The Social Dimension in the Internal Market. Documentation. Perspectives of Health Care in Europe Conference from January 15 th 16 th, 2007 in Potsdam

Transcription

1 The Social Dimension in the Internal Market Perspectives of Health Care in Europe Conference from January 15 th 16 th, 2007 in Potsdam Documentation

2 Imprint Publisher Bundesministerium für Gesundheit (Federal Ministry of Health) General European Health Policy Planning EU Presidency Task Force Friederike Botzenhardt Friedrichstraße 108 D Berlin Tel.: + 49 (0) Fax: + 49 (0) z31@bmg.bund.de Spitzenverbände der gesetzlichen Krankenkassen (Federal Associations of Statutory Health Insurance Funds) c/o IKK Bundesverband Dirk Ruiss Friedrich-Ebert-Straße (TechnologiePark) D Bergisch Gladbach Tel.: + 49 (0) Fax: + 49 (0) dirk.ruiss@bv.ikk.de Co-ordination Gesellschaft für Versicherungswissenschaft und -gestaltung e. V. (Association of Social Security Policy and Research) Hansaring 43 D Köln Tel.: + 49 (0) Fax: + 49 (0) b.garbe-emden@gvg-koeln.de Copy editing: Maria Zens, Bonn; Frank Töpper, Köln Type setting and layout: neues handeln GmbH, Köln Printing and binding: Bundesministerium für Arbeit und Soziales, Bonn All rights reserved

3 The Social Dimension in the Internal Market Perspectives of Health Care in Europe Conference from January 15 th 16 th, 2007 in Potsdam Documentation

4 Inhalt Introduction 3 Health as a Location Factor: Basis for Stability and Growth Welcome address Ulla Schmidt Federal Minister for Health, Germany 4 Rolf Stuppardt President of the Federal Association of Guild Health- Insurance Funds, Germany 6 European Health Policy in the Framework of the Lisbon Strategy Robert Madelin European Commission, Director General of DG Health and Consumer Protection 9 Health Care in Europe an Overview Professor Dr Reinhard Busse Department Health Care Management, Technical University of Berlin, Germany; European Observatory on Health Systems and Policies 11 PERSPECTIVE 1 General Regulatory Framework: Competition and Regulation in the Internal Market what Mixture is best for Europe? Professor Yves Jorens Faculty of Law, University of Ghent, Belgium 17 Professor Dr Dr Bert Rürup Institute for Macroeconomics, Technical University of Darmstadt, Germany 20 Panel Discussion 23 PERSPECTIVE 2 Do we need a regulatory framework following the jurisdiction of the ECJ? Nick Fahy European Commission, Deputy Head of the Health Strategy Unit, DG Health and Consumer Protection 26 Evelyne Gebhardt Member of the European Parliament 29 PERSPECTIVE 3 Patients and Patient Mobility: European Opportunities for Insured Persons and Patients The Euregion Meuse-Rhine as an example of Cross-border Health Care Provision Professor Dr Jacques Scheres MD PhD Euregional Co-ordinator; University Hospital Maastricht azm; HOPE Working Party on cross border co-operation in healthcare 34 Patients and Patient Mobility: European Opportunities for Insured Persons and Patients John Bowis Member of European Parliament 40 Panel Discussion 43 The Future of Health Insurance in the Light of a Balance between National Sovereignty and European Cooperation Outlines of a European Consensus Robert Madelin European Commission, Director General of DG Health and Consumer Protection 45 Dr Doris Pfeiffer President of the Association of Health Insurance Funds for Employees (VdAK/AEV), Germany 48 Dr Klaus Theo Schröder Secretary of State, Federal Ministry for Health, Germany 50 Annex The Programme 52 Potsdam Declaration by the German Statutory Health Insurance Funds 55 Answer from the German Federal Government in Co-operation with the Laender on the Commission Communication on Community Action on Health Services 58 Panel Discussion 31

5 PREFACE Introduction On 15 / 16 January 2007 the conference The Social Dimension in the Internal Market Perspectives of Health Care in Europe was held jointly by the German Federal Ministry of Health and the Federal Associations of Statutory Health Insurance Funds in Potsdam on the occasion of the German EU presidency. The conference, which is documented in the present publication, made an important contribution to the discussion on health care potential in Europe. The participants of the conference dealt with the question as to what sort of interaction between competition and regulation would be necessary in order to tap this potential in an optimal manner, while at the same time promoting social cohesion and social inclusion. In this context, the competencies of the Member States and cooperation at European level were taken into consideration. While realigning the Lisbon Strategy in 2005 the Council of Ministers focussed on growth and employment. Social protection constitutes an integral part of the Lisbon Strategy and, as such, has an important share in promoting social cohesion on the one hand; on the other hand, it is to be viewed as a productive factor due to the growth potential of social and health services. Sustainable investments in health are an important foundation for societal development they reduce the burden of illness and the consequent costs connected to illness. Not only do they have positive impacts on the participation of ill and disabled people in society and on the reduction of individual hardship, they also have a positive influence on productivity, the labour market and social protection. At the same time, public health is a dynamic economic sector with a great potential for employment and for the future. However, it is also necessary to seriously consider the meaning of health and health care with regard to the productive capacity, prosperity and stability of societies. At the same time, one must acknowledge that the public health sector differs from other markets: demand can only be influenced to a limited extent by demanders; the competencies are unequally distributed between providers and demanders. Also, in contrast to other markets, the solidarity-based health systems in Europe are generally characterised by financing according to productive capacity and performance according to necessity. The structures and the scope of service within each individual system are diverse, because the organisation of health systems and medical care is the responsibility of each Member State. Nevertheless, the four freedoms of the internal market for persons, goods, services and capital and the relevant jurisdiction of the European Court of Justice (ECJ) influence these systems, even though they primarily concern issues of cross-border health care. The health systems in Europe are, therefore, both national and European markets with special characteristics. The health systems in Europe all face similar challenges due to demographic changes, international competition in respect of business location and the continual development in health and information technology. In this context, the reform of the health care systems has come to the fore of current debates in Europe. Already, with the expansion of the Open Method of Coordination in the area of health and long-term care, the EU has initiated a process for the mutual exchange of information concerning options for reforms within the health systems of Member States. Furthermore, the Commission encourages an improved cooperation at European level in different sectors in its Communication on patient mobility and health care developments in Europe. These and other initiatives as well as the rulings of the ECJ have either directly or indirectly influenced the national health systems of Member States. These developments have been accompanied by an intensive discussion process concerning the scope of competence of the EU in the field of health care which has been further stimulated due to the consultation process for legislative measures in the field of health services that has been introduced by the Commission. The speeches and discussions at the conference made an important contribution to the discussions on the application of community legislation in the fields of competition and the internal market to health services. Also, the question about the increased value of a community framework in comparison to ECJ rulings and in view of the improvement of cooperation between Member States was dealt with in detail. The present publication reflects the speeches and discussions of the representatives of the Federal Ministry of Health, the Federal Associations of Statutory Health Insurance Funds, the EU institutions as well as of politicians and scientists of different European Member States.

6 HEALTH AS A LOCATION FACTOR: BASIS FOR STABILITY AND GROWTH Welcome address* Ulla Schmidt, Federal Minister of Health, Germany Ladies and gentlemen, I wish you a warm welcome to our conference Perspectives of Health Care in Europe, and would like to take this opportunity to wish you a happy I would like to add: hopefully you will all stay healthy; that makes life easier for us ministers! I am glad that so many representatives of the governments, of the institutions responsible for health care and other health associations from all Member States have attended this conference in order to discuss the important question of cross-border health care. I would like to wish a particularly warm welcome to the representatives of the new Member States of Bulgaria and Romania. We look forward to an intensive cooperation with you in the European Union, and we already had the opportunity in the past few years to test this cooperation and get used to each other. I would like to wish an equally warm welcome to the high-level representatives of the European Commission and the delegations of our partners in the trio presidency of Germany, Portugal and Slovenia. In the last year, Germany, Portugal and Slovenia successfully cooperated in order to draw up a joint 18-month programme. We are the first to use these opportunities of the trio presidency and be able to perform pioneering work in this context. I am very grateful to our partners in Lisbon and Ljubljana, as well as those in Vienna, Helsinki and Paris, for the constructive cooperation. We have succeeded in sensibly coordinating the programmes of the consecutive presidencies. Here, I would also like to particularly welcome the representatives of the European Parliament. I regard it as a very good sign that the parliamentarians have also come to Potsdam to attend this event because many things that we discuss here and what is subsequently incorporated in the decision-making processes must also be agreed with the European Parliament because this is the democratically legitimate basis for the cooperation in Europe. Access to health services represents one of the three focuses of the presidency programme of the Federal Ministry of Health. The principal terms for our presidency programme in European health policy are innovation, prevention and access to health services. Our first principal term innovation is the basic element of every successful health policy. With health care that corresponds to the latest level of scientific knowledge we can, on the one hand, better fulfil patients needs; on the other hand, we can trigger principal economic impulses for the attainment of the Lisbon objectives. Health always means two things: health stands for social responsibility and the social dimension of the internal market, but it also means prosperity and economic dynamism. Our second principal term is prevention. The priority of prevention over treatment is the necessary response to the current and future challenges of the health systems. Increasing strain by the demographic change can only be overcome for the European health systems with a successful prevention policy. This is geared towards a sustainable change in consciousness and behaviour. In the German presidency programme, this particularly applies to the combating of communicable diseases. Our focus will be the combating of HIV/AIDS, above all AIDS prevention, which is the topic of a Minister Conference in Bremen on 12 and 13 March AIDS can only be successfully combated with a functioning civil society. Good AIDS prevention accepts people as they are and thus makes demands to the openness and tolerance of societal systems. We need a European consensus on this, which I would like to specify in more detail during the minister conference in Bremen. A further important field of prevention is the promotion of a balanced diet and exercise. We need the exchange of best-practice experience in Europe in order to improve the national results. Our conference in Badenweiler from 25 to 27 February 2007 will present new approaches on this and will contribute to improving European exchange on these prevention fields. The third principal term of our presidency programme is access to health services. This topic will also be focused on in this conference. In my opinion, the regulatory framework for cross-border health services in Europe will represent the most important legislative project of the European health policy in the next few years. We thus have the opportunity to enable the citizens of Europe to experience the specific advantages of the cooperation in the EU: it is positive I myself am from a border town if for example the insured from my home town of Aachen could be treated in a Maastricht doctor s practice without any formalities. We should strengthen this trend. Over the course of time, this can lead to European cooperation on a voluntary basis, e.g. in the treatment of rare diseases. *Translated from the German original.

7 WELCOME ADDRESS This brings about advantages that the citizens can directly experience and contributes to a Europe of results. I am convinced that the observed or sometimes perhaps merely described weariness with Europe can only be effectively countered with such results and good cooperation. A successful European health policy must promote European cooperation in suitable areas. But it must also acknowledge the differences between the historically developed national health systems. That is why we must use a diversity of instruments for the European cooperation, ranging from complete legal harmonisation to a harmonisation of minimum requirements and punctual cooperation to European political dialogues without reference to legislative measures. Two examples of this are: quality and safety of pharmaceuticals should be uniformly ensured based on European law in all Member States of the European Union. This particularly applies to the sector of new pharmacotherapies. We need a harmonisation of quality and safety. I therefore support the ongoing legislative projects for innovative therapies and will do my utmost to decisively bring forward their progression under the German presidency. The design and organisation of the health systems, on the other hand, remains a task of the national states. The competition of the systems for the best care also creates the basis for good health systems in Europe. In the sector of health care, the EU should clarify the issues arising from cross-border health services. I thank the European Commission for the introduction of the consultation process on this important matter. We need careful consideration as to how we can establish a balance between freedom on the internal market and national sovereignty. Ulla Schmidt design and the financial basics of their health systems. The planned Community framework must correspond to this. It is also important to protect the patients freedom of choice in the European Union. The legislation of the European Court of Justice has established basic key principles for this purpose. Based on this, EU citizens can in principle make use of health services throughout the EU and claim for reimbursement of costs in their home country up to the amounts reimbursed by their home health insurance fund or health care system. These basic principles are good, but for specific matters we need legal clarifications for service providers, for the insured and for patients. An EU-wide regulation could make an important contribution to this. It is thus very pleasing that the European Commission is carefully preparing these regulations. We need widespread consultation with all concerned. This conference brings together health care practitioners and government representatives, and I am hoping for content impulse for the debate on the future course of the European health policy. The health systems of the Member States are different this must be sufficiently taken into account in the Community framework. But in spite of all differences, they follow uniform guiding principles: universality, equity of access and solidarity. Further development can be built upon these uniform guiding principles. The health systems of the EU ensure the observation of these principles with different measures and procedures. I advocate that these differences will be retained. Legal certainty for the health systems of the Member States is therefore an important goal of this process. They should in future be able to decide on the organisation and We want to politically continue this interesting specialist discussion, the results and the suggestions that it provides at the informal council of EU Health Ministers in Aachen on 19/20 April I am certain that by the end of the German presidency, we will have established clear outlines for a regulation. Our Portuguese and Slovenian friends will then negotiate a legislative proposal of the European Commission in the Council. Together, we can achieve continuous progress. Politics and health insurances will hopefully hold a fruitful dialogue during the course of this conference.

8 HEALTH AS A LOCATION FACTOR: BASIS FOR STABILITY AND GROWTH Welcome address* Rolf Stuppardt, President of the Federal Association of Guild Health Insurance Funds, Germany If we are to give health care in Europe a future perspective, we first have to assign high priority to health care in the individual Member States. The statutory health insurance in Germany, which can now look back on a more than 100-year tradition, has made a significant and decisive contribution to Germany having what is, in principle, an established, functional and internationally recognised system of health protection. As a statutory health insurance fund, we guarantee affordable and comprehensive coverage in the event of illness to more than 70 million insured. From preventive checks for newborn babies to organ transplants, our insured have access to every necessary medical care which is in line with the recognised status of medical progress. Financing based on solidarity principles guarantees that every member is only charged an amount that he or she can financially afford, mainly based on his or her income and irrespective of personal health history or health risks. With annual expenditure on benefits of more than 130 million EURO, we bear the lion s share of the total expenditure in health care, and thus represent a significant economic and growth factor of the overall economy. Also in terms of the labour market and employment policies, statutory health insurance is a stability factor. Today, there are already more than four million people employed in German health care. Almost every tenth workplace here and rising is thus related to health; that is more employees than in the automobile industry. From the range of European health systems, these principles stand out in the interest of patients and the insured and offer relative degrees of freedom that no other state-regulated health system provides. Distance from the state, self-government and financial autonomy of action of the payers on the basis of a generally binding social law have meant that our insured have thus far been spared the deficits of other EU systems. We therefore deem it as politically and economically necessary and sensible to maintain this, and wherever possible to expand it, instead of adopting structural principles that are already failing to bring about the desired results elsewhere. Social security generates trust and certainty that we need in order to cope with the challenges of modern societies in terms of flexibility and willingness to take risks. The higher a society s differentiation, labour division, mobility and individuality, the most important the anchors become for life s big risks such as unemployment, long-term care and of course illness. In this sense, social security per se becomes a production factor. Productivity and modernisation of society thus require stable social security systems and a stable statutory health insurance. This viewpoint was also expressly championed by David Byrne, the former European Commissioner for Health and Consumer Protection. From our viewpoint, the financial sustainability that is often demanded by liberal economists cannot be an end in itself, but must always be regarded in the light of the goal of a social sustainability for people in Europe. This social sustainability must begin before the onset of the poverty threshold and from a holistic viewpoint must comprise a comprehensive access of people to high-quality social security services. A Europe that is close to its citizens needs the principle of diversity. The German health system is significantly shaped by its partially individual, but successful structural principles of solidarity, benefits in kind, self-government, freedom of choice of the insured and plurality. In both crisis situations and periods of prosperity, these principles have proven more than successful. They are special features of the German health and social policy, which enjoy large-scale societal acceptance and may not be put at risk, neither by national nor by European decisions. Key questions that are connected to the European perspective, which affect and concern us as statutory health insurance funds, are: n How should health insurance be adjusted in the structure of Europe s regulatory policy? n Must health insurance inevitably and bindingly for all Member States alone follow the competitive European development? n Or are other instruments required here in order to attain the declared goal of strengthening Europe as an economic area? n Will all Europe s integration endeavours also satisfy the actual needs of the insured and ill? *Translated from the German original.

