Pharmaceutical Medicine, Biotechnology and European Law

Edited by Richard Goldberg, Julian Lonbay 
Cambridge University Press  January 2001  

Hardback  247pp  ISBN 9780521792493      £83.00
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. The book reviews the impact of European law on movement of health care professionals and pharmaceuticals, patent and trademark rights, the Product Liability Directive, laws on product liability and intellectual property claims. It examines recent developments in drug regulation, particularly data protection, abridged applications for marketing authorisations and the European Medicines Evaluation Agency. A compelling analysis is made of the Biotechnology Directive morality clauses. This important study offers a valuable resource for the pharmaceutical and biotechnology industries, legal academics and practitioners alike.


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.

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Cambridge University Press : European Commission : biotechnology : health & beauty : pharmaceuticals : regulations

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