582 Original articles and reviews which shouldunderpinprofessional practice”[4]. codes “serveprincipallytolay downrightsandduties guidelines. duct. Codesofethicsmayalso containvalues,rulesand ten statementofprinciplesorstandardsrightcon- DEFINITIONS particular referencetoItaly. article offerssomefoodforthoughtontheissue,with proaches totherelationsbetweenthem,present literature [3].Without presumingtooffernew ap- and havebeenabundantlyexaminedinthespecialised between codesofmedicalethicsandlegalsystems. sional settingandinsociety, aswellontherelations the roleof“CodesMedicalPractice”inprofes- of reference. codes ofethicshealth professionals areamajorpoint tions, healthprofessionalsandthepublic,inwhich particularly consciousofthedynamicsbetweeninstitu- ternational decision-making processes” [1] the ISS is training” [1,2]. control, prevention,communication,consultationand tional level,through“research,surveillance,regulation, protection ofpublichealthbothinItalyandatinterna- (Istituto SuperiorediSanità,ISS)isthepromotionand FOREWORD it offerssomefoodforthoughtintheongoingdebate. to proposenewavenuesforexplorationoftherelationsbetweenethicsandlegalsystems, services offeredbytheprofessions.WhileItalianInstituteofHealthdoesnotclaim not onlyforethicistsandjurists,butalsomembersofthepublic,whobenefitfrom are complexandhavebeenextensivelyexaminedintheliterature.Thetopicisimportant Relations betweenethicsingeneral–andmedicalparticularlegalsystems Abstract 2 Carlo Petrini thought and thelegalsysteminItaly:foodfor The relationshipbetweenmedicalethics DOI: 10.4415/ANN_16_04_20 Ann IstSuperSanità2016|Vol. 52,No.4:582-586 E-mail: [email protected]. Address forcorrespondence: CarloPetrini,Unità diBioetica,Presidenza,IstitutoSuperiore diSanità,Via GianodellaBella 34,00162Rome,. 1 President, IstitutoSuperiorediSanità,Rome,Italy Unità diBioetica,Presidenza,IstitutoSuperioreSanità,Rome,Italy According to“Thenewdictionary ofmedicalethics”, A codeofethicscanbesuccinctlydefinedasawrit- Ethics andthelawhavealwaysbeencloselyentwined In Italythe“Code”isnotincorporatedinlegislation. The ISS intends to take part in the ongoing debate on As an “increasingly central actor in national and in- The missionoftheItalianNationalInstituteHealth 1 andWalter Ricciardi 2 efit andregulationofthemembers ofthegroup.Har ries proposedbyFrankel)and areprepared for theben- and regulatoryclauses(i.e. calls “codesofconduct” instead includeeducational actly toFrankel’s “aspirational”standards.WhatHarris kel’s, whathecallsa“codeofethics”correspondingex- members andoutsiders”)[7]. cating grievances,eitherbetweenmembersor professional conductandtoserveasabasisforadjudi- tory (“whichincludeasetofdetailedrulestogovern choices inmorallyambiguoussituations”);andregula- help theindividualprofessionalmakemoreinformed combine principles with explicit guidelines that can of right and wrong behaviour”); educational (“which here isnoattempttodefinewithanyprecisionnotions ciples towhichpractitionersshouldstrive”,where“(t) tional (“astatementofidealsorbroadlywordedprin- bers ofaprofession”[6]. standards ofbehaviourforpersonswhoarenotmem- profession; and (3) documents that specify values and haviour forprofessionalsbutaregeneratedoutsidethe the profession;(2)documentsthatsetstandardsofbe- ally generateddocumentsthatgovernbehaviourwithin ics” Spicerdrawsadistinctionbetween“(1)profession- forms (…and)bearavarietyofnames”[5]. it applies”,addingthat“codescomeinmanydifferent represent thevaluesofgrouporprofessiontowhich tion of aspirations, regulations, and/or guidelines that clearly defined.Pritcharddefinesa“code”as“acollec- Harrison’s classification is partially identical to Fran- Frankel identifiesthreetypesof“standards”:aspira- In thethirdeditionof“Encyclopediabioeth- The meaningoftheterm“code”isnonethelessnot the secondandthirdcatego- • • • • Key words medical ethics legal aspects code ofethics bioethics - 583 Medical ethics and the legal system in Italy

