This time last year we analysed the UK Government’s annual Life Sciences Competitiveness Indicators (LSCIs) report alongside the MHRA’s Annual Report. At that time, the state of the UK clinical trials landscape and the need for international collaboration post-Brexit emerged as key themes of concern. This year’s equivalent reports, published in July, deliver a similar message, and the UK industry has expressed concern about how the UK is measuring up internationally.
These reports indicate that key to the continued success of the UK on the life sciences global stage are:
- improving the research and clinical trials environment;
- international strategic collaboration; and
- continued investment.
1. The UK life sciences research environment
A key theme in the LSCI 2023 is continued comparative poor performance by the UK research environment, including clinical trials. There was a continued decline on the previous year in set-up and approval times for clinical research, with the UK dropping to ninth out of 10 in the median time between clinical trial application to a regulatory authority and first-dose-to-patient.
The MHRA Annual Report in turn reveals a number of related key KPI metrics were not met, including a significant drop in the percentage of clinical trial applications assessed within 30 days of submission – with only 25.9% met against a target of 98%. Other relevant metrics not met included those concerning timelines for licensing and approvals of medicines and medical devices in the UK.
The MHRA largely blames resourcing challenges for this performance, which it says it is addressing. It also points to the planned reforms outlined in its recent response to the UK clinical trials consultation, which it intends will position the UK as “the leading country for conducting clinical research”, although we are yet to see the concrete drafting in this regard (for our further analysis of this development see here). The Government also refers to the recent O’Shaughnessy Review into UK clinical trials and its planned response intended to reverse this downturn, although so far we have only seen a very high level response in this regard.
2. International collaboration and strategic partnerships
LSCI metrics for the UK relating to international collaboration remained broadly stable in terms of UK export and import values – hovering around the middle of the pack for each, but overall well behind the front runners (e.g. the USA) – and there was a small increase in the overall value of the UK’s export of pharmaceutical products (based on 2021 data).
The MHRA was overall very positive in the Annual Report about its commitment to stronger international collaboration, highlighting international partnerships, while at the same time confirming it had “deepened [its] position as a sovereign regulator” post-Brexit. The MHRA’s Corporate Plan, also published in July, includes “delivery of scientific and regulatory excellence” through strategic partnerships – including partnerships with international regulators – as one of its four strategic priorities for the next three years, with a plan to become the international “partner of choice”.
The MHRA commits in its Corporate Plan to deliver a new MHRA Science Strategy by March 2023 which will outline partnerships with “measurable benefits” that support robust regulatory decision making. Notably it also commits, by March 2025, to deliver a sustainable strategy for medical products in conjunction with international regulators to “contribute to addressing the climate emergency”.
3. Investment in UK life sciences
The indicators revealed a consistent decline in the UK’s comparative investment performance, including in inward life sciences investment, and against metrics showing reduced inward foreign direct investment (FDI); shares of IPOs; and equity finance raisings.
The Government acknowledged the “substantial drop” with respect to inward FDI, where the UK fell to ninth from second out of 18 comparators, while countries such as Ireland and India saw comparative increases, but contextualised this by explaining that the USA also saw a comparative decrease over the same period.
The UK Association of the British Pharmaceutical Industry (ABPI) was vocal in its criticism of the UK’s performance, in particular with respect to FDI, which it links to the recent, much-discussed increase in branded medicine revenue clawback rates, and calls on Ministers to “fix” the commercial environment to make the UK a “genuinely attractive investment prospect”.
- While the LSCIs and MHRA KPIs do sometimes make for gloomy reading, it’s fair to say they cover a reference period of intense change – both fundamentally from a post-Brexit regulatory perspective, and institutionally within the MHRA.
- In the clinical trial space, the recent O’Shaughnessy Review and planned clinical trial regime overhaul represent genuine opportunities for significant reform, and we hope to see concrete proposals with respect to both soon.
- There have also been recent indications of intention by the UK Government to work more closely with international regulatory peers on life sciences – from the recent extensions regarding UK recognition of EU regulatory approvals, to indications of potential longer term embedding of recognition of international approvals into the UK approvals and regulatory framework, which will be welcomed by industry.