Health Union: a stronger role for the European Medicines Agency
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Better crisis preparedness and management for medicinal products and medical devices
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New EU platform to monitor and report medicine shortages
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Increased transparency on shortages, clinical trials and marketing authorisations
The EU will be better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively.
Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the EU’s medicines regulator with 655 votes in favour, 31 against and 8 abstentions.
The European Medicines Agency (EMA) will be better equipped to monitor and mitigate shortages of medicinal products and medical devices considered to be critical in order to address public health emergencies. Two “shortages steering groups”, for medicines and medical devices respectively, will be created and the EMA will set up and manage the European Shortages Monitoring Platform to facilitate data collection.
All actors in the supply chain will be involved more closely, including expert advice from observers representing patients and medical professionals, as well as marketing authorisation holders, wholesale distributors or any other relevant healthcare stakeholders.
The agency will also set up a public webpage with information on shortages. Data related to clinical trials and product information on authorised medicinal products will be made available more timely and transparently.
Quote
Rapporteur Nicolás González Casares (S&D, ES) said: “The new regulation 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
Following the final vote in plenary, the text will be published in the EU Official Journal shortly after. The regulation will apply as of 1 March 2022.
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 COVID-19, which includes a proposal to increase the powers of the European Medicines Agency.