ris’s third category covers “codes of practice”, meaning and in Law no. 251 of 10th August 2000 [17], which documents written for non-members [8]. regulates the nursing, technical and rehabilitation At the international level, after the Second World War healthcare professions as well as obstetricians. This law several institutions drew up codes of conduct and other reiterates the meaning of codes of conduct but is not documents setting out the “duties, principles, rights and addressed to all healthcare professionals. responsibilities that are global in the sense that they ap- The issue of codes of conduct is addressed in part ply worldwide, without reference to nations or national of a bill currently before Parliament, the “Decree en- boundaries” [9]. Some of these documents refer to abling the Government to legislate in the matter of reviews multiple professional categories while others are spe- clinical drug trials, together with measures to update cific: “In the ethics of health care, explicit statements of essential levels of care, and to reorder the healthcare

ethical standards have been formulated for physicians professions and the managerial levels of Health Minis- and and other health professionals, for persons conducting try employees” [18]. The bill envisages that the national medical experiments involving human subjects, for ad- healthcare professional federations emanate a “code of ministrators and for patients and other laypeople who conduct, approved by their respective national councils make health care decisions” [10]. and addressed to all members of professional associa- articles Although the law and ethics are clearly distinct, codes tions in Italy”. The bill further expects the associations of ethics and of professional practice frequently fall into of healthcare professionals and their respective national a “grey area” not covered by the statute book, where federations to “promote and ensure: the independence, they provide indications of correct behaviour. Similar autonomy and responsibility of the professions and of indications are also found in other documents, such as professional practice: professional/technical quality; en- riginal guidelines, regulations and statutes. hancement of the social function (of healthcare); the O protection of human rights and of the ethical standards CODES OF ETHICS IN ITALIAN LAW of professional practice indicated in the codes of con- In Italy professional orders and colleges (or, in their duct, in order to ensure the protection of individual and absence, associations or societies) have at various times collective health”). issued their own codes of conduct. The Italian legal sys- tem considers such codes as “non-pecuniary contracts” THE “CODE OF MEDICAL CONDUCT” [11]. IN THE ITALIAN LEGAL SYSTEM Until fairly recently there were no explicit references The earliest “Code of Medical Conduct” in Italy was to codes of conduct in Italian legislation. They were drawn up by a committee established by the Federa- specifically introduced in Articles 22 and 31 of Law no. zione Nazionale degli Ordini dei Medici (FNOM, Na- 675 of 31st December 1966 on the “protection of per- tional Federation of Physicians’ Associations) in 1953 sons and other subjects in regard to the processing of and approved in 1954 [19]. Although the code was personal data” [12], and in the subsequent Legislative initially conceived above all as a means of reciprocal Decree no. 196 of 30th June 2003 which approved the guarantees, over the years it has increasingly become a “Code for the protection of personal data” [13]. Article guide for physicians. 12 (“Codes of Conduct and Professional Practice”) of The current version was adopted by the National this Code requires that the Italian Data Protection Au- Federation of Physicians’ and Dentists’ Associations thority “shall encourage, within the framework of the (FNOMCeO) on 24th May 2014. On 19th June 2016 categories concerned and in conformity with the princi- [20] Article 56, regarding “informational advertising in ple of representation, by having regard to the guidelines the health sector” (which had been challenged by the set out in Council of Europe recommendations on the Data Protection Authority on 24th September 2014) processing of personal data, the drawing up of codes [21] was amended. of conduct and professional practice for specific sec- Article 1 of the Code defines the nature of the Code, tors, verify their compliance with laws and regulations identifies the subjects to whom it is addressed and for- by also taking account of the considerations made by malises its compulsory nature for all members of the the entities concerned, and contribute to adoption of Associations: it “defines the set of regulations, informed and compliance with such codes”. In the wake of this by principles of medical ethics, that govern the profes- law two codes were drawn up concerning the processing sional conduct of surgeons and dentists (…) listed on of data acquired for purposes of economic, social, be- their professional registers. In agreement with the ethi- havioural, epidemiological and biomedical research: the cal principles of humanity and altruism and with the “Code of conduct for professions whose activities pro- civil principles of subsidiarity, it commits the physician duce statistics within the national statistics system” [14] to protect individual and collective health by monitor- and the “Code of conduct and good practice for the ing the dignity, decorum, independence and quality of processing of personal data for statistical and scientific the profession. It also regulates the private conduct of research purposes”, which is addressed to professionals physicians where this is relevant and affects the deco- who process data for scientific or statistical purposes rum of the profession. Physicians must know the Code outside the national statistics system [15]. and comply with the guidelines attached to it: they Codes of conduct are also mentioned in Law no. 42 must take the professional oath, which is a constituent of 26th February1999 [16], which contains provisions part of the Code”. applying to healthcare professionals (though it refers Article 2 (“disciplinary authority”) confirms, among only to nursing, technical and rehabilitation personnel) other things, the duty of each member to know the con- 584 Carlo Petrini and Walter Ricciardi

