Covington & Burling LLP

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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, whose practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law and product liability and safety. Chambers UK Guide to the Legal Profession has described him as a “talented” lawyer, who “receives very encouraging feedback from clients”, and notes “his impressive attention to detail.” According to the Legal 500 UK Guide, the team has “notable expertise in food law regulation, led by ‘excellent analyst’ Brian Kelly.” He is “‘highly competent in understanding legal and technical biological issues” and “strong on food and drink product liability.”

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 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 eHealth 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

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 ...

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 ...

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 ...

French Pilot on Mandatory Country of Origin Labelling (COOL) for Dairy and Meat in Processed Foods

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 ...

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 the EU internal market for cosmetics.

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 ...

New EU Medical Device 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...… ...

B2B or not B2B: Application of the NHCR to Business-to-Business Commercial Communications

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 ...

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 for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest. But we have set out key considerations on this below based on two proposed models being discussed.

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 ...

The Psychoactive Substances Act 2016: An Example of Poor Drafting and Unintended Consequences for Food?

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 ...

New Novel Foods Regulation: A Step Towards a Simpler and Faster Procedure?

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

General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case

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 ...

Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer ...

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 ...

PARNUTS: Out with the Old and in with the New

Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, was published in the Official Journal of the European Union on 12 June 2013. The new Regulation allows the Commission to create specific compositional and information requirements and update the list...… ...

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

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 ...

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

This post originally appeared on our sister blog, InsideMedicalDevices. 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 ...

CJEU Clarifies Medical Device Borderline

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

CJEU Clarifies Medical Device Borderline

This post originally appeared on our sister blog, InsideMedicalDevices. 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...… Continue Reading

European Commission Adopts List of General Health Claims

Originally published as Covinton E-Alert on May 25, 2012 On 16 May 2012, the European Commission adopted the much delayed list of permitted general health claims (Permitted List) for foods after scrutiny of the list by the European Parliament and the Council ended on 27 April 2012. The Permitted List contains just 222 health claims...… Continue Reading

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International Law Office Clients Choice Awards 2015, Healthcare & Life Sciences Law – UK
Chambers UK, Product Liability: Food "Star Associate" (2015-2017)
Chambers UK, Product Liability - Mainly Defendant (2013-2015)
Chambers Europe, TMT (2017)
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)

Representative Matters

Pro Bono

Memberships and Affiliations

Previous Experience

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Accolades

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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