9 WELCOME ADDRESS The great European sociologist Ralf Dahrendorf uttered the phrase that the welfare state is the most intensive form of the nation state a statement that has not lost any of its validity over the course of the past decades. Social insurance with its statutory regulations, public goods and financing based on solidarity principles is a central point of reference of the identity of our society and one which may not be jeopardised. This principal thought is confirmed in the European Community Treaty by the defined principle of legislative subsidiarity. This requires decisions on structural design and organisation to always be primarily made on an individual state level and not by the EU. Today and probably also in the future, no one will seriously dispute that health and social policy must also in the future primarily remain a national responsibility. Why do we regard this as so important? It is neither politically nor economically sensible to endeavour to bring about centralistic orientation and control mechanisms in a field of action such as social security, which is predominantly determined by sociocultural values. Health care with its important values such as social justice, solidarity and large-scale access to high-quality services may not fall victim to a rationalisation logic that is geared towards commercial interests. Health and other sectors of social security are not marketable economic goods, but they are the expression and symbol of the common good. The market-oriented concept of social services, which is mainly pursued by parts of the European Commission, would lead to an erosion of the social policy goals and thus imply a loss of democratic control options. Thus, it is not just about the type of organisation close to the market or far from the market but ultimately about the content and scope of publicly guaranteed social security. In view of the pursued social policy goals, the choice of means is in no way neutral. It is the expressed goal of statutory health insurance to use the opportunities of the European internal market in the interest of our insured. For this reason, together with the other social insurers in Germany, we founded a representation at EU level in 1993 in Brussels. Thus, we decided at an early stage, in the interest of our social security systems and our insured, to actively participate in EU policy. As a result, Europe must return to the state where high value is constantly attached to subsidiary-governed social security in the EU. Only who strengthens the social dimension on the European internal market as a support to the social policy component of the Lisbon Strategy without reducing it to the lowest common denominator only who offers a stable social perspective can bring the EU closer to its citizens again. Rolf Stuppardt For the health sector, this means that strategies that are not citizen-friendly or abstract regulatory texts may not prevail. Clarity and transparency are important, also with regard to cross-border health care. The citizen must not get lost in an increasing grey area of overlapping responsibilities of the different political levels of action. We therefore believe that we do not require any further legal regulations for crossborder health care. In the Potsdam declaration of the German statutory health insurance funds, we summarised what we regard as the four most important points in terms of Europe s further development as follows: 1. Cohesion in Europe must be promoted by amplifying the social dimension! We must do our utmost to tie the supranational economic and investment area of the EU with a more patent social-economic perspective for citizens than has been the case heretofore. As a consequence, in the interest of improved cohesion within the EU, the Lisbon Strategy also urgently needs to be flanked by a strong social policy. In this process, the Member States in question must remain the decision-making level subject to voter scrutiny in the shaping of future social policy in the healthcare sector. By no means may the principle of subsidiarity be circumvented and undermined by Internal Market legislation. This is the only way in which those Member States with a strong leaning towards the social welfare state can ensure a high level of social protection in the context of intense Internal Market competition. 2. Sustainable reform strategies in the Member States should be supported by applying international experience. Healthcare reforms are carried out regularly in many EU Member States. In structuring these reforms, the political players can learn from the experience of the other Member States. European exchange of experience at the different political and institutional levels should hence be continued and intensified. However, since major struc-

10 HEALTH AS A LOCATION FACTOR: BASIS FOR STABILITY AND GROWTH tural elements of the healthcare systems are differently structured at national level, reform strategies can only be successful if national peculiarities are taken into account. National sovereignty in the organisation of healthcare systems and the validity of the principle of subsidiarity are already derived from the fact that funding comes from the national solidarity-based community and from taxpayers. Within this framework, the statutory health insurance funds are calling for consistent reform strategies which are capable of securing, sustainably and in the long term, the European healthcare systems ability to perform under the conditions of a fast-changing labour market, of massive demographic change and ongoing medical and technological progress. 3. The mobility of Europe s citizens must be secured! Europe and its citizens need transparency also when it comes to cross-border healthcare provision. The necessary European framework has been created in the shape of Regulation (EEC) No. 1408/71 (and its successor, Regulation (EC) No. 883/04). In order to enable citizens to make optimum use of their rights to healthcare in Europe, they need simple, universally-accessible information as to the possibilities and conditions of the cross-border claiming of benefits. European initiatives have already been taken to this end, and the statutory health insurance funds are also making their contribution on behalf of the insured. With its case-law on patient mobility on the basis of the reimbursement procedure, the ECJ has increased cross-border accessibility to medical services for all citizens of the EU in formal terms. This was already transposed into national law in Germany as of 1 January 2004 in the course of the Statutory Health Insurance Modernisation Act (GKV- Modernisierungsgesetz). At the same time, Parliament created the possibility for the statutory health insurance funds to conclude contracts directly with service-providers in other EEA countries. The statutory health insurance funds support the call for the adoption of the rights created by the ECJ by all Member States where this has yet to take place. The statutory health insurance funds however consider that the cross-border cost reimbursement right established by the ECJ can, in practice, only supplement the existing procedure under Regulation (EEC) No. 1408/71, but cannot provide an equivalent alternative. All in all, there is no need to create further sources of law in addition to national law and Regulation (EEC) No. 1408/71. Unanswered questions on patient mobility can be solved within this existing set of rules. 4. Subsidiarity and cooperation must be strengthened! Health care structures which are highly responsive to citizens needs are indispensable for citizens acceptance of care. The goal may not be a European super state, but the networking of national cultural and social areas. There is no need for new European regulations in the healthcare sector for this to be achieved. Existing regulations also ensure cross-border uptake of benefits. Cooperation schemes are helpful, such as the Euregios, and diverse other supra-regional cooperation mechanisms which are very well taken care of by existing EU law. Only subsidiary policy-making competence, supplemented by networking and cooperation among the Member States, can maintain responsiveness to citizens needs and transparency while simultaneously making use of all the advantages proffered by the large economic and social area constituted by Europe. People need to clearly confess to social dimension and subsidiarity. Our health market is loyal to specific locations, characterised by large numbers of staff and growth oriented. Furthermore, it needs an organised and efficient enablement of demand by state health insurance to which there is no alternative. Whoever maintains these strengths is making an important contribution to the European idea and to political and economic stability.

11 INTRODUC TION European Health Policy in the Framework of the Lisbon Strategy Robert Madelin, European Commission, Director General of DG Health and Consumer Protection Health Means Wealth is a theme which at the European level has been pushed quite hard not only by the current commission of Mr Kyprianou, but also by his pre-decessor and the work that has evolved from Martin McKee and others in The theme stands for the proposition that it is necessary to understand the many inputs to good health as well as to acknowledge, as a society, that health is not just a pleasant commodity. Accordingly, the focus cannot only be put on technical innovation and solidarity. Health is also a crucial component in the sustainability of the European economy. It forms the foundation on which work and advancement for the EU citizens is based. Healthy adults and healthy children are the basis for increased productivity which in turn leads to a more competitive economy as these adults will be able to work harder and play harder for longer. Just to put it in perspective: across the EU Member States almost 10 % of GDP is accounted for by health systems, with millions of employees, and 20 % of that expenditure is used for pharmaceuticals. At the same time there are differences in levels of trust and in models of provision. Nonetheless, a healthy society automatically results in a healthy workforce. According to a case study on mental health, in Germany for instance, 18 million workdays were lost in 2002 due to depression. However, the consequent loss of billions of Euros would have been avoidable. On the one hand, patients must be made aware of the fact that depression is curable and, on the other hand, health care providers need to be trained in that respect and made aware that they can make a contribution. These two aspects will lead to better treatment, faster results and even the avoidance of suicides in this field. It must be said, however, that even though this represents an area of a possible health threat to the European citizen it is currently underfunded in most European countries. Is it possible that a debate at European level can do something to rectify this problem? Clearly, it is a common challenge. Another common challenge is obesity overweight and malnutrition. The figures (e.g. 18 % of the school children in the EU 25 are overweight) once more speak for themselves and this again is a challenge for all health care systems and all European politicians. The European platform and the German platform are working together on nutrition, to draw attention to the magnitude of this problem. The European Council decided in 2005 that healthy life years would be among the structural indicators for the Lisbon Agenda. Thus, the healthy life years of European citizens are a key performance indicator for Europe s jobs and growth strategy. But what is the link between health and the health outcomes in Europe? In order to illustrate this it is worth looking at the top 7 determinants of avoidable diseases and premature death across the 27 European countries, most of them being related to behavioural-driven determinants of health. With regard to these broad figures due weight ought to be given to the health care strategy of any locality within Europe focussing on prevention, health education, health literacy as well as on the provision of services for those who are already drifting into dangerous areas due to certain behavioural choices or certain social circumstances. At the current time a gender gap exists which is increasing in some countries. There are also gaps depending on one s social standing and where one lives within the EU. Therefore, the home address as well as the gender and the social status will determine the number of each individual s healthy life years. The combination of these aspects produce Robert Madelin

12 HEALTH AS A LOCATION FACTOR: BASIS FOR STABILITY AND GROWTH very different outcomes across the EU. The macro-economic studies that have been carried out at European level suggest that if the pursuit of healthy life years were to be taken seriously, the increased health costs which will ensue from the demographic future of Europe could be reduced by more than half. However, if the potential available is not used to maximise healthy life years, costs will explode. This ought to be seen also in the light of the relationship between health and workforce participation that I mentioned earlier. Overall, the picture is improving from a low basis in some cases. However, this process will not continue forever. It can be noted that in some countries, e.g. the Baltic states, the gap in life expectancy according to gender is widening. Similarly, a male in his forties from Warsaw has double the risk of dying before his 65th birthday than a person of the same age living in London. To a large part this is due to CVD and a good portion of that, in turn, is dependent on the composition of the diet. It cannot be expected, however, that becoming conscious of these differences across Europe and understanding the causes will result in a European master plan. But it may help different decision makers across the EU to highlight the importance of improving health conditions through simple or, in some cases, even non-health interventions. Since the fact has been acknowledged that investment in health can bring growth, jobs and social cohesion, efforts in this area are being supported through the Strurctural Funds. As part of the new health and cohesion policy in the budget period 2007 to 2013 the Member States of the European Union will be enabled to use part of the 300 billion Euros available under the Structural Funds to finance the modernisation of health infrastructure, medical equipment and devices, laboratories, IT, exchange of experience projects, the training of medical professionals, information campaigns, further education, post-graduate studies for researchers and other research and information study projects. Although the funds will not cover vaccines, medicines, salaries or current expenditure, with health having become part of an economic strategy since Lisbon 2005 European funding available to health care providers has been significantly increased. Thus, depending on the specific requirements of the respective regions the different elements of health care provision can be part funded. Two particular elements of the work in Brussels this year are the Health Strategy and health services. In the Health Strategy, the ideas which are the focus for the work at local level will be drawn together; at national level and across the EU to set a European reference point that will ensure the advocate for health is ever present in all debates. It is not a top-down strategy but a bottom-up attempt to give a voice to health in the three areas which the Barroso Commission has identified as its priorities: prosperity, solidarity, security. In addressing those three pillars some of the complexities surrounding the aspects of health are captured. Thus, particular attention will be put on health in all policies, trying to bring research or regional development into the picture as well as the global aspects like communicable diseases or the trade and health aspect which the WHO is also looking at. The health strategy debate will be an important opportunity to raise the profile of health in this strategic vision of what should be done. The health services initiative will be discussed in more detail by other contributors. These two pillars together will allow for a decisive move forward to set up the right framework for health under this presidency. To conclude, it should be made quite clear that firstly, the input from the Commission will only be of high quality if the ministries and organisations of each respective Member State communicate to the Commission what they think. The period of consultation is not quite over. So with the impetus given by this conference a lot of new input will hopefully be received. The second point to make is that Aachen will be the beginning of a period that will shape what the Commission s initiatives in these areas should look like. Therefore it is necessary to structure the future discussion and to ensure that health insurers and others also have very much a voice in discussing what to do next. These are the parameters as they appear from Brussels. 10

13 INTRODUC TION Health Care in Europe an Overview Professor Dr Reinhard Busse, Department Health Care Management, Technical University of Berlin, Germany; European Observatory on Health Systems and Policies Health Care in Europe an Overview is clearly a vast topic and therefore difficult to summarise. The overview will be given within the realm of five parts. The first will consider the actors and organisation, thus discussing whether Bismarck s and Beveridge s grandchildren are look-alikes. The Beveridge type systems can be described as tax-funded and originally integrated systems in which ministers determine everything. The Bismarckian Social Health Insurance systems on the other hand are said to be self-governed and bottom-up systems. Whether this description still applies today, shall be discussed in the first part. The second aspect which needs to be considered is financing, i.e. how the funding-mix in the 27 EU countries looks like, how much is spent on health care, and whether we can observe a distinct EU way of health care financing. This will be followed by the third section which is going to deal with the question of ensuring access to and quality of health care. In the fourth section, services, costs and reimbursement within the countries of the EU shall be highlighted and compared. Finally, health care and its contribution to wealth and productivity will be illustrated briefly. When addressing health care systems with all their peculiarities a simple framework is necessary to really see whether there are major differences between countries. Thus, it might be helpful to imagine a triangle. The first two important actors, the population on the one hand (of which some will be ill occasionally or chronically and then called patients), and the providers consisting of physicians, hospitals, pharmacies and so on on the other hand form the basis of the triangle, with each element placed in one of the corners. First of all the the tax-funded National Health Service type systems need to be described. As soon as it is talked about the NHS, most people automatically think of the integrated system in the UK before the reforms of the 1990s. In this context, integrated means the integration of the payers and the providers and not, as understood for example in Germany, an integration among various providers, all placed in the provider corner. The classical integrated NHS type systems were structured in the following manner: The population paid through general taxation to the central government. Internally, within the government, the money was handed to the Ministry of Health. Public providers and public hospitals were part of the same institution called National Health Service in the UK (as well as in many other countries, like Italy or Spain, where the name of the system has merely been translated into the respective language). Through this set-up, the government-run NHS was both the payer and the provider and the government also functioned as regulator. Thus, the system consisted next to the population of only one big actor. Depending on the country, the choice between providers was limited. Sweden resembled one of the clearest cases as its citizens could only receive treatment in their county. Even if the neighbouring county s hospital was virtually next door, it was only possible to get treated in ones own county s hospital. Anyhow, the system in these NHS countries changed and one of the big inventions of the 1990s was a so-called Purchaser-Provider Split which separated these two functions. Both sides remained public and the Department of Health still managed the system overall. But a part of the Yet, modern health care systems and this is often where the differences come into play are characterised by the existence of a third element known as the third-partypayer which does not only represent the financial intermediary but also has relationships to both the population and the providers. Therefore, it is situated at the tip of the triangle. Professor Dr Reinhard Busse 1 1

14 HEALTH AS A LOCATION FACTOR: BASIS FOR STABILITY AND GROWTH bureaucrats had the money now and the (larger) remainder of the employees of the NHS were providing the services. An internal market was established in which contracts were signed and money followed patient treatment as defined in these contracts. The purchaser provider split also implied that the hospitals status had to be transformed. They could no longer be part of the core central administration, but they had to become autonomous, at least to a certain degree in order to be able to sign a contract with the people forming the purchaser (placed at the top of the triangle). The hospitals were no longer directly managed by the ministry but by chief executives, boards and so on. The reason for taking these steps was that people were now able to choose where to receive treatment. Instead of having to tell citizens to go to a specific hospital because the money for them had been allocated to that place, the money available for health care would now follow the patients, at least to a certain extent. The next note-worthy development in many of these countries had to do with the central government. First of all, it originally had a triple role being regulator, payer and provider at the same time. The providers were then made autonomous in many countries where this was not the case previously, and later on, the remaining double role of regulator and payer was split up in such way as to devolving the payer role to the regional governments. The central government could thereby concentrate on its role as regulator. While this was already the case in Sweden, this kind of restructuring took most obviously place in Spain and in Italy, but also in a certain respect in the United Kingdom where now Scotland and Wales run their own health care systems. It is slightly more complicated within England where separate institutions first health authorities, then Primary Care Trusts are the purchasers. The last major change concerned the payer-provider relationship. At some point the purchasers were so experienced in negotiating and signing contracts with public hospitals that they extended their network of providers to private not-for-profit or even for profit hospitals. Spain represents a very good example of that. By signing contracts with private for-profit hospitals the purchasers have mixed something that was previously an impossible thing to do for those countries where public financing went with public provision and private financing went to private hospitals exclusively. Nowadays it is accepted in most tax-funded countries that public money can also go to private providers. If this new type of NHS-system is compared with the classical social health insurance system, it becomes obvious that the two systems are actually very similar: third-party payers are separate from national governments, the population has access to both public and private providers which are contracted by the third-party payers. Of course, there still remain some differences, such as the main source of financing in social health insurance systems are not general taxes, but social health insurance contributions (which, however, are mixed with large tax subsidies in some countries, e.g. Austria). Another decisive difference is that Bismarck type systems have sickness funds, not regional governments or Primary Care Trusts as third-party payers. An additional difference still is that some of the countries with the Bismarck type system offer a choice not only of providers, which is now true across all countries, but also a choice of payers, i.e. a choice of the sickness fund. But surely, it will soon be heard of the first tax-funded system which opens the payer role to competition. It has been done so in other industrial sectors, e.g. telecommunication, electricity and so on. All in all, the first observation is that the basic configuration of actors is now similar across all EU Member States. Financing is another important aspect of health care. There are four ways to finance it. The first way is through taxes; people pay general or earmarked, direct or indirect taxes to the general government, from where the money goes to the third party payers regional governments, health authorities etc. and is finally paid to the providers. This kind of financing is a prepaid one as people do not pay at the time of utilisation but in advance. Another means to finance health care consists in social health insurance contributions. Although the basis is different it is paid on wages, the way does resemble the first one. You prepay a certain amount of money, which is mainly based on income, to contribution collectors which are not always the sickness funds. In many social health insurance countries, social health insurance contributions are collected by the tax office which keeps this money separate from general taxes, similar to what is done with church taxes in Germany. This way they are only managed by the tax offices and are not kept as general taxation. The money is then allocated utilising a formula to the sickness funds which in turn pay the service providers. This model is also a prepaid one. The third alternative to finance health care is through voluntary health insurance, sometimes called private health insurance. But private health insurance has that double notion that you never know what is private. Is it a decision to be privately insured or are the third-party payers under private law? Thus, the term voluntary insurance appears to be more appropriate as it already reveals what it means; namely that people have the choice of whether to buy insurance or not. In this case, the third-party-payer would be a private health insurer which reimburses either the provider directly or the patient for his/ her invoices. The financial resources are also prepaid. 12

