What does Brexit mean for medical regulation?

30 January 2017 (Last Updated January 30th, 2017 06:25)

On 17 January 2017, UK Prime Minister Theresa May outlined her vision for a hard Brexit, clarifying the government’s ambitions for a post-Brexit Britain. With the European Union (Notification of Withdrawal) Bill now on its way through parliament, the official date of triggering Article 50 is swiftly approaching.

What does Brexit mean for medical regulation?

On 17 January 2017, UK Prime Minister Theresa May outlined her vision for a hard Brexit, clarifying the government’s ambitions for a post-Brexit Britain. With the European Union (Notification of Withdrawal) Bill now on its way through parliament, the official date of triggering Article 50 is swiftly approaching.

The announcement that current European law will be adopted into UK law was well received by many, as this will mitigate some of the instability upon leaving the EU. Although not explicitly stated, it implies that the Medical Devices Regulations (MDR) and the In Vitro Diagnostics Regulations (IVDR) will be adopted in the UK. The alignment between UK and EU regulation of medical devices could provide an interesting opportunity for medical device companies looking to gain entry into the European market. If a trade deal enables relatively easy access for CE Marked products between the UK market and the EU market, the UK could become a more favorable location for medical device companies. However, with the country leaving the Single Market and negotiations yet to begin, this optimistic scenario is unlikely to materialize.

For pharmaceutical companies, the situation is arguably less clear. In a meeting with the health committee, Health Secretary Jeremy Hunt stated his aim to foster the “closest possible relationship” between the European Medicines Agency (EMA) and UK regulators, but added no explanation of what this may entail. This uncertainty in regulation is a concern for many pharmaceutical companies, especially considering the long timelines involved in drug development. In an effort to mitigate the growing concerns, Hunt is holding meetings with CEOs of pharmaceutical companies in an effort to make the UK appear a more attractive location for R&D, but any progress made will be dependent on the result of negotiations with the EU. For some companies, the risk of regulatory uncertainty is likely to overshadow the potential benefits Hunt can currently offer, which could lead to some R&D sites moving overseas in the next two years.