Health Policy and European Union Enlargement
Study Proposal

Editors
Martin McKee
Laura MacLehose

In March 1998, accession negotiations were formally opened with six countries: the Czech Republic, Estonia, Hungary, Poland, Slovenia and Cyprus. The process was widened in February 2000 to include six additional candidates: Bulgaria, Latvia, Lithuania, Malta, Romania and the Slovak Republic. Turkey is also a candidate country for accession to the EU although not yet in accession negotiations. While groups of countries have started the negotiation process, this does not imply that negotiations will be concluded at the same time. Negotiations are conducted individually with each candidate country and the speed of negotiation depends on a range of factors, including the degree of preparation undertaken by the country and, to some extent, the ongoing institutional reform within the existing EU. Accession of these countries to the EU will bring benefits but also challenges for both the EU and those acceding to it.

Among the challenges for the pre-accession countries is the need to implement the accumulated body of existing EU law, the Acquis Communautaire. Although, formally, the EU does not have competence in health care, this being a matter reserved for governments of member states under the principle of subsidiarity, there is a large number of provisions in relation to free movement of goods, services, and people that do affect health care arrangements and have implications for health. Other policies, such as parts of the Common Agricultural Policy (CAP), can also be considered to have impacts for health status and care in member states. These impacts will become clearer as health impact assessment of 'non-health' EU policies is carried out. In addition, there are a number of disease specific surveillance activities which are closely linked to health services action. Among the issues to be addressed are the extent to which regulatory systems of acceding countries meet EU standards, how comparable EU health priorities are with those of the accession countries, and the extent to which existing national legislation of accession countries may conflict with EU law, which will have primacy.

This new round of accession to the EU is simply one further step in a process of enlargement that began as long ago as 1973, when Denmark, Ireland and the United Kingdom joined the original six members. As recently as 1995, Austria, Sweden and Finland joined. Consequently there is now a considerable body of experience that can be drawn upon by those countries that are currently negotiating accession.

It is, however, essential to recognise that the EU has evolved in many ways since it was established in the 1950s, of which some have a direct or indirect effect on health. In addition, the relatively wide gap between the wealth and health of the EU and pre-accession countries compared to the countries most recently joining the EU in 1995 also has implications for health systems in both the EU and the pre-accession countries.

Large differences exist between the accession candidates in terms of health systems and health status of the population. However, while the candidate countries each differ with respect to health and health care system, taken overall the health status of the candidate countries' population differs negatively on most key indicators in comparison with that of the EU average. Identifying the key health challenges for the candidate countries and to what extent these might or might not be addressed by accession to the EU also needs consideration.

Infant mortality is significantly higher in all candidate countries, with the exceptions of Slovenia, Malta and Czech Republic, extending to over three times the EU average in Romania. However, the EU and the candidate countries both show an overall trend of improvement for this indicator over the last two decades. Life expectancy at birth, which dropped in candidate countries during the early 1990s but is now generally rising, remains around two to eight years below that of the EU (with the exception of Malta, which closely mirrors the EU average).

The pattern of communicable disease also differs between the EU member states and candidate countries with candidate countries showing, for some diseases, a reversal of earlier progress in disease control. Tuberculosis, for example, is significantly higher than the EU average (with the exception of Malta) and rose to over six and seven times as high in Lithuania and Romania, respectively, in 1998. In contrast to the EU, there is an increasing trend in cases of tuberculosis in many candidate countries. Similarly, sexually transmitted diseases such as syphilis show dramatic increases over the past decade in over a third of candidate countries whereas a continued steady and low incidence is found in the EU. Importantly, many cases of syphilis arising in the EU can be linked to eastern Europe, reflecting the increasing international sex trade. Other communicable diseases, such as viral hepatitis, generally show decreases over the last decade, and approach average EU levels. Accession to the EU will have implications for surveillance of communicable disease as candidates will have to participate in new surveillance arrangements set up within the EU, and will face pressure for enhanced prevention and control. In terms of non-communicable disease, almost all candidate countries show significantly higher mortality rates of chronic illness such as ischaemic heart disease, lung cancers and chronic liver disease and cirrhosis. Injuries and indicators of poor mental health also show high levels in many of the candidate countries and are important contributors to morbidity and mortality.

In terms of health systems, the candidate country systems have faced severe financial and structural challenges over the past decade. Many suffered temporary collapse of their economies. This has translated into a shortage of resources for the health sector. In response to the financial situation and new thinking in health systems management countries have also started undertaking analyses of staffing levels and health systems organisation to see where more effective use of limited resources might be made. In financial terms, the EU countries spend on average nearly twice as much of GDP on health as do the candidate countries. Figures from 1999 showed that per capita real spending in the EU was over ECU 1500 while it was below ECU 300 in the then ten candidate countries. Such low spending not only poses challenges to the provision of health care in the candidate countries but may also have implications for the current EU member states when candidates accede.

In light of the moves towards EU enlargement issues such as possible staff migration, patient demands, differing health priorities, adequacy of surveillance and disease prevention and control and others need to be considered. Issues such as consumer safety (of food, toys and other products), and tobacco legislation, already addressed in a number of EU laws, also need to be reviewed in the candidate countries.

