The health ministers of the EU Member States will meet in Luxembourg on Tuesday 14 June for an EU Council meeting to discuss the vaccine strategy, the European Health Data Space, the EU global health strategy and health support for Ukraine.
European Health Data Space. The first exchange of views, as part of a public consultation, will concern the proposal for a regulation on the European Health Data Space or EHDS (see EUROPE 12944/11). The Presidency wants to base the EHDS on European principles for digital ethics. It suggests two lines of discussion for Ministers: the expected benefits of EHDS in light of the lessons learned from the Covid-19 pandemic and the identification of principles, work and recent advances that could support efforts to develop EHDS.
Health technology assessment. Under ‘other business’, the European Commission will provide Ministers with information on the implementation status of the Health Technology Assessment (HTA) Regulation. Adopted on 13 December last as part of the European Pharmaceutical Strategy, this regulation proposes new assessment rules, in particular to encourage the emergence of innovative medicines.
The European Commission will inform Ministers on the implementation of the Regulation on Medical Devices.
Vaccine strategy. The informal lunch provides an opportunity for ministers to discuss the EU’s vaccine strategy. The discussion is expected to be wide-ranging, according to an EU source, and should cover different aspects of the EU vaccine strategy, such as anticipating a potential resurgence of the epidemic in the autumn, or the vaccine procurement strategy.
The discussion is set to continue in the afternoon, as the Polish delegation – on behalf of the Bulgarian, Croatian, Estonian, Hungarian, Latvian, Lithuanian, Romanian, Slovak and Slovenian delegations – will open the debate on the joint letter to the European Commission “concerning the revision of provisions on vaccine purchase contracts with regard to surplus vaccines”. These delegations are of the opinion that the agreements reached by the European Commission with Pfizer-BioNTech and Moderna to postpone supplies of SARS-CoV-2 vaccine, are not sufficient. They want to introduce several amendments to the advance purchase agreements concluded between the European Commission on behalf of the Member States, and the vaccine manufacturers.
Data on the market entry in Europe for drugs. The Austrian, Belgian, Irish, Luxembourg and Dutch delegations will provide a briefing on gaps in relevant data on the market entry in Europe for drugs and potential solutions.
Acute hepatitis and monkeypox. The European Commission will provide Ministers with an update on the increase in acute hepatitis and monkeypox cases, in regard to which monitoring is being carried out at European level (see EUROPE 12963/16, EUROPE 12846/4).
Health response to the Ukraine crisis. The European Commission will update Ministers on medical evacuations of Ukrainian patients and injured Ukrainians to European countries (see EUROPE 12965/13).
Global health. At the end of the session, ministers will exchange views on the revised EU Global Health Strategy, which dates back to 2010. They will be invited to answer the following questions: - What priorities should be included in the new EU strategy? - How could the EU27 and the European Commission strengthen their coordination and influence over global health? A note prepared by the outgoing French Presidency to guide the exchange of views refers to the global agreement on pandemics being negotiated so that the WHO executive are given powers on preparedness and responses to future pandemics (see EUROPE 12963/4).
Passing on the Presidency baton. At the end of this last ‘Health’ session under the French Presidency of the Council of the European Union, the outgoing Presidency will hand over the baton to the new Presidency, in this case the Czech Republic, who will hold the office for 6 months.
Link to the agenda (in French language): https://aeur.eu/f/22x
Link to the “Global Health” framework note: https://aeur.eu/f/231 (Original version in French by Emilie Vanderhulst, Aminata Niang)