Procurement, purchase and manufacturing of crisis-relevant medical countermeasures and raw materials

1. Where this measure is activated, the Health Crisis Board shall advise the Commission on the appropriate mechanism to purchase crisis-relevant medical countermeasures and raw materials, either through the activation of existing contracts or the negotiation of new contracts, using available instruments, such as Article 4 of Regulation (EU) 2016/369, the joint procurement procedure referred to in Article 12 of Regulation (EU) 2022/2371 , or European Innovation Partnerships, established by Regulation (EU) 2021/695 of the European Parliament and of the Council ( 13 ) .

In particular, the Health Crisis Board shall advise the Commission on the need to use a purchasing mode whereby the Commission acts as a central purchasing body on behalf of Member States, either in conjunction with other available instruments or as an autonomous procurement mode.

2. Where appropriate, Member States may mandate the Commission to act as a central purchasing body to procure crisis-relevant medical countermeasures and raw materials on their behalf, under the conditions laid down in this Article.

Member States shall be free to participate in the procurement procedure, including through opt-out mechanisms and, in duly justified cases, through opt-in mechanisms.

The Commission shall, in close coordination with the Health Crisis Board, draw up the proposal for a framework agreement to be signed by Member States that wish to be represented by the Commission (‘participating Member States’) to act as a central purchasing body for crisis-relevant medical countermeasures.

3. The framework agreement referred to in paragraph 2 shall include procedural rules for the initiation and preparation of procurement procedures set out in this Article, the practical arrangements for Member States’ free participation, including the conditions and time frames for possible opt-in and opt-out by Member States, as well as the practical arrangements for the involvement of participating Member States throughout the procurement process as well as allocation procedures of procured crisis-relevant medical countermeasures.

4. Assisted by the Health Crisis Board, the Commission shall carry out the procurement procedures and conclude the resulting agreements with economic operators on behalf of the participating Member States, in accordance with Regulation (EU, Euratom) 2018/1046.

The Commission shall inform the Health Crisis Board, on a regular basis, of the progress made in the procurement process and on the substance of negotiations. The Commission shall take the utmost account of the advice of the Health Crisis Board and of the real needs of Member States. In particular, the Commission shall only consider launching negotiations where a sufficient number of Member States have expressed their support.

5. All participating Member States shall be associated to the procurement process. To that effect, the Commission shall invite participating Member States to nominate representatives to take part in the preparation of the procurement procedures as well as the negotiation of the purchasing agreements. Representatives of participating Member States shall have the status of experts associated to the procurement process, in accordance with Regulation (EU, Euratom) 2018/1046.

Where the Commission intends to conclude a contract containing an obligation to acquire crisis-relevant medical countermeasures, it shall inform the participating Member States of such intention and the detailed terms. The participating Member States shall have the opportunity to express their comments on the draft contracts, that the Commission shall take into consideration. If the opt-out mechanism is applied, participating Member States shall have the right of at least five days to opt out.

6. Procurement referred to in paragraph 2 shall be carried out by the Commission in accordance with the rules set out in Regulation (EU, Euratom) 2018/1046 for its own procurement. When duly justified by the extreme urgency of the health crisis or when strictly necessary in order to adapt to unforeseen circumstances in the evolution of the public health emergency, the following simplifications of procurement procedures may be used:

by way of derogation from Article 137 of Regulation (EU, Euratom) 2018/1046, possibility to provide, after the signature of the contract, proof or evidence on exclusion and selection criteria, provided that a declaration on honour has been submitted in that regard before the award;

by way of derogation from Article 172(2) of Regulation (EU, Euratom) 2018/1046, the Commission may modify the contract as necessary to adapt it to the evolution of the public health emergency;

by way of derogation from Article 165 of Regulation (EU, Euratom) 2018/1046, possibility to add, after the signature of the contract, contracting authorities that are not identified in procurement documents;

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 from the date on which the draft contracts resulting from the procurement carried out for the purposes of this Regulation are sent, which shall be no later than 24 hours as from the award.

7. In line with the framework agreement referred to in paragraph 2, the Commission may have the ability and responsibility, on behalf of participating Member States and according to their needs, to enter into purchase agreements with economic operators, including individual producers of crisis-relevant medical countermeasures. Those agreements can include a prepayment mechanism for the production or development of such countermeasures in exchange for the right to the result.

In order to enter, on behalf of all participating Member States, into purchase agreements with economic operators, representatives of the Commission, or experts nominated by the Commission, may carry out on-site visits in cooperation with relevant national authorities at the locations of production facilities of crisis-relevant medical countermeasures.

8. The Commission shall have the ability and responsibility to activate the Network of Ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (EU-FAB) facilities in order to make available reserved surge manufacturing capacities to ensure the delivery of crisis-relevant medical countermeasures and raw materials, corresponding to the agreed quantities and in accordance with the timing of the EU-FAB contracts. The Commission shall conduct specific procurement procedures for those agreed quantities of crisis-relevant medical countermeasures.

9. Where the Commission provides financing for the production and/or development of crisis-relevant medical countermeasures, the Commission shall have the right to require the licensing, under fair and reasonable conditions, of intellectual property and know-how pertaining to such countermeasures, if an economic operator abandons their development effort or is unable to ensure their sufficient and timely delivery under the terms of the agreement concluded. Further conditions and procedures relating to the exercise of that right may be set out in specific agreements with economic operators.

10. The deployment and use of the crisis-relevant medical countermeasures shall remain the competence of the participating Member States. In cases where the negotiated amounts exceed demand, the Commission, at the request of the Member States concerned, shall elaborate a mechanism for reallocation, resale and donation.

11. The Commission shall ensure that participating Member States are treated equally when carrying out the procurement procedures and when implementing the resulting agreements.

COUNCIL REGULATION (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level