Health, Technological Development and the Law

Eurohealth

RESEARCH • DEBATE • POLICY • NEWS Volume 13 Number 2, 2007

Regulating nano-technology: new legal challenges?

E-health: but is it legal?

Zsuzsanna Jakab on developments at the European Centre for Disease Prevention and Control

Dutch health insurance reform: the role of collectives • Palliative care Health service quality in Bulgaria • Experience from public-private partnerships in Eastern Europe Eurohealth Health, law and technological change LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom C The speed of technological advance can be truly fax: +44 (0)20 7955 6090 email: [email protected] breathtaking; possibilities that a few years ago were www.lse.ac.uk/LSEHealth confined to the realms of science fiction are rapidly Editorial Team becoming reality. Most obviously, the way in which we communicate has been transformed beyond all EDITOR: David McDaid: +44 (0)20 7955 6381 O recognition. We live in a world of instant access, email: [email protected] through mobile phones, laptops and PDAs, to the FOUNDING EDITOR: information superhighway. Moreover, social Elias Mossialos: +44 (0)20 7955 7564 networking platforms, such as Facebook, are being email: [email protected] used to a scale never envisaged by their creators; their DEPUTY EDITOR: Sherry Merkur: +44 (0)20 7955 6194 M potential for marketing and brand placement is the email: [email protected] subject of millions of euros of research. EDITORIAL BOARD: Reinhard Busse, Josep Figueras, Walter Holland, Julian Le Grand, Martin McKee, Elias Mossialos The health sector is not immune from these changes. SENIOR EDITORIAL ADVISER: Not only do we have access to health information on Paul Belcher: +44 (0)7970 098 940 the internet, albeit sometimes spurious, but we may email: [email protected] M book hospital appointments, download personal DESIGN EDITOR: medical records, use remote diagnostic technologies Sarah Moncrieff: +44 (0)20 7834 3444 email: [email protected] and perhaps purchase health care products. This SUBSCRIPTIONS MANAGER growth of e-health in all its forms, according to Celine Champa Heidbrink: +44 (0)20 7955 6840 Van Doosselaere and colleagues, has therefore as many email: [email protected]

serious implications for health care regulators and Advisory Board E lawyers as it does for the medical professions. They Anders Anell; Rita Baeten; Nick Boyd; Johan Calltorp; note the uncertainty about the full legal implications Antonio Correia de Campos; Mia Defever; Nick Fahy; of using many e-health applications; further Giovanni Fattore; Armin Fidler; Unto Häkkinen; Maria Höfmarcher; David Hunter; Egon Jonsson; Meri Koivusalo; clarification, they argue, at European level is merited. Allan Krasnik; John Lavis; Kevin McCarthy; Nata Menabde; Bernard Merkel; Stipe Oreskovic; Josef Probst; Tessa Richards; Richard Saltman; Igor Sheiman; Aris N Having a more flexible legal framework to respond to Sissouras; Hans Stein; Jeffrey L Sturchio; Ken Thorpe; technological change can also be applied to the Miriam Wiley potential use of nanotechnology. As well as ethical Article Submission Guidelines concerns, resultant legal issues concerning consent, see: www.lse.ac.uk/collections/LSEHealth/documents/ privacy, and use in the context of research remain to be eurohealth.htm

fully debated. In this issue Jean McHale calls for an Published by LSE Health and the European Observatory effective and pro-active, rather than reactive, EU on Health Systems and Policies, with the financial support T of Merck & Co and the European Observatory on Health response to these new challenges. Systems and Policies. Eurohealth is a quarterly publication that provides a forum Preparedness is a theme also found elsewhere in this for researchers, experts and policymakers to express their views on health policy issues and so contribute to a issue of Eurohealth. We are delighted to include a constructive debate on health policy in Europe. contribution from Zsuzsanna Jakab, Director of the The views expressed in Eurohealth are those of the authors European Centre for Disease Prevention and Control. alone and not necessarily those of LSE Health, Merck & Co or the European Observatory on Health Systems and Poli- The ECDC provides some excellent examples of how cies. technology may be harnessed to collate and The European Observatory on Health Systems and Policies disseminate information on rapidly emerging and un- is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, expected health threats in Europe and beyond. Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the Open Society Institute, the World Bank, the London School David McDaid Editor of Economics and Political Science, and the London School Sherry Merkur Deputy Editor of Hygiene & Tropical Medicine.

Design and Production: Westminster European email: [email protected]

Printing: Optichrome Ltd

ISSN 1356-1030 Contents Eurohealth Volume 13 Number 2

Health, Technology and the Law Olga Adeeva was until August 2007 Research and Development Officer at 1 eHealth…… but is it legal? the European Observatory on Health Celine Van Doosselaere, Petra Wilson, Jean Herveg and Systems and Policies, Berlin Hub, Denise Silber Germany

4 Regulating nanotechnology: new legal challenges? Lidia Georgieva is Head of Health Risk Management, MARSH Bulgaria. Jean V McHale Peter Groenewegen is Department Head, Netherlands Institute for Health Health Policy Developments Services Research and Professor of Social and Geographical Aspects of 7 Public-private partnerships in Eastern Europe: Case studies Health and Health Care at Utrecht from Lithuania, Republika Srpska and Albania University, the Netherlands. Katja Kerschbaumer Jean Herveg is Senior Researcher, Centre de Recherche Informatique et 10 Dutch health insurance reform: the new role of collectives Droit, Faculty of Law, University of Peter P Groenewegen and Judith D de Jong Namur, Belgium.

Zsuzsanna Jakab is Director, European Public Health Perspectives Centre for Disease Prevention and Control (ECDC), Stockholm. 14 Medicine, care of the dying, and care of the chronically ill Milton Lewis Judith de Jong is a Researcher at the Netherlands Institute for Health Services 16 ECDC: Tackling the free movement of microbes Research and Head of the Health Care Consumer Panel. Zsuzsanna Jakab Katja Kerschbaumer is a Junior Professional Associate in the Human European Snapshots Development Department, Europe and Central Asia Region at the World Bank, 19 Promoting the quality of health services in Bulgaria Washington, D.C. Olga Avdeeva and Lidia Georgieva Milton Lewis is Honorary Senior Research Fellow, Australian Health Policy Institute, University of Sydney, Evidence-informed Decision Making Sydney, New South Wales, Australia. 21 “Mythbusters” Early detection is good for everyone Jean V McHale is Professor, Faculty of Law, University of Leicester, United 23 “Bandolier” The case for chocolate Kingdom.

Denise Silber is Director and Founder, Basil Strategies.

Celine Van Doosselaere is EU Affairs Monitor Manager, European Health Management Association, Brussels. 24 Publications Petra Wilson is Director Public Sector 25 Web Watch Healthcare, Cisco.

26 News from around Europe HEALTH, TECHNOLOGY AND THE LAW eHealth…… but is it legal?

Celine Van Doosselaere, Petra Wilson, Jean Herveg and Denise Silber

Summary: Unconstrained by familiar points of entry to health care or traditional channels for delivering information or care, the eHealth revolution has as many serious implications for health care regulators and lawyers as for medical professionals. In the context of the Commission’s eEurope Action Plan, the “Legally eHealth” study established a baseline report on existing EU level legislation, its impact on the delivery of eHealth and an analysis of the legal and regulatory barriers and gaps that may exist. This article gives an overview of some of the issues studied and key recommendations made.

Keywords: eHealth, Security and Privacy, Liability; Data Protection and Ownership eHealth is a broad term with many defini- In response to the lack of legal certainty such as picture archiving and communications, including health informatics, health about the use of eHealth tools, the tions systems (PACS), as well as clinical telematics, ICT (information and commu- European Commission, through its support systems such as operating theatre nication technology) for health, connected eHealth Action Plan, called for a study to systems (OR), decision support systems health, medical computing, or medical establish a base-line report on existing EU (DSS); and systems linking key health care informatics, all of which are used to level legislation, its impact on the delivery actors such as General Practitioners describe the use of a wide range of infor- of eHealth and an analysis of the legal gaps Systems, and electronic prescribing mation technology applications and which may exist. The ‘Legally eHealth’ systems linking general practitioners (GPs) services in the healthcare setting. For the study, which we present in this article, was with pharmacies (eRx). ‘Legally eHealth’∗ study described in this completed in response to that call. Having established what concepts and article we use the term eHealth as defined tools were included in eHealth, we next by the Action Plan for a European eHealth The ‘Legally eHealth’ Framework classified the stakeholders in eHealth into Area: “the application of information and The one year study, completed in May four groups of actors: citizens and patients; communication technologies across the 2007, looked in detail at three particular clinicians and care providers; payers, whole range of functions that affect the legal aspects of using information society policy-makers and governments; and, health sector”.1 technologies (IST) in health care: privacy, vendors, suppliers and commercial liability and competition. Although other eHealth is premised on a fundamentally partners. All four groups of actors have legal issues arise in the context of new patient experience unconstrained by highly significant but not always equal providing health care services using familiar points of entry and structures or roles to play in health care. We looked in eHealth tools, we focussed on these three traditional channels for delivering infor- particular at the tensions that can arise as the main legal issues with European mation or care. Not surprisingly therefore, between clinicians and patients with level implications. the eHealth revolution has as many serious respect to privacy and confidentiality, or implications for health care regulators and We first looked at the key tools and appli- between governments and vendors with lawyers as for medical professionals, cations and then the main stakeholders and respect to competition in the health care including questions about patient and existing regulations that have an impact on market. professional identification, maintenance of the use of eHealth. These covered a wide The study considered the impact of patient confidentiality in an environment range of information technologies found in European data protection legislation, of electronically shared care, as well as hospitals and primary care settings, European consumer protection and questions of liability for care provided in including administrative tools such as liability legislation, and European compe- this new environment. hospital information systems (HIS), tition law. We analysed this legislation in summary records and discharge letters; detail, and followed the analysis by a series clinical applications of a technical nature Celine Van Doosselaere is EU Affairs Manager, European Health Management Association, Brussels, Petra Wilson is * European Commission contract #30-CE-0041734/00-55. Study on Legal and Regu- Director Public Sector Healthcare, Cisco, latory Aspects of eHealth, ‘Legally eHealth’. Partners in the study include the European Jean Herveg is Senior Researcher, Health Management Association, the Centre de Recherche Informatique & Droit Centre de Recherche Informatique et (CRID) at the Facultés Universitaires Notre-Dame de la Paix (Namur, Belgium), and Droit, Faculty of Law, University of Basil Strategies. Special thanks are due also to Cisco Systems Internet Business Solutions Namur, Belgium and Denise Silber is Group who gave technical input and writing support. Further details on the Study can Director and Founder, Basil Strategies. be obtained from EHMA (www.ehma.org) or European Commission Email: [email protected] (http://ec.europa.eu/information_society/activities/health/studies/index_en.htm)

1 Eurohealth Vol 13 No 2 HEALTH, TECHNOLOGY AND THE LAW

that allows for proper balancing of patients’ and public health interests, without recourse to the concept of consent.

On eHealth and product liability Traditionally, medical liability is restricted to the relationship between the patient and the health practitioner (usually a doctor). When a patient is a victim of medical negligence or of a medical error, he or she will usually seek to introduce a civil or criminal lawsuit against the doctor. However, the use of eHealth tools, as well as the multi- plication of intermediaries in the field of health services, is changing the legal rela- tionships between the various actors, and often makes it more difficult for a patient to know where liability lies if something goes wrong. of small case study ‘vignettes’ which tives are probably sufficient to meet the Although general legal rules have been demonstrated the practical implications of needs of IST in health, further clarification agreed to provide consumers with a legal the key legal concepts. Key legal aspects of specific legal duties would be helpful. guarantee of high quality products and studied in the ‘vignettes’ included: Data protection legislation is now well services, the legal texts do not specifically established in Europe: while health data is Electronic Medical Records address health or eHealth. The current EU always sensitive and requires special – responsibility of the service provider to level law is applied within the general protection, such data may be processed on the physician context of service provision and product the basis of patient consent; or in the vital delivery, whether by traditional or elec- – responsibility of the physician to interests of the patient; or for the purpose tronic means. As a result it is often difficult his/her patients of medical diagnosis and care provision; or, to ascertain which EU level legislation Sale of medical products on line in certain cases, if there is a substantial applies to an eHealth product: is it – responsibility of the manufacturer's public interest in such data processing. considered a medical device, a software website We believe that generally the existing data package, and does other legislation (for – responsibility of the consumer protection legislation at EU level and its example, on hazardous substances) also transposition at Member State level are apply? In terms of health goods, whether Distance monitoring products sufficient to allow eHealth tools and appli- eHealth or traditional, standard contracts – responsibility of the manufacturer, cations to be used efficiently in health care. for sale of goods will apply. In general – responsibility of the service provider However, we recommended that the therefore in the eHealth arena, the purchaser of an eHealth good will need to Using digital records pedagogically European Commission and Member States make reference to the relevant national – protecting patient anonymity cooperate, in particular through the Data Protection Working Party set up under legislation based on Directive 1999/44/EC eHealth industry Article 29 of the Data Protection on the Sale of Consumer Goods. – role of the state versus private sector Directive, to address uncertainties in the The study concluded that while specific – monopoly and competition role of consent to the processing of eHealth sale of goods legislation is medical data; the necessity to state a We concluded with recommendations to probably not needed, it might be appro- finality of purpose for data collection; and the European Commission on further priate to consider the adoption of specific technical aspects of data processing and regulatory activities to support the imple- EU level guidelines on the sale of eHealth storage security. mentation of eHealth. goods in order to encourage the adoption There are particular difficulties connected of EU wide markets in eHealth tools In this article we outline the three legal with the concept of ‘consent’ in health rather than the fragmented national level aspects we studied and the key recommen- related data processing. A particular markets one sees currently. dations made. problem with consent lies in the fact that, Beyond the sale of the product, Directive in order to be valid, consent must be freely 2001/95/EC on General Product Safety On data protection given. Thus, if the creation of electronic requires that any product put on the The study looked in detail at the require- medical records is a necessary and market for consumers, or likely to be used ments of EU privacy and data protection unavoidable aspect of providing good by them, is safe. Further it requires that legislation, providing a thorough exami- quality health care, then withholding producers provide consumers with the nation of the Data Protection Directive consent may be to the patient’s detriment. relevant information enabling them to (95/46/EC) and the Directive on Privacy in We argue therefore that it would seem assess the risks inherent in the product, Electronic Communications (2002/58/EC). appropriate for the European Commission and take appropriate actions to avoid these We looked carefully at the existing regula- to coordinate the adoption of specific rules risks (withdrawal from the market, tions and concluded that while the Direc- for the processing of health information warning to the market consumers, recall

Eurohealth Vol 13 No 2 2 HEALTH, TECHNOLOGY AND THE LAW products already supplied etc). poses difficult questions concerning of the European Commission should be competition within public and private encouraged to examine the recent decisions National authorities have been established markets in situations where the distinction of the European Court of Justice (ECJ) on to monitor product safety and to take between the two is often very hard to the application of Articles 81 and 82 to appropriate measures to protect establish. health care providers, in order to draw up consumers and an information system has clear guidelines establishing when a health been put in place which imposes collabo- The principles of free trade and free care provider will be regarded as an under- ration not only between distributors, competition are among the most important taking and when not. Such guidelines producers and the national authorities but economic principles supported by the should address the widest possible range of also between Member States and the European Community. It is therefore not health care providers and suppliers, European Commission (RAPEX).2 This surprising that the European Community covering traditional and eHealth care. system has thus far not been used well (if at has adopted a wide range of legislation to all) for eHealth products, which are still support free competition through a legal Further to Article 86(2), the Treaty rather new and for which little legal system that prohibits any disloyal practices provides that an undertaking normally guidance currently exists. Accordingly, the that restrict competition. subject to the rules of competition law may study recommended that the European be exempted from their application if it has The core of European competition law is Commission should adopt policy tools to been entrusted by a public body to provide found in the rules applying to private firms encourage the use of the RAPEX system a Service of General Economic Interest or ‘undertakings’ in Articles 81 and 82. for eHealth products. (SGEI)4 and if the application of the rules Article 81 prohibits agreements and on competition would obstruct the We also noted also that some eHealth concerted practices with an anticompet- performance of the particular tasks products are considered medical devices, itive objective or effect on the market, assigned to them. While it is left up to in the terms of Directive 93/42/EC on while Article 82 prohibits abuse of a Member States to define the services they Medical Devices. The Directive includes in dominant position. Article 86(2) states that consider as SGEI, considerable lack of its definition of medical devices electronic the rules on competition also apply to clarity still exists at EU level on the desig- equipment and software manufactured or public undertakings, as long as the “appli- nation of health services. promoted for medical purpose. Thus, cation of such rules does not obstruct the monitoring devices, for example, could be performance, in law or in fact, of the Recognising that many European health considered as medical devices under the particular tasks assigned to them.” systems are provided through public European Medical Device legislation, funds, the European Commission has, in a The rules of competition law on abuse of while eHealth tools used for the adminis- number of communications, suggested that dominant position and concerted practices tration of general patient data will health services are not generally to be are defined by the Treaty to apply only to generally not be considered medical regarded as SGEI nor are they to be those organisations classified as ‘under- devices unless such a product (for example, included in the wider definitions of takings’. The key question for purposes of a laptop, printer, screen, etc.) has had a Services of General Interest (SGI) or Social health care providers is therefore whether specific medical purpose assigned to it. Services of General Interest (SSGI)*. The any of the parties to an eHealth service are Commission has instead proposed that, It is clear that more clarity is needed on the deemed to be undertakings and therefore because health services have such a unique extent to which eHealth products are subject to competition law. character, special targeted rules on health covered by Medical Devices Legislation. Recent case law at national and EU level3 services of general interest should be estab- Many of the currently available moni- has established that publicly funded health lished. However, despite first raising this toring devices are covered only by general bodies may, in certain circumstances, be issue in 2001, the European Commission product liability, not by a specific liability subject to competition law. However, the has yet to clarify the position of health provision. It is suggested that further case law is unclear and would seem to services and their possible exemption from consultation on the application of medical provide that the same institution may, in competition law. devices legislation to eHealth tools takes some aspects of its conduct, be regarded as place to establish if special guidelines The study recommended that the an undertaking (if it offers goods or should be issued. Commission adopt a communication or services on the market) but in other aspects guidelines setting out clearly the circum- (such as contracting out certain care On competition law stances under which a health service services) will not be considered an under- Health services, in most European coun- provider may make use of the provisions taking. tries, are provided at least to some extent on SGEI in the Treaty and thus be though direct taxation and compulsory This ambiguity in law will be unsettling for exempted from competition law. Such health insurance. However, most eHealth both public and private sector health care guidelines should address the changing services are offered through private enter- providers. The study recommended, nature of health services, recognising that a prises and businesses and thus eHealth therefore, that the appropriate committees wide range of actors from both public and

* For the evolution of the definition on Services of General Interest, see Green and White Papers at http://europa.eu/eur-lex/en/com/gpr/2003/com2003_0270en01.pdf (COM(2003) 270 final, May 2003) and http://europa.eu/eur-lex/en/com/wpr/2004/com2004_0374en01.pdf (COM(2004) 374 final, May 2004), announcing a more systematic approach in the field of social and health services of general interest. This systematic approach is proposed by a Communication from the Commission ‘Implementing the Community Lisbon programme: Social services of general interest in the European Union’ (COM(2006)177, April 2006), available at http://ec.europa.eu/employment_social/social_protection/docs/com_2006_177_en.pdf. For more information, see http://ec.europa.eu/employment_social/social_protection/questionnaire_en.htm.)

