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Lincoln Tsang

Partner
Languages: Chinese, French
Areas of Practice
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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.

Lincoln’s practice is listed as Band 1 in Chambers UK 2024. Clients say he “has extremely deep subject matter expertise” and “is a complete star, a genius and jolly friendly with it, a rare combination indeed.” Clients comment: "Lincoln Tsang has represented us in important cases and on commercially sensitive strategic issues." “Lincoln is extremely knowledgeable and practical. He puts legal and regulatory issues in executable actions. He is particularly experienced in market access and approval of medicines for rare diseases.”

Experience

M&A Transactions

  • Advised Jounce Therapeutics, Inc., US-headquartered biotech company, on its business combination via a proposed all share merger with UK-headquartered biotech company Redx Pharma plc
  • Advised leading global private markets firm Partners Group, acting on behalf of its clients, on its investment in GHO Capital Partners’ portfolio company Sterling Pharma Solutions, a global Contract Development and Manufacturing Organisation
  • Advised Humble Group AB, a Swedish food-tech and FMCG-group supplying the next generation of products that are good for people and the planet, on its up to SEK 1.384 billion acquisition of Solent Global Limited, a leading international supplier of healthy foods and personal care products
  • Advised Avista Capital Partners and Nordic Capital and Swiss pharmaceutical company Acino on the sale of Acino to ADQ
  • Advised Partners Group on its acquisition of Pharmathen, a European pharmaceutical company, from international investment firm BC Partners on behalf of its clients. The transaction values Pharmathen at an enterprise value of around EUR1.6 billion
  • Advised NeoGenomics, Inc., a leading provider of cancer-focused genetic testing services and global oncology contract research services, on its acquisition – including its financing via private placement of equity – of Inivata Ltd, a global, commercial stage liquid biopsy platform company, headquartered in Cambridge, UK

Regulatory and Compliance

  • Advising a major international food manufacturer on regulatory submission to support health and nutritional claims concerning a glucoraphanin-enriched food product 
  • Advising an agriculture company on regulation of a variety of food products based on gene-editing transgenesis to develop specific genotypic characteristics. 
  • Advising on food supplements on borderline product classification and health claims of a food supplement. 
  • Advising an international food nutrition company on a health claim for infant formula enriched with a fatty acid
  • Advising a company on importation of gelatin into the EU for encapsulation for food supplements and compliance with the Specified Risk Material to prevent transmissible spongiform encephalopathies 
  • Representation of companies in various decisions before the EMA’s advisory committee and European Commission relating to orphan designations and maintenance of orphan designation
  • 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 a biopharmaceutical company in a commercial dispute resolution governed by International Chambers of Commerce
  • Co-counsel in the European Court of Human Rights case of Narbutas v. Lithuania (Application No. 14139/21)
  • Successful representation of an international pharmaceutical company in a pre-action judicial review application on the legality of regulatory decision-making on product approval
  • Representing a biopharmaceutical company in a commercial dispute before the London Court of International Arbitration 
  • 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*

Government Experience

  • Non-Executive Director, Board of the National Institute for Biological Standards and Control; Member, Governance and Audit Committee; Member, Scientific Policy Advisory Committee (appointed by UK Ministers) (2004-2009)
  • Commissioner, British Pharmacopoeia Commission (2006-2016); Chair, Biologicals/Biotechnology Committee; Vice Chair, Nomenclature Committee (appointed by UK Ministers)
  • Non-Executive Member, Regulatory Oversight Committee, Health Protection Agency (2009-2013) (appointed by UK Ministers)
  • Member, UK Ministerial Industry Strategy Group (2005-2011)
  • Special Advisor to Council of Europe Legal Affairs Committee (2009-2013)
  • Advisor to World Health Organisation (1996-2006)
  • Advisor to European Medicines Agency (1995-2002)
  • Advisor to European Commission (1993-2002)
  • Advisor to European Council (1993-2002)
  • Advisor to Singapore Health Sciences Authority (2003)
  • Advisor to Korea Food and Drug Administration (2006)
  • Advisor to Gulf Cooperative Council (2008)
  • EU representative on International Conference on Harmonisation; Chair of Gene Therapy Expert Group (1997-2001)
  • Senior Official and Head, Biologicals and Biotechnology, Medicines and Healthcare products Regulatory Agency (1990-2002)
  • Member, Medical Research Council Stem Cell Bank Steering Committee (2001-2002)
  • Member, Gene Therapy Advisory Committee (1997-2002)

*Experience prior to joining Ropes & Gray

Areas of Practice

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