Parliamentary Office of Science and Technology on Regulating Clinical Trials

Clinical trials are essential to establish the safety and efficacy of medicines and are strictly regulated in the EU. The current EU regulatory framework is due to be replaced by a new EU Clinical Trial Regulation in 2019. After a period of review The Parliamentary Office of Science and Technology have released a POSTnote that examines how this may effect the UK healthcare industry, including issues around clinical trial transparency. It also examines options for UK regulation of clinical trials post-Brexit, including a description of the more general issues facing UK patients and clinical researchers post-Brexit. 

The report outlines the challenges and opportunities arising from the uncertainties associated with Brexit. These include staff recruitment and retention, an unknown future relationship between the MHRA and the EMA, access to, and transparency of, clinical trials data and access to new medicines.

  • The NHS and the clinical research sector both employ a significant number of EU nationals. There are serious concerns in both sectors about staff recruitment and retention for UK positions post-Brexit. The UK is one of the largest recipients of research funding from the EU.
  • Many stakeholders are concerned that any loss of funding through this pathway will threaten the UK’s position as a world leader in the life sciences.
  • Since the Brexit decision was announced, there has been considerable speculation over where the EMA, currently based in London, will be located.
  • It is likely that the UK will have to leave the EMA. The MHRA is a leading regulator within the EU and is noted for driving innovative regulatory approaches and practices. But there are concerns that on its own the MHRA has sufficient resource to act independently
  • If the UK leaves the European regulatory system, then regulator access to the EU portal and database may become restricted after Brexit, although this is unclear.  Reducing the ability of UK researchers to access data on clinical trials may also prevent research studies such as meta-analyses being performed, although other stakeholders dispute this.
  • Stakeholders have expressed concerns that the loss of an EU wide market authorisation procedure after Brexit could delay the availability of new medicines in the UK.

The report puts a positive spin on various aspects of the UK that may work in its favour in a new market environment. The report refers to the 2017 government backed strategy document claimed to strengthen the UK life sciences sector that includes a proposal to increase the number of clinical trials conducted in the UK by 50% over the next 5 years. The strategy suggests that the UK is well placed to conduct novel clinical trials compared with other EU countries because of its strengths in emerging technologies such as genomic medicine and gene- and cell- based therapies, as well as the increasing use of digital systems within the NHS. This speculation based on an industry that has thrived in the EU environment, has been jumped upon by Brexit supporters such as Boris Jonhson in his letter of 15 September to The Telegraph entitled My vision for a bold, thriving Britain. However, better informed individuals have already attacked his poorly constructed argument. Similarly, we hear today that the concerns over NHS staffing are being realised with reductions in the number of EU nurses coming to UK having fallen by 90% since Brexit vote

The question remains whether the report, which is created to inform our government leaders, has missed an opportunity in adopting a unopinionated position that makes very limited assessment of the threat to the UK life sciences industry.

 

NIKE