The European Parliament today adopted the provisional agreement reached in the Council on increasing the powers of the European Medicines Agency (Coreper) by 655 votes to 31, with 8 abstentions.
The European Medicines Agency will be better equipped to monitor and mitigate shortages of medicines and medical devices vital to dealing with public health emergencies. Two “steering groups for deficiencies” will be set up, for medicines and medical devices respectively.
At the same time, Coreper will set up and manage the European Deficit Monitoring Platform to facilitate data collection. All actors in the supply chain will be more actively involved in this management, for example through the provision of consulting services by observers representing patients and health professionals, as well as by licensors, wholesalers and other healthcare professionals. care.
The Agency will also set up a public website with information on deficiencies. Data related to clinical trials and product information related to approved medicines will be made available quickly and transparently.
The rapporteur, Nicolas Gonzalez Casares (Socialists, Spain), stated: “The new regulation makes the Agency and all actors in the supply chain more transparent, by integrating them more actively into the relevant processes and by strengthening cooperation between the EU agencies. Clinical trials for the development of vaccines and therapies will be supported, enhancing transparency on these issues. The new EU Deficit Monitoring Platform will provide the Agency with a key tool for monitoring the supply of medicines and preventing shortages. In short, more transparency, more participation, better coordination, more effective monitoring and more prevention. “
The Commissioner of Health, Stella Kyriakidou, in a message on Twitter, welcomed the approval of the agreement, noting that “after today’s vote in the EP, we are approaching a strengthened European Medicines Agency”. He also noted that this means “ensuring the availability of basic medical supplies for future crises, greater capacity to monitor deficiencies and faster and more transparent clinical trials and procedures”.
Following the final vote in plenary, the text will be published in the Official Journal of the EU. The regulation will apply from 1 March 2022.
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