To accede to the European Union, candidate countries must be able to comply with the 'Copenhagen Criteria'. The criteria outline three areas: stability of institutions guaranteeing democracy; the existence of a functioning market economy and capacity to cope with competitive pressure and market forces; and the ability to take on obligations of membership including political, economic and monetary union. In practical terms, acceding countries must implement the entire accumulated body of existing EU legislation known as the 'acquis communautaire'. Currently, it is estimated that the acquis runs to 80,000 pages of documentation and it is continually expanding. Thus, candidate countries must be aiming for what one commentator described as a large 'moving target'.

Much international assistance has been made available to the candidate countries and other nations of Central and Eastern Europe over the past decade to improve the health and welfare of their populations. The World Bank, the European Union and bilateral aid from governments of Western Europe and North America have played important roles in helping stabilize economies and support reform processes. WHO and other agencies have played roles in giving technical assistance in support of health reform and to other health-related activities. New players in the health sector, in the form of local and international non-governmental organisations (NGOs), have also made contributions in a number of applicant countries.

EU aid is now more closely linked to the accession process and reviews of progress towards accession are made regularly. There is, however, a need to examine to what extent EU support is addressing the health needs of candidate countries, both those specifically related to accession as well as taking account of their broader health needs.

An analysis of the challenges that lie ahead is now needed. The accession process has implications beyond the fifteen countries of the EU and the ten candidate countries, with countries beyond the current candidate nations already amending legislation to become more closely aligned with EU systems in the event of possible future accession or closer integration. Lessons may be available from those countries that recently joined the EU and from those that have begun the process of amending legislation and practice. Little information is yet available on the subject of health and accession. Thus, this study would provide valuable information to both acceding and current EU members at this key stage in the enlargement process.

This analysis will seek to identify common challenges to health and health care in the pre-accession countries, to describe in brief the health and health system situations of some of the candidate countries and identify how and whether the accession process will meet the health needs of the countries, and, by undertaking comparative analysis of past experiences, draw lessons and potential solutions for health policy in these pre-accession states. The study will not aim to analyse each and every aspect of EU legislation that may directly or indirectly relate to health care or health status but will focus on key areas currently of concern to both current EU member states and accession countries.

The study aims to address the needs of national and regional policy makers together with the academic community in the pre-accession and EU countries. It will aim to provide an overview of implications of the accession process for health, and will highlight challenges and opportunities for the pre-accession countries. The study will provide a conceptual framework that can be used by policy makers in developing their health planning in relation to the accession process. It recognises that accession will not address many of the health challenges faced by the countries concerned so it will also examine health-related areas where candidate countries lag behind Western Europe that need to be considered separately.

The development of the study is based upon a broad consultation process with partners in WHO, the World Bank, the European Investment Bank, the European Commission, and from discussions with representatives of a number of candidate countries and with academics from both within the EU and in candidate countries.

Objectives

The objectives of this comparative analysis are as follows:

To provide an overview of the history of the development of the EU and outline the context in which accession to the EU is taking place and to present key legislative issues relating to health in EU law
To outline the health and health system situations of the candidate countries and describe their key challenges and needs
To identify and analyse common challenges in implementing EU legislation relating to health
To describe experiences of each country so far in responding to these challenges, which may be relevant to other pre-accession countries
To generate generalisable policy lessons
To identify health related areas requiring attention beyond that provided for in the accession process.

Outline
Foreword
Part 1 Context

Martin McKee, LSHTM, Laura MacLehose, WHO, Elke Jakubowksi, WHO

This chapter will describe the main developments in the EU from its beginnings in the 1951 Treaty of Paris to the present time. The key treaties and their changing interpretation through rulings of the European Court of Justice will be summarised. The enlargement process will be described together with the obligations and benefits of accession in terms of health.ay

This section will provide an overview of the health care and consumer protection systems in the pre-accession countries and outline the legal requirements in relation to health and safety that they will have to take up in accession. The chapter will describe what is meant by the 'acquis communautaire', the EU accumulated body of policies, laws, practices, obligations and objectives that have been agreed or developed in the EU. The key elements that have implications for health will be summarised and explained. A Delphi study will be used to identify some of the key issues as perceived by national policy makers.are the challenges and what are the needs?

Martin McKee, LSHTM, Laura MacLehose, WHO, Author on EU aid programmes (to be announced)

The health status of the populations (and sub-populations, where appropriate) of the candidate countries will be described. Descriptions and groupings of the health care systems of the candidate countries will be given, covering health care models, methods of financing and staffing. The chapter will aim to draw out the challenges, differences and common lessons and consider to how these will impact on accession and whether accession will meet these needs.

In this section the main programmes and initiatives that have been put in place by the EU to facilitate the accession process will be analysed in relation to their implications for health. The reinforced pre-accession strategy of the EU, incorporating the Accession Partnership frameworks (which now include the EU Phare assistance) and National Programmes for the Adoption of the Acquis (NPAA) will be described.

Questions that will be considered include: To what extent is health addressed in the EU accession assistance programmes? Do the accession programmes address the health priorities identified by the candidate countries own national health plans? What have the successes and failures so far with the accession partnerships in relation to health and what are the opportunities to further improve the partnership arrangements? How do the EU accession partnerships link with other international assistance to the health sector in candidate countries?

