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Brian Kelly

Partner

London +44 20 7067 2392

Brussels +32 2 549 5241

  • About
  • Representative Matters
  • Credentials
  • About

    Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington's Global Food Industry Group. Brian's practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our "world-class [regulatory and public affairs] team and describes him as a notable practitioner who is "very ambitious, thorough with a sharp intellect". The Chambers UK Guide quotes clients saying: "his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases."

    Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European "Brexit" related issues including tariffs. 

    Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

    Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts. 

    Brian is an honorary lecturer at University College London.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters

    Brian has represented food and drug clients before the European and domestic courts in precedent cases involving cutting edge issues. Illustrative examples are below:

    European Court of Justice

    • T-302/21 Aboca and others v European Commission - representing a number of companies and trade associations in challenging the EU/EFSA-wide prohibition on certain botanical preparations added to food in a precedent case under European fortified food rules. On-going.
    • T-296/12 Health Food Manufacturers Association, Dutch Health Food Association and Others v European Commission and others - lead advocate in a precedent case challenging the legality of the Nutrition and Health Claims Regulation 1926/2006 and its implementing regulation 432/2012.
    • Represented AbbVie, MSD, PTC Therapeutics and other innovative pharmaceutical companies and trade associations before the General Court and the Court of Justice of the EU in challenging the legality of the European Medicines Agency’s decisions to disclosure clinical and non-clinical data, including securing interim relief (e.g., C‑389/13 P(R), C-175/18 P, T-729/15)
    • T-329/16 Bristol Myers Squibb v EMA - represented BMS in challenging the legality of a decision by the European Medicines Agency to remove a pharmaceutical product from the orphan register.

    UK and Ireland

    • Guilin GFS Monk Fruit Corp v UK Food Standards Agency, Food Safety Authority of Ireland and Food Standards Scotland (2023) in the first case challenging the novel food consultation process under Art. 4 of the Novel Food Regulation. 2023 (on-going)
    • Health Food Manufacturers Association as intervener in Healthspan v FSA regarding the CBD consultation process (2021).
    • R (otao Blue Bio) v Medicines and Healthcare products Regulatory Agency (2016) and Health Food Manufacturers Association - lead advocate for the HFMA in both the Administrative Court and the Court of Appeal in challenging one of the first “food / medicine” borderline matter to come before the English courts.
    • R (otao Novartis) v 12 Clinical Commissioning Groups (2018) - represented Novartis Pharmaceuticals in a challenge to the legality of health policies that recommended use of medicines “off-label” when licensed alternatives existed.
    • Premaitha v NHS Wales and Illumina (2016) - successfully represented Illumina in a precedent case in the Technology and Construction Court dealing with the classification of diagnostic equipment and software in the scope of a public tender.

    Regulatory Advisory Matters

    • Advise on digital health and health information issues to clients in the software, telecoms and life science industries.
    • Represented clients in UK and EU judicial review proceedings and other administrative actions, in particular relating to health claims on foods, transparency of clinical trial reports, data exclusivity.
    • Successfully represented clients in relation to advertising and labeling disputes before the Advertising Standards Authority and Prescription Medicines Code of Practice Authority (PMCPA).
    • Administrative and procurement law challenges to healthcare-related tender decisions.

    • Advice and successful representation before the National Institute for Health and Clinical Excellence (NICE) and their Appeal Board

    • Regulatory advice to life sciences companies on establishing joint working and risk-sharing relationships with the NHS in England and Wales.

    • Advising food clients on general and specialist EU matters involving health and nutritional claims, PARNUTS, novel foods, genetically modified foods, borderline/classification issues and ingredient reviews.

    • Advising and co-ordinating international food and cosmetic safety matters and recalls.

    • Regulatory due diligence for a number of food, drug and cosmetic companies.

    Areas of Expertise

  • Credentials
    Education
    • College of Law, London, L.P.C., 2005
        • Distinction
    • College of Law, London, G.D.L., 2004
        • Commendation
    • University of Sheffield, B.S., 2000
        • Neuroscience
        • Hons
    Bar Admissions
    • Higher Rights of Advocacy in the Supreme Court of England and Wales
    • Solicitor of the Senior Courts of England and Wales
    • Law Society of Ireland
    Pro Bono
    • Represented a couple in challenging a decision of a UK health authority to refuse medical treatment.
    • Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
    Accolades
    • International Law Office Clients Choice Awards 2015, Healthcare & Life Sciences Law – UK
    • Chambers UK, Life Sciences: Regulatory (2019-2025) 
    • Chambers UK, Product Liability: Food (2019-2025)
    • Chambers UK, Product Liability: Food "Up and Coming" (2018) and Food "Star Associate" (2015-2017)
    • Chambers UK, Product Liability - Mainly Defendant (2013-2015)
    • Chambers Europe, Regulatory: Agro/Food (2018-2020) and TMT (2017-2018)
    • Legal 500 EMEA, EU Regulatory - Food (2016-2017) 
    • Legal 500 UK, Life Sciences and Healthcare (2021-2022)
    • Legal 500 UK, Product Liability (2012-2016)
    • Legal 500 UK, Pharmaceutical Liability & Biotechnology (2015-2016) 
    • Medical Journalist of the Year, UK Medical Journalists’ Association Awards (November 2002)
    Memberships and Affiliations
    • Digital Health Legal, Editorial Board Member
    Previous Experience
    • Trained with Covington & Burling LLP
    • Schering-Plough Limited, seconded to the in-house legal team
    • Science and Technology Reporter for Clinica World Medical Technology News
    • Clinical News Editor for Pulse, a national medical newspaper

    Areas of Expertise

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