Introduction

The development of modern pharmaceutical products has led to a vast improvement in health care globally. Drugs and vaccines have virtually eradicated some of the major health scourges of years gone by, such as smallpox. Improvements in treatment of what were regarded as fatal conditions, such as HIV/AIDS, have resulted from the development of drugs such as AZT. Nonetheless, whilst such developments have great potential, sadly there have been some instances in which pharmaceuticals have been viewed in a considerably less positive light. The drug Thalidomide, given to pregnant women in the 1960s, was linked to the development of major congenital disabilities. Less than a decade later, it was alleged that the pertussis vaccine resulted in infant brain damage. The controversy regarding the administration of vaccines continues to this day, in the light of claims made linking the administration of the combined MMR (measles, mumps and rubella) vaccine to autism. Thus, much of the legal (and political and ethical) debate regarding pharmaceuticals has focused upon the risks which they pose and the need for appropriate regulation, and the prospect for compensation should harm arise from the use of a pharmaceutical product. These concerns are also reflected in the developments which have taken place in EU law in this area.

In this chapter, which considers the regulation of pharmaceuticals, in common with our overall approach in this book, the focus is on the effects that legal norms promulgated at EU level with respect to the regulation of pharmaceuticals have on national health law and policy in the Member States.

Introduction

The law's engagement with public health provides one of the earliest illustrations of the interface between health and legal regulation. The scourges of typhoid, cholera and the plague led to nation states introducing explicit legal regulation of such diseases. This took the form in many instances of draconian legislative restrictions upon personal freedom. References to the isolation of lepers are to be found in the Old Testament. Practices of quarantine can be traced back to 1000 and Venetian legislative statutes concerning plague quarantine relate to 1127. By the fourteenth century, overseers in Venice were authorised to spend public money for the purpose of quarantining persons, goods and ships on an island in the lagoon.

While, for centuries, detention was the response to perceived dangers to public health, over time, the law in some European countries began to be used to facilitate a more sophisticated response. Concerns regarding the spread of disease were linked to poor living conditions and inadequate sanitation. The revolution in public health in the UK, for example, was linked to the reforming zeal of Edwin Chadwick, who argued that the root cause of infectious disease could be found in poor sanitation. Through the reports of the Royal Commission on the Health of Towns established in 1843, the momentum developed for legislative amendment. In 1848, the UK passed the Public Health Act which, rather than the “reactive” quarantine practices, can be seen as one of the major steps towards “proactive” public health.

Health law and the European Union

In 1996, a young British woman, Diane Blood, sought to use sperm which had been collected from her recently deceased husband, Stephen Blood, while he was critically ill with meningitis. Although Stephen and Diane Blood had discussed having a family, crucially, Stephen had not given written consent for the taking of his sperm. In English law, the use of the sperm was prohibited under the UK Human Fertilisation and Embryology Act 1990. However, relying on Diane Blood's EU law right to receive medical treatment in another Member State, the English Court of Appeal granted Diane Blood permission to receive the treatment she sought in Belgium. Diane Blood subsequently gave birth to a son, Liam. In 2003, another British woman, Yvonne Watts, sought a hip replacement for her arthritic hip in France, to avoid an NHS waiting list. She then attempted to reclaim the cost of her treatment from her local National Health Service Trust. The Trust refused, and Yvonne Watts brought an action in the English High Court, challenging their decision, claiming that it was ultra vires, contrary to provisions of the UK Human Rights Act 1998, and contrary to her free movement rights under EU law. She lost on the facts, but the case is currently subject to an appeal and has been referred to the European Court of Justice.

Introduction

As we noted in chapters 1 and 2, health law is concerned with “rights” of individuals, for instance, to access elements of health care, or to particular standards of treatment in the health care context, or even to health protection. Health law is also centrally concerned with the legal construction of responsibilities– primarily that of the state in relation to the provision of health care services or in the area of safeguarding public health. However, in general, as is recognised by international and national (constitutional) law, national governmental institutions hold a primary responsibility for health care provision, health protection and promotion of health within their territories. In the case of the Member States of the EU, however, this responsibility for health is not located solely with national institutions, but may in some circumstances lie with the institutions of the EU, or in interactions between national and EU institutions. The notion of legal responsibility is constructed in EU law by reference to the powers or “competence” of the Community. This chapter therefore considers Community competence in the field of health.

The general context here – the allocation of competence within the EU's system of governance – is very much a matter of current concern for the EU, as reflected in the Laeken Declaration and the Draft Treaty Establishing a Constitution for Europe (DCT). This concern relates to the overall questions of legitimacy of the EU's “constitutionalised” legal order that were raised in chapter 2.

Introduction: what is the European Union?

The question this book sets out to answer is: “how – to what extent and in what ways -does EU law affect health law and policy?” Chapter 1 offered an indication of what we (and others) mean by “health law and policy”. This chapter turns to the other part of the question: EU law. It is obviously impossible to develop an understanding of the impacts of EU law on health law and policy without a contextualised understanding of the legal system of the EU. We hope that this book will be of interest to a diverse group of readers, many of whom may have no background in EU law. This chapter therefore provides an introduction to the EU's legal order, its general principles and its institutions. The aim is to provide a framework within which the more detailed analyses offered by subsequent chapters may be placed. This framework provides historical context; it also aims to elucidate the legal structures and institutional mechanisms of the EU.

The legal order of the EU is unique. It differs from both the national legal systems of its component Member States and from traditional international law. It is also a legal order with a clearly articulated dominant purpose: that of “integration” of the markets, economies, and (ultimately) related policies of its Member States.

