Outsourcing

The Brexit Countdown: Is there still an Opportunity for Conducting Clinical Trials in the UK?

Outsourcing

07:00, July 5 2018

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Malcolm Thomas, Agile Sciences Inc., debates some of the regulatory challenges that Brexit may pose for those companies seeking to initiate clinical trials in the U.K.

What do we know about the Brexit situation today? The simple answer is probably ‘not very much.’ Anyone who has followed the Brexit saga over the past year will probably agree that there is still no clear indication as to what will happen when the U.K. finally achieves independence from the European Union (EU) or European Community (EC) in March of 2019. There are obviously a multitude of issues in play here from trade to free movement throughout the EU. For those of us following the negotiations, it still remains a very confused and confusing situation with even members of the cabinet failing to reach an accord.

That said, what inferences can we draw for the future of clinical trials in the U.K.?

The U.K. has always been seen as a desirable location to conduct clinical trials. Administered mainly by the National Health Service (NHS) through the UK Clinical Research Collaboration, the U.K. offers significant benefits over domestic (U.S.) trials in several key areas:

  • Quality is without question and many multi-national clinical research organizations (CROs) have sizeable operations in the U.K.
  • Cost structure is part of a transparent system-wide measurement of research quality ensuring consistent value-for-money
  • Patient access through the NHS system having extensive patient records ensures efficient recruitment, faster startup times and better performance on enrollment

This is not meant to be an exhaustive list but rather a few key points that we have highlighted as part of the decision process.

There are Certain to be Challenges after Brexit...

There are currently two governing bodies that control licensing of medicines, the European Medicines Agency (EMA), part of the EU, and the Medicines and Healthcare products Regulatory Agency (MHRA), responsible for licensing and regulation in the UK. Currently, there is regulatory harmonization across the EU which ensures no duplication of effort when conducting trials. In addition, the EMA is based in London with obvious benefits to the U.K. life sciences sector. After the Brexit decision in 2016, the EU has started planning to relocate the EMA to Amsterdam. This will result in a loss of U.K. participation and expertise in this important body and a good deal of bickering as to who will pick up the default lease payments on the Canary Wharf property.

There is also free movement of people across the EU resulting in shared scientific infrastructure as well as access to patients for enrollment into trial areas where the appropriate population is not available locally. There are other European initiatives, such as the European and Developing Countries Clinical Trials Partnership (EDCTP) that is reliant on matching funds from the EC which mat be at risk after 2019.

Finally, and again this is not a comprehensive list but rather a summary of key programs, rare disease research and trials would obviously benefit from the ability to draw patients from all over the EU not just the U.K.

But There are Will Also to be Opportunities after Brexit

It is well documented that the U.K. hosts a disproportionately large number of clinical trials while significant elements of regulation and governance are determined by the EU. Brexit poses the opportunity for the U.K. to break from these regulations and possibly make better arrangements for addressing restricted research areas, further expanding the scope of clinical trials.

New U.K. regulations could also satisfy not only the domestic regulator but also others around the world such as the U.S. FDA as well as those of the EU.

The U.K. is working to improve the secondary use of data from clinical trials post-Brexit. Anonymized patient level data, currently sparsely available, will contribute to the timely evaluation of medicines and other health technologies under the new system. The NHS also hopes to use Brexit as an opportunity to further encourage support for turning the NHS into an NHS Research Service where parts of the health care system can be engaged in research and trials with patients as willing contributors.

The U.K. also has significant partnerships and collaborations outside the EU which should be unaffected by Brexit and would actually strengthen transnational research and trials.

Key to a continuation of cross-border studies and their multiple benefits in the clinical trials area will be the U.K.’s access to the new EU Clinical Trials portal which is slated to become operational in 2018.

How Should this Affect any Decisions at This Stage?

There is no doubt that the U.K. offers tangible advantages when considering a location for clinical trials. As already noted, the U.K. carries a disproportionate amount of the load for trials in the EU.

While the issues around Brexit are still very murky it seems unlikely that there will not be a concerted effort by the U.K. and EU to maintain the scientific and regulatory framework already in place.

In conclusion, while there are no clear resolutions to the issues described above, the current climate should still favor planning on conducting trials in the U.K. if economic and scientific considerations are the decision drivers. Whatever the politicians decide, the past has shown that pure science tends to survive regardless.

 

Malcolm Thomas

Chief Executive Officer

Agile Sciences Inc.

 

Further Reading

For those with the desire to learn more, I would recommend the following:

http://researchbriefings.files.parliament.uk/documents/CBP-8148/CBP-8148.pdf

https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/hpra-brexit-guidance---human-and-veterinary-medicines.pdf?sfvrsn=6

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