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Brian Kelly

Partner

London +44 20 7067 2392 bkelly@cov.com Download V-card

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Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington's Global Food Industry Group. Mr. Kelly's practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Mr. Kelly 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."

Mr. Kelly’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, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Mr. Kelly has also been advising on UK and European "Brexit" related issues including tariffs.

Mr. Kelly 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.

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

Mr. Kelly is an honorary lecturer at University College London.

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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).

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.

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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.

Digital Health Legal, Editorial Board Member

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

European Commission publishes Guidance relating to COVID-19 and Public Procurement

The European Commission has recently issued Guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis. The Guidance is intended to highlight to Member State authorities the flexibilities available to them under the EU public procurement framework and in particular the Public Procurement Directive 2014/24/EU. ...

DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19

On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers. The Department of Education and Cabinet Office has published guidance on key workers for COVID-19. The guidance...… Continue Reading

UK sets deadline for novel food authorisation of CBD products

The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications. After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other...… ...

The CJEU clarifies the test to determine when a general, non-specific health claim is “accompanied” by a specific health claim

Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists. In Case C-524/18, Dr. Willmar...… ...

Brexit Day Marks a Beginning, Not an End

This evening, at 11:00 p.m. GMT, the UK will leave the European Union. Brexit day marks a beginning, not an end. The UK today embarks on a complex process of negotiating new arrangements for trade and cooperation with the EU and partners around the world. Regulatory divergence seems inevitable, given that the UK will want to make its own decisions on existing ...

Covington Advises Illumina on Clinical Human Genome Sequencing Project

London—Covington represented Illumina on its partnership with Genomics England, to sequence up to 500,000 whole genomes for the NHS Genomic Medicine Service. This partnership is part of the wider ambition to analyse up to 5 million genomes by 2024, to enable the UK to maintain its position as a global leader in genomics. Under this partnership and guided by ...

NHS England Publishes Draft Commercial Framework for Medicines

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be ...

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001. PTC Therapeutics International Limited (“PTC”) ...

Reconciling Personalized Nutrition with the GDPR

As with anything personalized, be it advertising, medicines or training schedules, also personalized nutrition — using information on individual characteristics to develop targeted nutritional advice, products, or services — risks being affected by the feared GDPR. Kristof Van Quathem discusses the topic in Vitafoods’ Insights magazine of January 2019, ...

Reconciling Personalized Nutrition with the GDPR

Proposed Changes to UK Allergen Labelling Law

Introduction The Department for Environment, Food & Rural Affairs (“DEFRA”) has announced a consultation regarding proposed changes to allergen labelling laws for food prepacked for direct sale in the UK. This follows the death of Natasha Ednan-Laperouse in July 2016, which was the result of an allergic reaction after consuming a baguette from Pret a...… ...

Consultations on UK Medicines and Medical Devices Regulation in Case of a "No Deal" Brexit

On August 23, 2018, the UK Government published several technical guidance notices relating to the regulation of medicines and medical devices in the event of a “no deal” or “hard” Brexit, i.e., a scenario where the EU and UK fail to conclude a withdrawal agreement and an associated transitional period and where the UK becomes a “third country” from midnight CET ...

UK Government Issues “No Deal” Brexit Notices for the Food & Beverage Sector

Over the past months, the Government has regularly posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019. The UK Government has now published four notices...… Continue Reading

Enforcement of the Nagoya Protocol in the Food, Drugs and Cosmetics sectors - state of play

The Nagoya Protocol to the Convention on Biological Diversity entered into force on 12 October 2014. It imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the cosmetics, food, pharmaceutical and other life science sectors. It now has more than 100 contracting parties, including the European Union.

CQC report on online primary health services shows progress

Brian Kelly and Raj Gathani are quoted in a Digital Health Legal article regarding a report published by the UK’s Care Quality Commission on "The state of care in independent online primary health services." According to Kelly and Gathani, “The report illustrates some of the teething problems in the inspection system, particularly when applied to online ...

Covington: Drawing on Life Science Sector Depth to Tackle Complexity

James Gubbins, Lucinda Osborne, and Brian Kelly are quoted in a Biotech and Money article providing an overview of Covington's Life Sciences practice and discussing the legal implications of issues facing the sector. “Having an international practice, having a team in London, on [the U.S.] East Coast and West Coast, and in Asia, who encompass that regulatory ...

Increasing Pressure on Orphan Medicinal Product Designations in the EU

In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...

