Category: Market/Novel Tech

Month: 06 Jul 2016

Issue: not yet available

Brexit decision is likely to have significant impact on drug development and IP protection.

The decision by the UK electorate on June 23rd to leave the European Union (EU) is likely to have a number of significant consequences for drug R&D and intellectual property (IP) protection within both academe and industry. Most notably, the European Medicines Agency (EMA), headquartered in London, may not continue to be located in the UK in the event of a UK departure, while the promised location for the pharmaceuticals division of the Unified Patent Court (UPC), also in London, may come under revision. The current framework of UK and EU legislation that governs the initiation and performance of clinical trials, similar to a raft of other UK and EU legislation, will need to be evaluated in respect of whatever new economic, legal and political reality emerges from the pending UK-EU negotiations.

 

The UK electorate voted by a margin of 17,410,742 in favour of leaving, versus 16,141,241 in favour of remaining, following the running of a long-awaited UK referendum on membership of the EU. The turnout of eligible voters was 72.2%. The relationship between the UK and EU has been characterised by significant tension in recent years, most notably led by the UK Independence Party (UKIP) but equally arising from considerable euro-scepticism within the current majority government Conservative party. Most political parties in the UK, including the Conservatives, Labour, the Liberal Democrats and the Scottish National Party campaigned in favour of remaining, while UKIP and the Democratic Unionist Party supported a leave vote.

 

On June 16th, a week before the referendum, the British Medical Journal (BMJ) published an editorial advocating a remain vote but later came under criticism for not presenting both sides of the argument. In their editorial, the BMJ argued that a decision to exit the UK would reduce NHS spending by an estimated £135 per head of population, that the position of one in ten medical personnel that work within the NHS and were trained abroad would be jeopardised, and that the EMA would have to move if the UK exited the EU, reducing the UK’s influence in the regulation of clinical trials and potentially making the UK less attractive to pharmaceutical investment. The prospect of the EMA moving from its UK location would not only impact the several hundred employees working for the agency, but could also remove a significant level of expertise that currently benefits the UK national regulatory agency (MHRA). If such personnel seek alternative opportunities in London the EMA itself also loses out.

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