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Mythbust

We don’t need to quit EU to repeal clinical trials directive

by Luke Lythgoe | 04.05.2016

Myth: Clinical Trials Directive is damaging to UK science.

InFact: A new Clinical Trials Regulation will replace the flawed Clinical Trials Directive. The new rules have been well received by the scientific community.

More information

When Brexiteers attack the EU on science, they often cite the Clinical Trials Directive (CTD). This flawed attempt to harmonise drug trials across the EU 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.

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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.

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”.

This article is an adaptation of a piece that previously appeared on InFacts.

Edited by Hugo Dixon

Categories: Industry

2 Responses to “We don’t need to quit EU to repeal clinical trials directive”

  • 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 fact that The Clinical Trials Directive took over ten years to put right shows what is wrong with the EU: it cannot introduce necessary changes quickly. Like the Common Fisheries debacle, it shows what happens when you have an executive over which there is no effective parliamentary control.