When Brexiteers attack the EU on science, they often cite the Clinical Trials Directive (CTD). This flawed EU law bogged researchers down in red tape. Justice secretary Michael Gove says it “slowed down the creation of new drugs to cure terrible diseases”. Vote Leave lambasts the directive several times on its website.
What Brexit campaigners don’t mention is that the EU has recognised the CTD’s failings and is now replacing it. A new Clinical Trials Regulation (CTR) will come into force as early as this year.
Building a framework for rigorous testing of pharmaceutical products across 28 different countries is a balancing act between keeping delays and costs for researchers to a minimum, while maintaining quality control and transparency to protect patients. The CTD fell short of this.
In a report by the UK Parliament’s science and technology committee, everyone from Cancer Research to the NHS slammed the CTD for burdening researchers with extra costs and “unnecessary administration without clear upsides”, although it did improve safety.
The European Commission also admitted the failings. In a 2012 speech, health and consumer policy commissioner John Dalli spoke of the 15% decline in clinical trials in the EU, the doubling in bureaucracy costs and a 90% increase in delays. Most importantly, he announced a new regulation to replace the old system.
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The new Clinical Trials Regulation (CTR) cuts the bureaucracy of the old directive. It streamlines the authorisation process for drugs trials, cuts red tape for products that pose minimal risks and simplifies reporting procedures.
What’s more, the regulation creates an open database. This allows scientists to see the trials carried out by other researchers and so helps them speed up their own inquiries.
The CTR has been met with praise from the same organisations which criticised the CTD. The NHS recognised the “positive changes”, while Cancer Research said the new regulation will help “beat cancer sooner”.
The Leave campaign faces an uphill struggle proving the EU is anti-science. In a recent report, 93% of researchers said the EU was beneficial to science.
Vote Leave’s other main line of attack has been to criticise the EU for abolishing the post of chief scientist. But it failed to mention that it had been replaced by a body of seven scientists – a move welcomed by experts including the Royal Society.
If the best the Leave camp can do is point to errors of the past that have already been remedied, it is clutching at straws.
Edited by Hugo Dixon
The Leave campaign isn’t clutching at straws – there is nothing wrong with pointing out how terrible the EU Clinical Trials Directive (CTD) 2001/20/EU was for UK medical research. In 2004, Britain was one of the best places in the world to do clinical trials – we were conducting 12% of them worldwide. Cutting edge. But the EU’s disastrous directive cut it to 1%! And according to the EU’s own figures, the average delay for launching a clinical trial increased by 90% to 152 days after the introduction of the CTD.
The new EU Clinical Trials Regulation (CTR) 534/2014 is scheduled to come into force in 2020 in a major step forward in UK medical research – with red tape cut, the shackles are off clinical innovation. And what Remainers fail to discuss with regards to the new regulation is that it happened because of pressure from the UK over a number of years to get the EU to reform it – and we also led the negotiations on its replacement, which has been widely welcomed by Europe’s research sector, including academia, medical research charities, and industry – although it doesn’t take effect until after we leave the EU, and so it won’t be covered by the Repeal Bill, meaning that our future alignment with the new EU Clinical Trials Regulation (CTR) will be subject to negotiations.
Government issued guidance on medicine, medical devices, and clinical trials regulation in a ‘no-deal’ Brexit reveals for clinical trials, 2004 regulations will remain in force and will be adapted using powers under EU (Withdrawal) Act.