3 Eurohealth Vol 13 No 2 HEALTH, TECHNOLOGY AND THE LAW private enterprises will be involved in the Interest, the Lisbon agenda and long-term Plan for a European eHealth Area. provision of both traditional and eHealth care, as well as heated debates on health Brussels: Communication from the services. In order to encourage adequate services with the Services Directive, little Commission to the Council, the European investment in eHealth services, both public emphasis has been given to an impact Parliament, the European Economic and and private enterprises must have legal assessment of the proposed legislative Social Committee and the Committee of the Regions, COM(2004)356, 2004. certainty on their position with respect to responses to health services in general. competition law. Moreover, none have considered in depth 2. See http://ec.europa.eu/consumers/ their impact on eHealth services. Given dyna/rapex/rapex_archives_en.cfm Conclusion however, that the development of eHealth 3. Federación Nacional de Empresas de eHealth is important for Europe, it can markets is considered to have major Instrumentación Científica, Médica, 5 drive up service quality, improve patient economic potential for Europe, further Técnica y Dental (FENIN) v Commission safety, contain costs and facilitate access to legal clarifications are necessary both to of the European Communities. Court of health care. The ‘Legally eHealth’ study encourage the development of these First Instance (EC), Case T-319/99, Court has examined aspects of European law markets in optimal conditions, all the of Justice of the European Communities, related to data protection, liability and while respecting the unique nature of Case C-205/03. consumer protection, and competition law. health services. Therefore, in addition to 4. Commission of the European Commu- It has identified that a significant body of the specific recommendations made on nities. Services of General Economic European law already addresses a number each of the three clusters of legal issues, the Interest, summaries of legislation. Available of the key legal issues in eHealth. study calls for a mainstreaming of eHealth at http://europa.eu/scadplus/leg/en/lvb/ However, there is still great uncertainty in impact assessment across all European l26087.htm policy initiatives. the eHealth actors, ranging across public 5. Independent Expert Group on R&D and bodies, big industry and small enterprises Innovation. (Esko Aho chair). Creating an about the full legal implication of using Innovative Europe. Luxembourg: Office REFERENCES and offering eHealth services. for Official Publications of the European 1. Commission of the European Commu- Communities, 2006. Available at It is notable that despite the large numbers nities. eHealth: Making Health Care http://ec.europa.eu/invest-in- of communications on Services of General Better for European Citizens – An Action research/pdf/download_en/aho_report.pdf

Regulating nanotechnology: new legal challenges?

Jean V McHale

Summary: The development of nanotechnology has huge potential for medical science. However at the same time it gives rise to a range of legal and ethical regulatory challenges for the EU and Member States. This paper explores first what is meant by nanotechnology and its use in medicine. Secondly, it considers some of the ethical and regulatory challenges discussed by the European Group on Ethics in Science and New Technologies in their recent Opinion on the ethical aspects of nanomedicine. It suggests that there are many legal and ethical issues which will need to be further explored at both EU and Member State level, including the diversity of current regulatory structures applicable in this area, issues of consent, privacy and the regulation of risk.

Key words: Nanotechnology, Medicine, Health, Law, European Union

The rise of nanotechnology in general and understand how the body functions at ative medicine. It has to interface nanoma- nanomedicine in particular has led to molecular level. ‘Nano’ itself refers to ‘one terials (surfaces, particles or analytical considerable debate and controversy.1 billionth’ and originates from the Greek instruments) with ‘living’ human material ‘Nanotechnology’ can enable us to better word meaning ‘dwarf’. As the European (cells, tissues and body fluids). It creates Technology Platform Report comments: new tools and methods that impact significantly on existing conservative prac- Jean V McHale is Professor, Faculty of “It is an extremely large field ranging from tices”.2 Law, University of Leicester, United in vivo and in vitro diagnostics to therapy Kingdom. Email: [email protected] including targeted delivery and regener- The development of this technology may

Eurohealth Vol 13 No 2 4 HEALTH, TECHNOLOGY AND THE LAW result in more efficient interventions in is the scale of nanotechnological devel- to undertake an ethical review of relation to illness.3 Nanotechniques can opment and the wide range of issues with nanomedicine which would enable the involve the use of technologies which are which nanotechnology is concerned, future appropriate ethical review of more cost-effective and accurate, such as which may give rise to notable regulatory proposed projects concerning nanoscience the ability to enhance resolution to a challenges. Developing technologies give and nanotechnology.5 single-molecule analysis of any sample. rise to issues of legitimacy and the need to Theis Expert Group highlighted one Nanowire arrays enable testing of a single ensure public trust and confidence, as we uncertainty in this area, namely that there pinprick of blood. This reduces the have seen in the context of the debates over was no clear legal definition of nanomed- prospect of invasive procedures but still embryo research and stem cell technology. icine.3 They also identified a major prac- enables efficient testing results and can tical problem in attempting to take a enable such tests to be undertaken at home Nanotechnology and the EU holistic approach to the regulation of 2 The immense potential of nanotechnology easily and with little pain. nanotechnology, namely that there is a in general, and that in relation to health in Use of nanotechnology in imaging, such as diverse range of forms of legal regulation particular, has already been identified by ultrasound, may result in a much more of such technologies. So, for example, at the European Union. The EU has been precise diagnosis. The use of miniaturised EU level regulation of nanotechnology responding to the challenges of nanotech- imaging systems makes it possible for may arise in the context of the regulation nology. In 2004 the Commission issued the image-based diagnosis to be undertaken, of pharmaceuticals6 or medical devices7 Communication Towards a European not simply in research centres, but much where other health care law principles are strategy for nanotechnology.4 This iden- more widely. This has the advantage of applicable, such as consent, confidentiality tified the potential of nanotechnology but potentially enabling the earlier detection of and data protection.8 It was not necessarily also recognised its risks and the need for disease, with a consequent need for less always obvious which precise regulatory the early identification and resolution of invasive and lower cost treatments.2 regime would apply. safety concerns. Nanotechnology also enables the devel- One notable concern regarding the devel- It noted the need for effective research and opment of miniature devices which may be opment of nanotechnology is that of development support. It stressed the need used in treatment itself. This can reduce safety. A United Nations Education Scien- for effective coordination of national the invasiveness of procedures and lead to tific and Cultural Organization report on measures through mechanisms such as the the development of new forms of the ethics and politics of nanotechnology ‘Open Method of Co-ordination’. It was treatment. commented that the question of safety of recognised that there was a need for a nanotechnology and nanomedicine raised: Nanopharmaceuticals may deliver “world class infra structure” with “poles particular molecules through biological of excellence”. This document also high- “two concerns: the hazards of nanopar- barriers such as blood-brain barriers. lighted the need for recognition of ethical ticles and the exposure risk. The first Carriers on the shell of these molecules can principles in accordance with the EU concerns the biological and chemical be targeted at molecules which are typical Charter of Fundamental Rights and effects of nanoparticles on human for cancer. Nanotechnology may also facil- Freedoms and other European and inter- bodies or natural ecosystems; the itate regenerative medicine. It may enable national documents.4 second concerns the issue of leakage, the improvement of the activation of genes spillage, circulation, and concentration It also identified the need for effective which stimulate regeneration, through of nanoparticles that would cause a communication of such information 9 stem cell therapy with nanotechnology hazard to bodies or ecosystems”. within the scientific community. In based upon magnetic cell sorting identi- addition, the Communication noted the There are concerns that there may be a risk fying/activating and guiding stem cells to importance of international cooperation. It of toxic effects to patients. There is also the the particular part of the body which needs suggested that there should be an interna- possibility of side-effects to patients where regenerating. There is also the prospect of tional debate on those matters of global nanomedicines cross blood-brain barriers. continuous medication through implants concern, including public health, safety, It has also been suggested that there are with controlled administration of drugs the environment, consumer protection, health-related risks from the effects of over a period of time. In addition, access risk assessment, regulatory approaches, nano-pollution on the environment. The to nanotechnology may also facilitate methodology, nomenclature and norms”.4 European Ethics Group recommended tissue engineering.2 that there should be more research into the safety of nanomedical products/devices.3 But is nanotechnology really ‘something Ethical review The Group was of the view that without new’? As has been commented: The European Technology Platform on strategic risk research public confidence in Nanomedicine, an industry-led con- “In many cases nanotechnology includes nanotechnologies could be reduced sortium, brought together the key stake- technology which has been in use for a through real or perceived dangers. It was holders in the area to examine the impact long time and most of the concepts used important for the relevant authorities to of nanotechnology.2 As part of the are not strictly speaking new. For instance, assess the risks of nanomedicine and that Communication from the Commission to the mode of action of all pharmaceutical both national and EU bodies concerned the Council, the European Parliament and products occurs at nano scale. Nanomed- with safety of patients and citizens should the Economic and Social Committee, icine essentially provides tools that may be review the safety of nanotech devices. entitled Nanosciences and nanotech- useful for well identified medical nologies: an action plan for Europe 2005– While the European Ethics Group recog- problems.”3 2009, the European Group on Ethics in nised a range of regulatory issues, they Nonetheless, although not totally new, it Science and New Technologies were asked rejected the introduction of a new broad

5 Eurohealth Vol 13 No 2 HEALTH, TECHNOLOGY AND THE LAW regulatory structure for nanomedicine. genetic diagnosis the line between Instead it was thought that changes should ‘negative’ and ‘positive’ selection may REFERENCES come from within existing structures.3 be blurred.” 1. Hunt G, Mehta M. Nanotechnology, However, they were concerned with Risk, Ethics and Law. London: Earthscan, The Group noted that, in future, it may be ensuring that the differences within the 2006. the case that neurological stimulation of range of regulations already in existence brain activity goes beyond therapeutic and 2. European Technology Platform. would be addressed by regulatory bodies. diagnostic use. The Group suggested that Nanomedicine: Nanotechnology for Health It was noted that while many of the Brussels: European Technology Platform, appropriate monitoring and guidelines as problems associated with new materials 2006. Available at to the use of nanotechnology in this are addressed through product liability ftp://ftp.cordis.europa.eu/pub/nanotech- particular area should be introduced. They legislation, at the same time there are diffi- nology/docs/nanomedicine_bat_en.pdf were also of the view that priority should culties in ascertaining the risks and related not be given to “enhancement tech- 3. European Group on Ethics in Science liability from negligence. Further concerns nologies”, rather health care concerns and New Technologies to the European relate to the use of patenting in hindering should first be addressed. Commission. Opinion on the Ethical the therapeutic availability of such Aspects of Nanomedicine. Brussels: technology. Opinion No 21, January 17 2007. Available Conclusions at The Group also expressed their concern at Where do we go from here? Nanotech- http://ec.europa.eu/european_group_ethics the prospect of internet tests using nology does have great potential, but is it /activities/docs/opinion_21_nano_en.pdf nanotechnology becoming available. They truly ‘special’ and different? The answer to suggested that in the interest of consumer this question is surely both yes and no.10 4. Commission of the European Commu- nities. Towards a European Strategy for protection, policies should be developed to Yes because it is a new technology with Nanotechnology. Brussels: Commission of monitor the introduction of tests directly potential new risks, but at the same time in the European Communities, COM 338, marketed to customers.3 As with any new other ways it can be seen as not being that May 2004. Available at technology, there are also challenges in new at all. It is derivative upon regulation http://ec.europa.eu/nanotechnology/pdf/ relation to nanotechnology in terms of the across a wide range of different areas and nano_com_en_new.pdf provision of information as part of an this will, clearly in itself, give rise to 5. Commission of the European Commu- ‘informed consent’ process. particular regulatory challenges. nities. Nanosciences and Nanotechnologies: The Expert Group emphasised the need The report of the European Group on An Action Plan for Europe 2005–2009. for transparency and public trust. Recog- Ethics in Science and New Technologies Brussels: Commission of the European nising the on-going nature of the chal- raises a series of important issues which Communities, COM 243, 2005. Available lenges faced by nanotechnology, the need to be addressed. Nanotechnology is at ftp://ftp.cordis.lu/pub/nanotech- Group suggested that there was a need for included in the Seventh Research and nology/docs/nano_action_plan2005_en.pdf inter-disciplinary research on the ethical, Development Framework programme 6. See Regulation (EC) 726/2004 legal and social implications of the tech- under the theme ‘Nanosciences, 7. See Directives 93/42/EEC and nology. They proposed that there should Nanotechnologies, Materials and New 90/385/EEC. be a dedicated European network on Production Technologies’.11 nanotechnology ethics, established and 8. See Directive 95/46/EC Both at EU and Member State level, there financed by the Commission under the 9. United Nations Educational, Scientific is a need for prioritisation between Seventh Research and Development and Cultural Organization. The Ethics and different types of nanotechnology. The Framework Programme. Politics of Nanotechnology. Paris: lines between therapeutic and non- UNESCO, 2006. Available at They also suggested that initiatives should therapeutic uses will pose challenges. http://unesdoc.unesco.org/images/0014/00 be developed to enhance information Ethical concerns over the implications of 1459/145951e.pdf exchange between research ethics nano-scale implants, such as brain implants 10. Royal Society and Royal Academy of committees in different Member States. in relation, for example, to issues of impact Engineering. Nanoscience and Nanotech- Interestingly, the report also suggests that on autonomy, integrity, self-identity and nologies: Opportunities and Uncertainties. measures should be taken at a European freedom will need further exploration. London: Royal Society and the Royal level to create databases not only for Equally, the resultant legal issues Academy of Engineering, 2004. Available scientific aspects of nanomedicine but also concerning consent, privacy, and use in the at http://www.nanotec.org.uk/ for their ethical, legal and social implica- context of research remain to be fully finalReport.htm tions. debated. The challenge, as with other new 11. Commission of the European Commu- One other concern raised by the Expert technologies such as embryo research and nities. Proposal for a Decision of the Group was the prospect of any overlap stem cell therapy, is to balance public European Parliament and of the Council between medical and non-medical uses.3 demand for the development of new Concerning the Seventh Framework They noted that there was a possibility that medical therapies with public concerns Programme of the European Community regarding the risks that these new tech- for Research, Technological Development “the distinction between therapeutic nologies entail. An effective pro-active, as and Demonstration Activities. Brussels: goals and enhancement goals may Commission of the European opposed to reactive EU response, is to be become less clear, if for example, predis- Communities, COM 119, April 2005. welcomed in dealing with these challenges position tests are available more easily across the Member States of the EU. and cheaply. Especially in the repro- ductive context of pre-implantation

Eurohealth Vol 13 No 2 6 HEALTH POLICY DEVELOPMENTS Public-private partnerships in Eastern Europe:

Case studies from Lithuania, Republika Srpska and Albania

Katja Kerschbaumer

Summary: Public-private partnerships (PPP) in the health sector have become a viable tool for governments seeking to reduce financial pressure without lowering quality standards and unreasonably burdening patients. Lithuania, Bosnia and Herzegovina, and Albania have successfully established several partnerships with the private sector. Key factors for a PPP’s success include: the active involvement of patients and medical staff, an enabling legislative framework, the conduct of feasibility studies and the introduction of performance control mechanisms.

Keywords: Public-Private Partnership, Health Care, Concession Contracts, Outsourcing, Lithuania, Republika Srpska, Bosnia and Herzegovina, Albania

Many countries are looking at various to a wide range of clinical and ancillary Clinic concession contracts in Vilnius, forms of public-private collaboration services, such as design and construction, Lithuania (PPC) in order to support reforms and catering, laundry, clinical support services A major problem in hospitals in the improve efficiency and fiscal sustainability (for example, laboratory analysis) and municipality of Vilnius had been the in the publicly financed health sector. To specialised clinical services (for example, shortage of funds for essential maintenance date, there is limited information available haemodialysis). It may even be used to and renovation, as well as for the purchase on the different options for PPC, in outsource the management of an entire of modern information technology and particular on reasons for success, the hospital. medical equipment. Waiting times for necessary institutional and financial appointments and surgery were also Contracts may stipulate that the private requirements and ways to manage the disproportionately long. Medical sector be responsible for all or some related financial risk. personnel were not very motivated, due to project operations; financing might be a lack of direct responsibility or incentives. PPC in the health sector can take a variety undertaken jointly or by either the public of forms, with differing degrees of public or private sector alone. In practice, the There were however public concerns over and private sector responsibility and risk. main types of PPP frequently encountered any suggestion of reforming the system, They are characterised by the sharing of in the health sector include: concession because of the discovery of a corruption common objectives, as well as risks and contracts (in which asset ownership scandal in 2004 related to the proposed rewards, as might be defined in a contract remains in public hands, but where the establishment of a PPP clinic in Kaunas. or manifested through different arrange- private partner is responsible for new Doctors were also key opponents of ments, so as to effectively deliver a service investments, as well as operating and main- reform; they feared losing their privileges, or a facility to the public. taining assets), management and service including informal payments from their contracts, leases, the creation of brand new patients. These negative attitudes were Health care public-private partnerships joint venture projects or privatisation. overcome through ongoing meetings (PPP) typically involve the Ministry of between representatives of the munici- Health or the national health insurer The following three case studies report pality, doctors and patients, as well as signing a contract with the private sector initial experiences with public-private through a major information campaign in for a specific service. PPPs can be applied arrangements in South-Eastern and the press and television. Most importantly, Eastern Europe.

Katja Kerschbaumer is a Junior * On 4–5 December 2006, The World Bank, together with the International Finance Professional Associate in the Human Corporation advisory and investment team and the Slovenian Center of Excellence in Development Department, Europe and Finance, organised a two-day workshop on public-private collaboration in health. This Central Asia Region at the World Bank, article is based on three case studies that were presented by country representatives at the Washington, D.C. workshop. Background material as well as all presentations given at the workshop can Email: [email protected] be found on the Bank’s website: www.worldbank.org.

7 Eurohealth Vol 13 No 2 HEALTH POLICY DEVELOPMENTS meetings between private investors and as ‘concession contracts’, with the whole Minister of Foreign Economic Affairs, the medical personnel allowed trust between procedure largely governed by the Health Insurance Fund Director, the the two groups to develop. Given the fact Lithuanian Law on Concessions. In the hospital director and successful bid winner that Lithuania is facing a major lack of case of the above clinic, the contract was – the Dutch firm International Dialysis health care professionals because of 50 pages long and signed by four parties: Center (IDC).* The contract itself was migration to other European Union coun- the director of the municipality’s adminis- very simple and only eight pages long. tries where salaries are higher, it was tration, the concessionaire, the firm estab- From a legal standpoint, the outsourcing crucial to reach consensus with these lished by the concessionaire and the clinic of dialysis services could be undertaken professionals. director. An administrative committee was without the need to pass new laws or use created by Vilnius municipality to other legal instruments. This could be Through a selection process, the munici- supervise the process of drawing up the achieved simply through a contract with pality of Vilnius chose two of eight contract. the services provider, supported by laws potential clinics for the introduction of governing companies with limited liability PPP. There were no firm criteria for this A key challenge in this project was that and foreign companies. selection; the municipality simply wanted some (very limited) property rights in the the clinics to be ‘representative’ with clinic building and equipment were held by Republika Srpska (RS) first began using regards to their size and economic the Ministry of Health rather than the the PPP contractual model in 2000. As the performance. Thus, one large and one municipality. This made it impossible for National Health Insurance Fund did not small clinic, both of average performance, the municipality to lease these assets have a specific estimate of costs of were chosen. In addition, in order to directly to the ‘Special Purpose Vehicle’ treatment provided in the state ensure that the population would not (SPV – a limited company set up to fulfil a haemodialysis centre an economic analysis avoid using those hospitals where reforms narrow objective and legally isolate a high was conducted. This found that treatment would be introduced, politicians chose risk project from a parent company set up could in fact be obtained at a lower price clinics located in areas without easy access for the contract). However, the Ministry of in the private sector. Based on this finding, to alternative health care providers. Health instead was able to enact legislation the Government of RS decided to collab- transferring these limited property rights orate with private health care institutions, The municipality of Vilnius also hired to the municipality who in turn could lease being mindful of three objectives: consultants to carry out a feasibility study, this to the SPV. improvements in the quality of the including a patient survey in 2005/06. The national health care system; increased study evaluated ten different options for Some would have liked to have gone even access to high quality medical services; and collaboration with the private sector: these further than these arrangements to lease cost reduction within a self-sustaining involved various combinations of facilities to the private sector. The advisor health system. contracting out maintenance and/or to the mayor of Vilnius called the medical services, privatisation and concession contract a ‘second-best The direct investment now made by IDC outsourcing of management. According to solution’, suggesting that the clear desirable includes the renovation of the existing the study, only private sector participation option would have been privatisation. Such haemodialysis centre in Banja Luka and that included several different activities a view however was not reconcilable with the construction of a brand new building was financially viable. the views held by the general public, and in for the Bijeljina Centre. The total particular by health service users, that investment made by IDC for construction, The contract put out to tender thus health care provision should be a core reconstruction and all medical and non- included the renovation and maintenance responsibility of the state alone. medical equipment equated to €4 million. of clinic buildings as well as administrative and health care services. A two year The price for one treatment by IDC is Specialist dialysis services in Banja Luka timetable was put in place to issue the fixed in the contract (in fact the only figure and Bijeljina, Republika Srpska, Bosnia concession. This would run for 25 years, written in the contract) and includes a and Herzegovina with each clinic needing to reach 30,000 whole set of services. The contract also The dialysis centres of Banja Luka and patients to break even. The investment into bound IDC to a number of obligations Bijeljina provide another example of how one clinic from the successful conces- including the core functions of establishing individual clinic services can be out- sionaire, a Lithuanian firm registered in and managing the dialysis centres for the sourced. The PPP process benefited from Cyprus, is €4 million. The firm is projected period of the contract duration; purchasing no opposition from either the public or to start making a profit in eight years. and installing new equipment; providing government. Indeed, patients were very patients with one meal during every It is expected that the new arrangements supportive and even went to the treatment; having complete responsibility will lead to an increase in the number of construction sites to witness progress and for training local medical personnel; and patients per doctor and the installation of a enquire as to when the new centres would guaranteeing to increase their salaries. patient registration system by the private be ready. Fulfilment of the terms of the contract is investor. This registration system will be Thus a contract was signed by the Prime overseen by the Ministry of Health, the slowly extended by the Ministry of Health Minister, the Minister of Health, the Insurance Fund and the two host hospitals. to all clinics in Lithuania. It is also anticipated that a decrease in waiting times from their current level of 40 minutes to (even- tually) 15 minutes will also lead to an * When the tender was issued, RS had not yet passed legislation on public procurement. increase in patient satisfaction. The tenders were simply held on the basis of ‘general practice’: advertisements were published in daily newspapers and a minimum of three acceptable bids were required for These PPP contracts are expressly labelled opening the evaluation procedure.

