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Government report recommends clinical trial and digital health regulation reform 16 Aug 2021

In June, the government published a comprehensive report by the Taskforce on Innovation, Growth and Regulatory reform.  The Prime Minister commissioned the taskforce, led by Rt Hon Sir Iain Duncan Smith MP, Rt Hon Theresa Villiers MP, and George Freeman MP, to review the UK’s overall approach to regulation following Brexit.  The taskforce examined the opportunities of regulatory independence in supporting cross-sector innovation.

Across industries, we are experiencing an unprecedented explosion of new technologies and innovation. Yet, to fully harness the potential of recent technological advances, regulatory frameworks need to keep pace with this change.

The report provides a comprehensive set of recommendations that aim to put innovation at the heart of regulatory frameworks while ensuring the necessary protections with ‘simple, agile, and proportionate’ regulations.

The report provides specific proposals for high-impact, high-growth areas, including clinical trials and digital health.  Within the clinical trials setting, the taskforce seeks to reform the underlying infrastructure and ultimately create a new UK clinical trials framework to replace the EU’s Clinical Trials Directive.  This framework would focus on innovative approaches including novel trial designs, patient recruitment, translational medicine protocols, and streamlined processes within a unified health research data structure.

The task force notes that while there has been improvement in the last decade, the UK had seen a gradual decline in its share of clinical trials.  However, the response to the pandemic has revealed the potential of our life sciences approach and role as a leader in supporting accelerated clinical trials and regulatory processes.

The suite of proposals for clinical trials includes expanding the remit of the MHRA to promote UK leadership in regulatory innovation and creating a joint unit incorporating MHRA-IT, NICE & NHSE to reform NICE Value Assessment and Procurement.  A proposed reform of ICH GCP guidelines would embrace novel endpoints and the use of synthetic control arms.  With data flow and integral component of the clinical trials framework, the group recommend a central ‘dataspine’ and single data controller to enable an increased volume and flow of data to ensure the correct information reaches the right stakeholders.

As the importance of digital health initiatives grows, the group further recommends establishing a dedicated regulatory pathway for new digital health technology.  Specific proposals in this space include setting up a new digital health regulatory unit within the MHRA, to develop a regulatory route for increasingly popular Consumer Healthcare Apps.

In his response to the task force report, the PM noted that it would provide a valuable template for future regulatory reform underway within the remit of the government’s Better Regulation Committee.  The government continues to consult widely with industry and civil society as they progress these matters.

The initiative reflects many of the key topics that we have discussed during our recent breakfast briefings, forums, and articles including our meeting on regulatory innovation in February, and our writing on ILAP.

To read the full report, click here.

To watch the recording of our virtual breakfast briefing discussing regulatory innovation and medical affairs trends, click here.

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