15 INTRODUC TION The fourth option is to finance health care out of pocket. People pay the provider directly at the time of utilisation. Out of pocket can be both cost sharing (patients pay the remainder of what the third-party-payer does not pay at the time of utilization) or it can be completely private where patients pay for the whole treatment themselves. These four financing alternatives can be differentiated in two ways: One is prepaid versus out of pocket at the time of utilisation. Another option is to differentiate between public and private. Then taxes and social health insurance contributions form one group called public and voluntary health insurance and out of pocket the other which is called private. In America (without the US) 56 % of health care is financed publicly, which is roughly comparable with South East Asia, but considerably lower than in the US. Out of pocket financing reaches still 35 % which is about twice as high as in the EU 15 countries. After having discussed the various funding sources, the percentage of GDP appears to be interesting within this context. The 27 EU countries health care financing has remained quite stable since There are a few countries where the percentage of GDP is rising, but not dramatically. The average has therefore gone up a bit, but not drastically. The EU 15 countries have a very similar percentage of expenditure around the average of 9 %, varying from 7.5 to 11. In the 12 new Member States expenditure is lower, about 7 % on average and varying between 5.5 and 9, thus reaching up to the average of the EU 15 countries. In the European Union, health care is mainly financed by taxes or social health insurance contributions. By looking at the old EU 15 countries, on average 75 % are paid publicly, either through taxes or by social health insurance, but usually by a mixture of both. 5 % on average is financed through voluntary health insurance and 18 % are paid out of pocket. Clearly, it can be calculated that 2 % are missing, because there are also some other ways of financing health care. The figures of the 12 new members differ somewhat. Public financing is a bit lower with 71 %, voluntary insurance is considerably lower with only 2 %, and out of pocket is higher with 26 %. The differences between the two types of the EU might appear substantial but what happens when they are compared with other countries health care funding? The largest share of the US unlike what many people think is also publicly financed, due to Medicare and Medicaid etc., but it is, with only 45 %, considerably lower than in both parts of the European Union and it is almost as high as their voluntary insurance with 37 %. The out of pocket financing is a bit lower than in the EU 15 countries, but comparable. The former Soviet Union countries public financing is as high as in the US and therefore considerably lower than in the EU. Basically, voluntary insurance does not exist and 50 % are paid out of pocket. Southeast Asia can be characterised by great variation. The financing of health care by public means amounts to 53 %, which is a bit higher than in the US and former Soviet Union countries, yet comparable. Voluntary insurance does not exist either and out of pocket payment is a bit lower but still adds up to 40 % - with some of its countries reaching 80 %. India s health care is in fact financed out of pocket by 80 %! Other countries should also be taken into account in order to find out whether the percentage of expenditure may be the same everywhere in the world. The US, for instance, is up at 15.5 %. Other regions shall also be mentioned in accordance with the WHO s regions of the world. The Western Pacific has a lower average than the 12 new EU countries, but America without the US has an even lower average than the Eastern Mediterranean which mainly comprises the Arab world starting from Marocco in the West, then Northern Africa, the Middle East and so on. There the average lies by more or less 5 %. The same average can be found in the Commonwealth of Independent States as well as in Africa. South East Asia has the lowest. In conclusion it can be noted that except for the US, the EU has got the highest average. What is also striking is that, except for the countries of the former Soviet Union, the variation inside the other country groups is much larger than within the European Union. For instance, the variation in the Western Pacific goes up to 13 %. Thus, what is usually said about Germany having the third highest percentage in the world is not true. This rumour has only been spread because people usually only concentrate on a few countries and forget that there are other countries in the world where the percentage of expenditure is in fact much higher. Moreover, it can be observed that there is actually a distinct European way of financing health care. Despite such exceptions like Greece and Cyprus, the EU countries finance their health care very similarly and also the percentage of GDP which is put into health care is more alike inside the EU than in other parts of the world. Another important aspect is the production of health. It consists of two groups of external inputs, firstly the health of the population, i.e. the health status. Secondly, the production is based on human, technological and financial resources The health care system itself contains the well-known triad inputs, processes and outputs. The patients with their demands on the one hand and the structures and organisation i.e. the way in which the human resources, technologies 13

16 HEALTH AS A LOCATION FACTOR: BASIS FOR STABILITY AND GROWTH and money are put together and what can be offered on the other represent the inputs for the health care system. These two come together to form processes (patient-physician contacts, hospital stays, imaging and so on). The last part within the health care system are the direct results, the health care outcomes; e.g. are people satisfied, do patients die on the operation table and so on. Finally, all components result in a mid- to long-term health gain. Naturally, this is not only due to the health care system, but also other societal systems like environment, nutrition, education etc., all of which contribute to health gain. What ought the 27 health ministers learn out of this in consequence? There is a common set of questions which needs to be considered: Is health care funding fair and sustainable? These two aspects imply the question how to distribute the financial burden across the population and to guarantee its sustainability in the long run. Further questions follow, e.g. is the personnel well-qualified? Are the institutions of high-standard and the technologies effective? Are the patients receiving appropriate services? Does the health system produce high-quality results? Are these worth the money invested in them? Not only are these questions virtually the same across all health care systems but EU health ministers have come to basically equal answers: First, it is necessary to ensure universal access to proper treatment. The idea of universal coverage entails that everybody is entitled or mandated to have a health insurance or cover under the statutory tax finance system and that there are cost sharing limits for people with low income and/ or high health needs. Second, when it comes to the structural quality of a health care system it is important to have certain instruments in place, such as professional certification and recertification, provider accreditation and re-accreditation, health technology assessment and maybe a concentration of services. Processes are steered ex-ante by guidelines and disease management programmes to enlarge the degree of appropriate services for patients ( to do the right thing ). This could still mean that the surgery is lousy, which is the reason why a term like quality, which is often discussed, needs to be properly defined within each scope it is used for. Anyhow, while guidelines and disease management programmes are to be seen as ex ante aspects of improving process quality, ex post components will be things like reviews on whether the right thing has been done or not. For the health care outcome it is not only important that the correct patient is undergoing the surgery, but that the operation is also done correctly ( do the thing right ). Benchmarking, league tables, registers etc. are used to this end. Regarding the overall quality, all EU health care systems face the same challenges and therefore answers are very similar. Partly due to the existence of organisations like the European Observatory on Health Systems and Policies, this is not surprising. Clearly, the governments are given advice and fortunately some governments also do listen, hence these instruments can be found in many countries. But when looking at guidelines, it is obvious that often providers or physicians have advanced further than the governments think. Guidelines are often pan-european guidelines. What is going on in health care practice today? About 100 hospitals across nine EU countries have been examined by the HealthBASKET project researchers with regard to the types of services used, the intensity of the use of human resources, associated costs and reimbursement received. Ten specific case vignettes were defined. The physicians in the chosen hospitals were then asked what they have done with such a patient and how much time they and the other staff have spent with the patient. After that the accounting department was asked how much the treatment and the human resource input cost. Furthermore, information on reimbursement for these patients was gathered. On the basis of this study it can be concluded that there are no overall country-specific cost patterns. In fact, huge variations exist within the countries, i.e. there are relatively cheap hospitals in Italy and there are very expensive hospitals in Italy, as is the case in The Netherlands and in Spain etc. In summary, it can be observed that the costs for treatment differ greatly in the EU, both within and between countries. With regard to this fact, it appears legitimate to ask why countries pretend to need their own specific reimbursement systems? Why is every country developing its own DRG system? Finally, the benefit of this discourse shall be illustrated. Life expectancy is visibly rising all across the European Union. Unfortunately, it will take the New Member States quite a long time before they merge with the former EU 15 countries. Nevertheless, there will not be clearly separate groups anymore in a few years. Some of the new Member States will even catch up with the older ones very soon. Life expectancy is rising and public health people say it is due to nutrition and alike. So, what is the role of health care then? We have examined this by looking at the decrease in mortality (or the increase in life expectancy) due to conditions where medical care can make a difference and for those where medical care cannot make a difference. The rapidness of the decline for the medically amenable conditions can then be compared to the other conditions. Therefore, according to data from the 1970s and 1980s, about 40 % of the improvement in population health is attributable to health care, which is not everything, but which is a big part of the whole. With regard to more recent data on 20 EU Member States concerning the death rate per population a change in health care-amenable causes becomes obvious in almost all 14

17 INTRODUC TION countries. Medical care is responsible for a good part of the decline in mortality, whether it is 33 % or 40 % will differ from country to country. Based on these facts, the increase in life expectancy can also be rated in monetary terms as people can work longer and contribute longer to the GDP. So every extra Euro that is invested into the health care system results in more health, which automatically contributes to the GDP. The return on investment differs between 50 % and 270 %. So even 47 % in France means that for each Euro which additionally went to the health care system the GDP growth was 1.47 Euro, i.e. 47 cents on top of what has been invested. Needless to say that this is an excellent return-on-investment rate. A rough correlation between expenditure and life expectancy in the EU countries shows that for every percentage point of GDP that is spent more on health care, two years in life expectancy are gained. This should lead to a re-evaluation of the previous political objective to spending very little in relation to GDP in order to achieve in cost containment. But the the more, the better equation is not valid across the board. It does not work with hospital beds for instance. It is therefore always necessary to think wisely about what to spend the money on. But if the spending versus life expectancy equation holds generally true and there are several aspects which point into that direction, it is necessary to look at the lowest spenders. Slovakia, Estonia and Romania have been identified as the lowest spenders, but they are not only the lowest spenders, the life expectancy in those countries is quite low as well. If health care increases wealth, then it is in the common EU interest that low spending countries increase their health expenditure. If they keep their cost effectiveness equal and just spend 1 % more, they would already gain 2 years of life expectancy and thereby would actually move up quite high within the life expectancy rates of the EU. In summary, an understanding of how similar health care already is across the Union might lead to a stage where not the differences are emphasised, but the similarities on which a common health care system could be built ensuring the best health care for all the citizens in the EU. 15

18 PERSPEC TIVE 1 PERSPECTIVE 1 General Regulatory Framework: Competition and Regulation in the Internal Market what Mixture is best for Europe? 16

19 INTRODUC TORY SPEECH General Regulatory Framework: Competition and Regulation in the Internal Market what Mixture is best for Europe? Professor Yves Jorens, Faculty of Law, University of Ghent, Belgium Welfare states are national states. The organisation of health care systems are therefore a matter for the Member States, notwithstanding the gradual, but limited expansion of the competences of the European Union in the field of social policy and public health. But far more important than the increase in competences attributed, is the influence of the internal market rules. It cannot be denied that health care is an economic market where goods and services are delivered and that in principle could be supplied by private actors operating in a purely commercial market. On the other hand, health care is not a normal market as there is information asymmetry: suppliers still determine demand, rather than the well-informed consumers. Doctors can be seen as operating in a triangle structure, the third party being a national health service or a sickness fund. Health care is also a fundamental right. The health care market, therefore, cannot be left completely open to free competition. Member States have widely developed a system of collective responsibility and solidarity. Thus, in a time where national social security systems evolve in a direction of a kind of hybrid system with a mix of public and private elements of health care, it cannot be left completely open to free and perfect competition. Trying to combine these elements, market-oriented elements with principles of solidarity, is however a very difficult issue, requiring a lot of legal fine-tuning; in this respect, the European Court of Justice has played an important role and will continue to do so. In the following, two issues of particular interest will be highlighted: Health insurance and the internal market, in particular competition and, very briefly, the access to health care. may qualify as undertakings. However, the ECJ accepted two exceptions to this fundamental principle. The first one applies to undertakings exercising sovereign powers. Could it e.g. be said of the German Health Care Institutions that they are not subject to the anti-competition rules as they have a statutory duty to provide benefits in kind? However, sovereign exemption does not apply even when a body is exercising official authority as long as it trades products and services alongside private undertakings that seek to make a profit. The second exception applies for purely social activities. This concept has been brought up by the ECJ. When judging if an economic activity takes place, one needs to examine how much space the legislator has left for a free market system and to what extent a solidarity principle has been developed. However, balancing on the very thin line between the economic and social character of an institution is not an easy task, and the cases examined by the ECJ made it perfectly clear how difficult it is to draw that line. Defining the term of social security also involves great difficulty. Elements such as contributions related to income, no relation between contributions and benefits, compulsory affiliation, and no real possibility to influence the level of contributions seemed to be the four characteristics, as presented by the ECJ, which provided the distinction if one was talking of an undertaking or not. The last element, however, has become extremely questionable in the wake of the AOK case concerning the German sickness funds dealt with by the ECJ. It seems logical that when sickness insurance funds can differentiate (part of) As a matter of course, introducing elements of competition will leave health care systems vulnerable to the application of competition rules. In this respect, the question of competition in connection with health care can be subsumed under one issue: Is a state authorised to set up any form of solidarity between members of a certain collective group confronted with certain risks? In order to answer this, firstly one will have to establish whether health care institutions are undertakings in the traditional sense and thus subject to the accordant European Treaty rules. Naturally, health care providers perform economic activities, so in this respect they Professor Yves Jorens 17

20 PERSPEC TIVE 1 the level of contributions irrespective of income, they will be considered as undertakings. Are contributions not to a certain extent also the financial compensation for delivering services? The ECJ finally came to the conclusion that this one element of compensation is not sufficient and that they were not undertakings. Notwithstanding these clear elements of competition between the German sickness funds, the judgement of the ECJ made clear that one should not only look at the internal organisation but rather at the ultimate aim of the system: solidarity and redistribution. The problem remains however that the line between entities that are undertakings and entities that are no undertakings is very unclear and impossible to draw in general. The crucial question in terms of public policy is: At what point is this balance of solidarity the degree of a certain solidarity in a scheme no longer sufficient to be exempted from European economic law? Are certain types of solidarity, income solidarity, solidarity by scope, risk solidarity, solidarity between schemes etc., more decisive than others for the outcome of this weighing exercise and which other factors? How far can the ECJ go without compromising its own authorities? Moreover, even when we are dealing with an undertaking as there are not enough solidarity characteristics, this does not mean that competition law applies in full. An exemption for the application may be found in the renowned Article 86 (2) of the EC Treaty which provides that companies entrusted with the operation of services of general and economic interest (SGEIs) are subject to the rules of competition insofar as the application of such rules does not obstruct the performance, in law or in fact, of the particular tasks assigned to them. In joined cases, Albany, Brentjens and Drijvende Blokken, the ECJ explicitly considered matters of solidarity to make a distinction between entities that were regarded as undertakings and such that were not. Even more remarkable was that the ECJ said in its considerations that the activities of the Community are to include not only a system that does not distort competition in the internal market but also a policy in the social sphere. The interpretation of Article 86 has produced a long list of complex and from time to time puzzling case law from the Court of Justice, however showing an obvious change in approach from an economic measurement to a value judgement seeing to the requirements of social policy. In that respect, Article 86 could be successfully invoked in order to set aside the application of the competition rules. In particular, if a certain activity does not fulfil the conditions to qualify as a core solidarity activity, but still displays enough solidarity elements, including compulsory affiliations: Article 86 (2) can then become a counterweight to the application of the normal Treaty rules a status which is reinforced by Article 16 of the EC. This brings us to the basic question whether the concept of social services of general interest could constitute a safeguard or counterbalance to the increasing influence of market-based rules. One will straightforward agree that the concept of SGEIs indicates services of which the provision to the citizens is of particular importance within a given society and it is therefore submitted to a number of common values and principles (human dignity, solidarity, social justice, social cohesion ), which perfectly fits in terms of health care. Health care evidently represents a strong pillar of the European model of society. However, legally binding provisions on services of general interest are absent in Community law. We do only have Article 86 (2) which aims at economic services, implicating a number of difficulties as regards qualification. It is clear that this article could become the key element in finding a balance between the application of EU competition rules and socially inspired activities, as a third way next to the state prerogative and solidarity -exemptions. But should this issue continue to be dealt with on a case-by-case basis? Is Article 86 (2), however, to be considered to be the right path to mitigate potential undesired impacts of the European economic law on a health care policy? Should the Treaty provide a general derogation clause for social security and, consequently, how do we define social security? Or must the answer rather be found in secondary legislation? Could we find the consensus on a European legislative framework and standards for health care as a service of general economic interest in which common values are laid down and thus legal safeguards as to solidarity, equality, accessibility, affordability etc. would become a part of Community law? Expressing this kind of considerations could still be considered today as building castles in the air, but touching on emanations of the legal uncertainty regarding the relation between national health care policy and the EU competition and internal market rules, there is a strong case for these issues to be sorted out within the scope for the policymaking of the Community. If we do not succeed in this, the legislative powers of the Community will probably be condemned to tail along after case-to-case solutions of the ECJ. Eventually, what this all means in practical terms can be examined by dealing with the issue of access to health care an issue of equity without any doubt. It is often argued that negative harmonisation as it is pursued by the European Court of Justice in its health care rulings encroaches upon the sovereign powers of the Member States to independently organise their health care systems. Can the ECJ be blamed for using the internal market provisions, notably Article 49 ECT, as a thinly veiled disguise for expanding Community competences circumventing the explicit terms of the Article 152 (5) ECT? It cannot. It is the effect of a measure on movement that triggers internal market rules, not the sphere of life that it regulates. The qualification, in the ECJ s health care rulings, of medical services even when provided within the frame- 18