Commission publishes draft rules on country of origin/place of provenance indications for primary ingredients

On 4 January 2018, the European Commission published a draft implementing regulation laying down rules for the application of Article 26(3) of Regulation (EU) N° 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (“FIC”), as regards the rules for indicating the country of origin or place...… Continue Reading

The Brexit battle over food

Brian Kelly spoke at November's Food Matters Live event in London and is quoted in a Better Wholesaling article examining challenges facing the food industry in the wake of Brexit. Commenting on the threat of new tariffs, Kelly said, "It is very complicated and businesses will need to upskill on this.”

Brexit ruling “only adds to uncertainty” in the UK food industry

Brian Kelly is quoted in an EU Food Law article regarding the UK High Court ruling requiring its government to have Parliamentary approval before triggering Article 50. According to Kelly, the decision added uncertainty around Brexit, although it did also present a lobbying opportunity for the industry as well. “The immediate impact of the judgment is that, as ...

POLITICO Pro Morning Health Care, presented by Lilly: Brexit wobble — WHO DG candidates compete

Brian Kelly and Grant Castle are quoted in a Politico Pro “Morning Health Care” article regarding the High Court ruling that the UK government does not have the legal power to invoke Article 50 without Parliamentary approval. According to Kelly, “This presents an opportunity for individual companies and the industry to engage with members of Parliament to ensure ...

Spanner In Works For UK Gov’t’s Brexit Plans; Industry Looks To Ongoing Talks With Ministers

Brian Kelly is quoted by The Pink Sheet in an article regarding the UK High Court’s ruling that its government does not have the right to trigger Article 50 without Parliamentary approval. According to Kelly, the judgment presented "an opportunity for individual companies and the [life sciences] industry to engage with members of Parliament to ensure that their ...

Covington Promotes 13 New Partners

WASHINGTON—Covington has promoted 13 lawyers to its partnership. “Our new partners reflect the excellence, strengths, and diversity of the firm and will play important roles in the firm for decades to come and will help drive our key practices to even greater success in the years ahead,” said Timothy Hester, Covington’s chair. The new partners, who are based in ...

Highest EU Court Rules on Ban to Market Cosmetics Tested on Animals

On September 21, 2016, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-592/14 European Federation for Cosmetic Ingredients v UK Secretary of State for Business. The Court has ruled that animal tests performed outside the European Union (EU) to comply with non-EU rules should not be used for the product safety assessment to gain access to ...

4 Ways Brexit Could Affect the Supplement Industry

Brian Kelly is quoted in a Nutritional Outlook article regarding the ways Brexit could affect the supplement industry. According to Kelly, “If the UK went down a Norway or EEA model approach, it’s very unlikely that there’d be any material change to the legal position.” He continues, “The UK’s implementation of EU existing food law would remain valid and the UK ...

EU Updates MEDDEV 2.1/6 Guidance on Standalone Software

On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012. MEDDEV 2.1/6 generally stands as a...… ...

Impact of Brexit on Food and Drink Regulations

Last week, the UK voted to leave the European Union in an advisory referendum. The impact of Brexit on food and drink regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...

Downer? Could the UK Psychoactive Substances Act spell disaster for the food & supplements industry?

Brian Kelly is quoted extensively in this Nutra Ingredients article discussing the UK Psychoactive Substances Act and its possible effect on the food supplements industry. According to Kelly, “Despite criticism and proposed amendments about unintended targets the law has been pushed through. It’s a poorly drafted law when it comes to food.” He continues, “You ...

Covington Advises Illumina on Partnership with Genomics England

LONDON, 5 August, 2014 — Covington & Burling advised Illumina on its partnership with Genomics England to provide infrastructure and expertise for a four-year project that aims to make the UK the world leader in genetic research into cancer and rare diseases, through funding research to decode 100,000 human genomes - a patient's personal DNA code. The deal is ...

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International Law Office Clients Choice Awards 2015, Healthcare & Life Sciences Law – UK
Chambers UK, Life Sciences: Regulatory (2019-2020)
Chambers UK, Product Liability: Food (2019-2020)
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, Product Liability (2012-2016)
Legal 500 UK, Pharmaceutical Liability & Biotechnology (2015-2016)
Medical Journalist of the Year, UK Medical Journalists’ Association Awards (November 2002)

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Brian Kelly

Representative Matters

Pro Bono

Memberships and Affiliations

Previous Experience

News and Insights (Showing 5 of 79) (Showing 79 of 79)

Accolades

COVID-19: Legal and Business Toolkit

Practices

Industries

Education

College of Law, London, L.P.C., 2005

College of Law, London, G.D.L., 2004

University of Sheffield, B.S., 2000

Bar Admissions