(Source: European Parliament)
Reinforced cooperation among EU bodies and countries during public health emergencies
Improved prevention, preparedness and response planning at EU and national levels
Clearer rules for joint procurement of medicines and medical devices
Finalisation of first Health Union package based on lessons learned from COVID-19 pandemic
Parliament and Council reached a provisional agreement on how the EU and member states should deal more efficiently with future serious cross-border health threats.
EU negotiators secured agreement on Thursday on a series of measures to reinforce action at European level to support cooperation and coordination among EU countries, in particular between neighbouring border regions, and allow the EU to better anticipate and respond to serious cross-border health threats.
The Commission will now be able to formally recognise a public health emergency at the EU level, which would trigger stronger intra-EU cooperation and allow for the timely development, stockpiling and joint procurement of medical countermeasures.
Prevention at the centre of addressing health threats
In light of the lessons learned from the COVID-19 pandemic, the new law requires better planning and coordination both at EU and national levels. Parliament successfully managed to place prevention at the heart of the fight against health threats, and secured strengthened mechanisms to prepare for and respond to health crises. The European Centre for Disease Prevention and Control (ECDC) will undertake regular assessments of prevention, preparedness and response planning at national level.
Stronger framework for joint procurement of medical countermeasures
The agreement clarifies procedures for the joint procurement of medicines and medical devices. It includes the possibility to limit parallel procurement and negotiation activities by participating countries, in case of products purchased jointly at the EU level. To ensure transparency, the Commission will be required to inform Parliament about all joint procurement procedures and grant access to MEPs to the relevant contracts (while ensuring adequate protection of business secrecy and commercial agreements).
Other measures foreseen by the regulation include:
– strengthening the role of the Health Security Committee (HSC) to better support member states in the prevention and control of health threats;
– close cooperation between all EU bodies, including the new European Health Emergency Response and Preparedness Authority (HERA); the Commission is required to carry out an evaluation of HERA’s role by 2024 and assess whether it should become an independent entity;
– An EU-level plan will include an overview of available resources, such as the RescEU stockpile, and a mapping of production capacities for critical medical products.
Rapporteur Véronique Trillet-Lenoir (Renew, FR) said: “This legislation clearly responds to the 74% of European citizens who want greater European competence in crisis management. The European Health Union is being built step by step. We will continue this project in the context of discussions on a future convention on the revision of the European treaties.”
Parliament and Council will have to formally approve the agreement before it can come into force.
As part of building a European Health Union, on 11 November 2020 the Commission proposed a new health security framework, based on the experience dealing with the coronavirus. The package includes a proposal for a regulation on serious cross-border threats to health. The first two components of the package have already been finalised, with a stronger role for the European Medicines Agency and extending the mandate of the European Centre for Disease Prevention and Control.