21 INTRODUC TORY SPEECH work of a social security system as economic services within the meaning of Article 49 ECT can rightfully be regarded as a landmark. It brings the delivery of health care within the scope of liberalising and harmonising regulation by the Community institutions under various legal bases. There is a prima facie Community competence under Article 95 ECT for creating a European health care system. Almost any regulatory or institutional aspect of national health care systems is both an obstacle to movement and a distortion of competition. Thus, on the face of it, there is legislative competence to create a European health care scheme, with common rules on health care standards, hospital financing, gatekeeping, etc. and possibly with a European basic benefit package. However, the broad competence under Article 95 ECT is contained by the principles of subsidiarity and proportionality. It is highly doubtful whether substantive harmonisation of the national health care systems as opposed to common measures which merely expand upon the already existing requirements of internal market law could ever be justified in the light of these two general principles of European Union law and no one is willing to do that. The same most probably holds for an amendment of the ECT. There is a great deal of options for legal change in the field of patient mobility, taking into account that there are today two different ways for citizens of making their social security institution pay for the costs of healthcare which they received in another Member State. And it is understood that there is a need for it as it would bring about a number of advantages (like a clearer and more transparent picture of the rights one derives from Community law). Finally, there will be a clear view of whether the citizens have the right to seek health care abroad or not, instead of having to deal with infringement procedures on a case-by-case basis. Also, proposing a soft or hard instrument (directive or regulation) would appear to be more efficient, allowing us to take flanking measures on informational rights, medical liability etc, issues which are not as such dealt with by the ECJ, but are needed to ensure a proper implementation of the mobility of patients. The call however, for legal certainty, does not merely relate to a codification of the principles set out in the case law of the Court; it also implies the desire to return to a single legal procedure for the assumption of cross-border medical expenses. The design of any such framework is basically a function of the answers given to two questions: will the assumption of the costs of (certain types of) cross-border care be contingent upon the granting of prior authorisation or not? And, secondly, in accordance with which legislation that of the State of affiliation or of the State of treatment will these costs be assumed? There is a need to circumscribe the available options, by establishing standards which, in our view, a solution should conform to. These standards, which could be described as parameters, are twofold. It appears we have to adopt two parameters which should be considered as crucial. One would be well advised to not detract from the current rights that citizens have. Taking rights away from the public is always harder than not giving them in the first place. And secondly, legislative action by the Community should not afford insured persons an unrestricted right to assumption of the costs of cross-border care beyond the bounds of the healthcare coverage provided by the social security scheme in the State of affiliation. On a more formal basis which is the legal instrument in which these options could be implemented? It would seem that, legally speaking, all possible scenarios considered above could be included in the framework of the coordination regulations, through the use of Articles 42 and 308 ECT, having the obvious advantage that the European legal framework for individual patient mobility would be laid down in one legal instrument. Other legal bases are available for codifying the healthcare case law, i.e. Articles 47(2) jo. 55 ECT upon which the Bolkestein proposal is based and, in particular, Article 95 ECT, Admittedly the procedures would then not be regulated in a single legal text. Reliance on these legal bases would be easier in institutional terms, since they do not, unlike Article 42 ECT, require unanimity in the Council. Moreover, a directive, which is the instrument prescribed by Article 47(2) ECT and for which the possibility exists under Article 95 ECT, seems to be more appropriate to regulate the sensitive area under consideration. The coordination regulations, whilst they may well accommodate the principles of the healthcare rulings, seem an ill-suited framework to regulate at least some of the flanking measures as consumer rights and medical liability. To conclude with, the whole debate as such is not a question of fundamentally changing the different social protection schemes, but rather accepting the fact that health care systems have to be adapted to the circumstance that more and more people will use the possibility to go abroad acting as consumers. This, undoubtedly, confirms the need for an improved European framework of reference providing benchmarks to quality standards, equivalence of medical practice, licensing and accreditation and patient rights. This, however, cannot only be done in the private market, because it is exactly by social security that people are free to choose. The French Lacordaire once said: Entre le fort et le fiable, c est la liberté qui opprime et la loi qui affranchit (Between the strong and the weak it is freedom that oppresses and the law that frees) Whatever freedom we are looking at, the freedom to choose a health care provider or whatever else, social security should never in that respect reduce the freedom of persons more than necessary for making solidarity and equal opportunities effective. 19

22 PERSPEC TIVE 1 General Regulatory Framework: Competition and Regulation on the Internal Market what Mixture is best for Europe? 10 Theses* Professor Dr Dr Bert Rürup, Institute for Macroeconomics, Technical University of Darmstadt, Germany Thesis 1 There is no country with a functioning state order where the privatisation of the health risk has been made to that extent that the free market is given responsibility for the range of medical services. Everywhere naturally to varying extents central areas of production, financing and distribution of medical services are excluded from what is otherwise market economy controlled. The reasons for this deviation from the market economy principle are, on the one hand, the information asymmetries between the insured and the insurers and, above all, the limited consumer sovereignty in the relationship between patients and doctors. This structural inferiority of demand for medical services is based on a substantial gap in medical knowledge, or on the fact that the patients often demand services that they neither want nor need and the quality of which they are unable to assess. In this context, economists refer to the possibility of supply-induced control of demand. The second argument as to why largely market economy solutions are not fully applied in health care is that an individualisation of insurance against health risks without taking into account the income situation of the patient or the insured obviously violates elementary concepts of justice worldwide. Thesis 2 Competition is however not the same as market. As a pendant to cooperation, competition is a general societal control mechanism that does not just take place and can be established on profit-oriented markets. Based on the aforementioned information asymmetries it would however be completely wrong to assume that competition has no place in the health system. The information asymmetries that are immanent in the health system forbid the large-scale organisation of competition following the example of a goods market. On the other hand, these information asymmetries do not forbid the placement of competition in the service of health policy as an instrument for increasing efficiency. 20 That is why it is an important task of the legislation as well as of the state regulation in the health sector to create prerequisites so that the protagonists will as far as possible behave as if they were in competition so that there are strong incentives for an efficient use of resources. European competition law in that respect is also favourable with regard to systems that are otherwise outside of market control. Thesis 3 Irrespective of a required instrumentalisation of competition for the mobilisation of economic efficiency reserves, the insurmountable structural inferiority of the patients visà-vis the providers of medical services implies that the effects of competition as a control mechanism primarily become apparent with health insurance funds. Because it is here that consumer sovereignty is less limited than is the case with medical services. Starting points for more intensive use of competition as a control mechanism therefore lie in the competition between health insurance funds and, respectively, in a largely unrestricted possibility to switch to another health insurance fund. In a liberal society, people must be able to make their own decision: each of the insured must be able to choose his or her own insurer this applies to any insurance system. Thesis 4 Many economists, many politicians and also many journalists who regard themselves as liberal are advocating risk-equivalent premiums for health insurance funds, like those for example in motor insurance. Such risk-adjusted premiums however do not make much sense at least in my eyes in the health sector in terms of insurance economics. Because health insurance regardless of whether private or statutory cannot be compared to a motor insurance. In fact, individualised premiums will only increase efficiency if the risk activity concerned is sufficiently responsive with respect to premium levels. In other words: in terms of insurance economics, risk-adjusted premiums can only be justified if the individual insured is able to independently influence the risk probability by his or her behaviour. This ap- *Translated from the German original.

23 INTRODUC TORY SPEECH plies to the selection of horsepower and one s own incorrect conduct. This is why it makes sense to levy risk-adjusted premiums in these cases. In the health sector, however, there are only some borderline cases where it is possible to precisely define what percentage of diagnosed health conditions are caused by the patients themselves, are genetic or a result of environmental influences. Hence we should refrain from the concept of mobilising efficiency reserves by means of riskadjusted premiums. Of course, the cost consciousness of the insured must also be increased. But this cannot be achieved by means of risk-adjusted premiums; instead we should consider cost sharing systems. Thesis 5 If we are talking about a more cost-effective provision of health, it cannot be about advocating a cost containment policy that has become an end in itself. A strictly income-oriented expenditure policy might be necessary in the short-term. However, this is not the right concept in terms of a policy because such a policy prevents the health sector from developing in accordance with the preferences of the insured. After all, it goes without saying that in an ageing affluent society the preferences of the insured are changing. That is why an income-oriented expenditure policy is inappropriate in such a society. Such a policy will hamper the growth of a national economy. Because in ageing affluent societies the growth sectors are and should be regarded less as cost drivers but more as employment-intensive pillars of growth. Thesis 6 Increases in health expenditure both in absolute terms and in relation to the gross domestic product is not a problem that requires political countermeasures if and this is important these increases in expenditure n are the result of an increasing multimorbidity as the consequence of ageing of the population, n are the result of a progress in medical technology that improves the patients quality of life and extends their life expectancy, or if they n are the result of a change in preferences of the population as the consequence of e.g. an increase in prosperity. Thesis 7 Increases in health expenditure do represent a problem that politicians must deal with if n they result from inefficient organisational and incentive structures or from a lack of competition between the service providers, on the one hand, and the health insurance funds, on the other hand, and n the health expenditure is connected to labour costs, i.e. if the type of financing of increased health expenditure is associated with a macroeconomic loss of employment and of growth. Since economically reasonable increases in expenditure in the health sector are regularly also accompanied by Professor Dr Dr Bert Rürup dysfunctional increases in expenditure, it should be undisputed that every state irrespective of the degree of competition within their health system must have an effective instrument for cost control. This is particularly valid in view of the continuously existing possibilities of a supply-induced control of demand. Thesis 8 Due to the heterogeneity of the existing health systems in the EU, as well as to the different social and health policy objectives, in spite of the introduction of the Open Method of Coordination (OMC) in health care, there is only a rather broad and not very specific reference framework for common health policy goals on a European level. This reference framework is entitled the European social model. For the health sector, attempts were made to specify these common objectives by the Council conclusions of April 2006 to common values and principles of the EU health systems. Closer observation will however show that these values and principles are rather open to interpretation. These values and principles are as follows: n Universality n Access to good quality care n Equity n Solidarity Nobody will contradict these goals, but their consequences in terms of tangible actions are rather minor. Because in view of these European goals, there is an extraordinarily broad scope for action which does not (yet) force convergence of the systems. The Council s conclusions regarding sustainable funding of the health system are equally vague. In my opinion, these health policy principles cannot yet provide concrete guidelines for action in terms of the restructuring of the health systems. Thesis 9 Irrespective of the shortcomings in coordination and respectively harmonisation, the competition created by the EU on the basis of the freedoms of the internal market generates a healing relationship of tension between national sover- 21

24 PERSPEC TIVE 1 eignty in health care, on the one hand, and market economy convergence, on the other hand. The following are examples of this relationship of tension between the unchangingly strong national control and organisation, on the one hand, and restrictions by European law, on the other hand: n The EU internal market law undoubtedly provides possibilities to avoid national waiting lists, age limits and limitations to the catalogue of benefits. This partly thwarts national expenditure control systems not by agreements in the health policy sector, but by competition regulations. n National control measures such as budgeting, price regulation, licensing barriers or bans on multiple ownership for service providers (keyword: Doc Morris in Germany) seem like impermissible market interferences from the viewpoint of the EU internal market or antitrust law. If it comes to a convergence of the systems and this can be assumed this convergence will be less a result of genuine health policy objectives, and more a result of a certain convergence towards competitively organised systems imposed through competition law. Thesis 10 Competitive impulses that arise from the internal market due to the four basic freedoms can and should be used in a future-oriented reform of the national systems, in particular to break down antiquated lobby interests. For Germany, this means that it is vital to overcome the earnings limits for compulsory insurance which in terms of insurance economics cannot be justified, as they lead to inefficiencies that are generated by a segmentation of the health insurance market. Here, also in view of competitive aspects, it should be the case that in the sector of basic health care, with stipulations regulated by state institutions, a joint insurance market should be established and there is no option, based on income or employment, of insuring oneself with insurance companies that operate according to different financing and contribution measurement processes. On such a uniform market, every provider, whether private or state, should provide basic cover according to the same competitive regulations and should have to calculate the premiums based on the same principles. That is why I hope that this competitive thinking will lead to us overcoming such outmoded concepts, which are not only found in other countries, but also in Germany. EU law does not question the national cost control and regulating measures as a whole, but in specific forms, and thus tends to foster competition and stimulate deregulation. This pressure is politically beneficial. As little as the Common Values and Principles define certain guidelines for the convergence of the health systems, and although it is right that each country should and must take its own path because politics is inevitably always characterised by a certain path dependence, we can bet that this convergence process, communicated via European competition law, will lead to more competitively organised systems. I expect that, faced with this European competition law, the tax-funded and highly regulated systems will be placed under pressure. Although there is open development, this openness will and should move more in the direction of competition. 22

25 PANEL DISCUSSION Panel Discussion Participants: Franz Knieps, Director General Public Health, Health Insurance and Long-Term Care Insurance at the Federal Ministry of Health, Germany; Dr. Hans-Jürgen Ahrens, President of the Federal Association of the General Local Health Insurance Funds (AOK), Germany; Mervi Kattelus, Ministerial Advisor (Legal Affairs) at the Ministry of Social Affairs and Health, Finland; Jean-Louis Rey, Assistant to the Director for Social Security at the Ministry of Health and Solidarity, France; Jerôme Vignon, Director at the DG Employment, Social Affairs and Equal Opportunities of the European Commission. Moderation: Michaela Hoffmann, Wirtschaftswoche/Correspondence Agency Berlin. The panel discussion of the first section focused on the question as to whether, and to what extent, market mechanisms and competition can contribute to reaching the goals in health care policy in Europe and whether there is a need for additional EU-wide regulations. The discussion participants shared the opinion that the goals of universality, solidarity and access to high-quality health services agreed within the Open Method of Coordination (OMC) provided an important orientation in determining the future development of health care policy in the EU Member States and that it is necessary to safeguard those goals. The panel participants also agreed that, although health care holds an exceptional position within the Internal Market and should not be put on a level with other markets, a limited degree of competition and market mechanisms can be useful in order to enable health care systems to provide efficient and high-quality health services. In this context, Jerôme Vignon emphasized that the Member States are faced with similar issues such as an aging society and the problem of financial sustainability. In his opinion, these challenges can only be met by combining social responsibility on the one hand with open markets and competition for increased efficiency on the other. The Member States will develop different mixed models, depending on their different traditions and cultures in health policy. competition law have stimulated some movement in the structure of health care provision. This can be seen, for instance, in the decision to permit mail-order services in pharmaceutical care. However, Mr Knieps would prefer to rely on an open political process that is more prone to taking into account the differences between the various systems, including their strengths and weaknesses. He believes that the measurability of the performance of different health care systems according to various indicators and, thus, the comparability of the systems in question are very limited. On the other hand, the question of whether and to what extent the case law of the European Court of Justice (ECJ) have led to the need for additional EU legislation was subject to fierce discussion. Dr Hans-Jürgen Ahrens can see no reason for enlarging or expanding the legal framework. To a large extent, the decisions of the ECJ correspond to the concepts of the mandatory sickness funds for instance, in the areas of compe- Franz Knieps also attaches much importance to the process of mutual learning and appreciates the exchange of experience in health care management, a process in which Germany has intensively participated with neighbouring countries. In his opinion, such processes for influencing policy supported by European jurisdiction and in particular by EU Dr Hans -Jürgen Ahrens, Jerôme Vignon, Michaela Hoffmann, Franz Knieps, Mervi Kattelus, Jean-Louis Rey (f.l.t.r.) 23

26 PERSPEC TIVE 1 tition between care providers. In his opinion, there is still much room for expanding competition for the purpose of increased efficiency and cost effectiveness. Dr. Ahrens sees no contradiction between the decisions of the EJC concerning the freedoms of the Internal Market on the one hand and cost management at the national level on the other hand. For instance, the EJC has already accepted and acknowledged the possibilities of cost management in the form of fixed payments in Germany. Ahrens believes the focus should be rather on implementation of the existing legal framework and on a more extensive use of those opportunities already available. Approaches developed within cross-border cooperation projects such as e.g. different Euregio projects for the improvement of cross-border health care in the border region of Germany, the Netherlands and Belgium should be further expanded in order to offer patients greater options for mobility. Jean-Louis Rey endorses the view that concrete political actions are necessary in order to expand and support patient mobility. He considers patient mobility a specific added value for EU citizens and deserving of political support. Until today, only a very limited circle of experts is dealing with the issue of patient mobility; in addition, urgently needed political leadership has been lacking. In his opinion, this has led to a situation in which the rulings of the ECJ have, from the political point of view, been unsatisfactory. Consequently, he claims that specific steps be taken to increase patients mobility before embarking on new legal initiatives. Mr Vignon believes that the many ECJ rulings have revealed conflicts between the areas of authority of the EU and those of the Member States, thus exerting a negative impact on legal certainty. EU institutions are responsible primarily for guaranteeing competition and the Internal Market, whereas the Member States are first of all responsible for setting and following the values in health care policy. Mr. Vignon thus endorses the idea of creating a more precise legal framework which would restore legal certainty without violating either the solidarity principle or the sovereignty of the Member States in shaping their laws. According to him, the OMC as a confidence-building process may contribute to increasing Member States acceptance of legislative measures at the EU level. Mervi Kattelus believes that the values of health care policy as agreed upon by the health ministers of all Member States could best be safeguarded by a legislative framework at the EU level. Since the ECJ has in particular to guarantee the principles of free movement of persons and services, with the Treaty and the regulations concerning the coordination of social security systems being the only instruments to rely upon, the ideas and values of health care systems cannot be efficiently protected at present, Ms Kattelus says. On the other hand, she can imagine that the creation of a legal framework for health services would cause EJC jurisdiction to make greater allowance for the social dimension of Europe. Ms Kattelus also emphasizes that the fears that the case law would lead to enormous demands on the Finnish health care system have not proven true, however, since the number of patients seeking medical treatment abroad is still very small. Summing up the discussion, Ms Hoffmann identifies a consensus among the panel members that the health care systems hold an exceptional position within the Internal Market. National cost management on the one hand and competition on the other hand are not always seen as incompatible. There is a consensus that in many cases both elements are necessary for achieving efficient and high-quality health care. EJC case law has increased pressure on the systems but in many cases has thus far respected and acknowledged specific national elements of cost management. 24

