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1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame.

2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the parties determining the practical arrangements governing that procedure and the decision-making process with regard to the choice of the procedure, the joint procurement assessment as referred to in paragraph 3, point (c), the assessment of the tenders and the award of the contract.

3. The joint procurement procedure referred to in paragraph 1 of this Article shall comply, where it is used to procure medical countermeasures in accordance with this Regulation, including in the framework of Article 8(1) of Regulation (EU) 2022/2372, with the following conditions:

(a) participation in the joint procurement procedure is open to all Member States, European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046;

(b) the rights and obligations of the countries referred to in point (a) that do not participate in the joint procurement are respected, in particular those relating to the protection and improvement of human health;

(c) before the launch of a joint procurement procedure, the Commission prepares a joint procurement assessment which shall indicate the general envisaged conditions of the joint procurement procedure, including as regards possible restrictions to parallel procurement and negotiation activities by the participating countries for the countermeasure in question during the specific joint procurement procedure; that assessment shall take into account the need to ensure security of supply of medical countermeasures concerned to the participating countries. Based on the joint procurement assessment and the relevant information provided therein, such as on envisaged price ranges, manufacturers, delivery time frames and the proposed deadline for decision on participation, the parties to the Joint Procurement Agreement shall express their interest in participating at an early stage. Those parties to the Joint Procurement Agreement which have expressed their interest shall subsequently decide on their participation in the joint procurement procedure under the conditions jointly agreed with the Commission, taking into account the information proposed in the joint procurement assessment;

(d) the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade and does not cause distortion of competition; and (e) the joint procurement does not have any direct financial impact on the budget of the countries referred to in point (a) that do not participate in the joint procurement.

4. The Commission shall, in liaison with the Member States, ensure coordination and the exchange of information between the entities organising and participating in any action, including, but not limited to, joint procurement procedures for and development, stockpiling, distribution and donation of medical countermeasures, under different mechanisms established at Union level, in particular under:

(a) stockpiling under rescEU referred to in Article 12 of Decision No 1313/2013/EU;

(b) Regulation (EU) 2016/369;

(c) the Pharmaceutical Strategy for Europe;

(d) the EU4Health Programme established by Regulation (EU) 2021/522;

(e) Regulation (EU) 2021/697 of the European Parliament and of the Council ; and (f) other programmes and instruments supporting biomedical research and development at Union level for enhanced capacity and readiness to respond to cross-border threats and emergencies, such as measures adopted under Regulation (EU) 2022/2372.

5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of medical countermeasures and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001.