Eurohealth Vol 13 No 2 8 HEALTH POLICY DEVELOPMENTS

IDC Banja Luka and IDC Bijeljina became conflict health care systems more cost satisfaction levels have increased. One operational in April 2001 and May 2002 effective and of higher quality. problem that still remains however lies providing services to 84 and 100 chronic with the distribution system. Although the patients respectively. Both have expanded Hospital catering in Tirana, Albania food is prepared by the Italian company’s their operations; currently, IDC Banja In 1996, a survey of the 1,450-bed Mother staff, it has continued to be distributed by Luka provides services to more than 180 Theresa University hospital in Tirana indi- hospital employees and unfortunately patients and performs more than 2,500 cated that patients were very dissatisfied food often still does not reach the patient. haemodialysis treatments per month; with the food served, such that 80% was This situation will be taken into consider- comparable figures for IDC Bijeljina are refused. All food was being prepared in ation when drafting new contracts, so as to 200 patients and 2,700 treatments per one central kitchen and then distributed to guarantee that all companies have an obli- month. The two centres now account for the six different hospital buildings. The gation to directly deliver meals to patients. more than 50% of all RS’s dialysis patients. kitchen and its equipment were in a poor The increase in the number of patients state; moreover electricity and running Conclusion – the future of PPP treated is primarily due to the decreased water were not always available. These case studies from three countries in mortality rate of dialysis patients. Quality Frequently food intended for patients the World Bank’s Eastern Europe region assurance is carried out by annual patient actually ended up in the hands of hospital indicate that factors for successful public- surveys conducted according to ISO employees and their families. private collaboration include support from standard 9001:2000. key stakeholders including government, Considering these challenges, the hospital patients and health care professionals; this One unforeseen challenge that the centres administration decided to outsource support can be built through information must face was the introduction of value catering services to a specialist company. and communication campaigns. added tax (VAT) from 2006. While health An assessment of needs was conducted, the care service delivery is exempt from this cost of the service calculated and the docu- It is also important to have appropriate tax, the dialysis centres must pay 17% ments for the tender prepared. enabling institutional, legal and regulatory VAT on all equipment purchased. This is frameworks in place; sufficient measures The contract was subsequently awarded problematic as the centres now have to were already in place in the three countries to an Italian firm for approximately deal with an inevitable increase in expen- highlighted here. Almost every model of US$66,000. This value is adjusted twice a diture, without any possibility of being PPP or PPC can be created through a year to take account of official inflation able to pass this increase on to patients, contract, provided the country has a sound rates reported by the National Statistical since the activity price is already fixed in legal framework (civil code that includes Institute. Approved by the Minister of the contract. A regulation that would sophisticated contract law) in place and a Health, the ten-page contract requires the waive health care service providers from constitution that does not forbid the delivery of 1,125 meals a day, stipulates VAT on all equipment is being discussed. privatisation of health care services. different diets for different illnesses and is Initially, IDC Banja Luka and Bijeljina not a concession contract. The successful It is also important before embarking on contracts were awarded for seven and nine bidder is also responsible for the any PPP venture to undertake feasibility years respectively. The Ministries of construction of a new fully equipped studies to ensure risk management and Health and Social Welfare and Foreign central kitchen, as well as training for the risk-sharing mechanisms between the Economic Affairs will now sign new much reduced work force of 25 employees private and public partners are put in place. contracts with both centres for an addi- (compared with 69 under the old system). Control mechanisms to evaluate the tional fifteen years. Based on these positive Under the terms of the contract, the performance of these newly created experiences, the National Health private contractor directly employs the entities are also required. Insurance Fund has issued PPP guidelines* catering staff. It is also responsible for Given that all these preconditions are put as a foundation for future privatisations, purchasing foodstuffs, general expenses in place, a PPP can be a success for all with the ultimate goal of privatising 80% and maintenance costs. The menu must stakeholders and help ease the financial of all state dialysis centres. also be approved by a doctor. pressures on any state’s health budget, The success of the pilot has also triggered The Italian company has invested provide high quality services for patients, interest in using this model in other areas US$700,000 in building and furnishing the and increase employee satisfaction through such as radiotherapy and radiology. The new kitchen, upgrading the electrical and training and higher salaries which may also government is now looking at ways to heating systems, improving delivery dissuade staff from seeking employment attract other international investors and to services and staff training. In turn, the elsewhere. promote more competition in the private hospital provides space within its premises delivery of health care services. Neigh- and makes a fixed monthly payment. The The author wishes to thank those who bouring countries have also requested service is controlled by a support service were directly involved in these PPP more ‘how-to’ information, expressing unit within the University Hospital projects and assisted in research for this their interest in learning from this type of Centre. article: Ruta Vainiene, former Advisor to PPP, in an attempt to make their post- the Mayor of Vilnius, Lithuania; Aferdita Both the quality of the food and patient Tafaj, Economic Director of the Mother Theresa University Hospital, Tirana, * The definition of PPP in RS according to the Health Insurance Fund guidelines for PPP Albania and Marijan Bilic, Director of in the health sector is: a cooperation between public/state institutions and private oper- the International Dialysis Centre Banja ators whose aim is to finance, construct/reconstruct, provide management, maintain Luka, Republika Srpska, Bosnia and infrastructure or provide services. Herzegovina.

9 Eurohealth Vol 13 No 2 HEALTH POLICY DEVELOPMENTS Dutch health insurance reform: the new role of collectives

Peter P Groenewegen and Judith D de Jong

Summary: In the new Dutch health insurance system individuals have the option of joining a collective insurance contract. Insurers are allowed to offer premium reductions of up to 10% to members of collectives, based on the number of insurees. Collectives might exert more influence on insurers than individuals because of the threat of moving large numbers of the insured from one insurer to another. Collectives have become an important feature in the new health insurance system as two-thirds of the Dutch population aged eighteen and over are now insured as part of a collective. Most collectives are employment based and specifically put more emphasis on premium levels than on service or quality of care compared to other collectives, such as patient organisations.

Key words: Health insurance, Reform, Premiums, Collective contracts, the Netherlands

In January 2006, after years of gradual dealings with insurance companies. By pool is formed by all the insured of one preparatory steps, a new health insurance uniting in collectives, individuals, it was insurance company, irrespective of the law was introduced in the Netherlands.1 thought, might be able to exert more type of contract. One of the new elements is the possibility influence on the policies of insurance A brief outline of the insurance reform is of collective insurance. In the old system, companies compared to those individually given in Box 1. One of its aims is to collective contracts only existed in private insured. Insurance companies have an improve quality of care and secure afford- insurance where employers could nego- incentive to keep collectives satisfied ability and long-term access to care by tiate collective contracts for their privately because of the threat of losing a collective means of a system of regulated compe- insured employees. In the new system, contract and thus a large number of collective insurance is open to everyone insured individuals. tition. In the insurance market, insurers who is, or becomes a member of, a compete to attract as many insurees as The Netherlands is quite unique with collective (whatever the basis of the possible, presumably by offering a good respect to the possibility of collective collective) that has a contract with an balance between premium level and service insurance. Social health insurance systems insurance company. Any group of indi- quality. In the purchasing market, insurers are employment based, or at least started viduals, whether united through will presumably contract health care as employment-based systems.2 In employment, sports, patient interests or providers with the best balance of price Germany, company funds (Betrieb- even any other organisation formed solely and quality. However, purchasing activities skrankenkassen) can still be limited to for the purpose of obtaining collective are supposed to be steered by the prefer- employees (and their dependents) of one insurance, can enter into a contract with an ences of those being insured. specific company. In contrast to Dutch insurance company. employer-based collectives, these company Since the implementation of the new law One of the reasons to include this possi- funds are separate risk pools. Private in 2006, the number of individuals that bility in the new insurance law was to give health insurance in the United States is also have taken out collective insurance has the insured more of a voice in their predominantly employment based. Over been much larger than expected. This new 60% of non-elderly Americans had emphasis on collective contracts sat well with the strategies of insurance companies Peter Groenewegen is Department Head, employment-based health plans in 2002. Netherlands Institute for Health Services Most employment-based health plans are as it was consistent with their objective of Research (NIVEL) and Professor of Social self-insured, i.e. the employer is financially securing as large a share of the insurance and Geographical Aspects of Health and responsible for paying the health care market as possible. Although collectives Health Care at Utrecht University, the claims of its employees.3 However, these have now become a major phenomenon on Netherlands. Judith de Jong is a examples are different from the Dutch the Dutch health insurance landscape, it Researcher at NIVEL and Head of the collectives, whether employer based or remains to be seen whether they will be Health Care Consumer Panel. not. The Dutch system has national able to exert much influence on the Email: [email protected] prospective risk adjustment and the risk insurers.

Eurohealth Vol 13 No 2 10 HEALTH POLICY DEVELOPMENTS

To insurance companies, collective Box 1: The Dutch health insurance law contracts are attractive, at least in the initial years of the new system, as they can help Abolition of distinction between private and public insurance. attract as big a share of the insurance market as possible, even at the risk of Insurance under private law with public limiting conditions. losing money on collective contracts. Collective contracts may have economic Obligation for every citizen to take out health insurance. advantages as a result of lower administrative costs, when the collective guar- Obligation for insurance companies to accept every citizen without premium antees payment of the nominal premium. differentiation, risk selection or risk adjustment. Certainly they appear to have been Free choice for citizens between insurance organisations (switching is possible popular. An unexpectedly high number of once a year). individuals are now insured via collective contracts; 55% of all those insured during Premium level: nominal (typically around €1,100 per year) plus income related 2006, increasing to 63% in 2007.5 The like- contribution initially paid by employees and then subsequently reimbursed by lihood of being collectively insured is employers; overall half of the total costs of premiums will be from nominal higher for those of working age, men, premiums and the remainder from income related contributions. those with a higher educational attainment level, as well as those who perceive their Compensation for low income individuals. health as good.9 These differences are, to Basic package is identical for everybody, with a choice between schemes where some extent, related to the fact that the health care providers are directly paid by insurance companies and schemes biggest category of collectives are those where individuals initially pay the bills and then are reimbursed by their organised via employment. insurance companies. Organisational basis of collectives Complementary insurance (not obligatory and not necessarily with same insurer A wide range of organisations provide as basic package). collective insurance; however, almost three-quarters of those with collective Choice of deductible (minimum €100, maximum €500). insurance are insured through their employer (Figure 1).The principal reasons No-claim premium reimbursement if annual health care costs less than €255. for employers to offer their employees the option of collective health insurance are to 1 Sources: Bartholomée Y, Maarse H, 2006, Ministry of Health, Welfare and Sports, maintain their reputations as good 4 2006. employers, as well as the incentives that collective insurance has in attracting and This article therefore focuses on the new the percentage of premium reduction may retaining employees. The dependents of position of collectives in the Dutch health only be based on the size of the collective employees can also be collectively insured insurance system and focuses on high- and not on other characteristics of the via their employer. lighting who is taking out collective collective or its members. Thus, collectives Municipal social service departments insurance and their characteristics and of similar size should receive a similar usually have a collective contract for those motivations. It also highlights the origins premium reduction. For complementary dependent on social welfare benefits. of collectives, i.e. whether they are linked insurance, the size of premium reduction Collective contracts for these groups are to employment or some other basis; and to is not limited by law. Premium reductions also attractive to insurance companies as discuss whether collective contracts to date are on average 7%.7 However, the the nominal premiums are directly paid by actually increase the power of the insured cheapest insurance premiums without any social service departments. A small and in what direction. The information reduction are still cheaper than the most used here is derived from regular surveys number of individuals are also collectively expensive, even with a maximum 6 of participants of two large panels: the insured via patient organisations. A reduction of 10%, as monthly premiums notable example is the Diabetes Patients’ Health Care Consumer Panel and the for the basic package for 2007 before any Organisation (DVN), which has formu- National Panel of People with Chronic € discount are at their cheapest 85, lated its own terms of reference and subse- Health Problems and Disabilities (both € compared with 100 for the most quently invited insurance companies to run by the Netherlands Institute for 8 expensive insurance schemes. make offers to the organisation. Health Services Research, NIVEL), as well as through a survey among collectives.5,6 It is also important to note that individuals The DVN is however one of the biggest cannot be forced to join a collective patient organisations in the Netherlands Collective or individual insurance insurance contract. Thus, if an employer and the risk adjustment system is such that Collective insurance is attractive to negotiates a collective contract, its insurance companies receive higher potential insurees because the law allows employees have the choice of joining this compensation from the central fund for insurance companies to offer a reduction collective contract, joining some other diabetics. For many of the smaller patient of up to 10% on the nominal premium collective contract (for example, through a organisations it is much more difficult to (around €1,100 annually) for members of voluntary organisation they are a member have a collective contract, both as a result a collective. The insurance law states that of) or having an individual contract. of their size and because the risk

11 Eurohealth Vol 13 No 2 HEALTH POLICY DEVELOPMENTS

Figure 1: Collective insurance by organisational basis, 20075 and therefore could be defined as a collective. Even insurance companies with other legal status can establish an association of their insurees, so as to be able to give them a discount on the grounds of being part of a collective. However, if all those insured are receiving such a discount, one could ask whether this in fact really is a discount? Nevertheless, insurance companies might still be able to attract additional insurees as a result of such discounts.

Possible influence on insurance companies One of the aims of the new insurance system is that the insured exert influence on insurance companies through the threat of switching insurers. This influence should lead to an optimal balance between the nominal premium, services of the insurance company, and the quality of care purchased by the insurer. Table 1: Percentage of collectives that judged an aspect as (very) important in their choice of insurance company (19 employers’ collectives and 23 other collectives) The main reasons why individuals switch insurer are the premium level and their Aspect Employers Other wish to join a collective contract with collectives another insurer. Collectives could also be in a better position to influence insurers Premium Premium reduction for additional insurance 95% 83% because of their size. The question then is to what extent collectives choose an Premium reduction for basic insurance 89% 87% insurance company on the basis of the premium or of service and purchasing Premium for additional insurance 89% 78% quality? In general, younger and healthier people Premium for basic insurance 84% 70% choose more on the basis of the insurance premium, while older and less healthy Deductible and related premium reduction 21% 35% people tend also to take into account quality aspects of the insurer and the care Content Coverage of additional insurance 89% 100% that they purchase.9 The NIVEL survey of of the collectives indicates that this is the same insurance Quality of contracted providers 79% 96% for employment-based collectives, compared with other collectives (Table 1). Coverage for specific aids or drugs 63% 78% Patients’ collectives, in particular, Special care programmes 37% 65% emphasise service and quality aspects of collective contracts. In this way they Quality of Service 84% 100% could, in theory, contribute to the goals of the insurance insurance reform. However, as Figure 1 company Reputation 79% 78% illustrated, they are quantitatively of minor importance compared to employers’ collectives. adjustment may be less preferential. A collective. Examples might include a NIVEL survey showed that patient organ- collective of individuals who buy their The NIVEL survey also shows that patient isations have to put more effort into nego- insurance through a specific internet site organisations are in a different position tiating collective contracts than and thus automatically become part of a from employment-based collectives, in employers.6 It is therefore possible that collective, or those who buy their that they more often drive the initial smaller patient organisations, which are insurance through a chain of retail process of contacting an insurer. Negotia- less professionally organised, do not chemists. In the case of insurance tions also take longer and premium reduc- always have the means to negotiate a companies with the legal status of cooper- tions tend to be smaller. One reason for the collective contract. atives, by which members are not individ- smaller premium reductions might be that ually liable for any deficits of the fund, the the percentage of members of patient A new phenomenon is the special purpose insured are nonetheless formally members organisations that join the collective

Eurohealth Vol 13 No 2 12 HEALTH POLICY DEVELOPMENTS contract is lower than the percentage of reform to be achieved, the willingness of The New Care System in the Netherlands: employees that join the collective contracts individuals to switch between insurers is Durability, Solidarity, Choice, Quality, obtained by their employers. However, if important, if they are dissatisfied with Efficiency. The Hague: Ministry of Health, the premium reduction is related to the either price or quality. In practice however, Welfare and Sports, 2006. Available at: type of collective and its members, differ- it is only the young and healthy who are http://www.minvws.nl/en/folders/z/2006/t ences might develop in the costs of health likely to switch on grounds of price alone. he-new-health-insurance-system-in-three- insurance between different population Switching for other population groups languages.asp. sub-groups. One implication might be that may be more difficult. The newly estab- 5. NIVEL web site. Available at population sub-groups that generate lished Dutch Health Care Authority www.nivel.nl/stelselwijziging higher health care costs have less access to (NZa) which monitors the health 6. Van Ruth LM, De Jong JD, collective contracts. Another question is insurance market does however have the Groenewegen PP. De rol van whether or not individuals would use the authority to intervene if it believes that the collectiviteiten in het nieuwe zorgstelsel. collective if they were dissatisfied with interests of consumers are under threat.10 [The Role of Collectives in the New their insurer? In one survey of the Health Insurance System]. Utrecht: NIVEL, 2007. Nonetheless, for the time being, collectives Care Consumer Panel, 16% of the collec- are not likely to have much impact on the 7. Vektis. Verzekerdenmobiliteit en tively insured indicated that they would purchasing activities of insurance keuzegedrag. Hoe staat het ervoor in 2007? turn to their collective in the event of companies. They may however have more [The Mobility of the Insured and Decision complaints. impact on their service orientation, partic- Making. What is the Situation in 2007?] April 2007. ularly if and when the collectively insured Conclusions collectively voice their dissatisfaction over 8. Kies Beter [Choose Better]. Available at Approximately two-thirds of the Dutch the services of any insurance company. http://www.kiesbeter.nl/Zorgverzek- population is now collectively insured; eringen however, it is unclear whether or not the 9. De Jong JD, Groenewegen PP. Wisselen percentage covered by collective contracts REFERENCES van zorgverzekeraar in het nieuwe stelsel: will continue to increase. Individuals 1. Bartholomée Y, Maarse H. Health een vergelijking van het zoek- en might be lured into collective contracts by insurance reform in the Netherlands. wisselgedrag van chronisch zieken en the headline reduction in premiums Eurohealth 2006;12(2):7–9. gehandicapten met dat van de algemene without looking too closely at absolute 2. Amelung V, Glied S, Topan A. Health bevolking. [Switching Health Insurer in the differences in premium cost. Furthermore, care and the labor market: learning from New Insurance System: A Comparison of if the number of collectively insured the German experience. Journal of Health Search and Switch Behaviour of the Chron- continues to grow, it may be questioned as Politics, Policy and Law 2003;28:693–714. ically Ill and Disabled and the General to the basis of any premium reduction. If Population] Utrecht: NIVEL, 2006. 3. Glied S, Borzi PC. The current state of everybody receives a premium reduction 10. Dutch Health Care Authority. Monitor then the premium without reduction is employment-based health coverage. The Journal of Law, Medicine and Ethics zorgverzekeringsmarkt: de balans 2007. solely a virtual option . 2004;32:404–9. [Monitoring of the Health Insurance For the overall aims of the insurance Market: The Balance 2007] Utrecht: NZa, 4. Ministry of Health, Welfare and Sports. 2007.

