Would Brexit Place the UK in a Regulatory Quandary?

14th June 2016 (Last Updated December 13th, 2018 15:17)

Henry Kerali asks what impact a Brexit could have on UK clinical research

Would Brexit Place the UK in a Regulatory Quandary?

Across the British Isles, public discourse in recent months has centred on the United Kingdom’s place within the European Union. The two political campaigns at the heart of the debate – Vote Leave and Vote Remain – have engaged in a bitter war of words as each camp argue their case for and against the UK’s membership in the EU.

Within the industry, general consensus leans toward the UK staying in the EU, with two of pharma’s biggest players, AstraZeneca and GlaxoSmithKline, recently signing a letter declaring their preference to remain. On this, experts have argued that if the UK left the EU, the cost to start-up and conduct trials would sky rocket, thereby damaging the UK’s clinical trials market.

Meanwhile, the much maligned EU Clinical Trials Directive (CTD), established in 2001 (adopted in 2004), has been used by those in the leave campaign as a prime example of why UK clinical research would fare better outside the confines of the EU. Critics argue the directive has created a lot of bureaucracy in application procedures making the UK uncompetitive in the market. And critics have a point. After the CTD was implemented in 2004, research in the UK declined at an alarming rate. For instance, between 2000 and 2003, non-commercial trials dropped from 600 to fewer than 300 trials between 2004 and 2007.

Since the CTD, the European Medicines Agency (EMA) has sought to harmonise the EU’s regulatory framework in an effort to make it more integrated. With the EMA introducing updated regulations (due to take effect in October 2018), a new submission process will seek to ease the regulatory burden on trial sponsors with the creation of one centralised portal. This would enable sponsors to carry out multi-site trials across the EU with a single application.

Industry ‘Remainers’ have cited these upcoming changes, as a key determinant why the UK must stay in the EU. Indeed, much of the industry has queried how a Brexit could impact clinical research from a regulatory standpoint. There are fears that if the UK left the EU and were forced to submit applications outside of the EU’s framework, this could have a deleterious effect on UK clinical research as a whole.

Nevertheless, when it comes to non-EU countries operating within EMA rulings, there is precedent. While Liechtenstein, Norway and Iceland – all members of the European Economic Area (EEA) – already abide by the EMA’s clinical trial regulations, it shows this could be the course the UK adopts if pollsters choose to leave.

With the referendum fast approaching on June 23rd, the overall result could have far-reaching implications for clinical research in the UK. A vote to remain in the EU, then it’s as you were. But if the UK votes to leave, could that place clinical research in a regulatory quandary? That remains to be seen.

We wait with baited breath…

 

Photo Credit: Jeff Djevdet via speedpropertybuyers.co.uk/

 

References
Astra and Glaxo sign Letter, Pharma Forum – http://pharmaphorum.com/news/astrazeneca-and-glaxo-sign-letter-warning-of-european-exit

What would Brexit mean for UK Clinical Research?, Pharmaceutical Technology – https://www.pharmaceutical-technology.com/features/featurewhat-would-brexit-mean-for-uk-clinical-research-4824855/

Europe’s framework for Clinical Trials is good news for UK Scientists – https://www.theguardian.com/science/political-science/2016/feb/19/europes-framework-for-clinical-trials-is-good-news-for-uk-scientists-and-patients

EU in or out? What a pro-Brexit vote could mean for UK medical device companies – https://medtechengine.com/article/brexit-uk-medical-device-companies/