Legal provisions of COM(2020)175 - Proposal for a COUNCIL REGULATION activating the emergency support under Council Regulation 2016/369 and amending its provisions in respect of the COVID-19 outbreak

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Article 1

Emergency support under Regulation (EU) 2016/369 is hereby activated to finance expenditure necessary to address the COVID‐19 pandemic for the period 1 February 2020 to 31 January 2022.

Article 2

By way of derogation from the first subparagraph of Article 114(2) of Regulation (EU, Euratom) 2018/1046, the global budgetary commitments giving rise to expenditure for support under Regulation (EU) 2016/369 shall cover the total costs of the corresponding legal commitments entered into until the end of the activation period referred to in Article 1 of this Regulation, 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 the first subparagraph of Article 114(2) of Regulation (EU, Euratom) 2018/1046.

Expenditure shall be eligible as from the date of activation of the emergency support referred to in Article 1.

By way of derogation from Article 193(3) of Regulation (EU, Euratom) 2018/1046, grants may be awarded for actions already completed before 15 April 2020 provided that the actions started after the date of the activation referred to in Article 1 of this Regulation.

Article 3

Regulation (EU) 2016/369 is amended as follows:

(1)Articles 3 and 4 are replaced by the following:

‘Article 3

Eligible actions

1. Emergency support under this Regulation shall provide a needs‐based emergency response, complementing the response of the affected Member States aimed at preserving life, preventing and alleviating human suffering, and maintaining human dignity, wherever the need arises as a result of a disaster referred to in Article 1(1). Without prejudice to the activation period as referred to in Article 2(1), emergency support may also be granted in view of addressing needs in the aftermath of a disaster or preventing its resurgence.

2. Emergency support, as referred to in paragraph 1 of this Article, may include any of the humanitarian aid actions which would be eligible for Union financing pursuant to Articles 2, 3 and 4 of Regulation (EC) No 1257/96, and may consequently encompass assistance, relief and, where necessary, protection operations to save and preserve life in disasters or in their immediate aftermath. It may also be used to finance any other expenditure directly related to the implementation of emergency support under this Regulation. In particular, emergency support may be used to finance the actions laid down in the Annex.

3. Without prejudice to paragraph 4, emergency support under this Regulation shall be granted and implemented in compliance with the fundamental humanitarian principles of humanity, neutrality, impartiality and independence.

4. The actions referred to in paragraph 2 shall be carried out by the Commission or by partner organisations selected by the Commission. The Commission may in particular select, as partner organisations, non‐governmental organisations, specialised services of Member States, national authorities and other public bodies, international organisations and their agencies and, where appropriate and necessary for the implementation of an action, other organisations and entities having the requisite expertise or active in the sectors relevant for disaster relief, such as private service providers, equipment manufacturers as well as scientists and research institutions. In doing so, the Commission shall maintain close cooperation with the affected Member State.

Article 4 - Types of financial intervention and implementing procedures

1. The Commission shall implement the Union’s financial support in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (*1). In particular, Union financing for support actions under this Regulation shall be implemented by means of direct or indirect management in accordance with points (a) and (c), respectively, of Article 62(1) of that Regulation.

2. Emergency support under this Regulation shall be financed by the general budget of the Union and by contributions which may be made by Member States and by other public or private donors as external assigned revenue in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046.

3. Union financing for support actions under this Regulation to be implemented by means of direct management may be awarded directly by the Commission without a call for proposals, in accordance with Article 195 of Regulation (EU, Euratom) 2018/1046. To that effect, the Commission may enter into framework partnership agreements or rely on existing framework partnership agreements concluded pursuant to Regulation (EC) No 1257/96.

4. Where the Commission implements emergency support operations through non‐governmental organisations, the criteria concerning financial and operational capacity shall be deemed to be satisfied where there is a framework partnership agreement in force between that organisation and the Commission pursuant to Regulation (EC) No 1257/96.

5. 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.

6. 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.

7. In the event of procurement procedures as referred to in points (b) and (c) of paragraph 5, the Commission shall follow the rules set out in Regulation (EU, Euratom) 2018/1046 for its own procurement.

(*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:

‘1.   Union financing may cover any direct costs necessary for the implementation of the eligible actions set out in Article 3, including the purchase, preparation, collection, transport, storage and distribution of goods and services under those actions as well as investment costs of actions or projects directly related to the achievement of the objectives of the emergency support activated in accordance with this Regulation.

2. The indirect costs of the partner organisations may also be covered in accordance with Regulation (EU, Euratom) 2018/1046.’;

(3)the following Annex is added:

‘ANNEX

Eligible actions

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.

.

Article 4

1. By way of derogation from Article 1(6) of Decision No 1313/2013/EU, all the capabilities of the Union Civil Protection Mechanism may be used in the context of the procurement and delivery of medical countermeasures under the procedures provided for in this Regulation.

2. By way of derogation from Article 172(1) of Regulation (EU, Euratom) 2018/1046, the contracting authorities shall be entitled to request the delivery of goods or services as from the date of sending the draft contracts resulting from the procurement carried out for the purposes of this Regulation. Draft contracts shall be sent no later than 24 hours as from the award.

3. By way of derogation from Article 172(2) of Regulation (EU, Euratom) 2018/1046, the Commission may modify the contracts referred in paragraph 2 of this Article as necessary to adapt to the evolution of the current health crisis.

4. By way of derogation from point 30 of Section 2 of Chapter 1 of Annex I to Regulation (EU, Euratom) 2018/1046, and for the purposes of awarding the contracts referred to in paragraph 2 of this Article, the authorising officer may merge the content of the evaluation report and the award decision into a single document and sign it. The electronic signature referred to in point 30.1 of Section 2 of Chapter 1 of Annex I to Regulation (EU, Euratom) 2018/1046 and signatures of ensuing contracts may be substituted by a confirmation through a secured email or simply scanned signature.

5. As relevant, the derogations set out in paragraphs (1) to (4) of this Article, as well as the necessary derogations to the Joint Procurement Agreement referred to in Article 5 of Decision No 1082/2013/EU, shall apply to all procedures for medical countermeasures, whether new or ongoing at the time of the entry into force of this Regulation, with a view to awarding on the basis of evaluated offers within a deadline of 24 hours.

6. The derogations set out in this Article shall apply until 31 January 2022.

Article 5

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply from 1 February 2020.

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