Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union

Article 1

Subject matter and scope

Article 2

Activation of the emergency support

Article 3

Eligible actions

Article 4

Types of financial intervention and implementing procedures

Emergency support under this Regulation may be granted in any of the following forms:

(a) joint procurement with Member States as referred to in Article 165(2) of Regulation (EU, Euratom) 2018/1046 whereby Member States may acquire, rent or lease fully the capacities jointly procured;

(b) procurement by the Commission on behalf of Member States based on an agreement between the Commission and Member States;

(c) procurement by the Commission, as wholesaler, by buying, stocking and reselling or donating supplies and services, including rentals, to Member States or partner organisations selected by the Commission.

In the event of a procurement procedure as referred to in point (b) of paragraph 5, the ensuing contracts shall be concluded by either of the following:

(a) the Commission, whereby the services or goods are to be rendered or delivered to Member States or to partner organisations selected by the Commission;

(b) the participant Member States whereby they are to directly acquire, rent or lease the capacities procured for them by the Commission.

Article 5

Eligible Costs

Article 6

Complementarity and consistency of Union action

Synergies and complementarity shall be sought with other instruments of the Union, in particular with respect to those instruments under which some form of emergency assistance or support may be offered, such as Regulation (EC) No 2012/2002, Decision No 1313/2013/EU, Regulation (EC) No 1257/96, Regulation (EU) No 223/2014 of the European Parliament and of the Council (²), Regulation (EU) No 513/2014 of the European Parliament and of the Council (³), Regulation (EU) No 514/2014 of the European Parliament and of the Council (⁴), Regulation (EU) No 515/2014 of the European Parliament and of the Council (⁵) and Regulation (EU) No 516/2014 of the European Parliament and of the Council (⁶).

Article 7

Protection of the financial interests of the Union

Article 8

Monitoring and evaluation

Article 9

Entry into Force and activation

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

The following actions may be financed in case of pandemics with large‐scale effect:

(a) temporary reinforcement of the medical workforce, exchange of medical professionals, hosting foreign patients or other type of mutual support;

(b) deployment of temporary healthcare facilities and temporary extension of existing healthcare facilities to relieve pressure on existing structures and increase overall healthcare capacity;

(c) activities to support the administration of large‐scale application of medical tests and prepare the necessary scientific testing strategies and protocols;

(d) setting up temporary quarantine facilities and other appropriate measures at the Union borders;

(e) development, production or purchase and distribution of medical products;

(f) increases and conversions of production capacities for medical products as referred to in point (e) to address supply shortages;

(g) maintenance of the stock of medical products as referred to in point (e) and their disposal;

(h) actions to support the necessary steps to obtain approval for the use of the medical products as referred to in point (e) if required;

(i) actions to develop appropriate methods to track the development of the pandemic and the results of measures implemented to address it;

(j) organisation of ad‐hoc clinical trials of potential therapies or diagnostics according to trial standards agreed at Union level;

(k) scientific validation of medical products, including potential new testing methods.

The above list is not exhaustive.