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Deal on stronger role for EU medicines regulator

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Parliament and Council have reached a provisional agreement to make the European Medicines Agency more effective in tackling shortages of medicines and medical devices, ENVI.

The European Medicines Agency’s (EMA) capacity to manage the availability of medicinal products and medical devices will be strengthened with the creation of two “shortages steering groups”, for medicines and medical devices respectively. These steering groups will meet regularly and whenever the situation requires, in preparation for or during a public health emergency. They will welcome expert advice from observers representing patients and medical professionals, as well as marketing authorisation holders, wholesale distributors or any other relevant healthcare stakeholders.

During negotiations, Parliament successfully insisted that the members of these groups must not have interests in related industry sectors that could affect their impartiality. Summaries of the proceedings and recommendations must be made publicly available.

Increased transparency on shortages, clinical trials and marketing authorizations

Upon Parliament’s proposal, the EMA will set up and manage the European Shortages Monitoring Platform to facilitate the collection of information on shortages, supply and demand of medicinal products. The agency will also establish a public webpage with information on shortages of critical medicines and medical devices.

Furthermore, during a public health emergency, sponsors of clinical trials conducted in the EU will be required to make the study protocol publicly available in the EU clinical trials register at the start of the trial, as well as a summary of the results.

When a medicinal product is granted marketing authorisation, the EMA will publish, among others, product information with details of the conditions of use and clinical data received (containing anonymised personal data and no commercially confidential information).

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Rapporteur Nicolás González Casares (S&D, ES) said: “With this agreement, Parliament makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies. Moreover, we pave the way to promoting clinical trials for the development of vaccines and treatments, boosting transparency on those issues. And, with the new European Shortages Monitoring Platform, we provide the Agency with a key tool to monitor medicines supply and prevent shortages. In short, more transparency, more participation, more coordination, more effective monitoring and more prevention.”

Next steps

Parliament and Council are now expected to endorse the content of the agreement, before it can enter into force.

Background

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 strengthen the mandate of the European Medicines Agency.

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