The report sets out a new regulatory and governance pathway which is intended to remove unnecessary delays, complexity and bureaucracy and speed the development of healthcare innovations for patients.
The AMS’s work in capturing and detailing the significant barriers to conducting medical research in the UK is extremely helpful. The introduction of a more streamlined approach for clinical trials would improve the competitiveness and attractiveness of the UK to companies looking to invest in R&D with a direct benefit of improving patient’s access to new treatments.
The report identifies that obtaining NHS permissions is the single greatest barrier to health research, and recommends the introduction of a National Research and Governance Service to streamline NHS R&D permissions. This has been an area of concern to BIA and its members, and addressing it would remove a significant hurdle, particularly for those companies conducting multi-centre trials in small patient populations.
The report also highlights the need for a cultural change around health research within the NHS, which the BIA whole-heartedly supports.
The proposed solutions would make the initiation of clinical studies in the UK faster and easier, but the BIA believes that these changes could be implemented more effectively, than through the establishment of a new independent Health Research Agency (HRA) as recommended in the AMS report.
Alan Morrison, Chair of the BioIndustry Association’s Regulatory Affairs Advisory Committee, said:
“The Academy of Medical Sciences report includes recommendations which are a step in the right direction towards improving the governance framework and creating a better environment for health research in the UK. However, the BIA continues to believe that it would be more efficient and effective to build upon and expand existing competencies within MHRA rather than create a new body to oversee the regulation and governance of health research, as recommended by the AMS report.”
Greater consistency of advice and engagement with all stakeholders has been identified in the report as vital for clinical trial authorisations. In particular, the BIA recommends the introduction of a ‘one-stop shop’ for small companies and academic investigators, similar to the European Medicines Agency’s SME Office, enabling enhanced guidance and communication.
Nigel Gaymond, BIA Chief Executive said:
“Clarity and certainty of the regulatory pathway is essential for industry, and the manner of introduction of changes will be critical. The BIA looks forward to working with government and other stakeholders in the development of legislative proposals to the ultimate benefit of both patients and the UK bioscience industry.”