The government recently consulted on proposals intended to improve the UK’s clinical trials legislation – the objective being to take advantage of Brexit to design legislation that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as a world-leading base for life sciences.
The overarching theme of the proposed changes is one of streamlining requirements and implementing a more proportionate approach in a number of key areas, including safety reporting and the trial approval process. The intention is that blockers to innovation and overly prescriptive requirements should be identified and removed, whilst still ensuring regulatory oversight of trials. The protection of trial participants, the consultation stresses, should remain at the heart of legislation.
The consultation received a large number of responses – over 2000 – from a variety of stakeholders. The government has now issued its response.
According to the government response, there is agreement with the overarching idea of enabling more proportionate and risk appropriate approaches to clinical trials. However, some concerns were raised by responders about the proposals, including whether proposals to streamline safety reporting could compromise trial participant safety. It remains to be seen how the issues raised will be implemented in actual legislation and the government will now proceed to prepare draft legislation for further review.
Clearly, the question at the forefront of the minds of many responders is to what extent it is possible to maintain existing safety standards while at the same time relaxing legislation sufficiently to enable the UK to achieve the government’s desired “leg up” over other potential clinical trial locations. We will be providing our analysis of the draft legislation when it is available.