The subject of this paper is the role of the European Union (EU) in shaping the health policies of member states. In this paper, the term shaping is used for two policy processes, agenda-setting , and policy formulation, since these two processes are sometimes used interchangeably (Hill, 2010: 145, Versluis, van Keulen, and Stephenson, 2011: 133). Health policy is not a common EU policy and the EU has a very weak legal competence in that area. However, the EU has a great role in shaping the health policies of member states, regardless of their real needs and financial possibilities, through different mechanisms, such as hard and soft law and direct influence on domestic actors. The purpose of this paper is to explain the functioning of the EU health policy with the help of Europeanization and neo-functionalism and to show the logic of the EU’s influence and mechanisms, which enable the shaping of the health policies of member states. The role of the EU in shaping health policies and transferring them to the national level will be shown on the example of rare diseases policy. The time frame covered in this paper is from the beginning of the 1990s, namely 1992, until 2015 – the period when the rare diseases policy is shaped. The Maastricht Treaty was adopted in 1992, and this Treaty mentiones for the first time the EU health policy. The next important events were the establishment of EMA in 1995 and EURORDIS in 1997, whose activities enabled the adoption of the official Orphan Regulation (EC) No 141/2000 in 1999. The shaping of the rare diseases policy was monitored until 2015, when the Republic of Croatia adopted the National Program for Rare Diseases 2015-2020, when the EUROPLAN project finished and the International Federation of Rare Diseases International (RDI) was established with the “aim of making rare diseases a world public health priority” (Eurordis, 2015b). The paper is divided into several chapters. The literature review shows the existing state of the EU health policy – functioning of EU hard and soft law, and the rare diseases situation at the national and EU level. A definitionof Europeanization and neofunctionalism is given in the next chapter, which shows their relation to the health policy. The second chapter gives a theoretical framework and work model used to explain the logic of the EU’s influence and mechanisms. The theoretical model illustrates how intertwined Europeanization and neofunctionalism are, and at the same time, it shows the involvement of actors in the process. The methodology chapter gives an overview of the methodology used in the paper – case study, qualitative VI interview, policy network, actor analysis. The research questions are listed below, and one dependent and three independent variables with their indicators are formed. The third chapter presents an analysis and its results. The conclusions of the research are given in the final chapter. EU health policy is first mentioned in the Maastricht Treaty (1992), Article 129, and the following a treaty on health policy is the Amsterdam Treaty (1997). The Lisbon Treaty (2007), in Article 168, ensures a high level of human health protection – “Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health.” At the same time, it is stated that the “EU will respect the competences of member states in defining their health policies, in health care organization and the provision of health services”. Despite the fact that member states formally have full responsibility for their health policy, it is possible to see that EU has increased its competence in the field of healthcare over the time (Lelieveldt and Princen, 2011: 180). The EU's broader competence for healthcare is possible for several reasons. Namely, EU health policy has fundamental contradictions in its essence (Mossialos et al, 2010: 4); the Lisbon Treaty explicitly states that health policy is under the competence of member states, but at the same time “health systems involve interactions with people (patients, health professionals), goods (medical and pharmaceutical devices), services (health insurance) and capital, whose freedom of movement is guaranteed by the founding contracts and the Court of Justice of the EU” (Mossialos et al, 2010: 4, Greer, 2011b: 187-188). Health policy is influenced by constitutional asymmetry between EU policies that promote market efficiency and those that promote social protection (Scharpf, 2002, cited in Greer, 2011b), where market policies have the advantage. The national health policy is under the influence of the different EU areas that are not necessarily linked to the health sector. The influence of these areas on the health policy of member states forms a patchwork (Hervey and Vanhercke, 2010: 85) of the different areas: the internal market, social affairs, public health, entrepreneurship and economic policy. This division of the responsibilities is also visible in the work of the European Commission's Directorates-General: DG Health and Food Safety, DG Internal Market, Industry, Entrepreneurship and SMEs, DG Employment, Social Affairs and Inclusion. VII EU uses very successfully hard and soft law in order to