Negotiators from the European Parliament and the EU Council reached an agreement, on Thursday 28 October, on the draft regulation aimed at reinforcing the role of the European Medicines Agency (EMA) to better equip the EU against health crises. This is the first of the three texts of the “European Health Union” package to be the subject of an Interinstitutional Agreement (see EUROPE 12600/24).
The text adopted, which will enter into force in March 2022 - with a few exceptions - therefore consists of an update of the EMA’s mandate.
In particular, it gives the European agency new responsibilities for monitoring stocks of medicines and medical devices, assessing high-risk medical devices as well as developing medicines in the event of a public health emergency.
Steering groups
Two steering groups on shortages will be set up within the EMA: one dedicated to shortages of medicines, the other to shortages of medical devices. They will meet on a regular basis as well as on an ad hoc one in case of a health crisis.
These groups will work on the basis of advice from organisations representing patients and health professionals, marketing authorisation holders and wholesale distributors of medicines and medical devices.
Both should be composed of one representative of the Agency, one representative of the Commission and one high representative appointed by each Member State. The lists of members will be published on the EMA website.
MEPs also wanted the agenda and minutes, recommendations and any group votes to be made public.
In this respect, they have essentially succeeded in getting the EU Council to guarantee that the members of the groups do not have interests in the industrial sectors concerned and that summaries of the work and recommendations are made public.
In terms of transparency, the adopted regulation also provides that during a health emergency, sponsors of clinical trials conducted in the EU will be required to publish the protocol of their study in the EU clinical trials register at the start of the trial and to provide a summary of the results.
Shortage monitoring platform
The other major demand of the European Parliament in these negotiations was the creation of a “European Medicines Supply Database (EUMSD)” (see EUROPE 12757/2).
MEPs managed to safeguard the principle, but were forced to make concessions on the form. The Parliament's rapporteur Nicolás González Casares (S&D, Spain), however, welcomed the introduction of “an essential tool to monitor the supply of medicines and to prevent shortages”.
The adopted text confirms that a database to collect information on shortages will be introduced. However, according to our information, it requires that the database is not created from scratch, but is linked to an existing database within the agency.
The Regulation establishing the EMA, adopted in 2004, provided for the implementation by the EMA of a “publicly accessible database on medicines” (Article 57(1)(l)).
All this is accompanied by an upgrade of the data protection provisions.
On the financial side, lastly, the adopted regulation simply states that “the financing of the Agency’s activities in support of the work of the Medicines Shortages and Medical Devices Shortages Steering Groups, the Emergency Task Force, their working parties and expert panels shall be ensured by the Union”, a European source confirmed to EUROPE. This funding should be provided under the EU4Health programme (see other news). (Original version in French by Agathe Cherki)