A clear 'yes' to the European Health Union, albeit scope for improvement.

Once the European Parliament (EP) had adopted its position on strengthening the role of the European Medicines Agency (EMA) as early as July, it adopted the reports on two further "crisis regulations" by a majority on the 15th of September. 598 MEPs voted in favour of extending the European Centre for Disease Prevention and Control's (ECDC) range of functions. The legislative proposal covering serious cross-border health threats found 594 supporters. Parliament has now determined its negotiating position on the first legislative package for the European Health Union. The EC had previously agreed upon its mandate between Member States end of July (see also NEWS August 2021).

Strengthening ECDC for core activities

The Report submitted by Joanna Kopcińska (ECR, Poland) about the ECDC made it clear yet again that all three regulations are part of an interlinked package for creating a European Health Union and it must be seen in this context. The proposal to establish a HERA crisis and resilience agency should also be included here. The ECDC itself is poorly resourced with an annual budget of about 60 million euro and 300 jobs. Sufficient resources will have to be ensured. The legal basis for the EC's proposal is Article 168(5) Treaty on the Functioning of the European Union (TFEU), which provides for EU action 'to combat the major cross-border health diseases, implement monitoring and early warning measures as well as combat serious cross-border health threats, etc.'. However, this does not involve harmonising the Member State's laws and regulations. Therefore, the ECDC should focus primarily on its core tasks of identifying, assessing and communicating current and emerging threats from communicable diseases.

Cross-border health protection needs good data

The Report about the draft regulation covering serious cross-border health threats comes under the main 'Solidarity’ heading, especially with third-world countries and Africa. The focus should not be exclusively on pandemics according to rapporteur Véronique Trillet-Renoir (RENEW, France). We should also be able to respond to chemical and environmental threats. In principle, Member States will need more support to ensure that the data is collected and exchanged. The availability of comparable data will be the basis for improved and coordinated action in a crisis. The EWRS (Early Warning and Response System), which is an instrument managed by the ECDC, should be updated with modern technology to ensure its interoperability with international, European, national and regional warning systems, regardless of the nature of the threat. All of the medicinal products should be included in the preparedness and resilience plans and they should be assessed with regard to stockpiling, shortage risks and the production capacities available for these products. The EP is in favour of strengthening it as opposed to the EC’s position, which is to assert more influence on the the countries in the Health Security Committee. The parliament should be given an observer role here.

Bottlenecks must be tackled as a matter of priority

The Report submitted by Nicolás Gonzáles Casares (S&D, Spain) about the proposal for a regulation to strengthen the role of the EMA had already received the green light from the EP on July 8 with 587 votes in favour and it focuses on the problem of medicinal product shortages. It proposes the setting up of an electronic platform that will provide national authorities with real-time access to data about unmet demands. This would be realised by linking national level databases, which will be managed by the relevant national authority, to a European level data bank, managed by the EMA. This should make it possible to know the demands and supplies, flows, volumes as well as the unmet demands of distributors, hospital and public pharmacies. Suggestions should also be made as to how the planned emergency task force will be able to support the development of crisis-relevant vaccines and medicines, e.g. through standards for clinical trials. 

Whereas the second political trialogue about the EMA regulation will take place of September, the trialogues about the ECDC and the cross-border health threat proposals will start in October. Clarification of the technical details has already begun. 

Whereas the second political trialogue about the EMA regulation will take place of September, the trialogues about the ECDC and the cross-border health threat proposals will start in October. Clarification of the technical details has already begun.