Advanced Health Leadership Forum Sample issue include: • Leadership and evidence-based management An innovative programme for senior health executives workshops • Effective policy implementation and strategies for health systems change A 14-day earned certificate programme from the University of California, Berkeley School • How to assure quality of Public Health in which renowned senior • Public vs. private health insurance mix faculty and policy leaders from key • Innovations in payer and health delivery connections First session: international and national organisations • Lessons learned from managed care 6–13 January 2008 interact with high-level participants re: techniques/innovative budgeting techniques University of California, evidenced-based solutions to key policy and • The use of risk adjustments for a variety of purposes Berkeley, San Francisco management issues. Participants grapple in a • Pharmaceutical innovation and regulation Subsequent session: practical manner with the issues and options • Defining benefit packages including explicit priority late June 2008 that have been converging internationally. setting/ rationing England Speakers include: Richard Feachem, First • Making use of the new consumerism Executive Director, Global Fund to Fight • ‘Information therapy’ prescriptions for consumers AIDS, Tuberculosis and Malaria; Ian Morrison, • Technology changes and future health care http://ahlf.berkeley.edu well-known futurist; Leonard Schaeffer, predictions to prepare for Email: Meg A Kellogg Chairman of Wellpoint; high level officials • Workshops on infectious disease preparedness and [email protected] from Kaiser Permanente such as CEO George health care ethics Halvorson, and expert faculty from UC • IT and care management systems including a field Berkeley and UC San Francisco. trip to Kaiser Permanente

13 Eurohealth Vol 13 No 2 PUBLIC HEALTH PERSPECTIVES Medicine, care of the dying, and care of the chronically ill

Milton Lewis

Summary: The palliative care movement began in Great Britain and spread quickly, not only to the United States, Australia, Canada, and New Zealand, but also to continental Europe. This article provides an overview of material covered in a new book entitled ‘Medicine and Care of the Dying. A Modern History’. Historically, concern about palliative care has developed separately from that about better care for the chronically ill. But the same demographic and other forces are now shaping the context in which more patient-centred services are needed. Palliative care and care for the chronically ill should be better integrated, as should health services generally.

Keywords : History, Care of Chronically Ill, Palliative Care, Dying

Medicine, Death, and Dying western society to find meaning in dying The subsequent chapter is more narrowly A historian of medicine and public health, and death. Furthermore, American concerned with the history of medicine’s I recently published Medicine and Care of philosopher of medicine, Daniel Callahan approach to cancer and is something of a the Dying. A Modern History.1 The main sees a struggle within medicine between a case study of the tensions between aim of this study was to explore the rela- research imperative, with its ultimate goal advancing scientific knowledge for the tionship between modern medicine’s of overcoming death itself, and a long- long-term attainment of cures compared approach to the care of the dying and the standing clinical imperative to treat death with caring compassionately here and now changing social, cultural, demographic, as part of life and to make the process of for the terminal patient. Promoting the economic and political context over the dying as humane and comfortable as humane care of patients dying, mainly of last two centuries or so in five ‘Anglo- possible. cancer was, of course, the prime concern Saxon’ countries: the United Kingdom, the of the pioneers of modern hospice and United States, Australia, Canada and New Structure palliative care like United Kingdom’s Zealand. The first two chapters of the book provide Cicely Saunders. a broad background, ranging over the rela- Although the study takes this specific tionships between medicine and religion The book also includes a detailed account geographical focus, I believe it is of interest and the internal development of scientific of the ways in which this movement to those involved in palliative care, as well medicine in the west since the sixteenth spread from the United Kingdom to other as health services generally, across Europe. century. Medicine was deeply influenced ‘Anglo-Saxon’ countries, showing how the Given ongoing media concern in Europe by a Cartesian body-mind dualism that in original hospice idea was adapted to local (as in other parts of the western world) practice favoured the material and deper- organisational and financial conditions. about access to means of euthanasia, the sonalised the patient, while at the same Recently, selected letters of Dr Saunders, chapter on the history of the euthanasia time the Christian view of death as a tran- covering the first forty years of the debate, as well as that on the development sition to a superior, supernatural reality movement in the United Kingdom, have of palliative care services and policy, will 2 was losing its meaning for an increasing been published. The correspondence perhaps be of greatest interest to readers of number of people. Material success, provides a fascinating, blow-by-blow Eurohealth. earthly happiness, and collective mastery account of the pioneering phase of the The rise of modern scientific medicine has of the natural world were attracting more hospice and palliative care project. been marked by a growing conflict and more adherents as the goals of the It also shows that from an early date that it between a medical-reductionist view of good life. had international dimensions. Cicely human functioning and a deep and wide- In the course of the nineteenth century, Saunders frequently exchanged infor- spread cultural need in late-modern, experimental physiology, cell biology and mation on palliative care and related bacteriology also provided medicine with a subjects like euthanasia and care of AIDS Milton Lewis is Honorary Senior hitherto unprecedented reliable knowledge patients with health professionals and Research Fellow, Australian Health Policy base. Thus the modern hospital and the hospice enthusiasts in countries across the Institute, University of Sydney, Sydney, laboratory became critically linked in the world; from North America to Europe (for New South Wales, 2006, Australia. process of producing and applying this example, Poland, West Germany, France Email: [email protected] new scientific knowledge. and Italy) to Africa, Asia and Australasia.

Eurohealth Vol 13 No 2 14 PUBLIC HEALTH PERSPECTIVES

Of the remaining three chapters in the Table 1 The 'Bridges to Health' model book, one relates the history of pain control. Clearly, effective pain Population Priority concerns Major health care Health care goals management has been and remains the sine characteristics components qua non of successful palliative care. Healthy Longevity by preventing Doctors’ offices, health Staying healthy Another chapter discusses the history of accidents, illness and early clinics and publicly available euthanasia from classical to contemporary stage illness progression health information times, although the emphasis is on the period from the late nineteenth century Maternal and Healthy babies, low Perinatal services, delivery Staying healthy when this discussion ceased to be confined infant health maternal risk, fertility and perinatal care; fertility to philosophical circles and later became control control/ enhancement the subject of serious public policy debate. The final chapter brings together observa- Acutely ill, with Return to healthy state with Emergency services, Getting well tions and conclusions, especially about likely return to minimal suffering hospitals, doctors’ offices, medicine’s heritage of materialism, reduc- health medications or short term rehabilitation tionism and the cultural roots of caring in late-modern, ‘secular’ societies. From the Chronic conditions, Longevity, limiting disease Self-management, doctors’ Living with illness late 1980s, the spread of palliative care with generally progression, accommo- offices, hospitalisations, or disability across Europe was rapid. When the ‘normal function’ dating environment accident and emergency European Association for Palliative Care visits was set up at the close of 1988, there were 42 members from nine European coun- Significant but Autonomy, rehabilitation, Home-based services, Living with illness tries. In less than a decade this had grown stable disability limiting progression, environmental adaptation, or disability to 8,481 members from 29 European coun- (including mental accommodating envi- rehabilitation and tries (plus 141 individual members from 27 disability) ronment, caregiver support institutional services countries outside Europe).3 “Dying” with short Comfort, dignity, life At-home services, hospice Coping with illness Resonance in Europe decline closure, caregiver support, and personal care services at the end of life While this book is concerned to a large planning ahead extent with developments in North America and Australasia, most if not all, Limited reserve Avoiding exacerbations, Self-care support, at-home Coping with illness the leading issues raised will have strong and serious maintaining function and services, 24/7 on-call at the end of life resonance in Europe. Certainly, this is the exacerbations specific guidance planning access to medical guidance case with philosophical issues concerning and home-based care the nature of modern medicine, the core values of palliative care, or debates about Long course of Support for caregivers, Home-based services, Coping with illness the legalisation of euthanasia. Even, for decline from maintaining function, skin mobility and care devices, at the end of life example, when considering the important dementia and/or integrity, mobility and family caregiver training and issue of the organisation of palliative care frailty specific advance planning support and nursing facilities services, the history of adaptation of the British hospice archetype is similar to that emerged as early as the 1970s in Poland, general issue of restructuring health care in other European countries. So the but only after the fall of communism were systems. This restructuring has the material in the book, in this respect, will services systematically developed in central objective of moving systems away from provide European readers with more in- and eastern Europe in the 1990s.4,5 their historical orientation to hospitals depth information about experiments in devoted to medical specialities and acute organisational forms in different but Towards integration of palliative care care, towards more community and home- relevant health systems in comparable and care of the chronically ill based care for people, especially older economically advanced countries. Historically, concern about palliative care people, with serious, chronic conditions. Diversity of service form was, of course, developed separately from that about The next logical step is to better coordinate the case in Europe itself virtually from the serious, chronic illness management, but palliative care and chronic illness care. The outset. The United Kingdom pioneered they are both in fact quintessentially ‘Bridges to Health’ model recently the process with inpatient hospice care patient-centred responses to the same developed for application in the United from 1967. Sweden introduced hospital- contemporary epidemiological, demo- States health system in response to the based home care in 1977, Italy a home care graphic, social and economic forces, Institute of Medicine’s six goals for care in programme in 1980, Germany hospital requiring basic changes in health system general (safety, effectiveness, efficiency, inpatient care in 1983, Spain a palliative organisation and medical practice. Across patient-centeredness, timeliness, and care unit within a hospital medical the economically advanced world, health equity), is one interesting conceptual oncology department in 1984, Belgium a services managers, researchers, clinicians approach to this task, as well as the larger palliative care unit and a home care service and policymakers are now focussed on the task of health care system restructuring .6* in 1985 and the Netherlands inpatient need for better quality, integrated care for hospice care in 1991. Interest in hospices chronic disease sufferers and on the more Focussed on the interests of patients,

15 Eurohealth Vol 13 No 2 PUBLIC HEALTH PERSPECTIVES rather than those of individual or institu- citizens in general, have become used to 1959–1999. Oxford University Press: tional providers, the proponents of the conceiving of the health care system in the Oxford, 2005. 7 model divide the whole population into old fragmented way. The ‘bridges to 3. Speck P. Palliative care organisations eight groups: those in good health; in health’ model offers new conceptual clarity with a global perspective. Palliative ‘maternal/infant situations’; those with and helps launch us on the journey to a Medicine 1999;13:70. acute illness; living with stable chronic more integrated system of health care. This 4. Hardy A, Tansey EM. Medical conditions; with serious but stable promises to improve quality of care for the enterprise and global response, disability; with failing health near death; chronically ill and the dying as well as 1945–2000. In: Bynum WF, Hardy A, with advanced organ system failure; and other population groups. Jacyna S, Lawrence C, Tansey EM (eds). with long-term frailty. Each group has its The Western Medical Tradition 1800 to own service priorities, as well as definitions 2000. Cambridge University Press: of optimal health, and the model REFERENCES Cambridge, 2006, p. 446. encourages us to think how programmes 1. Lewis MJ. Medicine and Care of the 5. Wright M, Clark D. The development for groups that meet the universal need for Dying. A Modern History. Oxford of palliative care in Poznan, Poland. integrated care might be promoted, as University Press: New York, 2007 European Journal of Palliative Care specified in Table 1.6 2. Clark D (ed). Cicely Saunders. Founder 2003;10(1):26. Many health professionals, and indeed of the Hospice Movement. Selected Letters 6. Lynn J, Straube BM, Bell KM, Jencks S F, Kambic RT. Using population segmen- tation to provide better health care for all * Earlier, Joanne Lynn explored the implications for organisation of palliative care of the : the ‘Bridges to Health’ model. Milbank different ‘illness trajectories’ of serious chronic conditions in the last phase of life: for a Quarterly 2007;85(2):185–208. short period of evident decline (mostly cancer); for chronic illness with intermittent exacerbations and sudden dying (mostly organ system failure); and for slow dwindling (mostly 7. Schoenbaum SC, Gauthier AK, Koren frailty and dementia). See Lynn J. Sick to Death and Not Going to Take it Anymore! MJ. Commentary on the ‘Bridges to Reforming Health Care for the Last Years of Life. University of California Press: Berkeley, Health’ model. Milbank Quarterly 2004. 2007:85(2):209–11.

ECDC: Tackling the free movement of microbes

Zsuzsanna Jakab

Summary: Now entering its third year, the European Centre for Disease Prevention and Control (ECDC) is showing the value of having an expert agency to support EU Institutions and Member States in meeting the challenge of managing communicable diseases in an interconnected world: strengthening EU preparedness and response to disease outbreaks and consolidating EU level disease surveillance. The Centre produces scientific advice and risk assessments on a wide range of issues; communicating the results of its activities via Eurosurveillance (an independent scientific journal), as well as using new technologies such as webcasting. ECDC’s first ever Annual Epidemi- ological Report, published in June 2007, analyses ten years of surveillance data from across the EU and identifies a number of key public health challenges posed by communicable diseases. ECDC’s Multi-Annual Strategy for 2007–2013 focuses on how the Centre can help address these challenges.

Key words: EU Health Policy, ECDC, Communicable Diseases, Surveillance, Epidemiology

A generation ago, when a WHO-led new era. All the major scourges would without warning, and that ‘old’ diseases global programme had just succeeded in soon be eliminated, and epidemics would can re-emerge, sometimes in new drug eradicating smallpox, many public health be consigned to the history books. Unfor- resistant strains. Furthermore, SARS high- experts believed we were at the dawn of a tunately, the emergence of HIV/AIDS in lighted the speed with which a communi- the 1980s and SARS (Severe Acute Respi- cable disease can spread internationally in Zsuzsanna Jakab is Director, European ratory Syndrome) in 2003 shattered this the age of globalisation. This interconnect- Centre for Disease Prevention and illusion. We are now painfully aware that edness of public health in Europe and Control (ECDC), Stockholm. new communicable diseases can appear internationally, was one of the main

Eurohealth Vol 13 No 2 16 PUBLIC HEALTH PERSPECTIVES reasons why the European Union estab- her post on 1 March 2005. By May 2005 a Surveillance Networks had their own data- lished a European Centre for Disease core staff was in place and ECDC became bases and systems of reporting. With a Prevention and Control (ECDC). operational. growing number of networks, the need for coordination and a standardised approach Although still a young organisation, Why ECDC was created to data collection became urgent. To ECDC has become a key partner for EU Increasing the interconnectedness of its address this need, ECDC has been and EEA/EFTA countries in the fight Member States’ economies and societies is conducting an external evaluation and against infectious diseases. The Centre a central objective of the European Union. assessment of the existing EU wide surveil- played a significant role in the EU’s The Union is built on four freedoms: the lance networks. response to the arrival of H5N1 avian free movement of goods, persons, services influenza in the EU neighbourhood in the Already in 2007, Member States will report and capital. However, as people, farm autumn of 2005, providing an overall their data to a single EU level surveillance animals and food cross borders they will assessment of the public health risk asso- database hosted by ECDC (TESSy – The inevitably, on occasion, take unwanted ciated with this development, scientific European Surveillance System). This task microbes with them. This ‘free movement guidance on the protection of people includes managing the delicate transfer of of microbes’ means that public health exposed to infected birds and participating their various existing surveillance data- developments in one EU country can be of in international missions to affected coun- bases to ECDC. A number of benefits immediate concern to its European tries. Working closely with the European arise from this approach, in particular the partners. For example, big hotels in major Commission and WHO Europe, ECDC standardisation of procedures, databases EU cities typically have guests from across developed a methodology to help coun- and outputs. This in turn allows for the the EU, so a disease outbreak centred on tries assess their preparedness against a tackling of infectious disease surveillance such a hotel can have implications for possible influenza pandemic. By the end of in a synergistic way, in order to better numerous Member States. Food producers this year ECDC officials will have understand and control the threat posed in the EU typically sell to clients across the conducted preparedness assessment visits by infectious diseases. In addition, EU, so investigating food borne outbreaks to all of the EU and EEA/EFTA Member ECDC will also be responsible for the can also require cross border investigation. States. maintenance of networks of reference laboratories. EU cooperation on the surveillance of ECDC is also developing input to the communicable disease started in the 1980s European Commission on actions to Vigilant to the emergence of health with the EuroHIV network and expanded address the continuing challenge of tuber- threats during the 1990s. By 2004 there were some culosis in the EU and held a scientific ECDC is tasked with reinforcing and sixteen EU funded networks carrying out seminar on tuberculosis in March 2007.2 It developing Europe’s rapid alert systems disease surveillance and linking disease has also led an expert group to investigate against disease outbreaks. The Centre is experts. Since the late 1990s Member States the emergence of drug resistant strains of constantly monitoring health threats have also been exchanging information on Clostridium difficile in EU countries and across the EU and, as intended, is taking disease outbreaks with the potential to established a network of national focal over the responsibility of hosting the spread across borders, via the EU’s Early points on antimicrobial resistance issues. Warning and Response System (EWRS) on information technology system that public health threats. ECDC’s disease-specific activities are supports the Early Warning and Response carried out within seven horizontal System. ECDC was created to consolidate and projects which cover the range of 49 ECDC’s early warning and response further develop this cooperation. Surveil- communicable diseases that are notifiable activities are based on three main sets of lance networks had been funded on a at EU level.* The Centre has expanded functions: a ‘round the clock’ availability project by project basis, often focusing on from 40 staff at the end of 2005 to nearly of specialists in communicable diseases, a just one or a small group of diseases. 200 staff by the end of 2007. Though much daily briefing where all active threats are ECDC’s mission was to develop a long smaller than its US namesake, and consid- discussed and decisions are made about term surveillance strategy and consolidate erably smaller than the public health epidemic intelligence processes and ECDC existing activities. ECDC was to assist the institutes of France, Germany and the UK, actions to be taken, as well as a database to European Commission in running the it can still make a sizeable scientific store, process and report potential health EWRS and offer a pool of expertise and contribution. resources to help respond to incidents. The threats (the Threat Tracking Tool – TTT). Centre was also given the role of expert Improving EU level disease surveillance Furthermore, a state of the art Emergency advisor to the EU Institutions and As already mentioned, a core task for Operations Centre (EOC) has been set up Member States on communicable disease ECDC is the consolidation and devel- at ECDC’s premises, in order to ensure issues. opment of a Europe wide surveillance optimal communication and coordination system that provides high quality, compa- mechanisms for risk assessment with all What has been achieved rable and easy to access information on all Member States. It is used on a daily basis Enabling legislation to create ECDC was infectious diseases of interest at EU level. for standard epidemic intelligence activ- passed by the European Parliament and By 2005, when the Centre became opera- ities, but allows for rapid and efficient 1 Council in the spring of 2004. The tional, each of the sixteen Designated response and communication should a Centre’s first Director, Zsuzsanna Jakab, who was formerly the State Secretary at the Ministry of Health in Hungary, was * 46 diseases are specified in Commission Decision 2003/542/EC, plus West Nile Virus, SARS appointed at the end of 2004 and took up and human cases of H5N1 avian influenza which are also notifiable.

