Reinforcing the mandate for EU medicines regulator
- Better equip EU to manage future health crises
- New EU database to monitor and report medicine shortages
- Enhanced coordination and transparency on clinical trials
On Thursday, Parliament adopted its position for negotiations with Council on extending the mandate of the European Medicines Agency and strengthening its role.
To enhance the agency’s powers in crisis preparedness, management for medicinal products and medical devices, MEPs call for the creation of an interoperable digital EU database aimed at detecting, predicting and preventing shortages of medicinal products. The new database would facilitate, on a permanent basis, access and exchange of information between the Agency and corresponding national authorities.
The experience of running clinical trials during the pandemic revealed a number of shortcomings, including duplication of efforts, the under-representation of important population subgroups in trials, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration between trials. To improve on this, MEPs call for more coordinated, well-designed and transparent clinical trials.
The report was adopted with 587 votes in favour, 28 against and 81 abstentions.
More details on the adopted text are available in the committee vote press release and in the plenary debate recording.
Rapporteur Nicolás González Casares (S&D, ES) said: “The pandemic has shown that the EU and its member states were not prepared to tackle a challenge of this magnitude. Agencies such as the EMA did not have an adequate mandate or sufficient resources. We are now strengthening the EMA’s capacity to deal with future emergencies. Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies. Moreover, we want to promote clinical trials for the development of vaccines and treatments, reinforcing public information about them. With the new database, we also provide the Agency with a crucial tool to monitor medicines supply and prevent shortages at all times. In short, more transparency, more participation, more coordination and more prevention.”
As part of building a European Health Union, the Commission proposed on 11 November 2020 a new health security framework fit for future health challenges, based on lessons learnt from combatting the coronavirus, which includes a proposal to reinforce the mandate of the European Medicines Agency.