tents of the Code: “Non-compliance with, or breach of objectives pursued by the Association” [26] and that, the Code or of the Oath, even when due to ignorance, given that current legislation entrusts professional as- constitutes a disciplinary offence and shall be consid- sociations with disciplinary authority over their mem- ered in accordance with the procedures and terms es- bers, the regulations contained in codes of practice are tablished by the professional association”. This article de facto also legal rules that form the basis for charges corresponds to Article 5 of the Criminal Code, which of illicit conduct. states that “ignorance of the law does not excuse” (igno- Put briefly, the Italian “Code of Medical Conduct” rantia juris non excusat). The article was reviewed by the contains extra-legal rules applicable within the profes- reviews

Constitutional Court, which in its decision no. 364/88 sional category, but of which legal doctrine and case- [22] declared it to be partially unconstitutional because law in the matter of professional duty are increasingly

and of its failure to exclude “unavoidable ignorance”. The taking note.

Court pointed out that each person is duty-bound to be This trend is set to accelerate if and when a bill current- acquainted with basic legal precepts and that any person ly before Parliament becomes law. This bill, “Provisions who operates in a specific professional field who is igno- concerning the professional responsibility of healthcare rant of the criminal laws regulating that field is culpable. personnel” [27], does not explicitly mention the “Code articles

While these provisions refer to criminal laws, they can be of Medical Conduct”, but gives special consideration to applied to Article 2 of the “Code of Medical Conduct”. guidelines. Health professionals are required, in the ex- Later versions of the “Code of Medical Conduct”, ercise of their healthcare duties – except in very specific down to the current one, tended to follow the evolution circumstances – to comply with rules of good clinical riginal of legislation, adapting the code to new laws. But good practice and care and with the recommendations laid O practice was, at least until recently, considered an ex- down in guidelines drawn up by scientific associations tra-legal matter. With its ruling no. 10842/03 [23], the and research institutions listed in a Health Ministry de- Court of Cassation affirmed that: “unless they are in- cree and included on a special register. corporated into legislation (…), provisions laid down in codes of conduct drawn up by professional associations THE CODE OF MEDICAL CONDUCT AND have neither the essence nor the characteristics of laws THE LEGAL SYSTEM: FOOD FOR THOUGHT such as those subject to Article 12 of the Civil Code, Although there may be even major differences be- but are an expression of the powers of self-government tween the approaches to medical ethics of different of the Associations (or Colleges), so that their authority nations, medicine, like disease, knows no boundaries: (…) derives not only from professional custom but also a common feature in all the codes of medical practice from the regulations issued by the above Associations drawn up in the last century is an explicit reference to (or Colleges) to set down the duties of correct behav- the Hippocratic tradition [28], which forms the back- iour with which their members should comply and to bone of most such codes [29]. regulate their disciplinary function”. In other words, the This is certainly true of the “Principles of European Court stated that none of the ethical provisions issued Medical Ethics” [30] adopted by the European Con- by professional associations can be considered as laws ference of Medical Orders (CEOM) on 6th January of the land unless they are transposed into legislation, 1987 (to which an Appendix was added on 6th February because they lack the essential requisites. 1995), and of the European Charter of Medical Ethics” This approach, however, was overturned by the [31] adopted on 11th June 2011 by the CEOM in the same Court in its ruling no. 26810/07, which stated wake of the “Sanremo consensus document” [32] pro- that breaches of regulations laid down in professional moted by the FNOMCeO. codes should be treated as breaches of the law. In other Among the useful features of codes of ethics are their words, the Court considered such codes as rules of law ability: to encapsulate in a single document all the indi- with which members of professional associations must cations concerning the values, principles and standards comply and which complement objective law for the that each profession should pursue; to draw a clear line purposes of identifying disciplinary offences [24]. With between what is and what is not tolerated; to encourage this ruling breaches of regulations contained in codes of the public’s trust in the different professions. good practice are considered in the same way as ordi- Some of these benefits could be enhanced if the texts nary legislation, and carry the same consequences. of these codes were incorporated into legislation [33]. This approach was again confirmed by the Court According to Paul Honigman “For medical ethics to be of Cassation in ruling no.16145/08, which stated that effective, they must be incorporated either directly or disciplinary measures “are to be treated as legislation indirectly in the law of the land, at least in a democratic supplementary to general clauses, which are to be in- society. ‘Indirectly’ means that the state may delegate terpreted taking account of different legislative sources, to a subsidiary body the responsibility for ensuring that albeit of infralegislative rank, such as regulations of pro- ethical standards are maintained and enforced. Medical fessional ethics” and that the “Code of Medical Con- ethics which are divorced from the law of the land are duct” “represents a legal source that can be qualified likely to be merely academic and lacking in effective- as a ‘legal standard’ whose legitimate interpretation is a ness. This does not mean that there can never be occa- quaestio iuris” [25]. sions when in moral and idealistic terms it is the duty of The Constitutional Court also affirmed that “mem- the medical practitioner to uphold abstract principles bership of an Association creates a professional ob- of medical ethics even if the law of the land dictates ligation to behave in a manner compatible with the otherwise” [34]. 585 Medical ethics and the legal system in Italy