17 Eurohealth Vol 13 No 2 PUBLIC HEALTH PERSPECTIVES major international public health event independent scientific in-house journal of infection and campylobacteriosis. Even occur. In addition, ECDC can assist coun- ECDC. Following ten years successful though they do not cause such serious tries by mobilising Outbreak Assistance collaboration between the lnstitut de Veille disease as the priority diseases mentioned Teams and contributing experts to interna- Sanitaire in Paris, France and the Health above, the high number of cases already tional teams if needed. Protection Agency in London, United represents a huge challenge. Kingdom and under the auspices of the Technical and scientific advice European Commission, the ECDC took The future of ECDC Another core task of ECDC is to provide over the funding and publication of this In June 2007 ECDC’s Management Board sound and independent technical and journal in March 2007. Eurosurveillance is endorsed the key principles of a long term scientific advice. For this the Centre brings available in three separate formats: weekly strategy to develop the Centre’s activities together technical expertise in specific and monthly online releases and a quar- and help address the key challenges iden- fields through its various EU wide terly print compilation.5 tified in it’s Annual Epidemiological networks and ad hoc scientific panels. Report. There is a long term and ambitious These panels have been set up in order to The EU’s main challenges in infectious agenda for ECDC to work on in the area answer specific questions forwarded to the diseases of communicable diseases. Equally Centre by the European Commission and The Centre launched, in June 2007, its first though, it is possible that the Centre’s Member States. Two scientific panels have ever Annual Epidemiological Report, a mandate could be expanded to include already produced scientific advice, one on key publication that for the first time some other public health issues. avian influenza and the other on seasonal offers an overview of the situation in This autumn, following a public tender, influenza vaccine and pneumococcal respect of communicable diseases in 25 EU ECDC will appoint an independent vaccine. Their work has been published as countries and Iceland and Norway. It also consultant to conduct an evaluation of the technical reports. Currently, scientific examines the social and demographic Centre’s activities. The results of this eval- panels are addressing questions regarding contexts over the last decade, in order to uation will be given to the Centre’s the human papilloma virus (HPV) vaccine make action proposals for decision makers Management Board, who in turn will make and influenza H5N1 human vaccine. to strengthen prevention, control and recommendations to the European surveillance in Europe. As already mentioned, ECDC has been Commission. Based on the results of the working with the European Commission The report shows that the incidence of evaluation and the recommendations of and the WHO Regional Office in Europe most of the 49 diseases analysed by ECDC the Management Board, the European to assess national pandemic preparedness has either declined or remained stable over Commission will decide, probably plans through country visits and by organ- the past ten years, which confirms that towards the end of 2008, whether the ising regional workshops. It has already public health systems in the EU are ECDC’s Founding Regulation needs to be produced a report with a first preparedness generally good at fighting infectious amended. review of 27 countries (25 EU member diseases. But this should not lead to states plus Iceland and Norway),3 with a complacency, as some negative trends were second status report to be released after identified. The fact that new infectious REFERENCES completing the assessment of all EU coun- diseases can emerge without warning, and 1. Commission of the European tries. This report is the first formal docu- existing viruses and bacteria can adapt or Communities. Regulation (EC) No mentation of the EU’s pandemic mutate, should also not be underestimated. 851/2004 of the European Parliament and preparedness status; it describes progress of the Council of 21 April 2004 establishing This report also gives a clear picture of the made and highlights areas where further a European Centre for Disease Prevention major health threats faced by Europe in the improvements are needed. and Control. Brussels: Commission of the area of infectious diseases, which also European Communities, OJ L 142, 30 represent the areas identified by ECDC as Communicating on ECDC’s activities April 2004. priorities in its work plan. These include The Centre has a mandate to communicate the growing problem of antimicrobial 2. ECDC. ECDC Scientific Seminar on both to stakeholders and the general public Tuberculosis. Brussels, European resistance and healthcare associated infec- about its activities. Reports and guidelines Parliament, 22 March 2007. Available at tions, as well as the rising rates of are made available on ECDC’s website and http://ecdc.europa.eu/tbseminar HIV/AIDS; with an estimated 30% of the media is kept updated on the Centre’s HIV positive individuals in the EU being 3. ECDC. Pandemic Influenza major activities through press releases, unaware of their infection. Another threat Preparedness in the EU. Stockholm: press conferences and webcasts.4 is tuberculosis, which is rising among ECDC, 2007. Available at: Currently the Centre has an interim http://ecdc.europa.eu/pdf/Pandemie_prepa vulnerable groups such as migrants, and website which is being continuously redness.pdf. also where cases of drug resistant tubercu- improved until a fully fledged webportal is losis are being seen across the EU, partic- 4. ECDC webcasts can be viewed at in place in 2009. Information addressed to ularly in the Baltic States. http://ecdc.europa.eu/webcast the general public will be offered in all EU official languages, while information Not to be dismissed is the ongoing threat 5. For more information about Eurosur- veillance see: http://www.eurosurveil- targeted at experts and public health posed by seasonal influenza, which each lance.org officials will be published in English only. winter causes hundreds of thousands of people in the EU to become seriously ill. The leading open access European scien- ECDC’s epidemiological report shows tific journal devoted to communicable two further diseases with very high diseases, Eurosurveillance, became the incidence numbers, namely Chlamydia

Eurohealth Vol 13 No 2 18 EUROPEAN SNAPSHOTS Promoting the quality of health services in Bulgaria

Olga Avdeeva and Lidia Georgieva

From the mid-1990s, Bulgaria has been some hospitals have the International informed about the relative risks and undergoing significant economic, political Organisation for Standardisation (ISO) benefits of treatment alternatives and can and social change arising from the chal- certificate. However, these initiatives have participate in making final decisions on lenges of transition and the structural neither been very successful, nor well courses of action to adopt. measures needed to achieve EU accession received, due to a lack of incentives to in January 2007. Health system reforms, as reward such high quality care, as well as Contracting to enhance the quality of an integral part of economic and social the poor links between the accreditation health services reforms, have aimed to make the Bulgarian process and any difference in payments Enhancing the quality of health services health system more efficient and received from the NHIF. was one key reason for the introduction of responsive to patients’ needs by improving Amendments to the Act on Professional contracting reforms. This shift to both the delivery and quality of services. Organisations of Physicians and Dentists contracting between the NHIF and health providers was accompanied by a move Specific mechanisms were expected to in 19982 imposed an obligation on these away from historical or norm-based budg- promote better quality health services and professional associations to establish rules eting to performance related payments. provide solutions to a range of challenges, for good medical practice for their including: competition between providers respective members. As a result, the Quality control mechanisms in contracts for contracts with the National Health concepts of life-long learning and between providers and the NHIF oblige Insurance Fund (NHIF); inclusion of continuing education have been accepted providers to participate in a comprehensive quality control mechanisms in these and viewed as a component of any quality quality assurance system. Contracts now contracts; and increased choice for assurance system. specify the process of service delivery, as Bulgarians, in terms of both service Patient empowerment is a new and well as the medical standards and guide- providers and voluntary health insurance important approach to improving the lines to be followed by providers; all of plans. quality of health services in the country. which are expected to lead to quality Different methods are used to give patients improvements. Legal and structural improvements to a greater say over their medical care, such Both public and private sector providers facilitate better quality as in choice of provider and improved can enter into contracts with the NHIF to The quality of medical services in Bulgaria access to information. A process for deliver services. The NHIF specifies the is now monitored by the Ministry of patient complaints and appeals is also requirements that providers must meet in Health, NHIF, the Bulgarian Medical 1 enshrined in both the 2004 Health Act order to be eligible to participate in the Association and the Union of Dentists. and the Act on the Professional Organisa- provider selection process; an initial Standards for different medical specialities 2 tions of Physicians and Dentists. quality assurance measure in theory were laid out in the 2004 Health Act.1 This 3 excludes those providers that do not meet also outlined the responsibilities of the 28 The 1998 Health Insurance Act and the 4 minimum structural quality requirements. regional health centres and the Ministry of National Framework Contract also However, these measures of selective Health in controlling the competencies of outline the individual’s right to choose contracting are not applied fully in medical specialists and monitoring the general practitioner, without adminis- practice, thus the potential to facilitate quality of care. trative or geographical constraints. Indi- viduals can also choose in which hospital quality improvements has not been fully In 2003, hospital accreditation, undertaken to be treated, although most will still be realised. by an Accreditation Council at the assigned a specific consultant within this Ministry of Health, was introduced; now hospital. Since 2005, some patient groups Methods of provider payments and have been able to choose their own incentives to achieve better quality specialist without general practitioner New methods of paying providers were Olga Adeeva was until August 2007 (GP) referral, as in the case of mothers in intended to increase efficiency and ensure Research and Development Officer at the respect of paediatricians and gynaecolo- the high quality of services. Case-based European Observatory on Health Systems gists. Considerable progress has also been payments (clinical pathways) for public and Policies, Berlin Hub, Germany. Lidia made through the transition from a pater- and private inpatient providers were intro- Georgieva is Head of Health Risk nalistic to a more autonomous approach to duced in 2001. Although there are discus- Management, MARSH Bulgaria. decision making. Now patients are sions regarding the efficiency of NHIF

19 Eurohealth Vol 13 No 2 EUROPEAN SNAPSHOTS payments, in particular these are thought Improving quality by generating and other amenities that are often to have improved the continuity and coor- competition otherwise paid for out-of-pocket. Yet, the dination of care across different disciplines Privatisation was seen as the most market for voluntary health insurance and sectors, as well supporting clinical powerful tool in Bulgaria to increase both remains limited due to financial barriers to effectiveness and clinical audit. quality and competitiveness. Competition access that most individuals must contend between GPs encouraged by this privati- with. So far it has not contributed signifi- In Bulgaria, inpatient public sector health sation process might, it was thought, force cantly to quality improvements in health personnel are, in the main, salaried; less productive GPs out of business. services for the general population, except however, the incentives of additional However, this potential for productivity for those services provided by health performance-related bonuses have since improvement has been limited, due to the professionals reimbursed by both the 2002 been included in provider contracts lack of competition between providers in public and private sectors who are thus with the NHIF. These bonuses link the some rural areas, as well as the continued able to treat public and private (including promotion of quality to the reim- existence of incentives for cream skimming VHI funded) patients differently. bursement process. and supplier induced demand. The mixture of approaches implemented in The question of how to provide incentives Private practice was legalised in 1991 and Bulgaria, with the goal of promoting the to achieve high quality in primary care has expanded significantly: private outpa- quality of health care services, has both remains an open issue. The establishment tient facilities now account for about 30% advantages and limitations. Regardless, it of independent (private) practices for of all medical centres, 95% of all can be viewed as a substantial undertaking, primary care physicians and the creation of specialised individual and group practices that has been complemented by changes in a system of general practitioners (GPs) was and 16% of all hospitals.5 In 1992, the one of the most successful steps in the the organisation and financing of health municipalities were also given ownership reform process. This reform changed the care, coupled with a commitment to of most health care facilities. Following the environment in which GPs now operate, efficiency and the needs of patients. legal framework of the Health Establish- from a system of salaried physicians into a ments Act,6 state and municipality-owned system based on capitation, adjusted for facilities were transformed into private REFERENCES age and gender, with the payment of state and municipality-owned enterprises. bonuses dependent on the evaluation of 1. Health Act 2004. State Gazette 2004;88 By making use of the economic instru- activity indicators and quality parameters. (06.11 with amendments). ments of competition and private property, Higher levels of remuneration have also 2. Act on the Professional Organisations of it was hoped to set in motion a process that been made available to those working in Physicians and Dentists 1998. Official would result in better quality services and sparsely populated and/or harsh remote Gazette 1998;83. more successful management of health care regions, as well as for the provision of so- facilities’ resources. Despite this, the 3. Health Insurance Act, 1998. State called ‘socially important’ services, such as private market has remained limited, since Gazette 1998;70. preventative services and child immuni- providers that do not have contracts with 4. National Framework Contract. State sation. Introducing this capitation the NHIF must rely on out-of-pocket Gazette 2000; 42 (with amendments). payment mechanism into the reim- payments by patients. bursement system also has given GPs an 5. National Centre of Health Informatics. incentive to invest in improvements in the Voluntary health insurance (VHI) in Public Health Statistics. Sofia: NCHI, quality of their services, in order to attract Bulgaria now supplements coverage of the 2005. patients who now are ‘shopping around’ state’s basic benefit package by offering 6. Health Establishments Act, 1999. State for the best primary care services. variety in providers, waiting times, quality Gazette 1999;88 (with amendments).

Health Economics, Policy and Law International trends highlight the confluence of HEPL invites high quality contributions in health economics, politics and legal considerations in economics, political science and/or law, within the health policy process. HEPL serves as a its general aims and scope. Articles on social forum for scholarship on health policy issues care issues are also considered. The recom- from these perspectives, and is of use to mended text-length of articles is 6–8,000 words academics, policy makers and health care for original research articles, 2,000 words for managers and professionals. guest editorials, 5,000 words for review articles, and 3,000 words for debate essays. HEPL is international in scope, and publishes both theoretical and applied work. Considerable Instructions for contributors can be found at emphasis is placed on rigorous conceptual development and analysis, and on www.cambridge.org/journals/hep/ifc the presentation of empirical evidence that is relevant to the policy process. All contributions and correspondence should be sent to: Anna Maresso, Managing Editor, The most important output of HEPL are original research articles, although LSE Health, London School of Economics and readers are also encouraged to propose subjects for editorials, review Political Science, Houghton Street, London articles and debate essays. WC2A 2AE, UK. Email [email protected]

Eurohealth Vol 13 No 2 20 Mythbusters

Myth: Early detection is good for everyone

Sometimes patients schedule annual visits be high. Even with common conditions, to health professionals even if they do prevalence will still be low enough to not have any symptoms, because clini- lead to many false positives. These false cians might discover something with results cause stress and anguish for their specialised knowledge and tech- patients who do not actually have the nologies that enable ‘early detection’ of condition.6,7 A test that provides a false illness. Doctors and advocacy organisa- negative result is also problematic, as it tions often encourage this screening of can lead to complacency and a false sense healthy people, in the belief it is good of security – for example, a common practice. urine dipstick test to detect diabetes could fail to do so in four of every five Unfortunately, many widely used tests patients who have the disease.6 are not very accurate, or they find conditions for which there is no effective Another problem with many screening treatment. At their worst, they leave tests is ‘leadtime bias’ – the test could patients worse off than they were before. discover a disease before the patient feels ill, but it does not actually extend the No clear answers patient’s life. This early detection can Evidence-based guidelines suggest that artificially inflate survival time by instead of an annual health check-up, for moving up the diagnosis date, making the which there is no evidence, doctors test appear to be useful even though should tailor screening to individual mortality does not in fact change.8,9 patient health profiles and move to ‘opportunistic’ screening – taking the Exhibit A: The PSA test time to talk about prevention and Early detection is often an important screening when patients come see them strategy in the fight against cancer, partic- for an acute problem.1–4 ularly with cancers that are aggressive and must be found early to improve the According to some researchers, doctors patient’s odds of survival. However, one should also focus screening on people of the more widely used tests – to detect who can benefit the most, provide prostate cancer, a relatively slow-growing follow-up treatment, and monitor their form of cancer – is quite problematic. patients’ compliance with medical recommendations. Finally, they should screen The prostate-specific antigen (PSA) test only for conditions that cause serious does not detect cancer itself – only a illness or functional difficulties, and only biopsy can do that – but rather levels of a when an accurate test and effective protein produced by the prostate gland treatments are available.5 which is associated with prostate cancer. The test leads to treatment for many Of course, no test is 100% accurate. If a cases of cancer that, if left alone, would condition is very rare in the population never become life-threatening. being screened, the false-positive rate will Advocates often claim that since the PSA test was introduced, deaths from prostate Mythbusters are prepared by Knowledge Transfer and Exchange staff at the Canadian cancer have dropped, but mortality rates Health Services Research Foundation and published only after review by a researcher started falling well before the PSA test expert on the topic. could have had an effect.10–12 The test is The full series is available at www.chsrf.ca/mythbusters/index_e.php. not recommended for widespread This paper was first published in 2006. © CHSRF, 2006. screening of men without symptoms,

21 Eurohealth Vol 13 No 2 A series of essays by the Canadian Health Services Research Foundation on the evidence behind healthcare debates

largely because of its high false-positive detection may result in increased anxiety 10. Gibbons L, Waters C. Prostate cancer – rate. Patients receiving a false-positive and even regret at having consented to testing, incidence, surgery and mortality. result can suffer anxiety, and they could the test.18 Health Reports 2003;14(3):9–20. have to undergo painful and unnecessary 11. Coldman AJ, Phillips N, Pickles TA. follow-up treatments that can have severe Conclusion Trends in prostate cancer incidence and side effects, such as impotence and Before any specific test is put into wide- mortality: an analysis of mortality change incontinence.10–11,13–14 spread use, patients and practitioners by screening intensity. Canadian Medical need to consider whether it is worthwhile Association Journal 2003;168(1):31–35. More importantly, research to date shows and accurate, and whether they would be that patients with prostate cancer who 12. Perron L, Moore L, Bairati I, Bernard empowered to do something with the take the test have no better odds of PM, Meyer F. PSA screening and prostate results. surviving than patients who do not. This cancer mortality. Canadian Medical Association Journal 2002;166(5):586–91. includes a recent study of more than 71,000 men, which found similar 13. U.S. Preventive Services Task Force. REFERENCES mortality among screened patients Screening for prostate cancer: recommen- compared to unscreened patients.15 A 1. Prochazka AV, Lundahl K, Pearson W, dation and rationale. Annals of Internal Canadian study also estimated only 16% Oboler SK, Anderson RJ. Support of Medicine 2002;137(11):915–16. evidence-based guidelines for the annual of tested men with prostate cancer would 14. U.S. Preventive Services Task Force. physical examination. Archives of Internal have their lives extended by treatment. Screening for prostate cancer: an update of Medicine 2005;165(12):1347–52. The rest would have died of another the evidence for the U.S. Preventive cause before the cancer had a chance to 2. Oboler SK, Prochazka AV, Gonzales R, Services Task Force. Annals of Internal become lethal.16 Xu S, Anderson RJ. Public expectations Medicine 2002;137(11):917–29. and attitudes for annual physical 15. Concato J, Wells CK, Horwitz R et al. examinations and testing. Annals of Exhibit B: Prenatal diagnosis of genetic The effectiveness of screening for prostate Internal Medicine 2002;136(9):652–59. abnormalities cancer: a nested case-control study. Not all early detection strategies are 3. Laine C. 2002. The annual physical Archives of Internal Medicine about prevention. In some cases, they can examination: needless ritual or necessary 2006;166(1):38–43. routine? Annals of Internal Medicine instead provide advance knowledge about 16. McGregor M, Hanley JA, Boivin JF, 2002;136(9):701–3. a medical condition that already exists. McLean RG. Screening for prostate cancer: However, sometimes this information can 4. Gordon PR, Senf J. Is the annual estimating the magnitude of overdetection. raise a series of difficult or uncomfortable complete physical examination necessary? Canadian Medical Association Journal decisions for some patients. Archives of Internal Medicine 1998;159(11):1368–72. 1999;159(9):909–10. One example is the practice of examining 17. Alfirevic Z, Sundberg K, Brigham S. foetuses early in the pregnancy to 5. Cadman D, Chambers L, Feldman W, Amniocentesis and chorionic villus provide early knowledge about birth Sackett D. Assessing the effectiveness of sampling for prenatal diagnosis. The community screening programs. Journal of defects and other problems. This can be Cochrane Database of Systematic Reviews the American Medical Association 2003;3(CD003252). accomplished through many forms of 1984;251(12):1580–85. non-invasive testing, including combina- 18. Green JM, Hewison J, Bekker HL, tions of blood test and ultrasound. 6. Greenhalgh T. How to read a paper: Bryant LD, Cuckle HS. Psychosocial papers that report diagnostic or screening aspects of genetic screening of pregnant In the case of genetic abnormalities such tests. British Medical Journal women and newborns: a systematic review. as Down’s syndrome, women considered 1997;315:540–43. Health Technology Assessment by health professionals to be of advanced 7. Streiner D L. Diagnosing tests: using and 2004;8(33):1 –109. age for childbirth (usually over age 35) misusing diagnostic and screening tests. are often offered invasive tests such as Journal of Personality Assessment chorionic villus sampling in the first 2003;81(3):209–19. trimester and amniocentesis in the second 8 Kramer B S. The science of early trimester.17 detection. Urologic Oncology The accuracy of these diagnostic tests is 2004;22(4):344–47. not in question. However, they may 9. British Columbia Cancer Agency. often raise a number of difficult decisions Screening for Cancer. Vancouver: British for mothers-to-be, including whether or Columbia Cancer Agency, 2005. not to terminate the pregnancy. Although Available at many mothers may appreciate this www.bccancer.bc.ca/HPI/CancerManage- information, for others this early mentGuidelines/ScreeningforCancer.htm#7

Eurohealth Vol 13 No 2 22 Evidence-based health care

The Case for Chocolate

Bandolier obviously has chocolate lovers among its readers, but chocolate lovers who want a healthy lifestyle. Can it really be true, they ask, that chocolate can be good for you? Henry's mother's hairdresser's friend was always of the opinion that a little of what you fancy does you good, but here a systematic review1 promised some evidence to support any prejudices.

Stearic acid Figure 1: Flavenol and procyanadin content of Observational studies of stearic acid (dietary, or chocolate compared with other foods high in serum levels) generally show that it is associated antioxidants with higher levels of heart disease, either as incidence or mortality. Stearic acid comes predominantly from meat and dairy products, so there is little surprise there. Stearic acid from chocolate is a small contributor to stearic acid intake, of about 5% in the average western diet.

