Navigating European Pharmaceutical Law

MARIE MANLEY is a Partner at Bristows in London, a law firm specialised in advising technology clients, and head of the Regulatory Department. She advises on IP matters (both contentious and non-contentious), focusing on European and UK regulatory and competition law in the bio-pharma, chemical, cosmetic, medical devices and food sectors; including life cycle management issues, advertising and product liability. MARINA VICKERS is a Senior Associate at Bristows in London, a law firm specialised in advising technology clients. She specialises in EU and UK regulatory law in the biopharma field, both contentious and non-contentious. She has published widely in the field and recently co-authored a chapter on the EU/UK legal framework for an American Bar Association book on Anda litigation strategy. The editors and contributors are delighted to donate all royalties from this edition to the Great Ormond Street Hospital Children's Charity.

1. Introduction ; 2. Patent Protection for Pharmaceuticals and Biopharmaceutical Products ; 3. Clinical Trials ; 4. Procedures for Obtaining a Marketing Authorisation and Legal Bases for Application ; 5. Pricing, Reimbursement and Health Technology Appraisals ; 6. Paediatrics ; 7. Orphan Medicinal Products ; 8. Biologicals ; 9. Regulatory Data Protection ; 10. Supplementary Protection Certificates ; 11. The Maximisation of IP Regulatory Rights and Lifecycle Management Strategy ; 12. The interaction between Intellectual Property Law and Competition Law ; 13. Access to Information ; 14. Litigating decisions of the regulatory authorities ; 15. Pharmacovigilance ; 16. Data Protection ; 17. The Promotion of Medicinal Products in the EU ; 18. Borderline Products ; 19. Product Liability ; 20. Licensing Consideration ; 21. Parallel Trade and Stock Management Policies