achieve its goals in shaping health policy. The hard law refers to the decisions of the Court of Justice of the EU and EU Regulations (Rodin and Ćapeta, 2008), which are binding in their entirety framework and work model used to explain the logic of the EU’s influence and mechanisms. The theoretical model illustrates how intertwined Europeanization and neo-functionalism are, and at the same time, it shows the involvement of actors in the process. The methodology chapter gives an overview of the methodology used in the paper – case study, qualitative VI interview, policy network, actor analysis. The research questions are listed below, and one dependent and three independent variables with their indicators are formed. The third chapter presents an analysis and its results. The conclusions of the research are given in the final chapter. EU health policy is first mentioned in the Maastricht Treaty (1992), Article 129, and the following a treaty on health policy is the Amsterdam Treaty (1997). The Lisbon Treaty (2007), in Article 168, ensures a high level of human health protection – “Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health.” At the same time, it is stated that the “EU will respect the competences of member states in defining their health policies, in health care organization, and the provision of health services”. Despite the fact that member states formally have full responsibility for their health policy, it is possible to see that the EU has increased its competence in the field of healthcare over the time (Lelieveldt and Princen, 2011: 180). The EU's broader competence for healthcare is possible for several reasons. Namely, EU health policy has fundamental contradictions in its essence (Mossialos et al, 2010: 4); the Lisbon Treaty explicitly states that health policy is under the competence of member states, but at the same time “health systems involve interactions with people (patients, health professionals), goods (medical and pharmaceutical devices), services (health insurance) and capital, whose freedom of movement is guaranteed by the founding contracts and the Court of Justice of the EU” (Mossialos et al, 2010: 4, Greer, 2011b: 187-188). Health policy is influenced by the constitutional asymmetry between EU policies that promote market efficiency and those that promote social protection (Scharpf, 2002, cited in Greer, 2011b), where market policies have the advantage. The national health policy is under the influence of the different EU areas that are not necessarily linked to the health sector. The influence of these areas on the health policy of member states forms a patchwork (Hervey and Vanhercke, 2010: 85) of the different areas: the internal market, social affairs, public health, entrepreneurship, and economic policy. This division of the responsibilities is also visible in the work of the European Commission's Directorates-General: DG Health and Food Safety, DG Internal Market, Industry, Entrepreneurship and SMEs, DG Employment, Social Affairs and Inclusion. VII EU uses very successfully hard and soft law in order to achieve its goals in shaping health policy. The hard law refers to the decisions of the Court of Justice of the EU and EU Regulations (Rodin and Ćapeta, 2008), which are binding in their entirety Schmitter, 2002), as well as applicable and compatible with other theories, such as federalism (Dosenrode, 2010b). The echo of the theory can be found, for example, in institutionalism, constructivism, etc. (Schmitter, 2002). This paper outlines the history of the emergence of neo-functionalism, its advantages, and disadvantages, and why this theory is still very much "alive" and can be applied / found in health policy (Mutimer, 1989, Greer, 2006). In this paper, the definition of neo-functionalism includes the spillover effect, the transfer of authority, the role of actors, and the influence of neo-functionalism on multilevel governance (Haas, 2004, Schmitter, 2002, Rosamond, 2000). These aspects can be found in the health policy formulated by the EU and can help to explain its implementation. For example, because of the spillover effect, health policies have come under the influence of market policies (Mossialos et al., 2010: 10). The influence of market policy is also visible in the transfer of authority (through supranational agencies), the decisive role of the Court of Justice of the EU, a spillover of DGS' responsibilities, and the role of actors. This paper analyzed the impact of the EU on shaping the health policy of member states based on the example of the rare disease policy. Rare diseases are defined as illnesses occurring in less than five individuals per 10,000 of the population (Croatian Society for Rare Diseases, 2015). According to the data provided by the DG Health and Food Safety (European Commission 2015), “between 27 and 36 million people in the EU are affected by rare diseases, which is 6-7% of the population, and it is estimated that there are 5 up to 8 thousand different diagnoses”. A large number of potential diagnoses pose an important public health problem. Furthermore, the fact that often whole families are treated for