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.
Rapporteur Nicolás González Casares (S&D, ES)
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.