Flavenoids in chocolate Chocolate, dark or milk, has higher levels of flavenoids or oxygen radical absorbance capacity than almost any other food, based on weight (Figures 1 and 2) or on energy. Only apples come close. Figure 2: Oxygen radical absorbance capacity of Chocolate and mechanisms chocolate compared with other foods high in antioxidants Over 20 small trials have studied the effects of Systematic review chocolate on physiological and biochemical The search was limited to parameters over the short term. The quality of English language studies the studies and the magnitude of the effects found in MEDLINE to cannot be seen from the review. Several reported mid-2005, which examined lower blood pressure, decreased low density at least one of several cholesterol oxidation, decreased platelet aspects of the relationship aggregation, improved endothelial function, and between chocolate and greater antioxidant capacity. cardiovascular health. Flavenoids and heart disease Results The review reports 11 prospective observational The review covered about studies of the association between flavenoid 140 publications and consumption and heart disease or stroke. Studies lots of them, and different ones, and is pretty nice looked at several different were conducted in populations of 500 to 40,000 on the whole for most of us. Eating too much aspects. (about 190,000 people in total), followed up for 5 to 28 years. Most reported some reduction in chocolate is not a good idea, though, because of coronary heart disease mortality. A meta-analysis the sugar and stearic acid it contains. Like so Bandolier is an online indicated a significant protective effect between many other things, a little chocolate taken journal about evidence- flavenoid consumption and risk of coronary heart regularly is likely to be a good thing; a little of based healthcare, written by disease mortality, with a relative risk of 0.81 what you fancy. Oxford scientists. Articles (95% confidence interval 0.71 to 0.92). can be accessed at REFERENCE www.jr2.ox.ac.uk/bandolier Comment 1. Ding EL, Hutfless SM, Ding X, Girotra S. This paper was first Many different polyphenols contribute to antiox- Chocolate and prevention of cardiovascular disease: published in 2006. idants in the diet. There is no absolute need to eat a systematic review. Nutrition & Metabolism © Bandolier, 2006. chocolate to get antioxidants. But chocolate has 2006;3:2.

23 Eurohealth Vol 13 No 2 NEW PUBLICATIONS

Eurohealth aims to provide information on new publications that may be of interest to readers. Contact Sherry Merkur at [email protected] if you wish to submit a publication for potential inclusion in a future issue.

National strategy to reduce social Translated from Norwegian, this Report then goes on to argue that targeted, user- inequalities in health to the Storting (Parliament) lays down oriented and specially adapted public guidelines for the government and services are necessary to ensure that the ministry’s efforts to reduce social inequal- whole population has access to equitable Norwegian Ministry of Health and Care ities in health over the next ten years. services. Services It forms part of the government’s broader Finally, steps towards reducing social policy for the reduction of social inequal- inequalities in health are highlighted, such ities, promotion of social inclusion and as: an inter-sectoral review; reporting combating poverty. The strategy aims to system; awareness-raising among decision- govern the ministry’s work on: annual makers in all sectors and on all adminis- budgets; management dialogues with trative levels; cross-sectoral tools (i.e. subordinate agencies and regional health health impact assessments, social and land enterprises; legislation, regulations and use planning); stronger partnerships and other guidelines; inter-ministerial collabo- local competencies for public health; and ration; organisational measures; and other strengthened research. available policy instruments. Contents: Introduction; Part 1: Reduce Report No. 20 (2006–2007) to the The report first describes social inequal- social inequalities that contribute to Storting, February 2007 ities in health in Norway. Then, policy inequalities in health; Part 2: Reduce social 99 pages instruments to reduce social inequalities in inequalities in health behaviour and use of health-related behaviours and health care health services; Part 3: Targeted initiatives Freely available at: access, as well as economic inequalities in to promote social inclusion; Part 4: http://www.regjeringen.no/pages/ society are discussed. Particular attention Develop knowledge and cross-sectoral 1975150/PDFS/STM200620070020000E is given to children and young people, the tools; Appendix: International N_PDFS.pdf labour market and workplace. The report experiences.

Hearts and Minds at Work in Europe: This report was prepared as part of a problems in the workplace. It argues that A European work-related public European Commission project entitled these interventions show a positive return health report on cardiovascular Workhealth, that began in Germany in on investment. Furthermore, these inter- diseases and mental ill health 2002. ventions are most effective when work health and public health aspects are It begins by reviewing the European addressed together. Wolfgang Boedeker and literature on disease and the workplace, Heike Klindworth arguing that although work is recognised Finally, the report provides recommenda- as a risk factor for two of the most tions to policy-makers and others, important disease groups in Europe – pointing out that effective and sustainable cardiovascular diseases (CVD) and mental health promotion and prevention calls for ill health – data on the occurrence of these collaboration across different professions diseases across occupations and economic and policy fields. sectors are rare. The report also draws Contents: Introduction; The burden of attention to the reverse of this CVD and mental ill health on work; relationship; the impact of disease on Relationship between CVD and mental ill work. health; The impact of work on CVD and Adding to the complexity are the links mental ill health; Strategies for healthy Federal Association of Company Health between CVD and mental ill health, as hearts and minds at work; Policy Insurance Funds, 2007 both diseases are potentially causes and recommendations; Annex A – Structure of ISBN 978-3-9800600-0-4 consequences of each other. the workforce in the EU; Annex B – Further readings; Annex C – The 137 pages The report concludes that because stress is WORKHEALTH II Consortium. known to be the most important work- Freely available at: related risk factor for CVD and mental ill http://www.enwhp.org/fileadmin/ health, sustainable stress prevention is the rs-dokumente/dateien/Hearts_and_ most effective way to tackle these Minds_at_Work_in_Europe.pdf

Eurohealth Vol 13 No 2 24 Please contact Sherry Merkur at [email protected] to suggest web sites WEBwatch for potential inclusion in future issues.

WHO International Clinical The objective of the WHO Registry Platform is to provide a complete view of research that is Trials Registry Platform accessible to those involved in health care decision-making. It also advocates for the public availability of a minimum amount of results information from clinical trials. The web site http://www.who.int/ictrp/en provides several resources including: The Clinical Trial Search Portal, which enables users to search a central database that contains trial registration data sets; The WHO Network of Collaborating Clinical Trial Registers that provides a forum for registers to exchange information and work together to establish best practice for clinical trial registration; and a list of primary registers that meet certain requirements and contribute data directly to the WHO Search Portal. These web sites are available in English.

Innovative Medicines Initiative The IMI is a proposed public-private partnership between the European Federation of Pharma- (IMI) ceutical Industry and Associations (EFPIA) and the European Commission with the overall goal of making Europe the world leader in pharmaceutical research. A key feature of the IMI http://www.imi-europe.org project is the way different stakeholders work together across Europe, establishing a new type of collaboration between industry, academia, regulators, health care professionals and patients. The IMI web site is available in English and provides details of the organisation, its objectives, news and events, publications for download and relevant links.

Healthcare Cost and Utilization Based in the United States, HCUP is a collection of health care databases and related software Project (HCUP) tools and products developed through a Federal-State-Industry partnership and sponsored by the Agency for Healthcare Research and Quality (AHRQ). HCUP databases bring together http://www.hcup-us.ahrq. the data collection efforts of State and private data organisations, hospital associations and the gov/home.jsp US government to create a national information resource of patient-level health care data since 1988. These databases enable research on a broad range of health policy issues, including cost and quality of health services, medical practice patterns, access to health care programmes, and outcomes of treatments at the national, State, and local market levels. The English language web site provides descriptions of and reports from the databases, related software, fact books and reports for download, news and events, as well as technical assistance.

Alliance for Health Policy and The Alliance for HPSR is a WHO-led international collaboration that aims to promote the Systems Research (HPSR) generation and use of health policy and systems research as a means to improve the health systems of developing countries. Its activities are conducted through a secretariat and over 300 http://www.who.int/alliance- partners worldwide under priority themes including: health workforce, health financing and the hpsr/en role of the non-state sector in health. The Alliance supports the development of national processes for evidence-informed policy-making and capacity for the generation, synthesis, dissemination and use of health policy and systems research knowledge. They regularly publish a newsletter, working papers and reports, all of which are available on-line.

Canada Health Infoway Launched in 2001, the Canada Health Infoway Incorporated is an independent, not-for-profit organisation whose members are Canada’s fourteen federal, provincial and territorial Deputy http://www.infoway- Ministers of Health. Infoway and its public sector partners have over 100 projects aimed at inforoute.ca delivering electronic health record (EHR) solutions to Canadians. The goal is to have an interoperable EHR covering 50% of Canadians by 2010. Details and documents about projects, annual reports, news and events and a newsletter for subscription are available from the web site in both English and French.

25 Eurohealth Vol 13 No 2 MONITOR

EUROPEAN MONITOR the international spread of help to ensure that outbreaks epidemics and other public and other public health emer- health emergencies while gencies of international concern International Health Regulations minimising disruption to travel, are detected and investigated enter into force trade and economies. Under the more rapidly and that collective In the early twenty-first century, IHR, countries will be required international action is taken to demographic, economic and to report all events that could support affected countries to environmental pressures have result in public health emer- contain the emergency, save lives created a unique combination of gencies of international concern, and prevent its spread. including those caused by conditions that allow new and WHO has already developed chemical agents, radioactive re-emerging infectious diseases and built an improved events materials and contaminated food to spread as never before. The management system to manage within 24 hours of assessment. experience of recent decades potential public health emer- shows that no individual The regulations also require that gencies. It has also been working country can protect itself from every country designate a with its partners to strengthen diseases and other public health National IHR Focal Point, the Global Outbreak Alert and threats. All countries are charged with providing to and Response Network (GOARN), vulnerable to the spread of receiving information from which brings together experts pathogens and their economic, WHO on a 24 hour basis, seven from around the world to political and social impact. days a week. Each country is respond to disease outbreaks. also committed to develop and The emergence and rapid spread David Heyman, WHO Assistant maintain core public health of SARS in 2003 was a clear indi- Director-General for Communi- capacities for surveillance and cation of how globalisation has cable Diseases, noted that while response. These capacities also made the world much smaller, “implementing the IHR is a include outbreaks of chemical, creating a need for collective collective responsibility and radiological and food origin. defences and for shared respon- depends on the capacity of all Countries are required to sibility in making these defences countries to fulfil the new establish these capacities as soon work. This is the underlying requirements, WHO will help as possible and within a deadline principle of the revised Interna- countries to strengthen the of five years after entry into tional Health Regulations that necessary capacities to fully force of the revised IHR. entered into force on 15 June. implement the Regulations. This The Regulations consist of a The IHR also recognises that is our responsibility and we comprehensive and tested set of international travellers be treated expect that the entire interna- rules and procedures which are with respect for their dignity, tional community is committed intended to help make the world human rights and fundamental to the same goal of improving more secure from threats to freedoms when health measures international public health News global health. are applied. However, they also security.” allow for examinations and other “SARS was a wake-up call for all More information on the revised required health measures to of us. It spread faster than we IHR can be viewed at protect against the international had predicted and was only http://www.who.int/entity/csr/ih spread of disease. Existing inter- contained through intensive r/en/index.html cooperation between countries national disease control programmes, addressing infec- which prevented this new World Health Report 2007 tious diseases, food safety and disease from gaining a foothold,” More than at any previous time environmental safety will also be said Margaret Chan, Director- in history, global public health strengthened. These programmes General of the World Health security depends on interna- make a vital contribution to the Organization. “Today, the tional cooperation and the will- global alert and response system greatest threat to international ingness of all countries to act as they allow the development of public health security would be effectively in tackling new and generic and threat-specific an influenza pandemic. The emerging threats. That is the capacities. threat of a pandemic has not conclusion of this year’s World receded, but implementation of The IHR also build on the Health Report published by the the IHR will help the world to recent experience of WHO and WHO in Geneva on 23 August. Press releases and be better prepared for the possi- its partners in both responding Entitled A Safer Future: Global other suggested bility of a pandemic.” to and containing disease Public Health Security in the information for Agreed by the World Health outbreaks. Recent experience 21st Century, it concludes with future inclusion Assembly in 2005, the Regula- shows that addressing public six key recommendations to can be e-mailed to tions establish an agreed health threats at their source is secure the highest level of global the editor framework of commitments and the most effective way to reduce public health security: full David McDaid responsibilities for countries and their potential to spread interna- implementation of the revised [email protected] for WHO to invest in limiting tionally. The Regulations will International Health Regulations

Eurohealth Vol 13 No 2 26 MONITOR by all countries; global cooperation in which cost Asian countries an estimated population behaviour (such as keeping surveillance and outbreak alert and US$ 60 billion in gross expenditure and children away from smoke) could have a response; open sharing of knowledge, business losses. major impact on respiratory infections technologies and materials, including and diseases among women and Some of the human factors behind viruses and other laboratory samples, children. Reducing levels of air public health insecurity identified in the necessary to optimise secure global pollution, as set out in WHO’s Air report, include inadequate investment in public health; global responsibility for Quality Guidelines, would save an esti- public health resulting from a false sense capacity building within the public mated 865,000 lives per year. of security in the absence of infectious health infrastructure of all countries; disease outbreaks; unexpected policy Low income countries suffer the most cross-sector collaboration within changes such as a decision temporarily from environmental health factors, governments; and increased global and to halt immunisation in Nigeria, which losing about twenty times more healthy national resources for training, surveil- led to the re-emergence of polio; conflict years of life per person per year than lance, laboratory capacity, response situations when forced migration obliges high income countries. However, the networks, and prevention campaigns. people to live in overcrowded, unhy- data show that no country is immune According to WHO, new diseases are gienic and impoverished conditions from the environmental impact on emerging at an unprecedented rate, often heightening the risk of epidemics; health. Even in countries with better with the ability to cross borders and microbial evolution and antibiotic environmental conditions, almost one spread rapidly. Since 1967, at least 39 resistance; and animal husbandry and sixth of the disease burden could be new pathogens have been identified, food processing threats such as the prevented, and efficient environmental including HIV, Ebola haemorrhagic human form of bovine spongiform interventions could significantly reduce fever, Marburg fever and SARS. Other encephalopathy (BSE) and Nipah virus. cardiovascular disease and road traffic centuries-old threats, such as pandemic injuries. The report also sets out the WHO influenza, malaria and tuberculosis, strategic action plan to respond to an Commenting on the publication of the continue to pose a threat to health influenza pandemic, drawing attention new country estimates, Susanne Weber- through a combination of mutation, to the need for stronger health systems Mosdorf, WHO Assistant Director- rising resistance to anti-microbial medi- and for continued vigilance in managing General for Sustainable Development cines and weak health systems. the risks and consequences of the inter- and Healthy Environments said that “Given today’s universal vulnerability to national spread of polio and the newly they were “a first step towards assisting these threats, better security calls for emerging strain of extensively drug- national decision-makers in the sectors global solidarity,” said Margaret Chan, resistant tuberculosis (XDR-TB). New of health and environment to set prior- Director-General of WHO. “Interna- health threats have also emerged, linked ities for preventive action.” tional public health security is both a to potential terrorist attacks, chemical Meantime, in a presentation at the Inter- collective aspiration and a mutual incidents and radionuclear accidents. governmental Midterm Review of Child responsibility. The new watchwords are World Health Report 2007 is available in Health and Environment Action Plans diplomacy, cooperation, transparency English, French and Spanish at in Vienna on 13 June, Roberto Bertollini and preparedness.” http://www.who.int/entity/whr/2007/ from the WHO Regional Office for World Health Report 2007 traces the Europe’s Special Programme on Health history of efforts to contain infectious New country specific data on impact of and Environment, made use of this data diseases (including plague, cholera and environmental factors on health to report that there are 5,000 preventable smallpox). It describes the evolution of On 13 June the World Health Organi- deaths every day in the European region. outbreak surveillance and response zation released the first ever country-by- Well tested environmental health inter- activities of international partnerships of country analysis of the impact ventions, he argued, could reduce total agencies and technical institutions. These environmental factors have on health. deaths in Europe by almost 20%, some include GOARN (Global Outbreak The data show huge inequalities but also 1.8 million lives every year. The range of Alert and Response Network), the demonstrate that in every country, years of life lost to environmental factors chemical and environmental health health could be improved by reducing varied fourfold across the continent, incident alert and response system, and environmental risks including pollution, with the lowest levels of risk reported in the Global Polio Eradication Initiative, hazards in the work environment, ultra- northern and western European coun- which is supporting surveillance of violet radiation, noise, agricultural risks, tries. The highest rates are all in the many other vaccine-preventable diseases. climate and ecosystem change. eastern part of the region: in the Russian Federation 54 disability adjusted years It shows how and why diseases are The new data show that 13 million of life are lost per 1,000 population every increasingly threatening global public deaths worldwide could be prevented year with similarly high rates of 49,48,47 health security. High and rapid mobility every year by making environments and 46 years of life lost per 1,000 popu- of people is one factor. Airlines now healthier. In some countries, more than lation in Kazakhstan, Turkmenistan, carry more than two billion passengers a one third of the disease burden could be Tajikistan and Kyrgyzstan respectively. year, enabling people and the diseases prevented through environmental Within the EU the highest rate of years that travel with them to pass from one improvements. Measure might include of life lost, 39 per 1,000 population is to country to another in a matter of hours. using cleaner fuel such as gas or elec- be found in Estonia, closely followed by The potential health and economic tricity, using better cooking devices, its neighbours Latvia and Lithuania with impact was seen in 2003 with SARS, improving the ventilation or modifying 38 and 34 years of life lost respectively.

