Institutional Build-up of EU Health Actors

The growth of substantive EU public health and individual health policy and law is matched by a historic build-up of EU institutional actors. The institutional expansion has increased the EU’s capacity for law- and policy-making in the field of health and as such the possibility for the growth of EU power in this area. This chapter traces the evolution and growing presence of EU institutional actors in human health. It outlines the relevance of the growing institutional capacity for creating EU health law and policy. Subsequently a sketch is drawn of the emergence of EU institutional involvement in health policy—while taking into consideration that it may not be possible to create an exhaustive overview of all health actors involved at the EU level. This outline illustrates the growth of a variety of institutional actors and the expanding number of ways these engage in health policymaking. Moreover, the chapter demonstrates various ways in which EU institutional involvement in health is continuously expanding and changing. It illustrates that there is ample opportunity for formal actors with legislative or regulatory powers to be involved in informal processes of coordinating policy in the shadow of hierarchy. The growing institutional presence of the EU in health policy over time, and the possible shift in power to the EU this can entail, again confronts us with the pressing issue of its impact on fundamental rights and values in health.

EU ‘Public Health’ and ‘Health-care’ Law and Policy

Taking into consideration the central health provision in the Treaty, which outlines that health is to be ‘mainstreamed’ in all other EU policies, it could be inferred that EU public health and health-care policy and law is either non-existent as an autonomous policy area, or that it is basically everything, in that all EU public policy is also health policy. This puzzle forms the starting point for this chapter, which describes the nature of EU power in the field of human health currently. The chapter first, as an initial exploration, questions the existence of a European authoritative concept of ‘health’. Second, the chapter takes into consideration the nature of EU policymaking in general and regarding health in particular and develops a concept of EU health law and policy, distinguishing between EU public health and EU health-care law and policy. Last, to draw out the scope of EU health policy more specifically, a historical overview is given of the involvement of the EU in health. The chapter conceptualizes EU power in the field of human health as authoritative allocations of value through the European Union political system with the object of protecting and promoting human health. This conceptualization draws out the scope of policy that will be the central focus for the following chapters.

European Union Rights and Values in Human Health

This book looks at the impact of the expanding power of the EU in terms of fundamental rights and values. The current chapter lays down the framework for this analysis. Law did not always have a central role to play in the context of medicine and health. The role of law grew after the Second Word War and the Nuremberg Doctors Trials (1947), in which preventing the repetition of atrocities that were committed in the name of medicine became a guidepost for future law regarding patients’ rights and bioethics. In the period after the War, across the EU Member States, health law developed as a legal discipline in which a balance was struck in medicine and public health between law, bioethics, and fundamental rights. The role of EU fundamental rights protections in the context of public health and health care developed in relation with the growth of multilevel governance and litigation (national, international, Council of Europe, and European Union). For the analysis here, this chapter develops an EU rights and values framework that goes beyond the strictly legal and allows for a ‘normative language’ that takes into consideration fundamental rights as an expression of important shared values in the context of the European Union. The perspective of EU fundamental rights and values can demonstrate possible tensions caused by EU health policy: implications in terms of fundamental rights can show how highly sensitive national policy issues may be affected by the Member States’ participation in EU policymaking activities.

The Silent Revolution in EU Health Law and Policy

The first chapter outlines that most national health laws assume a special connection between health law and policy and fundamental rights and values. The denial or approval of authorization of a specific controversial medication, or the payment for health care in a Member State other than the home state of insurance—and many of the other questions and issues that are addressed in the EU with regard to human health—illustrate that the involvement of the EU in human health can also involve controversial questions, where fundamental rights, bioethical issues, regulatory problems, and redistributive choices may intertwine. This calls into question the power the EU has in this regard, particularly if we take into consideration that human health law and policy are often seen in light of a special reciprocal relationship with fundamental rights and values. Infringements of fundamental rights can harm human health, for instance in cases of torture, or discrimination against people with a particular disease such as HIV/AIDS or mental disorders. At the same time health policy can affect fundamental rights, such as when obligatory vaccination programmes or quarantines are ordered. Hence fundamental rights and values form a benchmark for analysing the legitimacy of health policy. The specific values and rights that are internal to health law set the agenda for this book.

The EU Constitutional Constraints on the Intrinsic Relationship of Values, Rights, and Human Health

The main thrust of this last chapter is that, while the EU’s power in public health and health care is expanding, the current constitutional doctrines for constraining EU power in the field of human health are not designed specifically with human health in mind and therefore are not capable of safeguarding the values and rights that are intrinsically connected to human health law and policy. The constitutional setting of the EU affects the place and protection of values and rights in EU health law that are central to the health law of the Member States—values and rights such as human dignity, equality, and solidarity. At Member State level, EU law affects health law, as it is approached as a barrier to trade, whereas at EU level, health law is re-created, but its inherent values are often depoliticized through science or lose significance in light of ‘higher’ internal market objectives. If the EU is expanding its powers in human health, and there are constitutional constraints to offer fundamental rights protections to individuals and populations, the legitimacy of EU power in health can be questioned. Hence, considering the reciprocal relationship of health policy with fundamental rights and values, EU health policy has an important role to play in the legitimacy of the EU political system itself, and this might involve taking a step back from its growing power in the field of human health.

EU Public Health: Countermeasures to Swine Flu

This chapter is a case study on the EU’s response to a public health emergency in the form of countermeasures. More specifically, the scope of the case study is the involvement of the EU in the response to the outbreak of swine flu (influenza A H1N1) in 2009–10. The case study explores and maps legally the manner by which health policymaking can become strengthened through intertwining with more formal rules and the impact this may have for EU fundamental rights and values. It illustrates the growth and impact of EU health policy beyond legislative powers, where Member State engagement in EU health policymaking may have an impact beyond what is envisioned in law. The chapter first addresses how measures to counter a public health emergency can be taken at EU level, particularly focusing on the institutional actors. Second, the chapter identifies the countermeasures taken at EU level to combat the swine flu pandemic. Third, the chapter looks at the ways informal health policy (deliberately) intertwines with more formal regulation. Lastly, the impact of EU health law and policy in this particular case is analysed in terms of fundamental rights and values. The case study shows that the precarious balancing between public health and individual rights is not done by Member States alone.

EU Health Care: Access to Medical Care

This chapter examines developments regarding EU legislation in the area of health care, rather than public health. The chapter is a case study looking into the processes and the involvement of different EU institutional actors and policy mechanisms in the adoption of the Directive on patients’ rights in cross-border health care (‘the Directive’). First, the chapter introduces the Directive itself, and considers whether it expands access to health care across the EU. Second, it turns to the way the Directive was adopted, focusing particularly on the different roles of EU institutional actors and the discourse and controversies that developed in health care in the EU as a result of the legislative process. Last, the chapter addresses the expansion of EU health-care policy beyond the adoption of the new Directive that resulted from the increased discourse on health care and its impact for individual rights and access to health care.