Case-studies 1 & 2: EU assistance to candidate countries in relation to health and accession requirements: Outlines to be inserted

Part 2 Challenges, Responses and Potential SolutionsChapter 3 Closing the gap: a safe and healthy society?

Alison Wright Reid, UK, Eugenia Delcheva, Bulgaria, Karen Lock, UK, Laura MacLehose, WHO, Martin McKee, LSHTM/ WHO, Author, Poland (to be announced), Esa Osterberg, Finland, E Jakubowksi, WHO

The implications of Article 152 of the Amsterdam Treaty and other health related legislation will be considered in this chapter. The extension of the EU Treaties into the field of public health after the Maastricht summit paved the way for opportunities to promote health at a European level. The Commission has outlined three main strands for future action: improving information for the development of public health, reacting rapidly to threats to health, and tackling health determinants through health promotion and disease prevention. In addition, health is increasingly recognised as interfacing with the wider policy agenda and the Amsterdam Treaty calls for consideration of human health protection in the definition and implementation of all Community policies and brief activities.

This chapter will review progress towards compliance with key EU legislation related to health. Issues of surveillance, consumer safety (transport, home safety) and tobacco promotion (taking into account the recent ECJ ruling and the stated policy of member states to revisit this issue) will be considered. A recent study of communicable disease outbreaks involving more than one EU member state will be used to illustrate some of the complexities of developing surveillance and appropriate public health action. In addition, the issue of health impact assessment will be considered.

Review of EU legislation protecting the health and safety of people at work or affected by work outline – A Wright Reid (Final to be inserted shortly)

The introduction will identify the purpose of the review (to provide a clear understanding of EU health and safety policy and the issues surrounding pre-accession countries as well as the implications for both pre-accession countries and current member states).

The review will describe the basis of EU legislation concerning health and safety, the role of minimum versus maximum standards, the philosophies of goal-setting and proportionality and the role of risk assessment. The review will summarise the legislation, explain key features and discuss legal challenges brought to the legislation.

The review will outline the operation of the bodies involved in researching and producing EU legislation and should summarise the areas of work in progress and current priorities for future action.

Key differences of approach and scope amongst member states will be identified, and difficulties in drawing comparisons between member states will be highlighted. The review will outline national versus EU level policy responsibilities for health and safety legislation. Significant obstacles to implementation will be identified, and the measures employed to foster good practice will be described.

The review will also look at available data on different work-place injury rates in EU and accession countries and look at occupational safety system arrangements. It will conclude with a summary of implications of accession to the EU for candidate countries in terms of health and safety arrangements.

Draft outline for Case-study 4: Tobacco production and distribution: Enforcing EU legislation in Bulgaria – E Delcheva

This case-study will look at the enforcement of new health related legislation put in place as part of Bulgaria's arrangements to join the European Union (EU). The case-study will outline the new laws, describing the changes from the original Bulgarian legislation on this issue and then describe the implementation of the new laws and the measures put in place to enforce the implementation of them. Any special arrangements or allowances provided by the EU for delays in implementation will be described. Any challenges arising from the new implementation will be highlighted along with opportunities for enforcing the legislation.

The case-study will look at enforcing new EU legislation on tobacco control in Bulgaria focussing on free movement of goods and related tobacco legislation covered in the EU acquis Chapter 1 and other parts of the acquis.

Tobacco control directives and resolutions adopted by the EU between 1989 and 2001

Labelling Directives (& Smokeless tobacco), 1989,1992 89/622/EEC, 92/41/EEC Tar and nicotine yield to be printed on side of packet so 4% of packet covered. Health warning on front to cover at least 4% of packet. Warnings for packaging of tobacco products other than cigarettes. Introduces a ban on the marketing of certain tobacco products for oral use.

Advertising Directive, 1989, 89/552/EEC Bans all forms of TV advertising for tobacco products.

Tar yield Directive, 1990, 90/239/EEC Approximates laws governing the maximum tar yield of cigarettes and sets a maximum tar yield of 15mg per cigarette by 31st December 1992 and 12mg per cigarette from 31st December 1997.

Tax Directives, 1992, 92/78/EEC, 92/79/EEC, 92/80/EEC Set minimum levels of duty on cigarettes and tobacco.

Resolution on smoking in public places, 1989 Invites member states to adopt measures banning smoking in public places and on all forms of public transport (non binding).

Tobacco Regulation Directive2001/37/EC of On the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products – Commission statement. Official Journal of the European Communities L 194, 18/07/2001 P. 0026 – 0035

Taxation on manufactured tobacco,Council Directive 1999/81/EC On the approximation of taxes on manufactured tobacco other than cigarettes and Directive 95/59/EC on taxes other than turnover taxes which affect the consumption of manufactured tobacco. Official Journal L 211 , 11/08/1999 p. 47 – 49.

The first part of the case-study will describe existing Bulgarian legislation on tobacco products. The EU legislation to be adopted on tobacco will then be outlined. Any changes that the Bulgarian government has asked that the EU consider in relation to delaying or altering EU legislation in relation to adopting the EU tobacco legislation will then be described. This will incorporate arguments to delay adoption to 2015 from Bulgarian tobacco producers based around the following points:

Tobacco production is the main employment for the population in several regions of the country.

