations in connection with the exercise of the rights in question. Please note that the repealed Article 9 DPA provided expressly for this possibility that is not excluded in principle by private law rules.

801. Data subjects should not incur any cost in the exercise of their rights. How- ever, ‘Where requests from a data subject are manifestly unfounded or excessive, in particular because of their repetitive character, the controller may either: (a) charge a reasonable fee taking into account the administrative costs of providing the information or communication or taking the action requested; or (b) refuse to act on the request’ (Article 12, paragraph 5, GDPR).

802. Limitations to these rights (including the right to lodge a complaint to the Data Protection Authority) exist for speciﬁc cases of national relevance as provided today by Regulation 2016/679 and the new Article 2-undecies DPA. The rights referred to in articles 15 to 22 of Regulations 2016/679 may not be exercised with a request to the data controller or with a complaint pursuant to article 77 of the Regulations if the exercise of such rights may result in actual and concrete damage:

(a) the interests protected in accordance with the provisions on money laundering; (b) interests protected under the relevant provisions to support victims of extortion claims; (c) the work of parliamentary committees of enquiry established under Article 82 of the Constitution; (d) activities carried out by a public entity, other than public economic entities, on the basis of an express legal provision, for monetary policy purposes only, the payment system, the control of intermediaries and the ﬁnancial markets and the protection of their stability; (e) the conduct of defensive investigations, or the exercise of a right in court; (f) the conﬁdentiality of the identity of the employee who reports to pursuant to Law no. 179 of 30 November 2017, the illegal act of which he became aware by reason of his office.

803. Nevertheless, in several of the above-mentioned cases, the Data Protection Authority, also following a report submitted by the data subject, can exercise powers of enquires and of requests for information and production of documents provided by Articles 157, 158, 159 and 160 DPA.

Medical Law – Suppl. 119 (2020) Italy – 233 804–806 Part II, Ch. 1, General Description

5. National and Regional Electronic Data Records

804. The regulation of electronic data records is a shared competence between the State and Regions. Therefore regional regulations must comply with general principles. It seems to us that a full right to medical health records seems to emerge in light of the shift to electronic form in conformity also with EU regulations on the matter. Electronic Health Records are at the centre of the EU strategy for cross- border patients’ rights. Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare purported that personal health data should be able to ﬂow from one Member State to another so as to ensure continuity of care (see Article 4 (f) and 5 (d) Directive 2011/24/EU implemented by Article 5 paragraph 5 of D Lgs 38/2014).

805. The so-called EU Article 29 Working Group deﬁnes an EHR as follows: ‘a comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form and providing for ready availability of these data for medical treatment and other closely related purposes’ (Article 29 Data Protection Working Party, 2007). Similarly, the Italian Data Protection Authority has issued public consultation on Electronic Data Records, and in 2009, it established guidelines on EHRs aimed at protecting citizens’ privacy (Garante per la protezione dei dati personali, 2009). These privacy guidelines were further bolstered by national Guidelines on EHRs by the Health Department (Ministero della Salute, 2011).

806. Bearing in mind that the regulating of EHR is a shared competence between the State and Regions, and along the lines set by the Italian Data Protec- tion Authority, the Italian Ministry of Health prepared a document containing national Guidelines for the creation of a system of EHR (entitled ‘Guidelines for the use of an electronic system for clinical documentation in medical imaging’), which was published in the G.U. no. 50 of 2 March 2011 after the Memorandum of Understanding sanctioned by the State-Regions Conference of 10 February 2011. The implementation of the Guidelines by the Regions will be under the scrutiny of the Standing Committee for veriﬁcation of the LEA, pursuant to Article 9 of the State-Regions Agreement of 23 March 2005. This arrangement illustrates the strategic role attributed to e-health and EHR. Nevertheless, while some regional systems are quite well developed (e.g., Lombardy,77 Emilia-Romagna78 and Tuscany79) the interconnectivity of EHRs is not yet a reality at the national level. The state of the art reveals that the Italian system is running behind in dealing with these issues and signalling even a lack of awareness concerning potentialities and concerns in electronic health records.

77. See SISS: www.siss.regione.lombardia.it. 78. See SOLE, Sanità On Line: www.progetto-sole.it. 79. See www.regione.toscana.it/cartasanitaria.

234 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 807–810

6. Privacy or Other Concerns Related to Electronic Health Record Systems EHRS (Fascicolo Sanitario Elettronico, FSE)

807. The current legislation on the Electronic Health File (FSE) and that relating to the processing of personal data with reference to what is defined by the DPA is very patchy. It includes: Article 12, Law Decree no. 179 of 18 October 2012 ‘Fur- ther urgent measures for the growth of the country’; Law Decree no. 69 of 21 June 2013 ‘Urgent measures for the revival of the economy’; Prime Ministerial Decree no. 178. of 29 September 2015 ‘Regulation on the electronic health record’; the GDPR; Decree of 4 August 2017 ‘Modalities’ techniques and telematics services made available by the national infrastructure for the interoperability of the electronic health record (FSE) referred to in Article. 12, paragraph 15-ter of Decree- Law 18 October 2012, n. 179, converted, with amendments, by law 17 December 2012, n. 221’; Decree of 25 October 2018 ‘Amendment of the Ministerial Decree of 4 August 2017, concerning the technical methods and telematics services made available by the national infrastructure for the interoperability of the electronic health file (FSE)’. Against this backdrop, Article 12 of Decree 18 October 2012 no. 179, introduced a definition of ‘Fascicolo Sanitario Elettronico’ (FSE/EHR) establishing the scope, the controllers and the recipients of health data processing. It defines EHR as ‘The set of health and social-health data and digital documents generated by present and past clinical events related to a patient.’

808. The need to avoid a discriminatory use of EHRs may lead, as conﬁrmed by the EHR Italian Data Protection Authority Guidelines, to prohibited access, irrespective of the patient’s consent, for, potential insurers and employers. Such a prohibition may be set against the possible use of access to such market players, for example in order to avoid unnecessary medical tests prior to new employment or for issuing an insurance policy. A total ban on access might result in an excessive and unjustiﬁed limitation of personal freedom. Yet, this limitation to the principle of consent seems in line with the very role of consent according to the Italian Data Protection Code (Law no. 196/2003).80

809. Furthermore, precluding access to EHRs for insurers and employers is consistent with the aims of EHRs in that they, according to the Italian DPA Guidelines, ‘may be connected exclusively with the ﬁnalities of the interested parties’ treatment’.

810. However, it has been suggested that individuals may ask their general practitioner to extract81 from their EHR those medical records they want to communicate to an insurer/employer. Yet, this praxis would have the effect of permitting

80. See, for instance, Art. 20, according to which consent is neither a necessary nor sufficient condition for processing sensitive data. 81. Such possibility is admitted by Art. 29 Data Protection Working Party, Working Document on the processing of personal data relating to health in electronic health records (EHR), WP 131, 15 Feb. 2007, p. 19.

Medical Law – Suppl. 119 (2020) Italy – 235 811–814 Part II, Ch. 1, General Description reverse discrimination on the assumption that undisclosed data conceal existing illnesses thereby putting undue pressure on data subjects to actually reveal all available data on health, completely bypassing the public policy concerns sustaining the ban on access for insurers and employers.

811. Finally, we must mention the possibility of illegal access to EHRs. As a matter of fact, technology applied to data security can reduce these risks but cannot avoid them entirely. Nevertheless, the protection of EHR security is a key element for any successful implementation because it is a condition of the social reliability and acceptability of EHRs. Several procedures and (rights) are affected by the digitalization of medical records. Recent legislation (the so-called Balduzzi reform reaffirms it), for instance, led to the imposition of a system (after experimentation in 2011) according to which medical certiﬁcates are electronically transmitted by NHS physicians to the Italian Social Security Institute (INPS), and by the latter to both private and public sector employers.

812. Article 7 of Legislative Decree 38/2014 established the National Contact Point for cross-border assistance. The last paragraph (8) of the provision states that ‘8. The Ministry of Health shall activate the necessary procedures to ensure that the information referred to in this article is easily accessible and made available electronically on the portal of the Ministry of Health and in formats accessible to persons with disabilities.’

813. In a similar way, pursuant to Article 11, paragraph 16, of Decree 78/2010 (approved and amended by Law no. 122 of 30 July 2010) the Ministry of Health and the Ministry of Economy and Finance adopted the Decree of 2 November 2011, and relevant technical speciﬁcations, published in the G.U. no. 264 of 12 November 2011. These legal norms set down the technical procedures for the use of an electronic system for paper-based medical prescriptions within the NHS and the Health- care Services for Seafaring and Flight Personnel (Servizi Assistenza Sanitaria Naviganti, SASN). The implementation of the provisions of the aforementioned DM is left to the distribution plans that were to be signed by individual Regions by Sep- tember 2012.

814. To be more speciﬁc, the processing of personal data in non-electronic form or via EHRs (or Health Files (HF)) is aimed towards prevention, diagnosis, care and/or rehabilitation and must be compliant with the self-determination principle (sections 75 of the Data Protection Code DPA). Accordingly, every data subject should freely decide whether an EHR/HF should be set up by including the medical information concerning them, or whether their medical records should only remain available to the healthcare professional/body that drafted them without being necessarily fed into EHRs and/or HFs or other networking forms (see Guidelines on the Electronic Health Record and the Health File as published in Italy’s Official Journal no. 178 dated 3 August 2009).

236 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 815–818

815. In line with the above ‘Regardless of whether the clinical information relates to past or current clinical events, the data controller must enable data subjects to exercise their blanking rights both prior to including that information and thereafter’ (Guidelines on the Electronic Health Record and the Health File, paragraph 3).

816. The principle of consent for EHR is confirmed by the guidelines concerning legally incapacitated persons, for whom ‘the necessary consent should be given by the person(s) exercising parental authority. Once the data subject becomes of age, his/her explicit consent should be obtained anew by the data controller since (implicit) confirmation of the consent provided by the respective parents is not enough (see Article 82(4) of the DPA). The consent in question may also be given when the data subject that has become of age first gets in touch with the data controller for healthcare purposes. This is obviously without prejudice to the ex-post provision of consent in emergency cases and/or to protect the person’s health and/or physical integrity (see section 82 of the Data Protection Code)’. In short, the data subject must give two consents:

(1) consent to the feeding of the ESF, required to include in the ﬁle the data and documents relating to the services provided to the data subject; and (2) the consent to the consultation of the ESF, required to make the ﬁle accessible to health professionals who will take care of the data subject. In the absence of such consent, the FSE may only be used for purposes of government and research, however, adopting precautions that do not allow you to directly trace the identity of the data subject.

7. Special Cases a. Prescriptions 817. The medical prescription is a written document, drawn up by a physician- surgeon (i.e. graduated in medicine and surgery, qualiﬁed to practise the profession and enrolled in the professional register), which allows the patient to obtain from the pharmacist the delivery of medicines listed therein. The prescription of medicines is a typical and exclusive activity of the physician.

818. In the Italian legal system, there are different prescriptions. The ‘white recipe’ can be reused by the patient, while the one that allows for payment from the NHS cannot be reused and it requires the use of a speciﬁc form. Differently from the ‘white recipe’, it can only be ﬁlled in by doctors who are employed by or affiliated with the SSN. The prescription to be paid by the SSN, being produced by a physician employed or affiliated with the SSN, has the legal nature of a public act and the prescribing physician assumes the status of public official (employee physician) or public service appointee (affiliated physician by a convention), with very harsh penalties in the event of falsehoods.

Medical Law – Suppl. 119 (2020) Italy – 237 819–823 Part II, Ch. 1, General Description

819. The so-called limitative prescription is the one prescribing medicines whose use is limited to the hospital environment and that show on the package the words: ‘Use reserved for hospitals. The sale to the public is prohibited.’ It is also a ‘limitative’ recipe that prescribes drugs that can be sold to the public, but only under the therapeutic plan of hospital centres or special categories of specialized doctors. Finally, it is also a ‘limitative’ prescription that concerns medicines that can only be used by the specialist physician during the outpatient examination. The prescription for narcotic drugs is the prescription prescribing medicines for which the law on the regulation of narcotic drugs and psychotropic substances provides speciﬁc methods for their distribution and prescription. These are drugs based on the following substances: buprenorphine, codeine, dihydrocodeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone and oxymor- phone that are used for the control of pain in patients with serious diseases.

820. 820. Specific privacy rules are provided by the Italian DPA (Article 89-bis). It states as a general principle that ‘for prescriptions of medicinal products, where it is not necessary to enter the name of the person concerned, special precautions are taken in relation to the provisions of the DPA in the safeguards measures referred to in Article 2-septies [Safeguards measures for the processing of genetic, biometric and health-related data], including for the purposes of checking the correctness of the prescription or for administrative purposes or for purposes of scientific research in the field of public health’. b. Processing of Genetic Data and Data Relating to Bone Marrow Donors (Article 90 DPA) 821. For genetic data, the reference provision is the GDPR whose Article 9 prohibits the processing of genetic data except for the exceptions of paragraph 2. Pur- suant to Article 10 of the renewed DPA, the processing of genetic data is permitted in the cases provided for in ad hoc authorizations granted by the Data Protection Authority.

822. It is also permitted (Article 2-sexies DPA) for specified reasons of public interest. c. Data Processed by Means of Cards (Article 91 DPA) and Data Banks or Registers of the NHS 823. Particular attention is provided to the processing, in whatever form, of data disclosing health and sex life information. This applies also to data stored on cards (including non-electronic cards and the national services card) or processed by means of the said cards. This processing is subject to a strict observance of the necessity principle (Article 2-septies DPA and Articles 5 and 25 GDPR: Data Mini- mization Principle) according to which information systems and software must be respectively configured by minimizing the use of personal data and identification

238 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 824–829 data, in such a way as to rule out their processing if the purposes sought in the individual cases can be achieved by using either anonymous data or suitable arrangements to allow identifying data subjects only in cases of necessity.

824. Article 94 DPA (devoted to data banks, registers and ﬁling systems in the Healthcare Sector) has been repealed by D. Lgs. n. 101/2018. It stressed the need to abide by the minimization principle in relation to the processing of data disclosing health information as contained in data banks, ﬁling systems, archives or registers kept by entities in the healthcare sector.

825. Clearly in the new framework provided for by the GDPR and the strict reference to the principles of privacy by design and by default as cornerstones of the personal data protection, those speciﬁc rules were redundant.

C. Duty of Medical Secrecy

1. General Principle

826. Physicians’ activity is aimed at the prevention, care and rehabilitation of a person’s health state. The main obligations imposed by law on their activities are:

(a) to report to the legal authority, within twenty-four hours, all the cases to which she dealt with that could potentially present an indication of a criminal offence (obligation provided for in Article 365, Criminal Code); however, this provision does not apply when the report would expose the assisted person to criminal prosecution; (b) to report to the Mayor the causes of death within twenty-four hours from the death certificate; (c) to report, within two days after confirmation, the abortion cases she dealt with and also those she became aware of in the course of exercising her profession; (d) to report infectious and widespread diseases, verified or suspected ones, and report all facts that could be important to public health.

827. Article 622 of the Criminal Code (entitled Revelation of Professional Secrecy) punishes – if harm can result from the fact – with imprisonment of up to one year or a ﬁne between EUR 30 and EUR 516 ‘anyone who reveals information -acquired by reason of her status or office, or of her profession or art – without just cause or uses it to beneﬁt themselves or others’.

828. The crime is prosecuted on complaint of the victim.

829. In addition, pursuant to Article 21, Law 22 May 1978, no. 194 concerning the protection of maternity and on abortion ‘Whoever -apart from cases governed by Article 326 c.p. – becomes aware of information by reason of profession or office and subsequently reveals the identity – or otherwise disseminates information likely

Medical Law – Suppl. 119 (2020) Italy – 239 830–834 Part II, Ch. 1, General Description to reveal the identity – of those who made use of the procedures or interventions provided by this Act, shall be punished in accordance with Article 622 Criminal Code.’

830. The CME (Article 10) reﬂects these principles. It obliges the physician to keep secret all that is conﬁded in her or all that she becomes aware of in the exercise of her profession. Not even the death of the patient or cancellation of member- ship of the profession on behalf of the physician relieves physicians from the moral obligation of secrecy.

831. Indeed Article 10 CME states:

The physician must keep secret all that is confided in or of which she becomes aware in the exercise of her profession. The death of the patient does not exempt the physician from the obligation of secrecy. The physician has to inform her employees of the obligation of professional secrecy. Failure to comply with medical confidentiality constitutes serious misconduct which may arise when it leads to their own profit or that of others or to harm for the patient or others.

However, the revelation of professional secrets is accepted (Articles 10) ‘if jus- tiﬁed by a just cause provided for by law or by the fulﬁlment of a legal obligation’. See also 836ff.

2. Exceptions a. Testimony in a Court or Before a Parliamentary Committee 832. Physicians and surgeons, pharmacists, midwives, and any other operator involved in the health profession and generally anyone sworn to professional secrecy, except in cases in which they have an obligation to report to the court, are not required to testify in court on matters covered by professional secrecy (Article 200 cpp, and Article 10 CME).

833. However, if the judge has reason to doubt that the statement made by such persons to exempt themselves from giving evidence is unfounded, all necessary investigations can be carried out. If it is indeed unfounded, an order can be made to the effect that the professional must testify. b. Statutory Obligations to Disclose Conﬁdential Information 834. Those health professionals listed in Article 200 cpp must immediately deliver to the court, when requested, any acts or documents, eventually also in the original copy, and everything else considered relevant by reason of their office, appointment, ministry, profession or art, unless they declare in writing that it is a state secret or secret inherent to their obligations by virtue of their profession (Article 256 cpp).

240 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 835–841

835. Where the declaration relates to professional secrecy, the court shall, if it has reason to doubt the validity of it and believes that it could not proceed without acquiring the records, documents or sources of information referred to supra (see 834), establish the necessary investigations. If the statement is groundless, the court shall have seizure. See also 826.

3. Notiﬁcation of Criminal Acts

836. Any person, who, while exercising a health profession, becomes aware of a criminal offence that can be prosecuted ex officio, is obliged to report it to the judicial authorities. When this rule does not apply, professional secrecy (Article 622 cp and Code of Ethics) and the protection of privacy apply (GDPR and the Italian DPA as subsequently amended) meaning that physicians are obliged not to disclose information on a patient’s health or her sensitive data. The violation of professional secrecy involves both criminal penalties (imprisonment) and civil damages.

837. However, a duty to report (notify) criminal acts derives from the following articles of the Criminal Code (Title III Chapter I Crimes against Judicial Activity).

838. Article 361, entitled Failure to Report a Crime by a public official, states that ‘A public official who neglects or delays to report to the court, or other authority to which she has the duty to report, a crime of which she gained knowledge in the exercise of or because of her functions, shall be punished with ﬁne ranging from EUR 30 to EUR 516.’

839. The penalty shall be imprisonment of up to one year, if the offender is an officer or a judicial police officer, in possession of information regarding a criminal offence, which she was obliged to report. The preceding provisions shall not apply in the case concerning an offence prosecutable on complaint by the victim.

840. Article 362, Failure to Report by Public Service Providers, stipulates that:

The person in charge of a public service who fails or delays to report a crime, of those indicated in the previous article of which she has gained knowledge by reason of her service, to the authority shall be punished by a ﬁne of up to ¤103.

This provision does not apply in the case of an offence punishable on complaint by the injured party, nor shall it apply to the person in charge of socio-therapeutic- rehabilitation communities for offences committed by drug addicts entrusted to them in the implementation of the programme deﬁned as a public service.

841. Article 365, Failure to Report, speciﬁes that:

Whoever in the exercise of a health-related profession or employment has rendered their assistance in cases that may present the characteristics of a crime

Medical Law – Suppl. 119 (2020) Italy – 241 842–847 Part II, Ch. 1, General Description

for which one should proceed ex offıcio, omits or delays to report to the authority that referred to in Article 361 shall be punished by a ﬁne of up to ¤516.

This provision shall not apply when the report would expose the assisted person to criminal prosecution.

842. Article 378 concerns Aiding and Abetting and states that ‘Anyone … who helps someone to elude the investigations of the Authority, including those carried out by the organs of the International Criminal Court, or to escape from investigations carried out by the same, shall be punished with imprisonment of up to four years.’

843. Article 384, Cases of Non-Punishment, speciﬁes that ‘in the cases provided for in Articles 361, 362, … , 365, … , 378’, those who have committed a crime having been forced to do so based on the necessity to save themselves or a next of kin from risks of serious and unavoidable harm to freedom or honour shall not be punished.

844. A public officer is any person who exercises a public legislative, judicial or administrative authority, with authoritative powers and certiﬁcation authority. A public service officer is anyone who, for whatever reason, provides a public service with the exception of simple tasks and merely material performances. Examples of a public officer include public employees such as physicians, psychologists, biolo- gists, veterinarians, etc. Examples of a person charged with a public service, however, include the medical practitioner holding an agreement with the NHS.

845. Freelance professionals can also be public health servants or public service officers when assisting privately. Please note that the notion of public officer is still discussed in Italian criminal law.

846. The physician, when assisting a patient under her agreement with the NHS, is a public service officer, and when she visits privately, she is considered a freelancer. When assisting a patient as part of her civil service, a physician is considered a public official. While, when assisting privately (so-called freelance intramoenia activity), although in the public hospital facility, she is a freelancer. A medical doctor or a psychologist when assisting a patient in a private facility accredited and under contractual arrangements with the NHS is in charge of a public service.

847. In short, when acting as a freelance, a physician has no duty to notify to the Authority if the report:

(a) exposes the patient to criminal proceedings; (b) exposes herself or a relative to harm.

242 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 848–852

Another cause for exemption is if the physician failed to report forced by necessity to save himself or a close relative from a serious and unavoidable harm to freedom or honour (see supra 843).

848. The main offences prosecutable ex officio affecting the business of healthcare professionals (see 841) forcing a duty to report are crimes against life (e.g., murder, voluntary and negligent manslaughter, death as a result of another crime, incitement and assisted suicide pursuant respectively to Articles 575, 584, 589, 579, 586, 580 of the Criminal Code) and crimes against individual safety. Among the latter, are serious intentional personal injuries (e.g., either certainly or probably causing an incurable illness, loss of a sense, loss of a limb or mutilation rendering the limb useless, loss of use of an organ, loss of ability to procreate, deformation or permanent disﬁgurement of the face, abortion, female genital mutilation, such as clitoridectomy, excision and inﬁbulation pursuant to Article 582 of the Criminal Code); intentional injuries from which a disease lasting longer than twenty days is derived (Article 582 of the Criminal Code); aggravated intentional personal injury (e.g., that considered life-threatening or illnesses lasting more than forty days,); aggravated negligent personal injuries, if committed in violation of the rules for the prevention of accidents at work or if it affects hygiene in the workplace or causes occupational diseases (Article 590 Criminal Code).

849. Other relevant crimes requiring reporting include: crimes against personal freedom: kidnapping (Article 605 Criminal Code), sexual assault by a group (Article 609octies Criminal Code, in the speciﬁc provisions of Article 609septies Criminal Code); crimes against devotion to the dead: defamation of a corpse (Article 410 Criminal Code), destruction, removal or theft of corpses (Article 411 Criminal Code), concealment of a corpse (Article 412 Criminal Code), unlawful use of cadaver (Article 413 Criminal Code); the interruption of pregnancy in violation of the Law of 22 May 1978 194, or of speciﬁc provisions contained therein.

850. For instance, if a freelance medical professional or psychologist in assisting a patient becomes aware that the patient has sexually abused a child, she is not required to notify, because notifying would expose the patient to criminal prosecution. Instead, a physician or psychologist, assisting a patient in a public facility, who learns that the patient has sexually abused a child is always obliged to report such an incident.

851. Finally, a physician or a psychologist, assisting a patient as freelancer, who learns that the patient was sexually abused must report because notifying the crime does not expose the patient to criminal proceedings as a victim of a crime committed by another person.

852. Note, however, that professionals who report beyond their duties causing undue damage to their clients, may be responsible for violations of professional secrecy. See also 826.

