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Grant H. Castle

Partner

London +44 20 7067 2006

Brussels +32 2 549 5242

  • About
  • Representative Matters
  • Credentials
  • About

    Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

    He is one of the Co-chairs of Covington's Life Sciences Industry Group and is Head of Covington's European Life Sciences Regulatory Practice.

    Grant regularly advises on:

    • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
    • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
    • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
    • Advertising and promotion of both pharmaceuticals and medical devices; and
    • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

    Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

    Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as "excellent," "a knowledgeable lawyer with a strong presence in the industry," who provides "absolutely first-rate regulatory advice," according to sources, who also describe him as "one of the key players in that area,” whilst Chambers Global sources report that "he worked in the sector for many years, and has a thorough understanding of how the industry ticks." He is praised by clients for his "absolutely first-rate" European regulatory practice. Legal 500 UK notes that he is "highly competent in understanding legal and technical biological issues."

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Leading the successful defence of Roche in the first and only EU financial penalties infringement procedure bought by the European Commission against a pharmaceutical company for alleged breaches of the EU's pharmaceutical rules.
    • Assisting clients in over 20 proceedings before the EU General Court and Court of Justice, including:
      • The leading cases on transparency of clinical trial data, reversing the EMA's determination that clinical study reports are public documents to require a case-by-case assessment of whether they contain commercially confidential information - T-44/13 AbbVie v EMA and C-389/13 EMA v AbbVie; and T-718/15 and C-175/18 P PTC Therapeutics International v EMA and C-513/16 P(R) EMA v PTC Therapeutics International;
      • Successful defence of the first legal challenge against a centralized marketing authorization - T-326/99 Olivieri v Commission and EMEA;
      • Successful defence of regulatory data exclusivity for an innovative product on behalf of Shire Pharmaceuticals and Janssen in a leading case on the definition of a reference medicinal product - C-527/07 Generics (UK); and
      • A case that forced changes to the Commission's and EMA's positions on whether line extensions may be eligible for orphan status - T-80/16 Shire Pharmaceuticals Ireland v EMA and C-359/18 P EMA v Shire Pharmaceuticals Ireland.
    • Representing numerous clients in proceedings before the EMA's Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO), as well as proceedings before national regulators, including the UK MHRA and Irish HPRA.
    • Grant has been heavily involved in matters related to the National Institute of Health and Care Excellence (NICE) since its inception, provided strategic, practical and technical advice at all stages of both single (STA) and multi-technology (MTA), plus the highly specialised technology (HST) processes, as well as on the Cancer Drugs Fund, Innovative Medicines Fund and on patient access schemes and managed access agreements. He has handled over 30 appeals against negative or unhelpful final appraisal determinations. In Ireland, he has handled the only appeal to the Irish Courts against a negative recommendation by the Health Service Executive.

    Areas of Expertise

  • Credentials
    Education
    • Trinity College, University of Cambridge, Ph.D., 1994
    • Imperial College of Science, Technology and Medicine, B.Sc., 1991
        • First class honors
    Bar Admissions
    • Brussels
    • Solicitor, Ireland
    • Solicitor of the Senior Courts of England and Wales
    Languages
    • French
    Pro Bono
    • Pro bono work includes handling a successful appeal against a negative NICE on behalf of the sole appellant, a patient group called Solving Kids Cancer, resulting in changes to the way NICE assesses paediatric medicines. The product's manufacturer chose not to appeal.
    Accolades
    • LMG Life Sciences Europe, Life Sciences Star - Regulatory (United Kingdom) (2014-2015) 
    • Chambers UK, Life Sciences: Regulatory (2005-2024)
    • Chambers UK, Product Liability - Food (2013-2014) 
    • Chambers Europe, Life Sciences (2015, 2017-2020) 
    • Chambers Global, Life Sciences (2011-2018)
    • Who's Who Legal, Global Leaders - Life Sciences Regulatory (2011-2022)
    • Expert Guides, Best of the Best Global (2021) and Public Liability (2021)
    • Legal 500 UK, Hall of Fame - Life Sciences and Healthcare (2021-2023)
    • Legal 500 UK, Pharmaceuticals and Biotechnology (2008-2016)
    • Legal 500 UK, Product Liability, Defendant (2013-2016)
    Memberships and Affiliations
    • Grant has been a visiting lecturer at the University of Surrey, on a course leading to a Master of Science in Pharmaceutical Medicine/Clinical Pharmacology; Cardiff University, on a course leading to a Master of Science/Diploma in Clinical Research and on the Postgraduate Course in Pharmaceutical Medicine; and Cranfield University, on a course leading to Master of Science, Postgraduate Diploma, and Postgraduate Certificate in Medical Technology Regulatory Affairs.
    Previous Experience
    • Glaxo Group Research, Medicinal Chemist (1991)

    Areas of Expertise

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