Pharmaceutical Medicine, Biotechnology and European Law

Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.

Richard Goldberg (Edited by), Julian Lonbay (Edited by)

9780521792493, Cambridge University Press

Hardback, published 18 January 2001

280 pages
23.6 x 15.9 x 2.6 cm, 0.578 kg

'This important study offers a valuable resource for the pharmaceutical and biotechnology industries, legal academics and practitioners alike. It is up-to-date, well researched and presented, and gives an intriguing overview of some of the most pressing issues on the pharmaceutical and biotechnological scene in modern-day Europe.' Maastricht Journal of European and Comparative Law

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.

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.

Subject Areas: Biotechnology [TCB], Pharmacology [MMG], Legislation [LNZL], Laws of Specific jurisdictions [LN]