While representatives of the European Parliament and the Council of the European Union are just beginning negotiations on the draft regulation for a strengthened role for the European Medicines Agency (EMA), approximately thirty organisations, research centres and universities are mobilising to obtain guarantees on the transparency of clinical trials.
These stakeholders, who have come together under the ‘European Alliance for Responsible R&D and Affordable Medicines’, wrote to Member States on Thursday 9 September to ask them to ensure that the future regulation allows for the provision of information on clinical trials to be provided “in a timely, user-friendly, and complete manner”.
“This is essential in order to avoid unnecessary duplications and to accelerate the development of new therapies and vaccines, in particularly during a public health emergency”, said the signatories, noting that an amendment on the subject has already been incorporated into the European Parliament’s position (amendment 107).
The amendment in question, which the Alliance would therefore like to see supported by the Member States, requires that, “for the duration of a public health emergency”, sponsors of clinical trials conducted within the European Union publish their study protocol and then a summary of their results in the EU clinical trials register.
The amendment also requires that clinical data submitted in support of an application to market a medicinal product be made public, along with the eventual approval decision. This is to be done more quickly and in greater detail than is normally the case.
Inter-institutional negotiations (trilogues) on the draft regulation began at the end of July. The second meeting to take place between the European Parliament and EU Council negotiators is scheduled for the end of the month.
See the letter: https://bit.ly/3BYPOhv
See Parliament's position: https://bit.ly/390DEZf (Original version in French by Agathe Cherki)