MEPs agree to strengthen the European Medicines Agency’s capacity

They propose the creation of a digital EU database to monitor and report on shortages of medicinal products

Photo: EPA MEPs agree to strengthen the European Medicines Agency’s capacity

Public health MEPs agree to change the European Medicines Agency’s mandate to reinforce its role and better equip the EU to manage future health crises, EP Press service reported. The Committee on the Environment, Public Health and Food Safety (ENVI) adopted on Tuesday, with 68 votes in favour, 3 against and 8 abstentions, its negotiating position on the extension of the mandate of the European Medicines Agency (EMA). The position is scheduled to be voted on during the July plenary session.

MEPs propose the creation of an interoperable digital EU database to monitor and report on shortages of medicinal products. The database would facilitate, on a permanent basis, access and exchange of information between the Agency and national authorities. Each EU country would develop a platform for the real-time monitoring of medicinal supply, aiming to detect, predict and prevent shortages.

MEPs also seek the implement of coordinated, well-designed and large-scale clinical trials to obtain reliable evidence. Experience with clinical trials during the pandemic revealed many shortcomings, including duplication, the under-representation of important population subgroups, and a lack of collaboration. In addition, MEPs want information on clinical trials and marketing authorisation decisions to be publicised.

Newly established Agency bodies, such as the Medicines Steering Group and the Medical Devices Steering Group, should include permanent observers from bodies representing patients and medical professionals, as well as invite contributions from third parties including marketing authorisation holders, wholesale distributors, or other appropriate industry, patients’, consumers’ and healthcare professionals’ groups. Members of these

bodies must not have interests in related industry sectors that could affect their impartiality. The EMA should make these member lists and proceedings publicly available, MEPs add.

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 EMA's mandate.

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