This collection of essays seeks to examine several developing areas of the law relating to pharmaceutical medicine and biotechnology in the European Community. The essays address four such topics which have emerged in recent years, namely: (1) free movement of goods and persons, competition and intellectual property; (2) European drug regulation; (3) biotechnology; and (4) product liability, which is addressed along with transnational health care litigation.

The Treaty of Rome established rules on free movement of goods (Articles 28 to 30 (ex 30 to 36) EC) and competition (Articles 81 and 82 (ex 85 and 86) EC), which have had a profound effect on the use of intellectual property rights to prevent the importation of patented and trade-marked pharmaceuticals from one European State to another. Professor William Cornish's essay explains the doctrine of exhaustion of patent rights in the internal European Community (EC) and European Economic Area (EEA) market. Here, patent rights are exhausted to the extent that they cannot be used to prevent the importing of patented pharmaceuticals from one EEA State to another, when first marketing of the goods is by or with the consent of the owner of the patent for them in any of the EC/EEA countries. Although acknowledging the doctrine of exhaustion for parallel importation from one EEA State to another, Cornish convincingly argues against a rule of international exhaustion of patent rights for parallel importation of products into the EEA from countries outside it, since patent systems are incentive systems and thus patentees should be able to engage in international price discrimination. Nevertheless, he appears to take issue with Belinda Isaac's criticism of the international exhaustion principle in respect of trade mark rights.

For the purposes of citation of the European treaties, the Editors have decided that with each initial reference to a Treaty Article, the new Article number should be given, followed by the old Article number in brackets and then the abbreviation for the relevant Treaty: for example, Article 47 (ex 57) EC. It is sometimes more appropriate to refer to the old Article number initially: for example, when dealing with older cases before the Court of Justice of the European Communities. Here the Article will be referred to by its original number, with the new Article number in brackets, followed by the abbreviation for the relevant Treaty: for example, Article 57 (now 47) EC.

Both pharmaceutical medicine and biotechnology are rapidly developing scientific disciplines. European law has had to grapple with the complex issues that have emerged from these areas over the last few years. In view of this, the Institute of European Law at the University of Birmingham, in association with the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK, convened a conference at the University of Birmingham entitled ‘Aspects of European Health Care Law’. In the light of the Institute of European Law's function to provide a centre for supporting research and publication, we considered that the publication of a book on these topics would be a valuable contribution to a developing field. With the support of Cambridge University Press, we have been able to produce this collection, which will hopefully provoke a greater understanding of these issues.

We would like to thank, in particular, the President of the Faculty of Pharmaceutical Medicine, Professor Peter Stonier, for his assistance and encouragement in organising the conference. In addition, the conference itself was generously sponsored by Abbott Laboratories, Fournier Pharmaceuticals Ltd, Hoechst Marion Roussel Ltd and SmithKline Beecham. We would also like to thank Mrs Nadene Bryan for her secretarial and administrative assistance in respect of both the conference and the book.

The collection intends to reflect the legal position at 1 January 2000.

Introduction

Health care professionals across the EU prescribe and administer medicinal products every day. As this is a critical task they are closely regulated and must be fully qualified in order to do so. This chapter seeks to explain the development of European Community law (hereafter EC or Community law) and policy as it attempts to tackle difficulties arising for free movement of individuals involved in the health care sector. The difficulties are caused by differences in structures of the relevant professions, differences in the modes of provision of health care4 that are found in the fifteen Member States of the European Community (EC), as well as the limited competence of the EC to act in this area. After examining these issues the chapter sets out the methods used to liberate health care professionals and their patients from national boundaries. The application of internal market rules to health care activities is examined and the sectoral and general Directives on recognition of qualifications are analysed. The gaps left by these instruments are exposed in the context of the current revisions and case law of the Court of Justice of the European Communities (ECJ).

Regulation of professionals

The medical profession, in common with many other health care professions, has long been regulated both by the State and as a matter of self-regulation. The two prime motives of State control are to ensure the safety of the final consumers (patients) and to control the costs involved, as the State is heavily involved in paying them. As we shall see, the European Community has a strictly limited role in relation to the provision of health care, which remains primarily a national responsibility.