The great poverty and the large number of unemployed among that population and the absence of other real alternatives.

The forthcoming privatisation of the tobacco factories with expectations for economic prosperity.

The responses from the Ministry of Health and others opposing delays in adoption of legislation will also be covered. These will include the following points:

A higher percentage of tar contained in Bulgarian cigarettes.

The need for protection of the health of the people.

The case-study will also describe the 'key players' in the tobacco decision making process in Bulgaria who influence such key decisions in relation to tobacco policy-making and enforcement of implementation of new legislation and EU accession. These include the tobacco growers, cigarette producers (local and international), health advocates and others.

The case study will then describe the mechanisms that the Government of Bulgaria will put in place/ has put in place to ensure that the EU tobacco legislation is enforced (eg. inspection of advertising standards, inspections on tar content and cigarette packaging etc). Any problems occurring (or likely to occur) in implementation of the new legislation will be described.

Communicable disease control in the EU: detecting and managing communicable disease outbreaks across borders – LJ MacLehose and M McKee

European Parliament and Council Decision No 2119/98/EC and subsequent Decision 2000/57/EC formalised a system of disease specific communicable disease surveillance networks and a more general early warning and response network across the EU. There are now 9 disease specific networks in place and two more general early warning and consumer safety networks in place. Although the networks and the EU wide surveillance system have some way further to go to ensure that communicable disease surveillance in the EU is adequate, the networks have shown promise as a system of facilitating international cooperation. This case-study will look provide an overview of the EU communicable disease surveillance and control arrangements and describe measures that are underway or need to be undertaken to bring the candidate countries into the EU system. It will also look at some of the challenges that exist in the current EU member state arrangements and consider how these issues will be resolved or further exacerbated as the EU enlarges. To provide up to date information on these issues, the results of a specially commissioned survey of the national institutes for communicable disease surveillance and control in the candidate countries will be included.

Case-study (new): Joining the EU – raising or lowering health standards in accession countries – lessons from Finland and Poland on alcohol and tobacco policy: Esa Osterberg (Finland), Author to be announced (Poland)

While joining the EU is often expected to raise health standards in most accession countries, what happens when EU standards are lower than those in the accession country? Does the country have to lower its standards or are EU health laws legislating for 'minimum' standards only? In this case-study two examples of countries with stricter health legislation will be considered. One country, Finland, is already an EU member and the other, Poland, the largest of the accession countries, is in the process of acceding. In Finland alcohol pricing, retail and other laws were stricter than those required by the EU and felt by many in Finland to be important in limiting alcohol-related morbidity and mortality. However, these laws were found to restrict free movement of goods and Finland was therefore required to bring these policies into line with the less strong EU policies. The process of adopting the EU legislation and some of the consequences for health in Finland as a result of accession will be considered in this case-study. The case of tobacco restriction in Poland will also be considered. Poland is considered by many public health experts as being a European leader in its tobacco reduction policies. It has implemented an effective ban on advertising. However, will these policies be considered to inhibit free trade of goods across the EU? Will Poland have to abandon some of their key public health measures? These issues will be considered and broader conclusions about the relationship between EU trade regulations and protecting public health will be developed.

Case-study 5: The broader impact of EU legislation on health – health impact assessment and the potential for understanding influences of broader EU policy on health – K Lock, UK

Introduction: Brief introduction to background and methods of HIA. Some examples of how HIA has been applied in member states e.g National Policy appraisal in the Netherlands

HIA of non health sector policy in EC: The rise and future use of HIA in EC – DG Sanco proposals for use e.g pilot studies. The importance of assessing the health impacts of non-health sector policies (E.g using environment and agriculture as 'case studies')

The development of HIA in accession countries: Using cases studies (e.g. Poland and Lithuania) look at how HIA is being used- strengths and limitations. E.g in the environmental sector (as part of accession preparations to meet environmental pollution and environmental assessment directives). Capacity building: look at the current strengths and weaknesses of the public health and environmental health sectors in candidate countries, and their ability to carry out HIA.

Discussion: Pros and cons of HIA as an approach

Conclusions: Importance of HIA in re-focussing EU policies on promoting health as well as health protection.apter 4 Is there a doctor in the country? The challenges of the free movement of health professionals
Sally Nicholas, UK, Anne-Marie Rafferty, Elke Jakubowksi, WHO. Monika Zajak, Poland, Jim Buchan, UK

This chapter will consider the implications of EU legislation on free movement of professionals. This includes the need to strengthen regulatory bodies, which will face an increased workload; the need to designate recognised specialities, nominate competent authorities, develop specialist registers, implement the existing plan for general practice vocational training, and review the implications of the relevant Directives for the various professional groups concerned; and staffing levels and implications of salary differences. Case studies and analysis of workforce statistics will be used to illustrate challenges and potential policy solutions.

