(1)

The COVID‐19 crisis, declared a pandemic by the World Health Organization (WHO) on 11 March 2020, has affected the society and the economy of the Union in a dramatic way, requiring Member States to adopt a set of exceptional measures.

(2)

In addition to the economic and social impact of the pandemic, the healthcare systems of Member States are severely strained by the crisis. Member States are faced with increased demands in particular for medical equipment and provisions, essential public services and production capacities for such materials.

(3)

Rapid and diversified measures are needed to allow the Union as a whole to address the crisis in a spirit of solidarity under the constraints caused by the quick spread of the virus. In particular, such measures should aim to preserve life, prevent and alleviate human suffering, and maintain human dignity, wherever the need arises as a result of the current COVID‐19 crisis.

(4)

The nature and consequences of the COVID‐19 outbreak are large‐scale and transnational and, therefore, require a comprehensive response. The measures provided for under the Union Civil Protection Mechanism (‘rescEU’) established by Decision No 1313/2013/EU of the European Parliament and of the Council (1) and other existing Union instruments are limited in scale and therefore do not allow a sufficient response or make it possible to address effectively the large‐scale consequences of the COVID‐19 crisis within the Union.

(5)

Therefore, it is necessary to activate the emergency support under Council Regulation (EU) 2016/369 (2).

(6)

To allow for the level of flexibility needed to ensure a prolonged coordinated response under unforeseen circumstances as it is the case for the COVID‐19 crisis, for example, provision of medical supplies and medication, recovery measures, relevant medical research, it is necessary to ensure, by way of derogation from the first subparagraph of Article 114(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (3), that budgetary commitments made during the activation period can be used for concluding legal commitments during the entire duration of the activation period. This should be without prejudice to the obligation to cover also the costs of corresponding legal commitments entered into after the activation period in compliance with the n+1 rule set out in that subparagraph. Costs incurred under such legal commitments should be eligible for the whole period of their implementation.

(7)

In order to ensure equal treatment and a level playing field for Member States, it is necessary to allow for retroactive eligibility of costs as of the date of activation of the emergency support, including for actions already completed, provided they have started after that date.

(8)

In order to preserve the subsidiary nature of emergency support under Regulation (EU) 2016/369, such support should be strictly complementary to any assistance made available under other Union instruments.

(9)

In the context of the COVID‐19 crisis, it has become apparent that it is necessary to extend the scope of Regulation (EU) 2016/369 in order to provide financing to cover urgent needs for medical equipment and materials, such as respiratory ventilators and protective gear, chemical supplies for tests, the costs for the development, production and distribution of medication, other supplies and materials. It should also be made possible to finance actions to support the necessary steps to obtain approval for the use of medical products.

(10)

To alleviate the acute strain on the medical workforce and on State resources due to insufficient capacities of essential public services, and to maintain the viability of the healthcare system, a temporary reinforcement and exchange of medical professionals, as well as the treatment of patients from other Member States, should be supported financially or by organisational means.

(11)

Financial support should also cover training for professionals in healthcare and logistics in view of the fight against counterfeiting of healthcare supplies.

(12)

In view of the large‐scale consequences of COVID‐19, a rapid and comprehensive engagement of all relevant partners is required, including public authorities, public and private primary and hospital care suppliers and nursing homes. Activities to relieve pressure on the health infrastructure and to support groups of vulnerable persons at risk are needed.

(13)

In order to address supply shortages, production capacities for essential medical products such as medication, diagnostic tests, laboratory supplies, and protective gear, should be supported and funding should be provided to maintain a stock of those products.

(14)

Additional or alternative testing methods to increase capacity and relevant medical research should be assisted by financial and/or organisational means.

(15)

Contracting authorities from Member States are facing considerable legal and practical difficulties in purchasing supplies or services in emergency situations. In order to allow contracting authorities to derive maximum benefit from the potential of the internal market in terms of economies of scale and risk‐benefit sharing, it is of utmost importance to extend the possibilities for the Commission to purchase supplies or services on behalf of Member States. The Commission should be enabled to conduct the relevant procurement procedures. Where a contracting authority of a Member State conducts certain parts of the procurement procedure, for instance the reopening of competition under a framework agreement or the award of individual contracts based on a dynamic purchasing system, that contracting authority would be responsible for the stages it conducts.

(16)

For emergency situations, where it is necessary to carry out a joint procurement between the Commission and one or more contracting authorities from Member States, it should be made possible for Member States to acquire, rent or lease fully the capacities jointly procured.

(17)

The Commission should be allowed to buy, stock, resell and donate supplies and services, including rentals, to Member States or partner organisations selected by the Commission.

(18)

Regulation (EU) 2016/369 should therefore be amended accordingly.

(19)

Member States have declared, as parties to the Joint Procurement Agreement referred to in Article 5 of Decision No 1082/2013/EU of the European Parliament and of the Council (4), their agreement to the inclusion of ongoing joint procurement procedures under that Article in the fast-track procurement procedure established by this Regulation, under the conditions set out therein. The type of medical countermeasures to be procured and the distribution of the countermeasures to Member States should follow any agreement reached under those ongoing procedures.

(20)

The immediate award and performance of the contracts resulting from procurement procedures carried out for the purposes of this Regulation are justified given the extreme urgency of the current health crisis. For this specific purpose, it is necessary to allow derogations from specific provisions of Regulation (EU, Euratom) 2018/1046 and of Decision No 1082/2013/EU while duly documented by the contracting authority. The distribution of medical countermeasures under these procurement procedures should respect any distribution key that may have been agreed by Member States. EEA States that are signatories to the Joint Procurement Agreement to procure medical countermeasures may agree that their participation in EU-managed procurements of medical countermeasures will be subject as relevant to the rules and conditions set out in this Regulation. As those derogations are introduced as a consequence of the current COVID‐19 crisis, they should be temporary and apply for the same period as that of the activation of the emergency support under this Regulation.

(21)

Those measures will only attain their full potential if the medical countermeasures procured under the fast track and joint procedures reach the health care services in Member States without any delay. Member States should therefore keep essential transport flows moving, in particular through designated priority lanes, green lanes, at border-crossings along the trans-European transport network (TEN-T) and facilitate air cargo operations, during the COVID-19 outbreak. Union Civil Protection Mechanism transport resources should be used as necessary. For this specific purpose, it is necessary to provide for a derogation from Article 1(6) of Decision No 1313/2013/EU.

(22)

Given the situation related to the COVID‐19 crisis, this Regulation should enter into force as a matter of urgency.

(23)

In order to ensure equal treatment and a level playing field for Member States and provide coverage regardless of when the outbreak occurred in a given Member State, this Regulation should apply from 1 February 2020,

(1)

Articles 3 and 4 are replaced by the following:

(*1)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).’;"

(2)

in Article 5, paragraphs 1 and 2 are replaced by the following:

(3)

the following Annex is added: