The UK’s leading position as a location for phase I trials will be undermined if the country chooses to leave the EU in next month’s referendum, says a pharma trade body.
Moreover, patients in the UK would be denied inclusion in a centralised gateway for clinical trial applications – due to be implemented as a result of reforms to EU clinical testing regulations – and so be denied access to medical innovations.
The Association of the British Pharmaceutical Industry (ABPI) cites data showing that the UK is ranked number one for phase I trials, number two for phase II trials (after Germany) and third (behind Germany and Spain) for phase III studies.
This position will be under threat if the UK public vote in favour of Brexit on 23 June, according to ABPI chief executive Mike Thompson.
Others have argued the UK would benefit from leaving the EU as it would free the country from compliance with the unpopular Clinical Trials Directive (CTD), which has been criticised for adding layers of bureaucracy that have helped drive research to India and elsewhere.
However, the ABPI notes that the new EU Clinical Trials Regulation, due to come into effect in 2018, introduces a number of important reforms, including harmonised procedures for the assessment of clinical trial applications, greater collaboration between ethics committees, streamlined safety-reporting procedures and increased transparency in trial results.
“We know the old Clinical Trials Directive did not function effectively, yet the new clinical trials system will cut the bureaucracy of the old directive, and not only enable more much-need research, but will also underpin the EU as the home for clinical trials at global level,” said Thompson.
“By voting to leave, UK trials could face delay, as companies would deprioritise Britain for a more collaborative and harmonised approach available inside the EU,” he added.
The ABPI said Brexit would not only impact patient access to clinical research, but would also negatively influence the economic growth of the NHS, which benefits from investment in research by the life sciences industry.
This is not the first time the ABPI has come out strongly in favour of the Remain campaign as the referendum draws nearer.
Earlier this month, the trade organisation lent its signature to an open letter from more than 90 top executives in the UK biopharma industry which warned of “increased complexity and uncertainty” if the UK leaves the EU.