EU Clinical Trials Regulation 536/2014 (‘CTR’) is due to apply in member states in 2020 during the transition period after Brexit. It is a major change in the clinical trials process for investigational medicinal products because of more stringent governance requirements. Due to technical issues with the new EU Clinical Trials Portal and Database, the European Medicines Agency website suggests a revised timeline for full applicability of October 2021.  This is after the Brexit transition period which ends on 31 December 2020, although the terms of the Withdrawal Agreement permit a one-off extension by agreement of up to 2 years (31 December 2022). The government has ruled out any extension to the transition period and intends legislating to enshrine this in law.

In August 2018, Theresa May’s government indicated that if implementation of the CTR took place after Brexit, UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, in order that researchers conducting clinical trials can plan with greater certainty.  It remains to be seen whether the current government adopts the same stance

Organisations involved in clinical trials should continue to review their policies and procedures. The value of the life sciences sector to the economy and the government’s election campaign pledge to provide more support to the NHS may mean the UK aligns itself with the CTR in any event. Informed consent will be a significant issue in clinical trials as the CTR requirements are not identical to those introduced in the GDPR, the latter giving enhanced protection to health data. Those undertaking clinical trials will need to review their consent policies against the CTR, reconcile them with their data protection policies and ensure both also meet the requirements of the GDPR.  The extent of the GDPR’s reach to co-sponsors will also need to be factored in alongside the enhanced rights of data subjects to withdraw consent at any time, request deletion of data and be ‘forgotten’.

Medical Malpractice Forward View 2020

This article is part of Capsticks’ Medical Malpractice Forward View 2020. Read the other articles featured in this publication below:

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To discuss how any of these issues may affect your organisation, please get in touch with Majid HassanAnna WalshPhilip Hatherall, or Joanna Bower.