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The majority of pharmaceutical manufacturers responding to a survey have said the UK’s medicines regulatory environment has an ‘unfavourable’ impact on their decision to invest in research development.
Results of the survey, published in the Association of the British Pharmaceutical Industry’s (ABPI’s) report ‘Enhancing the role of UK medicine regulation’, published on 4 December 2024, revealed that 56% of respondents said the UK’s regulatory environment was ‘somewhat unfavourable’, while 22% said it was ‘very unfavourable’.
Among those with an unfavourable view, the most common reason (84%) was attributed to the “capacity and predictability of the MHRA [Medicines and Healthcare products Regulatory Agency]” (see Figure).
In a statement published alongside the report, the ABPI said the report focuses on the MHRA “as it embarks on a new phase in its leadership”.
“Reaffirming the MHRA’s status as a world-class regulator will be a key objective for its incoming new chair, Professor Anthony Harnden, and its new chief executive, when appointed,” it added.
The ABPI has made 12 recommendations across four themes: improving the transparency of the MHRA; improving the predictability and general delivery of the MHRA’s statutory functions; strengthening the MHRA’s development and retention of expertise and institutional knowledge base; and strengthening the MHRA’s engagement with stakeholders, including experts in regulatory innovation.
The ABPI based its report on research that included interviews with 20 senior pharmaceutical company representatives, patient associations and government organisations, as well as an online survey distributed to interviewees, ABPI members and other organisations.
Commenting on the report, Richard Torbett, chief executive of the ABPI, said: “The MHRA has long been regarded as a well-respected, global leader in medicines regulation, underpinned by solid expertise and innovative approaches. However, events in recent years have tested its resilience and capabilities.
“Our industry wants to support the MHRA to regain its world-class reputation. This report sets out a clear roadmap for the MHRA’s incoming leadership to ensure the UK can operate as a leading authority that supports the development of new medicines and can safely and swiftly bring new innovations and treatments to patients.”
Responding to the report, June Raine, chief executive of the MHRA, said: “The ABPI’s new report endorses our vision for the future of the agency, outlined in our business and corporate plans, as an agile and accessible regulator, enabling innovation and with an international voice.
“We continue to optimise our performance in delivering efficient and predictable services which meet stakeholders’ expectations, for the benefit of the patients and public health, and the life sciences sector.
“This includes, but is not limited to, our work overhauling the clinical trials regulations, relaunching ILAP [the Innovative Licensing and Access Pathway] to reduce the time from discovery to deployment, and introducing a world-first framework for the manufacture of innovative medicines at, or close to, where a patient receives care.”
In March 2024, The Pharmaceutical Journal reported that marketing authorisations from the MHRA for established medicines and variations to existing approvals were running more than 100 days over their statutory limits.
The MHRA has eliminated a backlog of national marketing authorisation applications as of December 2024 and embedded improvements in processing clinical trial applications into standard working practice.
