Pharma industry calls for overhaul of UK clinical trial regulation

The UK’s pharma lobby group is calling for government to “use both legislative and non-legislative levers to overhaul clinical trial regulation and approvals processes, with efforts conducted in parallel with international reforms.”

A report recently published by the Association of the British Pharmaceutical Industry (ABPI) includes the following recommendations:

• The Health Research Authority should be appropriately resourced to “deliver fully” on the national #MakeItPublic transparency strategy which aims to ensure that all clinical trials are registered and their results fully reported [TranspariMED strongly supports the aims of #MakeItPublic]

• “Establish a UK clinical trial registry to enhance opportunities for research involvement and participation and support the UK’s commitment to research transparency” [since Brexit, new UK drug trials can no longer be registered on the European trial registry EudraCT]

• “The development of a UK-wide Clinical Research Dashboard which reports on metrics relating to speed & efficiency, volume, quality, innovation, impact”

• “Develop and put into practice standardised approaches and guidance for innovative design and delivery of clinical trials” [this relates mainly to platform trials like the UK’s globally acclaimed RECOVERY Covid trial]

• “Reform the UK research ethics service to create a professionalised, accredited and streamlined offer” and “deliver new and expanding regulatory and ethics services for clinical trials”

More controversially, but maybe not surprisingly, the report also recommends that “the Medicines and Medical Devices Act 2021 should be used to mandate rapid timelines for regulatory approvals and reform clinical trial regulation.”

[The Act itself is controversial because it gives the government substantial powers to change the regulatory framework without parliamentary approval. It was passed to facilitate post-Brexit regulatory adjustments, but some observers warned that it gives the executive too much power to implement major changes without sufficient democratic oversight.]

Another possible point of controversy is the recommendation to “expand the range of model UK contracts agreed with industry and the NHS… For example, France has a mandated contract template which cannot be negotiated, accompanied with a comprehensive list of costed items.”

[Presumably, this would give NHS bodies less flexibility and leverage in negotiations with pharmaceutical companies about collaborations on medical research. It is unclear whether and how thi might affect Intellectual Property rights.]

The report contains a wealth of data on the number and type of clinical trials initiated in the UK and other major countries, including data on trends over time.