The UK government has proposed legislation to open the way for gene‑edited food products in England. The Genetic Technology (Precision Breeding) Bill (“Precision Breeding Bill”) sets out a new regulatory regime that may provide a faster and easier path to market for certain gene-edited plants, animals and derived products.Continue Reading UK Draft Bill Permits ‘Precision Bred’ Gene-Edited Plants, Animals and Products
Brian Kelly
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.
UK Aims for Faster and Fairer Access to Innovative Treatments as NICE Announces Major Changes to its Health Technology Appraisals Process
On 20 January 2022, the National Institute for Health and Care Excellence (NICE) announced major changes to the processes and methods by which it assesses the cost-effectiveness of medicines and other health technologies.
NICE is an independent expert body tasked with appraising the cost-effectiveness of medicines and recommending whether a product should be funded by the National Health Service (NHS). NICE is therefore considered the gatekeeper for medicines reimbursement; a positive recommendation obliges the NHS to fund a product.
NICE has announced a suite of detailed changes, which mark the culmination of a two-year-plus long “methods review”. NICE will implement the changes in new guidelines. They are due to take effect from February 2022.Continue Reading UK Aims for Faster and Fairer Access to Innovative Treatments as NICE Announces Major Changes to its Health Technology Appraisals Process
Growing calls for separate Nutraceutical regulation in the UK
Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the Government granted the MHRA powers to fast-track approvals for innovative medicines. More recently, two reports from Westminster bodies have proposed a new regulatory regime for so-called “nutraceuticals” (products that are part drug, part nutritional) to encourage investment.Continue Reading Growing calls for separate Nutraceutical regulation in the UK
CJEU Confirms that CBD is Not a Narcotic Drug
In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions. This is the case even where the CBD is derived from the whole cannabis plant. The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union. This is likely to have wide implications for the CBD industry.
Continue Reading CJEU Confirms that CBD is Not a Narcotic Drug
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…
Continue Reading European Commission publishes Guidance relating to COVID-19 and Public Procurement
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…
Continue Reading DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19
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…
Continue Reading UK sets deadline for novel food authorisation of CBD products
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.
Continue Reading The CJEU clarifies the test to determine when a general, non-specific health claim is “accompanied” by a specific health claim
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…
Continue Reading NHS England Publishes Draft Commercial Framework for Medicines
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”) had argued…
Continue Reading Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General