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Dr Bertollini emphasised that children diabetes, gender-sensitive strategies, infection in both the WHO European were particularly vulnerable to these obesity, oral health and tuberculosis. Region and the EU Neighbouring environmental factors. The importance Countries. The meeting will also be open At a global level, the Presidency has of taking more action to protect children to all countries of WHO Europe Region pledged to pay special attention to a was also emphasised in a prior meeting and other Neighbouring Countries. range of global health issues, in in Vienna where Lisette Van Vliet, particular in what concerns the World Again this meeting is linked into the Toxics Policy Advisor, at the non Health Organization, coordinating overarching theme of migration and governmental Health and Environment community positions in the field of health in the Presidency programme. Alliance, stated that development of the tobacco control (at the 2nd Conference Key objectives include reporting on the foetal brain can be disrupted by of the Parties of the WHO Framework present situation in the EU, WHO exposure to hazardous chemicals at Convention on Tobacco Control), at the European Region and neighbouring levels that would be less damaging for 2nd Meeting of WHO’s Intergovern- countries, identifying incentives and adults. mental Working Group on Public barriers to HIV prevention, treatment Health, Innovation and Intellectual and support to migrant and mobile Priorities for health under the Property, at the meeting of WHO’s populations, namely national legislation, Portuguese Presidency Intergovernmental Working Group on policies and practices. Furthermore, it is The centre piece of actions for health sharing of influenza virus samples and hoped to reach a consensus on the under the Portuguese Presidency will be on the implementation of the Interna- existing gaps and obstacles when the issue of migration. A conference tional Health Regulations. reporting HIV impact on migrant and entitled Health and Migration in the EU mobile populations and to agree on – better health for all in an inclusive The Presidency themes are consistent priorities and processes to address iden- society will be held in Lisbon on 27–28 with the focus on health promotion, tified shortcomings. September. It has the aim of mobilising disease prevention, access to health care Member States, national and interna- and innovation agreed as part of an 18 A conference on pharmaceutical inno- tional organisations and non govern- month programme with the Slovenian vation will take place in Lisbon from mental organisations to discuss and and German presidencies. It has also 19–20 November. The Conference work on proposals of intervention pledged to continue to develop the programme will focus on the discussion strategies and policies, in order to ‘Health in All Policies’ initiative estab- of the current pharmaceutical research promote health, prevent disease and lished under the Finnish presidency. and innovation model at EU level, improve access to health care for analysing innovation’s main current To this end a meeting of the working migrants. challenges related to its definition and group on Health and Health Systems quantification, financing and new R&D Specifically, the Conference’s objectives Impact Assessment (HIA/HSIA) will technologies. How regulators will adapt will be: to assess the twenty-first century take place in Lisbon on 5–6 November. regulatory environments to the new international migration moves and their This is one of the subgroups of the High scientific changes, promote cooperation impact on EU demography and the Level Group on Health Services and among stakeholders, namely through economy; to improve knowledge on Medical Care of the European partnerships, as well as the main reason migrants’ health status and health deter- Commission. It aims to develop meas- for the loss of competitiveness of Europe minants (accounting for the demo- urement tools on the impact of EU in comparison with the US, will also be graphic dynamics of the migratory policies on health and health systems. discussed. It is envisaged that this will process and its impact; the specific Following up the work of this group and result in the release of a set of concrete political and legal frameworks at both the Kuopio Conference on Health In All recommendations and solutions for the national and international levels; the Policies during the EU Finnish Presi- future of the pharmaceutical innovation socioeconomic integration of migrant dency, a network of experts, recently sector. families); to identify best practices about established, will be strengthened. The migrants’ access to health services main themes to be covered will include More on the health priorities of the (health promotion, prevention and HIA and HSIA methodologies of imple- Portuguese Presidency can be viewed at access to care), encompassing formal and mentation and procedures in Member http://www.eu2007.min- informal care, as well as social and States of the EU; as well as planned or saude.pt/PUE/en/conteudos/programa+ cultural activities aimed at facilitating ongoing HIA and HSIA, including da+saude/presidencys.htm inclusion; and to contribute to the defi- Commission funded projects. It is hoped nition of health policies and strategies to further develop a European network European Commission, businesses and aimed at improving migrants’ inte- on HSIA and publication and dissemi- NGOs create forum to battle alcohol- gration, which could be implemented at nation of the conference results. related harm both EU and Member States levels. On 7 June in Brussels, over forty busi- Work begun under the German presi- nesses and non-governmental organisa- Another priority is the European Health dency on both HIV/AIDs and pharma- tions signed the Charter establishing the Strategy. A round table on health ceutical innovation will continue. On Alcohol and Health Forum. The Forum, strategies in Europe was held on 12–23 12–13 October, a meeting of EU national scheduled to meet twice a year, is to July in Lisbon with the aim of furthering AIDS coordinators will take place in focus in particular on actions to protect the debate. The programme included Lisbon with a focus on consolidating the children and young people and to parallel sessions on disease specific collaboration between European coun- prevent irresponsible commercial strategies: cancer, cardiovascular, tries, with regards to the fight against alcohol communication and sales. EU

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Member States, European Institutions, commitments will be made public and all long-term future of pharmaceuticals in the World Health Organization and the will be observed within one single moni- Europe. The consultation is particularly International Organisation of Vine and toring framework. The results will also targeted at enhancing the regulatory, Wine will participate as observers. be made public through DG Health and non-regulatory and research & devel- Consumer Protection’s website. This opment frameworks for the pharmaceu- Previously in October 2006, the will allow the evaluation of successful tical industry. European Commission adopted a initiatives, which, in turn could be Communication setting out an EU The objective is to address the public examples for the other members of the Alcohol strategy to support Member health, scientific and economic chal- Forum to follow. States in reducing alcohol related harm. lenges that the Commission believes are The priorities identified in the Commu- In a speech at the launch of the Forum, being faced by the EU pharmaceutical nication were: to protect young people European Union Commissioner for industry. These include increased global- and children; reduce injuries and deaths Health and Consumer Protection, isation of the pharmaceutical sector and from alcohol-related road accidents; Markos Kyprianou, welcomed the ensuring the smooth functioning of the prevent harm among adults and reduce participation of such an impressive internal pharmaceutical market in an the negative impact on the economy; group of partners in the fight against enlarged EU. The Commission also raise awareness of the impact on health alcohol related harm. He did however believes that the pharmaceutical industry of harmful alcohol consumption; and caution that more would need to come will have to adapt in response to help gather reliable statistics. Ways in out of the Forum than the already advances in science and technology. which the EU could support Member announced actions to protect children According to the Commission, globali- States’ actions to reduce alcohol-related and young people and promote respon- sation in the pharmaceutical sector stim- harm included exchange of good practice sible commercial communication and ulates a need to improve the on issues such as curbing under-age sales. competitiveness of EU pharmaceutical drinking, exploring cooperation on He noted that all stakeholders had companies to take advantage of new information or tackling drink-driving. critical roles to play saying that he opportunities and to access foreign The move to establish the new Forum expected the forum “as representatives markets. Globalisation also reinforces comes at a time when an estimated of the alcoholic beverages industry to the need to maintain local EU research 200,000 Europeans die every year develop, distribute and market your and development capability; as the because of harmful alcohol use. More products in a responsible manner. While Commission document states “the than one out of four deaths among I know that much has been done already, centre of gravity for worldwide R&D young men is attributed to alcohol. there is much scope for further actions investment in the field is gradually According to the recently published regarding advertising, server training, moving to the United States and Asia. special Eurobarometer on Alcohol, one product presentation, and so on. I expect Europe should strive to regain territory in ten Europeans usually drink five or you as representatives of other economic it covered for most of the 20th century, more drinks in one session, which is the operators to take on your part of the when it used to be the home for pharma- widely used definition of binge drinking work; we all know that media, adver- ceutical innovation.” for men. This figure was particularly tisers, retailers, owners of pubs and bars The Commission believes that the func- high among the youngest respondents. play an extremely important role in tioning of the EU internal pharmaceu- Almost one in five young people in the changing attitudes and behaviours, espe- tical market could be improved by better 15–24 age group (19%) drink five or cially among young people. I also expect regulation in, for example, the areas of more alcoholic beverages in one session. a broad involvement of NGOs and I clinical trials or variations to marketing would welcome active participations The Forum will establish a Science authorisations. It notes that some from NGOs outside the public health Group which, on request, will provide existing regulations may be overbur- field; representing social, youth, families scientific advice and guidance on matters dening and affect competitiveness and consumer interests; while of course under discussion. The Forum can also without always bringing public health respecting each organisation’s scale of establish Task Forces. The first two have benefits. It also suggests that improve- resources.” already been established and cover ments to the internal market could be marketing communication and youth- The Charter establishing the European made by enhancing the transparency and specific aspects of alcohol. Alcohol Health Forum can be found at: harmonisation of national pricing and http://ec.europa.eu/health/ph_determi- reimbursement schemes. The importance In order to become a member of the nants/life_style/alcohol/alcohol_charter_ of patient safety is also emphasised with Forum, a business or NGO has to en.htm the paper stating that “recent analysis submit a written commitment to take has demonstrated the existence of action. In other words, all the members The special Eurobarometer on Alcohol is multiple and sometimes inefficient have to present a concrete action plan available at: http://ec.europa.eu/health/ requirements as regards pharmacovigi- with objectives and information on how ph_publication/eurobarometers_en.htm lance in the EU. The challenge is thus to the results will be monitored and eval- strengthen and rationalise drug safety uated. Participation for the sake of Commission consultation on the long monitoring, while avoiding unnecessary participation will not be possible as term future of pharmaceuticals. requirements that would impair patients’ members will need to report on what On 19 July Directorate General Enter- access to treatments.” Globalisation of they have done and their achievements. prise and Industry initiated a public the market can also contribute to consultation on how to improve the Furthermore, all action plans and increases in counterfeit medicines that,

29 Eurohealth Vol 13 No 2 MONITOR in turn, produce a greater need to sible for over half (52%) of deaths in the European Commission adopts White protect the health of EU citizens. WHO European Region and almost a Paper on Sport quarter (23%) of its disease burden On 11 July the European Commission The consultation document includes a (measured in Disability Adjusted Life adopted its first comprehensive initiative list of six key questions that respondents Years – DALYs). on sport. The White Paper recognises should use as guidance for their contri- the important social and economic roles butions. In addition to inviting Heart disease and stroke are leading of sport, while respecting the require- comments on the main challenges causes of death in all WHO European ments of EU law. It is the result of outlined in the consultation document, Member States, but there are widening extensive consultations over the past two other questions include a request for gaps between the eastern and western years with sport organisations, such as concrete measures to ensure the safety of parts of the Region. While CVD the Olympic Committees and sport medicines supplied in the EU, mortality rates have been falling in federations, as well as with Member addressing in particular counterfeit western Europe in recent decades, a rise States and other stakeholders, including medicines, and the provision of high can be seen in the more easterly parts of an online consultation launched in quality and affordable medicines to third the Region, with an almost ten-fold February this year to which the countries. difference in premature CVD mortality Commission received 777 replies. (deaths in people under 65 years of age) The Commission would also like emerging between countries. CVD Ján Figel, European Commissioner in suggestions on how to improve Europe’s mortality is a major contributor to the charge of Education, Training, Culture international competitiveness and foster almost 20-year difference in healthy life and Youth, said “this White Paper is the convergence and transparency as regards expectancy between the countries of the Commission’s contribution to the pricing and reimbursement in the EU. WHO European Region. The economic European debate on the importance of Views are also requested as to the appro- costs are also substantial: in 2003, CVD sport in our daily lives. It enhances the priateness of the current EU regulatory was estimated to have cost the EU visibility of sport in EU policy-making, framework for emerging technologies economy €169 billion. raises awareness of the needs and speci- like regenerative and personalised ficities of the sport sector, and identifies medicine, as well as nanotechnology. The aim of the Charter is to substan- appropriate further action at EU level.” tially reduce the burden of cardiovas- Responses are due by 12 October. cular disease in the European Union and The White Paper proposes concrete Following this public debate, the the WHO European Region and to actions in a detailed Action Plan named Commission intends to address a reduce inequities and inequalities in after the founder of the modern Communication to the Council of the disease burden within and between Olympic Games Baron Pierre de European Union and to the European countries. The Charter highlights the Coubertin. The Plan, in particular, Parliament on the future of the EU importance of governmental action, in addresses the social and economic single market in pharmaceuticals for partnership with non-governmental and aspects of sport, including public health, human use, outlining its vision and public health organisations, to create education and social inclusion. Specifi- strategy for the sector, as well as supportive policies and environments cally it includes proposals to develop concrete action items. The Communi- that help people adopt healthy types of new physical activity guidelines and to cation will build on this public consul- behaviour. An estimated 80% of heart create a EU Health-Enhancing Physical tation and will outline how its outcome disease, stroke and type 2 diabetes could Activity network. There will also be the was taken into account. be avoided if major risk factors were award of a European label to schools The consultation can be viewed at eliminated, but concerted action is actively supporting physical activities, http://ec.europa.eu/enterprise/ needed to reduce the numbers of while a range of EU programmes and pharmaceuticals/pharmacos/docs/ smokers and reverse obesity trends in funds including Progress, Lifelong doc2007/2007_07/consultationpaper- countries, as well as to implement best Learning, Youth in Action, Europe for 2007-07-19_en.pdf practice in cardiovascular care. Citizens, the European Social Fund, the European Regional Development Fund Commenting on the Charter Professor European Heart Health Charter and the European Integration Fund will Georgs Andrejevs, a member of the launched be mobilised to improve opportunities European Parliament’s Committee on On 12 June the European Heart Health for supporting social inclusion and inte- the Environment, Public Health and Charter was launched at the European gration through sport activities. Food Safety, said that “it is not aiming at Parliament. It was signed on behalf of a unified stance on health care; but EU sports directors discussed the White fourteen European professional and rather at achieving high standards in Paper in a meeting that took place in public health organisations in the tackling CVD throughout the EU. It is a Lisbon on 12–14 July. In response to the presence of representatives of Member lever for better policies on, for example, health messages outlined in the White States, national cardiac societies and the detection and management of people Paper, the directors highlighted the heart foundations. European Union at high risk and on care for those who importance of physical activity in Commissioner for Health and suffer from CVD. To that extent it “improving individual and public health, Consumer Protection, Markos represents a real tool in the promotion quality of life and life expectancy, with Kyprianou and WHO Deputy Regional of public health.” benefits that range far beyond the Director for Europe, Dr Nata Menabde, struggle against obesity and have a major were also present. More information on the Charter is impact on medical care costs”. available at http://www.heartcharter.eu/ Cardiovascular disease (CVD) is respon-

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The meeting conclusions urged govern- services free of charge. with others to convert our promises into ments, sports federations, the education action.” The initiative comes at a time when poor sector, urban planning, transport and the diets and low levels of physical activity While acknowledging the progress that media to work more actively to promote in Europe account for six of the seven has already been made, including more physical activity and “create a living leading risk factors for ill health. The than doubling aid for health from $6 environment that encourages the largest lack of physical exercise, coupled with billion in 2000 to $14 billion in 2005; a number of people to become physically unbalanced diets, has turned obesity into 60% decline in measles-related deaths, active”. a serious public health problem: obesity and increased access of two million The White Paper on Sport will now be related illnesses are estimated to account people to HIV/AIDs treatment, the two discussed by the European Parliament, for as much as 7% of total health care leaders stated that they recognise the the Council, the European Economic costs in the EU. Studies show that one in challenges ahead. Much of the increased and Social Committee and the three Europeans do not exercise at all in aid in recent years has targeted specific Committee of the Regions. Its findings their free time, while the average interventions but has not built strong will also be presented to EU sport European spends over five hours a day sustainable health systems that are ministers. sitting down. In most EU Member essential to deal with all the major causes States more than half of the adult popu- of ill health. And we know that weak In October, the Commission will lation is overweight or obese. It is also systems - the lack of health workers, organise a conference to discuss the estimated that almost 22 million children clinics, supplies of essential medicines White Paper with sport stakeholders. are overweight in the EU and each year and lack of sustainable health financing The White Paper is available at this figure is growing by 400,000. Young systems - are the main barriers to http://ec.europa.eu/sport/index_en.html people tend to retain excess weight making more rapid progress in throughout their adult lives and are improving health outcomes.” Commission and UEFA launch TV advert more likely to become obese. They noted that “of the MDGs, those to promote physical activity focussing on health are the least likely to The European Commission and the COUNTRY NEWS be met…half a million women still die Union of European Football Associa- unnecessarily every year in childbirth, tions (UEFA) will launch a joint TV ten million children do not reach their advertising campaign that aims to UK and Germany announce fifth birthday, and only one in four of encourage European citizens to make International Health Partnership those in need of AIDS treatment in physical activity part of their daily lives. On 22 August, UK Prime Minister Africa is able to receive it.” The thirty second advert encourages Gordon Brown and German Chancellor viewers to get out of their armchairs and Angela Merkel announced the formation They added that “global health assis- be physically active, using the slogan of a new international initiative, the tance is over complex with many “Go on, get out of your armchair”. It is International Health Partnership, as part different health partnerships and interna- expected to reach between eighty and of a global campaign to address the tional organisations providing support one hundred million viewers during each Health Millenium Development Goals through separate aid channels, leading in match week of the Champions League, (MDGs) and equivalent to the coordi- many cases to fragmented health as it will be aired free of charge in more nation process of the Fast Track provision on the ground. These compete than forty European countries at the Initiative on education, between devel- for limited trained staff and can function interval of each of this season’s 125 tele- oping countries and, donors, interna- outside the recipient countries’ priorities vised Champions League football games. tional health agencies and foundations. and structures. This fragmentation has This has been possible through a part- The aim of the initiative is to accelerate undoubtedly reduced the effectiveness of nership with UEFA which has offered progress towards MDGs 4, 5 and 6, much aid.” up the thirty seconds of airtime that it namely, reducing child and maternal The agreement, developed with bilateral, retains for social initiatives. It is the mortality, and tackling specific diseases international health and funding latest initiative from UEFA to promote such as HIV/AIDS by increasing access agencies, developing countries, and health through football (see news article to and use of health services and deliv- foundations commits all partners to: from Georgia). ering improved outcomes. The new working with country owned plans; initiative will be officially launched on 5 The advert is a product of co-operation creating a mechanism to agree donor September. It will bring together major between the Commission’s Health and support to national plans; coordinating donor countries, including the UK, Consumer Protection Directorate their efforts on the ground; and Germany and Norway, alongside inter- General, UEFA and the London-based focussing on the creation of sustainable national agencies including the World Abbott Mead Vickers.BBDO advertising health systems which deliver improved Bank and the World Health Organi- agency at a total production cost of outcomes. It is expected that partners zation. €515,000. The Commission had asked will coordinate their actions in order to the European Association of Communi- Referring to the G8’s commitment ensure that health plans are well cations Agencies to invite its member towards the improvement of health in designed, well supported and well imple- companies to make proposals to work developing countries outlined earlier in mented. on the project and AMV.BBDO’s the year, in a joint statement the Prime The importance of helping countries submission was chosen. The agency Minister and the Chancellor affirmed develop strong health financing systems provided all creative and management that they were “taking steps working was also reiterated by the leaders empha-

31 Eurohealth Vol 13 No 2 MONITOR sising the G8’s commitment to the turn what it deemed as “years of under Reimbursement System), which “Providing for Health” initiative aimed funding” in older people’s mental health. combines restrictions on profits and at helping countries develop strong price controls, is achieving both value for The Inquiry report reveals that mental national health financing systems which money and ensuring the contribution of health problems affect many more can ensure universal coverage. They the UK pharmaceutical industry to people in later life than previously stated that “this process will be closely improved health care quality and believed and that the nature of these and systematically linked and provide economic prosperity. It recommended problems is wider than often recognised. input to the Health Partnership in order the replacement of the current system It reveals that up to 2.6 million older to enhance sustainable structures for with a new system of value based pricing. people, one in four people over 65 and accessible and pro-poor health systems.” two in five people over 85, are living Timms said, “we agree with the OFT One major international non-govern- with depression or serious symptoms of that it is time to develop a pricing system mental organisation, Oxfam, immedi- depression and one in five people over which is fit for purpose for the twenty ately welcomed this health initiative, 80 have dementia. It also highlights that first century. We must ensure that any recognising that it will help to target aid older people with mental health services future pricing scheme delivers value, towards the health needs of poor coun- are often ignored and receive little rewards innovation and ensures a fair tries. Alison Woodhead, head of support services, and there exists a poor deal. The OFT report contained a Oxfam’s international campaign for level of services for people growing number of detailed proposals as to how health and education, said that it was “a older with longstanding mental health a future pricing regime would work. We great initiative that deserves widespread problems such as schizophrenia. Women are undertaking a continuing programme international support. Brown and over 75 the report claims, are more likely of detailed analysis of the OFT report’s Merkel should be congratulated for to take their own lives compared to any proposals, and will discuss this analysis following through on their G8 promises other age group, while men over 75 have with the industry, taking into account to improve health care. The challenge for the second highest suicide rate of all men their strong concerns about a number of them now is to make sure other coun- in the UK. the proposals. This is a highly complex tries get on board to ensure maximum area and there are a number of different Chair of the Inquiry, June Crown, said impact. There are women, men and models for taking work forward. We will that “Mental health problems in later life children in developing countries who are take this work forward over the coming are not an inevitable part of ageing. They dying because they don’t have access to months and will discuss proposals with are often preventable and treatable, and health care or any doctors or nurses to industry. We will then aim to make action to improve the lives of older attend to them. This Partnership could further proposals as part of the renegoti- people who experience mental health literally save lives, by coordinating ation of the PPRS.” difficulties is long overdue. Current investment in health care that is free, services for older people with mental The government’s initial response recog- public and well staffed. “ health problems are inadequate in range, nises that since the PPRS was established The full joint statement of the Prime in quantity and in quality.” fifty years ago, significant changes have Minister and the Chancellor can be occurred, both in the pharmaceutical The report also estimates that older viewed at http://www.number- industry and in the delivery of health people make a valuable contribution to 10.gov.uk/output/Page12904.asp care. It notes that blockbuster drugs are the economy and this is growing in rare, with innovation now increasingly absolute and relative terms. By 2021, the UK: Inquiry claims mental health focused on ever-smaller patient popula- unmet mental health needs of older services are letting down older people tions, creating major challenges in people will cost £230 billion per year in A mental health pandemic and an inade- ensuring affordable delivery of these lost workers, £15 billion from the quate Government response mean that benefits to patients. Although in absence of older carers, £5 billion from over 3.5 million older people who expe- agreement that changes need to be made, lost volunteers, £4bn from lost grand- rience mental health problems do not the government is mindful of the need to parents and £245 billion from lost have satisfactory services and support, ensure that any pricing system will consumers. according to the final report from the encourage research and reward inno- UK Inquiry into Mental Health The full report can be accessed at vation which delivers valuable new treat- andWellBeing in Later Life – a major http://www.mhilli.org/ ments. Any future pricing scheme must independent inquiry supported by the also provide stability, sustainability and UK-based NGO, Age Concern. UK: Government committed to revision predictability for industry. of pharmaceutical pricing arrangements The Inquiry makes 35 recommendations The OFT report on the Pharmaceutical Drugs pricing arrangements between the for ways to improve mental health Price Regulation Scheme can be found National Health Service and pharmaceu- services for older people. It calls for at: http://www.oft.gov.uk/advice_and_ tical companies should be updated, action to: eliminate age discrimination in resources/resource_base/market-studies/ according to Competitiveness Minister, mental health; challenge stigma, ageism price-regulation. Stephen Timms, publishing the and defeatism; work on preventing Government’s interim response on 2 problems; support older people and their Ireland: Review finds 13% of patients August to a recent report from the carers to help themselves and each other; admitted to hospital unnecessarily Office of Fair Trading (OFT). and improve housing, health and social The Health Service Executive (HSE) on care services. It also calls for government The OFT report questioned whether the 1 June published its Acute Hospital Bed action to provide leadership and over existing PPRS (Pharmaceutical Pricing Use Review. The review found that 13%

