(1)

Decision No 1313/2013/EU sets out the legal framework of rescEU. rescEU is a reserve of capacities at Union level aiming to provide assistance in overwhelming situations where overall existing capacities at national level and those committed by Member States to the European Civil Protection Pool are not able to ensure an effective response to natural and man-made disasters.

(2)

Commission Implementing Decision (EU) 2019/570 (2) sets out the initial composition of rescEU in terms of capacities and quality requirements. The rescEU reserve so far consists of aerial forest firefighting capacities, medical aerial evacuation capacities, and emergency medical team capacities.

(3)

In accordance with Article 12(2) of Decision No 1313/2013/EU, the capacities rescEU will consist of are to be determined by taking into account identified and emerging risks, overall capacities and gaps at Union level.

(4)

Over the last decades, major outbreaks of serious cross-border threats to health capable of human-to-human transmission, such as Ebola, the Severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), have put to the test the international community, calling for a coordinated response to limit the diffusion of those infectious diseases.

(5)

In July 2019, the World Health Organization (WHO) declared the Ebola virus disease outbreak in the Democratic Republic of the Congo (DRC) a Public Health Emergency of International Concern and the virus is still considered a high-risk disease. The Ebola virus can be unintentionally transmitted into the Union, as already witnessed during the 2013 West Africa outbreak.

(6)

In the context of extremely limited availability of both investigational vaccines and therapeutics, the stockpiling of Ebola countermeasures is an important preparedness measure in case of a transmission of the disease into the Union.

(7)

The global spread of this kind of highly infectious diseases, as also demonstrated by the novel coronavirus 2019-nCoV and the related coronavirus disease COVID-19 outbreak requires a coordinated action from Member States in order to avoid an escalation of the emergency across the Union, which has already been severely hit by these outbreaks.

(8)

The risk of transmission of COVID-19, as well as the transmission of other diseases, can be reduced if appropriate measures are taken, including the use of personal protective equipment and other relevant medical equipment.

(9)

Based on a technical report by the European Centre for Disease Prevention and Control (ECDC) (3), public health authorities in the Union are encouraged to plan for sufficient personal protection equipment supplies, particularly for their health professionals caring for patients infected with COVID-19.

(10)

In order to be prepared for the further spread of COVID-19 and to minimise potential shortages, the Council, in its conclusions on COVID-19 of 13 February 2020 (4) has called upon the Commission to continue examining all available possibilities to facilitate access to personal protective equipment needed by Member States.

(11)

In response to the Council conclusions, the stockpiling of medical countermeasures, intensive care medical equipment, and personal protective equipment aimed at combating serious cross-border threats to health should be included in the capacities of rescEU.

(12)

For reasons of consistency with other Union acts, the definition of ‘serious cross-border threats to health’ in this Decision should be the definition in Decision No 1082/2013/EU of the European Parliament and of the Council (5).

(13)

In accordance with Article 12(4) of Decision No 1313/2013/EU, quality requirements for medical countermeasures, intensive care medical equipment, and personal protective equipment capacities under rescEU should be based on established international standards, where such standards already exist.

(14)

The quality requirements for medical countermeasures such as investigational vaccines and therapeutics should therefore be based on minimum standards and requirements provided by the European Medical Agency (EMA) and the WHO. The quality requirements for intensive care medical equipment should be based on minimum standards provided by the WHO and the quality requirements for personal protective equipment should be based on minimum standards provided by the WHO and ECDC.

(15)

In order to provide Union financial assistance for establishing, managing and maintaining such capacities in accordance with Article 21(3) of Decision No 1313/2013/EU, the total estimated costs necessary to ensure availability and deployability thereof should be defined. Total estimated costs should be calculated taking into account the categories of eligible costs laid down in Annex IA to Decision No 1313/2013/EU.

(16)

Implementing Decision (EU) 2019/570 should therefore be amended accordingly.

(17)

The measures provided for in this Decision are in accordance with the opinion of the committee referred to in Article 33(1) of Decision No 1313/2013/EU,