European Commission Starts Construction of European Health Union
On 11 November 2020, the European Commission (the Commission) unveiled a series of proposals to start the development of the European Health Union (see, attached press release). Drawing lessons from the current fight against Covid-19, the Commission wants to strengthen the EU’s health security framework, reinforce the crisis preparedness and response role of EU agencies and increase coordination at EU level. As health is largely a national competence, the Commission’s proposals are likely to meet with resistance from Member States. At the same time, the fragmented response to the corona virus has shown that health policy may benefit from increased transnational powers in a few selected areas. The Commission’s Communication entitled “Building a European Health Union: Reinforcing the EU’s Resilience for Cross-border Health Threats” (the Communication) shows how the Commission seeks to move in that direction (see, attachment).
The Communication tackles the following policy areas and puts forward distinct proposals for each of them.
- Enforcing coordinated response at the EU level
The Commission will reinforce the existing institutional architecture which consists of the EU Health Security Committee, the Early Warning and Response System and the EU Integrated Political Crisis Response. Against this backdrop, the Commission has already proposed to expand the powers of the European Centre for Disease Prevention and Control (ECDC) whose work will feed into the decisions of these other entities. The Commission will also propose a system for the EU recognition of an emergency situation and for advice on response measures.
- Medical countermeasures
This category captures measures that apply to medicines (including vaccines), medical devices, personal protective equipment, testing material and kits, and laboratory equipment. First, the Commission will strengthen the existing Joint Procurement Agreement by adopting a range of measures, including an exclusivity approach that averts internal competition between the European Commission and Member States or among Member States. The Commission also envisages the participation of third countries. Second, the Commission wants to have the European Medicines Agency (EMA) take charge of medicine shortages by building on existing structures within EMA or involving EMA (see e.g., Van Bael & Bellis Life Sciences News Alert of 9 June 2020). But the Commission will also create new, EMA-hosted bodies. Concretely, the Commission envisages an array of improved or new structures, including an EU Executive Steering Group on shortages; an EU Executive Steering Group on medical devices; an EMA Emergency Task Force; EMA expert panels on high risk medical devices; enhanced EU clinical trials infrastructure; and a vaccine monitoring platform.
- Preparedness, response planning and reporting
Central to the Commission’s proposed action is the adoption of a binding EU health crisis/pandemic preparedness and response plan which in turn will involve a range of steps with a significant role for the Member States and for the ECDC.
- Epidemiological surveillance
The Commission wants to create a new epidemiological surveillance system which relies on artificial intelligence and other tools for modelling and risk assessment. Additionally, it will expand the access of the ECDC to health data as part of the emerging European Health Data Space.
- Laboratory findings, testing and contact tracing
The Commission has an ambitious plan to establish networks of both EU reference testing laboratories and transfusion, transplantation and medically assisted reproduction services. In addition, the Commission also contemplates the creation of an automated contact tracing system.
- Early warning and risk assessment capacity
The Commission will seek to establish a new risk assessment framework for all health hazards that will also prepare response measures.
- International cooperation
The Commission and the relevant agencies will continue to work with international stakeholders and partner countries.