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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.
- 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.
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.
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
September 12, 2019, Inside EU Life Sciences
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”) ...
February 19, 2019, Covington Digital Health
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, ...
February 18, 2019, Inside EU Life Sciences
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, ...
February 8, 2019, Inside EU Life Sciences
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...… ...
October 15, 2018, Covington Alert
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 ...
October 4, 2018, Inside EU Life Sciences
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
May 2018, Covington Alert
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.
April 2018, Digital Health Legal
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 ...
March 8, 2018, Biotech and Money
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 ...
February 2018, Digital Health Legal
January 31, 2018, Covington Alert
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 ...
January 9, 2018, Inside EU Life Sciences
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
December 11, 2017, Better Wholesaling
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.”
October 2017, Digital Health Legal
Brexit: Impact on Food & Drink Regulations
November 16, 2016, EU Food Law 2016
POLITICO Pro Morning Health Care, presented by Lilly: Brexit wobble — WHO DG candidates compete
November 4, 2016, Politico Pro
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 ...
November 4, 2016, EU Food Law
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 ...
Spanner In Works For UK Gov’t’s Brexit Plans; Industry Looks To Ongoing Talks With Ministers
November 3, 2016, The Pink Sheet
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
October 3, 2016
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 ...
October 2016, Digital Health Legal
French Pilot on Mandatory Country of Origin Labelling (COOL) for Dairy and Meat in Processed Foods
September 28, 2016, Inside EU Life Sciences
On 19 August 2016, France adopted Decree No 2016-1137 introducing mandatory country of origin labelling (COOL) for dairy and meat in processed foods. The national measures strengthen the regulatory framework that exists at the EU level, which already imposes COOL requirements on specific foodstuffs, such as unprocessed and pre-packed swine, poultry, sheep and ...
EU and Relevant National Case Law and Workshop on Constitution of a Health Claims Dossier
September 22, 2016, Autumn College on EU Food Law focusing on Health and Nutrition Claims & Food Information Conference
September 21, 2016, Covington Alert
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
August 26, 2016, Nutritional Outlook
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 ...
August 5, 2016, Covington Digital Health
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...… ...
July 15, 2016, Inside EU Life Sciences
On 14 July 2016, the Court of Justice of the European Union (CJEU) issued its decision in Case C-19/15 Verband Sozialer Wettbewerb v Innova Vital GmbH on the application of the Nutrition and Health Claims Regulation 1924/2006 (“NHCR”) to business-to-business (“B2B”) commercial communications. The CJEU ruled that B2B communications that were promotional in ...
June 30, 2016, Covington Alert
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 ...
Regulatory Framework for Personalised Nutrition and Claims
June 22, 2016, Personalised Nutrition Conference
Downer? Could the UK Psychoactive Substances Act spell disaster for the food & supplements industry?
February 26, 2016, Nutra Ingredients
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 ...
February 22, 2016, Inside EU Life Sciences
The UK has enacted new legislation to address the issue of so-called ‘legal highs’ following a number of cases of paranoia, seizures, hospitalisation and even death after consumption of certain psychoactive substances. The Psychoactive Substances Act 2016 (the “Act”) was granted Royal Assent on 28 January 2016. It is expected to come into force on...… Continue ...
January 7, 2016, Inside EU Life Sciences
A new Novel Food Regulation (EU) 2015/2283 (“Regulation”) was published in the Official Journal of the European Union on 11 December 2015. The Regulation aims to make it easier for food business operators to place novel foods and food ingredients on the EU market, while ensuring high level of consumer protection. Under the Regulation, novel...… Continue Reading
EU Borderline Law on Medicines and Foods
December 3, 2015, The Borderline Between Medicines and Foods
September 14, 2015, Inside EU Life Sciences
Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post. On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the ...
Health Claims on Food -- Legal Issues
April 21, 2015, Food Law Conference 2015 - A Review of the Latest Developments
Regulation of eHealth Products and Mobile Apps
February 25, 2015, Covington’s Life Sciences Essentials Webinar Series
Food: Food Labeling and Health Claims
November 13, 2014, Europe v. U.S. Food, Drug, Device & Tobacco Regulation & Policy: Emerging Issues and Comparative Analysis Conference
October 6, 2014, Covington E-Alert
The Legal Consequences of Non-Compliance
September 10, 2014, Freefrom Grocery & Foodservice Summit
August 5, 2014
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 ...
Product Liability Forum & Food Law Group Seminar - High Court Glucosamine Judgement
July 8, 2014, British Institute of International and Comparative Law (BIICL)
Case Law and Application to Nutrition and Health Legislation
April 3, 2014, 11th International Workshop - Nutrition & Health Claims Europe - 7 Years of Health Claims - Situation Analysis - Ways Forward
A Review of All the Latest Developments
March 11, 2014, Second Annual Food Law Conference
Nutrition & Health Claims Regulation: Lessons Learnt from EFSA’s Approved and Rejected Claims
March 6, 2014, 2nd International Workshop Nutrition Food Nutrition & Health Claims Legislation in Europe
Open Panel Discussion: Barriers to Commercialisation of Nanotechnologies
January 28, 2014, NanoEntrepreneurs Workshop "What does it take to commercialise micro & nanoscale research & development?
Hidden Pitfalls Under the New Regulations
November 27, 2013, Provision of Food Information to Consumers (FICR) Briefing Day
New Regulations on Food Additives, Flavourings and Enzymes
April 30, 2013, Food, Nutrition & Health Claims Legislation in Europe
February 1, 2013, Inside Medical Devices
The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines. The new guidance recognizes that medical devices — particularly software-based devices and ...
December 26, 2012, Inside Medical Devices
The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD). Case C-219/11 Brain Products GmbH...… Continue Reading
Commercializing Nanotechnology
September 6, 2012, Drug Delivery Technologies & Formulation
EU Data Protection Reform and Biobanks
July 12, 2012, SMI's 2nd Annual Biobanking
Commercialising Nanotechnology
June 12, 2012, SMI's RNAi, siRNA, miRNA and Nanotechnology
Health Claims for Food - Legal Issues
March 1, 2012, The Food Law Group Seminar
Sensor and Instrumentation
September 7, 2011, ESP KTN's Advances in non-invasive biosensing techniques for medical diagnostics and monitoring
Telehealth: Regulatory Issues
March 3, 2011, International Congress on Telehealth and Telecare
Pricing and Reimbursement of Medical Devices in the UK
December 1, 2010, Pricing and Reimbursement for Medical Devices and IVDs
November 30, 2010, EuroWatch
November 10, 2010, Covington E-Alert
NanoHealth - Regulatory Challenges
November 3, 2010, Nanotechnology in Clinical Practice: Needs and Opportunities
Biobanks - Ownership and Access
October 28, 2010, Biobanking & Biorepositories
October 2010, Regulatory Affairs Journal
Nanomedicine Regulation
July 8, 2010, Nanotechnology in Clinical Practice: Needs and Opportunities
Nanotechnology and Medicines - the Regulatory Framework
April 15, 2010, Nanomedicine Applications: Biosensors, Drug Delivery and Regulatory Issues
September/October 2009, RAJ Devices
- International Law Office Clients Choice Awards 2015, Healthcare & Life Sciences Law – UK
- Chambers UK, Life Sciences: Regulatory (2019)
- Chambers UK, Product Liability: Food (2019)
- 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 (2018-2019) 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)