The Slovenian Presidency reached an agreement on the extension of the mandate of EMA – EURACTIV.com
An interim agreement has been reached on a strengthened role for the European Medicines Agency (EMA) in crisis preparedness and crisis management in the field of medicines and medical devices, the health ministry said on Thursday (October 28th).
The agreement, negotiated by the Slovenian Presidency of the Council of the EU and the negotiators in the European Parliament, has yet to go through formal adoption procedures.
“Preparation and coordination at EU level are essential elements in the fight against future health crises. This agreement is an important element for upgrading the EU’s health structure, “said Health Minister Janez Poklukar.
He added that the EMA will be able to ensure that the medicines needed to deal with the public health emergency are available.
The Agency should set up a special platform to facilitate the monitoring of shortages, supply and demand for medicines, and set up a public website with information on which key medicines and medicines are in short supply.
Two steering groups would address drug and drug shortages, and summaries of their procedures and recommendations should be published.
The ministry noted that the updated draft mandate of the EMA is part of a broader package for the European Health Union, which includes an enhanced mandate from the European Center for Disease Prevention and Control (ECDC).
The package also includes a draft law on cross-border health risks and a proposal to establish a European Emergency Preparedness and Response Agency (HERA).
[Edited by Alice Taylor]