Some of the following questions will be addressed: What must be undertaken in candidate countries to meet EU standards in relation to the health professions? What lessons have been learned from current arrangements in the EU in relation to the movement of health professionals? What are the implications of accession for health professions? What impact will free movement have on the workforce in candidate countries taking into account wage differences? What arrangements are being made for professions not recognised within the EU (medical assistant etc)? How is quality control in training and professional work assured in candidate countries?

Review 3: A review of health workforce legislation and trends in the EU in relation to EU enlargement – S Nicholas, UK

Introduction: The introduction will identify the purpose of the review (namely to provide a clear understanding of EU policy on the movement of health professionals and the issues facing pre-accession countries as well as the implications for both pre-accession countries and current Member States).

Development of current day arrangements: The review will provide an historical overview of how the current day workforce legislation was developed starting from the first key workforce legislation enacted at EU level. Current day legislation will then be outlined. Implementation of the EU legislation will be discussed and challenges and opportunities highlighted.

Policy makers: The key health workforce decision-making bodies at EU level and their roles will be outlined and the decsion making processes for workforce issues discussed.

Impact and what needs to be done: The impact of the EU level workforce legislation will be discussed. To what extent health professionals are free to move around in reality will be outlined and particular barriers to such movement discussed. Areas where further work is needed to both ensure safety standards and smooth international workforce movement will be proposed.

Case-study 6 (AM Rafferty/J Buchan (UK) E Jakubowksi (WHO): Trends in recruitment of nursing staff from candidate countries to current EU member states with nursing shortages and future implications

To be announced

Draft outline for Case-study 3: Changing Workforce Legislation in Poland to bring training and regulation standards in line with EU requirements – M Zajac

This case-study will outline the changes that Poland is making to comply with EU legislation in relation to the health workforce as part of the EU enlargement process. The case-study will look at the new legislation that Poland is adopting and look at the process of adopting the new legislation. Opportunities and challenges arising throughout the process will be highlighted and discussed.

Poland's negotiation position in the area of free movement of persons: As a definition of the time frame for the process of harmonization and implementation of the Community law, the Government of Poland has adopted 31 December 2002 as the date on which Poland will be prepared for accession to the European Union. Poland will implement the provisions of regulations, directives, decisions, recommendations and resolutions. In accordance with this declaration, Poland undertakes to implement theacquis communautairein the area of "Free movement of persons" so that the relevant laws may operate, with reciprocity, between Poland and the other Member States as of 1 January 2003.

Mutual recognition of professional qualifications allows every citizen of EU Member State to practice their profession in another Member State. Poland accepts theacquis communautairein the area of "Mutual recognition of professional qualifications" and declares that Polish law will be accord with theacquisas of the date of Poland's membership in the EU.

Full approximation of Polish law to the acquis on doctors, dentists, nurses and midwives will be effected by the introduction of the principle of equal treatment of Polish citizens and nations of EU Member States in licensing, including, especially, the lifting of the Polish citizenship requirement. Procedures will be developed for the recognition of qualification according to the relevant directives. As to the provision of services by physicians, dentists, nurses and midwifes who are nationals of EU Member States, Polish law will impose on service providers obligations referred to in: Article 17 (1) (2) of Council Directive 93/16/EEC, Article 15 (1) (2) of Council Directive 78/686/EEC, Article 11 (2) of Council Directive 77/452/EEC, Article 13 (2) of Council Directive 80/154/EEC.

The requirement that persons performing those professions in Poland must know the Polish language will be maintained. However, current regulations requiring such persons to pass a formal language test will be lifted, as the European Court of Justice has held that formal language tests may lead tode factodiscrimination and are, therefore, incompatible with the European law. The knowledge of the Polish language will be checked by other means. Currently, Polish law does not require taking a formal Polish language test only in cases of foreign nurses and midwives.

Physicians, dentists, nurses and midwives - Training programmes: Training programmes for physicians in Poland generally conform to the requirements of the relevant directive. However, recent amendments (September 2001) inThe Act of the profession of physician(1996) regulate performance of physicians from EU Member States in Poland. First of all after Poland's accession to EU physicians with diploma gained in EU Sates will have the right: to provide services in Poland, to be a member of professional bodies, to establish and register private practice. The implications of this change will be discussed. Any objections to this change from the Polish medical profession will be outlined. Likely numbers of doctors entering the Polish medical workforce through this route will be considered.

Training programme for dentists in Poland is broader than in EU Member States. This is however, by no means contrary to the relevant directive. Broader medical knowledge of Polish dentists is meant to secure better quality of dental services. The issue, raised by the Commission, of the Polish title of "doctor of dentistry" instead of the title of "dentist" used across the EU Member States, will, therefore, not become an obstacle in the mutual recognition of qualifications. Poland will probably accept title of "dentist" so that to close the negotiation area of "Free movement of persons". Any objections to this change will be discussed and the reasons for any such objections outlined. Benefits or problems for the health sector from this change will be highlighted.

Training programmes for nurses and midwives in Poland are not up to the Community standards, as they require fewer hours of study. A new training programme for nurses, which conforms to the Community standards, has been gradually introduced in Poland. Most of relevant amendments tothe Act on the profession of nurse and midwife(1996) have been in force since March 2001. Regulations, which allow provision of services by nurses and midwives from EU Member State, will be in force after Poland's accession to The Community.

