In occasion of the ongoing trilogues on the European Medicines Agency (EMA) extended mandate, Members of the European Alliance for Responsible R&D and Affordable Medicines urge the Council to ensure the new Regulation enhances clinical trial transparency and upholds good governance.
As explained in a letter published today, it is crucial that information on clinical trials is made available in a timely, user-friendly, and complete manner. This is key to avoid unnecessary duplications and to accelerate the development of new therapies and vaccines, especially during a public health emergency.
An amendment proposed by the European Parliament (amendment 107; EP text) made reference to clinical trials transparency. It is now crucial that the Council’s position includes this amendment. If the EU wishes to be better prepared and to have a more effective response to future health crises, it will need to ensure the availability and accessibility of medicines across Member States. Reinforcing the role of the European Medicines Agency would be a critically needed step towards better preparedness and response to public health emergencies. In doing so, the EU should not miss the opportunity of ensuring transparency in clinical trials and reaffirming its role as a global leader in this area.
Alliance Members also support the EP proposed amendments regarding the adoption of an inclusive definition of shortages of medicines (i.e. one comprising shortages caused by the withdrawal of products from the market for commercial reasons), the participation of patients and consumers in related governance and activities of the involved Steering Groups, and the inclusion of requirements for transparency and conflict of interest.
Finally, the letter also highlights the need to ensure that the monitoring dashboard of the new Clinical Trials Information System (CTIS) is made publicly accessible in full.
Read the full letter here.
