The Voluntary scheme for branded medicines pricing and access (“VPAS”) is a voluntary agreement that regulates the price of the vast majority of branded medicines sold in the UK (including branded generics and biosimilars). VPAS is critical to the commercial interests of most innovative pharmaceutical companies operating in the UK. It has traditionally
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.
On 2 March 2023, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling clarifying various aspects around the classification of products as foods for special medical purposes (“FSMPs”). The CJEU reinforced and supplemented its prior ruling in Case C-418/21 Orthomol (see our blog here for further details).
This case touches on a number of concepts in the FSMP definition. As a reminder, Article 2(2)(g) of Regulation (EU) 609/2013 (the “FSG Regulation”) defines an ‘FSMP’ as:
“food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone” (emphasis added).
In summary, the CJEU concluded:
- In determining the borderline between an FSMP and a medicine, all characteristics of the product need to be taken into account to determine whether it is intended to meet particular nutritional requirements or to prevent or cure human disease.
- The concept of ‘dietary management’ has to be understood to require a link between the disease and the nutritional requirements arising from it, the satisfaction of which is indispensable to the patient. The nutritional requirements do not necessarily have to be satisfied through digestion.
- The concept that the dietary management of the patient cannot be met through ‘modification of the normal diet alone’ means that meeting nutritional requirements through supplementing or changing the normal diet is impossible, dangerous or very difficult for the patient.
- The term ‘nutrient’ has to be interpreted in accordance with Regulation (EU) 1169/2011 on food information to consumers (the “FIC Regulation”).
- A product is ‘used under medical supervision’, “if the recommendation and subsequent assessment of a health professional are necessary in light of the dietary management needs arising from a particular disease, disorder or health condition and the effects of the product on the patient’s dietary management and on the patient” (paragraph 81).
- In determining the borderline between an FSMP and a food supplement, all characteristics of the product need to be taken into account to determine whether it is intended to meet the nutritional requirements of a patient that could not be achieved through regular diet or whether it is intended to supplement the normal diet.
On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK). The ABPI Code sets out a number of overarching principles but does not address social media in detail. The PMCPA had some years ago published “digital guidelines” but these were archived for updating.
The first – and probably most important – thing to say about the Guidance is that it (finally) exists. Social media has become a major compliance headache for UK pharmaceutical companies. These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn. The absence of clear and codified guidance until now led to a lack of clarity. Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent. While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.
Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach. Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history. It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).…
On the 27 October 2022, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling regarding the definition of foods for special medical purposes (“FSMP”). The CJEU held that for a food product to be classified as an FSMP, it must cover the increased or specific nutritional requirements caused by the disease. It is not sufficient that the product counteracts the disease or alleviates its symptoms, as that would blur the lines between foods and medicinal products.
1. Background to the Dispute
This ruling arose in the context of an action brought by Verband Sozialer Wettbewerb e.V. (“VSW”) against Orthomol pharmazeutische Vertriebs GmbH (“Orthomol”) regarding two Orthomol products classification as FSMPs. This action was brought before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) at the first instance and was then appealed to the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany) which then referred the case to the CJEU for a preliminary ruling. …
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.…
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.…
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.…
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
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. The Guidance highlights…
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…