In some nations the codes of medical practice have medicine is based on the acquisition of scientific and been variously incorporated into legislation. experimental knowledge that is continually evolving, In , for instance [35], the “Code de déontolo- the underlying rule in this field consists in the auton- gie médicale” was updated a number of times before omy and responsibility of the physician”, who “must the current version of 7th May 2012 [37] was ratified by adapt his decisions to scientifically validated data and a decree of the Conseil d’État and incorporated in the methodologically sound evidence” (as established in Ar- “Code de la Santé Publique” (in Articles R.4127-1 to ticle 12 of the 1996 “Code of Medical Conduct” then R.4127-12). It is nonetheless worth noting that the code in force). The Court then stated that decisions taken by reviews is included not in the legislative section of the “Code de regional lawmakers that are not based on “acquisitions la Santé Publique” but in the regulatory section. of specific technical-scientific knowledge that has been

In the professional order of each Land validated by the competent authorities” but are based and adopts a code of medical conduct in accordance with on “assessments of a purely political nature” cannot the relevant laws of the specific Land (which also speci- override “fundamental principles based on current state fies which issues the code may address). In this way legislation”, and concluded that the “Code of Medical the code of conduct assumes the characteristics of the Conduct” presents a “meeting-point between the phy- articles source of law typical of public law institutions, to which sician’s professional decisions and his duty to take ac- category professional orders belong [38]. count of scientific and experimental evidence”. In Italy several rulings concerning professional liabil- In light of all the above there is good reason to pursue ity (in both civil and criminal proceedings) have treated the search for ways to improve the relations between the “Code of Medical Conduct” as a set of rules in com- ethics and the law, bearing in mind the complex nature riginal mon law against which the conduct of individual physi- of both. But it would be inappropriate to transform the O cians can be measured [39]. code into legislation, as this would lead to over-legisla- The possible incorporation of the complete text of tion. As we have seen, the fact that the “Code of Medi- the “Code of Medical Conduct” into legislation might cal Conduct” has not been incorporated into legislation make it more binding on physicians, though the trans- does not prevent it being recognised as being legally position of rules of good practice into legal regulations binding. could prove problematic [40]. At this point it is worth recalling that opinions ex- Acknowledgments pressed in legal literature and case law, and even in cur- This article follows on the debate during the “Day of rent legislation, may conflict with standards of good prac- study on sustainability and development of the Nation- tice and place physicians in seriously difficult positions. al Health Service” at the Istituto Superiore di Sanità on Nor should it be forgotten that the art of medicine 20th June 2016. differs from other professions, as the Constitutional Court aptly pointed out in its ruling no. 282 of 22nd Conflict of interest statement June 2002 [41] (which declared the constitutional ille- There are no conflicts of interest or any financial or gitimacy of Law no. 26 passed on 13th November 2001 personal relationships with other people or organiza- by the regional government of the , which had tions that could inappropriately bias conduct and find- suspended the application of electroconvulsive treat- ings of this study. ment, lobotomies and other psychosurgical therapies). The Court referred explicitly to the “Code of Medical Received on 30 August 2016. Conduct” to support the view that “as the practice of Accepted on 3 October 2016.

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