According to the EU directives Polish training programme for nurses will include 4600 hours of study. Polish education system has been transformed so that to create 3 years (equal to 4600 hours) of high university education for nurses (Bachelor) with possibility of extension to 5 years (Masters Degree). Moreover amendments tothe Act on the profession of nurse and midwifeinclude among others: directions and time frames of transformation of nursing education system, education standards, accreditation system of nursing schools etc. As of 2003 nursing schools will stop recruitment. Training for nurses will be present only within university curricula.

The changes that Poland needs to make in the nursing area are considerable. The case-study will outline benefits for the health sector and the population arising from the changes that Poland will make in this area. Any objections or challenges to these changes will be discussed together with the reasons for such objections. The implications of the new relationship between the medical and nursing sectors that will arise from the enhanced training of nurses will be considered.

Zoltan Szabo, Hungary, Petr Hava, Czech Republic, Martin McKee, LSHTM, Laura MacLehose, WHO, Author to be announced, Slovenia

Free movement of patients was an inevitable consequence of provisions in the Treaty of Rome. In this chapter the implications for both the current EU member states and pre-accession countries will be reviewed. The current EU arrangements cover temporary visits abroad for tourists, those on business, dialysis patients, students, transport workers and the unemployed seeking work. It also covers those seeking treatment for an existing condition, although in somewhat more limited circumstances. This area is, however, in a state of flux as a result of two European Court rulings (the Decker and Kohll rulings). Issues of public information, patient choice, gate-keeping to and payment for services will be considered. The implications of the free movement of goods and services will be considered in relation to the provision of health care and health insurance services.

Case-study/ Review 9: Bilateral Social Security Arrangements in the EU: implications for accession – Z Szabo (Hungary), P Hava (Czech Republic)

Background: In economic terms, health is the second-largest sector in the EU countries, and a major preoccupation for European citizens. The enlargement of the EU will predictably affect the existing health care services and social security systems both in the present and future Member States in different ways. These two systems have been considered in the past – by virtue of the principle of subsidiarity defined in Article 5 of the Treaty - as falling within the competence of the Member States (organization, funding, planning). However, in the Protocol annexed to the Treaty, it was stated that economies of scale could justify Community intervention. Without mentioning others, for this reason alone the possibility for the Community coordination (Article 140) in these two sectors cannot be completely ruled out. On the other hand, health care has increasingly come to be perceived as an economic activity, which must respect the European rules of economic integration (Article 99) and that of the internal market (Article 95). This includes not only the principles of free movement of goods (Article 28), services (Articles 49, 50), persons (Articles 18, 39, 42, 43), and capital but also European legislation on competition (Article 85, 86).

Current situation: The analysis of the cross-border patient "flows" from and to another Member State or non-EU country is the first step to understand the characteristics of such services. According to a 1990 study Italy was a major patient "exporter", and France was a major patient "importer". In the last ten years the situation has changed, but the multiple forces behind this movement are still in place, and seem to change as well. The motivation factors (proximity, quality, reputation, waiting times, communication, costs, procedures, information, etc.) are complex, personal as well as institutional. The conflicting interests of the different stakeholders (policy makers, governments, insurers, management, professionals, consumer, etc.) must be taken into consideration when designing the change process on the country and EU level, too. Hungary has bilateral agreements with the following EU-countries: Austria, Finland, Germany, Sweden, United Kingdom, EEC-country: Norway, EU-candidate countries: Bulgaria, The Czech Republic, Estonia, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, and non EU-candidate countries of the former Soviet Union and Yugoslavia with different, often conflicting conditions.

Topics to be covered by the review: The goal of this review is to give a realistic picture - in the context of issues collected in the first paragraph (Background) and of the actual problems stressed in the second paragraph (Current situation) - about the extent of cross-border patient "flows" in the EU Member States. Existing Community law (Item 1) and the European Court decisions (Decker, Kohll and also Pierik I. and II.) (Item 2) are the legal basis of this review. The case of The Czech Republic and Hungary (Item 3) as representatives of the ten or twelve EU-candidate countries can serve also as a pilot for the other candidates.

Community and Member State law and the situation around the principle of subsidiarity (Article 5), of free movement of goods (Article 28), services (Articles 49, 50), persons (Articles 18, 39, 42, 43).

The Treaty of Rome – free movement of patients.
The movement of health care services and insurance
Implications for and experiences of the current EU Member States
Cross-border agreements, Interreg projects, Full mobility projects
Stakeholders' motivation in favour or against cross-border care
Governmental organizations and NGO's on the Community level
Governmental organizations and NGO's on the Member State level
Non-organized individual professionals and patients (habits, fears, perceptions of reality and informational asymmetry modifying the need)The role of the European Court of Justice – trends and consequences: Cases and their message: after the ECJ (Kohll, Decker, Pierik I.-II.), before the ECJ (Vanbraekel, Smits Pearbooms, Müller-Fauré, van Riet), pending before the ECG (Heitbrink, Agnello, Jelinek). Consequences on the Community and Member State level – norm or exception

The current situation, implications and possible future scenarios in two candidate countries based on stakeholders' motivation mapping:  The Czech Republic, Hungary

Case-studies 6 B (Author to be announced): Movement of patients from Italy and Austria to Slovenia for specialist medical treatment: To be announced

Panos Kanavos, LSE, Reinhard Busse, WHO, Laslo Gulasci, Hungary

The single market has important implications for pharmaceuticals, even though many aspects are covered by the 'subsidiarity' concept. These will be discussed in this chapter looking at obligations on acceding countries and related challenges, responses and potential solutions. Some of the issues that will be covered include regulation and licensing of drugs and the role of the European Medicines Evaluation Agency (EMEA). Public health restrictions on the movement of certain goods and use of technological developments will also be examined.

