Total estimated costs of medical stockpiling rescEU capacities
Implementing Decision (EU) 2019/570 is amended as follows:
(1)
Article 1 is amended as follows:
—
point (d) is replaced by the following:
‘(d)
total estimated costs of emergency medical team type 3 rescEU capacities;’;
—
the following point (e) is added:
‘(e)
total estimated costs of medical stockpiling rescEU capacities.’;
(2)
Article 2 is amended as follows:
(a)
in paragraph 1, the third indent is replaced by the following:
‘—
emergency medical team capacities,’;
(b)
in paragraph 1, the following fourth indent is added:
‘—
medical stockpiling capacities.’;
(c)
in paragraph 2, the point (e) is amended as follows:
‘(e)
emergency medical team type 3 capacities: Inpatient Referral Care;’
(d)
paragraph 2, following point (f) is added:
‘(f)
stockpiling of medical countermeasures or personal protective equipment aimed at combatting serious cross-border threats to health, as referred to in Decision No 1082/2013/EU of the European Parliament and of the Council ( *1 ) .
( *1 ) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC ( OJ L 293, 5.11.2013, p. 1 )’;"
(3)
the following Article 3c is inserted:
‘Article 3c
Total estimated costs of medical stockpiling rescEU capacities
1. All cost categories referred to in Annex IA to Decision No 1313/2013/EU shall be taken into account when calculating the total estimated cost of medical stockpiling rescEU capacities.
2. The equipment costs of the total estimated costs of medical stockpiling rescEU capacities shall be calculated on the basis of market prices at the time when the capacities are acquired, rented or leased in accordance with Article 12(3) of Decision No 1313/2013/EU.
Where Member States acquire, rent or lease rescEU capacities, they shall provide the Commission with documentary evidence of the actual market prices or, where there are no market prices for certain components of those capacities, with equivalent evidence.
3. The categories of the total estimated costs of medical stockpiling rescEU capacities referred to in points 2 to 8 of Annex IA to Decision No 1313/2013/EU shall be calculated at least once during the period of each multiannual financial framework, taking into account information available to the Commission, including inflation. That calculation of the total estimated costs shall be used by the Commission for the purpose of providing annual financial assistance.
4. The total estimated cost referred to in paragraphs 2 and 3 shall be calculated where at least one Member State expresses interest in acquiring, renting or leasing a medical stockpiling rescEU capacity.’;
(4)
the Annex is amended as set out in the Annex to this Decision.
This Decision is addressed to the Member States.
ANNEXSupplementary provisions
ANNEX
In the Annex, the following Section 6 is added:
‘6.
Stockpiling of medical countermeasures and/or personal protective equipment aimed at combatting serious cross-border threats to health
Tasks
—
Stockpiling of medical countermeasures, comprising of vaccines or therapeutics, intensive care medical equipment, personal protective equipment, or laboratory supplies, for the purpose of preparedness and response to a serious cross-border threat to health ( 1 ) .
Capacities
—
Adequate number of doses of vaccines necessary for individuals considered to be at risk ( 2 ) linked to one or more cases of serious cross-border threats to health.
—
Adequate number of doses of therapeutics necessary to treat one or more cases of serious cross-border threats to health.
—
Vaccines and therapeutics shall fulfil one of the following requirements:
—
Marketing authorisation from EMA;
—
A positive recommendation for compassionate or emergency use from EMA or a national regulatory agency of a Member State;
—
A positive recommendation for expanded or emergency use from WHO and acceptance by at least one National Regulatory Agency of a Member State.
—
Adequate intensive care medical equipment ( 3 ) , to provide supportive care to one or more cases of serious cross-border threats to health, in accordance with WHO standards.
—
Adequate number of sets of personal protective equipment ( 4 ) for individuals considered to be at risk ( 5 ) linked to one or more cases of serious cross-border threats to health, in accordance with the standards of the ECDC and the WHO.
—
Adequate number of laboratory supplies, including sampling material, laboratory reagents, equipment and consumables ( 6 ) , to ensure laboratory diagnosis capacity for one or more cases of serious cross-border threats to health.
Main components
—
Appropriate storage facilities in the Union ( 7 ) and adequate stockpiling monitoring system.
—
Appropriate procedures ensuring the adequate packaging, transport and delivery of the products referred to under capacities, where needed.
—
Appropriately trained personnel to handle, and administer the products referred to under capacities.
Deployment
—
Availability for departure maximum 12 hours after the acceptance of the offer.
( 1 ) As defined in Decision No 1082/2013/EU.
( 2 ) Individuals considered at risk may comprise: high risk potential contacts, first responders, laboratory workers, health care workers, family members and other defined vulnerable groups.
( 3 ) This may comprise, but is not limited to, intensive care ventilators.
( 4 ) Covering the following categories: (i) eye protection; (ii) hand protection; (iii) respiratory protection; (iv) body protection; and (v) foot protection.
( 5 ) See footnote 2.
( 6 ) This may include, but is not limited to, RT-PCR reagents, such as enzymes, RNA extraction reagents, RNA extraction machine time, PCR machine time, primer and probe reagents, positive control reagents, PCR laboratory consumables (e.g. tubes, plates) and disinfectants.
( 7 ) For the purposes of the logistics of storage facilities, “in the Union” encompasses the territories of Member States and Participating States of the Union Civil Protection Mechanism.’