27 PERSPEC TIVE 2 PERSPECTIVE 2 Do we need a regulatory framework following the jurisdiction of the ECJ? 25

28 PERSPEC TIVE 2 Do we need a regulatory framework following the jurisdiction of the ECJ? Nick Fahy, European Commission, Deputy Head of the Health Strategy Unit, DG Health and Consumer Protection The consultations on the occasion of the Potsdam Conference on the Perspectives of Health Care Services in Europe give the European Commission the opportunity to contribute and discuss what it has in mind in this respect. In this, I will focus on the reasons for the Commission s perspective, where it originated and what will be the next steps. First of all, it is important to recall how this process started. The possible Community action on health services being discussed at this event did not start as an initiative of the European Commission. Over the years, many initiatives have indeed been launched by the European Commission in order to support co-operation of Member States, such as the Open Method of Co-ordination, longstanding discussions on social protection, support from the Public Health Programme and its predecessors and more. This process of discussion on health services, however, was not driven by the European Commission but by patients who were unhappy about the way in which rules were being applied. They were concerned about their ability to access health care services in other Member States and therefore brought court cases contesting their rights before the European Court of Justice. Thus, this debate is of fundamental interest to patients. all the health ministers of the time with other stakeholders including insurers, professionals, patients and providers in order to look at these questions. One of their recommendations was to acknowledge the need to improve legal certainty regarding the application of Community law to health systems, in order to reconcile the principles of internal market law and the responsibility of the Member States for running their own health systems. The Commission responded to that call through the proposed directive on services in the internal market, otherwise known as the Boltkestein Directive which explicitly included health services within its scope as well as cross-border provision of health care and reimbursement for health care provided in other Member States. Although that proposal had a great deal of merit, the European Parliament and the Council both considered that it was not the best tool to address these issues. They concluded that health services should be removed from the scope of that proposal and should instead be address through a specific framework in order to better reflect the specific nature and character of health services. The European Commission s perspective in all of this has been to bear closely in mind what would actually be the concrete result and benefit for patients and for health systems as a whole in acting or not acting, as it is clear that the responsibility in this area lies primarily in the hands of the Member States, a role which the Commission must and will respect. The reason for the Commission taking the initiatives being discussed here is because we were asked to. After the judgements of the European Court of Justice, beginning with the famous Decker and Kohll judgements, further rulings and further periods of debate followed. Many people were involved in those discussions and ultimately the Commission was called upon by the Council of Ministers, the Health Ministers themselves, to establish a forum for discussion to address the issue at European level, following the political engagement with these issues led by the Spanish presidency in particular. Thus, the Commission established a high level reflection process on patient mobility and health care developments within the European Union, bringing together nearly There are many reasons which explain why health services cannot be compared with more normal services. The clear message that there needs to be a more specific, better adapted framework for addressing these issues has been received. A basis for considering such a framework is this consultation paper. Rather than rushing into such a sensitive and complex area, the Commission s intention in issuing this consultation paper was to provide an opportunity for reflection, to put all the issues on the table and ask the Member States, the insurers, professionals and patients for their opinions and find out about what they feel should be the issues to be addressed, what the real questions regarding cross-border health care are and how they should be taken forward. The Communication itself has been provided as part of the conference documents. Nevertheless, it may be helpful to underline some of the key messages and some of the key orientations about the Commission s intentions. It has been illustrated in the Communication that there are some 26

29 INTRODUC TORY SPEECH guiding principles regarding the overall responsibilities of the Community for health as set out in Article 152 of the Treaty establishing the European Communities; to support the Member States in achieving their objectives within the health policy area, respecting their primary responsibility for health policy as a whole and specifically for health systems and health services, including the organisation and delivery of health services and medical care. However, respecting the responsibility of the Member States does not mean doing nothing. Indeed, a great deal has already been done. Co-operation is supported through the Health Programme on a wide range of issues. In the area of cancer, for instance, data was collected, comparative indicators were collected, comparisons were made that led to reorganisations of the cancer services in some Member States. The improvement in the quality of cancer care based on this European cooperation within those countries was much to the benefit of patients. Guidelines have also been agreed at European level, such as recommendations on cancer screening. These were the results of at least a decade of expert work and represent a scientific consensus which is an extremely valuable reference point for people working in the field and which is understood to be the best translation and presentation of scientific understanding of this issue across the Community as a whole. As these examples show, the Community acts to support Member States in this area in various ways. But there has also been clearer guidance from Member States within the recent months about the direction of any future Community action. The statement of common values and principles that was agreed by Health Ministers at the Council in June last year set out a range of common values and principles in order to provide a clear political framework for any possible activity in this area. Commissioner Kyprianou welcomed this effort as a very solid basis for any possible action the Community might take. Within that context, we have set out the Commission s hypothesis, which we wish to test against the results of the consultation. As set out in the Communication, we consider that Community action should be based on two pillars. One of these is about legal certainty and one is about rendering support to the Member States. The legal certainty issue deals with the consequences of the Court judgements and the precise effect of applying internal market rules to health services and medical care. The Court has already made clear that the application of internal market rules is not to be done without any consideration of the specific nature of the sector. In particular, the Court has already stated that public health objectives, such as providing a balanced hospital or medical service, and economic objectives as well as social objectives maintaining the viability Nick Fahy of social security systems, do constitute reasons which can justify barriers to free movement and therefore can justify exceptions to the principle of free movement within the internal market. However, a clear message from stakeholders in former discussions and in responses from the Council Ministers and the European Parliament in recent years was that there is neither enough clarity for patients faced with immediate questions about where they can go and on what conditions, nor for the people who run the health systems. And so the Commission has defined a range of areas based on those discussions about whether greater legal certainty should be provided on matters such as minimum information requirements and the responsibilities of Member States. There are specific terms such as without undue delay or hospital versus non-hospital. What do these terms mean? Do we need greater clarity on them at Community level? And what are the general responsibilities that Member States undertake with regard to the services provided on their territory? Whose rules should apply when cross-border services are provided? With technology being used more and more, in particular ehealth or remote diagnosis, you might have the patient and the provider in two different countries. Whose rules apply in those situations? There is also a whole set of ancillary issues which have repeatedly been brought forward by health ministers who have an overall responsibility; not for the fine print of Community law but for ensuring that there is a good health outcome. How do we ensure continuity of care? How do we ensure that the rules we have set allow the patients data and records to move and follow the patient so that care can be safely ensured and proper information is available? How do we know whose system of compensation will apply when something goes wrong? These are particularly important issues for patients. And in how far can those countries with a very high volume of cross-border patients, especially countries with very high tourist volumes, limit mobility to their areas in order to maintain sufficient hospital and medical service for 27

30 PERSPEC TIVE 2 their own citizens? Or to what extent can they charge different prices, for example to make up for the additional cost of investment in the services that they provide for non-residents? In many ways the legal questions are actually the minor ones. For now that substantive discussions about crossborder health care have started, the real potential lies within the practical questions of co-operation as well as in learning from the different systems and practices across the European Union. By looking at similar comparisons of outcomes for those areas where data is available significant levels of variation in healthcare outcomes, both within and between Member States can be found. Now, on the one hand this data could be interpreted negatively as it reveals the fact that patients across the European Union are receiving widely different standards of care and outcomes and lack the information they would need in order to decide and choose between different providers, or they have the information but lack the opportunity. But the positive side of it is that it holds an enormous scope for improvement. There is enormous scope for learning from each other if economies of scale and co-operation are achieved for the benefit of all patients across the European Union, whether they leave or do not leave their own country. Therefore, a variety of ways in which this could be achieved are listed in the consultation paper, such as creating networks of European centres of reference. These suggestions reflect the fact that highly specialised care requires a concentration of resources or expertise not every region or even every Member State may be able to provide. If it is possible to put a mechanism in place for co-operation on those kinds of conditions, centres can be created that provide services to patients from more than one Member State as well as access to specialist care even for people living in smaller regions, more remote regions or smaller Member States. It is possible to share best practices and knowledge with regard to the potential of health innovations. Why should every Member State have to undertake its own evaluation of new technologies? Health care is a very innovative science-driven area which is constantly evolving and constantly improving. Surely there is potential for working together and sharing the benefits of the results. Hence, the next steps taken should not just involve a legal instrument but consist of a package of instruments suited to the needs that are identified in the consultation process. Naturally, some of the questions were questions of legal uncertainty that need to be addressed. However, before a proposal for any legal instrument under Community law is presented, it will be necessary to see where exactly the areas are that require greater legal clarity, some of which may be quite narrow. Yet, practical co-operation does not necessarily imply the need for directives. Financial support could be talked about, such as building on with the practical co-operation already being piloted through the Health Programmes with the High Level Group on Health Services in Medical Care; the exchange of experience and best practice as a result of the open method of co-ordination could also be supported. There are no prejudged ideas about what the next steps should be from the Commission s perspective. The variety of tools and possibilities were set out in the consultation document. Currently, the responses from different stakeholders about what they consider should now best be addressed are awaited. Practical co-operation on health care as well as legal clarity will allow for better health care to be provided, so that our joint efforts will result in concrete benefits for the citizens. After all, the consultation shall always be assessed against these criteria. It is not our aim to promote people moving between different countries there is no particular Community benefit in people moving between different countries as such. However, the questions that need to be tackled are: Does it promote better health care? Does it enable patients to have the health care that they need in the most effective and efficient way possible, and does it support Member States and their health systems in providing overall health care as efficiently, as effectively and as safely as possible? We look forward to the outcome of the consultation on this issue in order to help answer these questions. 28

31 INTRODUC TORY SPEECH Do we need a regulatory framework following the jurisdiction of the ECJ?* Evelyne Gebhardt, Member of the European Parliament The topic The Social Dimension in the Internal Market and the conference per se give an important signal to the citizens, who quite justifiably expect the European unification to provide added value in social sectors such as health care. The decisive questions that we must thus consider in this context are how such a European added value can be generated for health care, where joint action is necessary and makes sense and which framework conditions must be created for this purpose. In order to answer these questions, we must first define the framework of the European dimension of health care. The legal scope of action of the EU is particularly related to the joint obligation to ensure a high level of health care for the almost 500 million citizens of the 27 Member States of the European Union. This mission is anchored as a cross-section principle at European level and must thus be taken into account in all fields of activity of the European Union. At the same time, the EU Treaty emphasises the exclusively complementary function of the EU as a support of the endeavours of the Member States in combating and preventing severe diseases and for ensuring the maximum efficiency in health care structures. The European scope of action must thus perform a balancing act of fulfilling the Community mission, whilst simultaneously respecting the nation states sovereignty in the organisation of their health care systems. In addition to this mission of primary law, due to the realisation of the four freedoms of the internal market, the increasingly close intertwined relationship between the economic and social systems of the Member States results in an additional need for European action in the health sector. For the EU as a whole, as well as for the individual Member States themselves, the additional European dimension in the health care sector is opening up new opportunities, but these are also accompanied by risks that must also be taken into account. I would like to briefly refer to two aspects in this context. First, it must be said that everywhere in Europe health care is a significant engine for growth and employment. Even in my federal state of Baden-Württemberg, which many people primarily associate with a high level of engineering and nice cars, the majority of people are long since employed in the health care sector. The economic factor of health has a very high potential. Health care is thus becoming an important pillar for the realisation of the ambitious goals of Lisbon for more growth and employment. We must take advantage of the opportunities offered by this potential and jointly work on optimising the health care systems with the help of the European cooperation. The Open Method of Coordination is undoubtedly an important approach here, although as a parliamentarian I cannot be satisfied with the purely intergovernmental form of this coordination. In addition to the significance for economic prosperity and employment, health care as a basic right implies a state obligation to which all people are justifiably entitled. This applies equally in all Member States of the European Union. Health care is thus a core element of public services of general interest. As a service of general interest, special entitlements must be taken into account in health care. This particularly concerns the general availability, the free access, the high quality and the financiability of medical services. Furthermore, in the health care sector, the position of the patients, which particularly deserves to be protected, must always be taken into account. They are generally unable to assess which services are necessary for their recovery and who can best offer these. The health services of general interest are provided locally, but they have to persist in the European context. The European dimension of health care must not incite any addi- *Translated from the German original. Evelyne Gebhardt 29

32 PERSPEC TIVE 2 tional risks, but in contrast it must contribute to minimising existing risks. This is not only valid from the patients viewpoint, but of course also from the viewpoint of the providers and payers in the health sector. The European Court of Justice has already reacted to the increasing opening of and interaction between the systems of health care in the Member States with a large number of rulings. The individual ECJ rulings have undoubtedly influenced the organisation of the national health systems. Let us consider, for instance, the rulings on cost reimbursement of outpatient or in-patient treatments in another Member State, to quote just one example. This influence must not result in the primary focus being placed on the search for suitable measures for warding off Community influences and protecting national health systems on the contrary! Instead, we require joint endeavours to form a European regulatory framework for health care. This framework must promote the potential described, whilst taking into account the special demands to these services and, not least, respecting the sovereignty of the Member States for the design and organisation of their health systems. In order to achieve this, a consensus at European level is required, and this is where the European legislators come in. How could and should such a regulatory framework look like? I have already made it clear that the health care sector, and incidentally the entire sector of public services of general interest, cannot simply be regulated by the general rules of the internal market. For this reason, I am glad that as a rapporteur of the European Parliament I have succeeded in completely removing the health services from the Services directive. Now, there is an opportunity for a sectoral solution which can take into account the special demands to health care. I am advocating the instrument of a framework directive. The framework directive would be a suitable instrument for generating the necessary legal clarity and certainty without robbing the Member States of the necessary scope for forming their national systems in detail. What should be included in the framework directive? With a view to the mobility of the patients, in my opinion the following rights must be granted above all: n The right to appropriate and qualified health care provided by qualified medical staff; n The right to understandable, competent and appropriate information and consultation provided by the physician; n The right to the documentation of the treatment and to have access to the documentation; n The right to confidentiality and data protection; n The right to submit a complaint. From the viewpoint of the national health care systems, it must also be ensured that the Member States retain their control capacity in the health care system. This is the only way that the Member States can fulfil their fundamental responsibility to provide health services that are universally available, of high quality, accessible to all and financed on the basis of solidarity. For this purpose, binding regulations on liability and compensation in case of treatment of patients from other Member States are required. Furthermore, binding regulations are required for cross-border activities of health care providers. This latter aspect of cross-border activity of the providers concerns questions on the right of establishment, mutual professional recognition and comparability of qualifications, as well as matters of labour law. There will undoubtedly be major disputes on the details of such a framework directive. We are still at the beginning, in the midst of the consultation process. Irrespective of this, many decision-makers are attending this conference, who are directly or indirectly involved in this European decision: I would like to encourage you all to constructively assist in the design of this regulatory framework, which should not be conceived as a protection mechanism, but instead must provide opportunities to also generate the desired European added value in the health care sector. Health care is an elementary pillar of our European social and success model; to secure and strengthen health care in Europe should be in the interest of us all. 30

33 PANEL DISCUSSION Panel Discussion Participants: Udo Scholten, Deputy Director General European and International Health Policies, Federal Ministry of Health, Germany; Martin Bontje, CEO of the Association of the Dutch Health Care Insurers ZN, Netherlands; Jonathan Mogford, Head of European Affairs, Department of Health, United Kingdom; Wolfgang Schmeinck, President of the Federal Association of the Company Health Insurance Funds (BKK), Germany. Moderation: Michaela Hoffmann, Wirtschaftswoche/Correspondence Agency Berlin. The necessity of a Community Framework for health care services was the topic of the panel discussion in Perspective 2. Jonathan Mogford noted that the UK Government believes codification of certain fundamental elements and principles that have resulted from ECJ jurisdiction over the past 10 years could be meaningful. Any codified legal instrument needed to assist the Member States and patients in ensuring legal certainty. For example, it is necessary to address the issue of cost coverage of cross-border utilisation of health services, or the question which regulations of access are to be respected in these cases. The regulations of the host country, i.e. the country in which treatment is provided, should apply. The question of access to medical services is a particularly complex issue in the United Kingdom, particularly because of the problem of different legal foundations for patient mobility Regulation 1408 on the one hand and the case law of the European Court of Justice on the other. The Member States agreed within the Council of Ministers on a statement of common values and principles in the provision of health care nevertheless, it is still necessary to accept the significant differences among Member States regarding health care services. This is safeguarded by the principle that the national health systems have the competence to determine the scope of services to be provided independent of whether a patient wants to cross a border or not. Despite the currently very low level of patient mobility, it is necessary to prevent possible difficulties related to increased mobility and to establish a Community Framework in order to safeguard such important fundamental principles. he deems it also necessary to protect the common values and principles agreed upon in June 2006 and to safeguard the autonomy of the Member States in organising and designing their health care systems. Denying the possibility to bypass the ECJ s interpretation of primary law via secondary legislation in the form of a Community Framework, Mr Scholten nevertheless believes that such a legal instrument may offer opportunities to enhance legal certainty and to influence future interpretations of basic freedoms by the ECJ. In his opinion, past rulings have demonstrated that the ECJ takes the decisions of Councils of Ministers into account. Besides creating a higher level of legal certainty, Mr Scholten also advocates an improved cooperation of the Member States at the EU level, for instance within the High Level Group on Health Care. In contrast, Martin Bontje does not see a need for legal initiative at EU level. Pointing at the integration of the ECJ rulings into the new Dutch health insurance law he argues that more efforts should be made instead to inform the public for instance about standards, expected costs and the possibility of cost coverage for services used. Mr Bontje thus welcomes the Commission s initiative to create a Europe-wide internet portal which would provide information to consumers. Udo Scholten would also prefer not to leave the question of cross-border health care services solely to ECJ case law and argues for the need to regulate health services within a Community Framework. In addition to the protection of basic freedoms as guaranteed by the ECJ, Udo Scholten, Jonathan Mogford, Michaela Hoffmann, Wolfgang Schmeinck, Martin Bontje (f.l.t.r.) 31