Medical Law – Suppl. 119 (2020) Italy – 243 853–856 Part II, Ch. 1, General Description

4. Consent of the Patient or Waiver

853. Article 12 of the CME establishes that ‘The physician may process sensitive data suitable for disclosing the state of health of the person only with the informed consent of the same or its legal representative and in the speciﬁc conditions provided for by law.’ However, this ethical norm is at odds with the new data protection regulation for which consent for processing health data is not required if ‘processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3; (i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and speciﬁc measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy’ (Article 9 lett. h and I GDPR). A limited abandonment of the duty of secrecy with consent of the patient or if (Article 12 CME) ‘processing is necessary to protect the vital interests of the data subject or of another natural person where the data subject is physically or legally incapable of giving consent (Article 9 lett. c GDPR)’ is possible. In the latter situation, however, permission must be obtained for any legal representative where previously appointed. The same exception is granted only to the extent, in the manner and with the exceptions established by law in cases concerning the refusal of patients ‘where there is the urgent need to safeguard the life or health of others’.

5. Deliverance of Medical Certiﬁcates to Third Parties

854. The medical certiﬁcate is the most common form of documentation of medical activity. It is a written testimony on facts and behaviours technically appreciable and measurable, production of which can yield particular entitlements and/or individual rights provided for by law. It can also determine speciﬁc consequences to the individual and society, which are relevant in legal and/or administrative terms.

855. The legal nature of the certiﬁcate may fall into one of three categories:

(1) a public deed drawn up by mandatory certiﬁcation; (2) an administrative certiﬁcate issued in the exercise of public functions; and (3) a private deed drawn up by a freelance professional. Accordingly then, the physician is not acting in her public function capacity.

856. Indeed, the certificate is intended to give legal significance to the facts that he medical doctor has ascertained. The certification of any condition must always

244 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 857–860 be preceded by a clinical evaluation of the patient. The Code of Ethics requires the physician to draw up the certificates only with statements that are derived from direct observations. It is important to remember that the clinical data must be kept distinct from the symptoms complained of or those reported by the patient. Medical certificates can also attest some key events in the life of an individual, such as birth and death, when the physician supplying the certificate was present for these events.

857. Pursuant to Article 24 CME, ‘The physician is required to issue to the assisted person certificates relating to the state of health that attest in a timely and diligent manner the anamnestic data collected and/or the clinical findings directly established or objectively documented.’ Also note that it may constitute a failure of official acts if physicians, who are public officials or charged with public service, refuse to give certificates (see 768ff).

858. The General Practitioner in the exercise of public functions (DPR 270/ 2000) has been recognized by case law, in relation to criminal law, as a public official (Article 357 Criminal Code) or a person charged with a public service (Article 358 cp). In exercising freelance activity, the physician qualifies as a service provider of public necessity (Article 359 cp) for which the Criminal Code provides for penalties less severe in cases concerning crimes committed in the preparation of a medical certificate. The distinction between public deed (Article 2699 cc) and administrative certification was clarified by judgment no. 257 of the Cass. 3 July 1989. The distinction is relevant in relation to the seriousness of the crime concerning the preparation of public deeds according to which the punishment relates. Accordingly, the public deed attests to facts known by the physician with public functions or to facts that occurred in her presence (e.g., certifications based on regional prescription book of diagnostic tests; death certificate and identification of causes; certificate of fitness to drive motor vehicles; certificate of suitability to carry firearms).

859. In administrative certification, however, the physician performing public functions certifies facts detected or acquired during the course of her professional activities (i.e. certificates of fitness to practise competitive sports). It should be noted that both the public deed and the administrative certification are based on the precondition that the physician will draw them up in exercising functions of a public official (Article 357 cp) or while charged with a public service (Article 358 cp).

860. The issuance of the certificate to strangers including information related to circumstances –circumstances that the patient does not wish to be disclosed – may constitute a ‘revelation on professional secrecy’ (see 826ff). The contents of the medical certificates are covered by professional secrecy pursuant to Article 10 of the Code of Medical Ethics. The content of the certification must state only what the patient allows to be disclosed in respect of privacy and professional secrecy, but of course within the limits of truth, clarity and completeness of the facts. The violation of the secrecy, without just cause, is punishable according to Article 622 Criminal Code if performed by a physician during her freelance profession. It is punishable

Medical Law – Suppl. 119 (2020) Italy – 245 861–864 Part II, Ch. 1, General Description more severely by Article 326 Criminal Code if committed by a physician in her public function capacity. It should be noted that where certificates are issued to entities other than the patient without acquiring prior consent, a form of breach of professional secrecy and privacy might arise. In line with the above, for instance, the sickness certificates can be consulted and downloaded online through the web portal www.inps.it (pursuant to Article 55-septies of D. Lgs. n. 165 of 30 March 2001, as amended by D. Lgs. n. 75 of 25 May 2017). In the event of sickness, the worker is no longer required to hand over a copy of the sickness certificate to the employer, but must simply contact his physician and notify the employer of his absence and an address for his/her availability. The physician fills in the telematic certificate on behalf of the worker and forwards it, through a special system, to the INPS. The Institute, through its web portal, makes available, both to workers and employers, the certificates and statements of sickness received. The employer can only view the worker’s statement of illness, a document that contains all the data of the certificate excluding the diagnosis. The worker, however, has the opportunity to view both the certificate and the medical statement including all the data relating to the disease.

D. Medical Fees

1. Right to Fees or Remuneration for Services

861. The general principle governing professional remuneration is that in each case the extent of the remuneration shall be appropriate to the work and the dignity of the profession. Article 2233 of the Civil Code clariﬁes that ‘The remuneration, in cases where it has not been agreed between the parties and cannot be determined according to the rates or usual practice, is determined by a judge after hearing the opinion of the professional association to which the professional belongs.’

2. Amount of the Fee

862. The so-called Tariff Act, 244 of 21 February 1963, established a national minimum rate determined by Decree of the President of the Republic, by the Min- ister of Health, after hearing the opinion of the FNOMCEO. It had to be revised every ﬁve years. It had to set the fee depending on the importance and delicacy of performance. Provincial orders were given the power to increase (or decrease), by up to a maximum of 30%, the national rate according to the particular local situation.

863. Article 2, lett. a of Act 248 of 4 August 2006, 4 July 2006 approved by Decree-Law 223 has abolished all tariffs. As a consequence, the general principles apply (see 861).

864. The CME (Article 54 as modiﬁed again in 2016 dealing with professional fees) maintains the principle of mutual agreement between patient and professional requiring that ‘The physician, in pursuing the dignity of professional practice and

246 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 1, General Description 865–870 the principle of preventive agreement, measures the fee to the difficulty and complexity of the professional work, the skills required and the means employed, while protecting the quality and safety of the service. The physician shall inform the person assisted in advance of the fee, which may not be subordinated to the results of the professional service.’

865. Medical doctors are required to inform the patient in advance about the fees for their professional services. They cannot be subject to performance results.

866. Even though physicians may, in certain circumstances, provide their services free of charge, this conduct must not constitute unfair competition or unlawful canvassing.

867. Fees for services provided for by physicians in their freelance profession within a public facility (so-called intramoenia) are set out in detail by the ASL or AO (in the programme of governance, see 63 supra) facilitating the dividing-up of the fee paid by the patient between the professional and the public healthcare facility. Similar private agreements exist in cases of professionals working together in an incorporated organization consisting of partners. These agreements must be noti- ﬁed to the pertinent Provincial Board (Article 65 CME). See 63, 151, 214.

3. Fee-Splitting

868. Any form of ‘comparaggio’ (for instance, fee-splitting by a general practitioner regularly referring patients to a specialist) is prohibited (see Article 31 of the CME) since it impairs the professional freedom of the physician and puts patients at risk. The physician should avoid any condition in which professional judgment concerning the primary interest, i.e., the health of citizens, may be unduly inﬂuenced by a secondary interest, i.e., both economic and non-economic (see Article 30 CME).

869. However, lawful reception of part of a physician’s fees by the healthcare facility she works for in return for services is considered lawful fee-splitting which is even regulated in case of intramoenia activities (see supra 173, 252, 867).

E. Unlawful Enrichment

870. Several laws (criminal and civil) prohibit undue relationships or agreements with third parties (e.g., pharmaceutical companies or individuals) that might lead directly or indirectly to proﬁtable situations for the physician if, for instance, she repeatedly prescribes particular drugs or uses particular medical devices, for instance, repeated use of a particular type of prosthesis.

Medical Law – Suppl. 119 (2020) Italy – 247 870–870 Part II, Ch. 1, General Description

Reference 4

In addition to sources previously quoted please see also for this part: F. Albeggiani, Profili problematici del consenso dell’avente diritto, Milano, Giuffrè, 1995. M.E. Arbour, La regolazione dei farmaci ad uso umano in seno all’UE al crocevia della salute e del mercato, in G. Comandé (a cura di), Gli scrumenti della precauzione: nuovi rischi, assicurazione e responsabilità, Milano, Giuffrè, 2006, 428–438. S. Barison, Assicurazioni sanitarie e test genetici in Italia e negli Stati Uniti: affınità materiali e differenze giuridiche fondamentali,inRiv. dir. civ., 2000, I, 143 ss. M. Bessone-G. Ferrando, voce ‘Persona fisica (dir. priv.)’, in Enciclopedia del Diritto, XXXIII, Milano, Giuffrè, 1983, 193ff. G. Berlinguer-V. Garrafa, La merce finale. Saggio sulla compravendita di parti del corpo umano, Milano, Giuffrè, 1996. M. Barni, Diritti, doveri, responsabilità del medico. Dalla bioetica al biodiritto, Milano, Giuffrè, 1999. F.D. Busnelli, Commentario alla legge 22 maggio 1978, n. 194. Norme per la tutela sociale della maternità e sull’interruzione volontaria della gravidanza (con C.M. Bianca), in NLCC, 1978, 1595ss. F.D. Busnelli-E. Palmerini, voce ‘Bioetica e diritto privato’, in Enciclopedia del Diritto, Aggiornamento, V, Milano, Giuffrè, 2001, 149. F. Busnelli-E. Palmerini, voce ‘Clonazione’, in Digesto IV ed., Disc. priv., sez. civ., Aggiornamento, I, Torino, Utet, 2000, 142ff. F.D. Busnelli, Problemi giuridici di fine vita tra natura e artificio,inRiv. dir. civ., 2011, 153ff. F.D. Busnelli, Il caso Englaro in Cassazione,inFamiglia, persone e successioni, 2008, 966ff. F.D. Busnelli, Cosa resta della Legge 40? Il paradiso della soggettività del con- cepito, in Riv. dir. civ., 2011, I, 153ss. F.D. Busnelli, La sorte degli embrioni in prospettiva bioetica e nella Legge 40, in Prefazione a La famiglia e il diritto fra diversità nazionale e iniziative dell’Unione Europea, a cura di D. Amram e A. D’Angelo, CEDAM, Padova, 2011, Ixss. S. Cacace, I danni da mancato consenso informato (nota a Cass. 9.2.2010 n 2847) in Nuova giur. Civ. comm., 2010, I, 790. S. Cacace, Informazione, consenso e rifiuto delle cure, in G. Comandé (a cura di), Diritto privato europeo e diritti fondamentali. Saggi e ricerche, Torino, Giap- pichelli, 2004, 77ff. Canestrari S. – Ferrando G. – Mazzoni C. M. – Rodota’ S. – Zatti P. (edts), Il governo del corpo, in Trattato di Biodiritto diretto da S. Rodotà E P. Zatti, Giuffrè, Milano, 2011. C. Casonato, Introduzione al biodiritto, Torino, Giappichelli, 2009. I. Cavicchi, La medicina della scelta, Torino, Bollati Boringhieri, 2000. P. Cendon, Il prezzo della follia. Lesione della salute mentale e responsabilità civile, Bologna, il Mulino, 1984. P. Cendon, I malati terminali e i loro diritti, Milano, Giuffrè, 2003.

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L. Chieffi, Ricerca scientiﬁca e tutela della persona, Napoli, ESI, 1993. G. Comandé – Gianclaudio Malgieri (edts), Guida ragionata per il trattamento e la sicurezza dei dati personali in Italia, Il Sole 24 ore, 2019. G. Comandé, Ricerca in sanità e data protection un puzzle … risolvibile,inRivista Italiana di Medicina Legale, Anno XXXV Fasc. 1 – 2019, 183–203. G. Comandé, G. Schneider, ‘Regulatory Challenges of Data Mining Practices: The Case of the Never-ending Lifecycles of ‘Health Data’’(2018), in European Jour- nal of Health Law, Volume 25, Issue 3, pages 284 – 307 G. Comandé, G. Malgieri, ‘Sensitive-by-distance: quasi-health data in the algorith- mic era’ (2017),inInformation & Communications Technology Law, Vol. 26, Iss. 3, pp. 229–249. G. Comandé. Malgieri, ‘Why a Right to Legibility of Automated Decision-Making Exists in the General Data Protection Regulation’ (2017), in International Data Privacy Law, Volume 7, Issue 4, Pages 243–265). M. Dogliotti, La potestà dei genitori e l’autonomia del minore, in Trattato Cicu- Messineo, Milano, Giuffrè, 2007. E. Dolcini, Fecondazione assistita e diritto penale, Milano, 2008. F. Giardina, La maturità del minore nel diritto civile, in Nuova giur. civ. comm., 2004, suppl. al n. 3, 95ff. B. Guidi, L. Nocco, The Debate Concerning the Off-label Prescriptions of Drugs: A Comparison between Italian and U.S. Law, 1–45; Lider Lab; ISBN: 20364423 (2011). L. Lenti – E. Palermo – P. Zatti (edts), I diritti in medicina,inTrattato di Biodiritto diretto da S. Rodotà E P. Zatti, Giuffrè, Milano, 2011. G. Montanari Vergallo, Il rapporto medico-paziente. Consenso e informazione tra libertà e responsabilità, Milano, Giuffrè, 2008. G. Iadecola, Consenso del paziente e trattamento medico-chirurgico, Padova, Cedam, 1989. T. Padovani, voce ‘Sterilizzazione’, in Enciclopedia del Diritto, XLIII, Milano, Giuffrè, 1990, 1085ff. G. Pedrazzi, voce ‘Consenso dell’avente diritto’, in Enciclopedia del Diritto, IX, Milano, Giuffrè, 1961, 143ff Aggiornamento, IV, Milano, Giuffrè, 2000, 712ff. M. Piccinni, Il consenso al trattamento medico del minore, Padova, Cedam, 2007. F. G. Pizzetti, Alle frontiere della vita: il testamento biologico tra valori costituzi- onali e promozione della persona, Milano, Giuffrè, 2008. M. Portigliatti Barbos, voce ‘Sterilizzazione’, in Digesto IV ed., Disc. pen., XIV, Torino, Utet, 1999. G. Resta, La circolazione dei diritti sul corpo umano, in Trattato Roppo, Milano, Giuffrè, 2006. A. Santosuosso, Il consenso informato, Milano, Giuffrè, 1996. A. Venchiarutti, La protezione civilistica dell’incapace, Milano, Giuffrè, 1995. P. Zatti-U. Nannini, voce ‘Gravidanza (interruzione della)’, in Digesto IV ed., disc. priv., sez. civ., IX, Torino, Utet, 1993, 270ff. See also individual contributions in the following collective works: C. M. Bianca – F.D. Busnelli edts, La protezione dei dati personali. Commentario a D. Lgs. 30 giugno 2003, n-196 (‘Codice della privacy’), Padova, Cedam,IeII, 2007.

Medical Law – Suppl. 119 (2020) Italy – 249 870–870 Part II, Ch. 1, General Description

C.M. Bianca, F. D. Busnelli, Commentario alla legge 22 maggio 1978, n. 194. Norme per la tutela sociale della maternità e sull’interruzione volontaria della gravidanza, a cura di, in NLCC, 1978. L. Bigliazzi Geri-U. Breccia-F.D. Busnelli-U. Natoli, Diritto civile, 1.1. Norme, soggetti e rapporto giuridico, I, 1, Torino, Utet, 1986, 101ff. U. Breccia-A. Pizzorusso, a cura di, Atti di disposizione del proprio corpo, Pisa, Plus, 2007, 269. FD. Busnelli-U. Breccia (a cura di), Tutela della salute e diritto privato, Milano, Giuffrè, 1978, 73fF. F. Cardarelli-F. Sica-V. Zeno-Zencovich (a cura di), Il codice dei dati personali, Milano, Giuffrè, 2004, 247. P. Cendon (a cura di), Un altro diritto per il malato di mente. Esperienze e soggetti della trasformazione, Napoli, ESI, 1988. G. Comandé (a cura di), Gli strumenti della precauzione: nuovi rischi, assicurazione e responsabilità, Milano, Giuffrè, 2006. F. D’agostino (a cura di), La sterilizzazione come problema biogiuridico, Torino, Giappichelli, 2002. G. Ferrando-L. Lenti (a cura di), Soggetti deboli e misure di protezione. Amminis- trazione di sostegno e interdizione, Torino, Gìappichelli, 2006. C.M. Mazzoni (a cura di), Per uno statuto del corpo. Milano, Giuffrè, 2008. R. Pardolesi (a cura di), Diritto alla riservatezza e circolazione dei dati personali, Milano, Gìuffrè, 2003. Liber amicorum per Francesco D. Busnelli: il diritto civile tra principi e regole, Milano, Giuffrè, 2008.

250 – Italy Medical Law – Suppl. 119 (2020) 871–874

Chapter 2. The Physician-Patient Relationship: Speciﬁc Cases

§1. THE MINOR PATIENT

I. General Principles

A. Children’s Consent

871. In general, the system seems to require, in addition to legal capacity (Article 1 Civil Code), the so-called capacity to act, deﬁned by the Civil Code (Article 2) as ‘the capacity to perform all acts for which there is established a different age’ (from majority established at 18 years). See also 684.

872. The role of the minor patients (technically without capacity to act) can be described in evolutionary terms. That is, the role of minors has constantly expanded in recent years both in practice and in legal opportunities aimed at respecting their will in relation to health and healthcare matters. Some documents refer to ‘approval/ dissent’ of the mature minor in relation to treatment and not to ‘consent’ (see, for instance, 2009 Recommendations regarding the implementation of compulsory examinations and treatment for mental health illness of the Conference of Regions and Autonomous Provinces).

873. If it is true that their medical treatment cannot be performed without the legal consent of their guardians (normally considered the parents pursuant to Article 320 cc), it is also true that the role of minors in the decision-making process is a variable with large variances. In principle, a guardian’s consent is required for non- patrimonial acts (as conﬁrmed expressly by Article 4 Law 211/2003 implementing Directive 2001/20/EC for clinical trials; Article 3 paragraph 2 Law 219/2005 and by Article 37 paragraph 1 CME).

874. The principle (of consent by guardians for all individuals without capacity to act, being minor or not) has not been seriously challenged by statute or case law. Nevertheless and, for instance, Article 4 Law 211/2003 speciﬁed ‘consent must, however, reﬂect the will of the child and may be revoked at any time without jeopardizing the continuation of required care’. Today Article 3 of Law 219/2017 clearly states that: ‘A person who is under the age of 18 or who is incapable has the right to the valorisation of his/her capacity for understanding and decision, in respect of the rights referred to in article 1, paragraph 1. S/He must receive information on the choices relating to his own health in a manner appropriate to his/her ability to be put in a position to express his/her will. 2. Informed consent to the medical treatment of the child is expressed or refused by the exercisers of parental responsibility or by the guardian taking into account the will of the minor person, in relation to his or her age and degree of maturity, and with the aim of protecting the child’s physical and mental health and life in full respect of his or her dignity.’

Medical Law – Suppl. 119 (2020) Italy – 251 875–878 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

875. Yet even with this specific set of rules, regulation of the issue must be derived from a large variety of sources also to define who has parental responsibility (e.g., the Civil Code articles on capacity, parental responsibility, legal representation, and specific rules in adoption cases) along with norms derived from EU law (e.g., laws on clinical trials and on blood transfusion; see supra 873) and overarching constitutional (Articles 13 and 32) and international principles (see also 36ff). Among the latter, we can note the EU Charter of Fundamental Rights protecting human dignity – Article 1– and psychophysical integrity conditioning medical treatment to free individual informed consent; the UN 1989 Convention on the Rights of the Child ratified by Law 176/2001 providing at Article 12 that ‘States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child’; the 1996 European Convention on the Exercise of Children’s Rights ratified by Law 77/2003 setting down, in Article 3, the right of a ‘child considered by internal law as having sufficient understanding’ to receive all relevant information, to be consulted and express his/her views and ‘to be informed of the possible consequences of compliance with these views and the possible consequences of any decision’; and the so-called Oviedo Convention establishing, in Articles 5 and 9 the general principles of informed consent.

876. To the above legal norms, we must add the many references contained in the 2014 CME for physicians and in the 2009 CME for nurses.

877. In short, although technically irrelevant, the will of children must be considered in the consenting process according to the general principle for which children and adults without full capacity have a right to participate in the decision- making process and to see their will receiving weight proportional to their age and wisdom in at least non-patrimonial and personal matters (see Article 6 paragraph 2 of the Oviedo Convention). Although the Oviedo Convention, ratiﬁed by Law 145/ 2001 but never implemented, is not legally binding, it has always had a signiﬁcant impact on case law. In addition, the 2014 CME for physicians expresses the concept in a similar, powerful way. Article 35, last paragraph calls the physician to take ‘due account of the views expressed by the minor in all decision-making processes concerning the minor’, Article 33 last paragraph CME imposes to the physician to guarantee ‘the minor useful information for him/her to understand his/her state of health and the planned diagnostic-therapeutic interventions, in order to involve him/ her in the decision-making process’.

878. The NBC has urged healthcare professionals to personalize treatment for children and adolescents with a view to establishing a relationship with them. With speciﬁc reference to consent to treatment, the NBC clariﬁed that personalizing the therapeutic alliance between the physician and the child should be pursued giving due consideration to the actual degree of maturity of the child, assessing the importance of the requested intervention and without prejudice to the prerogatives of the

252 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 879–885 legal representatives all the while aiming to develop and protect the rights of children (see the National Bioethics Committee ‘Bioethics With Childhood’ of 22 Janu- ary 1994).

879. The involvement of minors increases as they approach majority age and show maturity in a progressive way. Once they have acquired discernment, they should be heeded so as to better understand their psychological status and so that all essential information can be provided (see 894) and agreement to the proposed treatments can be reached (as clearly suggested by Article 33 and 35 CME). Once discernment capacity and parental education and care rights/duties coexist (mostly since adolescence), the goal is to coordinate (concert) their will in view of the prominent goal of preserving the moral and psychophysical well-being of the minor, a balancing that is today clearly regulated by Article 3 law 219/2017.

880. It is worth noting that discernment is not legally defined, nor has a rule of thumb definition been established in medicine. Nevertheless, the concept illustrates a capacity to be related to the actual situation and the actual treatment and covers an individual who understands the meaning of well-defined actions to be taken in a given context.

881. Once discernment is acknowledged, a sort of veto power is bestowed on minors in relation to medical treatments that are not considered mandatory by law or under the guarantees of the law. Otherwise, a clear violation of their right to health (Article 32 cost) and their personality would ensue.

B. The Role of Parents (and Legal Representatives)

882. It is obvious that parents shall decide in the best interest and for the effective protection of the health of their child.

883. Article 4 paragraph 1 lett. a Law 211/2003 on clinical trials, in requiring that consent ‘reﬂects the child’s will’ illustrates a general principle that has been expressed by the Court of Cassation in the Englaro case (Cass. 17 October 2007 no. 21748). Consent expressed by parents/legal representatives on behalf of the principal must be ‘truly expressive, based on clear, consistent and convincing evidence, of the voice of the principal, based on her personality, her lifestyle and her beliefs, corresponding to her way of understanding [before falling into unconsciousness] the very idea of human dignity’.

884. Note that informed consent to medical treatment does not require judicial authorization since it is not listed in Articles 374 or 375 Civil Code (see also Cass. 1233/1979). These provisions only refer to economically relevant acts.

