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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.
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.
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.....
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.
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