EU Life Sciences

Dr. Lincoln Tsang is a partner in the firm's London office, qualified as a lawyer and a registered pharmacist with post-graduate qualifications in biochemical toxicology. His practice is focused on the life sciences industry including pharmaceuticals, biotechnology, medical devices, in vitro diagnostic devices, cosmetics, and food with particular emphasis on the intersection of the law and public policy. He assists clients in developing strategies for research and development including product life cycle management, product acquisition, and risk and crisis management.

Dr. Tsang also advises foreign governments, various trade associations, and nonprofit and, charity organizations. He maintains an active pro bono practice.

Government Experience

Lincoln Tsang served as a senior official of the UK Regulatory Authority for nearly 13 years where he was head of biotechnology and biologicals. During his tenure in the Agency, he took a leading role in developing a number of UK and European policies governing medicines regulation. He was an advisor to the European Medicines Agency, European Directorate for the Quality of Medicines, and the European Commission. In such capacity, he held memberships and chairmanships on a number of advisory groups.He was an advisor to the World Health Organization concerning international trade of biological products, and the Council of Europe on counterfeits.

By ministerial appointment, Dr. Tsang serves as a nonexecutive member of the UK Health Protection Agency's Regulatory Oversight Committee, a Commissioner of the British Pharmacopoeia Commission, Vice Chairman of the Commission's Nomenclature Committee, and Chairman of the Commission's Biological and Biotechnology Specialist Group. He is also a member of the UK Ministerial Industry Strategy Group. He served for two terms as a nonexecutive Director on the board of the National Institute for Biological Standards and Control.

EU Life Sciences Representative Matters

• Regulatory data protection, market exclusivity and patent life extension.
• Appeals against decisions made by regulatory authorities.
• Crisis and risk management including matters relating to supply shortages and urgent drug safety.
• Classification of borderline products and emerging and high technology products.
• Development of reimbursement and pricing strategies.
• Advocacy before regulatory authorities, advertising/promotional regulatory bodies, and European Commission.
•  Representing clients in complaint proceedings to European Ombudsman on matters relating to breach of good administration behaviour.
• Representing clients in court and arbitration proceedings involving issues relating to European Community law and regulatory policy.