Pharmaceuticals Review outline: European Pharmaceutical Policy and implications for Current member States and pre-accession countries - P Kanavos

Introduction: Purpose of the review, Potential overlaps with other chapters (to be completed once a full book outline has been received), Structure of chapter: The introduction will identify the purpose of the review, namely to provide a clear understanding of EU pharmaceutical policy and the issues surrounding pre-accession countries as well as the implications for both pre-accession countries and current Member States.

European institutions, pharmaceuticals & health care technology: This will be a short brief outlining the role of each of the institutions below and their relevance to pharmaceutical policy and how they fit into the EU decision-making process. This section will not get into the detail of how decisions are taken at EU level.

Institutions: The European Commission and its DGs (Industry, Competition, Consumer, Research), The European Parliament, The European Court of Justice, The European Medicines Evaluation Agency

National versus Supra-national pharmaceutical policy: The purpose of this section will be to highlight the respective competence of national and supra-national institutions as this is shaped by the Treaties. It will highlight the competence of national health systems over pricing and reimbursement of pharmaceuticals and of other national authorities over industrial policy considerations. At EU level, transparency, safety and efficacy as well as the recent developments on approval of medicines, will be discussed.

Supra-national policy (safety and efficacy of medicines, registration and approval of medicines, transparency in decision-making process for market access; safety of medical devices)

National policy (pricing and reimbursement requirements; industrial & science policy)

Regulatory requirements for accession countries: The purpose of this section will be to critically appraise the acquis communautaire as it needs to be adopted by pre-accession countries. It will also attempt to provide an account of the problems that pre-accession countries have faced or are facing in incorporating this acquis communautaire in their respective legislative systems. The latter will require a small scale survey of policy makers in pre-accession countries

· The legal framework for pharmaceuticals and health care technology
· The Transparency Directive
· Patent term and patent term extension (SPC)
· Registration of pharmaceuticals
· Centralised procedure and mutual recognition
· The role of national regulatory authorities 

Issues for accession countries in accession negotiations: This section will provide a critical overview of the issues in which pre-accession countries and the acquis communautaire vary markedly; it will also attempt to evaluate the implications of these differences for pre-accession countries as well as current Member States.

o Parallel trade
o Market exclusivity
o Early working requirements (Roche-Bolar provisions)
o Patenting and retro-active application
o Industrial policy considerations and support of national industry
o National versus non-national industry
 

Conclusions

Case-study 7B: Lessons for the new EU enlargement from Spain: Pharmaceutical Supply in Spain in relation to Spain's accession to the EU – M Lobato

The accession of Spain to the European Economic Community posed a particular problem regarding intellectual property protection. Spain had an ineffective system of protection, with no product patents, SPCs or dossier data protection, which was in sharp contrast compared to the situation in other Member countries. It was a clear point in the negotiations that the Spanish Patent Law had to be amended in order to meet the European standard. This modification was introduced progressively, and Spain made use of all possible delays in the introduction of the new provisions. All candidate member States face similar problems, because correct intellectual property protection is a prerequisite for the EU accession.

The case study would deal with the comparison of the old and the new legal system, the main changes which were adopted and how this process interfered with the Health System. The provisional conclusion is that, due to the specific situation of medicaments, the economic impact of the new legal provisions was delayed at a very late period of time. Nowadays, the majority of medicines which are on the market are medicines not covered by product patent protection. In these cases, research-based companies rely heavily on data protection (effective in 1993). The question of parallel trade would be mentioned as part of the new legal environment.

Winners of the situation were mostly pharmaceutical companies, which had a considerable profit due to the expansion of the National Security System. However, some companies were among the losers, because they trusted in the perpetuity of the old system and their portfolio was mainly based on old inefficient medicines, which were expelled of the National Security System by a negative list (1992). There was a readjustment of the industry due to all these circumnstances. Other clear winners of the situation were consumers. The universality of the Health System meant great stress for the National Budget, but it was obviously an advantage for consumers. As to parallel trade, the obvious winners were Spanish and Importing States wholesalers.

The study would also briefly relate this legal situation with the reactions of the Spanish national industry. Generally speaking, the Spanish national industry obtained a limited profit of the delay of effective intellectual property protection. Industry –in general- had the advantage of the expansion of the National Health System. However, cost containment measures were also implemented in order to restrain the pharmaceutical expenditure financed by the public budget. A brief economic overview of the evolution of expenditure will show the dissociation of the introduction of new legal intellectual property provisions and the rise of pharmaceutical expenditure.

