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Evropski organ za pripravljenost in odzivanje na izredne zdravstvene razmere

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
Members of the European Parliament adopted the two legislative proposals of the first EU health package in a plenary vote on Tuesday 4 October: on ECDC mandate and on serious cross-border health threats.

The latter is set to provide the EU with a legal framework for preparing for such health threats and to establish a European early warning system for health threats and shortages of medicines.

In line with the CoR requests, the Parliament finds it "*crucial that those (prevention, preparedness and response) Union and national plans be prepared with particular attention paid to cross-border regions in order to enhance their health cooperation. Where appropriate, regional authorities should be able to participate in the drawing up of such national plans"

The recently published report on vulnerabilities of the global supply chains of medicines confirms the CoR observation that " public authorities do not have access to sufficient data to determine vulnerabilities" and that "more information on supply chains and the industrial aspects of pharmaceutical manufacturing in the EU and in non-EU countries is also needed". These points support the CoR call for a "vulnerability scoreboard": a cross-sectoral analysis of the state of preparedness and resilience of EU regions.

 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).



HERA - top 3 threats identified

The HERA Board presented a priority list of top-3 health threats that require coordination of measures at EU level in the context of medical countermeasures:

  1. pathogens with high pandemic potential
  2. chemical, biological, radiological and nuclear threats, and
  3. threats resulting from antimicrobial resistance.

This identification of the key threats launches the process to ensure the development, production capacity and scaling-up of manufacturing, procurement and potential stockpiling of medicinal products, diagnostics, medical devices, and personal protective equipment as well as other medical countermeasures to ensure their availability and accessibility in case of need.

12 Jul

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

New EU4Health action grant to support HERA

The action grant aims to establish a pilot network of top-class laboratories and research institutes with the expertise and capacities to support HERA in identifying emergent pathogens and ensuring the availability of medical countermeasures for improved health preparedness and response. In a health emergency outbreak, the network will have to support HERA in providing a timely, targeted, and tailored input on the identified health threat.

Deadline to apply: 18 August 2022.

Budget: € 25 000 000

19 May

HERA activities - first CBRN strategic stockpiles

To improve the EUs preparedness and response to public health risks such as chemical, biological, radiological and nuclear (CBRN) threats, the UE establishes - in close collaboration with the HERA - a €540.5 million rescEU strategic stockpile. This stockpile will consist of equipment and medicines, vaccines and other therapeutics to treat patients exposed to CBRN emergencies agents, as well as of rescEU decontamination reserve to provide decontamination equipment and expert response teams.

06 Apr
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