34 PERSPEC TIVE 2 Wolfgang Schmeinck shares this opinion and points out that Germany s health care reform of 2004 also integrated ECJ case law. He emphasises the fact that less than 1 % of treatments are performed as cross-border services. The majority of these services is performed within the framework of Regulation 1408, i.e. under complete legal certainty. A new framework must not cause additional bureaucracy. In his opinion the highest European added value can be achieved by further promoting bilateral cooperation in the frame of the EUREGIOs. A need for action was seen in particular in improving the state of information regarding the extent of patient mobility. The panel participants expressed the hope that the introduction of an electronic European health insurance card will lead to more reliable information. Enhanced knowledge of the reasons for seeking medical treatment abroad was considered to be even more important, since patient mobility can also set incentives for improving quality standards in the patients home countries. The panel discussion revealed that the need for a regulatory framework continues to be a controversial topic. On the other hand, the panel members agreed that there is a need for certain limitations to competition and internal market freedoms in order to maintain the operability of the national health care systems. In any case, the participants appeal to the EU Commission to carefully study the necessity for and extent of a regulatory framework. 32

35 PERSPEC TIVE 3 PERSPECTIVE 3 Patients and Patient Mobility: European Opportunities for Insured Persons and Patients 33

36 PERSPEC TIVE 3 The Euregion Meuse-Rhine as an example of Cross-border Health Care Provision Professor Dr Jacques Scheres MD PhD, Euregional Co-ordinator; University Hospital Maastricht azm; HOPE Working Party on cross border co-operation in healthcare 1. Cross-border Health Care in the Euregion Meuse-Rhine main items of the paper: n The Euregion Meuse-Rhine: where is it, who works on cross-border care, and what are they doing? n Other examples of cross-border care in Europe n What conclusions can be drawn from the experiences? What problems are there and what can be recommended for future policies and activities? 2. Royal suggestion The idea to set up a Euregion for improving crossborder co-operation between the most southern province of the Netherlands, i.e. Limburg, and the neighbouring regions in Germany and Belgium originally came from Queen Beatrix of the Netherlands when she was still crown-princess and visited Maastricht. Her enthusiasm and ideas were taken over by the governours of the border regions in Germany, Belgium and the Netherlands and so the Euregion Meuse- Rhine started in 1976 as a foundation under Dutch Law. 3. Geographical location of the Euregion Meuse-Rhine Broadly speaking, the EMR comprises the region around the city of Maastricht; it covers a large part of the Belgian-Dutch-German area between Brussels (B) and Cologne (D). The map below shows the Euregion Meuse-Rhine in more detail. The following regions participate in the EMR: n The region Aachen (D) with its capital Aachen (area marked in green); this region is part of the Federal State of North Rhine-Westfalia which is the formal partner region of the EMR n The Belgian province of Limbourg, with its capital Hasselt (blue) n The Belgian province of Liège, capital Liège (purple) n The German speaking community (GSC) of Belgium, capital Eupen (brown) n The Dutch Province of Limbourg, capital Maastricht (orange); The registered office of the foundation EMR is situated at Maastricht. The total number of inhabitants of the EMR amounts to 3.7 million, which untill recently represented 1 % of the total European population. However, in 2004 the EMR became smaller in a relative sense. After the access of the 10 new member states the European population grew to 480 million, thereby reducing the relative size of the EMR to 0.7 %. In January 2007 the EU expanded again due to the access of Bulgaria and Romania, rendering the EMR even smaller. There is a remarkable asymmetry in the size of the partner regions of the EMR as the German partner Rheinland has five million population, whereas the German speaking region of Belgium has only 70,000 (including many German immigrants). The EMR harbours six universities and three university hospitals (Aachen, Liège, Maastricht). In addition, there are more than 45 other hospitals in the EMR, of which the larger ones are indicated on the map marked in green. The cross-border orientation of the population in the EMR is rather vivid; working across the border is certainly not unusual. For instance, 30 % of the nursing and technical staff of the Maastricht University Hospital (azm) is of Belgian origin. 34

37 INTRODUC TORY SPEECH 4. The Euregion Meuse-Rhine is complex Altogether, the EMR is a complex Europe in miniature, consisting of: n 5 partner regions with various levels of autonomy n 3 different national law systems: Belgian, German and Dutch n 3 official languages: German, French and Dutch; many people speak two of these languages fluently; some people even speak all three of them, especially the inhabitants of the German speaking region in Belgium n 4 different cultures: the German culture; the Wallonian culture in the francophone area; the Flemish and the Dutch cultures which are also very different even though the languages are similar. n There is great asymmetry in size between the partners: the smallest partner has about population (GSC) whereas the largest partner has over 5 million (Rheinland). 5. Aims of the Euregional health care policy The general aim of the Euregion is to improve the integration of the population on both sides of the border and to eliminate the obstacles for cross-border economical, social and cultural co-operation. For the field of health and health care it has been further specified in the EMR: n To improve cross-border access and cross-border cooperation If citizens in the EMR choose to go to a hospital or doctor abroad (e.g. to escape waiting lists, or to see a highly qualified specialist) this should be facilitated as well as the cooperation of emergency services etc. n Quality of life and the socio-economical structure of the EMR will improve by cross-border access to highquality care within short distances and by the co-operation of universities and their clinics which is totally in line with European thinking. 6. How will the EMR reach its goals for crossborder health? To realise the goals set in its cross-border health care policy the EMR uses the following instruments: n The basic freedoms of Europe, especially those allowing free mobility of citizens (patients, doctors) and services n A number of recent rulings of the European Court of Justice have confirmed that these basic rights also apply to health care; the most famous of these rulings is the Decker-Kohll ruling from 1998, but the most important recent one is the Watt s case (2006) n In the Euregion Meuse-Rhine care providers such as hospitals, health insurances/sickness funds, ambulance and public health services have set up cross-border networks n Regional, national and European authorities support specific cross-border health projects, e.g. INTERREG-funding. 7. The importance of the Decker-Kohll ruling of the European Court of Justice The Decker-Kohll ruling of the ECJ in 1998 has accelerated and stimulated the possibilities for cross-border care enormously. During a Euregional Health Care Conference organised by the EMR in 1998 Mr Decker, a lawyer from Luxembourg, explained the motives and history of his case. He had a prescription for new spectacles, which he bought in Belgium (Arlon) and not in Luxembourg. His Luxembourgian health insurance therefore refused reimbursement and the Luxembourgian court supported this decision. However, the n To remove obstacles created by borders The legal, administrative and financial regulations of health and social care differ greatly between countries which, to a great degree, impedes cross-border care. These obstacles should be overcome. A special task for the authorities and the insurances/sickness-funds. n Create new chances For instance, neighbouring university clinics may profit from each others valuable medical expertise and technological equipment and co-operate in research and development; this is also of importance from a social-economical point of view. Professor Dr Jacques Scheres 35

38 PERSPEC TIVE 3 ECJ shared Mr Decker s perspective. The same applied to Mr Kohll s case, who is also from Luxembourg and whose daughter had orthodontic treatment in Germany. The Decker and Kohll cases are clear messages: the individual citizen (supported by the ECJ) has a powerful standing when it comes to shaping the new Europe. 8. Cross-border health care network in the EMR: participating hospitals The Euregion Meuse-Rhine harbours a network of 15 partner organisations which work together in the Crossborder health care in the Euregion Meuse-Rhine Interreg project. Project partners may be involved in bilateral projects with only one or a few, but also with the whole group of the network. The participating hospitals are: n Universitätsklinikum Aachen (D) n Academisch Ziekenhuis Maastricht (NL) n Centre Hospitalier Universitaire de Liège (B) n Ziekenhuis Oost Limburg Genk (B) n St. Nikolaus Hospital Eupen (B) 9. Cross-border health care network in the EMR: participating health insurances / sickness funds The following health insurances/sickness funds participate in the Euregional network: n Belgium: Christian Mutualities; Socialist Mutualities; (other Belgian mutualities participate in certain subprojects) n The Netherlands: CZgroep Zorgverzekeringen; VGZ n Germany: AOK, BKK, VdAK / AEV, IKK, TKK 10. What sorts of cross-border care have been realised so far? Insurers/Sickness Funds The following activities of the health insurers/sickness funds can be mentioned here: n The participating sickness funds and health insurers have substantially simplified and shortened the procedures which have to be officially followed for receiving permission to go to a doctor or hospital abroad (especially E112). With special permission of the competent authorities in the 3 countries they perform the IZOM project (abbreviation for the Dutch title Integratie Zorg Op Maat ) in which insured persons of the EMR automatically obtain permission to go abroad within the EMR for specialist medical care, including in-patient treatment where it is deemed necessary. Payment procedures have also been simplified n Insurers / sickness funds have made cross-border contracts with hospitals and doctors, especially in order to solve the problems of unacceptably long waiting lists n The CZ group and the AOK developed an International Health Card for their insured clients who go abroad for medical care: tens of thousands of them carry the card which greatly simplifies a visit to a doctor or hospital abroad and its payment. Several further versions of the card have already been introduced. 11. Cross-border contracts of sickness funds with hospitals and doctors abroad Dutch and German health insurers / sickness funds have made contracts with hospitals and doctors abroad where their clients can be treated earlier than in their own country. One of the most active insurers in this respect is the Dutch insurer CZ groep Zorgverzekeringen. Its most remarkable contract is the one with the Ziekenhuis-Oost Limburg Genk (Belgium). The table on the next page shows that in the years an increasing and substantial number of Dutch patients crossed the border for medical care in the ZOL Genk (data from L. Van Camp, 2005). 12. Reactions to the growing numbers of foreign patients in Belgian hospitals The increasing cross-border mobility of Dutch patients visiting Belgian hospitals caused responses from the public and the politicians in Belgium. There was concern that the growing number of foreign patients would cause waiting lists for their own population and that the foreign patients would receive priority status by paying higher prices. It was also feared that the Dutch patients would profit from the Belgian tax-payer, as the Dutch do not pay a share of the costs for certain hospital investments and infrastructure which in Belgium are financed by taxes. At the same time, however, Belgian entrepreneurs consider this situation an excellent chance to present the Belgian health care system as a high quality market product which might attract between 50 and 100,000 foreign, mostly Dutch, patients per year. This would create more than 6000 extra jobs in Belgium. 13. The strategic cross-border alliances of the Maastricht University Hospital (azm) Not only the health insurers / sickness funds, but also a number of hospitals in the EMR have active cross-border health care policies. The most obvious example is the co-operation between the University Hospital of Maastricht (azm) and two neighbouring hospitals, the Aachen University Clinical Centre (UKA) in Germany at a distance of 35 kilometres, and the non-university Algemeen Ziekenhuis Vesalius (AZV) in Belgium at a distance of 20 kilometres. After a long-standing but also low profiled co-operation the azm and UKA signed a strategic alliance to intensify their cross-border co-operation which should lead to: 36

39 INTRODUC TORY SPEECH n Complementarity of their advanced care provisions, such as transplantations, burns surgery, genetic metabolic diseases, etc. n Realisation of Centres of Excellence in certain fields, such as cardiovascular diseases and aortic surgery (TAAA, thoraco-abdominal aortic aneurysma), molecular imaging, particle radiotherapy, etc. n Eventually, a merger of the two university clinics to one transnational, Euregional top clinical centre should become possible. Symbolically, the new alliance was signed at the same table on which the Maastricht Treaty had been signed by the Member States in 1992 (the Treaty ). Several of the cross-border plans of azm and UKA have already been put into practice. An example: Professor Dr Michel Jacobs (azm), vascular surgeon and Head of General Surgery at the azm, has also been appointed Head of a new Vascular Surgery Department at UKA. On the days he works in Maastricht, he uses teleconferencing and other telemedical means for communication with his colleagues and secretary in Aachen and for supervising the activities in the operating theatres in the UKA. Also, there are telematic connections between the operating centres, e.g. for remote and online tele-surveillance of circulatory functions and of neural signal transduction in the spine. The alliance between the azm and the non-university hospital AZVesalius Tongeren in Belgium is of a different character. On the one hand, the azm is using the free operating capacity of the AZV for reducing the waiting lists in Maastricht. On the other hand, the small AZVesalius hospital which is located rather peripherally in Belgium can increase its productivity by treating and operating Dutch patients, and at the same time has more medical-professional and technological perspectives by being involved in the top clinical care and research activities of the azm. The fields of crossborder co-operation between the two hospitals comprise: n General surgery n Gynaecology n Medical Imaging n Surgery of (morbid) obesitas n Throat-, nose- and ear surgery n Oncology n Pediatrics n Neonatology n Cardiology n Plastic surgery 14. Other examples of cross-border health care in the Euregion Meuse-Rhine The EMR has also established close co-operation in the field of public health, especially emergency care. n Delivery of blood products in emergency cases n EUMED: Cross-border medical assistance in emergencies and serious accidents (ambulances, trauma helicopter, hospital capacities for casualties, etc.) n Education and exchange of ambulance staff n Euregional Health Reports n Risky behaviour in adolescence (drugs, alcohol, tobacco) n Etc. 37

40 PERSPEC TIVE 3 over 150 projects in order to establish good practices and recommendations for cross-border health care. 15. Euregional quality project With increasing cross-border care the quality management is becoming more and more important. Patients, doctors and insurance companies want to be informed about or assured of good hospital care abroad. More than 20 hospitals have joined in a Euregional Quality Circle and have signed a quality charter (20th December 2005) with the obligation to work together in improving and guaranteeing the cross-border hospital care quality in the EMR. The hospitals quality managers meet periodically; a number of working groups are comparing the various protocols for patient safety, discharge management, prevention of falls, patient satisfaction etc. 16. Infectious diseases and cross-border care (e.g. MRSA) The prevalence of antibiotic resistant hospital bacteria, especially MRSA (Methicillin Resistant Staphylococcus aureus) differs substantially between the European countries. Due to their rationally restricted prescription of antibiotics, the Scandinavian countries and the Netherlands have by far the lowest prevalence. The Dutch part of the EMR is a green oasis in this respect. However, with increasing cross-border mobility of patients and doctors the risk of an increasing importation and exportation respectively of MRSA does indeed exist. A Euregional network of hygienists and bacteriologists has been set up in order to develop a special MRSA protocol for hospitals in border regions, and for molecular typing of MRSA-positive isolates. The latter gives information about the spreading route of MRSA stems in the area and thus will help to develop preventive measures. The euregional spread of meningitis bacteria as well as the setting up of common policies, e.g. regarding the avian flue, are also a subject of this group. 17. A few other examples of cross-border health and hospital projects in the European Union (HOPE Study 2003; Lögd Study 2006) HOPE is the European Hospital and Healthcare Federation. In 2003 HOPE published a first European report on hospital co-operation in border regions with information about more than 150 cross-border hospital projects in 28 countries and at 37 borders in the EU. Most projects concerned crossborder co-operation in patient care (49 %), emergency care (20 %), education (22 %), and professional exchanges (11 %), research (20 %), telemedicine (8 %), and shared equipment (5 %). Other co-operation subjects were language courses (4 %), and managerial training/co-operation. An ongoing study by the Lögd NRW has embarked on a more profound analysis of 18. Conclusions, problems, recommendations The extensive experiences in the Euregion Meuse- Rhine (EMR) and other euroregions, the HOPE inventory and the Lögd analysis of over 150 cross-border health projects allow the following conclusions and recommendations: Conclusions: n Cross-border co-operation in health care is a reality throughout Europe n Cross-border hospital co-operation has a positive impact (for patients, hospitals, health insurances/sickness funds, and the health system) n There is a large diversity of projects n Authorities are not much involved; it is mainly a bottomup process n Projects rely very much on the leaders personal involvement n Certain Euregions (like the Euregion Meuse-Rhine) may well serve as European models for cross-border health and hospital care Main problems: n Funding and reimbursement issues n Language barriers n Cultural differences (patient, doctor, nurse) n Legislation, e.g. different health care systems n Liability / Insurance coverage n Prevalence and handling of MRSA n Cross-border integrated care Recommendations: n More commitment on the part of the national authorities, preferably involving bilateral national agreements, is needed and highly effective (see, e.g., Germany and France)! n Monitoring of cross-border patient mobility and health care activities and projects is needed n National hospital planning systems must be adjusted to cross-border co-operation of hospitals and patient mobility. This will also facilitate reimbursement solutions (again: bilateral agreements will help) n Standards for cross-border contracting and care purchasing are required n The High Level Group on Medical Services and Patient Mobility, the Council and the EC should take a more active role The European institutions have indeed become more active in recent years. In 2004, the European Parliament (rapporteur J. Bowis) formulated a resolution on patient mobility. Recently (September 26, 2006), the European Commission has launched a public consultation about patient mobility and health services in the European Union. During the first 38

41 INTRODUC TORY SPEECH month of the German Presidency, Minister Ulla Schmidt has already taken a lead in the development of a specific policy for cross-border health, patient mobility and medical services. Bilateral agreements between neighbouring Member States might offer a solution to the many legal, administrative and financial problems which in most cases seriously hamper cross-border health care development. Though older examples of such bilateral ministerial agreements do already exist (e.g. the Zeeuws-Vlaanderen agreement between Belgium and the Netherlands), it is in particular the French Ministry which has recently successfully followed this route to facilitate cross-border patient mobility and co-operation of health care institutions in border regions. Agreements have been made (or are being prepared) with Germany, Belgium, Spain and Italy. In my opinion such bilateral agreements present the most elegant and effective way in which neighbouring states can offer customised help to their citizens, hospitals and institutions to benefit from care possibilities just over the border. These citizens will experience the great value of the basic European rights and freedoms also in a field of utmost importance to their daily lives: their health, and health care. 39

