Council adopts law on the emergency framework regarding medical countermeasures

EU ministers adopted a new EU law which facilitates the timely purchase of and access to medicines, vaccines and raw materials, activates emergency funding and enables the monitoring of production facilities when another health crisis hits.

In recent months we have seen the havoc supply chain disruptions may create. A quick availability of medicines, vaccines and other medical products is vital in times of a medical crisis. With this law we put a system in place to ensure the timely supply of all the tools we need to fight the next pandemic.

Vlastimil Válek, Deputy Prime Minister and Minister of Health of Czechia

Monitoring of crisis-relevant countermeasures

In case of a health emergency, the Commission will be tasked to draw up a list of crisis-relevant medical countermeasures and raw materials and to monitor their supply and demand. The Commission, who will also receive support from the European Medicines Agency, will set up a system to monitor relevant information concerning the supply and demand of crisis-relevant medical countermeasures and raw materials within and outside the Union.

This exercise will help the EU to better assess the needs for producing and purchasing such countermeasures and raw materials.

Health Crisis Board

In case of an emergency, a Health Crisis Board will coordinate actions by the Council, the Commission, EU bodies and member states to ensure the supply of and access to crisis-relevant medical countermeasures. The Board will be composed of the Commission and one representative from each member state. Among other things, the Commission will have to consult the Board whenever possible before taking action.

Procurement and production

When it comes to the purchases of countermeasures and raw materials, the member states may mandate the Commission to act as a central purchasing body. The Commission must inform member states when it intends to conclude a contract and they also have the opportunity to express their comments on the draft agreement. In particular cases, member states have the right to opt out of the deal.

The new rules also provide for the possibility to activate EU-FAB - a network of ever warm production capacities for vaccines and medicines manufacturing. This would allow the EU to make quickly available reserved surge manufacturing capacities and avoid problems of insufficient manufacturing capacities.

Background

On 16 September 2021, the European Commission launched a European Health Emergency preparedness and Response Authority (HERA). Its purpose is to ensure the development, production and distribution of medicines, vaccines and other medical countermeasures (e.g. gloves and masks).

In addition to the launch of HERA, the Commission also proposed a Council regulation which constitutes the legal basis for crisis activities regarding medical countermeasures in the event of a health emergency.

On 20 December 2021, ministers reached a political agreement on the text which has subsequently been adapted to reflect cross-references to the regulation on serious cross border threats to health (which has also been adopted today). The regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the EU. It is entirely binding and directly applicable in all member states.