The shape which the UK’s life sciences regulatory regime will take post-Brexit is the subject of much anticipation (and trepidation in some quarters). A key question is how closely the UK will align with the EU and the wider international regulatory community.
Recent UK policy papers have emphasised the intention to foster innovation (e.g. the Medicines and Healthcare products Regulatory Agency (MHRA) Delivery Plan 2021-2023), and there are clear signs that the MHRA is keen to stake out its new found regulatory freedom and flex its regulatory muscles (e.g. with its recent consultation to overhaul the regulation of medical devices in the UK, see also this recent blog post). However, the direction of travel is not yet clear.
In a new report on 9 November 2021 from the Association of the British Pharmaceutical Industry (ABPI), “ABPI Vision Paper: UK medicines regulatory policy and global influence in a post-pandemic world”, the ABPI acknowledges the unique opportunities presented to the UK in a post-Brexit, post-pandemic world, but at the same time urges policy-makers to use this new regulatory freedom wisely with respect to pharmaceuticals.
The ABPI calls for the UK to seek to continue to be a gold-standard regulator on the world stage. The MHRA’s focus should be on working towards achieving an internationally competitive regulatory framework, and on ensuring the UK remains an attractive place for life sciences.
Multilateral engagement and international alignment are crucial to the ABPI’s vision. The UK should partner with its international “science allies” and not diverge significantly from its international regulatory peers. Drastic divergence could, the ABPI cautions, lead to negative consequences such as the UK becoming a late-launch, or a no-launch market for new treatments, as the industry struggles with the process of submitting multiple dossiers to regulators. The ABPI points out that, with only 2.4% of the global market for pharmaceuticals, the UK “cannot afford to substantially differentiate its regulatory regime to the point that it creates friction for global manufacturers”, and should rather seek to align with the likes of the US Food and Drug Administration and the EU’s European Medicines Agency.
Ultimately, the ABPI acknowledges that the UK needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the EMA, are nurtured.”
The report’s overall recommendations are grouped under three headings:
1. An internationally competitive regulatory framework, incorporating three themes: patient focused; innovation focused; and future focused. Specific recommendations include:
- the MHRA publish an annual report on how patient and public engagement has been embedded in regulatory processes;
- maximisation of early participation in the Innovative Licensing and Access Pathway (e.g. through better engagement);
- horizon scanning to identify international innovative regulatory practices; and
- MHRA assistance in achieving the industry’s climate change goals (e.g. through regulation that enables sustainable practices).
2. Influencing international regulatory policy, including:
- trade policies which prioritise the identification of new mutual recognition agreements with trading partners and expanding existing MR agreements;
- pursuing opportunities for regulatory cooperation with key trading partners to secure the position of the MHRA as a gold-standard regulator; and
- better engagement with plurilateral collaborations, bilateral relationships and multilateral forums, including mechanisms for industry input.
3. Factors critical for success, requiring:
- skills and resources – the MHRA should review critically its organisational culture, and focus on sufficiency of digital and data skills;
- adequate and stable funding of the MHRA; and
- greater collaboration and stakeholder engagement.
The ABPI’s Executive Director for Strategy and Partnerships, Colette Goldrick, commented:
"As the government begins to set out what Britain being a science superpower outside of the EU means, this is the perfect time to look at the important policies which attract companies to launch their products here in the UK.
"There are opportunities and pitfalls: we have seen what friction does to global supply chains and the same principle applies to regulation. Diverging from global medicines standards for the sake of it would be destructive and undermine the attractiveness of the UK.
"That’s why we want ministers to instead look at areas where we can do things faster and set the agenda for new types of medicines and vaccines, so that NHS patients can be some of the first in the world to benefit." (See also the related press release).
The report is the product of interviews and roundtable workshops with ABPI members. Its scope does not include medical devices regulation.