Pharmaceutical Medicine, Biotechnology and European Law

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European law has been faced with increasingly complex issues emerging from rapid developments in pharmaceutical medicine and biotechnology. A team of distinguished European legal practitioners and academics reassess the impact of European law on health care and pharmaceutical law. The essays are grouped under four themes: free movement of goods and persons, competition and intellectual property; European drug regulation; biotechnology; and product liability and transnational health care litigation. This important study offers a valuable resource for the pharmaceutical and biotechnology industries, as well as legal academics and practitioners.

A collection of essays reassessing the impact of European law on health care and pharmaceutical medicine. Themes include free movement of goods and persons, competition and intellectual property, product liability and transnational health care litigation, and European drug regulation. For those interested in the legal aspects of European health care.

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Editorial Reviews

From the Publisher
"...the collection of essays in Pharmaceutical Medicine vividly portrays the tensions and sheer ambition and complexities of superimposing European-wide bodies and law on national markets and member states to create a European market in pharmeceutical medicine and biotechnology...a welcome contribution." Journal of Legal Medicine
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Product Details

  • ISBN-13: 9780521792493
  • Publisher: Cambridge University Press
  • Publication date: 3/28/2006
  • Edition description: New Edition
  • Pages: 280
  • Product dimensions: 5.98 (w) x 9.02 (h) x 0.75 (d)

Meet the Author

Dr Richard Goldberg is a Solicitor and Lecturer in Law at the Faculty of Law of the University of Birmingham. He is the author of Causation and Risk in the Law of Torts: Scientific Evidence and Medicinal Product Liability, nominated for the SPTL Book Prize in 1999.

Dr Julian Lonbay is Senior Lecturer and Director of the Institute of European Law of the University of Birmingham. His publications include Training Lawyers in the European Community, International Professional Practice, Remedies for Breach of EC Law (edited with Biondi), Enhancing the Legal Position of the European Consumer, and Frontiers of Competition Law

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Pharmaceuticals, Patents and Parallel Trade

W. R. Cornish

Parallel importation and intellectual property

This essay is not intended for specialists in intellectual property or European Community law. It is addressed to those who, from time to time, have to wrestle with the baffling issue of when it is legal to employ patents for inventions as a means of resisting `parallel importation', and when as a matter of policy it is desirable to do so. My underlying aim is to set out arguments so that readers can judge for themselves. The arguments vary in relation to the different types of intellectual property - a factor which is often ignored in public debates. The distinctions involved are accordingly my starting point. Intellectual property rights (IPRs) - patents, copyright, trade marks and so on - exist to prevent those who do not have the rightholder's licence from producing and trading in certain goods or services where otherwise they would be entitled to do so. IPRs indirectly provide their owners with a freedom to trade in a market without direct competition from those with whom they have no connection. Thus composers and record producers have copyrights which they can use to attack pirates who have made illegitimate copies of their music and records; patentees of inventions can prevent their rivals from incorporating the inventive idea into their products, machines and processes. In essence, IPRs exist on a State-by-State basis and give rights against trading activities within national (or occasionally regional) boundaries. This strict concept of territoriality means that, for instance, patents for a given invention must be obtained for each country. In consequence, a patent may be granted for the invention in one State but not in another; or the equivalent patents may come to be owned by different persons in separate countries.

The practice of parallel importation does not relate to unauthorized invasions of an exclusive right by pirates, counterfeiters and other exploiters of the protected subject-matter. It concerns trade in `legitimate products' - goods which are initially produced and marketed by an IP rightholder, or by some associated company or licensee. Is the relevant intellectual property (be it patent, copyright, trade mark or whatever) available to stop the importation of such goods by an independent operator who quite properly buys them in one country and then tranships them to another?

This form of arbitrage sets in when the goods, though genuine rather than pirated, are differently priced in the two countries. The `parallel importer' buys them from a proper source in the cheaper country and exports them to the more expensive place without seeking a licence, thus threatening the higher price (and generally, the higher profit) there obtaining. Does the scope of the IPR in this second country, the country of importation, require him to secure that licence, or is the right in that country subject to a rule of `international exhaustion'? Will the answer to the question vary with the type of intellectual property in question? Will it depend on whether the product has been protected by intellectual property rights in the country where it is first marketed, so that the right-owner has already had one chance to sell free of competition from pirates and other product imitators?

