CaSE joins cross-sector call for government to align with EU clinical trials regulation

CaSE’s recent Brexit report, published to mark the anniversary of the triggering of article 50, sets out a number of policy asks from the science and engineering sector on regulation.

A thriving science and engineering sector requires a stable regulatory environment that facilitates trade, access to markets, and innovation. From aerospace to pharmaceuticals, parts and raw materials cross borders frequently in highly integrated European supply chains and operations are finely tuned, often on a ‘just in time’ principle.

CaSE’s asks on regulation include: 

• Prioritise stability and harmonisation of regulation in established areas
• Seek influence on regulation that impacts on UK science and engineering 
• Lead the world in regulation of emerging areas of science and innovation 
• Access and use scientific and technical expertise and advice 

CaSE has also produced a dossier compiling some of our members concerns and priorities for scientific regulations post-Brexit.

In our support for the harmonisation of regulation, CaSE came together with seven other science and medical research organisations earlier this week to ask the UK Government to commit to align with the EU Clinical Trials Regulation.  

The full statement reads as follows:

We would like to see the UK Government commit to align with the EU Clinical Trials Regulation. UK research expertise was a driving force behind the new Clinical Trials Regulation, and as a Member State we fully agreed to it. Yet because it is now due to come into effect after we have left the EU, it will not automatically become UK law.

This leaves the real possibility that we will fall out of alignment with our European partners on clinical trials; a significant hurdle for UK patients and researchers, as well as our world‐leading life sciences industry. In this scenario we would miss the opportunity to move to a regulation that the research community agrees is a vast improvement for patient safety and trial efficiency.

A failure to adopt the Regulation would make continued collaboration with our closest partners significantly harder. International collaboration is vital for clinical research, and means UK patients can continue to access potentially life‐saving experimental treatments. It is particularly important for rare, less common and paediatric diseases, where patient populations in individual countries are often too small to recruit sufficient numbers. 75% of clinical trials in the EU involve cross‐national collaboration, and this rises to 86% for rare disease trials.

Clinical trials can run over many years, and require significant planning. If researchers lack clarity as to the ease of conducting cross‐national trials, and the underlying conditions of the UK’s research environment, planning ahead becomes immeasurably difficult. With continued uncertainty around the future of internationally collaborative research in the UK, Government commitment to align the UK with the EU Clinical Trials Regulation and to seek UK access to its underpinning infrastructure would help provide the reassurance our research community so desperately needs.