Lincoln Tsang

Partner

Lincoln Tsang
  • LLB, University of London, 1994
  • PhD (Toxicology and Cancer Pharmacology), Aston University, 1989
  • BPharm (Pharmacy), University of London, 1985

Qualifications

  • Called to English Bar (Inner Temple)
  • England and Wales, Solicitor
  • Ireland, Solicitor
  • Hong Kong, Barrister (non-practising)
  • Chinese
  • French
  • Chair, Regulatory Affairs Advisory Committee, BioIndustry Association (2003-2010)
  • Member, Governing Council of the School of Pharmacy, University of London (2006-2012)
  • Fellow, Royal Pharmaceutical Society of Great Britain
  • Fellow, Royal Society of Chemistry
  • Fellow, Royal Society of Biology
  • Fellow, Royal Society of Art
  • The Worshipful Society of Apothecaries, London
  • Freeman, the City of London
  • Member, Drug Information Association Biotechnology Expert Group
  •  Member, European Law Association
  • LMG Europe Life Sciences, “Regulatory Lawyer of the Year” (2020)
  • Chambers Global, “Life Sciences: Regulatory/Compliance – Leading” (2009-2018)
  • Chambers Europe, “Regulatory: Life Sciences/Pharma- Band 1”(2017-2020)
  • Chambers UK, “Life Sciences – Band 1” (2012-2021)
  • The Legal 500 UK, “Leading Individual-Life Sciences & Healthcare” (2021)
  • The Legal 500 UK, “Product Liability: Defendant” (2010, 2011, 2013, 2021)
  • The Legal 500 UK, “Pharmaceuticals and Biotechnology” (2011, 2013-2020)
  • Who’s Who Legal, “Life Sciences (global) Thought Leader” (2019-2020)
  • ILO Client Choice International Awards, “Healthcare and Life Sciences” (2013)
  • Who’s Who Legal, “Life Sciences (England): Regulatory” (2016)
  • Who’s Who Legal, “Expert International Life Sciences Lawyers” (2018, 2010, 2011)
  • Legal Media Group, “EU and UK Life Sciences Star (2014)
  • PLC Which Lawyer, “Life Sciences: Regulatory” (2006, 2007, 2009, 2011)

Lincoln Tsang

Partner

Dr. Lincoln Tsang, partner and head of Ropes & Gray’s European Life Sciences Practice, qualified as a lawyer and a pharmacist with post-graduate training in toxicology and cancer pharmacology, concentrates his practice on UK, EU and cross-border regulatory compliance and enforcement, including litigation, internal investigations and public policy matters affecting the life sciences industry. Lincoln advises clients on research and development strategies, product life cycle management, product acquisition, and risk and crisis management. He also regularly represents clients before various regulatory bodies on a wide range of matters, including clinical trials, product approval, advertising and promotion, manufacturing, safety vigilance, and health technology appraisal relevant to pricing and reimbursement decision-making for medicines and medical devices. He has also appeared before various legislatures as an independent expert on product approval and market access of medical products. He is the first lawyer outside the United States to testify in a congressional hearing before the United States Senate as an expert on matters concerning access to treatments for rare diseases.

Before entering private practice, Lincoln was head of biologicals/biotechnology and a senior official at the UK Medicines and Healthcare Products Regulatory Authority, where he developed a number of UK and European policies governing medicines regulation, including advanced therapies, biologicals and drug/device combinations. He represented the EU and the UK on a number of international regulatory cooperative initiatives. He chaired the Gene Therapy Expert Group and the Transmissible Spongiform Encephalopathy Expert Group of the European Medicines Agency and served as an advisor to the European Commission, the European Directorate for the Quality of Medicines, the Council of Europe, the British Pharmacopoeia Commission, and the World Health Organization, among others. He was appointed by UK Ministers to serve as a non-executive board member of a number of governmental organizations. A thought leader in his field, Lincoln has authored numerous articles and speaks frequently at industry events.

Prior to joining Ropes & Gray, Lincoln was a partner at an international law firm in London.

