Podstawowe informacje o opinii  

Europejski Urząd ds. Gotowości i Reagowania na Stany Zagrożenia Zdrowia

Opinion Number: CDR 4928/2021
Rapporteur: CLERGEAU Christophe
Commission: NAT
Status: Adopted
Date: 28/04/2022
This opinion aims to:

draw attention to the current limitations in field of EU action in public health and examine the possibility of enhancing the EU role in health preparedness and response
highlight the unsufficient involvement of local and regional authorities in health resilience under the current proposal
argue that the democratic oversight is necessary
propose a better alignment betwee the HERA nad the Emergency Response Coordination Centre (ERCC)
advocate for a "health vulnerability scoreboard" and for a new legislation, modelled on the European Chips Act, to ensure that the EU is less dependent of foreign suppliers when it comes to active ingredients, pharmaceutical products and medical equipment

 considers that the objectives of securing EU health and protecting the population "cannot be sufficiently achieved by the Member States, either at central level or at regional and local level," and that greater EU intervention in this area is therefore in line with the principle of subsidiarity (para 3);

 is concerned about HERA's ability to succeed (7) and points out that cities and regions have to play an active role alongside the EU and Member States in developing new approaches to protecting communities. This role must be recognised at national and European level in accordance with the principle of active subsidiarity (24);

 finds that drawing up HERA's multiannual strategic plan is a top priority and must also involve the European Parliament, cities and regions (14);

 considers it essential for HERA to develop, in partnership with the other relevant EU bodies, a health security vulnerability scoreboard and to build, together with the Member States and regions, response programmes for the various kinds of emergencies and stress test programmes for health systems (17);

 stresses the need for an industrial and innovation policy ahead of crises, and the imperative need to create a new regulatory and support framework to give the EU sovereignty in the field of health and capacity to manufacture the products of R&I industrially (32); is convinced that what is happening in the field of semiconductors should be conceivable in the field of health (35).



Provisional agreement on cross-border major healthcare threats

On 23 June 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.The agreement places prevention at the heart of the fight against health threats and mandates the European Centre for Disease Prevention and Control (ECDC) to undertake regular assessments of prevention, preparedness and response planning at national level.

The agreement clarifies also 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.

Finally, it foresees to map the production capacities for critical medical products and to assess by 2024 whether HERA should remain an internal Commission's service or become an independent entity.

23 Jun