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What does Brexit mean for clinical trials?

On March 29th 2017, the UK government triggered Article 50 – officially starting the two-year period of negotiation before the UK exits the European Union. For the clinical trials industry, the build up to Brexit has mostly been characterised by uncertainty.

The UK enters negotiations with very little information about how Brexit will impact clinical trials. We do know that the UK is expected to leave the European Medicines Agency, and as such the EMA offices which are currently based in London will move to a different member state (many of which are already bidding to take on the 900 skilled workers who will leave the UK in the move). However, much of the material impact will depend on what happens during the next two years.

Many have expressed concerns for aspects of clinical research in the UK, while others believe that operating under EU directives has slowed and limited Britain’s research output.

Could Brexit help innovation? 

In October 2016, Angus Dalgleish (an oncology doctor best known for his research in HIV/AIDS) wrote in The Telegraph of his relief that the UK would be freed from what he sees as heavily restrictive EU directives. In the article, Dr Dalgleish stated “Post-Brexit we can get back to a freer, researcher-led and much more creative approach to regulating medical studies and saving lives.”

Dr Dalgleish believes that the EU’s system is overly bureaucratic and that lobbies are too powerful in pushing certain types of research. He claims the culture of the EU stops researchers from conducting original, inventive research and that it is too difficult to secure funding for innovative research within the EU. In the article, Dalgleish looks forward to a new era where pioneering studies can be kick started by investment from philanthropists and big businesses.

Whether Brexit will lead to a more innovative clinical research landscape in the UK remains to be seen, although Dr Dalgleish is optimistic. On the other hand, Article 50 is being triggered just one year before the EU brings new regulations into force that aim to streamline approval processes, with the intention of solving many of the regulatory issues highlighted in Dr Dalgleish’s article. One area to watch in the next few years will be how effective these new regulations are at improving the research environment for EU member states.

Could Brexit see the UK bypassed in clinical trials? 

Brexit has left many clinical trials experts concerned about a range of factors – in particular, the risk that operating outside the harmonised regulatory landscape of the EU will result in reduced access to clinical trials for patients.

In February 2017, The Independent reported that 600,000 patients could miss out on the chance to take part in clinical trials, as the larger participant pool offered by the EU may be more attractive than the much smaller pool of the UK population. One therapy area that could be particularly affected by this is rare diseases. Rare disease research typically requires a wide geographic reach, in order to access a large enough participant pool. Medical research organisations have raised concerns that research will centre on the EU, potentially bypassing the UK altogether.

As a direct follow on, access to new drugs could also be slowed if treatments are initially only approved and licensed for use within the European Union.

Looking to the future

Unfortunately, at this stage we can only speculate on how Brexit will impact clinical trials in the UK and beyond – however, clearly the priority for researchers, government and regulatory agencies will be on continuing to develop ground breaking healthcare for people all over the world; so we can be sure that all parties will do what they can to minimise disruption for patients and the industry.

MESM already operates on a global level, helping ensure clinical trials in over 80 countries are fully equipped with medical devices and ancillary supplies, and we’ll continue to support all our partners as the Brexit negotiations commence.