885. Parents jointly represent their children but can represent them separately for ordinary administration (Article 320 Civil Code). Legislative Decree no. 154 of

Medical Law – Suppl. 119 (2020) Italy – 253 886–889 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

28 December 2013 amended the Article to 320 Civil Code, which now reads as follows: ‘In the event of separation, with regard to children, the provisions contained in Chapter II of Title IX shall apply.’ Relevant is therefore Article 316 of the Italian Civil Code, which states: ‘Both parents have parental responsibility, which is exercised by mutual agreement, taking into account the child’s abilities, natural inclinations and aspirations. Parents shall agree on the child’s habitual residence. In the event of conﬂict on matters of particular importance, each of the parents may have recourse without formalities to the court, indicating the measures which they consider most appropriate. The judge, after consulting the parents and listening to the minor child who has reached the age of twelve and even younger if capable of discernment, suggests the determinations that he considers most useful in the interest of the child and family unity. If the conﬂict persists, the judge confers the power of decision on the parents who, in the individual case, consider the most appropriate to care for the interests of the child.’ Thus, parental authority is exercised by both parents. Decisions of interest concerning education for their children and health are taken by mutual agreement taking into account the capacity, the natural inclinations and aspirations of children. In case of disagreement, the decision is left to the judge. Limited to decisions on questions of ordinary administration, the court may determine that the parents exercise parental authority separately.

886. Henceforth, the distinction between ordinary and extraordinary acts is as relevant as difficult to draw. In the absence of a clear rule of thumb, those acts pre- senting high risks to the health and life of minors according to their invasiveness, severity, duration in time, and the probability of negative consequences due to their execution or their failure to be carried out, should be considered as extraordinary acts.

887. Representation by a single parent, in situations other than those related to ‘ordinary’ medical visits (e.g., vaccinations, medical visits concerning seasonal illnesses, for example, inﬂuenza) is admitted in cases of:

– forfeiture of parental responsibility (Article 330 Civil Code); – distance, incapacity, or other impediment that makes it impossible for one of the parents to exercise power (317 cc, disappearance pursuant to Article 48 cc, absence, pursuant to Article 49 cc, interdiction pursuant to Article 417 cc); – divorce, separation or marriage annulment resulting in the rupture of cohabitation if the child is entrusted to a single parent (Article 337 quarter, paragraph 4 cc).

888. However, the other parent has the right/duty to monitor and to cooperate with the representing parent.

889. In case of disagreement between parents, each of them can petition the Court for Minors (Tribunale per i Minorenni), pursuant to Article 316 cc. In these instances, the judge suggests the solutions that are considered to be in the best interest of the child after hearing all interested parties (including the child, see also

254 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 890–893

Article 23 lett. b of Reg. 2201/2003/EC concerning jurisdiction and the recognition and enforcement of judgments in matrimonial matters and the matters of parental responsibility that makes it a necessary requirement to hear the child). If suggestions are not accepted, the judge entrusts the decision to only one parent. Note also that the right to be heard of a child today is also established by Article 336 bis c.c.: ‘A child who is twelve years of age or older and even younger if capable of discernment is heard by the president of the court or by the delegated judge in the context of the proceedings in which measures concerning him must be adopted. If the hearing is in conﬂict with the best interests of the child, or is manifestly superﬂu- ous, the judge shall not proceed with the performance of the task and shall give a reasoned decision.’

890. Note that if the external representation of consent by one parent is abusive (e.g., without the due agreement of the other parent) it can lead (upon request of the other parent) to a limitation on parental authority (Article 333 cc), but it does not make illicit the professional activities of healthcare professionals performed according to the abusive consent.

891. It must be noted that the role of guardian is not always entrusted to the ‘natural protectors’, usually considered the parents or the legal custodians of the child. At least in one instance, the power to consent is entrusted to none of the above. Article 82 paragraph 2 lett. (a) DPA, for instance, provides, in cases of emergency, that even ex-post information needed to informed consent of processing should be given to ‘the manager of the institution where the data subject is hosted’ if the data subject is ‘in the physical impossibility, inability to act or inability to understand or to will’ and in the absence of ‘the person legally representing him/ her, or a close relative, a family member, a cohabiting or civilly united person or a trustee pursuant to Article 4 of Law no. 219 of 22 December 2017’. A similar situation exists for the case of unaccompanied foreign minors in relation to their next of kin in that their legal representation is entrusted to the main local authority providing the healthcare services. It is difficult to refer to the local authority as a natural protector since generally a natural protector is characterized by proximity to the individual, being close to her because they are relatives, or because close ties of cohabitation, solidarity or even of familiarity link them.

C. Parental Denial of Consent

892. In case parents deny (or discontinue) their informed consent and the physician is of the opinion that this is detrimental to the child, she has a legal and deontological duty to notify to the General Attorney at the Tribunale per i Minorenni according to Articles 32 and 37 CME in order to let her appreciate the needs and to seek appropriate judicial orders pursuant to Article 333 cc if considered appropriate.

893. Article 336 paragraph 1 and Article 77 cc attribute a similar power to relatives up to the sixth degree.

Medical Law – Suppl. 119 (2020) Italy – 255 894–900 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

D. Information

894. The provision of proper information to the child (even if still incapable of discernment) related to the forecasted procedures and effects of treatment is a clear preliminary element for lawful consent. While it is a general duty of parents in the exercise of their duties as guardians to provide such information and it is an ethical duty of the physician, in some instances it is a right enshrined in statutory acts.

895. Article 4 Law 211/2003 lett. b requires that children receive ‘from staff with experience with minors, information according to their capacity of understanding regarding the trial, the risks and beneﬁts’. In addition (lett. c) the investigator or the principal investigator must take into consideration the expressed will of the child to refuse participation or withdraw from the trial at any time if the minor is capable of forming an opinion and assessing the information provided.

II. Cases of Exclusive Child Consent

896. There are statutory provisions providing for the child to consent without the ‘help’ of parents or other legal representatives as if she was of majority age.

897. Female minors:

– can seek sexual counselling (Article 1 paragraph 1 lett. b Law 405/1975 on family counselling) and contraceptive drug prescriptions requiring medical control (Article 2 paragraph 3 Law 194/1978 on abortion); – can donate the placenta and hematopoietic stem cells from the umbilical cord after expression of informed consent at the time of delivery (Article 3 paragraph 2 and 3 Law 219/2005 on blood donation).

898. All minors (and those incapable of discernment) may apply to the public service or to an authorized private facility dealing with drug addiction to be subjected to diagnostic tests and to be integrated into a therapeutic and social rehabilitation programme while remaining anonymous even in relation to the records of these treatments (Article 120 paragraphs 2, 3 and 6 respectively of Law 309/1990 on prevention, treatment and rehabilitation of drug addicts). Parents or guardians can make the same application.

899. Similarly and for systemic coherence, medical results related to the HIV virus can be notiﬁed only to the data subject (Article 5 Law 135/1990).

900. Considering that these statutory provisions tip the balance between parental authority and educational rights, on the one hand, and minors’ self- determination in favour of the latter, it seems possible to infer a general principle applicable to those hypotheticals in which such a balance is not at stake, such as, in diagnostic treatments (see 879).

256 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 901–904

III. Cases in Which Child Consent Is ‘Forbidden’

901. There are instances in which minors’ consent is expressly forbidden. For instance, minors, even if in possession of the ability of discernment and seemingly aware of the limitations of the treatment of kidney, liver, or of bone marrow transplant from a living donor and aware of the personal consequences that this sacriﬁce involves, cannot consent to a transplant (see respectively Article 2 Law 458/1967, Article 1 Law 483/1999, Article 4 paragraph 2 law 52/2001).

IV. Special Cases

A. Mandatory Vaccinations

902. The general principle according to which mandatory vaccination should be performed was underlined in the 1990s. In particular, D.P.R. 355/1999 permitted the enrolment of non-vaccinated children in schools, de facto reducing incentives to liti- gate around the denial of consent to vaccination of the part of parents. Before this enactment, case law was rather stable in ‘forcing’ vaccination via Article 333 cc unless there were clear documented medical contraindications (see, Cost. 262/2004 upholding the principle of limiting parental responsibility to that end; see among several Cass. 3309/1994). Today some vaccinations are again compulsory to be admitted in school. Article 3, paragraph 3 of Decree-Law no. 73 of 7 June 2017 (converted into Law no. 119 of 31 July 2017) established that: ‘For educational services for children and kindergardens, including private schools, the provision of the documentation referred to in paragraph 1 [certifying the vaccination occurred] is a prerequisite for access.’

B. Blood Transfusions

903. The issue of blood transfusions emerges mostly in cases related to parental denial of consent because of religious beliefs (e.g., Jehovah’s witnesses). It becomes more problematic if it is the child refusing the treatment. In these cases, several constitutional freedoms are at stake and in conﬂict (religious freedom, freedom to educate one’s own children) with the minor’s right to health.

904. If conﬂict is real and actual, after having appreciated the suitable possibility of alternative treatments, with reasonably reliable and similar results of a transfusion, courts are rather interventionist, especially if the minor does not have discernment or does not oppose (see Cass. Feb. 8 1994 n. 1265 in Giur. it., 1995, I, 304). In these cases, the minor’s right to health prevails almost certainly over parental choice and freedoms also in light of their duty to protect their children’s life and health (Article 30 Cost. and 147 cc).

Medical Law – Suppl. 119 (2020) Italy – 257 905–911 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

C. Cancer Treatments

905. Cancer treatment has been an issue for a limited time, but it has established enduring principles especially in light of the expanding role of medicines alternative to those based on scientiﬁc evidence.

906. Litigation ensued in one instance where the parents opted to resort to the so-called Di Bella multi-therapy path that later proved totally ineffective. See paragraphs 64, 88.

907. From the few existing judicial interventions concerning minors, we can note that courts have decided to overcome parental lack of consent to the treatment (even against the will of the minor) only in cases where there is a high probability of success (close to 100%) of the scientiﬁcally evidence-based treatments. Once the probability of success falls to approximately 50%, judicial decisions have mainly refused to overcome the will of the interested parties.

908. Duration, invasiveness and painfulness of the treatment (e.g., chemo- therapy) are factors that often militate for the non-imposition. Note also that material physical imposition of treatment against the minor’s persistent will has not been ordered, to the best of our knowledge. On most occasions, the judicial order to perform the treatment has played a persuasive role without leading to the order of its material execution (see, for instance, App. Brescia 13 February 1999 and Trib. Min. 22 May 1999, in NGCC, 2000, I, 204).

D. Compulsory Sampling of Biological Materials (Treaty of Prüm)

909. Pursuant to the Italian adhesion to the 2005 Convention on the stepping up of cross-border cooperation, particularly in combating terrorism, cross-border crime and illegal migration (Law 85/2009), Articles 224bis, 349 and 359bis cpp permit the taking of compulsory biological samples and medical testing also on minors (since reference is generic to the ‘person’) in the cases they regulate.

§2. INTERDICTION,NON-(FULLY)-AUTONOMOUS PATIENTS AND ‘AMMNISTRAZIONE DI SOSTEGNO’

910. As mentioned (see 685), even where individuals have no natural or legal capacity whatsoever, simple substitution of consent is not anymore a viable solution.

911. The same applies to individuals who have legally lost their mental capacity and are therefore debarred, i.e. adults and emancipated minors, who are in a state of habitual mental inﬁrmity that renders them unable to provide for their own interests (Article 414ff cc). The habitual state of mental incapacity, albeit interspersed with moments of full capacity to act lucidly at certain intervals, must be considered.

258 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 912–915

Today this is clearly stated in Article 3 of law 219/2017: ‘3. The informed consent of the person prohibited under Article 414 of the Civil Code is expressed or refused by the guardian, after hearing the interdict where possible, with the aim of protecting the physical and mental health and life of the person in full respect of his or her dignity. 4. The informed consent of the incapacitated person is expressed by the incapacitated person him/herself. In the event that a support administrator has been appointed, whose appointment provides for the necessary assistance or exclusive representation in the healthcare sphere, informed consent is also expressed or refused by the support administrator or only by the latter, taking into account the will of the beneﬁciary, in relation to his or her degree of ability to understand and will. 5. In the event that the legal representative of the interdicted or incapacitated person or the support administrator, in the absence of the advanced treatment provisions (DAT) referred to in Article 4, or the legal representative of the minor person refuses the proposed treatment and the physician instead considers that it is appropriate and necessary, the decision is referred to the decision is referred to the giudice tutelare on application of the legal representative of the person concerned or of the subjects referred to in Articles 406 et seq. of the Civil Code [spouse, permanent cohabiting person, relatives up to the fourth degree, relatives up to the second degree, guardian or administrator or the public prosecutor] or of the physician or legal representative of the health facility.’ The position of those who are interdict is equated to that of the child and, like the situation of the latter, a person is appointed by the court to protect, to represent and where necessary replace those who are interdict while caring for their interests: the guardian (Article 424, 1 cc).

912. Indeed, real life presents a large number of situations regarding medical treatments in which the traditional dichotomies (legal/natural capacity; competence/ incompetence; minor/adult) are unable to capture the actual problems in protecting individual health and connected rights.

913. Most often, what is required is to follow a strict path between the need to preserve (even residual) autonomy and the aim of protecting health. In this grey area, the substitution of the patient’s will with that of the guardian/legal representative in the name of potential therapeutic advantages for the patient is not a solution capable of taking into account other fundamental interests. Even in the event of substitution for mental incapacity or for other reasons, the Oviedo Convention suggests (Article 6) that ‘The individual concerned shall as far as possible take part in the authorisation procedure.’

914. Therefore, it is worth analysing the consent paths available to individuals who, for different reasons, are not fully ‘autonomous’ and therefore not fully capable of catering for their interests resulting in the involvement of other individuals in the decision-making process (see for minors 872–908).

915. In practical terms, some legal rules in force (see, for instance, Article 5 Law 211/2003 implementing Directive 2001/20/EC) refer to ‘incapacitated adults incapable of giving informed legal consent’ apparently incorporating a functional notion

Medical Law – Suppl. 119 (2020) Italy – 259 916–920 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases of capacity more akin to common law systems than to the Italian legal tradition. It refers to the ability to consent to a speciﬁc medical treatment.

916. In this vein, the introduction (Law 9 January 2004, no. 6) of an official place for a ‘support administrator’ (amministratore di sostegno) who is charged with ﬁlling the gap between capacity and incapacity has found legal relevance and can assist with the implementation of Article 3 paragraph 2 of the Italian Constitution.

917. Article 404 cc opens with Title XII dedicated to protective measures for those lacking – wholly or partially – in autonomy. It reads: ‘The person who, due to an illness or an impairment of a physical or mental nature, is incapable, even partially or temporarily, to provide for their interests, may be assisted by a support administrator, appointed by the guardianship court of the place of residence or domicile.’ The Article continues by establishing that ‘those responsible for healthcare and social services directly engaged in the care and treatment of the person, aware of facts rendering the opening of proceedings for support administration appropriate’ are responsible for proposing the procedure to the probate judge or to provide notice to the Public Prosecutor.

918. Articles 404ff cc, as interpreted by case law, offers significant flexibility to the powers of the administrator ranging from substitution to assistance and permitting the administrator to fine-tune specific acts and basically meet the needs with a view to preserving the greatest amount of autonomy of the involved individual beneficiaries.

919. Although referring to a case in which legal incapacity accompanied natural incapacity, the Court of Cassation decision in the Englaro case illustrates principles of general application. In its point 7.2, it clariﬁes that:

In case of incapacity of the patient, the medical dutifulness ﬁnds its legitimizing foundation in the constitutional principles inspired by solidarity, which enable and compel the performance of those urgent interventions that result in the best therapeutic interest of the patient. However, even in such eventuali- ties, once overcome, the urgency [see above 772] of the intervention arising from the state of necessity, the personalistic principle [see above 678] sustaining the principle of informed consent and the principle of equal treatment between individuals, regardless of their state of capacity, render it necessary to recreate the dualism of subjects involved in the process of elaboration of the medical decision: between the physician who must inform about the diagnosis and treatment options, and the patient, through her legal representative, who may accept or refuse the proposed treatment.

920. In cases concerning individuals that have legal capacity but not natural capacity (therefore unable to provide valid consent to treatment), the physician is charged with a clear protective role. Nevertheless, it might not be clear who the physician’s interlocutor is as a result of the dualism evoked by the Court of Cassation’s

260 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 921–924 decision (supra 919). In the absence of a legal representative, the decision, it was suggested, might remain in the hands of the physician to decide in the best interest of the patient all the while attempting to involve those who can be assumed to be ‘natural protectors’ (see supra 892) of the patient (possibly using the procedure of Article 406 paragraph 3 cc).

921. The Court of Cassazione (Englaro 7.2) emphasizes that:

the provision in Art. 357 cc is central, which – read in connection with Art. 424 cc. – provides that ‘the guardian is charged with the care of the interdict person’, investing the guardian as the legitimate interlocutor of physicians in deciding on medical treatments to be practiced in favour of the interdict. Pow- ers of care for the inﬁrm also pertain to the person who has been appointed administrator of support (Arts 404ff cc., introduced by Law 9 January 2004, no. 6) through a decree of appointment which indicates the acts that this authorized person can carry out with a view to protecting the interests, even those of a personal nature, of the beneﬁciary (Art. 405 cc, section 4).

922. In synthesis, as stated at paragraph 7.3 of the quoted decision, ‘the guardian’s duties of care for the person are substantiated by providing informed consent to medical treatment which is addressed to the person in the state of incapacity’. The scope of this intervention has limitations ‘inherent to the fact that health is a personal right and … the freedom to refuse treatment’ implies the use of assessments of life and death, rooted in conceptions of ethical or religious, or (even) extra- juridical thereby purely subjective.

923. Indeed, ‘the personal character of the right to health of the incapacitated person means that the reference to the institution of legal representation does not transfer to a tutor … unconditional power to dispose of the health of the person in a state of total and permanent unconsciousness. In allowing the medical treatment or not, the guardian is subjected to two sets of constraints: she must ﬁrst of all act in the interest of the incapacitated person; and, in the search of the best interest, she must decide not ‘in place’ of the incapacitated nor ‘for’ the incapacitated, but ‘with’ the incapacitated therefore, reconstructing the presumed will of the unconscious patient, an adult before falling into such a state, taking into account the wishes she expressed before loss of consciousness, or inferring that will by her personality, her lifestyle, her inclinations, her values and her ethical, religious, cultural and philosophical beliefs’. See also in this direction Article 5 paragraph 1 Law 211/2003 on adults’ refusal of consent to clinical trials before incapacity.

924. The practical meaning of the progressive involvement in the decision- making process for medical treatment of patients who are not fully (legally or naturally) able to consent remains problematic. This is so even in those cases where there is a speciﬁc norm requiring it as in the case of the mentally ill patient (see Article 33 l. 833/1978) or for handicapped individuals for whom a legal deﬁnition is available.

Medical Law – Suppl. 119 (2020) Italy – 261 925–931 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

925. Law 104/1992 (Article 3) deﬁnes handicapped persons as those who have ‘a physical, mental or sensory impairment, stable or progressive, which causes learning difficulties, or difficulties in relationships or in employment integration and determines a process of social disadvantage or marginalization’. The statute makes reference in paragraph 2 to the ‘nature and consistency of the disability, to the overall individual residual capacity and the effectiveness of rehabilitative therapies’.

§3. THE MENTAL PATIENT AND INVOLUNTARY PLACEMENT

I. Legal Framework

926. Signiﬁcant changes have occurred in the last decades in the mental health sector in Italy. It has witnessed a radical shift from old mental health institutions (before 1978 and Law 180/1978) to new community-based psychiatric services. There have been two drivers behind these changes. The main and older one relates to the rights of patients and the studies of Professor Basaglia. More recently, economic considerations have been taken into account in managing the organization of services and its objectives. See infra 937.

927. The ﬁrst comprehensive law on mental health in Italy dates back to the beginning of the last century (Law 36/1904). It envisaged compulsory admissions that might last indeﬁnitely. Compulsory admissions implied the loss of civil and political rights.

928. The organization of mental healthcare and the provision of mental hospitals were a local responsibility of each province. They were not part of the general healthcare system. As anticipated (see 114ff), in the 1960s radical changes were set in motion (new services outside mental hospitals were instituted and long-term patients were discharged into the community) resulting in a call for a referendum to close down all mental hospitals in the country. This political movement resulted in Law 180/1978 further completed and incorporated into the general reform of the NHS in 1978.

929. Changes were radical in policy, organizational and, above all, legal terms.

930. Due to the gradual closure of existing mental hospitals, new admissions to existing mental hospitals were no longer allowed, nor was the construction or setting up of new mental hospitals or similar facilities permitted. The central stage of the mental health policy became prevention, care and rehabilitation – aims that were ascribed to community-based services called to deal with the full array of mental health needs of the community.

931. Compulsory treatment and admission to psychiatric wards from that moment became exceptional, time-limited and subject to very strict conditions. In

262 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 932–936 fact, compulsory treatment and admission are nowadays only permitted when outpatient interventions have proven to be ineffective or are refused by patients. In any event, the procedures offer signiﬁcant procedural safety and judicial safeguards. See 942ff.

932. From paper to reality, though, the situation appears quite different. Indeed, still in the 1990s national plans for mental health aimed at ‘the implementation of a comprehensive network of mental health services within each ASL, with speciﬁc emphasis on rehabilitation and crisis interventions, the creation of mental health departments, a greater attention to personnel training and the deﬁnitive dismantling of old mental hospitals’. It was only with the 1998–2000 national plan that clear standards for residential facilities in the community, the discharge of patients still resident in mental hospitals and the avoidance of basing new community-based services on the old mental hospital structure were set.

933. The Departments of Mental Health of the ASLs promote and coordinate mental health prevention, care and rehabilitation within their catchment areas. They have multidisciplinary teams, including psychiatrists, psychologists, nurses, social workers, educators, occupational therapists, secretarial staff and personnel with spe- ciﬁc training in psychosocial rehabilitation. Their facilities are supposed to be able to cover all the range of potential situations, from inpatient wards in hospitals with an emergency department to community mental health centres to which patients have direct access with no referral by a general practitioner required. Mental health inpatient wards are called upon to provide crisis interventions on a short-term basis – most often on a voluntary basis. Community mental health centres for outpatient care offer other types of intervention while Semi-residential facilities (day-hospital and day centre) allow complex diagnostic evaluation and health interventions in the short- and medium-term along with programmes promoting self-care and the practical and interpersonal skills useful for everyday life activities.

934. Residential facilities, placed in urban areas, are charged with promoting patients’ psychosocial rehabilitation and integration aimed at avoiding isolation. They offer different types of intervention in order to meet patients’ needs showing a large potential ﬂexibility.

935. It is important to note that, available data to date do not permit comparison among the various regions and a signiﬁcant variability in services is often referred to especially in relation to differences in regional health systems and their organization and ﬁnancing. See also supra 720, 721, 722, 723, 724, 726, 727, 728, and 731.

936. The definition of health as something more than the mere absence of disease perfectly fits ‘mental health’ which is referred to by WHO as a state of emotional, psychological and social wellness in which the individual is able to exploit her cognitive or emotional abilities, carry out her role in society, establish satisfac- tory relations with others and adapt to external conditions and internal conflicts. Accordingly, the mental patient is not simply a patient with a disease. In any event,

Medical Law – Suppl. 119 (2020) Italy – 263 937–941 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases her illness brings about more individual and social consequences (e.g., stigma). Also for these reasons, legal norms can be active promoters of fundamental rights or active instruments for denying them.

937. The first comprehensive legislation on mental patients, in 1904, subordinated care to custody in a mental hospital. It was a compulsory treatment ordered by the Questore (a public security officer) and accompanied by a medical certificate. It had to be notified to the competent court, which, after one month, automatically transformed the temporary compulsory treatment into a permanent residence in the asylum accompanied by debarment. In 1968 (Law 431/1968), under the stimulus of experimentations in the mental health facility of Gorizia and the ideas of Prof. Basaglia, profound changes in the system began to emerge: hospitalization could be voluntary and asylums were treated as hospitals. See supra 926.

938. In 1978, Law 180 changed the system. It promoted the freedom to choose whether or not to undergo an investigation or a medical treatment related to a disturbed psyche. Even mental illness does not necessarily render the sick person incapacitated and/or unable to resolve. Every, albeit minimal, possibility of wilful participation to the medical investigation or treatment had to be respected and enforced. As a premise, the statute establishing the NHS (no. 833/1978, Article 2 lett. h) lists among its primary goals the protection of mental health focussing on its prevention and by including psychiatric services in the general health services in order to eliminate all forms of discrimination and segregation even in relation to the speciﬁcity of therapeutic measures, and the promotion of recovery and social reintegration of the mentally disturbed.