Introduction: the roles of the EU in health law

Since Diane Blood sought to use EU law to enable her deceased husband's sperm to be exported, so that she could begin IVF treatment, the influence of EU law on health law and policy in the Member States of the EU has grown apace. Although today there is no single body of “European health law”, the EU is having an ever-widening involvement in relation to health, which is, in turn, affecting the manner in which individual Member States regulate their national health policies. Some of this involvement may be regarded as incidental or reactive, and indeed EU health policy, in general, has been described as having progressed very much on a “muddling through” basis. However, it is also the case that, in certain areas at least, there is, currently, an increasingly structured involvement. This is particularly notable in the fields of public health and research, but may extend to further areas in the future. Indeed, as we were finishing this book, the health ministers of the existing and future Member States, the European Parliament and the European Commission announced the conclusion of the “High Level Process of Reflection on Patient Mobility and Healthcare Developments in the EU”. The Commission will respond to the recommendations made by the report from that High Level process with a Communication in 2004. It is intended, at least by the Commission, that this will develop into an overall EU health strategy.

Introduction

In this chapter and the next, we consider two of the areas which would, in standard health law jurisprudence, be frequently considered as falling within the boundaries of “patient rights” (for instance, to confidentiality, protection of personal autonomy and dignity, consent to treatment, and so on) and the right to access health care services. As we noted in chapter 1, while it is the case that the law of the EU may, in some respects, affect those issues which are to be commonly found in health law textbooks, such issues are not neatly categorised under the “headings” of health law. Nonetheless, as we have seen already, there are certain areas in which the EU appears to be having an impact on health law in the Member States. One such area is that of access to health care services, as illustrated by the Diane Blood and Yvonne Watts stories with which we began this book.

In the case of access to health care services, the subject of this chapter, in many respects, the use of rights language in this context can be seen as something of a misnomer. A claim by an individual of a “right” to access health care services is wholly dependent upon the particular service being available. Where services are state funded, this depends on the resources available. Competing rights claims may arise. This is probably why there has been notable judicial unwillingness at national level to become embroiled in disputes concerning resource allocation.

Introduction

Health information privacy is one aspect of the right to privacy. Wacks regards the notion of “personal information” as essential to such a right. This he defines as being:

Much of the Anglo-American legal discourse concerning privacy in the common law tradition derives from a crucially influential article in the 1890 Harvard Law Review. The authors of this article, Warren and Brandeis, examined US case law and suggested that elements of this case law, such as defamation, copyright and breach of confidence, culminated in recognition of a right to privacy, which they regarded as being a “right to be left alone”. Health information is today commonly regarded as an important part of an individual's right to information privacy, and indeed information worthy of particular protection. Information privacy in the health context is integrally linked to the perceived inherent sensitivity of health information. In this chapter, we explore the effects of EU law on rights to privacy in health contexts, which include both health care and clinical research settings.

As we noted in chapter 1, there is no “European health law” in the sense of a harmonised set of health care or medical entitlements, applicable across the whole of the EU, determined by institutions at EU level, and indeed many elements of “health law” are not the subject of EU regulation.

Introduction

The regulation of health care professionals has a long and ancient history. The teaching and practice of physic and surgery dates from the days of Hippocrates and the works of Galen (131–201 AD). The Salerno School, a group which had settled in Salerno in Italy in AD 900, not only taught medicine but, it is believed, was the first to confer doctorates. Overt occupational control is illustrated through the operation of licensing procedures observable in certain European countries as long ago as the sixteenth century. Today, statutory regulation of health professional bodies is common across EU Member States. Our concern in this chapter is with the extent to which EU law has affected such regulation. As we will see, such effects have so far been limited, marginal and mainly indirect. They will probably remain so, unless significant cross-border movements of patients alter the political imperative for Member States to coordinate or even harmonise their regulatory standards.

Before we explore interactions between the EU's legal order and those of its Member States in the regulation of health care professionals, we need, briefly, to develop some parameters concerning who is a “health care professional”, and set out what elements constitute the “regulation” of such health care professionals. Our starting point here is that “health care professional” is a broader category than that of “doctor”. Different approaches have been advanced for identifying professions, including the health care profession.

Introduction

This chapter considers the ways in which the EU has become involved in the regulation of clinical research. The concerns of health lawyers with clinical research generally focus on the legal protection given to the rights of the subjects of (or participants in) clinical trials, in the light of a recognition that states have responsibilities to ensure protection of such rights.Post Nuremberg, the legal regulation of research activity has also been seen as a matter of particular concern for international bodies. One of the main drivers in this area is the need to ensure that research practices are ethical.This is reflected in a series of influential statements made by international bodies, such as the World Health Organisation and World Medical Assembly Declaration of Helsinki,and, in a European context, the Council of Europe in its Convention on Human Rights and Biomedicine 1997, and more recently in its draft Additional Protocol on Clinical Research.In the EU context, Community competence to regulate the rights of research subjects can be seen, for example, in various provisions within the Clinical Trials Directive, discussed below. The legal basis of this Directive is Article 95 EC, and Recital 10 explains that harmonised administrative provisions for the conduct of clinical trials are needed in order to ensure effective conduct of such trials in the EU. However, in spite of its apparent harmonisation-based rationale, the Clinical Trials Directive contains a number of provisions with an ethical dimension, and is to some extent framed in a human rights idiom, with particular reference to rights to physical and mental integrity, and privacy.