Socialist MEP Nicolás González Casares (Spain) presented his draft report on strengthening the role of the European Medicines Agency (EMA) to the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on Thursday 15 April.
Last November, the European Commission had presented a proposal for a regulation in this respect: this, together with a number of other tools (see EUROPE 12600/24), should help improve the Union’s crisis management capabilities.
Among the hundred or so amendments presented by Mr González Casares to flesh out the Commission’s proposal, one provides for the implementation of an “electronic platform” to better prevent shortages of medicines.
This would compile the data needed to track and trace medicines throughout the supply chain. It would also allow the volume of existing stocks and the level of demand to be determined.
“The platform should also act as a one-stop shop for marketing authorisation holders and wholesale distributors to provide the information required during major events and public health emergencies once fully implemented”, says the MEP in a new recital.
A welcome initiative
This platform, he detailed in his speech to the committee, would operate on two levels. At national level, each state would have its own database. And at European level, another database, managed by the EMA, would bring together the data contained in the national databases.
Cristian Buşoi (Romania), shadow rapporteur for the EPP, welcomed “a very good step in the right direction”, but hinted that he personally would table some amendments in this regard to make it even more effective.
The same observation was made by the MEP responsible for the Renew Europe dossier, Frédérique Ries (Belgium), who nonetheless welcomed a “key” proposal. “In 2021, we can no longer continue to send Excel files across Europe; we have to go digital”, she emphasised on this point.
She also called, as did several other groups, for the security and anonymity of the data affected by this initiative to be guaranteed.
Avoiding the administrative burden
A number of other changes have been suggested by the rapporteur, who believes, for example, that the section of the regulation on emergency preparedness is too weak. In this respect, he suggests regular meetings—not just in times of crisis—between a future “Medical Devices Steering Group” within the Agency and the emergency task force.
The Commission also proposed that lists of essential medicines and medical devices should be drawn up to ensure their surveillance. The rapporteur requires, here, that these lists contain different categories with different levels of priority among the medicines. However, this measure seems to have less of a consensus.
Several speakers—including Pierre Delsaux, Deputy Director-General for Health at the European Commission—stressed the importance of not creating an additional administrative burden for the EMA.
Referring to a telephone conversation with the Director of the European Medicines Agency, Ms Ries stressed that Emer Cooke had personally insisted that this initiative should not turn the EMA into a “labyrinthine system”.
To consult the draft report: https://bit.ly/3aiKI4l (Original version in French by Agathe Cherki)