939. In addition, it must be recalled that for mental patients, the general principle (Article 33 Law 833/1978) is the voluntary nature of treatments. Even in cases of compulsory treatment by law, it must respect the dignity of the persons and their civil and political rights, including as far as possible the right of free choice of physician and place of care (Article 33 paragraph 2 Law 833/1978).

940. Articles 33–35 and 64 of Law 833/1978 regulate the procedures (see infra 341ff).

II. Involuntary Placement in a Mental Hospital

941. There are only two types of involuntary ‘placements’ in mental hospital: the Compulsory Medical Examination/Observation (ASO) consists of a medical examination for people with mental disorders who do not agree voluntarily to undergo a medical examination. The mandatory medical treatment (TSO) submits patients suffering from mental disorders to compulsory medical treatment in a hospital. Both of them can only be temporary (Article 34 paragraph 1 and 3 Law 833/1978).

264 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 942–946

A. Admission for Observation

1. Simple Procedure (Non-emergency Cases)

942. The procedure (both for ASO and TSO) envisages three main steps:

(1) Medical step: the ﬁrst attending physician shall make a motivated proposal (Article 33, paragraph 3), which may or may not be validated by a physician of the ASL (Article 34, paragraph 4). (2) The powers of the Mayor: the Mayor, in consideration of his capacity as the local health authority, on the basis of a valid motivated proposal (supra 942), provides, or otherwise, the adoption of the TSO procedure as inpatient or outpatient (Article 33, paragraph 3). (3) Judicial phase: the guardianship judge, having considered the earlier acts (supra 942, 943), having considered the appropriate information, and eventually having arranged appropriate investigations, issues a motivated decree, validating or not, the decision of the Mayor (Article 35, paragraph 3).

943. The procedure is regulated in further detail by the 2009 Recommendations regarding the implementation of compulsory examinations and treatment for mental health illness of the Conference of Regions and Autonomous Provinces.

2. Emergency Procedure

944. By deﬁnition, a TSO is based on an emergency procedure since it can be ordered when it is not possible to schedule outpatient treatment. See 950ff, 959ff and especially 962.

3. Practical Modalities of the Admission for Observation

945. The order of the Mayor activates the procedure for the TSO. The Mayor has up to forty-eight hours to act after receiving certiﬁcation validating the proposed TSO. Within forty-eight hours after admission, the Mayor shall notify, by municipal messenger, her decision to the guardianship judge affiliated to the relevant jurisdiction. The judge, within the next forty-eight hours, considering the information and after having arranged the eventual investigations, by motivated Decree, decides to validate – or not as the case may be – the measure.

946. Information from professionals, in public or private practice, that have previously treated the patient, requests for intervention made by family members, neighbours, and the police, are elements that can be considered but can never be automatically sufficient to justify the request for an ASO.

Medical Law – Suppl. 119 (2020) Italy – 265 947–951 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

947. Only a physician can solicit the ASO and under restricted conditions (see infra):

(1) The physician of the Mental Health Department may propose the ASO only in cases where: (a) according to the information received, it appears legitimate to the best of her knowledge and belief, to suppose the urgent need for a (ﬁrst or yet another) psychological evaluation in order to assess the need for psychiatric treatment, but the psychiatrist is not able to visit the citizen because she personally experienced that the person in question (whether or not already known to her) is avoiding contacts (for instance, because of depar- ture at the time of the meeting, refusing to allow contact, unwillingness to agree on appointments with or without repeated unavailability); (b) despite having been able to visit the patient in her capacity as the propo- nent of the TSO, she has not been able to carry out a second visit for the validation required by law, due to the active refusal of the patient. (2) The non-psychiatric physician (Physician of General Medicine or of Continu- ity of Therapy or of Emergency) may propose the ASO according to the two previous cases, even when, despite having seen the person in question, she has doubts concerning the relevance of all elements required by law for the activation of a proposed TSO and deems necessary an evaluation based on a specialist psychiatric visit for which, however, the citizen does not give her consent.

948. Normally, the motivated proposal also contains guidance on the most appropriate place – i.e. that considered more acceptable by the patient – for the execution of the ASO.

949. It is established practice that an order for ASO, not performed within forty- eight hours, is no longer valid, and a new proposal would be required.

B. Prolonged Stay (TSO)

950.(See also supra 939–943, 945). To request and then carry out the TSO, three conditions must coexist:

– Presence of psychiatric illness requiring urgent therapeutic interventions. – Refusal of treatment by the person. – Inability to take timely measures outside hospitals (which is the default rule: ‘interventions for prevention, treatment and rehabilitation related to mental illness are usually implemented by services and regional offices outside the hospital’, see Article 34 paragraph 3, Law 833/1978).

951. An essential condition for activation is that the proposal is validated by the certiﬁcation of a physician from the public ASL who personally makes a second evaluation and uses it to motivate the validation.

266 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 952–957

952. Municipal police conduct the research into the sick person, and they also transfer the patient to the place of treatment. Public health personnel are charged with collaborating with the municipal police in this regard in suggesting appropriate precautions to make the transfer less traumatic and to conduct any medical interventions that may be necessary.

953. Any extension of the duration of the TSO, after the expiry of the ﬁrst seven days, can only occur as a result of a reasoned proposal to the Mayor by the Head of the Service of Psychiatric Diagnosis and Treatment in the facility to which the patient was admitted. The request must reach the Mayor forty-eight hours before the expiry of the TSO to meet the same guarantees of the ﬁrst period. Under current practice, renewal of the TSO must be sought every seven days.

C. Compulsory Treatment Outside the Hospital

954. In principle, the TSO outside the hospital enjoys only the administrative guarantee of the Ordinance of the Mayor. Its execution is carried out in a place with no particular constraints in relation to access and in a place familiar to the patient. The standard practice has limited the duration of the TSO outside the hospital to seven days, in analogy with the hospital admission TSO.

955. The places most often suggested for the treatment are the home of the patient (with the activation of home visits) and the Centre for Mental Health (requiring the patient to attend outpatient visits).

956. It is current practice, to communicate to the probate judge the order for outpatient TSO given by the Mayor, although the law does not require this. It is an additional safeguard for the citizen perceived as a person in a position of weakness and deserving of extra protection. Such reporting allows the judge, upon eventually assuming information and having arranged possible veriﬁcations provided for in paragraph 2 of Article 35, to implement the provisions in that article: ‘The probate judge shall take the urgent measures which may be necessary to preserve and to administer the assets of the sick person.’ To this, the beneﬁts provided for by Law 6 of 9 April 2001 in relation to the support Administrator should be added. This practice, although not mandatory, is recommended both to the Mayor and to the physician making the proposal.

957. If the TSO is initiated by the Mayor of a municipality other than that where the sick person is resident, it must be communicated to the Mayor of the latter town, as well as to the probate judge affiliated to the municipality of residence. Also, if the measure is adopted against foreign nationals or stateless persons, the Prefect must give notice to the Ministry of the Interior, and the competent consulate.

Medical Law – Suppl. 119 (2020) Italy – 267 958–963 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

D. ASO and TSO for Minors

958. Considering what we have set out thus far on the role of minors’ consent to treatment (see 871ff), it is clear that the issue of ASO/TSO for minors is emerging. In fact, this area is also dealt with by the 2009 Recommendations regarding the implementation of compulsory examinations and treatment for mental health illness of the Conference of Regions and Autonomous Provinces.

959. To date, the cases are mainly dealt with by intervening on the parental authority in those cases in which they refuse a treatment which physicians deem necessary for the protection of the child’s health. While for adults the law requires the giudice tutelare, i.e. the judge charged with overseeing the welfare of the child, to take the highest role of guarantee, mainly the court has the function of ensuring the protection of persons that would not be for several reasons – be they transient or permanent – able to protect themselves without help against possible abuses by those holding a position of authority over them. It is the Tribunale dei minori (Court of Minors) that is called upon to assume this role for minors. It is responsible for the protection of children in situations posing potential harm, including those related to healthcare.

960. Where there is a risk of severe injury to a minor, resulting from a failure to protect their right to health – persisting even after everything possible has been set in motion to capture the actual participation of the parents and of the child in relation to necessary interventions – the healthcare provider is in fact required to give notice to the Public Prosecutor at the Tribunale dei minori. The Public Prosecutor is then charged with the task of assessing whether there is actually a problem of protection, and thus whether it is necessary to activate the Tribunale dei minorenni, which has the ability to act proactively on parental responsibility.

961. It must be noted that such action only rarely results in the disintegration of parental responsibility forcing replacement with an entity rendered responsible for all actions in the interest of the child (a judicially appointed guardian).

962. In most cases, only the prescription of speciﬁc actions is necessary. The court assumes the role of external elective resource also in situations not materially urgent according to which the Tribunale dei minori assumes an authoritative and neutral stance whose intervention can protect both the minor and her relationship with the family and with the treatment team. In cases of extreme urgency, where immediate action must be taken, it is possible to directly report to the Tribunale dei minori.

963. Finally, we must recall the Constitutional Court decision (no. 438/2007) which has declared unconstitutional a Regional Law on the use of psychotropic substances for children and adolescents. In its decision, the court stressed the importance of informed consent in relation to the nature of personal rights.

268 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 964–967

III. The Rights of an Involuntary Placed Mental Patient

964. The involuntary placed mental patient enjoys several procedural guarantees (see supra 942ff) and fully maintains the ability to consent (or dissent) to medical treatments for physical illnesses in addition to their civil and political rights, including as far as possible the right of free choice of physician and location of care (see 3, 650, 651, 652). Furthermore, she (as any other interested individual) may propose to the court in possession of territorial jurisdiction an appeal against the decision validated by the probate judge. The parties may bring legal proceedings without a lawyer and may be represented by a layperson with written authorization. The action may be brought before the Court by registered letter with acknowledgement of receipt.

965. During the mandatory medical treatment, the patient has the right to communicate with those who she deems appropriate. Anyone may address, to the Mayor, a request for revocation or modiﬁcation of the decision permitting the prolonged TSO.

966. These applications for revocation or modiﬁcation must be decided within ten days. The measures for revocation or amendment shall be adopted using the same procedure of the decision revoked or amended.

967. Beyond legally recognized rights, twenty years after the implementation of Law 180/1978 the CNB produced a list of recommendations including a sort of bill of rights and duties towards mental patients (National Bioethics Committee Psy- chiatry and Mental Health: Bioethical Guidelines Outline and Recommendations). These patients are considered to be those particularly vulnerable subjects whose full citizenship must be:

concretely defended and promoted, in the ﬁrst instance through the respect of certain rights and/or by the fulﬁlment of certain fundamental duties, such as:

– the right to treatment without any coercion and in full respect of human dignity with access to the most suitable techniques of medical, psychological, ethical and social action; – the right to the elimination of any kind of discrimination (sexual, cultural, religious, political, economic, social, ethnic) in relation to the form of treatment, even when the latter is restrictive of their freedom; – the right to rehabilitation and reintegration through (not only) access to housing and employment; – the right not to be subjected to any form of physical and/or psychological abuse; – the duty to protect from the consequences of self-destructiveness (i.e. self- accusation, declarations of unworthiness, etc.) vis-à-vis the family, employers and judicial authorities; – the duty to attain optimal conditions of hospitalization and communication with the outside world;

Medical Law – Suppl. 119 (2020) Italy – 269 968–971 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases

– the duty to defend parenthood, a duty that ought to be implemented in full respect of the prevailing interest of minor children. To this end it is necessary to arrive at a trade-off between the duty of beneﬁcence versus patients and the right of the under-the-age child to a healthy and balanced development.

IV. The Closing of Judicial Psychiatric Hospitals (Ospedali Psichiatrici Giudiziari, OPGs)

968. Article 3ter, subsections 2 and 3, D.L. 22 December 2011 no. 211, has phased-out Judicial Psychiatric Hospitals (OPGs). While regional healthcare facilities (by way of health authorities) have assumed the responsibility for healthcare in prisons and in the institutions and services related to the juvenile justice system. Those patients considered unsuitable for release from OPGs in addition to the direct management of the various Departments of Mental Health (Dipartimenti di Salute Mentale, DSMs) have been transferred to small regional structures expressly designed to accommodate those that fail to meet the criteria for release.

§4. THE DYING PATIENT

969. Modern medical science has inﬂuenced the dying process not only in relation to the development of treatments that effectively avoid death, but (perhaps) mostly, by prolonging the natural process of dying. This could be said to be true in several domains, such as, oncological diseases, intensive care, and neurological degenerations (e.g., Alzheimer’s); areas in which life-sustaining treatments are frequently used and can ‘indeﬁnitely’ prolong life (i.e., sustain life itself without actually treating the relevant disease). All these interventions aid or substitute vital organic functions (for instance, nutrition, digestion, breathing, blood circulation) in instances where, until recent times, death would have occurred. See also supra 5, 669ff.

970. Against this bedrock and the problematic rules on informed consent to treatment, the issues surrounding the dying patient are rather diverse and cannot be reduced to a vote for or against euthanasia. It has mainly to do with the appropriateness and proportionality of treatment for a given patient in a given context in light of the expected results, all the while preserving dignity.

971. Article 16 of the CME, dedicated to diagnostic and therapeutic obstinacy, requests that physicians, in consideration of the patient’s wishes if expressed, ‘refrain from obstinacy in diagnostic and therapeutic treatments from which there is fundamentally no expected beneﬁt to the health of the patient and/or improvement in quality of life’. In other words, it directs physicians to refrain from inappropriate treatment that exceeds the pursued treatment aim (see Cass. 21748/2007 the so-called Englaro case).

270 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 972–974

I. Euthanasia

972. In Italy, contrary to other European countries, there is no legislation explicitly dedicated to euthanasia. To date (27 November 2019), there are ﬁve pending legislative proposals on the matter. Voluntary, active euthanasia is compared to murder (Article 575 cc). In cases where the consent of the patient can be proven, the penalties applied are those provided for in Article 579 cc (entitled Murder of the Consenting). The sanction ranges from six to ﬁfteen years of imprisonment.

973. Furthermore, assisted suicide is considered a crime under Article 580 of the Criminal Code. Passive euthanasia is also banned; however, the difficulty that arises in proving culpability renders it more elusive than other denunciations. However, in a recent judgment (of September 25, 2019 n. 242), the Constitutional Court established that ‘who facilitates the execution of the suicide purpose, autonomously and freely formed, of a patient kept alive by life-support treatments and affected by an irreversible disease’ is not punishable. The Court made the non-punishment conditional on compliance with the rules laid down in the legislation on informed consent, palliative care and continuous deep sedation (Articles 1 and 2 of Law 219/2017) and the verification of both the conditions required and the methods of execution by a public structure of the NHS, after hearing the opinion of the ethics committee competent in the territory. The Court has underlined that the identification of these specific conditions and procedural modalities, derived from norms already present in the system, has become necessary in order to avoid risks of abuse towards especially vulnerable persons.

II. Withholding or Withdrawing (Cessation) of Treatment

974. Withholding or withdrawing a treatment is a right of the patient able to give proper consent to treatment. It has nothing to do with euthanasia (supra 972, 973) or suicide (see also 975–978). The patient can refuse (and obtain a withhold/ withdrawal order) any treatment, no matter how pertinent, appropriate, or useful it is considered. A conscious patient does not encounter the limits of therapeutic obstinacy of treatment in deciding on the treatments she wants. From a patient point of view, there is no difference between the refusal of a blood transfusion, limb ampu- tation, dialysis, or use of a mechanical ventilator. The line between causing death and letting a person die is clearly drawn by Articles 35 and 17 of the CME. See supra 690. Law 219/2017 today states that the patient can also refuse the health treatment that keeps him/her alive. See Article 1 paragraph 5: ‘Any person capable of acting has the right to refuse, in whole or in part, … , any diagnostic assessment or medical treatment indicated by the physician for his/her illness or individual acts of treatment. He/she also has the right to revoke the consent given at any time, with the same forms as those referred to in paragraph 4, even when the revocation involves the interruption of the treatment. For the purposes of this law, artiﬁcial nutrition and artiﬁcial hydration are considered health treatments, since they are the administration, on medical prescription, of nutrients through medical devices. If the

Medical Law – Suppl. 119 (2020) Italy – 271 975–977 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases patient renounces or refuses health treatments necessary for his or her survival, the physician shall suggest to the patient and, if the patient consents, to his or her relatives, the consequences of such decision and the possible alternatives and shall promote any action of support to the patient, also availing himself or herself of psychological assistance services. Without prejudice to the possibility for the patient to change his or her will, the acceptance, revocation and refusal shall be recorded in the medical record and in the electronic health record.’ In addition, see Article 4 provisions for which ‘Any person of legal age and capable of understanding and willing, in view of a possible future inability to self- determine and after having acquired adequate medical information on the consequences of his/her choices, may, through the DAT, express his/her willingness in matters of health care, as well as consent or rejection with respect to diagnostic tests or therapeutic choices and to individual medical treatments.’

III. Termination of Treatment (at the Request of the Patient)

975. Any patient able to consent to treatment has a right to obtain the termination of a treatment she does not want (anymore) even if the withdrawal would lead to death. See supra 718, 719; see also supra 919, 921, 922, 923. This was the case even before law 219/2017.

976. Using the words of the Supreme Court in the Englaro case:

The refusal of medical and surgical therapies, even when such a refusal leads to death, cannot be mistaken for euthanasia, i.e. actions that intentionally shorten life essentially leading to the death of a person, by reason of expressing refusal –as opposed to choice – meaning that the disease will follow its natural course. On the other hand, it is necessary to reiterate that the responsibility of the physician for failure to cure – similar to the legal obligation to engage in or continue therapy – ceases when such an obligation desists: and the obligation, based on the consent of the patient ceases – giving rise to the legal duty of the physician to respect the wishes of the patient contrary to treatment – when consent is withdrawn following the refusal of treatment from the patient.

977. This is also true in cases concerning unconscious patients (see supra 919, 921, 922, 923). In this regard, the Court stated that:

If the patient lies for many years … in a permanent vegetative state, resulting in radical inability to relate to the outside world, and is kept alive artiﬁcially by a nasogastric tube ensuring the provision of nutrition and hydration, the judge at the request of the guardian representing her may allow deactivation of

272 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 978–978

such healthcare (subject to the application of the measures suggested by science and medical practice in the interest of the patient and after cross- examination of the guardian ad litem) only where the following requirements are satisﬁed: (a) when the condition of vegetative state is, according to a rigorous clinical appreciation, irreversible and there is no medical basis, according to sci- entiﬁc standards recognized at international level, to suggest that the slight- est possibility of some, albeit weak, recovery of consciousness and a retrieval of perceptions related to the outside world, and (b) if the instance at hand is really expressive of the very idea of human dignity, based on clear evidence, unequivocal and convincing, of the voice of the patient herself taken from her previous statements, or expressed by her personality, her lifestyle and her beliefs, corresponding to her perceptions prior to her falling into unconsciousness.

978. If one of the two requirements is absent, the court shall deny permission and must then give prevalence to the unconditional right to life, regardless of the degree of health, autonomy and capacity for discernment of the person concerned and the perception that others are likely to have of the quality of life itself (Cass. 21748/2007). However, these issues are now regulated by law 219/2017. Today law 219/2017 has intervened with details on this issue, clearly establishing that the patient can refuse or suspend the care that keeps him or her alive (Article 1, paragraph 5, mentioned above). Moreover, speciﬁcally with reference to the circumstance of the unconscious patient, in Article 4, the DAT are regulated in a substantial way: ‘1. Any person of age and capable of understanding and will, in anticipation of a possible future inability to self-determine and after having acquired adequate medical information on the consequences of her choices, can through the DATs, express their wishes on health care, as well as consent or refusal with respect to diagnostic tests or therapeutic choices and individual health care treatments. She also indicates a trusted person, hereinafter referred to as the “trustee”, who acts on her behalf and represents her in relations with the doctor and health care facilities. 2. The trustee must be a person of age and capable of understanding and will. [ … ] 3. The trustee’s appointment may be revoked by the instructing participant at any time, in the same way as for appointment and without any obligation to state reasons. 4.[ … ] 5. Without prejudice to the provisions of paragraph 6 of Article 1, the physician is required to comply with the DATs, which may be disregarded, in whole or in part, by the physician, in agreement with the trustee, if they appear manifestly inconsistent or do not correspond to the current clinical condition of the patient or if there are therapies not foreseeable at the time of subscription, capable of offering concrete possibilities of improving living conditions. In the event of a conﬂict between the trustee and the doctor, the procedure is carried out in accordance with paragraph 5 of Article 3. 6. The DATs must be drawn up by public deed or by authenticated private deed, or by private deed delivered personally by the instructing participant

Medical Law – Suppl. 119 (2020) Italy – 273 979–980 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases to the civil status office of the place of residence of the instructing participant, which provides for the entry in a special register, if established, or to the health facilities, [ … ].’

IV. Pain Relief and Palliative Care

979. Until 1999, the availability of palliative care was very limited, concentrated mainly in northern Italy and mostly left to the efforts of voluntary organizations. Over the years, however, attention to pain relief and palliative care has increased, mostly due to the effort of non-profit organizations and to the attention that National Health Plans have devoted to implementing rehabilitative programmes and palliative care, improving healthcare for terminally ill patients by strengthening medical and nursing home care, palliative and analgesic therapy, psychosocial support for patients and their families, as well as promoting voluntary organizations and setting up new hospice structures. In 2001, home care for terminally ill patients was included in the LEA. The 2003–2005 National Health Plan recognized that there was a real need for palliative care for all patients suffering from any kind of progressive, incurable illness. The first legal framework was provided for by Law no. 39/1999 extending funds to Regions for establishing hospices. Sub- sequently, national legislation defined the minimal structural, technological and organizational standards for (new) hospices (see infra).

980. Finally, comprehensive legislation was adopted. Law no. 38 of 15 March 2010 deals with pain relief (‘Measures to Ensure Access to Palliative Care and Pain Therapy’). It had been anticipated by specific projects since 2001, for instance, the ‘Hospital Without Pain’ project, approved at the State-Regions Conference in 2001 in favour of offering medical treatments to patients suffering from chronic pain, renamed, as indicated in Article 6, to ‘Hospital-Territory Without Pain’. It anticipated the passage from a hospital-centric vision to one that would instead provide for a greater care presence throughout the territorial setting (Article 5, paragraph 3 of Law 38/2010) detailing the minimum organizational and structural requirements related to the definition of the network of pain therapy, with an organization currently pending approval. Today, Article 2 of Law 219/2017 reiterates this point and adds that: ‘1. The physician, using means appropriate to the patient’s condition, must make every effort to alleviate his or her suffering, even in the event of refusal or revocation of consent to the medical treatment indicated by the physician. To this end, appropriate pain therapy is always guaranteed, with the involvement of the general practitioner and the provision of palliative care as per Law 38 of 15 March 2010. 2. In cases of patients with poor short-term prognosis or imminent death, the physician must refrain from any unreasonable obstinacy in the administration of care and from resorting to unnecessary or disproportionate treatment. In the presence of suffering refractory to health treatments, the physician may resort to continuous deep palliative sedation in association with pain therapy, with the patient’s consent. 3. Recourse to or rejection of continuous deep palliative sedation shall be justified and shall be recorded in the medical record and the electronic health record.’

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981. Law 38/2010 guarantees the right of citizens to have access to palliative care and pain therapy. Accordingly, it amends the Consolidated Law on the Disci- pline of Narcotic Drugs and Psychotropic Substances: Prevention, Treatment and Rehabilitation of Drug Addiction (P.D. no. 309 of 1990) by simplifying the prescription of opioid non-injectable drugs. It states that the physicians of the NHS will no longer be required to prescribe this class of medicine on special prescription books, but rather they must do so by using the simple book of prescriptions of the NHS.

982. It also stipulates (Article 7) that the characteristics of pain observed and its evolution during hospitalization, as well as the analgesic technique and the drugs used, their dosages and the results achieved via pain relief treatments should be recorded in the medical and nursing care sections of medical records.

