Practice Focus

Dr Lincoln Tsang is a partner in the firm's London office. He is both a lawyer and a registered pharmacist with post-graduate qualifications in toxicology and biochemistry. 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 relating to life sciences. He assists clients in developing strategies for research and development including product life cycle management, product acquisition, and risk and crisis management.

In addition to advising the life sciences industry, Dr Tsang also advises foreign governments, various trade associations and nonprofit and/or charity organizations. He maintains an active pro bono practice. He presents and writes widely on regulatory law and public policy.

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 a number of European institutions such as the European Medicines Agency, European Directorate for the Quality of Medicines, and the European Commission. In such capacity, Dr Tsang held memberships and chairmanships on a number of advisory groups including such topics as biological products, bovine spongiform encephalopathy (BSE), vaccine products, blood products, and emerging technologies such as gene and cell therapies. He also represented the European Commission on the International Conference on Harmonisation where he led the discussion group on gene therapy. He was an advisor to the World Health Organization concerning international trade of biological products.

By ministerial appointment, Dr Tsang currently serves as a Non-Executive 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 Vice Chairman of the Commission's Biological and Biotechnology Specialist Group. He is also a member of the UK Ministerial Industry Strategy Group Sub-Group Forum. He served for two terms as a Non-Executive Director on the board of the National Institute for Biological Standards and Control until its merger with the Health Protection Agency.

Representative Matters

• Regulatory data protection, market exclusivity and patent life extension
• Appeals against decisions made by regulatory authorities
• Classification of borderline products and emerging technology products
• Development of reimbursement and pricing strategies
• Advocacy before regulatory authorities and European Commission
• Assisting clients in filing complaints to European Ombudsman on matters relating to breach of good administration
• Serving as an expert in court and arbitration hearings involving issues relating to European Community law and regulatory policy