Dr Peter Feldschreiber

4 New Square

Dr. Peter Feldschreiber is dually qualified as a barrister and physician. He specialises in medical and healthcare law including medical products liability, pharmaceutical and medical devices regulatory law, clinical negligence and personal injury and medically related employment litigation.

Casework includes the Aspirin Reyes Syndrome product liability litigation, Atomic Veterans Litigation, the morning after pill litigation, the Seroquel litigation, Foetal Anti-convulsant Syndrome Litigation, Cochlear Implants and Cardiac Stent Litigations and judicial review and references to the ECJ on pharmaceutical regulatory issues.

He has held appointments as Senior Medical Assessor and Special Litigation Coordinator to the Medicines and Healthcare products Regulatory Agency, Department of Health.

Dr Feldschreiber is General Editor of The Law and Regulation of Medicines (Oxford University Press) and is Consultant Editor for the Volume on Medical Products for Halsburys Laws of England and the Lexis Nexis series on updates of UK and European Law. He is co-author of the chapter on the regulation of healthcare products in Butterworths Healthcare Law and Practice/

He is retained counsel to a number of solicitors' firms and has experience of international litigation regarding drug induced injury. He has also published extensively on the law of causation and European regulatory procedure. He has published research into the repair of DNA following ionising radiation whilst working at the Institute of Cancer Research.

Practice Areas

Panels

Contributing Author
Q&A Panel

Membership

Professional Negligence Bar Association
Personal Injury Bar Association
COMBAR
Society of Pharmaceutical Medicine
Drug Information Association and the Medico-Legal Society British Institute of International Comparative Law

Education

1974 - MBBS Kings College Hospital, University of London
1995 - LLB Hons. Thames Valley University
1991 - Fellow of Faculty of Pharmaceutical Medicine, Royal College of Physicians

1 Contributions by Peter Feldschreiber

PRACTICE NOTES

UK and EU regulation of unlicensed and off-label medicines: Specials, EAMS, NIMAR, compassionate use, supply, advertising, case law and liability

This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes, authorisation status, scope of permitted use, and resulting liability under applicable law in both jurisdictions where relevant and explained. An introduction to unlicensed medicinal products and off-label use of medicinal...

Life Sciences

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