983. Article 2 defines palliative care as ‘the set of therapeutic interventions, diagnostic and welfare based, aimed at both the sick person and to her family, aimed at the treatment and total active care of patients whose underlying disease, characterized by an unstoppable evolution and poor prognosis, is no longer responding to treatment’. It also defines the notion of ‘pain management’ as the set of diagnostic and therapeutic interventions designed to combat chronic diseases, suitable and appropriate drug therapies, surgical, instrumental, psychological and rehabilitative treatments variously integrated with each other with a view to developing appropriate diagnostic and therapeutic pathways towards the suppression of pain. Finally, it describes the patient entitled to them as the person suffering from a disease with chronic and evolutionary patterns, for which there is no treatment or, if they exist, are inadequate or are found to be ineffective towards the stabilization of the disease or the significant prolongation of life. Also included are those suffering from a disease with moderate to severe chronic pain.

984. Article 5 paragraph 3 of Law 38/2010 also prescribes – via an agreement at the Conference of the State and the Regions – the deﬁnition of the minimum requirements and the organizational arrangements necessary for the accreditation of structures of care for the terminally ill and units of palliative care and pain therapy directed at the adult and paediatric patient. Identifying quantitative and qualitative elements that must be present in the three-level network of assistance, while not interfering with the right of every patient to a customized treatment programme that meets the main needs of the patient and her family, should serve to guarantee equity of access in terms of both quality and appropriateness of care in a uniform way throughout the country.

985. Due to the regional allocation of powers on healthcare, the legislative model – organized in a three-level structure encompassing Hospitals (Hub), territorial structures (Spoke) and networks of general practitioners (medici di medicina generale, MMGs) – has not been implemented in an organic fashion. In the system, MMGs and paediatricians (pediatri di libera scelta, PLSs) of the patient’s choice play an important role. It is their responsibility to refer the patient to the appropriate

Medical Law – Suppl. 119 (2020) Italy – 275 986–992 Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases structure, although no speciﬁc training on issues affecting painful conditions in their territory of relevance has been offered to them (to the best of our knowledge at least).

986. Within this three-level system, normally patients needing palliative care would consult their general practitioner to obtain a referral for ADI for terminally ill patients. Of course, a patient can also have free access to any public hospital where palliative care and pain relief services are available, and she can also freely approach voluntary associations delivering palliative care. However, specialist palliative care units within hospitals, hospices, day-care centres and home care are not yet available in all regions.

987. In addition, a speciﬁc model for the paediatric patient has not been fully developed. That being said, the general goal is to promote the home as a place of care and to have residential facilities dedicated exclusively to paediatric patients. For these patients, the regional networks of palliative care and of pain management ‘converge into a single network, with the reference centre coinciding with the Hub in consideration of decisive contributions from paediatrics, the hospital and patients’.

988. The tasks and objectives of these organizations vary among Regions.

989. In some regions, a space is dedicated to paediatric patients within hospices for adult patients while several regional systems (especially in the south of the country) present important problems related to the coordination of palliative care and home care within the network in addition to a lack of homogeneity concerning the offer of care made, often caused in consideration of budget deﬁcits.

990. It must be recalled as well that palliative practice and pain therapy should be distinguished from terminal sedation to a lawfully consenting patient both in clinical and ethical terms.

991. The relevance of palliative care and pain management acquired in the Ital- ian healthcare system is illustrated also by the attention of the legislator to the education and vocational training of the personnel involved. Indeed, Article 5, paragraph 2 (Law 38/2010) requires the identification of professionals working within the available service networks, through an agreement at the Permanent Con- ference for relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano. Pursuant to Article 8, according to specific decrees and collaboration with the Ministry of Health, the Ministry of Scientific Research and the Universities, master training programmes have been approved aimed at training palliative care physicians, physicians of pain management, physicians of palliative care and pain treatment for the paediatric patient, and psychologists and nursing figures.

992. Accordingly, five different master’s in Palliative Care and Pain Therapy were instituted by specific ministerial acts of 4 April 2012 published in the G.U. of 16 April 2012. They are expressly devoted to professionals with specific expertise

276 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Specific Cases 993–994 and experience in the field of palliative care and pain therapy, including those with expertise in paediatrics, with particular reference to general practitioners (medici di medicina generale, MMGs) and medical specialists in anaesthesia and intensive care, geriatrics, neurology, oncology, radiotherapy, paediatrics, and to physicians with three years of experience in the field of palliative care and pain management, to nurses, psychologists, social workers and to other professional figures deemed essential.

993. In more detail:

– A Master’s in ‘Palliative Care and Pain Management’ has been reserved for the health professions of nurse, paediatric nurse, physiotherapist, and rehabilitation therapist. The programme lasts for one year and requires the acquisition of 60 training credits (40 towards theoretical training and 20 towards vocational training). Defined basic, characterizing specific educational objectives for nurses and paediatric nurses and for physiotherapists and occupational therapists have been set out. The regulation also delineates mandatory training activities which contribute to the acquisition of professional skills and standards and requirements of the training network. – A Master’s in advanced training and qualification in ‘Pain Therapy’ has been reserved for physicians holding one of the specializations listed in Article 5 paragraph 2 of Law 38/2010. This twelve-month programme requires the acquisition of 60 training credits (30 towards theoretical training and 30 towards vocational training). – A twenty-four month (requiring the acquisition of 120 training credits in total; 60 towards theoretical and 60 towards vocational training) Master’s in advanced training and qualification in ‘Palliative Care’ has been reserved for physicians holding one of the specializations listed in Article 5 paragraph 2 of Law 38/2010. – A two years (requiring the acquisition of 120 credits in total of which 60 should be devoted to practical activities) Master’s in advanced training and qualification in ‘Pain Therapy and Paediatric Palliative Care’ has been reserved for physicians holding a specialization in paediatrics and to those specializing in anaesthesia, resuscitation and intensive care who have specific training and experience in paediatrics. – Finally, a one year (requiring the acquisition of 60 credits in a total of which 40 should be devoted to theoretical training and 20 to practical activities) Master’s in ‘Palliative Care and Pain Therapy’ has been reserved for first-/second-level graduates specialized in psychology.

994. For all the outlined master’s programmes, the provisions identify the learning proﬁles, the educational objectives, the mandatory practical activities, and the standards and requirements of the training networks. In addition, today, paragraph 10 of Article 1 of Law 291/2017 states that ‘The initial and continuous education of physicians and health care professionals includes training in the areas of patient relations and communication, pain therapy and palliative care.’ Recently the Prime Minister’s Decree ‘Deﬁnition and updating of the essential levels of assistance’, referred to in Article 1, paragraph 7, of Legislative Decree no.

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502 of 30 December 1992 (17A02015) was published in OJ no. 65 of 18 March 2017 – Ordinary Supplement no. 15). Transposing all the legislation progressively adopted, the following levels of assistance are foreseen within the Local Network of Palliative Care:

− Article 21 Integrated care pathways: the unitary access to health and social services is guaranteed, as well as the taking in charge of the person, the multidi- mensional evaluation (VMD) of the needs under the clinical, functional and social profile with the definition of the therapeutic-rehabilitative and care needs in the individual care project (PAI). An important novelty is the approach by pathway, with the VMD that helps to identify the patient with palliative care needs. The palliative care confirmed by the LEAs in this framework leaves the time horizon of the end-stage and extends to the early stages of the incurable disease with unfavourable evolution. − Article 23 Home palliative care: these are provided by the UCP (Palliative Care Unit) and no longer within the ADI: they are the UCPs that provide both basic and specialist palliative cares, thus ensuring the unity and integration of care pathways with a care team of reference on the pathway and not on the care setting. The specialist specificity of palliative care that is no longer framed in the undifferentiated container of home care aimed at non-self-sufficiency and fragil- ity that does not require a palliative approach is guaranteed. The coordination of care is punctually characterized (paragraph 3 Article 21, paragraph 1-a and 1-b Article 23) contributing to clarify the responsibility of the care relationship. − Article 31 Specialist Centres for Palliative Care – Hospice: these guarantee assistance to patients in the final phase of their lives at local level. − Article 38 Ordinary acute care: For the first time, palliative care is expressly mentioned as a clinical, pharmaceutical or instrumental service, necessary for diagnostic and therapeutic purposes, which must be guaranteed during ordinary hospitalization.

V. Physician-Assisted Suicide

995. Assisted suicide refers to the provision of medical assistance to a person who has decided to die by suicide. See also 102, 848, and 973.

996. It is differentiated by the execution of the lawful will of a patient refusing (therefore requesting the withdrawal of) a treatment as is inferred from the well- known Welbi case (GUP di Roma 23 July 2007) according to which a physician, upon request of the patient unplugged the respirator that was supporting the life of Piergiorgio Welbi. See also 973ff.

997. Pursuant to Article 580 of the Criminal Code, anyone who decides to take their own life or reinforces another’s will to do the same, or in any manner facilitates the implementation of such, shall be punished, if the suicide occurs, with imprisonment of between ﬁve and twelve years. If the suicide does not actually

278 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 2, The Physician-Patient Relationship: Speciﬁc Cases 997–997 occur, then the said person shall be punished with imprisonment of between one and ﬁve years, provided that the suicide attempt results in a serious or very serious personal injury. However, after decision 242/2019, see supra 714, 972ff.

Medical Law – Suppl. 119 (2020) Italy – 279 998–1003

Chapter 3. Speciﬁc Activities

§1. TERMINATION OF PREGNANCY (ABORTION)

I. Short Overview of the Existing Legal Rules on Termination of Pregnancy

A. Scope of the Law

998. Law 194/1978 (of 22 May 1978) sets down the rules governing the social protection of motherhood and those related to abortion. It has made lawful termination of pregnancy procedures under certain conditions. Prior to this law, induced termination of pregnancy was in all instances a crime and remains so outside the boundaries of Law 194/1978 (see Articles 19–21).

999. Law 194/1978 sets a larger perspective than a mere regulation of permitted procedures and conditions for terminating a pregnancy. This perspective is clear from the following goals of the statute pursuant to Article 1:

(1) the State shall guarantee the right to conscious and responsible procreation; (2) the State shall recognize the social value of motherhood; and (3) the State shall protect human life from its beginning.

1000. The law also excludes that the voluntary interruption of pregnancy is a means of birth control ‘and makes it a duty of the State, Regions and other territorial entities to act so as to avoid that abortion is used for the purpose of limiting births’.

1001. These goals coexist and are strictly related to constitutional principles (Articles 2, 13, 32, 31, 37). In addition, they are clearly pursued by speciﬁc legislation on family counselling, maternity protection, and civil and criminal rules protecting health.

1002. Where termination comes within these legal boundaries, it is considered, under the conditions provided for by law, as a medical treatment enlisted among the LEPs.

B. Conditions

1003. Termination of pregnancy is not deﬁned as a right but as a treatment, offered and permitted upon materialization of certain conditions (set out in Articles 4 and 6 of the statute) and in adherence to the protection of women’s health. The law distinguishes the conditions and the modalities for termination within the ﬁrst ninety days of pregnancy (Articles 4–5) and for termination after that period (Article 6).

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1004. Article 4 permits the termination of pregnancy to a woman who alleges circumstances for which the continuation of pregnancy, childbirth or motherhood would result in a serious threat to her physical or mental health, in relation to:

(a) her state of health; or (b) her economic; or (c) social; or (d) family situation; or (e) to the circumstances in which conception occurred; or (f) to forecasted anomalies or malformations of the embryo.

1005. If attempts to overcome the reasons mentioned supra at 1004 (under b, c, d) fail, then the physician provides a certiﬁcate, signed also by the woman, attesting to the pregnancy and the abortion request. After seven days, the woman can seek the termination of pregnancy at an authorized facility. In case of a medically cer- tiﬁed emergency case, abortion can be performed disregarding the seven-day waiting period.

1006. The contacted physician cannot refuse the certiﬁcate nor can she express in the certiﬁcate an evaluation on the actual existence of the requisites prescribed by law.

C. (So-Called) Therapeutic Termination of Pregnancy

1007. Following the end of the ﬁrst trimester of pregnancy, requirements to obtain an abortion are more stringent and (apparently) objective. Article 6 permits abortion after the ninetieth day of pregnancy only:

(a) when the pregnancy or childbirth constitutes a serious threat to the woman’s life; (b) when ascertained pathological processes, including those related to signiﬁcant anomalies or malformations, that constitute a serious threat to the physical or mental health of the woman are detected.

1008. These conditions shall be ascertained by a physician of the obstetrics and gynaecology service of the hospital in which the abortion should be performed (Article 7, paragraph 1).

1009. Note, however, that the option sub (b) (supra 1007) is excluded in cases where there is a possibility of an independent life for the foetus after the birth. In relation to sub (a) (supra 1007), termination of pregnancy is permitted, but the physician performing the surgery must take all measures necessary to safeguard the life of the foetus (Article 7 last paragraph).

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1010. The enactment of Law 194/1978 – signiﬁcantly entitled Rules for the Social Protection of Motherhood and on Abortion – initially instigated a surge in the number of abortive interventions during the 1980s. This surge was also due to the simple fact that the issue of abortion, previously deemed illegal, had surfaced in a signiﬁcant way. In the following years however the situation stabilized.

D. Father’s ‘Participation’

1011. Article 5 conditions the woman to involve the father of the child in the discussion (paragraphs 1–2) alongside the physician or the public healthcare facility attempting to overcome the reasons sustaining the mother’s choice to terminate the pregnancy (supra 1006 at b, c, and d). In any event, such discussions must be carried out ‘respecting the dignity and privacy of the woman and of the person named as the father of the conceived’.

1012. This almost irrelevant position of the father in the decision-making process is possibly due to the framework of the procedure which is exclusively termed as a medical treatment for the woman (see 1003).

II. Termination of Pregnancy by a Physician

1013. Termination of the pregnancy is performed by a physician affiliated to obstetrics and gynaecology facilities in general hospitals or at private facilities spe- ciﬁcally authorized to terminate pregnancies. The physician must also verify that there are no medical contraindications to abortion (Article 8). Moreover, the physician who performs the termination is required to provide information relating to birth control to the woman in addition to information on the various abortive procedures which have to be implemented in a way that respects the personal dignity of women. In the presence of pathological processes, including those related to anomalies or malformations of the conceived, the physician who performs the termination of pregnancy must provide the necessary information to the woman for the prevention of these processes (Article 14).

1014. Healthcare personnel can declare themselves objectors for moral reasons. Moral objection exempts healthcare personnel from carrying out the procedures and activities speciﬁcally and necessarily designed to terminate the pregnancy, but it does not exempt them from the care antecedent and consequent to the intervention. Furthermore, Article 9 paragraph 4 clariﬁes:

that hospitals and licensed nursing homes are required in any event to ensure the accomplishment of the procedures provided for in Art. 7 and the performance of the interventions resulting in the termination of pregnancy according to the procedures required under Arts 5, 7 and 8.

282 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1015–1019

1015. Finally, according to Article 9 paragraph 5, moral objections cannot be invoked when, given the special circumstances, personal intervention is necessary to save the woman’s life in imminent danger.

III. The (So-Called) Morning after Pill

1016. In 2000 a drug, now commonly known as ‘the morning after pill’ was released onto the market (D. Lgs. on Health 26 September 2000, n. 510 authorizing admission into the market – AIC). It interrupts the process whereby the egg is released into the uterus but is impeded, if the drug is administered within seventy- two hours of the sexual intercourse, from being fertilized. The rate of success is pro- portionally higher the earlier the drug is taken after intercourse. D. Lgs. n. 510/ 2000 was not intended to interfere with or modify Law 194/1978 but TAR Lazio (12 October 201 no. 8465), which was charged with reviewing Decree 510, set the point when the egg nests in the uterus wall as the moment when pregnancy begins. Since 2016 the ‘morning after pill’ has become, for women of age, a drug without the need of medical prescription (AIFA no. 219 of 1 February 2016, published in the Official Gazette no. 52 of 3 March 2016).

IV. Pharmacological Termination of Pregnancy (RU 486)

1017. See also 1016. Although much discussed, the AIFA (Italian Agency for Pharmaceutical Drugs) has authorized the use of RU486 (determination 1460/2009) for use in hospitals within seven weeks from amenorrhea and in respect of the procedures provided for by Law 194/1978.

1018. In 2010, the Ministry of Health transmitted to Regional Health Depart- ments the opinion of the High Council for Health (Consiglio Superiore di Sanità), advising that RU 486 be administered only to inpatients up to the moment of full expulsion of the foetus. Yet, Regions are split among those ones requiring ordinary and lengthy admission to hospital and those permitting day-hospital for administering RU486.

§2. STERILIZATION

1019. Law 194/1978 has abolished the crime of procured inability to procreate along with the entire Title X of Book II of the Penal Code, dedicated to offences against the integrity and health of the race. Even though it is clear that sterilization against an individual’s will is illegal and punishable (Article 582 and Article 583 paragraph 2 no. 3 cp), it is much less clear if, absent a therapeutic need, Article 50 cp decriminalizes the sterilization of a consenting adult. Indeed, Article 5 cc seems to prevent the validity of such consent. For a long time, case law has been split on the matter (see 1021).

Medical Law – Suppl. 119 (2020) Italy – 283 1020–1024 Part II, Ch. 3, Speciﬁc Activities

1020. The possibility of therapeutic sterilization of consenting adults has been admitted, for instance, in case a possible pregnancy – due to heart or kidney disease – may endanger the health or life of the woman (pursuant to Article 50 cp on victim’s consent and 54 cp concerning necessity).

I. Surgical Contraception

1021. The Court of Cassation (Cass. V, 18 March 1987) has admitted the lawfulness of surgical contraception on the assumption that it does not create a permanent impairment, as described by Article 5 cc, but can rather improve the mental health of an individual voluntarily seeking the sterilization. The arguments follow the lines already covered for therapeutic sterilization (see supra 1020).

1022. Yet, surgical contraception remains illegal if it is related to those mutila- tions that are prohibited by Article 583bis cp (mutilation of female genitals). The latter punishes ‘anyone who, in the absence of therapeutic needs, causes a mutilation of female genitals (clitoridectomy, excision and inﬁbulation and any other practice which causes effects of the same kind) or causes, in order to impair the sexual functions, any other injury to female genital organs other that which cause an illness in body or mind’.

II. Sterilization of Mentally Handicapped

1023. Sterilization against individual will is a serious personal injury punishable according to Article 583 paragraph 2 cp. It runs against Article 33 Law 833/1978 (see supra 669ff).

1024. According to the NCB (National Bioethics Committee, The bioethical issue of non-voluntary sterilization, 20 November 1998) forced sterilization, both in juridical and ethical terms, is always to be considered illicit. The NCB stigma- tizes in particular:

– ritual sterilization, because the respect due to all cultures does not imply acceptance of practices which affect the corporeality of the human person in a coercive and irreversible manner, depriving its identity of an essential dimension; – the sterilization of criminals, inﬂicted on those who have committed sex crimes, based on principles concerning the integrity of the body of the offender and non- discrimination between innocence and guilt; – demographic sterilization, considering that the implementation of this policy resorts directly or indirectly to coercive techniques, it is to be condemned on bioethical grounds, as it is an offence to human dignity and a person’s fundamental rights; – eugenic sterilization, especially of the inﬁrm, as it does not respect the dignity of the person with disabilities, as it is motivated by the intent to facilitate or econo- mize on the activity of caring for the actual patient.

284 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1025–1028

§3. MEDICALLY ASSISTED CONCEPTION

I. Legal Framework

1025. There is no doubt that the background for medically assisted conception is related to the constitutional principles protecting health and dignity. However, in addition, Italy has a (much discussed) statutory framework that was introduced only in 2004 with Law no. 40 of 19 February and the subsequent implementation of various decrees. The goal of medically assisted conception is, in the words of the named statute, ‘To facilitate the solving of problems arising from human reproductive sterility or infertility’ while the law is intended to ‘ensure the rights of all parties involved, including the conceived’.

1026. Access to the practice is permitted only ‘when it is found impossible to remove otherwise the causes that are hindering procreation and is in any case limited to cases of sterility or unexplained infertility documented by a medical report and to cases of sterility or infertility due to an ascertained cause and certiﬁed by a medical report’ (Article 4). These objective criteria seem to preclude access to couples that are not sterile or infertile but, for instance, have a transmissible genetic disease, the transmission of which would be prevented if conception were medically assisted (but, contrary to this, see, for instance, Trib Salerno, 9 January 2010, in Famiglia e minori, 2010, p 13). It should be noted that the Constitutional Court, with judgment no. 162 of 9 April – 10 June 2014, declared the constitutional illegitimacy of article 4, paragraph 3 of Law no. 40 of 19 February 2004 (Rules on medically assisted procreation), ‘in so far as it establishes for the couple referred to in Article 5, paragraph 1, of the same law, the prohibition of the use of medically assisted heterologous procreation techniques, if a pathology that is the cause of absolute and irreversible sterility or infertility has been diagnosed’. Furthermore, the Constitutional Court, with judgment no. 96 of 14 May – 5 June 2015, declared the constitutional illegitimacy of article 1, paragraphs 1 and 2, and article 4, paragraph 1, of the same statute, in so far as they do not allow the use of medically assisted procreation techniques to fertile couples carrying transmissible genetic diseases, in accordance with the criteria of seriousness set forth in article 6, paragraph 1, letter b), of law 22 May 1978, no. 194 (on the voluntary interruption of pregnancy).

1027. With reference to subjective criteria for access (Article 5), it is only permitted to ‘couples of age and older of different sexes, married or cohabiting, of childbearing potential, both alive’. The last requirement precludes post-mortem medically assisted conception. The statutory provision is generic. However, case law (TAR Lazio, 21 January 2008, no. 398) has clariﬁed that the requirement that both members of the couple be alive refers to the period in which procedures are instigated since Article 14 paragraph 1 forbids embryo destruction and Article 6 paragraph 6 forbids the withdrawal of consent (after the fertilization of the egg).

1028. Indeed, joint, written, informed consent of the couple is necessary. Not more than seven days should pass between the manifestation of the will and the application of medical assistance. Article 6, in requiring it, speciﬁes in great detail

Medical Law – Suppl. 119 (2020) Italy – 285 1029–1033 Part II, Ch. 3, Speciﬁc Activities the information, additional to the one normally provided for medical treatment, to be offered to the couple. It requires the physician to inform the couple ‘in detail [about the] methods, bioethical issues and possible health and psychological side- effects arising from the application of the techniques themselves, and on the probability of success and the risks deriving from them, as well as on the legal consequences for the woman, for the man, and the unborn child’.

1029. In addition, the couple should be given the option of resorting to procedures for adoption or of child entrustment under the law as an alternative to medically assisted procreation. In addition, applicants – at the time of access to the techniques of medically assisted procreation – must be made aware of – and sub- scribe to – the legal consequences of Article 8 and Article 9 of the law (respectively, the children born have the status of ‘children born into marriage’ or children recognized as the couple’s barring any denial of paternity or requests of anonymity by the mother). See 747.

1030. The original text of the law prevented the production of more than three implantable embryos. However, the Constitutional Court (8 May 2009, no. 151) has declared the aforementioned restriction to three embryos illegitimate as contained in paragraph 3 of Article 14, ‘in so far as it does not provide that the transfer of the embryos to be implemented as soon as possible, as stated in this rule, must be made without prejudice to the health of the woman’.

II. Use of Donor Gametes

1031. Before the intervention of the Constitutional Court, the law forbade the use of techniques of heterologous medically assisted procreation (Article 4). Yet, the statute did not sanction any couple that avails of such treatment, perhaps on the assumption that the intervention will in any case take place abroad. After the mentioned (see 1026) interventions of the Constitutional Court, the use of donor gametes is permitted.

1032. Article 9 paragraph 1 prevents the spouse or partner, whose consent emerges from conclusive acts, to bring an action for denial of paternity (in the cases envisaged in Article 235, ﬁrst paragraph, points 1 and 2 and in Article 263 cc) if recourse is made to techniques of heterologous medically assisted procreation. Moreover, in case of application of heterologous techniques, ‘the donor of gametes does not acquire any legal parental relationship with the born child nor do rights or obligations ensue’ (Article 9 last paragraph). See also 1035.

1033. Children in any event acquire the status of children born into marriage or recognized natural children of the couple utilizing the technique.

286 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1034–1038

III. Surrogacy

1034. Law 40/2004 deals with surrogate maternity even though it does not deﬁne it. Article 12 paragraph 1 expressly punishes it sanctioning ‘anyone in any capacity’ who ‘uses – for procreation – the subrogation of motherhood’ with imprisonment between three months and two years and with a ﬁne ranging from EUR 300,000 to EUR 600,000.

