Regulatory review: a positive response in Whitehall and on Capitol Hill

The Academy's report, 'A new pathway for the regulation and governance of health research' (January 2011) set out a series of recommendations to substantially improve the regulation and governance pathway and the culture within which it operates.

Implementation of report recommendations:

Since the launch of the report, the Academy President and working group chair, Sir Michael Rawlins FMedSci, have met with senior officials from the Department of Health and Treasury to inform uptake of the recommendations, culminating in the announcement of a number of initiatives in the Government's recent 'Plan for Growth'. Published alongside the 2011 Budget, the Plan for Growth explicitly acknowledged the impact of our report, with the Academy uniquely cited throughout the section on life sciences. Many of the Academy's recommendations are to be taken forward, including:

  • The creation of a new Health Research Regulatory Agency (HRRA), with the aim of streamlining regulation and improving the cost effectiveness of clinical trials. As recommended by the Academy, this will be established with the National Research Ethics Service at its core, and the new Agency will work with the MHRA to promote proportionate standards for compliance and inspection of clinical trials.
  • New incentives for efficiency in research initiation and delivery. Our report identified delays in NHS Trusts approving research as the major bottleneck in the regulation and governance process. In response, the Government has stated that future NIHR funding will become conditional on organisations meeting milestones in the R&D approval process, including a 70 day benchmark from funding being agreed to the recruitment of the first patients into trials.
  • Adopting a proportional approach to the EU Clinical Trials Directive. The Government stated their intention to reduce "perceived gold plating" and increase the proportionality of the EU Clinical Trials Directive and its implementation. Government will seek to influence the European Commission and European Parliament to change the Directive and further reduce its burden.

Further detail on these announcements is available on the National Institute for Health Research website. In a media statement the Academy welcomed these steps and we now look forward to seeing how these initiatives are developed and ensuring that changes to the regulatory environment in the UK are implemented effectively.

Presentation to the U.S Institute of Medicine

As part of the wider dissemination of this report, Sir Michael recently visited Washington DC to present to a meeting of the U.S Institute of Medicine's (IOM)Forum on Drug Discovery, Development and Translation. The Forum includes leaders from private sector sponsors of biomedical and clinical research; federal agencies sponsoring and regulating biomedical and clinical research and the academic community.

The Academy's report was well received, with participants impressed by the Academy's impact in the UK and noting that the UK and the US face many similar regulatory challenges. We look forward to building on these links with the IOM in future activities.

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