In the years of IPR resurgence - the late eighties and early nineties the United States sought to persuade negotiators of the TRIPs Agreement 3 that there should be a blanket rule of non-exhaustion of all IPRs which would operate at the international level. This was proposed as a founding principle of fair (as distinct from free) trade for the brave new World Trade Organization. The idea met a wave of hostility and no functioning rule on the subject was imposed on the States which are now ratifying the TRIPs.4 The great majority of States consider that they are net losers from conceding IPRs, since, for the present, the really valuable rights will be owned by multinational enterprises; at best they hope to be buying some key to enhanced industrial development, which will bring its return through a gradual shift towards more domestic invention, creativity and production of goods and services. In the meantime, there is no reason to furnish a legal device which would prevent the importation of legitimate goods from cheaper markets abroad: hence, for instance, the recent introduction in New Zealand of a blanket rule in favour of international exhaustion for all intellectual property.

IP poficies: the divergences

Most of the world remains uninformed about IPRs. Yet if the problem over parallel imports is to be resolved in a way which makes reasonable sense, it is vital to have some grasp of the different types of protection, their particular subject-matter and the policy objectives at which the State is aiming in granting the right.

Patents are granted over technical and scientific conceptions which constitute inventions. They are therefore directed at ideas which, in a few outstanding cases, can have profound effects on the structure of industries and on the opportunities and benefits available to society as a whole. Such an effect emerges from time to time in the pharmaceutical industry, where patents can be granted both for substances which are shown for the first time to have therapeutic value and for the discovery of new uses for known substances. A new antihistamine or tranquillizer or whatever may effectively replace the drugs in previous use and the firm with the patent may increase in size and importance to a striking degree, at least for the duration of the patent. The market power which the patent confers in these lucky cases.....

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Table of Contents

Notes on the contributors; Preface; Introduction Richard Goldberg and Julian Lonbay; Part I. Free Movement of Goods and Persons, Competition and Intellectual Property: 1. The free movement of goods I: pharmaceuticals, patents and parallel trade Professor W. R. Cornish; 2. The free movement of goods II: pharmaceuticals, trade marks and parallel imports Belinda Isaac; 3. The free movement of health care professionals in the European Community Julian Lonbay; 4. EC competition law, drugs and intellectual property: recent developments Professor Leigh Hancher; Part II. European Drug Regulation: 5. Data protection and abridged applications for marketing authorisations in the pharmaceutical industry Ian Dodds-Smith; 6. The role of the European Medicines Evaluation Agency (EMEA) in the harmonisation of pharmaceutical regulation Antoine Cuvillier; Part III. Biotechnology: 7. The morality clauses of the Directive on the Legal Protection of Biotechnological Inventions: conflict, compromise, and the patent community Deryck Beyleveld, Professor Roger Brownsword and Margaret Llewelyn; Part IV. Product Liability and Transnational Health Care Litigation: 8. The development risk defence and the European Court of Justice; increased injury costs and the Supplementary Protection Certificate Richard Goldberg; 9. Transnational health care litigation and the Private International Law (Miscellaneous Provisions) Act 1995, Part III Jonathan Harris; Index.

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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 organizing 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.

Richard Goldberg

Julian Lonbay

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This book strikingly demonstrates the reach and impact of European law in the sector of public health, and in particular medicine, the pharmaceutical industry and the medical professions.

Professionals and specialists in many different aspects of pharmaceutical medicine - on the technical side, on the clinical side, on the commercial front - are now confronted daily with the requirements of European law to an extent which, only a few years ago, was almost unimaginable.

Lawyers, for their part, have seen new fields of practice emerge, as it has proved necessary to apply the principles of European law to an increasingly Europeanised market in medical products and medical services. From a starting point forty years ago in the embryonic provisions of the EEC Treaty, a very substantial body of Community legislation and case law of the European Court of Justice has emerged in recent years. Community-wide rules on free movement, competition, patents and trade marks overlie national markets and prevail over national law. Europe-wide bodies have developed - in competition policy, in trade marks and patents, and in the testing and evaluation of medicines, to name only a few.

Within this rapidly growing field, the essays published in this book tackle a wide variety of topics: the impact of European rules in all the above areas on pharmaceuticals; the free movement of health care professionals; European drug regulation; biotechnology and the moral limits on the legal protection of inventions; product liability; and transnational health care litigation.

Among the book's qualities is the way in which the selection of topics illustrates, from different perspectives, some common themes. In the creation of the single European market, a balance has to be struck among a variety of competing interests: to mention only some, balancing the interests of free trade and fair competition with the interests of the pharmaceutical industry and the need to promote research and investment; at the same time seeking to ensure the provision of effective health services, to guarantee the rights of the health care professional, and not least to protect the concerns of the patient as well as of the public generally.

For all of these constituencies, this book will provide much of interest.

Francis G. Jacobs
Court of Justice of the European Communities

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