1035. Also, Article 12 paragraph 6 punishes, with imprisonment from three months to two years and a ﬁne ranging from EUR 600,000 to EUR 1 million, anyone who in any form, ‘produces, organises or advertises the marketing of … surrogacy’.

§4. HUMAN GENETICS

I. Overview and Possibilities

1036. Genetic tests are not prohibited in general. On the contrary, they have been admitted in relation to Law 194/1978 (see Cass. 1488 29 July 2007 recognizing the causal link between ascertaining serious pathologies in the foetus and the choice to have an abortion), and Article 6 Law 104/1999 (stipulating that the Regions mush provide ‘services related to genetic counselling and prenatal diagnosis with a view to preventing genetic disorders that can cause physical, mental, or sensory neuromotor diseases’. However, see also the Supreme Court case conﬁrm- ing that eugenic abortion remains forbidden: Cass. 14 July no. 16123/2006).

1037. Nonetheless, some problematic restrictions emerge in cases concerning in vitro tests on embryos. Indeed, among the explicit statutory prohibitions, we ﬁnd that prohibiting ‘any form of eugenic selection of embryos and gametes’ (Article 13 paragraph 2 lett. b; see also 1150). If an analysis of pre-implantation (still on the embryo in vitro) reveals a sick embryo, the law literally requires its implant. How- ever, if the embryo roots and the foetus develop, it remains the right of the mother to have an abortion, revealing a clear contradiction in the Italian legal system. How- ever, following the Constitutional Court decision 151/2009, an implant is prevented if it can create risks for the mother’s health. Thus, the contradiction has been solved (once again) by case law with a systemic and constitutionally oriented reading of the system. Finally, the Constitutional Court intervened on this point, with judgment no. 229 /2015 (declaring the constitutional illegitimacy of Article 13, paragraphs 3, letter b), and 4 of Law 40/2004, in the part in which they contemplate as a crime the conduct of selection of the embryos also in the cases in which this is exclusively ﬁnalized to avoid the implantation in the uterus of the woman of embryos affected by transmissible genetic diseases meeting the criteria of gravity as per Article 6, paragraph 1, letter b), of Law n. 194/1978.

1038. Furthermore, the law prescribes that produced embryos shall ‘always’ be implanted, a prescription that is now limited by the decisions of the Constitutional

Medical Law – Suppl. 119 (2020) Italy – 287 1039–1041 Part II, Ch. 3, Speciﬁc Activities

Court (see 1025–1037). Accordingly, only observational pre-implant tests have been permitted by case law and by the 2004 guidelines (subsequently reformed in 2008) implementing Law 40/2004. Genetic screening tests, thus, were not permitted. Yet, later case law (Trib. Cagliari 22 September 2007 and Trib. Firenze 19 December 2007) declared pre-implant genetic tests permissible grounding the result on a constitutionally oriented reading of Law 40/2004. In 2007, the TAR Lazio (no. 398) invalidated the 2004 guidelines precluding genetic tests. Consequently, the 2008 guidelines (DM 11 April 2008) amended the original ban for in vitro tests (See also 1149).

1039. Pursuant to Article 12 paragraph 7:

Anyone who performs a process aimed at creating a human being descending from a single starting cell, and, with regard to nuclear genetic genes considered potentially identical to another human being, either alive or dead, shall be punished with imprisonment from ten to twenty years and a ﬁne ranging from 600,000 to one million euro. The physician is also punished by way of per- petual disqualiﬁcation from practice.

§5. REMOVAL AND TRANSPLANTATION OF ORGANS AND TISSUES

I. Scope of the Organ Transplantation Law

1040. Article 5 cc provides that ‘Acts causing harm to one’s own body are prohibited when they cause a permanent diminution of physical integrity or are otherwise contrary to law, public order or morality.’ In principle, this permits any other harmful act. Subsequent statutes provided for select organ donations and sampling (see infra) but it was only with the Law of 1 April 1999, no. 91 (‘Provisions for Removal and Transplantation of Organs and Tissues’) that the development of the transplant network became an objective of the NHS. After this statute, the existing Italian Transplant Network was consolidated with the National Transplant Centre and divided into four national, interregional, regional and hospital/authority levels (see the State-Regions Agreement of 13 October 2011) positively affecting the culture of donation and placing the Italian National Transplant System among the ﬁrst in the European rankings for quality, safety and efficacy.

1041. Article 3, paragraph 8bis of D.L. 30 December 2009, no. 194, converted into Law 26 February 2010, no. 25 (the so-called decree of a ‘thousand exten- sions’), provides that a citizen’s identity card may contain information on one’s consent or objection to the donation of organs and tissues.

288 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1042–1048

II. Removal of Organs from Living Donors

A. The Organ Transplantation (Donation) Law

1. General Conditions

1042. In Italy, organ and blood donation is grounded on the principle of solidarity. Accordingly, the whole community is called to cooperate. Thus, for instance:

– employed donors are entitled to paid leave the day of donation (partially paid by the State; Article 8 l. 219/2005); – all kidney donors and liver lobe donors are entitled to welfare beneﬁts provided for by law whether they are self-employed or employed. They are also insured against immediate and future risks associated with the surgical intervention and the disability suffered (Article 5 l. 458/1967); – procedures for donation are exempted from registration tax and stamp duty.

1043. Organ and blood commerce is illegal and criminally sanctioned (in the case of blood, the donor is also sanctioned, whereas in relation to liver and kidney commerce, prosecution is reserved to the middleman. See Article 22 Law 219/2005 and Articles 6ff Law 458/1967).

1044. While blood donation cannot have a speciﬁc addressee, kidney donation must include the designation of the intended recipient.

2. Minor Donors

1045. Article 3 paragraph 3 Law 91/1999 sets out that ‘for children under the legal age declaration of intent regarding the donation is manifested by parents exercising parental authority’. In case of disagreement between the concerned parents, manifestation of willingness to donate is not possible. The manifestation of will to donate to unborn children for those that would not be competent to act for minors entrusted or admitted to public or private institutions is not permitted.

1046. See also supra 875 for minors’ consent to placenta donation.

3. Informed Consent

1047. Informed consent is always revocable up to the moment of removal. Since the law only requires legal age and ability of discernment, in principle it seems that legally incapacitated individuals can donate.

1048. See also 901ff.

Medical Law – Suppl. 119 (2020) Italy – 289 1049–1055 Part II, Ch. 3, Speciﬁc Activities

4. Special Cases – Kidney

1049. By way of derogation from the prohibition laid down in Article 5 of the Civil Code, it is possible to donate – for free – a kidney for reasons of transplantation between living persons. Only parents, children, and blood-related siblings of the patient that are of majority age, subject to compliance with the procedures prescribed by law, may donate a kidney. Derogation from this general rule – permitting donation by other relatives or unrelated donors – is allowed only in cases where the patient does not have these relatives or where none of them are appropriate or available (Article 1 l. 458/1967).

1050. Planned removal and assignment of one’s kidney in favour of a given patient must be submitted to the court of the place of residence of the donor or the seat of the Institute that approved the transplant. Permission is conditioned on the age of majority of the donor, her possession of the ability of discernment, her knowledge of the limitations of the treatment of kidney transplant from a living donor, and that she is aware of the consequences that her personal sacriﬁce entails.

1051. The court must also ascertain that the donor has decided to donate a kidney freely and spontaneously.

1052. Kidney donation is a gratuitous act and does not tolerate the attachment of conditions or other ancillary determinations of will. Indeed, and in fact, any private stipulation providing for monetary compensation or other beneﬁts in favour of the donor, in an attempt to urge her to donate, is void and of no effect (Article 6 Law 458/1967).

1053. The decision to donate is revocable up to the time of surgery and does not give rise to any rights in favour of the donor. Of course, the patient must consent to the transplant, except in cases of emergency. – Liver

1054. Partial liver transplantation between living persons is allowed in derogation from the prohibition laid down in Article 5 cc.

1055. Liver donation is considered a gratuitous act and adheres – insofar as compatible – with the provisions of Law of 26 June 1967, no. 458 (the rules for kidney donation for transplant between living persons; Law 483/1999 see 1049–1053).

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– Cornea

1056. Pursuant to Article 3 of Law 301/1993, removal of the cornea is performed by medical personnel, in respect of the corpse, in public and private healthcare facilities as well as at home. The cornea grafts are made in public and private health facilities and do not require any special authorization.

1057. Pursuant to Article 6-bis of Law 91/1999, cornea donation is gratuitous. The removal of corneas from cadavers is permitted after obtaining the consent of the spouse where the couple have not been legally separated or, failing that, of children of age less than 18 years or, in the absence of the latter, the parents of the deceased donor unless there is clear written evidence of a refusal to donate. For interdict persons (i.e., individuals to have legally lost their mental capacity and are therefore debarred) and for minors, assent is expressed by legal representatives. However, Law 91/1999 provided for (Article 27, paragraph 2) the repeal of Article 1 of Law of 12 August 1993 no. 301, from the date envisaged by the opt-out system (see 1080, 1081, 1083) and ‘from the date on which the activation of the information system of transplants provided for in Article 7 is foreseen’.

5. Duties of the Physician Removing Organs

1058. Removal shall be performed in such a way as to avoid unnecessary mutilation or dissections. After extraction of the organ(s), the corpse must be reas- sembled with the utmost care (Article 4 paragraph 1 Law 91/1999).

1059. Pursuant to Article 14 of Law 91/1999, the medical board ascertaining death referred to in Article 2, paragraph 5, of Law of 29 December 1993, no. 578, must prepare a report on the death where authorization to extract organs has been granted.

1060. The medical team that proceeds with the extraction is required to prepare a report of the procedures for ascertaining the intention expressed by the subject while alive on the removal of organs as well as of the modalities of the removal. The two medical teams, i.e., the one performing the extraction and the one ascertaining the intention of the donor, must be different (Article 18 paragraph 1).

1061. Moreover, the medical and administrative personnel involved in extraction and transplant activities are required to guarantee the anonymity of the data relating to the donor and the recipient (Article 18 paragraph 2 l. Law 91/1999).

B. Therapeutic Substances of Human Origin

1062. Law 91/1999 provided rules concerning the therapeutic use of human tissue and organs. D.L. 191 6 November 2007 (transposing European Directive 2004/

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23/EU) imposed quality and safety standards related to processes involving human tissues and cells intended for human application. The subsequent D.L. of 25 Janu- ary 2010, no. 16 (implementing Directives 2006/17/EC, 2006/86/EC, and 2004/23/ EC) deﬁned (amending Law 91/1999) the technical requirements for the donation, procurement and testing of human tissues and cells, as well as requirements in terms of traceability and notiﬁcation of serious adverse reactions and events.

1063. Article 5 of D.L. 6 November 2007, no. 191 provides that the procurement and testing of human tissues and cells must be undertaken by the staff meeting the requirements of current legislation. In addition, they must have appropriate training and experience in the ﬁeld approved by the Regions and Autonomous Prov- inces.

1. Stem Cells and Cord Blood Banks

1064. Article 12 of D. Lgs. 6 November 2007, n. 191 (implementing Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells) establishes the general principle according to which the donation of tissues and cells must be voluntary and free. It also commands (Article 13) that all the requirements of the regulations for informed consent, expression of will and authorization for donation are met. The Ministry of Health, in agreement with the Per- manent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano, has established the necessary measures to ensure that donors, their relatives or any person that grants donation authorization on behalf of donors receive, in addition to all the information required by law, that explicitly laid down in the Annex to L/D. 191/2007.

1065. The principle of voluntary (and informed consent) and gratuitous donation is also conﬁrmed for donations of the placenta and blood from the umbilical cord (Article 3 paragraph 3 Law 219/2005; see also 676, 898, 1074).

1066. All collected data, including genetic information, to which third parties have access, must be made anonymous so that neither donors nor recipients remain identiﬁable. Furthermore, the identity of the recipient is not revealed to the donor or her family and vice versa (Article 14).

1067. Cord Blood Banks are organized in a national network (the Italian Cord Blood Network (ITCBN), instituted by DM 18 November 2009. Their legal framework establishes minimum organizational, structural and technological requirements (see State-Regions Agreement of 29 October 2009).

1068. Article 6 of D. Lgs. 6 November 2007, n. 191 provides that tissue banks (institutions in the legislative language) – in which activities related to testing, processing, preservation, storage or distribution of human tissues and cells intended for

292 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1069–1071 human application – must be licensed and accredited by the Regions and Autono- mous Provinces. The State-Regions Agreement of 20 April 2011, set the Guidelines on the accreditation of blood banks (pursuant to D.L. 191/2007) according to international and national standards. Regions and Autonomous Provinces can suspend or revoke the authorization and accreditation of a biobank or of a single procedure associated with the preparation of tissues and cells if an inspection or control measure – implemented pursuant to Article 7 of Law 191/2007 – demonstrates that a particular biobank or process does not meet the requirements.

1069. In the absence of a more organic regulation, several emergency interventions have ﬁlled the gap (see Ordinance 11 January 2002, and 4 May 2007 according to which allogeneic donation is always permitted for charitable purposes pursuant to Article 3, paragraph 3 of Law no. 219/2005) albeit restricted to public facilities (Article 3 DM 18 November 2009). The autologous storing of cord blood in Italy, however, is forbidden (Article 2 paragraph 8 DM 18 November 2009) even though the transfer abroad of such blood (Article 3 DM 18 November 2009) for personal use – upon approval of the child delivery healthcare facility and of the National Centre for Transplantation – is permitted.

1070. According to Article 2 paragraph 3, the storage of cord blood intended for use in families posed with a risk of having a child affected by genetically determined diseases for which the use of stem cells from cord blood has been deemed scientifically and clinically appropriate is permitted upon the presentation of a reasoned clinical care document issued by a medical specialist in the relevant clinical field. A list of these genetically determined diseases is periodically updated, although it is possible to obtain storage in cases of specific diseases not yet included in the mentioned list. Today in Italy, there are public and private banks for the preservation of cord blood. The donation to public banks is based on principles of solidarity with the aim of saving the life of any person who is compatible with the unity. Private banks store cord blood for the donor or a member of his family. Private banks do not follow the same stringent acceptance criteria as public banks and can therefore also store cord blood units that do not meet the critical characteristics (volume and number of cells) that are necessary to be able to perform a successful transplant for a future adult patient.

2. Transfusions and Blood Donation

1071. The national blood system, as designed by Law no. 219 of 21 October 2005, operates in synergy with various actors: National Institutions, Regions, Asso- ciations and Federations of voluntary blood donors, and scientiﬁc associations. Within the system, the principle of national and/or regional self-sufficiency applies. According to this, a programme has been set up that indicates the regional and national need for blood in consideration of past experience, real needs, necessary levels of production, the resources, the criterion of system ﬁnancing, the methods

Medical Law – Suppl. 119 (2020) Italy – 293 1072–1077 Part II, Ch. 3, Speciﬁc Activities related to interregional and intra-regional compensation, and the import and exportation levels that could be necessary for the country. The aim of the norm is to guarantee to all citizens equal quality and security in transfusion therapy. The Ministry of Health, according to the methods established through speciﬁc normative decree, must authorize the importation and exportation of blood and it must have the consulting approval of the National Commission for Transfusion Service (D.M. 7 Sep- tember 2000).

1072. In general, blood services (donation and transfusion) are regulated by a complex set of provisions under both National and European Law. Law no. 219 of 21 October 2005 profoundly reorganized the national blood network, deﬁned its basic principles and strategic objectives. It introduced, though respecting regional competences, several innovations: it established both national and regional bodies (the National Blood Council CNS and the Regional Blood Coordinating Centres (Strutture regionali di coordinamento, SRCs); it included blood services in the deﬁ- nition of LEA; and it provided recommendations for the reassessment of requirements for authorization and accreditation facilities.

1073. The same statutes set the strategic goals of the system focusing on blood and blood product self-sufficiency at both regional and national levels, high levels of quality and safety of products and services provided by the blood system, appropriate management and clinical use of blood resources as indivisible and supra- regional interests that the Regional and the National Health Authorities shall cooperatively pursue.

1074. Blood and blood product donation are based on the ethical principle of voluntary, regular, responsible and non-remunerated donation (Law no. 219, of 21 October 2005). Any person of at least 18 years can donate after expressing informed consent and their condition to donate has been veriﬁed.

1075. All the above are in line with national laws transposing European Direc- tives on blood, blood components and blood medical products.

1076. Overall, the production and transfusion of data related to the use of the three main components of blood transfusion (red cells, platelets and plasma) are substantially in line with the average of similar data in European countries comparable to Italy in relation to the socioeconomic level.

1077. Donation of blood or blood components, as well as the removal of peripheral hematopoietic stem cells (with a view to allotransplantation and autotransplantation) and hematopoietic stem cells from umbilical cord blood, is permitted within the facilities expressly authorized by the Regions (Article 3 of Law 219/2005).

294 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1078–1083

3. Bone Marrow

1078. Bone marrow donation is mostly regulated by Law 6 March 2001, no. 52 pursuant to which it is voluntary and gratuitous (Article 4). It is open to citizens of legal age, enrolled in the special National Register of bone marrow donors that have been subject – at an enabled facility – to peripheral blood sample for the deﬁnition of the HLA genetic system.

1079. Bone marrow donors enjoy the same rights as blood donors (Article 5 Law 52/2001) for the period required by the procedures established by law. See 1042ff. In details, bone marrow donors with an employment relationship are entitled to paid leave for the time they need to carry out the following acts: (a) sampling for the purpose of identifying genetic data; (b) samples necessary to deepen compat- ibility with patients waiting for a transplant; (c) verification of suitability for donation. Furthermore, the donor is also entitled to maintain normal remuneration for the days in hospital necessary for the removal of bone marrow blood, carried out under hospitalization and for those following the donation, for the complete restoration of his or her physical state, as certified by the medical team that carried out the bone marrow sampling. Relevant social security contributions are credited in accordance with Article 8 of the Act 23 April 1981, no. 155. To this end, the employer is certified, by the services that have rendered the health services, access and practices relating to the procedure of donation to which the dependent marrow donor has been subjected.

III. Removal of Organs after Death

A. (Incomplete) Opting-Out System

1080. Law 91/1999 regulates the removal of organs and tissues from a person whose death has been ascertained pursuant to Law 578/1993. It regulates the activities of sampling and tissue transplantation and removal and transplantation of organs. This discipline also applies to living persons, to the extent compatible.

1081. Article 4 of Law 91/1999 provided for a procedure of silent approval. According to this, ‘citizens are required to declare their free will in order to donate organs and tissues of one’s own body after death and are informed that the non- declaration of intent is considered as consent to donation’.

1082. Those who have not declared their intention to donate as prescribed by law, are regarded by the law as non-donors.

1083. In practice and despite several secondary legislative attempts to implement the rule (notiﬁcation of a blue card for donation, required inscription on identity cards), there is still some confusion on the practicality of the presumptive will to donate. Therefore, the traditional provisions set out in Article 23 Law 91/1999

Medical Law – Suppl. 119 (2020) Italy – 295 1084–1088 Part II, Ch. 3, Speciﬁc Activities maintain a signiﬁcant role – in all cases where there is no record of a positive declaration or a written objection – for the period corresponding to the period of observation after the death of the patient. See 477ff; see 1085ff.

B. Ways to Object

1084. If the data entered into the information system of transplants referred to in Article 7 Law 91/1999 shows that the person has been informed of the presumption of law, then the removal is permitted unless, within the period of observation that must be observed before a death can be pronounced, a handwritten statement of intention contrary to the removal is presented. See 1085ff.

C. Establishment of Death

1085. Today, the law (Article 1 Law 578/1993 and the implementing regulation DM 22 August 1994 582 as amended by DM 11 April 2008) provides only one deﬁ- nition of death: ‘Death is identiﬁed by the irreversible cessation of all encephalic functions.’ Prior to this statute, the laws only made reference to criteria referring to Article 2 (paragraphs 1 and 2):

(1) Death from cardiac arrest is said to have occurred when breathing and circulation have ceased for a period of time long enough to result in the irreversible loss of all encephalic functions and can be ascertained with the procedures laid down by decree of the Minister of Health [electrocardiogram for at least 20 minutes pursuant to Article 1 DM 22 August 1994 582]. (2) Death of patients with encephalic injuries and submitted to resuscitation measures is said to have occurred when there is irreversible cessation of all encephalic functions and is established by the clinical-instrumental procedures deﬁned by the decree of the Minister of Health.

1086. If neither procedure (see 1085) is followed (Article 4 Law 578/1993) ‘nobody can be closed in a coffin, subjected to autopsy, a preservative procedure, cold storage, be buried, entombed, or cremated earlier than twenty-four hours from the time of death, except in cases of decapitation or mangling of the body’. This is in line with Article 8 of Law 285/1990.

1087. In cases of cornea donation, death can be ascertained as well by electrocardiogram for at least twenty minutes (see Article 2 paragraph 2 Law 301/1993).

1088. With reference to the death of individuals, Law 578 of 1993, on ascertaining brain death, regulates the procedures to be followed in cases where a patient is in intensive care in a critical condition. When there is the simultaneous presence of a state of unconsciousness, absence of stem reﬂexes, brain electrical silence, the anaesthetist on-duty or the department manager must request the establishment of a medical panel consisting of three specialists (a resuscitator, a forensic scientist and

296 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1089–1093 a neurophysiologist). The panel of specialists proceeds to the observation of the patient according to a protocol established by law. The periods of observation (Article 4) depends on the age of the patient: twenty-four hours if the patient is younger than 1, twelve hours if between 1 and 5 years, and six hours after 5 years.

1089. During the period of observation, death is established when the simultaneous presence of the following conditions is detected:

(a) absence of a state of vigilance and consciousness; (b) the absence of brainstem reflexes: photo-motor reflex, corneal reflex, reactions to painful stimuli on the trigeminal nerve area, motor response in the territory of the facial stimulus painful applied everywhere, vestibular ocular reflex, gag reflex, cranial reflex; (c) absence of spontaneous breathing with documented values of arterial CO2 not less than 60 mmHg and blood pH of not more than 7.40, in the absence of artificial ventilation; (d) absence of brain electrical activity, documented by an EEG performed according to the technical modalities set out in Annex 1 to this Decree, of which it is an integral part; (e) absence of brain blood flow documented previously in special situations envisaged by Article 2, paragraph 2 (Article 3 DM 11 April 2008).

1090. It is worth noting that the technical conditions for ascertaining death are set by secondary regulations pursuant to primary legislation.

D. Special Cases (Prohibitions in Law 91/1999)

1091. The withdrawal of the gonads and of the brain is prohibited (Article 3 paragraph 3 Law 91/1999).

1092. Article 19 (paragraphs 2 and 4 respectively) forbids the export of organs and tissues to States that permit the free trade and import of tissues and organs for transplant and to States whose legislation provides for the possibility of withdrawal and relative sale of organs from cadavers of people sentenced to death.

E. Anonymity

1093. See supra 1061.

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F. Autopsies

1094. Where possible, the authorities can request an autopsy. The removal of organs for donation can be conducted prior to an autopsy upon authorization of the competent Public Prosecutor.

§6. RESEARCH

I. Research with Human Beings

A. Field of Application

1095. The legal (and ethical) foundations of research are the same as those related to medical activity: protection of the fundamental right to health contained by Article 32 Const. and international charters (see also 1099f). Research and experimentation with human beings is legitimate when implementing Article 32 Cost. Consequently, participation in a trial is designed as a right that expresses a healthcare need in the absence of certainty in traditional treatments for the given case. It is permissible insofar as is essential for the protection of the fundamental right to health.

1096. The distinction between therapeutic trials and experimental treatments followed by the physician in a specific attempt to benefit a given patient (for instance, the use of adult drugs for children) must be borne in mind. Indeed, a specific legal framework exists only for pharmaceutical experimentation (extended to medical devices). Nevertheless, the secondary legislation defining the minimum requirements for ethical committees (DM of health of 12 May 2006 and further modifications) expressly states that ‘The minimum requirements set out in this Decree are for reference, as applicable, for evaluations regarding biomedical research and healthcare, as well as for evaluations of the trials with medical devices referred to in D. Lgs. n. 46 of 24 February 1997 and L. D. 14 December 1992, no. 507’ (Article 11).

