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.

Taskforce on Innovation, Growth and Regulatory Reform Report

On 16 June 2021, the UK’s Taskforce on Innovation, Growth and Regulatory Reform (“TIGRR”) published a report setting out their vision for the UK’s approach to regulation post-Brexit. In this report, TIGRR makes 120 recommendations covering three broad areas: a new UK regulatory framework based on core principles of UK law; specific regulatory reforms in high-growth sectors; and proposals for how these regulatory reforms could be delivered. The report focusses heavily on principles that the UK should adopt post-Brexit. The overarching theme of these ambitions is removing unnecessary regulatory burdens, boosting innovation and the UK’s long-term competitiveness, and a departure away from the EU model of regulation.

As part of the UK Government’s renewed scrutiny of current regulations, TIGRR’s report explores new possibilities for food and drug regulation post-Brexit. One of the report’s recommendations is to introduce a separate regulatory regime for nutraceuticals. TIGRR explains that a new pathway is necessary to fill the gap between food and pharmaceutical regulation and to help the fast-growing sector “realise its potential.” In particular, they propose fixing the current lack of a clear regulatory framework for assessing, verifying and authorizing medicinal claims for nutraceuticals.

All Party Parliamentary Group on Access to Medicines and Medical Devices Report

In July 2021, the growing need for separate nutraceutical regulation was highlighted again by the Parliamentary Group on Access to Medicines and Medical Devices. In a report, the group summarizes and comments on stakeholder views on potential improvements to the MHRA. Stakeholders proposed a licensing process review and a clearer regulatory framework for “nutri-foods.” The Parliamentary Group appears to agree, citing the similar calls made by TIGRR and the current backlog of borderline products for review, which it says stifles innovation.

Conclusion

These reports are significant as, beyond nutraceuticals, they more generally signal a departure away from the EU model of regulation for medicines, medical devices and borderline substances. The proposals also include adaptive approaches to medicines regulation and the use of artificial intelligence in healthcare. Industry should keep abreast of these developments and the opportunities they present, in particular for regulator, policy and corporate investments.

Covington lawyers have a well-established nutraceutical practice in the UK (e.g., R (otao Blue Bio) v MHRA) and the EU, having represented clients before the English courts and the European courts on borderline matters, and working with the appropriate regulators to agree appropriate branding and ingredients.

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Photo of Brian Kelly Brian Kelly

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…

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.