42 PERSPEC TIVE 3 Patients and Patient Mobility: European Opportunities for Insured Persons and Patients John Bowis, Member of European Parliament The importance of the Lisbon Agenda of a Competitive Europe, but also the fact that prerequisites to that economic health are both human health and environmental health has been acknowledged by the German Presidency. It is often said by the development aid policies: No Wealth without Health. Indeed, there is no physical health without mental health. In the past, it sometimes seemed to have been forgotten that this also applies to the economic prospects of our own community and European continent. For the report on patient mobility in 2004 Louis Pasteur s words appeared to be a suitable introduction: La Science ne connaît pas de frontieres parce que la connaissance appartient a l humanité et que c est la flamme qui illumine le monde. (Science recognises no borders, because knowledge belongs to humanity, and is the torch which illuminates the world.) However, by the time I presented the report to the Council of Health Ministers during the British Presidency, I had replaced the introductory quotation by one from Jean Giraudoux : Jamais poète n a interpreté la nature aussi librement qu un juriste la realité. (No poet ever interpreted nature as freely as a lawyer interprets the truth.) The point which is intended by this is that it is lawyers of Europe who decide policy for patient mobility. Why? Because the politicians have failed to do so and lawyers are continuing to interpret the treaties and respond to individual or groups of patients, who appeal to them for clarity of their rights which politicians have failed to provide. Should unelected lawyers decide national and EU health policy? Those who agree with this situation will not need to do anything except pay the resulting bills. But those who believe that it is the task of the ones who were elected to national or European Parliament will agree that legal certainty needs to be given without further delay. It is not necessary to panic if one is concerned about the so-called creeping Treaty competence. It is not meant for vast numbers as most of the EU citizens are local community animals, who are not overly ambitious to sample the 40 delights of beds and bedpans in remote hospital or clinic environments. Language may be a deterrent for many. Anyhow, patients prefer local treatment, if it is available. If it is not, they prefer regional. Only if patients have waited too long and are at the end of their tether, are most of them interested in exploring other options. Some may have relatives or close friends in other parts of Europe and that may be an incentive to see what is available there. But most citizens are not packing their bags as a result of ECJ judgements. It is hoped that domestic services will be improved and the range of expectation extends from interested to impatient, to see how the new rights are to be realised. So what has been achieved up to now? For a long period of time the E111 and E112 system, and E121 for people retiring abroad, prevailed. The E111 is now of course the Electronic Health Card. Thus, it is possible to travel temporarily throughout the EU and, if an unplanned medical requirement occurs, the card only needs to be presented and treatment will be received on the same basis as applies to local residents. The E112 is the basis of the MEP s and the ECJ s current concerns. This gives EU citizens the right to receive, with prior authorisation, planned treatment in another EU country and have the bill sent back home. This will not pose a great problem for a Luxemburger, who has long used the system efficiently. It does, however, pose quite a problem for most other EU citizens, whose governments have placed rather too many obstacles in the path of obtaining the necessary authorisation. So nothing has changed in the Treaties but it has been realised that mobility rights (and not health rights) should permit E112 to be a reality. There have been a range of cases to and from the ECJ to develop these rights. In 1998 the rulings on Kohll and Decker, two Luxembourg citizens, confirmed that they could go to Germany and Belgium to receive orthodontic treatment and to obtain spectacles respectively. This left the question open of whether such treatment and services could only be nonhospital services. In 2001 two Dutch citizens, Geraets-Smits and Peerbooms received respectively PD treatment in Germany and coma therapy in Austria. These cases confirmed

43 INTRODUC TORY SPEECH that in-hospital treatment was covered by the Treaties. The further Dutch cases of 2003, Mueller-Fauré and Van Riet ruled that prior authorisation was not necessary for non-hospital treatment. The most recent case of the British woman, Yvonne Watts, was referred to the ECJ, not by the patient but by the British courts. It challenged the requirement for prior authorisation for in-patient hospital treatment and questioned whether a health authority could refuse authorisation by subsequently reducing the previously set waiting time for treatment. In the event it left a number of issues unclarified but made clear both that the judgements applied as much to taxpayer (Beveridge) models of health service funding as to compulsory insurance (Bismark) ones, that a national waiting list policy was not enough and that the British policy lacked clarity. Thus, national health policies in each Member State of the EU prevail. There is no question of a Pan-Europe health service. Article 152 is safe. Of course, it is necessary to try the best to sustain the health of the citizens, but then it is up to the Member States to run health services and give medical treatment. Clearly, this distinction is sometimes a nuisance but always a reality in policy making. EU policy makers have to live with that and find a way to improve the health of their citizens without interfering with the autonomy of national health services and member states. Nevertheless, new powers for the patient to bypass sluggish national or local services, if they are not up to a reasonable standard of waiting time, are coming. Even then, the ECJ still wraps patients rights in a cocoon of provisos. The treatment sought must be normally available in the home country and the cost must be comparable in order to prevent, for instance, dashing off for abortions because one s own country does not permit them. There is also no racing across the border from a less well-off country to have an expensive treatment in the next door wealthier country unless of course one is prepared to pay the difference. Both things are deterrents against mass patient movements. But and it is a big and multiple BUT without clarity, systems and guidance, we are going to see major concerns, as patients and their medical advisers seek to find their way through the complexities of the system. Health service budget holders whether in health service provider management or health service purchasing management or the budget controllers in governments, in regions or in insurance companies are going to be left exasperated as they try to cope with totally unpredictable demand for service funding. Patients have questions, not unlike those of their GP, specialist or local manager: John Bowis n Do I qualify? n What is Undue Delay? Are there differences for undue delay between different conditions, different diseases, different disorders, but also between different individuals, including their age? n How do I apply, if I need to? n How do I or my GP decide what my options are? Do I have to take what is recommended to me or can I go anywhere in the EU as the ECJ suggests, to any country, to any hospital, to any specialist, to any aftercare? n Can I top up if the price is higher than in my home Member State? n Who decides if the type of treatment complies with the new criteria? I need to know before I go and not find out later. How do I appeal, if I disagree? Or do I have to go to court each time? n Who will have access to checks on health professionals? n How will patient records be exchanged? n Who pays for my travel / and for an accompanying person, say if I am a child or frail? n What channels of complaints are there if something goes wrong? n How will reimbursement be effected? n What will be the international interface between different systems (Beveridge/Bismarck)? And between Euro & non-euro zone countries? Do we need a central clearing house for claims and payments, national or European? n Is mental illness covered? European legislation will be needed to answer some of these questions and national legislation for others. Guidance is needed to provide clarity for the patient and the practitioner alike. It will be necessary to test the water and adapt according to experience. It is necessary to speed ahead with frameworks for health services, health professionals and patient safety. There is still time to get this right. After all, most people will prefer a managed option. Experience of bilateral & multilateral agreements between health services and between governments has already been made, e.g. the UK s Waiting 41

44 PERSPEC TIVE 3 List Initiative contracts in Bruges and Thessaloniki. There are already examples of regions, e.g. the Maastricht/Aachen/ Liege experience and that of Veneto and Slovenia, crossing borders and there are hospitals under Interreg building alliances, such as between Strasbourg, Luxembourg and Liege. But over time more people will seek and find solutions to their health needs in other Member States. It will be seen as a spur to improvement of home health services if their citizens are opting to go abroad. They cannot, under the ECJ rulings, be forced to go to the country or hospital with existing cross-border contracts and agreements. It will be useful additional income for receiving services. It will in time be accepted that not every country will have to cover every aspect of health, especially for rare or less common diseases. Maybe it will then be necessary to consider whether legislation is needed to make this simpler still with our Centres of Excellence (Reference Centres Concept). It is also important to look at how the electronic health card is working currently they seem to be developing with different types and amounts of information in them. Arrangements will have to be made with regard to dealing with large scale retirement populations from other Member States e.g Southern Spain, Malta and Cyprus. E121 is currently, but secretly, operating through bilateral grant payments. But secrecy surrounds the amounts and how they are calculated and there is no public accountability as to how it is spent and whether it is enough or too much. However, it is a good sign that Member States swiftly accepted the principles of the ECJ judgements and sought to manage rather than challenge these. It is also a positive sign that the Commissioner pledged in the EP that he would bring forward proposals on the management of the new system and a new opportunity as soon as it was clear that patient mobility would not be within the scope of the services directive. The Parliament voted by 554 votes to 12 in support of the report on patient mobility calling for clarity. People have voted with their challenges to the law, and ECJ has responded and confirmed their rights. Now political action is needed to put in place a system which will be welcomed by the citizens of Europe and, as importantly, will show them that Europe brings real benefits and added value and so will help to bridge that widening gap between Europe s leaders in the Parliament, in the Commission and in the Council and its citizens. A quotation from Werner Heisenberg, the great German Physicist and Nobel Prize winner, shall conclude this report. He wrote the following words in 1969, just seven years before his death : Ein Fachmann ist ein Mann, der einige der gröbsten Fehler kennt, die man in dem betreffenden Fach machen kann und der sie deshalb zu vermeiden versteht. (An expert is someone who knows some of the worst mistakes that can be made in his subject and how to avoid them.) It is known in politics that in taking difficult policy decisions many mistakes are often made; but the biggest mistake of all is often not to take a difficult decision. Therefore, an agreement is now relevant to bring forward legal certainty to the principle of patient mobility that the ECJ has endorsed. This needs to be at EU level where that is appropriate, and at Member State level and below that, where that too is appropriate. Either way, action is necessary. 42

45 PANEL DISCUSSION Panel Discussion Participants: Dr Tit Albreht, Advisor to the Director, Institute for Public Health, Slovenia; Günter Danner, Deputy Director of the European Representation of the German Social Insurance in Brussels; Dr Alexandre Diniz, Director of the Department for Health Services, Ministry of Health, Portugal; Helga Kühn-Mengel, Member of Parliament, Commissioner of the Federal Government for Patients Affairs, Germany. Moderation: Michaela Hoffmann, Wirtschaftswoche/Correspondence Agency Berlin. All panel participants confirmed that there already exist many examples of specific and successful cooperation within the EUREGIO framework. Dr Tit Albreht reports on a research project which examined patient mobility across various European regions. As part of this project, his institute explored the region comprising Slovenia, Italy and Austria. All three types of patient mobility could be observed and documented in the region, with the number of Kohll-Decker-cases being still quite marginal. In Dr Albreht s opinion, cross-border services will intensify over the next years. Despite many positive experiences, Dr Albrecht can still detect many difficulties, as already reported in the introductory presentations. As an example, he mentions a hospital in a Slovenian border region that had concluded an agreement with a hospital in a neighbouring country about the mutual transferral of patients in need of specialised treatments. Finally, this cooperation could not be realised since the social security administration of one of the countries denied approval. Dr Albreht expresses the hope that such obstructions can be overcome in the future. Dr Alexandre Diniz refers to the long-term cross-border cooperation between Portugal and Spain, especially between the Douro region in northern Portugal and the adjacent Galicia region, as well as between the Alentejo region in southern Portugal and the adjacent Andalusia region. A lot of experience has been gained with patient mobility as well as with the provision of services. Meanwhile, a joint committee has been established and supports cooperation in crossborder policy. Several concrete joint projects e.g., in the field of professional education, cooperation in emergency health care services or in telemedicine have been initiated. Mr Günter Danner emphasizes that cross-border cooperation within the EUREGIO framework takes place within relatively small and well defined areas with the integration of various local participants. This Europe en miniature, however, cannot be compared to patient mobility across larger distances. Mr Danner believes that EU institutions do not have any legal authority here; instead, each Member State is responsible for implementing EU law in its national social legislation and to integrate the corresponding administrative regulations. In this context, Mr Danner identifies substantial differences among the Member States. According to him, several Member States such as Germany have managed implementation into national law excellently; other states, however, have not done their homework yet. He calls on the Member States to meet their socio-economic responsibility to develop health care systems according to their national health policy, yet integrating the relevant EU regulations. Ms Helga Kühn-Mengel emphasizes that, based on the experience with cooperation within the EUREGIO framework, it is possible to draw conclusions that may impact the process of shaping a regulatory framework on the EU level. In Another question raised was if and to what extent experiences from cross-border cooperation may be integrated into any prospective EU legal framework for health care services. Dr Tit Albreht, Günter Danner, Michaela Hoffmann, Dr Alexandre Diniz, Helga Kühn-Mengel (f.l.t.r.) 43

46 PERSPEC TIVE 3 particular, she points out economic and qualitative aspects which frequently offer advantages to patients in cross-border cooperation, such as competence centres for rare diseases or highly specialised services. There is a particular need for action to support patients rights to information and public participation; in this respect, some EU countries can provide examples of best practice to be followed. There are large differences among the individual Member States in providing information about patient mobility, she says, and much remains to be done in that field. In her opinion, safety of medications is another important joint task for the EU as a whole. The other discussion participants shared the opinion that equal access to cross-border health services is a critical issue. Dr Albreht observes an urgent need for action in informing patients about the options and requirements for receiving medical treatment abroad. In addition, he believes that costs play a crucial role in the decision whether to seek treatment abroad. Dr. Albreht believes that the cost differences between the new and old Member States pose the threat that the patient s purse will become the decisive factor in access to (potentially better) medical services abroad. It is thus important to first and foremost focus the political efforts on reducing the great variety in the quality of services provided in individual countries. In this context, Mr Danner stresses the option of enhancing access to medical progress for a broader share of the population in his own country as well as in other EU countries. He identifies underfinancing of medical care providers in the new Member States as a particularly critical issue, because it sets incentives for the most competent medical care providers to either move into the domestic private sector or to go abroad. Consequently, public institutions run the risk of losing their professionalism and to become unable to provide high-quality services. Summing up the discussion, the moderator, Ms Michaela Hoffmann, comes to the conclusion that patient mobility should be viewed as a specific added value for EU citizens. It is necessary, however, to increase transparency regarding the options and requirements for patient mobility, while at the same time putting more effort into patient information. Given the different levels of quality of medical services in the Member States, guaranteeing equal access remains an important challenge for the future development of cross-border health care. 44

47 CLOSING SPEECH The Future of Health Insurance in the Light of a Balance between National Sovereignty and European Cooperation Outlines of a European Consensus Robert Madelin, European Commission, Director General of DG Health and Consumer Protection There is a high degree of consensus on the sorts of challenges that health care providers face across the European Union, consisting in the increased diversity between social situations in the Union of 27, funding aspects, the challenges of new technology and the challenges of ever more demanding citizens not only in the wealthy Member States but throughout the Union. Health ministers have reminded us of our common values and that the expectations of what health care provision is supposed to deliver are high. Some of the shared challenges can neither be very efficiently met within the local authority nor within the regional authority or national setting. Yet, it is clear that most of the future action which needs to be taken will be decided and delivered at local level. Exceptions to that have been discussed many times, e.g. patient mobility includes citizens seeking health care outside their home country or their country of residence or the country where they are insured, depending on how the term home country is defined. There are other issues which reach a little beyond central doctor-patient-relations such as cross-border health threats, e.g. the management of pandemics (MRSA). There may be common challenges such as healthy ageing where a multitude of conceivable individual solutions could be found. It might be better to face such common challenges by pooling our resources. Finally, there are common challenges to be faced in terms of the drivers of health determinants where no man is an island within Europe. citizens ought to be an objective or just an aspiration. Will the good health of Europe be the random outcome of people doing good things or can it be achieved more efficiently through organisation? Certainly, it is not only a question of organisation, preferences or local traditions. It is also a moral question and it would be one great failure to answer this moral question only in the health field but not in many other fields underpinning the current doubt as to whether European co-operation and friendship really have any significance. Especially in an area like health, which is of interest to each and every citizen, the professionals and administrators in the sector not only have the power to do something by cross-border co-operation in order to improve the delivery of their core business objectives namely health. They can also make an unequalled contribution to the health of Europe which is obviously an issue of utmost concern. The actions being taken at European level to support health do not need to be mentioned in detail here. There are many actions underway at European level to support health. Regarding any brain drain, the Polish Minister for Health has pointed out that health providers and trainers of health professionals are tracking the dynamics of cross-border professional movement. The EU has a common interest in hav- A single economy is increasingly evolving, the link between health and wealth is becoming more widely appreciated, government heads across Europe have claimed that they want everybody to live longer in good health, which the Lisbon Healthy Life Years commitment has emphasised. If the Union wants to support Healthy Life Years, it has to somehow organise the means to do so. It would be one more, frankly speaking, rather European mistake to state that even though Healthy Life Years is an objective, there is no plan to achieve it. This would mean that it is not an objective but merely an aspiration. The underlying moral challenge facing the health community in Europe is whether the health of our Robert Madelin 45