Eurohealth Vol 13 No 2 32 MONITOR of patients were unnecessarily admitted alone, but the way local health systems number of target areas including exam- to hospital and that 39% of the patients are configured to treat and care for that ining the case for introducing an MRSA in hospitals surveyed could have been patient that results in inappropriate screening programme; targeting skin and treated in an alternative setting on the occupancy of an acute bed. A broad soft tissue infections; reducing blood day of care, if appropriate alternatives range of community and home-based stream infections and ensuring addi- had been available. The review was care options are needed to ensure tional surveillance data are put to use in conducted across 37 hospitals and a total patients are placed in the most appro- the areas of general medicine and care of of 3,035 patients were randomly sampled priate setting.” the elderly out of a patient population of 8,322. John O’Brien, National Director and the The Scottish Minister for Health and Acute medical and surgical inpatients manager who headed up the Winter Wellbeing, Nicola Sturgeon, said that the were the focus of the review. Initiative, observed that the report indi- “study is one of the most detailed of its The findings will be used by the HSE to cates that “the solution for many of the kind in the world. For the first time, we drive hospital performance improvement logjams within our hospitals may have a true picture of the extent of infec- and the re-configuration of services to actually lie outside those hospitals… tions in our hospitals. The compre- achieve an increase in the levels of there are many patients occupying beds hensive nature of the survey means that appropriate placement of patients who would not be doing so if there were it may appear Scotland’s rates of HAI outside of hospital settings and reduce alternative community-based options.” are worse than elsewhere. This is not inappropriate admissions, as well as an necessarily the case – like for like The Acute Hospital Beds Review is over-dependence on the hospital system. comparisons with other countries, available at http://www.hse.ie/en/ including England and Norway, show The work was carried out using the Publications/HSEPublicationsNew/ that Scotland’s rates are similar. But HAI Appropriateness Evaluation Tool (AEP) AcuteHospitalReportsGuidelines/ is a serious problem that must be – a method originally developed in the AcuteHospitalBedReview2007/reports/ tackled.” US but widely used in Europe. The prin- FiletoUpload,7020,en.pdf cipal alternatives to acute admission The Scottish Executive’s HAI task force identified for these patients were: access Scotland: New measures to tackle oversees an extensive, high quality to assessment/diagnostics without health care associated infections programme of action which so far has admission to a hospital; access to a non- A task force set up to tackle health care included developing a HAI code of acute bed with therapy support, for associated infections (HAI) is to step up practice, developing a national cleaning example, physiotherapy; and home- its work following the publication on 11 services specification, introducing a based patient care including general July of the most comprehensive study national hand hygiene campaign, intro- practitioner support, therapy, specialist ever undertaken into the extent of infec- ducing targets for board chief executives nursing, community nursing and home tions in Scotland’s hospitals. Scotland to meet and the introduction of educa- care packages. now has a more comprehensive picture tional initiatives like the Cleanliness of HAI than any other country in Champions programme. The findings suggest that change across Europe and armed with this information three main areas would reduce the The Scottish government have also will be able to target measures to tackle number of patients deemed ‘inappro- stated that new investment in tackling hospital infection where they are most priate’ based on AEP criteria. First, HAI beyond 2007–08 will form part of needed. better prevention and management of the spending review announcement later chronic illness within the community to The National HAI Point Prevalence in 2007. The Point Prevalence Survey reduce demand on the acute hospital Survey, carried out by Health Protection will also be carried out at intervals in setting. Second, further developing Scotland between October 2005 and future to evaluate trends in HAI. capacity in responsive community based October 2006, included all 45 acute More information on the survey at services, to help avoid unnecessary hospitals and a sample 22 community http://www.hps.scot.nhs.uk/news/spdetai admissions to acute care and to facilitate hospitals, recording the presence of all l.aspx?id=105 earlier discharge and a return to inde- types of infections on the day of the pendence. Third, changing internal survey. It found that the prevalence of Russia: New rules for children’s organ organisational factors within hospitals HAI was 9.5% in acute hospitals and transplants that can influence length of stay, bed 7.3% in community hospitals. The In July the Ministry of Health and Social occupancy and bed utilisation. survey also estimates for the first time Development announced plans to the total cost of HAI in acute hospitals – Dr Marie Laffoy, Assistant National develop instructions regulating the £183 million a year. The study also Director for Strategic Planning in the transplantation of organs to children. At found that the highest numbers of HAI HSE’s Population Health Division, present, child donors are prohibited, but in acute hospitals were present in the emphasised that “detailed analysis of the the Ministry plans to legalise organ care of older people, medical and data shows that the most important transplants from children. The rules are surgical wards. Almost all (92%) of the factor influencing appropriate placement currently being studied by the Russian Clostridium difficile infections recorded of a patient is the system of care delivery Academy of Sciences’ Medical Research were found in the care of older people rather than factors concerning the Institutes. It is expected that the revised and medical specialties. patients themselves. It is not the instructions will require that organs for complex nature of the patient condition In response to the report, the HAI Task transplants are taken from patients after or the fact that the patient is old or lives Force will focus their efforts on a brain death, a diagnosis that must be

33 Eurohealth Vol 13 No 2 MONITOR confirmed after twelve hours. Such deci- programme has been developed in year and are based on a concept of fun sions would be made by a team of expe- Belarus. football that downplays competition and rienced medics led by the chief doctor of is designed to develop confidence and The document has been distributed to all the hospital in question. The permission teamwork. “Children and adults across relevant ministries and departments. Its of the donors’ families would also be eastern Europe love football,” said main goal is to protect present and required. Anders Levinsen, director of the CCPA. future generations from the health, envi- “We use this shared passion to help The new legislation would bring Russian ronmental and economic consequences bring together divided communities, and policy into line with most high income of tobacco smoke. The programme also leave behind equipment and training that countries which allow children to be aims to reduce demand for tobacco helps local football clubs maintain or organ donors after their deaths. goods, and thus related morbidity and develop activities for children.” Currently Russians are forced to take premature mortality. The programme their children abroad for such opera- includes measures to increase awareness Heart disease and strokes in Georgia, tions, although the associated high costs within the population of the dangers of Armenia and Azerbaijan kill more are prohibitive for most individuals. The smoking, as well as ways to quit people than all other causes combined. potential demand for such operations is smoking and treat tobacco addiction. It “We hope to motivate youngsters to eat significant. According to the Moscow is hoped that by 2010 that the number of healthy diets, remain physically active Organ Donation Coordinating Centre, smokers aged 15 or under will fall by and avoid smoking, so that they can 30% of the 5,000 Russians who need 20%, those aged 16–20 by 10% and avoid the early death and disability that organs transplants each year are those aged 21–30 by 7%. Experts also causes much pain, suffering and poverty children. The plans have been welcomed predict a decrease in the rates of female and which is a barrier to our economic by many health care professionals, but and child passive smoking. growth,” said Dr Merab Mamatsashvili, some activists oppose the proposed president of the Georgian Heart Foun- More information at http://www.belta. legislation, arguing that it is immoral and dation. by/en/news/society?id=171445 could lead to the mass abuse of rules by More information at doctors. Georgia: Street football used to promote http://www.uefa.com More information at: http://en.rian.ru/ child health russia/20070713/68920290.html With the help of the Union of European Hungary: Investigation into possible Football Association (UEFA), children price fixing in the pharmaceutical Head of Russian pharmaceutical from Georgia, Armenia and Azerbaijan industry company Protek charged with bribery have been highlighting the role that In June, the Hungarian Competition On 17 August, prosecutors in Moscow sport can play in maintaining a healthy Office (HCO) began an investigation said that they had charged Vitaly lifestyle. UEFA’s partner, Open Fun against the Hungarian Chamber of Phar- Smerdov, the head of the Protek pharma- Football Schools (OFFS), teamed up macists (HCP), the Association of Inno- ceutical company, with bribing health with the Georgian Heart Foundation to vative Pharmaceutical Manufacturers, insurance officials in order to receive organise street football events in the the Hungarian Pharmaceutical Manufac- sales licenses. Smerdov was previously a Georgian capital Tbilisi in May. The turers Association, the Generic Medi- witness in a high profile inquiry into OFFS and the Georgian Heart Feder- cines Manufacturers and Distributors possible corruption in Russia’s ation came together as a result of Association, the Vaccine Manufacturers Mandatory Medical Insurance Fund UEFA’s support for World Heart Day. and Distributors Association and the (FOMS) which opened late last year. Pharmaceutical Wholesalers Association, As part of events organised for Heart FOMS executives had been accused of due to an alleged infringement of the Week in Tbilisi, more than one hundred accepting bribes from the heads of Competition Act. children between the ages of eight and regional branches of the fund, and phar- twelve played street football and A leading Hungarian newspaper, maceutical and other commercial basketball around the theme of ‘healthy Világgazdaság, reported that HCO companies involved in distributing life through physical activity’. Seven of began its investigation in response to a medication and medical equipment the children who took part have heart complaint from the Hungarian Trade under a state-run programme to provide conditions or diabetes. Children from Association. Világgazdaság quoted Péter free or subsidised drugs to low-income Armenia and Azerbaijan joined local Szolnoki, head of the HCO’s cartel unit, population groups. Smerdov’s lawyers youngsters in street football matches on who stated that the HCO had already have appealed against his arrest and the six temporary football grounds. The conducted a thorough preliminary inves- court’s refusal to release him on bail of Ministry of Public Health and Georgian tigation regarding the complaint, which two million rubles ($78,000). non-governmental organisations alleged price fixing of non-reimbursed http://en.rian.ru/russia/20070817/72149 working to combat tobacco and alcohol medicinal products, as well as an 302.html abuse were involved in other activities unlawful concerted effort by pharmacies during the week. and pharmaceutical companies to Action in Belarus against tobacco prevent the sale of certain over-the- Open Fun Football Schools are Experts from the Republican Centre for counter medicines outside of pharmacies. organised by the Danish Cross Cultures Hygiene, Epidemiology and Public Projects Association (CCPA). They Mr Szolnoki said that preliminary inves- Health in Belarus have drafted a benefit more than 30,000 eastern tigations had revealed that the HCP and programme against tobacco for 2008 to European children of all skill levels each the other Associations had communi- 2010. This is the first time such a

Eurohealth Vol 13 No 2 34 MONITOR cated regularly on the current prices of individuals with fatigue syndrome, more nursing profession as a fundamental pharmaceutical products, and that the commonly known as burnout, would no pillar in the sound functioning of the HCO had therefore decided to launch longer be able to be signed off as sick by NHS. The government has already formal competition supervisory their doctors after the guidance comes introduced measures to develop and proceedings, in the form of a full investi- into effect from 1 October. In Sweden make improvements to the nursing gation. Another Hungarian daily, Napi some 30,000 people a year are estimated profession through the passing of Royal Gazdaság, also reported that the HCO to have more than two weeks off work Decree 450 in 2005. This focused on will allege that this communication was due to exhaustion. specialities within nursing and approved unnecessary to ensure the safe supply of the recognition of new degree standard Jörgen Herlofson, who devised the medicinal products. qualifications as the basis on which to criteria by which burnout is defined by enter these specialities. The Associations are claiming that they Sweden’s National Board of Health and were not in fact involved in the chain of Welfare, writing in an article in the The government will thus publish a draft communication because the pharmaceu- newspaper Dagens Nyheter, claimed that document on the role of nursing, tical manufacturers sent their manufac- stress-related illnesses were not being intended to be the springboard for turer prices to the HCP directly, and not taken seriously. He said that the subsequent consultation with all stake- via the Associations. The HCO may National Board of Health and Welfare holders. This initial document will be take up to a year to complete its investi- had chosen an ‘anti-humanist’ ideology developed by the proposed expert gation. and that the main reason was clearly to working group, which itself will be save money. “I and many others are hosted within the National Council of More Swedes going abroad for medical deeply disappointed, worried and suspi- Specialists in the Health Sciences, a treatment cious,” Herlofson wrote. multi-disciplinary body considered most The number of Swedish patients treated suitable for this task. However as reported by the Local, the in other EU countries at the expense of man behind the scheme, Jan Larsson, The work of this expert group marks the the Swedish state doubled between 2005 said that this had been “a gross misinter- beginning of what is anticipated to be a and 2006, according to new statistics pretation. The ambition is to bring profound debate over the role the from the Swedish Social Insurance forward better and more targeted sick nursing profession currently occupies Administration (Försäkringskassan). leave practice”. Those with fatigue within the NHS, as well as how it can The English language daily newspaper syndrome would still in fact qualify for adapt to future demands. The report will The Local reported that 2,000 people sick leave benefits, but this would be assess the current situation, identify new had planned treatment abroad in 2006, accompanied by more action from the health and social care demands, and compared to only 900 in 2005 and just health care system intended to help these determine their consequences for the 150 in 2004 when the scheme to fund individuals return to work as quickly as functions and skill-mix of the nursing non-emergency treatment abroad was possible. Social Insurance Minister, profession, as well as the knock on introduced. Dental treatment was most Cristina Husmark Pehrsson, also stated effects for other health care professions. popular followed by treatment for that the new guidelines were one means The report is expected to be completed muscle and joint problems. The majority of helping more people back to work. “I by 15 December, when consultation of individuals were treated in Finland, would be sorry if they were misinter- with all relevant stakeholders will begin. with Germany the principle destination preted. Nobody thinks that a politician In addition to the chair, the expert for specialist care. Spain, Portugal and can get involved in how long a doctor working group will have eight members. the Baltic states were the most common gives people sick leave. That is entirely The Ministry have given assurances that destinations for dentistry. The total cost up to individual doctors”. its composition will be broad in order to of overseas treatment in 2005 and 2006 The guidelines have caused controversy be fully representative. It will include was 25 million kronor, which can be since they were released. The Swedish one representative of the 17 contrasted with a total health care Medical Association (Läkarförbundet) Autonomous Communities that make budget in excess of 340 billion kronor has backed the new rules, while many up Spain, one each from the Ministries The report from Försäkringskassan is patients’ groups have been critical. of Health and Consumers and available in Swedish at Education and Science, three from the http://www.forsakringskassan.se/omfk/ Spain: Expert group to consider future nursing professions and two from other styrning/regeringsuppdrag/2007/halso_ of nursing in the National Health medical professions. The importance of sjukvard_07 System adequate representation, including all On 10 July the Ministry of Health and facets of nursing on the working group, Controversy over new guidance on enti- Consumers ordered the establishment of has been strongly emphasised by the tlement to sick leave in Sweden an expert working group to help begin a decision to appoint a member of the In August new guidelines on the criteria consultation process over the role played National Commission on Nursing to the for sick leave were published by the by nurses within the National Health group, with a second nurse coming from Swedish National Board of Health and Service (NHS). a care and welfare background and the Welfare (Socialstyrelsen). The intention third from the world of academia. This initiative continues a direction of of the new guidance is that people with work undertaken by the Ministry of More information (in Spanish) at mild or insignificant stress-related Health and Consumers which has been http://www.msc.es/gabinetePrensa/ problems should not be put on sick leave conscious of the importance of the in the first instance. It was feared that

35 Eurohealth Vol 13 No 2 News in Brief

Climate change: Europe must adapt in often unhealthy situations, to care for caused children to choose aggressive Climate change poses a double chal- prisoners in need and to promote the toys. It also did not provide any support lenge: Europe must not only make deep health of prisoners and prison staff. This for a link between video game playing cuts in its greenhouse gas emissions but requires that everyone working in and aggressive feelings, aggressive also take measures to adapt to current prison understand how imprisonment thoughts or aggressive behaviours, and future climate change, in order to affects health, what prisoners' health despite all these outcomes having been lessen the adverse impacts of global needs are and how evidence-based well studied. Furthermore, the available warming on people, the economy and health services can be provided for longitudinal studies of video game the environment. This is the key everyone needing treatment, care and playing and excess weight in children message of a Green Paper published by prevention in prison. Other essential did not support a link, while there was, the European Commission which sets elements are being aware of and accept- in fact, strong support to suggest that out options for EU action to help the ing internationally recommended playing video and computer games has process of adaptation to climate change standards for prison health; providing positive effects on cognitive abilities. across Europe. Adaptation implies professional care with the same The report is available at taking action to cope with changing adherence to professional ethics as in http://www.fhi.se/upload/ar2007/ climatic conditions, for example by other health services; and, while seeing Rapporter%202007/R200518_video_ using scarce water resources more individual needs as the central feature of computer_game.pdf efficiently or ensuring that vulnerable the care provided, promoting a whole- people are properly cared for during prison approach to care and promoting heat waves. The Green Paper consulta- the health and well-being of people in tion runs until November and will custody. Windmill 2007: The future of health contribute to future EC proposals. care reform in England The guide is available at In a new paper from the independent More information at http://www.euro.who.int/document/ health think tank, the Kings Fund, Sarah http://ec.europa.eu/environment/ e90174.pdf Harvey, Alasdair Liddell and Laurie climat/eccp_impacts.htm McMahon report on the findings of the Windmill 2007 initiative. This is named EU to study electronic chips for after the 'Rubber Windmill', a simula- EurLife database of quality of life in- eHealth tion modelling process developed in dicators In July the Commission launched a 1990 to explore how the health service The EurLife database, maintained by the tender to examine the options for using was responding to the internal market European Foundation for the Improve- Radio Frequency Identification (RFID) being developed at the time. The new ment of Living and Working Condi- technology in healthcare, with applica- study included a two-day simulation of tions, and which deals with the objective tions ranging from the identification of a fictional but realistic health economy living conditions and subjective well- patients in hospitals to tagging pharma- from 2008 to 2011 and extensive discus- being of European citizens, has recently ceutical products. The main objective of sions of the emerging findings with a been updated. New indicators have been the study will be to assess the expected range of stakeholders. Among the key added, as well as data for more recent features of RFID applications in the messages of the paper is the need for a years. National coverage has been health care market and to build future clear set of rules for competition within expanded to include the 27 EU Member scenarios in the field. It is also set to the NHS to ensure that all players, States and Turkey. The database will be identify possible obstacles and needs commissioners, providers, public sector updated again in 2008 with results from for policy actions or specific research and private, can plan for the future and the second European Quality of Life activities on the subject. that the emergent market works in the Survey. interests of patients. More information at The database can be accessed at http://ted.europa.eu/udl?uri=TED:NO- The report is available at http://www.eurofound.europa.eu/areas/ TICE:163980-2007:TEXT:EN:HTML http://www.kingsfund.org.uk/ qualityoflife/eurlife/index.php publications/kings_fund_publications/ windmill_2007.html Impact of video and computer games WHO guide to the essentials in on child health prison health The Swedish National Institute of This new publication from the WHO Public Health has undertaken a system- Additional materials supplied by Regional Office for Europe, edited by atic review looking at the effects of EuroHealthNet Lars Møller, Heino Stöver, Ralf Jürgens, playing video and computer games on Alex Gatherer and Haik Nikogosian the health of children and young people. 6 Philippe Le Bon, Brussels. outlines some of the steps prison The review found that there was only Tel: + 32 2 235 03 20 systems should take to reduce the public limited evidence to suggest that playing Fax: + 32 2 235 03 39 health risks from compulsory detention violent video and computer games Email: [email protected]

eurohealth Vol 13 No 2 36 Eurohealth is a quarterly publication that provides a forum for researchers, experts and policy makers to express their views on health policy issues and so contribute to a constructive debate on health policy in Europe

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