1097. It extends the role of ethical committees to experimental treatments (as deﬁned supra 1096) insofar as they are able to produce new knowledge capable of being generalized in clinical practice.

1098. It is also difficult to distinguish between (pure) research (scientiﬁc experiments) and therapeutic experimentation since in the medical area it is difficult to distinguish between them in practical terms. For instance, research on stem cells poses legal and ethical issues also in the preclinical phase. Nevertheless, and to the extent feasible, here we will mostly focus on therapeutic experimentation on human beings using the term ‘clinical trials’ in order to encompass those instances in which human beings (healthy or otherwise) are involved in the experimentation but do not necessarily beneﬁt individually.

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B. General Provisions Concerning the Protection of Subjects of Experiments

1099. The actual national general legal framework relies mostly on D. Lgs. n. 211/2003 and 200/2007 implementing EU directives on pharmaceuticals, D. Lgs. n. 219/2006 implementing Directive 2001/83/EC and Directive 2003/94/EC. All these legal rules have been amended and modiﬁed over the years. In addition, M.D. of 12 May 2006 on basic requirements for ethical committees for medical drugs trials must be recalled. Furthermore, Article 3 paragraph 3 of D. Lgs. n. 200/2007 states that ‘Clinical trials are carried out in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association, (1996) and in compliance with the standards of good clinical practice and applicable regulatory requirements.’ Although, technically not binding in Italy (see 877) the Oviedo Convention on Human Rights and Biomedicine (see supra 674) offers principles of clear relevance to which the above-mentioned Ministerial Decree of 2006 makes express reference: The ethical, scientiﬁc and methodological evaluation of clinical trials by the ethics committee has as a reference the provisions of D. Lgs. n. 211 of 2003, the Hel- sinki Declaration in its latest version, the Oviedo Convention, the mentioned standards of good clinical practice and the updated guidelines of the European Agency for the Evaluation of Medicinal Products concerning the evaluation of the effectiveness of clinical trials. In this context, the rights, safety and well-being of individuals involved in the study are the most important considerations and should prevail over interests of science and society.

1100. Several provisions of the legislation implemented for drugs experimentation has been extended to other areas of biomedical research to the extent they are compatible.

1101. The rules for medical devices are rather complex and are mainly contained in D.L. 507/1992 concerning active implantable medical devices and D.L. 46/1997 for all other medical devices. Law 37/2010 implementing Directive 2007/ 47/EC modiﬁed both these statutes. Law 3/2018 (Article 1) delegated the Govern- ment to adopt one or more legislative decrees for the reorganization and reform of the current provisions on clinical trials on medicinal products for human use, achieving the necessary coordination with the current provisions and with Regula- tion (EU) no. 536/2014 of the European Parliament and of the Council of 16 April 2014. The delegation was mainly implemented by Legislative Decree no. 52 of 14 May 2019. This last amended several articles of various statutes on clinical trials especially to take into account the importance of gender medicine.

1102. All in all, the general framework:

– creates a positive duty to follow the principles of GCP; – prescribes the following of all the legal rules required to obtain authorization to produce and market new drugs;

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– requires previous authorization by an ethical committee set up according to the MD of 2006 (supra 507); – subjects both the experimentation and production of drugs to a system of controls; – puts in place a penalties system so as to protect the rights of individuals subject to experimentation procedures (however this applies only to drug testing).

1103. Social sanctions (refusal to publish results in violation of the prescribed norms) and professional ones remain an important element of the system.

1104. The CME as well devotes speciﬁc rules to experimentation. Article 48 CME on Biomedical research and human experimentation reads:

The Doctor carries out on humans the experiments supported by scientiﬁcally based protocols and inspired by the principle of safeguarding life and psychophysical integrity and in respect of the dignity of the person. Human experimentation is subject to the written informed consent of the person recruited and the simultaneous and appropriate information of the family doctor indicated by him or her. The physician shall inform the recruited subject about the purposes, methods, foreseeable beneﬁts and risks, without prejudice to the right of the recruited subject to interrupt the trial at any time, guaranteeing in any case continuity of care. In the case of a minor or incapacitated person, the trial is allowed only for preventive or therapeutic purposes related to the existing pathological condition or its evolution. The physician shall document the minor’s wishes and take them into account [see supra 895].

Every kind of experimentation, including clinical trials, needs to be programmed and implemented according to appropriate protocols within the existing legal framework and having received prior approval by an independent ethics committee.

1105. Article 49 CME deals with clinical trials and provides that experimentation can be included in diagnostic and/or therapeutic treatments, only if it is ratio- nally and scientiﬁcally capable of being of diagnostic or therapeutic use for those interested citizens. In line with the Helsinki Declaration, paragraph 2 further requires that ‘The drafting of the ﬁnal report of an experiment is the exclusive and non-delegable competence of the investigating physician.’ Paragraph 3: ‘The physician shall ensure that the person recruited is not deprived of established treatments essential to maintaining or restoring the state of health.’

1106. Finally, Article 50 of the CME on animal experiments stipulates that physicians shall carry out animal testing in accordance with the regulations and shall pursue the use of appropriate methods and means to avoid unnecessary suffering. Article 50 last paragraph states expressly that the above is without prejudice to the rules on moral objection. Please note that law 3/2018 (Article 2, paragraph 12) provides that from the date of entry into force of the decrees referred to in paragraphs 5 and 7 of Article 2, the decree of the Minister of Health of 23 November 1999, published in the Official Gazette no. 21 of 27 January 2000, as well as articles 6, 7,

300 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1107–1110

8 and 9, paragraphs 9 and 10, of Legislative Decree 211/2003 are repealed. To date, however, not all implementing decrees have been promulgated.

1. Respect for Ethical and Scientiﬁc Quality Requirements

1107. All research protocols are required to abide by ethical rules and scientific quality requirements. The laws (Article 3 paragraph 3 D. Lgs. n. 200/2007) refer to the guidelines for GCP, defined in their introduction (p. 5) as ‘an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Dec- laration of Helsinki, and that the clinical trial data are credible’. The GCP aims at protecting fundamental rights of individual subjects while ensuring scientific quality of the research. The law fosters these goals by requiring that the trial is ‘conducted in accordance with the protocol that has previously received the favourable opinion of an independent ethics committee’.

1108. The protocol ‘deﬁnes, among other things, the criteria for inclusion and exclusion of clinical trial subjects, the monitoring, and the aspects relating to the publication of data’. Indeed, the investigator and the sponsor are called to ‘take into account all the information concerning the starting and implementation of clinical trials expressed by the Ethics Committee and the Competent Authority’ (Article 3 paragraph 7 D. Lgs. n. 200/2007).

1109. Scientiﬁc quality is also guaranteed by two requirements provided for in Article 3, paragraphs 8 and 9, of D. Lgs. n. 200/2007. Anyone who leads or participates in the realization of a trial must be fully qualiﬁed with regard to education, training and experience to perform their tasks. In addition (paragraph 9), the protocol must establish ‘pre-determined procedures and mechanisms to be complied with in order to ensure the quality of every single aspect of the trial’.

1110. Quality and scientific appropriateness is also assured by the duty to record, process and store all clinical trial information ‘in such a way that it can be communicated, interpreted and verified accurately’ (Article 3, paragraph 10). The investigators must ensure as well that all investigational products are manufactured, managed and stored in accordance with applicable standards of good manufacturing practice. They must be used in accordance with the approved protocol (paragraph 11). Law 3/2018 provides among its guiding criteria: ‘f) without prejudice to the guarantee of maintaining high quality standards, simplification of procedures for the use for clinical research purposes of biological or clinical material remaining from previous diagnostic or therapeutic activities or for any other reason held, subject to the provision of informed consent by the patient on the use of biological material that directly affects him; g) definition of procedures for evaluation and authorization of a clinical trial, ensuring the involvement of patient associations, especially in the

Medical Law – Suppl. 119 (2020) Italy – 301 1111–1116 Part II, Ch. 3, Specific Activities case of rare diseases, through: 1) the identification and role of the general manager or head of the department in which the clinical trial is to be carried out; 2) the identification of the tasks and purposes of the territorial ethics committees; 3) the guarantee that the persons in charge of the validation and evaluation of the application are free of personal and financial conflicts of interest [ … ]; 4) the establishment, at the Higher Institute of Health, of a national list of qualified and experienced subjects, selected through public notices, on the basis of predefined criteria and requirements; 5) the definition of the minimum contents that contracts for clinical trials that, for the investigators, certify their impartiality, impartiality and independence must present; 6) [ … ]’.

2. Scientiﬁc Acceptability

1111. For clinical trials to be valid from a scientiﬁc perspective, they must be described in a clear, detailed protocol and guided by ethical principles in all their aspects (Article 3 paragraph 5 D. Lgs. n. 200/2007).

1112. Only scientiﬁc acceptable trials are permitted from a legal and ethical standpoint. The clinical and non-clinical information available on a drug in the process of being tested should be adequate to justify the proposed clinical trial (paragraph 6). See also point 2.5 CGP.

3. Proportionality (Balance Between Beneﬁts and Risks)

1113. Before a trial begins, foreseeable risks and drawbacks must be assessed against the anticipated beneﬁt for both individual trial subject(s) and the community. A trial may be initiated and continued only if the anticipated beneﬁts justify the risks (Article 3 paragraph 2 D. Lgs. n. 200/2007).

4. Informed Consent of the Subject

1114. Voluntary participation is essential. Before starting the trial, it is necessary to acquire the speciﬁc free and informed consent of the person to be subjected to experimentation (paragraph 4).

1115. In line with the GCP (point 4.8) informed consent must be given in writing (see supra 700).

1116. Article 3 of D. Lgs. n. 211/2003 provides that consent is given after the subject participating in the trial, or her legal representative if the subject is not able to give informed consent:

– has had ‘the opportunity, in a prior interview with one of the investigators, to understand the objectives, risks and inconveniences of the experimentation, the

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conditions in which it will be implemented, and also has been informed of her right to withdraw from the trial at any time’ (lett. b,); – has been informed of the nature, signiﬁcance, implications and risks of the clinical trial. If the person concerned is unable to write, she may, exceptionally, provide oral consent in the presence of at least one witness, in accordance with the legal provisions in force (lett. d).

5. Primacy of the Human Being

1117. ‘The protection of the rights, safety and welfare of trial subjects shall prevail over the interests of science and society’ (Article 3 paragraph 1 of D. Lgs. n. 200/2007. See also point 2.3 GCP). Human subjects are always to be considered as a goal, not as tools. These basic principles guiding therapeutic experimentation (mostly phases II and III) require careful cost-beneﬁt analysis for every individual subject.

1118. The right to privacy and confidentiality remains paramount as well. The law stipulates the (Article 3 paragraph 11 D. Lgs. n. 200/2007, Article 3 lett. c D. Lgs. n. 203/2011) ‘confidentiality of records that could identify subjects, respecting the privacy and confidentiality required by applicable regulatory requirements’.

6. Favourable Opinion of an Ethics Committee

1119. See supra 1107. a. Definition of ‘Ethics Committee’ 1120. See 479, 480, 481. See also 30, 48, 63, 106, 137, 182, 484f. b. Ethics Committees in Hospitals 1121. See 488–490. On this point, law 3/2018 provides, in Article 1 paragraph 2, among its guidelines for: ‘g) definition of the procedures for evaluation and authorization of a clinical trial, ensuring the involvement of patient associations, especially in the case of rare diseases, through: 1) [ … ]; 2) the identification of the tasks and purposes of territorial ethics committees’. c. Composition of the Committee 1122. See 491–494. d. The Competences of the Committee 1123. See 495–498.

Medical Law – Suppl. 119 (2020) Italy – 303 1124–1129 Part II, Ch. 3, Specific Activities e. Task of the Competent Ethics Committee(s) 1124. See above. The ethics committees are called to guarantee both the scientific nature of the research and the protection of involved subjects. It is for the Com- mittee to make sure trial subjects receive proper, full and clear information to allow their actual self-determination. It also oversees health integrity protecting trial subjects from excessive risks in comparison to their expected benefits. The protection of trial subjects’ dignity and the risks of abusing their vulnerability is a paramount duty of the Committee.

1125. The opinion refers to the protocol, the quality of the research proposed, the quality of the involved investigators, and suitability of proposed facilities (see Article 1 lett. d D. Lgs. n. 200/2007, Article 2 lett. m D. Lgs. n. 211/2003 Article 1 paragraph 1 MD 12 May 2006).

1126. The Committees are also required, expressing their assessments, to take account ‘that, in principle, patients in the control group cannot be treated with placebo if known effective treatments are available, or if the use of placebo involves suffering, prolongation of illness or risk’ (Article 5 paragraph 3 MD 12 May 2006). f. Time Limits to Issue an Opinion 1127. Ethics committees must make their mode of assessment, of adopting opinions, rules and expected timeframe for the evaluation of experiment proposals, subject to the maximum time required by law (within sixty days from the date of receipt of the request made by the trial sponsor in the prescribed form; see Article 6 D. Lgs. n. 211 of 2003; MD 12 May 2006 Article 4) publicly available. The time limit can be suspended (until reception of information) once and if the Committee requires additional information to that already provided by the promoter of the trial. g. Legal Value of an Opinion 1128. The positive opinion of an ethical committee is an unavoidable preliminary element of any research. It binds the promoter, the investigators and their institutions. Their preventive control has eventually a preclusive effect on the clinical trial.

7. Intervention of a Qualiﬁed Healthcare Practitioner

1129. ‘The medical care given to subjects in the trial and medical decisions taken in their interest always fall under the responsibility of a qualified physician or, where appropriate, of a qualified dentist’ (paragraph 10 Article 3 D. Lgs. n. 200/ 2007). In relation to the qualification of involved experimenters see supra 1107–1110, 1111f.

304 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1130–1135

8. Liability Rules (Civil, Administrative and Criminal)

1130. See 1131.

9. Insurance-Related Issues

1131. Article 6 lett. i of D. Lgs. n. 211/2003 sets out the necessary elements to be evaluated by the insurance committee and the compensatory provisions of the protocol. The envisaged system undermines the role of fault (with reference to liability insurance coverage) and establishes time limits for detecting damages and for ﬁling compensation claims. Law 3/2018 envisaged among its guiding criteria: ‘m) reformulating and rationalising the administrative sanction system for the violation of the regulations in force and of the provisions contained in the legislative decrees issued in implementation of paragraph 1, taking into account the responsibility and functions performed by each subject, with particular regard to the responsibility of the investigator and the structures involved, as well as the substantial or formal nature of the violation, though’. However, Legislative Decree 59/2019 did not intervene on this point.

1132. The Inter-ministerial Decree of 14 July 2009, in producing a standard insurance policy model, prescribes the minimum requirements of insurance policies. As a sanction, if the insurance policy violates these minimum standards, the Decree excludes products produced following these (incorrectly insured) trials from being granted market authorization (Article 5) and voids all opinions of the Com- mittee disregarding these insurance matters.

1133. Promoters must carry liability insurance that should make explicit reference to the proposed study, with a description of the essential elements, covered by the Decree (Article 1).

1134. The insurance policy must guarantee speciﬁc coverage compensation for damage caused to individuals by the activity of experimentation, for the whole period of experimentation. It shall cover the liability of the investigator and the sponsor, without excluding damages involuntarily caused as a result of an accident and/or attributable to negligence, imprudence or inexperience, as long as they are apparent within twenty-four months from the date of conclusion of the trial. Under the law, the date of conclusion of the trial is the last medical-surgical, diagnostic and/or therapeutic performance undertaken according to the protocol of experimentation for the last enrolled patient.

1135. In the case of experiments potentially capable of causing damage detect- able after a longer time period, the minimum time coverage of posthumous risk must be appropriately extended.

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1136. For trials on minors (as well as for clinical trials programmes applying gene therapies, cellular therapies and radiopharmaceuticals), such extension must provide coverage of at least ten years related to the veriﬁcation of a normal mental and physical development.

1137. Reﬂecting the needs of the market, the Decree envisages also that:

If the certificate provides for a term of validity shorter than the actual duration of the experiment, the promoter, at each end of the period of validity of the certificate of insurance is required to submit to the Ethics Committee the certificate of renewal before the expected due date (Art. 1 para. 2).

1138. The insurance policy must cover death, all health impairments permanent and/or temporary, and patrimonial damages that are a direct result of the trial and traceable to the civil liability of all parties involved in the realization of that trial. Every three years, an M.D. updates the statutory minimum and maximum of damages to be covered.

1139. The obligation of insurance does not apply to non-interventionist trials or observational studies (Article 4).

C. Speciﬁc Provisions for the Protection of Minors Participating in Experiments

1140. Article 4 of D. Lgs. n. 211/2003 expressly sets down provisions to protect minors involved in clinical trials. Those provisions add to the general ones described so far. It requires a series of additional conditions:

(a) the informed consent of the parents or at least one parent in the absence of the other or of the legal representative in compliance with the regulations in force. The consent must, however, reflect the will of the child and may be revoked at any time without jeopardizing the continuation of necessary assistance; (b) the provision of information from staff with experience with minors according to their ability to understand the trial, the risks and benefits; (c) the investigator or the principal investigator must take into account the explicit will of the child to refuse participation or withdraw from the trial at any time where the minor is capable of forming an opinion and assessing the information referred to in point (b); (d) the group of patients must derive some direct benefit from the clinical trial and only if such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods. In addition, the research must relate directly to a clinical condition from which the minor suffers or be of such a nature that can only be carried out on minors; (e) relevant scientific guidelines, adopted by the European Agency for the Evalu- ation of Medicinal Products (EMEA) must be followed;

306 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1141–1144

(f) clinical trials should be designed in such a way as to minimize the pain, dis- comfort, fear and any other foreseeable risk in relation to the disease and developmental stage of the child. In addition, the risk threshold and the degree of ailment must be deﬁned speciﬁcally and continuously monitored; (g) protocol must be approved by an ethics committee with paediatric expertise or that has previously made use of advice regarding clinical, ethical and psychosocial problems in paediatrics; (h) the interests of the patient always prevail over the interests of science and society.

1141. The law is unclear with reference to non-therapeutic trials, although it refers to the beneﬁts to the group of patients (see 1140). It is possible to infer from the lack of reference to individual beneﬁts that, with all due cautions, non- therapeutic trials are in principle permitted (see also infra 1146). For their exceptional nature and the safeguards see the Oviedo Convention Article 18 paragraph 2 and Article 29 of the Helsinki Declaration (2008).

1. Informed Consent of the Parents or the Guardian

1142. Informed consent from the parent or the guardian is a necessary prerequisite for clinical trials involving children. See also supra 1103, 1104, 1105 and especially 1140.

2. Respecting the Explicit Will of the Minor

1143. See supra 1103, 1104, 1105 and especially 1140. However, we may question the exact meaning of ‘the investigator or the principal investigator takes into account the explicit will of the child to refuse participation or withdraw from the trial at any time’. Nevertheless, it seems indubitable that refusal or withdrawal of consent by a minor capable of forming an opinion and assessing the information provided must be respected (see also supra in general 872–908).

D. Speciﬁc Provisions for the Protection of Adults Incapable to Consent to an Experiment

1144. See supra 1103, 1104, 1105. Article 5 of D. Lgs. n. 211/2003 deals expressly with the protection of adults unable to give valid informed consent clarifying that (in addition to the requirements of Article 3) participation in clinical trials by incapable adults who have not given or not refused informed consent before occurrence of the incapacity is possible only if:

Medical Law – Suppl. 119 (2020) Italy – 307 1145–1147 Part II, Ch. 3, Speciﬁc Activities

(a) where the informed consent is provided by the legal representative, then consent must reflect the subject’s presumed will and may be revoked at any time without prejudice to the subject herself; (b) the person has received adequate information reflecting her ability to understand the trial and the related risks and benefits; (c) the investigator or where appropriate the principal investigator, takes into account the explicit wish of a subject during the trial having regard to the subject’s capacity to form an opinion and assess such information in deciding to refuse participation or to withdraw from the clinical trial at any time; (d) no incentives or financial inducements are given except compensation that, if the promoter of the trial is a public entity, may be granted only within the limits of the budget appropriations allocated to it; (e) the research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods and relates directly to a clinical condition that would endanger the life or cause a debilitating medical condition from which the subject suffers; (f) clinical trials have been designed in such a way as to minimize the pain, dis- comfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of ailment shall be specifically defined and be continuously monitored; (g) the protocol has been approved by an ethics committee competent both in the field of the disease in question and in the characteristics of particular patient population at issue or after having sought advice in relation to the clinical, ethical and psychosocial context of the disease and of the patient population concerned; (h) the interests of patients must always prevail over those of science and society; (i) there must be a reason for expecting that administering the medicinal product to be tested produces a benefit to the patient outweighing the risks or that it does not produce any risk.

1145. In addition, paragraph 2 provides that in cases of temporary incapacity ‘at the time of reacquisition of her own decision-making skills, the subject must be requested to provide informed consent for the continuation of the trial’.

1146. The law is silent with reference to non-therapeutic trials, while Article 48 of the CME is explicit in permitting only the experimentation for preventive and therapeutic purposes for both minors and incapable persons. See 1104.

E. Speciﬁc Provisions for the Protection of Persons Whose Consent Cannot Be Obtained Due to Emergency

1147. As a preliminary issue, we should deﬁne emergency situations in relation to the limited context here. They are those in which there is no time to nominate a guardian because the experimental treatment must be administered without delay in the immediate aftermath of incapacity. Accordingly, a person must be incapable due to sudden traumatic events or abrupt worsening of pre-existing conditions.

308 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1148–1150

1148. In principle, in the absence of the conditions required by Article 5 of D. Lgs. n. 211/2003 (see 1144–1146) clinical trials appear to be forbidden. Neverthe- less, D. Lgs. n. 200/2007 refers to the Helsinki Declaration and to the GCP. The former (Article 29 of the 2008 version) provides that:

the study may proceed without informed consent provided that the speciﬁc reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative.

The latter similarly provides (GCP 4.8.15):

When ascertainment of prior consent of the subject is not possible, and the subject’s legally acceptable representative is not available, enrolment of the subject in the trail should ﬁrst satisfy the required measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or her legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other required consent [see GCP 4.8.10] should be requested.

F. Research with Embryos In Vitro

1. Prohibited Procedures with Embryos In Vitro

1149. Article 13 of Law 40/2004 prohibits ‘any experimentation on human embryos’. However, the law provides an exception in that it is permitted ‘provided that it pursues solely therapeutic and diagnostic objectives related in relation to the protection of the health and development of the embryo itself, and if there are no alternative methods’ (paragraph 2). See also 1026.

1150. The same law further speciﬁes that the following procedures (sanctioned by administrative and criminal sanctions) are prohibited:

(a) the production of human embryos for research purposes or experimentation or for purposes other than that provided for by Law 40/2004; (b) any form of eugenic selection of embryos and gametes or interventions which, through techniques of selection, manipulation or by artiﬁcial processes, however, are aimed at altering the genetic patrimony of the embryo or gamete or to predetermine genetic features, with the exception of interventions with diagnostic and therapeutic purposes, provided in Article 13 paragraph 2 Law 40/2004; (c) cloning by nuclear transfer or embryo splitting or early ectogenesis and for procreation and research;

Medical Law – Suppl. 119 (2020) Italy – 309 1151–1154 Part II, Ch. 3, Speciﬁc Activities

(d) the fertilization of a human gamete with a gamete of different species and the production of hybrids or chimeras.

The ban under letter a) and b) was affected by the Constitutional Court which, with judgment of 229/2015, declared it unconstitutional in so far as it contemplates as a crime the conduct of embryo selection even in cases where this is exclusively aimed at avoiding the implantation in the womb of the woman of embryos affected by genetic diseases.

2. Prohibition to Create Embryos In Vitro Solely for Research Purposes

1151. The production of human embryos ‘for research or experimentation or otherwise for purposes’ other than as provided by Law 40/2004 (see supra 1149ff) is also forbidden (see Article 13 lett. a).

§7. PROFESSIONAL FREEDOM:PRESCRIBING DRUGS –TREATMENT WITH DRUG- SUBSTITUTES

I. Legal Framework of Professional Freedom

1152. Against the bedrock of the constitutional principles protecting health, there are two sets of relevant rules: statutory provisions mainly addressing ﬁnancial issues and the CME.

