The Group of the Progressive Alliance of Socialists and Democrats (the S&D Group) is today calling on the European Commission to speed up implementation of the new European Clinical Trial Regulation. The S&D Group is the second largest political group in the European Parliament with 190 members from all 28 EU member states.
The call follows the recent clinical trial tragedy in France, where one patient died after taking part in a Phase 1 clinical trial. The European Clinical Trial Regulation is currently scheduled to take effect in 2018, when it will become law that all European drug trials must be registered and report results in a publicly accessible trial registry.
Matthias Groote MEP, S&D spokesperson on health and environment, said:
“The S&Ds fought for the transparency measures agreed in the Clinical Trials Regulations in 2014. These measures need to be put in place as soon as possible to ensure better patient safety and more effective medical advancement.
“It is vital that there is public access to the results of all clinical trials, which is currently not the case in Phase 1 trials. As this regulation will not come into force before 2018, the S&D Group wants clarification from the European Commission on the progress of the implementation of this new regulation, as well as more details on the case of the clinical trial in France.”
Gilles Pargneaux MEP, S&D member of the health and environment committee, added:
“Publishing all data relating to clinical trials is a necessary condition to reassure European citizens however. Protecting public health is an absolute exception to the trade secrets and commercial confidentiality pharmaceutical companies demand.”
The new regulations require the implementation of a new clinical trial portal and database to take effect, which continue to face delays.
Richard Stephens, Chair, National Cancer Research Institute Consumer Forum, and an increasingly impatient patient said:
“More to the point though, researchers can and should be complying with the spirit of the regulation already. They can put patients’ interests first and start being open and transparent straight away. They can embrace the principle while we wait for the portal. Let’s see some good deeds even if haven’t yet got a good database.”