Experience

Regulatory and Compliance

  • Developed research and development strategies for approval, pricing and reimbursement for pharmaceuticals, medical devices and emerging technologies, including gene therapy, cell therapy and tissue-engineered products.*
  • Advised on regulatory data protection, market exclusivity and patent life extension.*
  • Counseled crisis and risk management, including matters relating to supply shortages and urgent drug safety.*
  • Advised on classification of borderline products and emerging and high technology products.*
  • Assisted in the implementation of pharmacogenomic testing for development of personalized medicines.*
  • Routinely appeals against decisions made by regulatory authorities, health technology agencies and pricing authorities.*
  • Developed a global regulatory compliance process for advertising, promotion, anti-bribery and corruption, as well as good pharmacovigilance, clinical, and manufacturing practice.*

Legislative and Public Policy

  • Advocacy before regulatory authorities, advertising/promotional regulatory bodies, and European Commission, European Parliament, and national parliaments.*
  • Testified before the United States Senate as an independent legal and regulatory expert on matters concerning timely access to treatments for rare diseases.*

Litigation and contentious matters

  • Representing clients in complaint proceedings against European institutions to European Ombudsman on matters relating to breach of good administration behavior.*
  • Representing clients in court and arbitration proceedings involving issues relating to European Community law and regulatory policy.*
  • Assisting clients in cross-border litigation matters.*
  • Leading recent cases European Courts: T-33/17 Amicus Therapeutics UK Ltd; Amicus Therapeutics v European Medicines Agency; T-733/17 GMP-Orphan SA v European Commission and Appeal Case C-575/19P; T-337/18 Intercept Pharma Ltd, Intercept Pharmaceuticals Inc v European Medicines Agency and Appeal Case C-576/19P against European Union General Court decision.*

*Experience prior to joining Ropes & Gray

Government Experience

  • Nonexecutive Director, Board of National Institute for Biological Standards and Control (by ministerial appointment)
  • Non-executive member, Regulatory Oversight Committee, Health Protection Agency (by ministerial appointment)
  • Commissioner, British Pharmacopoeia Commission (by ministerial appointment)
  • Vice Chairman, Nomenclature Committee, British Pharmacopoeia Commission
  • Chairman, Biological and Biotechnology Specialist Group, British Pharmacopoeia Commission
  • Head of Biologicals and Biotechnology, UK Regulatory Authority
  • Member, UK Ministerial Industry Strategy Group
  • Member of advisory committees within the European Medicines Agency, the European Commission
  • Member of Steering Committee on Certification Scheme including transmissible spongiform encephalopathy minimization of the European Directorate for the Quality of Medicines
  • Special Advisor to Council of Europe Legal Affairs Committee on matters relating to counterfeits and bribery and corruption

Disclaimer

Ropes & Gray International LLP is a limited liability partnership registered in Delaware, United States of America and is a recognised body regulated by the Solicitors Regulation Authority (with registered number 521000).
  • LLB, University of London, 1994
  • PhD (Toxicology and Cancer Pharmacology), Aston University, 1989
  • BPharm (Pharmacy), University of London, 1985

Qualifications

  • Called to English Bar (Inner Temple)
  • England and Wales, Solicitor
  • Ireland, Solicitor
  • Hong Kong, Barrister (non-practising)
  • LMG Europe Life Sciences, “Regulatory Lawyer of the Year” (2020)
  • Chambers Global, “Life Sciences: Regulatory/Compliance – Leading” (2009-2018)
  • Chambers Europe, “Regulatory: Life Sciences/Pharma- Band 1”(2017-2020)
  • Chambers UK, “Life Sciences – Band 1” (2012-2021)
  • The Legal 500 UK, “Leading Individual-Life Sciences & Healthcare” (2021)
  • The Legal 500 UK, “Product Liability: Defendant” (2010, 2011, 2013, 2021)
  • The Legal 500 UK, “Pharmaceuticals and Biotechnology” (2011, 2013-2020)
  • Who’s Who Legal, “Life Sciences (global) Thought Leader” (2019-2020)
  • ILO Client Choice International Awards, “Healthcare and Life Sciences” (2013)
  • Who’s Who Legal, “Life Sciences (England): Regulatory” (2016)
  • Who’s Who Legal, “Expert International Life Sciences Lawyers” (2018, 2010, 2011)
  • Legal Media Group, “EU and UK Life Sciences Star (2014)
  • PLC Which Lawyer, “Life Sciences: Regulatory” (2006, 2007, 2009, 2011)
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