rare diseases presents economic and social problems (Hyry et al., 2013). The people affected by rare diseases are often faced with a number of problems in exercising their health rights. Rare diseases are specific for a number of reasons, and “patients suffering from rare diseases have traditionally been marginalized due to limited scientific research on illnesses, a small number of patients, lack of medical expertise, little public awareness, and a small number of medicines available to them” (Aagaard and Kristensen, 2014: 39). Not only at the EU level, but in Croatia as well there is very little research on rare diseases. IX All individual components (Europeanization, neo-functionalism, rare disease policy, EU health policy, actors, hard and soft law) are linked together within the theoretical model in order to answer research questions and hypotheses. With this theory and framework set out for the purpose of this research, this paper will try to answer a number of research questions. Research questions are: 1. How are decisions made and policies related to health issues created at the EU level? 2. What mechanisms does the EU use to achieve the desired results? 3. Why and how does the EU impose specific health policies to member states, regardless of their real needs and financial circumstances? 4. Did a need for a particular health policy already exist in a member state and has been further strengthened by the EU or has a policy been imposed? 5. Who are European and national actors throughout the process and what is their role? 6. How do all of these changes reflect on patinets’ rights to healthcare in member state? In order to give an answer to all these questions and follow the changes in the rare diseases policy one dependent and three independent variables have been set up: Dependent variable 1. Change of the health policy – example of a rare diseases policy The changes in the rare diseases policy are measured by the number of legal acts adopted at the EU and national level during the period from 1992 to 2015 in the area of rare diseases. Legislative changes are measured at several levels: - Adoption of national plans / programs / strategies / measures for rare diseases - Orphan drug market regulation - Regulation of clinical trials - Establishment of national and supranational agencies responsible for rare diseases. - Impact of the pharmaceutical industry - Health insurance coverage for patients with rare diseases - Research on rare diseases - Medical experts dealing with rare diseases Independent variables 1. Decisions made with the help of a decision-making process based on soft law X Soft law decisions are measured by the number of recommendations and opinions pertaining to rare diseases, the number of EU and national consultations on rare diseases and the number of research and projects carried out. These variables were measured at the EU and national level in the period from 1992 to 2015 2. Decisions made with the help of a decision-making process based on hard law Hard law decisions are measured by the number of legal acts adopted at the EU and national level in the period from 1992 to 2015 in the area of rare diseases. Several levels are included: the regulation of the orphan drug market, the adoption of national plans/strategies/measures for rare diseases, patients' rights under the national health insurance system, and the establishment of national and supranational agencies responsible for rare diseases and reference centres at the national level dealing with rare diseases. 3. The power of national actors The strength of the national actors is measured by the number of patient organizations founded for people with rare diseases, the number of professional associations dealing with rare diseases, the number of pharmaceutical companies dealing with drugs for rare diseases, and the number of medical specialists involved in this area at the national level. Within this variable, the networks between the actors are described at the national and EU level, as well as the actors’ strengthening capacities over the period from 1992 to 2015. Drawing upon the theory of neo-functionalism and the concept of Europeanization, this paper shows that the implementation of EU health policy is complex and that there are many indicators that need to be included in order to demonstrate this complexity. The research has shown that there are certain mechanisms and logic which the EU uses in order to influence member states' health policies, which appear to be under their very limited jurisdiction. The theory of neo-functionalism and the concept of Europeanization were applied to the rare diseases policy in order to demonstrate the mechanisms and logic that EU actors apply in the field of healthcare when shaping individual health policies. The example of the rare diseases policy has shown the complementary nature of soft and hard law, and their success in achieving their goals with the help of domestic and EU actors. The adoption of the Orphan Regulation in 1999, the establishment of EMA, and certain decisions of the Court of Justice have contributed to the creation of a substantive basis for the