The European Parliament’s position is now known on two of the three texts that make up the new EU legislative package on health crises (see EUROPE 12600/24).
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopted on Tuesday 29 June—by 67 votes to 8 with 1 abstention—the report by Joanna Kopcińska (ECR, Poland) on the draft revision of the regulation establishing the European Centre for Disease Prevention and Control (ECDC). A week earlier, it approved by 68 votes to 3 with 8 abstentions the report by Nicolás González Casares (S&D, Spain) on the draft regulation to strengthen the role of the European Medicines Agency.
Both reports still need to be approved by the Parliament as a whole, which should be a formality. Mr González Casares’ report will be voted on in plenary next week and Ms Kopcińska’s report in September.
European Centre for Disease Prevention and Control
On the revision of the ECDC’s mandate, MEPs will propose that it also cover major non-communicable diseases, such as cardiovascular and respiratory diseases, cancer, diabetes, and mental illness.
They would also like ECDC to establish an EU health steering group on a permanent basis, launch a platform to monitor national immunisation coverage levels, and provide assistance to national authorities to better help them develop their sequencing capacity (see EUROPE 12713/14).
Finally, MEPs would like to see the EU-27 develop national crisis preparedness plans and provide more data on communicable disease surveillance to support the Centre’s work.
European Medicines Agency
With regard to the draft regulation on the EMA, MEPs will in particular call for an article to be added to the initial draft requiring the creation of an online platform that would give an idea of the stock of medicines available at any given time and thus enable the detection and prevention of risks of shortages.
They would like this platform—called the European Medicines Supply Database (EUMSD)—to be functional in all circumstances, not just in times of crisis.
Once fully implemented, it “should also act as the sole portal for marketing authorisation holders and wholesale distributors to provide the information required during major events and public health emergencies” the report says.
The creation of this platform will not be the only demand from Parliament in the negotiations. In total, its position contains almost 100 amendments to the original proposal.
For example, it will ask that the two steering groups to be set up within the Agency—one dedicated to medicines shortages, the other to medical device shortages—meet at regular intervals and “whenever the situation requires it”.
MEPs will also suggest that the Commission and Member States should be required to provide “substantiated justification” if recommendations made by a steering group are not taken into account.
These are all proposals that have not been considered by the EU Council. The latter adopted its negotiating position on this text in mid-June (see EUROPE 12741/7). Discussions between the EU-27 will still be necessary, however, on the ECDC regulation (see EUROPE 12746/11).
To consult Parliament’s position on the EMA: https://bit.ly/2UVKsn9 (Original version in French by Agathe Cherki)