48 THE FUTURE OF HE ALTH INSURANCE ing a farsighted view of the requirements of the medical profession in order to train sufficient staff collectively and not just rely on the relative attractiveness of better hospital conditions in some Member States to retain them. We need to plan, not ignore, the consequences of the fact that there exists already the right to move on the basis of mutual recognition of qualifications. In the field of pharmaceuticals the EU is performing better. There is a European Medical Agency and a pharmacovigilance system in place. However, it still happens that errors are discovered via the internet before being detected by the pharmacovigilance system, such as the case of the mislabelled vaccines in Poland at the end of Nevertheless, the EU is shaping up well in this field. Through the research budget, medical technologies and techniques as well as health care provision know-how are already being funded. This contribution is quite large and the potential benefits from working together are becoming gradually clearer. In fact, frontiers are always a very fertile ground for co-operation. And a number of examples such as from the Euregio are encouraging as to the scale to which the commitment of individual professionals can grow. Moreover, in this world of modern communication technology, distance is fortunately no longer a deterrent. Yet, it is not the intention to send patients from the furthest west to the furthest east in what is now a rather large European Union. The challenge is whether it will be possible to go beyond the obvious neighbourhood activities and build up similar co-operation where it makes sense. Thus, the questions to ask are: where does it make sense, and what is the added value? It is no good doing something at European level just to show that Europe is moving forward. But it is sensible to cross the borders when the scale or nature of the action is such that co-operation will enhance efficiency. A good deal of progress has already been made since the last Commission s reflection process around patient mobility and healthcare developments in the EU in For instance, a common approach to Health Technology Assessment has been planned not to force the same conclusion about drug use on every provider across Europe, but to avoid the situation where 27 different assessment processes exist simply to gather the basic data. The judgement that will be reached, will be reached by local providers and ultimately by clinicians, but nevertheless with scope for shared health technology assessment. When looking at issues such as mammography standards or the Europe Against Cancer programme, it can be seen that sharing data is a stimulus for improved local provision. The standards in the mammography area which were agreed with European support among clinicians now set the benchmark for upgrading performance in different local systems. Europe Against Cancer, which was a relatively inexpensive series of programmes in the late 80 s and the early years of this millenium, was instrumental in driving local reforms and has consequently saved hundreds of lives since then. The survival rates were extended by improving clinical practice. This was not due to somebody, for instance in the UK, stating that they were not doing well and therefore deciding it might be better to copy measures from other countries. The mere fact that there was a gap in survival rates and that European-wide benchmarking revealed that one country could do better induced the clinicians to search for options to improve their processes. Within this framework the EU can provide technical and political support and a platform for health providers, e.g. in the area of prevention, to come together at European level and learn from each other: the German platform Ernährung und Bewegung (Diet and Exercise) gave good examples in this respect to other Member States, taking away from the discussions and focussing more on tangible projects. Thus, even the market leaders can sometimes both give and receive from these European level activities. Everybody in this area should be encouraged to talk to people outside the health field in their national systems. It ought to be noted that the European emphasis on better regulation, which is often seen as a European search for deregulation, is rather the opposite in practice. It is an opportunity to get non-health-experts to think about the impact on other policies dealing with health. The impact assessment work which is being propagated in Brussels by Vice-President Verheugen is an ideal opportunity to make non-health policy makers a little more health literate. That is certainly the spirit which the Commission s new impact assessment board has adopted for its task. Of course, these different examples spread beyond health care provision as a core business, and spread well beyond patient mobility. These two issues about the health care services reform and patient mobility are the tip of the iceberg the issue of health represents. It is necessary to see the links between the policies that are pursued in Brussels and the policies that could be shaped between all the other parties involved in order to create an overall strategy. A couple of facts about the internal market need to be mentioned. A debate about the very nature of the relationship one can create between health policies, on the one hand, and internal market discussions, on the other hand, has taken place. It is often and rightly said that health services are not services equal to those of a service station on a motorway and therefore they should not be treated in the same way. Naturally, providing health services differs from the classical economic model in many ways. By and large, there are no competing suppliers with equivalent or substitutable goods across health care. Customers or patients do not possess comprehensive information about different treatment 46

49 CLOSING SPEECH possibilities and prices do not depend upon the classic supply and demand process. The reasons for the model of classical economics not applying to the health system are manifold. At the same time, some benefits are drawn from the single market in areas such as pharmaceuticals and health technology. Certainly, the approach in Brussels is that health services should not be treated as market services in general, but ways ought to be found to achieve some of the benefits that the market approach or the diversity of opportunity in the market can offer without compromising fundamental health values or social values. In this respect, it is very encouraging that health ministers want the health issue to be taken out of the Services Directive. First of all, common values must be defined before decisions regarding reforms or strategies for the health services can be made. The sequencing of discussions in the Health Council has been adequate and as long as values have precedence other issues will also be dealt with in an optimum manner. To conclude with, the current stage of the health services initiative is that the consultative phase has reached the half-way point, and the Potsdam conference will hopefully produce even more substantial contributions to the consultative process. Hereby, it is necessary to take into account that it might be considered rather unkind of the Commission to ask everybody in Europe as well as every organisation to respond to the single consultation as it might be quite embarassing in given constitutional set-ups depending on which Member States one lives in. Who should decide what the input ought to be? At this stage the different views are collected and they are not going to be weighed depending on where they come from. That will be done later, when and if the Commission makes its proposals, and it will be up to the Council and Parliament to decide. At this stage, input to the consultation will be weighed by their intellectual quality. Thus, good ideas from a private citizen may be more influential than a poor submission from a large member state. Clearly, once all the input has been gathered, it cannot be simply added up with the average being the final answer. Therefore, the informal meeting of ministers in Aachen in April will be crucial for a first exchange between the Commission and the Health Ministers and it is also important to reach out to others who do not participate in such a meeting but hold crucial powers and responsibilities in the field, which is necessary for further refinement of the consensus. It does not mean that the process will last forever, but this way it can be promised that the Commission is not going to shut the door at the end of the consultations just to open it again later for handing over a proposal. This is a multi-step process where everyone should be participative. When a public opinion poll is carried out in a Member State, its citizens often reply that, if they could get better or earlier treatment they might be willing to go abroad, even though only two in a hundred actually know how to do it and only one in a hundred has actually done it. It is a genuine problem that patients do not know better and if patients do not know, probably many doctors do not know either and if the doctors do not know it is probably because personnel in the public services have also certain doubts and hesitations. We are crucially underselling the status quo simply by not describing it. Thus, clarity on what is possible and what is allowed or not allowed would be the first important requirement for provider organisations, for purchasers, for health insurers, for health professionals and especially for the patient. Beyond that, whether there should be other activities either to legislate, to refine law or to launch initiatives, will depend on the crucial test of value. The main point in the consultation is to find out about what is sensible to do and then do it. With the Commission approaching its next stages this year, other actors might do so with open minds as well. So far, some of the responses to the consultations included people saying that the status quo was perfect. Hopefully, when the next stage of the discussion is reached, everyone will be self-critical enough to recognise that the status quo is never perfect. The key question is whether it is worth taking the risk of moving away from the status quo? But this is a highly political question. Nonetheless, by approaching it with an open mind and with the well-being of the patient and not the comfort of the system being the priority, the right path is being followed. 47

50 THE FUTURE OF HE ALTH INSURANCE The Future of Health Insurance in the Light of a Balance between National Sovereignty and European Cooperation Outlines of a European Consensus* Dr Doris Pfeiffer, President of the Association of Health Insurance Funds for Employees (VdAK/AEV), Germany The topic of this event is the Social Dimension on the Internal Market, a topic that many people cannot specifically comprehend initially, but one that directly affects them and concerns them in their everyday life. This is because many fears that the citizens associate with the development in Germany and in Europe are due to the fact that the social dimension or the value of social issues in the discussions and disputes of the past years have not been as much at the forefront, as would have been sensible and desirable. Instead, priority was given to an economic viewpoint that exclusively rated the social security systems as a cost factor. This exclusivity is definitely questionable. People failed to recognise the significance that is particularly held by the systems of social security for the stability and thus also for the productivity in a society. Thus, the fears of the citizens are understandable as to whether the forms of social security will also survive in the future. This applies just as much to national politics as to the EU. I therefore welcome the comment of Robert Madelin that it is important in Europe to first discuss values and where we actually want to go as a society, and only then to ask what the hurdles are in the realisation of these envisaged values and how they can be overcome. It is important to stick to this order. Therefore, it is a very welcome development that in summer 2006 the European Parliament began to discuss the European social model and made a decision on this. Based on this, social policy should not just be regarded as a cost factor, but also as a positive factor for economic growth in the countries of the European Union. To regain the trust of the citizens in the EU project and to emphasise the commitment of the EU to a social project, it is therefore vital to display much more proximity to the citizens than was previously the case. People must realise that this EU project is related to their living situation and that it is worth supporting. It must become clear that it is not a purely technocratic, cost-oriented and economically-oriented project, but rather one that is related to people s lives. This is also one of the principal reasons why we must repeatedly focus on the principle of subsidiarity. This is about questions of delimitation of competences, as they have already been discussed during this event: what is in the competences of Eu- 48 rope? What is the task of the national states? It is important to ensure that this Europe continues to remain close to its citizens, so that the problems are solved locally and not as may seem to many people in a faraway bureaucracy that the citizens can neither understand nor see and that regulates something that has little to do with their lives. Subsidiarity means: support in the sense of helping people to help themselves for the respectively smaller units this applies to families, communities, the national state and of course to the European level. We must create the prerequisite so that the respectively smaller unit can become active; there must be support to enable its further development. Therefore, the EU is both obliged to support the activities of the Member States, whilst simultaneously exercising a certain self-restraint when it comes to issues that can be dealt with by the national states. European actions are helpful when it comes to e.g. areas of public health, e.g. global health hazards such as bird flu/sars. A further area in which the support at European level makes sense is the promotion of the exchange of information and experience among the Member States. This was also elaborated several times during the course of this conference. The communication of best-practice models, for instance, is a reasonable approach so that we can learn from each other. It is about learning how others deal with problems, which solutions they take and, ideally, not making the same mistakes. Because it is true that the problems and challenges in the Member States are frequently similar. However, we have 27 different systems in Europe, which have grown over the course of history and are characterised by different cultural and socioeconomic framework conditions. They cannot simply be lumped together; it is necessary to look at them in different ways. Yesterday, Prof Reinhard Busse explained the assimilation trends of the various systems, but the example of Euregios, on the other hand, showed many differences which in detail could cause many problems. However, it is not just about system questions, but also about questions of mentality and attitudes. Just because nurses or caregivers are allowed to do one thing in one country doesn t necessarily mean they can do this in another country. Sometimes, such issues are dealt with in a very dif- *Translated from the German original.

51 CLOSING SPEECH ferent way and cannot simply be decided from above. That s why we mustn t forget these differences when talking about the actual cross-border possibilities. It is therefore vital to find a balance between European competences and national sovereignty in order to generate acceptance and trust also among the citizens. Our joint goal is a more efficient control of the health systems within the national states as well as beyond. But as a rule, health services are location-dependent services and health markets are not like other markets thus, there is a good reason why health services are in the responsibility of the Member States. Thus the citizens rapidly perceive Brussels contribution to this topic as interference that fails to take account of the specific national features. The majority of systems in the EU are based on the principle of solidarity and are characterised by redistribution elements. All of them are very interested in attaining longterm financing and ensuring general access to health services. However, the individual financing regulations and the organisation of access to health care services differ greatly. In the past, the jurisdiction of the European Court of Justice led to a few rulings that initially caused quite a stir about the possible consequences. The result and this is also confirmed again during the course of this conference is that the jurisdiction of the European Court of Justice has not led to serious consequences for the systems. We can however take the opportunity to make use of the cross-border services. In this context, the German legislator has introduced corresponding cost reimbursement regulations in the Social Code. At the same time, it is also possible for the financers to conclude contracts with foreign service providers in order to develop reliable framework conditions for the insured. For the general topic of this event, it is important to note there is a consensus on the fact that the location factor of health is the basis for stability and growth. This is why we have to convey the social values in Europe: they are a principal element of a community that is not only based on economic principles, but also places a stronger focus on the social dimension. Regarding Europe not only as an economic area, but also as a social area is a principal feature of differentiation in comparison to world regions such as Asia or the USA. In Europe, we are a community that is not just based on economic framework conditions. This is a point that we can and must emphasise even more strongly in the future. I am glad that this aspect of Europe has recently been focussed on even more, but that s not yet enough and we should continue to deal with the social dimension of Europe and to further promote it. A further topic of this event was the question as to whether a regulative framework as a result of the jurisdiction of the European Court of Justice is necessary. We believe that such a framework is not necessary. Of course, we need valid information and greater transparency for the insured and for patients who would like to make use of services beyond their Dr Doris Pfeiffer national borders. I have already pointed out that the German legislator has already realised this. However, in my opinion, the introduction of a regulative framework is not the main priority, but it is more important to first study the dimension of the actual use of cross-border health services, and then to precisely check what the individual problems and difficulties are that occur in this context. These specific problems must then, of course, be properly solved. I can only agree with Robert Madelin: it s not as if things couldn t get any better, but in my view it does not make any sense to organise an all-embracing legal framework in such a form that would possibly trigger new problems. That s why I think it is better to take a look at specific details that could be improved the example of Euregio near Maastricht has been presented during the course of the conference and shows that already in a decentralised process needs-oriented possibilities can be found in order to provide a regional solution to the existing problems. A further important topic is the promotion and expansion of information offers and a greater transparency for the insured. The EU has provided a good basis for this with the development of its internet portal. To continue in this direction will make Europe considerably more transparent and perceivable for its citizens. I don t think that people have to know that there is the EEC directive 1408/71. I don t think most people in Germany know that there is a Social Code V. But it is very important for the citizens to know when and where they can make use of which health services, which quality these services have and how they can be sure that these services are financed on a high-quality level at affordable costs. There is certainly a lot to be done on these matters. As an outlook for a European consensus, I would like to summarise the central points as follows: we are justifiably holding on to the subsidiarity principle as this enables us to ensure that Europe remains close to its citizens; we promote common social values in and for Europe; we promote transparency for the citizens; we continue to improve the exchange of information because we can certainly learn from each other. And we have to avoid overregulation because that would be detrimental to Europe s image. We would do well to limit ourselves to what is necessary, but we really should keep to this. 49

52 THE FUTURE OF HE ALTH INSURANCE The Future of Health Insurance in the Light of a Balance between National Sovereignty and European Cooperation Outlines of a European Consensus* Dr Klaus Theo Schröder, Secretary of State, Federal Ministry of Health, Germany During the course of this conference, it has become apparent that the European health policy I ll consciously call it that is a very complex task. Forming this is therefore also a particularly rewarding task. The special features lie in the already addressed double function, which is a typical and intrinsic part of health care. On the one hand, health care intensively promotes a wide range of innovations. It creates a large number of jobs. Of course, there is not always an equal distribution of these, but overall there is a positive effect. On the other hand, all our European health systems are also associated with burdens for taxpayers or contribution payers by refinancing themselves through health insurance funds or the state budget. The solution of the conflict therefore inevitably lies in a balancing act: it can certainly not be about erecting a kind of protective wall against the freedoms of the internal market in our unified Europe. On the other hand, I am grateful that this has been emphasised in many ways during the course of the event health care is not a market like other markets that we know. In all Member States of the European Union, health care serves as an instrument for fundamental safeguarding against elementary risks of life. To this extent and this is where a joint position becomes apparent the mechanisms in health care must satisfy the welfare state requirements and common values of a European social model. It was nice to hear that it was possibly love, but at least the European Court of Justice, which set in motion many of the focuses of our discussion. In this discussion of the past few years, it has become apparent that we on the level of the European Parliament, in the discussion of the involved councils and also within the Commission have developed a high sensitivity for the necessary balance of the performance and the financing of the access, always with a view to the solution of the addressed conflict. I have the impression and would like to include this in our health policy debate: in the last few months, the citizens have very clearly experienced that this 50 Europe has not only become larger and more complex; this Europe takes a much closer look when it comes to our specific needs, for example in terms of an illness or an accident. That is why the necessary and difficult discussions are also an encouraging sign. Many Member States have transposed the principles of legislation of the European Court of Justice in national law. It has always bothered me and this was also addressed here again why the first reactions to the legislation of the European Court of Justice at the end of the 1990s gave the lasting impression that we lose and thus everyone loses. This impression can t be right. In the further formation for the practice in the Member States and in our European Union as a whole, in terms of the question on the regulatory framework, we must hold even more in-depth discussions, alone due to the undeniably different starting points and occasions. For people in our countries, there is not only cross-border care, something on which we received an interesting report as part of this event. In this Europe, we are not only, but often, tourists. We are frequently on business trips and this does not just apply as it may seem at first glance to top managers and internationally active consultants, but also e.g. to lorry drivers who travel through Europe and use the necessary services. The older people in Europe, as we know this applies at least to the Germans, use the freedom of establishment in old age for a completely different purpose and would like to live in a more favourable climate. Do we actually have the right, in the event of rare hereditary diseases, to say the patient may only go in search of the best treatment in his or her own national state? Isn t this perhaps an offer, an opportunity to operate a joint centre of excellence? Because even the bigger Member States of the European Union would scarcely be capable of providing for an appropriate offer for those who are suffering from such a disease. I believe and get the impression that the Commission and the European Parliament also believe that it would not be functionally appropriate and would not satisfy political *Translated from the German original.

53 CLOSING SPEECH expectations if we left the details of what is concerned solely to the European Court of Justice also in the future. We must face the challenge of turning health care in Europe with all its differences into a political project in the interest and in view of the needs of people in our Europe. We need equal competition. We need instruments of quality assurance and much more. We are convinced that a corresponding basis absolutely could generate legal certainty. Legal certainty is a first prerequisite for planning certainty in all sectors involved. This applies, in terms of the German health system, to the financers, it applies to the service providers, it naturally also applies to the patients. Health care in this sense is a component and cornerstone of the European social model. I realise that legal certainty alone as is often the case in a national framework will not help to form everyday life. For this purpose, it is also important to learn from each other culturally, to understand the social context. It is also important to recognise different viewpoints on and focuses of health care. However, this only remains possible if we open up these possibilities where they are necessary for everyday life. To this extent, we believe that it is useful to, on the one hand, continue along the chosen path with market freedoms and, on the other hand, continue to pursue the necessary regulation. In order to ensure the special diversity that also constitutes the value of this European social model in all its forms, it will be important to equally value and continue to enable the use of the control mechanisms and instruments, which are valid, currently used and set to be used in the future in the respective systems. The differences between the systems that we have in Europe are reflected in distinguishing and various control instruments and thus move between the regulations that are a result of the Treaty and are similar to the cartel and state aid law. Dr Klaus Theo Schröder That is why it seems necessary to us to actively approach the challenge with which we are faced. We should take sufficient time for the law-making in the sector of health care. If we can make any contributions to this during our presidency, we will do so. Robert Madelin has already pointed out that we would like to use the informal meeting of health ministers in Aachen on 19 and 20 April 2007 as a forum for the political exchange of opinions on this topic, and perhaps there will also be a possibility for discussion at the formal meeting of health ministers in Brussels on 31 May At the very least this is directed at our Slovenian and Portuguese friends we will do everything to get the discussion going so that they can continue to work in a more structured manner on this difficult matter. If we succeed in mastering the challenge of finding a way between necessary social security and freedom in our Europe, including and particularly in the sector of healt care, which the citizens regard as added value for Europe and accept in such a central field of services of general interest; then, without overestimation, we can take the health policy and make an important contribution to convergence in our Europe. 51