A short consideration of the new approach to Intellectual Property of the Spanish Authorities would be provided. This new approach is more sensitive to the needs of innovation and has shown some results in Spanish R&D activity. The conclusion would be useful for candidate member States. A reform of intellectual property protection and of the Health system is unavoidable, but it could work for the advantage of the own candidate member State.

To be inserted: Case-study 8: Health technology assessment and implications for EU enlargement – R Busse and L Gulasci

Part 3 Looking to the future

Laura MacLehose, WHO, Martin McKee, LSHTM, Ivana Bozicevic, Croatia

Although the process of accession will require countries to address many aspects of their health systems, in their broadest senses, many challenges will remain. Health status in many of them is likely to continue to lag behind levels achieved in the west. The EU's public health programme will address some challenges to health but not all, and it cannot substitute for soundly based national public health policies and appropriate concern for health impact of non-health policies. Tackling the legacy of under- and inappropriate investment in healthcare infrastructure will be a high priority. There is a danger that a preoccupation with meeting the formal requirements for accession will lead to these issues receiving inadequate attention. This chapter will seek to place accession within the wider health and health care challenges facing the countries involved.

Health priorities of the candidate countries - M McKee, LJ MacLehose

The results of a specially commissioned Delphi survey of Ministers of Health and Directors of Institutes of Public Health of the candidate countries on health challenges and needs for candidates countries in relation to EU accession will be described and discussed.8 Prospects for the future

Observatory staff guided by Advisory Panel

This concluding chapter will draw on the issues arising in the preceding sections bringing together lessons learnt so far. Specific issues that must be addressed will be identified and ways to do so will be proposed. Prospects for health in the EU will be considered with the expansion of the EU beyond the current pre-accession states in relation to lessons learned through the analysis of the current accession process. Issues arising for health from the new neighbours of the expanded EU will be considered alongside a brief summary of the more distant EU enlargement possibilities.

Draft outline: Looking beyond the new borders: the Stability Pact countries and health and accession – I Bozicevic, Croatia

In April 1997, the European General Affairs Council proposed a Regional Approach for Western Balkans aiming to develop further bilateral relations with Albania, Bosnia and Herzegovina, Croatia, the Federal Republic of Yugoslavia and the former Yugoslav Republic of Macedonia. Two years later, at the European Union initiative and under its leading role, the Stability Pact for South Eastern Europe was adopted as a political declaration of commitment aiming to strengthen peace, respect for human rights and democracy in the region. In May 1999, the EU had begun a new phase in its relationship with the five countries of the south-eastern Europe - Albania, Bosnia and Herzegovina, Croatia, the Federal Republic of Yugoslavia and Republic of Macedonia through the Stabilisation and Association Process (SAP). The SAP clearly recognises those countries as potential candidates for the EU accession and strongly emphasises the improvement of regional co-operation as the prerequisite for their potential EU membership.

The Stabilisation and Association Process offers these countries a prospect of gradual integration to the European structures and principles, based on Stabilisation and Association Agreements (SAA). SAA is specifically focused and adapted to the situation in each country, thus enabling some faster integration than others. The countries must first meet the minimum conditions defined by the Council of Europe on 29 April 1997 concerning democratic, economic and institutional reforms.

The first Parliamentary Conference of EU and Stability pact countries held in September 2001 in Brussels established close work relationships between European Parliamentary institutions on Stability pact issues.

The SAA are signed (as on December 17, 2001) with Croatia and Former Yugoslav Republic of Macedonia thus providing them the status of potential candidates for the EU membership on the basis of the Treaty on the European Union and fulfilment of the Copenhagen criteria. The negotiations for the SAA are opened with Albania. A Memorandum of Understanding free trade liberalisation and facilitation by South-East European countries was signed in June 2001 in Brussels. Its aim is to complete the network of free trade agreements in the region by the end of 2002, creating market of up to 55 million consumers.

Health sector and the Stability Pact In the framework of the Stability Pact, health sector is addressed through the Working Table II and under the initiative of social cohesion. In the meeting held in Paris in 2000 the health sector was identified among several other areas (employment and vocational training, social protection and housing) that required action plans and strategies for further development.

Present partners in the social cohesion initiative are, in addition to Stability Pact beneficiary countries: Austria, Italy, France, Germany, Greece, Switzerland, Slovenia, Council of Europe, Council of Europe Development Bank, European Trade Union Confederation, the World Health Organisation, the International Labour Organisation, the European Trade Union Confederation, the International Organisation of Employers, the Friedrich Ebert Foundation and the United Nations Development Programme.

The Expert Sub-Group for Health is lead on an informal basis by the WHO and the CoE. Its main aim is to assist governments in defining national priorities for the health sector, reduce health inequalities and modernise legislative and regulatory framework. Under this initiative, each country was asked to propose its project and thus identify priority areas for the country. The decision for which to provide the financial support will be made soon. One of the proposed projects addresses the issue of improvement of the quality of health information in the region, and the other improvement of control and surveillance of communicable diseases – these areas are identified as the priorities for public health action by the European Commission.

In this case-study, further details on the stability Pact arrangements as above will be outlined. In addition, the following questions will be considered: What preparations are underway for SP in terms of accession and health? What are the main challenges for SP countries and accession and health? Will accession meet the health challenges of the SP countries?