implementation of hard law in member states, although more subtle soft law has had a farther-reaching role. Neither soft nor hard law would have been XI able to contribute to the change had strong actors, both at the EU and domestic level, not been involved in their implementation. The theoretical model will show the impact of the concept of Europeanization and the theory of neo-functionalism on EU health policies, and thus the influence of the EU on the health policies of member states. Europeanization and neo-functionalism are compatible, their combination clarifies the implementation of health policy in the European environment, and its influence on member states, as presented in this paper based on the example of rare disease policy. Europeanization as a concept of multilevel governance and the ability of domestic actors to influence national policies with the assistance of EU institutions and supranational agencies can help in the presentation of the implementation of health policy. With the help of neo-functionalism and Europeanization, the effects of hard (Regulations, Directives, EU Decisions) and soft law (declarations, recommendations, guidelines, opinions) can be monitored. European actors, who participate in the decision-making process, use hard and soft law to achieve their goals, and with the help of the theory of neo-functionalism and the concept of Europeanization can be showed and explained. In this paper, an example of a rare disease policy is used to show how (and why) this policy is downloaded to member states. The national and European actors play a major role in this process, acting horizontally and vertically, and through various mechanisms, they are successful in imposing policies on member states. The shaping of a policy on rare diseases also includes legal regulations that can be imposed on member states, although a large part of the "imposition" of policy takes place through informal mechanisms - soft law can evolve into hard law. The supranational agencies, such as European Medicine Agency (EMA), also play a part in the whole process, considering that they have been given authority and more power in the decision-making process than the member states that are expected to abide by EU decisions. At the national level, domestic actors, with the help of soft law methods and European actors (which help them strengthen their capacities), have been successful in including a rare disease policy on the agenda with the aim of making some legal changes. In this paper, several research methods were used - case study, actor analysis, policy networks, and semi-structured qualitative interviews with key actors at the EU and national levels. XII For the purposes of this paper the case study design was narrowed down to health policy, specifically, the rare diseases policy shaped at the EU level and then transferred to the level of the The Republic of Croatia. This case study design allows a to abide by EU decisions. At the national level, domestic actors, with the help of soft law methods and European actors (which help them strengthen their capacities), have been successful in including a rare disease policy on the agenda with the aim of making some legal changes. In this paper, several research methods were used - case study, actor analysis, policy networks, and semi-structured qualitative interviews with key actors at the EU and national level. XII For the purposes of this paper the case study design was narrowed down to health policy, specifically the rare diseases policy shaped at the EU level and then transferred to the level of the Republic of Croatia. This case study design allows a deep insight into the process of policy shaping. The analysis of the actors involved in public policy shaping includes the mapping of the actors, an analysis of their relationships, interests, resources, and their interdependence (Hermans and Thiesse, 2009). The analysis of policy networks (Börzel, 1997) shows how actors interact (at the EU and national level) and exchange resources to be more effective and jointly make some changes. The 10 semi-structured interviews were conducted with key actors; rare disease experts at the EU and national level (three with European actors, representatives of EUORDIS – Rare diseases Europe, DG Health and Food Safety and EMA respectively, and seven with national actors, representatives of state bodies, professional societies, medical institutions, patient associations, pharmaceutical industry). A semi-structured interview generally allows a deeper and better insight into a process. In addition, during an interview, participants can be more easily accessed and issues not mentioned in official documents can be discussed (Weiss, 1994). This kind of interview is a valuable supplement to other methods as it provides different perspectives of different actors participating in a process. Rare diseases are a developing area and this paper can contribute to a better understanding of the implementation of EU health policy and it can clarify how national governments and the public may adopt a policy for a particular group of people with disabilities or EU asylum policy.