Two UK government reports highlight where progress is needed for the UK life sciences industry (and its regulator)
Two recent UK government reports highlight areas where further progress is needed if the UK is to succeed in retaining its gold standard regulatory position in life sciences and in becoming a newly independent life sciences powerhouse post-Brexit.
In this article we examine three themes emerging from the MHRA's Annual Report and the Life Sciences Competitiveness Indicators Report: i). innovation and access to medicine, ii). clinical trials, and iii). international collaboration.
Noting the ABPI's dismay at the UK’s performance in certain of the Life Sciences Competitiveness Indicators, we also consider some developments since the reference period, as well as some major changes on the horizon, which should impact those metrics significantly in the year ahead.
In more detail:
Both reports highlight the substantial achievements of the UK life sciences industry and of the UK regulator in a “landmark year…of challenge and change” (per Dr June Raine, CEO of the MHRA), for example, with COVID-19 vaccine development, with ongoing substantial efforts to modernise the MHRA as an organisation, and success in the UK as a quality research and talent centre.
However, the MHRA is clearly under strain, and the message from both reports is clear that much work remains to be done to realise its vision of being a “world class sovereign regulator with the patient at its core” (per Stephen Lightfoot, MHRA Chair), and to establish the UK as a life sciences global powerhouse post-Brexit.
The MHRA failed to hit some key performance metrics, and the Chief Executive of the Association of the British Pharmaceutical Industry (ABPI), Richard Torbett, went as far as to say that the UK’s performance against Life Sciences Competitiveness Indicators (LSCIs) “ought to ring alarm bells across Government”.
We examine three themes emerging from these reports in further detail, relating to innovation, clinical trials and international collaboration.
1. Innovation and accelerating access to medicine
Innovation has been a watchword of the MHRA and UK government in respect of life sciences post-Brexit. The MHRA's Annual Report highlighted “pulling scientific innovation through the regulatory system” as a key underlying principle, and scientific innovation and healthcare access were principles one and two from its list of six “strategic areas of focus”. Reducing time to market for innovative medicines and devices is described as a particular objective.
However, while the MHRA's Annual Report announced some successes, for example with the Innovative Licensing and Access Pathway (with higher-than-expected applications in the reporting period), as well as with the Early Access to Medicines Scheme, it failed to meet key performance indicators (KPIs), including:
- Deadlines for validation of new marketing authorisations (MAs);
- Deadlines for the assessment of applications for new active substances MAs;
- Deadlines for assessment of new European MAs (including via Mutual Recognition Procedures); and
- Deadlines for molecular immunology batch release.
At the same time, the LSCI Report demonstrated that the UK’s count of life sciences patent applications (generally considered a “good proxy for where and when innovative life sciences activity takes place”) has declined (6th out of 13 measured).
The MHRA explained its failures to meet these KPIs through a combination of resource constraints, human error and a hangover from issues during the previous reporting period, and said that matters are now much improved. More recently, the MHRA has been keen to emphasise its continued commitment to supporting innovation, for example, it has just launched its “Innovation Accelerator” guidance page, with a dedicated “Innovation Office” for innovation-related queries, and at the same time published case studies demonstrating recent MHRA successes in guiding applicants through innovative healthcare product regulatory processes.
2. Clinical trials
Impacting also on speed of access to medicine, the MHRA's Annual Report discusses the objective of realising the UK government’s aim to “make the UK the best place to develop and run clinical trials”.
However, it is clear that aim has not yet been achieved, and some of the results give cause for concern. For example, the MHRA did not meet a KPI in this arena relating to deadlines for providing Independent Scientific Advisory Committee feedback in respect of research applications via the CPRD (clinical practice research datalink).
According to the LSCIs, the UK took longer to set up clinical research than most comparator countries up to 2020 (7th out of 10), with a longer length of time between first application to a regulatory authority and the first patient receiving a first dose, and with a lengthening of this period between 2018 and 2020 by 25 days (with a median of 247 days). At the same time, the ABPI pointed out that, while some countries (such as Spain) are increasing their global share of clinical trial recruitment, the UK is not.
The MHRA also did not achieve its target to expand the CRPD database coverage to 25% of the total UK population. While the reasons given for this failure are external to the MHRA, better access to and utilisation of health data will be crucial to the future success of the UK life sciences industry (not only for clinical trials) as outlined recently by Ben Goldacre (see further here) and in the UK’s recent Health Data Strategy policy paper.
The UK government is yet to outline the results of its clinical trials consultation (see our analysis here), but there is some optimism in the MHRA's Annual Report that its “innovative” proposals there will resolve some of the issues it has experienced.
3. International collaboration
The MHRA states that it has “fully recognised” the importance of working with its partners in healthcare, with “leveraging international partnerships” listed as one of its six areas of strategic focus.
From an international perspective, the MHRA highlighted collaborative working via the ACCESS consortium and via Project Orbis (an FDA initiative related to innovative cancer treatments). However, both of these items featured in the previous annual report and there were few new concrete examples in this year's edition.
International collaboration (in the form of trade) was also one area where the UK performed relatively poorly in the LSCI Report, with import and export values for pharmaceutical products declining in recent years and “notably lower than the majority of comparator countries” (9th and 10th for exports and imports respectively, out of 20). The ABPI in its appraisal gave these indicators particular focus.
In terms of activity since the period reported on in the Annual Report, the MHRA has taken some steps towards further international collaboration by joining three international partnerships in June of this year (the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the Medical Devices Innovation Forum). The degree of international collaboration which will be ultimately reflected in the revised regulatory regime for clinical trials and medical devices regulation in the UK remains to be seen.
- The ABPI’s concern following the publication of the LSCI Report is understandable, and is borne out to a degree in the MHRA’s failure to meet important KPIs.
- With respect to the three areas of concern highlighted here, there has been further progress since the reference period for both reports.
- Additionally, the year ahead will be one of huge change, and it remains to be seen how these developments will impact the success of the UK as a life sciences hub (and in due course the relevant metrics of concern outlined):
- There will be massive regulatory change in the UK, with the anticipated clinical trials reforms, as well as those related to the regulation of medical devices, see further analysis here).
- There will also be significant political change, and the ABPI’s position is that it is “critical that under a new Prime Minister, Ministers across Government take an urgent look at how to reverse these trends and ensure that the Life Sciences sector is in a position to drive the UK’s economic recovery”.