1153. Among the former, the Law of 17 February 1998, no. 23, as modiﬁed by law 94/1998, stipulates (Article 3) that ‘the physician, when prescribing a medicinal product or other industrially produced medicinal product, shall comply with the therapeutic indications and the ways and routes of administration provided for by the marketing authorization’.

1154. However, in individual cases, the physician may, according to her direct responsibilities and after informing the patient and obtaining her consent, use an industrially produced medicinal product for reasons other than those generally permitted:

if the physician considers, based on documented data:

– that the patient cannot be successfully treated with medications that have already been approved in terms of therapeutic indications; – instructions; – the mode of administration and consumption provided that the intended use is known and complies with evidence from publications in international sci- entiﬁc journals (see also Art. 13 para. 7 and 8 of the CME). See also 1096.

310 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Speciﬁc Activities 1155–1158

1155. This option in no case permits the supply of medicines to be reimbursed by the NHS. Paragraph 5 makes it clear that ‘a violation by the physician of the provisions of this article is the object of disciplinary proceedings’. However, in its ruling 185/1998, the Constitutional Court declared ‘the constitutional illegitimacy of the combined provision of Article 2, paragraph 1, last proposition, and Article 3, paragraph 4, of the d.-.l. 17 February 1998, no. 23 (Urgent provisions concerning clinical trials in the oncological field and other measures in the health field), in so far as it does not provide for the provision by the national health service of medicines used in the treatment of cancer diseases, for which the trial referred to in Article 1 is ordered, in favour of those who are in conditions of insufficient financial means, in accordance with the criteria established by the legislator, within the objective, subjective and temporal limits laid down in motivation’.

1156. Article 13 of the CME states that:

1. Prescription for the purposes of prevention, diagnosis, treatment and rehabilitation is a direct, speciﬁc, exclusive and not delegable competence of the physician, commits its autonomy and responsibility and must follow a detailed diagnosis or a well-founded diagnostic suspicion. 2. The prescription must be based on the available scientiﬁc evidence, on the optimal use of resources and on the respect of the principles of clinical efficacy, safety and appropriateness.

On this basis, the physician is accorded autonomy in programming the selection and application of each diagnostic and therapeutic instrument, even on an inpatient basis, subject to the patient’s freedom to reject the treatment and to assume responsibility for the refusal.

1157. The same Article (paragraph 5 of the CME) states that physicians must have ‘adequate knowledge of the nature and effects of the drugs, their indications, contraindications, interactions and predictable individual reactions, as well as the characteristics of the use of diagnostic and therapeutic methods’. It also requires them (paragraph 4) to adjust, in the interest of the patient, their decisions in conformity with the accredited scientiﬁc data or methodologically founded evidence: ‘The physician takes into account the diagnostic and therapeutic guidelines accredited by authoritative and independent sources such as recommendations and assesses their applicability to the speciﬁc case.’

1158. Article 1 of Law 219/2006 deﬁnes a medical drug on the basis of its presentation or of its function:

(1) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings. (2) Any substance or combination of substances which may be used or administered to human beings either with the aim of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

Medical Law – Suppl. 119 (2020) Italy – 311 1159–1164 Part II, Ch. 3, Speciﬁc Activities

1159. The aim of this double deﬁnition is to subject all substances that are only described as performing a medicinal function to medicinal products regulation.

1160. The same law classiﬁes medicinal products. The main distinction for our purposes is between (a) medicinal products subject to medical prescription-with restrictions on both their place of use and role of medical prescription (see Articles 88–94 of Law 219/2006) – and (b) medicinal products not subject to medical prescription. These are divided into (1) so-called over-the-counter medicinal products or those related to self-medication, and (2) remaining medicines obtainable without a prescription. Drugs under (a) must be clearly identiﬁed as such on their marketing boxes.

1161. Pursuant to Article 96, non-prescription medicines are those that do not meet the criteria laid down in Articles 88–94 (for prescription drugs) for which the pharmacist can give advice to the customer. In contrast to medicines requiring prescription, those without the need for prescription may be advertised in accordance with the law, i.e. those products ‘that, by their composition and therapeutic aim, are designed and manufactured for use without the intervention of a physician for diagnosis, prescription or monitoring during the treatment and, if necessary, with the advice of the pharmacist’ (Article 115).

1162. Article 5 of Law 17 February 1998, no. 23 allows physicians ‘to prescribe magistral preparations based exclusively on active ingredients described in pharma- copoeias of the countries of the European Union or in industrially produced medicines for which trade has been authorised in Italy or in another country of the European Union’. It should also be noted that ‘the prescription of magistral preparations for oral use may include active ingredients other than those provided for in the … [previous sentence], if these are contained in non-pharmaceutical products for oral use, regularly marketed’ in the countries of the European Union; likewise, the prescription of magistral preparations for external use may include active ingredients other than those provided for in the ﬁrst sentence of this paragraph, if these are contained in cosmetic products regularly marketed in those countries. In any case, these prescriptions are subject to the prohibitions and limitations established by the Ministry of Health for reasons of public health protection.

1163. It must also be noted that in prescribing medicinal products, general practitioners are also bound, by their national contract with the Healthcare System, to promote and disseminate proper use of pharmaceutical products in their daily care activities and to contribute to cost containment. See supra 164, 200, 201, 327.

II. Control over Professional Freedom

1164. All ethical and legal constraints provided for by law and the CME aim to beneﬁt the patient. Yet, the NHS imposes economic constraints to cut costs (see 164ff) on general practitioners and paediatricians impacting professional freedom

312 – Italy Medical Law – Suppl. 119 (2020) Part II, Ch. 3, Specific Activities 1165–1169 when it comes to the prescription of drugs. See supra 164, 200, 201, 327. Viola- tions of such financial constraints are limited and subject to disciplinary sanctions and financial limitations.

III. Prescription of Drugs

1165. The prescription of medicines falls under the sole responsibility of the prescribing physician with reference to the selection and indication of the pharmacological therapy, to the pathology observed, as well as the timing, dose and mode of administrating the drug. As a result, the physician who transcribes the prescription of a specialist physician shares the therapeutic choice and assumes responsibilities.

1166. This responsibility encompasses ethical, social and economic considerations as regards the reimbursement of the drug prescribed by the NHS. See supra 1155.

IV. Treatment with Drug-Substitutes

1167. Medical doctors are responsible for proposing the treatment. However, the law prescribes the possibility of substituting a pharmaceutical product with its generic counterpart. A generic medicinal product is ‘a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate studies of bioavailability’ (Article 10 of Law 219/2006).

1168. Moreover, Law 149 of 26 July 2005 obliges pharmacists to notify the patient of the possibility of substituting the medicinal product prescribed by the physician with a drug equivalent, at a lower price. See also 1154, 1162.

V. Off-Label Prescriptions

1169. Pursuant to Article 3 paragraph 2 D.L. 17 February 1998, no. 23 and subsequent modifications, in individual cases, the physician may, according to her direct responsibility and after informing the patient and acquiring consent, use an industrially produced medicinal product according to the specifics set out above (see supra 1187) provided that the intended use is known and complies with evidence from publications in international scientific journals, or in cases recognized for the purposes of Article 1, paragraph 4, of the Decree-Law of 21 October 1996, no. 536, ratified by Law 23 December 1996, no. 648. This applies if the physician herself considers, on the basis of documentable data, that the patient cannot be successfully treated with medicinal products for which therapeutic indication on a particular mode of administration have already been approved, and as long as such use

Medical Law – Suppl. 119 (2020) Italy – 313 1170–1170 Part II, Ch. 3, Specific Activities is known and complies with work appeared in publications in international scientific journals. See also 1154. D. Lgs. n. 36/2014 introduced paragraph 4-bis, where it is envisaged: ‘Even if there is another therapeutic alternative within the scope of the authorized medicinal products, after evaluation by the Italian Medicines Agency (AIFA), the medicinal products that may be used for a therapeutic indication other than the authorized one are included in the list referred to in paragraph 4, with consequent provision at the expense of the National Health Service, provided that such indication is known and in accordance with research conducted within the national and international medical-scientific community, according to parameters of cost- effectiveness and appropriateness. In this case, AIFA activates appropriate monitoring tools to protect patient safety and takes timely decisions.’

1170. These rules seem in line with point 35 of the Helsinki Declaration (2008):

In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.

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Iakovidis, I. ‘Towards Personal Health Record: Current Situation, Obstacles and Trends in Implementation of Electronic Healthcare Records in Europe’. Interna- tional Journal of Medical Informatics 52, no. 123 (1998): 105–117. Kidd, M.R. ‘Personal Electronic Health Records: MySpace or HealthSpace?’. BMJ. 336 (2008): 1029. Kori, J.B. & M.S. Quattrone. ‘Litigation in the Decade of Electronic Health Records, Use of EHRs May Raise New Risks of Malpractice Liability’. New Jer- sey Law Journal 188, no. 11 (2007): 845. Loughrey, J. ‘The Confidentiality of Medical Records: Ineducational Autonomy, Patient Privacy, and the Law’. Northern Ireland Legal Quarterly 56, no. 3 (2005): 293. Mordini, E. et al. Ethics, e-Inclusion and Ageing, Studies in Ethics, Law, and Tech- nology 3 (1) Article 5. Solovy, A. ‘The Big Payback: 2001 Survey Shows a Healthy Return on Investment for Info Tech’. Hospitals & Health Networks (2001): 40. Steinbrook, R. ‘Personally Controlled Online Health Data-the Next Big Thing in Medical Care?’. N. Engl. J. Med. 358 (2008): 1653. Svantesson, D.J.B. Fundamental Policy Considerations for the Regulation of Inter- net Cross-Border Privacy Issues, Policy & Internet 3 (3) Article 7 (2011). Terry, N.P. & L.P. Francis. ‘Ensuring the Privacy and Confidentiality of Electronic Health Records’. University of Illinois Law Review (2007): 681. Ueckert, F. et al. ‘Empowerment of Patients and Communication with Health Care Professionals through an Electronic Health Record’. International Journal of Medical Informatics 70, no. 2–3 (2003): 99. Ventafrldda, C. & Rlpamonti, et al. ‘Symptom Prevalence and Control during Can- cer Patients’ Last Days of Life’. Journal of Palliative Care 6 (1990): 7–11. Wang, S.J. et al. ‘A Cost-Benefit Analysis of Electronic Medical Records in Pri- mary Care’. The American Journal of Medicine 114, no. 5 (2003): 397.

318 – Italy Medical Law – Suppl. 119 (2020) Index

The numbers here refer to paragraph numbers.

Abortion transfusion, 341, 517, 552, 601, 603, distress, 667 610–615, 702, 875, 903–904, 974, evaluation of law, 998–1002 1071–1077 history, 335, 1037 venepunctures, 341–342 infanticide, 20, 21, 23, 67 Bone marrow donation, 700, 1078 legal conditions, 1003 moratorium, 1005 Child abuse, 850, 959 refusal by physician, 1013–1014 Clientele, 346, 359, 369, 638, 652, 852 registration document, 86 Code of professional ethics RU, 1017–1018 binding force, 91 physician-patient relationship, 408 Access to medical data, 741, 774–779, 986 Collegiality, 443, 448 Acupuncture, 350–351 Competence for health policy and Ambulatory care, 20, 106, 155, 209, regulation 325–327 municipalities, 11, 131 Anonymity, donor, 331, 1061 provincial health officer, 111 Appeals Council of Order of Physicians regions, 7, 48, 63, 64, 106, 134, 137, composition, 369, 461–466 181, 182, 242, 483, 627, 771, 804, disciplinary procedure, 435, 444–460 806, 1072 duty to care, 411, 414 state, 7, 63, 64, 242, 243, 483, 627, 804, functions, 461–478 806 impartiality, 426, 428, 446, 455, 456 Consent publicity, 440 amministratore di sostegno, 916 Artificial insemination, 84, 96 cancer treatments, 905–908 Automatic ‘external’ defibrillator, bis, 226, compulsory sampling, 909 229 denial Autopsy, 1086, 1094 from parents, 892–893, 902, 903 Autotransplantation, 1077 medical secrecy, 826–860 minor, 682, 720, 872, 897, 901, 958, Biobank 1046, 1143 bone marrow, 821–822, 825, 901, 1079 presumed consent, 702–705 research with human persons, 672 cord blood banks, 1064–1070 scope, 657 stem cells, 341, 897, 1064–1070, 1077, Contraception surgical, 1021–1022 1098 Contract for medical services, 67, 380, 537 tissue, 331, 412, 417, 700, 1040–1094 Blood Data bank, 775, 776, 823–825 blood pressure measuring appliance, 345 Death, definition, 24, 54, 330, 479,

Medical Law – Suppl. 119 (2020) Italy – 319 Index

589–591, 975, 976, 1085–1090, 1092 Healing arts, 285–286 Debarment, 376, 377, 379, 394–397, 416, Healthcare system 427, 429, 430, 431, 435, 449, 937 ﬁnancing, 167–175 Dentist hospital sector, 197–198, 812 monopoly, 298, 301 mental healthcare, 20, 928 Deontologic jurisprudence, 63, 89, 91, 380, preventive healthcare, 73, 80, 315 383, 421, 479, 892 regulation, 65, 77, 83, 158, 230 Diploma for practice of medicine school healthcare, 260, 277, 289 assimilation based on mutual Health insurance, 109, 172, 197 Health law, 59–103, 113, 267, 314, 417, recognition, 291, 292 449 exemption, 290, 311 Hospitals visa, 307–312 accreditation, 105, 133 Donor, anonymity, 331, 1061 deﬁnition, 211, 273, 937, 954, 986 Donor gametes, 1031–1033 liability, 573–580 Drugs territorial organization, 63, 199–232, off label, 1169–1170 237, 266 prescription, 25, 187, 652, 817–820, 897, Human bodily material, 233, 351 1164–1166 treatment with substitute, 1152–1170 Illegal practice of medicine, 340, 353–365 Duty of care, 922 Infanticide, 729 Duty of patients, 643–645 Informational privacy, 783 Informed consent, 124, 267, 317, 408, 412, Effort obligation, 526, 531, 534–537, 575 418, 496, 506, 512, 516, 519, 583, 643, Eye-examination 649, 650, 658, 659, 663, 666, 668–671, Embryo in vitro. See Medically assisted 674, 676–678, 683, 686, 688, 690, 692, procreation; Research 703, 718, 740, 875, 884, 892, 897, 919, Ethics committee 922, 963, 970, 1028, 1047–1048, 1064, hospital, 488–498, 1121 1065, 1074, 1114–1116, 1140, 1142, research, 479, 484, 485, 487, 496, 504, 1144, 1145, 1148 1124 Insurance Euthanasia, 408, 410, 591, 970, 972–974, civil liability, 253, 629, 1138 976 genetic testing, 97, 663–667 Experiment. See Research research, 485 Experimental protocol, 87, 1137 Internship, 270, 276 Expert, 491, 494, 501, 569, 581, 630, 992, In vitro fertilization, 1150 1140, 1170 Involuntary placement Eye-examination admission for observation, 942–949 fee-splitting with the NHS, 173, 252, prolonged stay, 950–953 867–868 fee-splitting, 868, 869 Liability Freedom of association, registration on hospital, 573–580 list, 384–385 physician, 518, 522, 523, 526–527 Freedom of opinion, 41–51 vicarious, 573–580 List of Order of Physicians General medical practice freedom of association, 384–385 licensing commission, 269–275 inscription, 313 licensing criteria, 269–275 medical residence, 276 postgraduate medical education, 269–275 refusal, 390–393 Genetics registration, 367, 372–398, 400, 401 testing, 97, 664, 666, 1036, 1038 removal, 396–398 Group therapy, 349 restriction on registration, 249

320 – Italy Medical Law – Suppl. 119 (2020) Index

striking off (see Debarment) continuing education, 238, 241, 268 Living wills, 102 illegal practice, 353–364 Loss of a chance of a better result, 544, medical education, 233–275 572 practice of medicine, 314–352, 475 specialization, 267, 302, 525 Medical activities Medical records, access acupuncture, 350–351 addition, 741 advice, 345, 352 copy, 742, 745 blood pressure measuring appliance, 345 next of kin, 746–747 eye-examination, 346 Medical report, involuntary placement, 937 general, 339, 346 Medical secrecy group therapy, 349 child abuse, 850 preventive medicine, 339 psychoanalysis, 347–348 colleague, 322, 408 psychotherapy, 347–349, 569 donor gametes, 1031–1033 radiographies, 343–344, 367 exceptions, 832–833, 844, 853 self-care, 340 medical certificates, 826, 830, 831, 844, venepuncture, 341–342 854–860 Medical certificate, 812, 854–860, 937 minor, 832–833, 844, 853 Medical council, 404, 406, 413, 735, 821, testimonial privilege, 832, 833 1018 Medical studies, 532, 563 Medical data, 741, 774–779 Medical team, 712, 1060 Medical disciplinary law, code of Mentally retarded patient, sterilization, professional ethics, 399–460 1023, 1024 rules of professional conduct, 361, 413, Mental patient 419 access in medical file, 814–815 Medical education, competences care within a family, 946, 962, 967 internship, 270, 276 definition, 936 numerus clausus, 240, 276, 277 involuntary placement, 926–968 postgraduate medical education, 238, right to complain, 967 239, 254, 256, 257, 264, 269–275 right to treatment, 967 specialization, 239, 240, 249, 251, 253, Midwives, 367, 832 257, 259, 260, 267 Minor, donor Medical file medical treatment, 1058–1061 electronic file, 805, 814, 815 transplantation of organs, 1045, 1046 Medical law, definition Misconduct, 404, 505, 599, 830 functions, 59–62 Mortality, 21, 23, 24, 67, 636, 717 sources, 63–88 Mutual insurance fund, 197 Medically assisted procreation access, 334, 1029 National Council of Order of Physicians artificial insemination, 96 advice, 422, 423 definition, 97, 334 code of professional ethics, 407 donor gametes, 1031–133 composition, 470–473 general conditions, 334 functions, 474–478 implantation of embryos in vitro, 1037 repertory of jurisprudence, 423 monopoly of fertility centres, 1034 National Council on Bioethics, 707, 712, surplus embryo, 84, 1030, 1037 715 surrogacy, 1034–1035 No-fault liability Medical office, 111, 250, 369, 950 blood-related infections, 606 Medical profession compulsory vaccination, 679 access, 233–279 non-compulsory vaccination, 608 competences, 242–243 for research, 496

Medical Law – Suppl. 119 (2020) Italy – 321 Index

Non-conventional practices in medicine, illegal practice of medicine, 340, 408 353–365 Non-interventional research, 1139 inscription on list, 313 Nulla poena sine lege, 519 legal conditions, 280–313 Nullum crimen sine lege, see Nulla poena legal diploma, 287, 289–292 sine lege medical activities, 287, 317, 329–352 Numerus clausus, 240 medicine, 280–504, 765 Nursing profession, 203 monopoly, 287–313 Pre-implantation genetic diagnosis, bis, Officer of health, 845 1038 Preventive medicine, 199, 399 Order of Physicians Primary care, 154, 155, 189, 199–201, 213, contribution, 477 219–221, 223, 237, 276, 322–324, 769 disciplinary competence, 399–460 Privacy, 93, 267, 642, 748–753, 759, 764, history, 369–371 783, 793, 805, 807–817, 836, 860, 1011, registration on list, 367, 372–398 1118 suspension, 360, 430 Professional freedom visa, 313 abuse, 95, 339, 348, 358, 361, 400, 413, Organ and tissue donation 420 consent, 1046, 1047, 1053, 1057, 1064, control, 1164 1065, 1074, 1081 Professional liability general, 417, 700, 776, 1042–1044, causation, 540–553 1049, 1064 civil, 518, 519, 522, 524–580 gratuitousness, 1052, 1055, 1057, 1065, criminal, 518, 519, 530, 581–600 1078 damages danno biologico/ danno alla salute, 558 Pain relief with life-shortening effects, economic, 517, 554, 561 979–994 non-economic, 517, 554, 558, 567–571, Palliative sedation, 979, 990 687, 703 Paramedical profession, 350, 575 fault, 511, 535, 536, 538–539, 558, 575, Patient rights 599, 609, 618, 658 rights related to medical record, 732–747 professional standard, 407–415 right to free choice, 514, 650–655, 964 tortious, 416 right to information, 656–662, 667 vicarious liability, 573–580 right to informed consent, 643, 645, 649, Professional standard, 407–415 650, 657–659, 663, 668–671, 674, Provincial Council of Order of Physicians 676–678, 683, 686, 688, 690, 692, advice, 422 703, 718, 740 composition, 461–466 right to lodge a complaint, 759–764, 802 disciplinary competence, 399–406 right to palliative care, bis, 713, 714 disciplinary procedure, 436, 444–460 right to protection of privacy, 642, disciplinary sanction, 399, 424 748–753 duty to care, 94, 381 right to quality care, 646–649 fee, 369, 862 right to representation, 754–758 functions, 461–478 Pharmacist normative authority, 419–420 role in the NHS, 228, 231 precedent authority, 421 system of turns of duty, 485 preventive control, 310, 348 Physician, title, 233, 289, 410, 917 professional freedom, 868 Physiotherapist, 228, 298, 350, 993 publicity, 440 Practice of medicine registration on list of Order, 367, freedom of association, 384–385 372–398 healing arts, 285–286 removal of list, 396–398

322 – Italy Medical Law – Suppl. 119 (2020) Index

Provincial health officer, 111 Secondary use of human bodily material Provincial medical board, medicament not for research purposes, 1150 midwives, 367 for research purposes, 1150 nurses, 102 Self-care, 229, 340, 933 paramedical profession, 350, 575 Specialization visa, 310 access, 72, 277, 327 licensing commission, 269–275 Quality assurance, 619–637, 647. See also licensing criteria, 269–275 Risk management training plan, 239, 240, 251, 252, 289, 363 Recipient, 331, 662, 667, 703, 807, 822, Sterilization 1044, 1061, 1066 mentally handicapped, 1023–1024 Refusal of treatment, 53, 102, 413, 668, 670, 675, 694, 702, 704, 706, 708, 709, Suicide, assistance, 102, 591, 848, 973, 713, 715–718, 741, 903, 919, 922, 950, 995–997 959, 976, 1156 Surgical contraception, 1021–1022 Removal of human bodily material, after Surrogacy, 1034–1035 death from living donor, 901 Terminal sedation, bis, 900 Removal of organs, after death Testimonial privilege, 832–833 from living donor, 1042–1079 Therapeutic exception, 668 Remuneration, 199, 248, 359, 496, 861, Therapeutic freedom 1074 Title, abuse of title Research, 41, 120, 208, 210, 211, 233, 234, physician, 41, 233, 240, 289, 308, 366, 256, 338, 343, 479, 484, 485, 487, 496, 388, 410, 411, 413, 414, 537, 917 499, 501, 504, 626, 641, 749, 817, 818, Transplantation, after death 952, 991, 1095–1151, 1170 autotransplantation, 1077 Research, with embryos in vitro consent, 412, 901 with human persons, 1149–1151 minor, 901, 1045, 1057, 1104 Result obligation opting-out, 1080 sterilization, 1019–1024 transplant coordinator, 331, 1072 Right not to know, 662–666 Right to complain, 759–763, 802 Vaccination, 106, 153, 157, 168, 281, 322, Right to consent, 517, 682, 687 339, 601–610, 614, 644, 679, 728–730, Right to healthcare, 31, 61, 121 887, 902 Right to information, 623, 656–662, 667 Vicarious liability, 573–580 Right to palliative care, 981 Visa Right to privacy, 1118 attribution, 313 Right to refuse treatment, 53, 706, 708, restriction, 297, 672, 1030, 1160 714, 716, 717 withdrawal as a sanction, 312 Risk management, 619–637, 648, 649 withdrawal for health reasons, 312 Rules of professional conduct, 407–423, 648 Withholding of treatment, 974 Wrongful birth, 618 Secondary care (inpatient), 199, 208, 213, Wrongful conception, 737, 755, 756, 758, 328 791, 891

Medical Law – Suppl. 119 (2020) Italy – 323 Index

324 – Italy Medical Law – Suppl. 119 (2020)