FantasticSearch

(1) The ad-hoc measures taken by the Commission in order to restrict the spread of COVID-19 were reactive, and the Union was not sufficiently prepared to ensure the efficient development, manufacturing, procurement and distribution of crisis-relevant medical countermeasures, especially in the early phase of the COVID-19 pandemic. The pandemic also revealed insufficient oversight of research activities and manufacturing capacities as well as vulnerabilities related to global supply chains.

(2) The experience gained has shown the need for a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency, in order to enable the Union to take measures that are necessary to ensure the sufficient and timely availability and supply of such countermeasures where that is appropriate to the economic situation. To that effect, this Regulation aims to establish an instrument of economic policy fundamental to avoid the adverse economic consequences of health crises, such as negative growth, unemployment, market disruptions, fragmentation of the internal market, and impediments to swift manufacturing – consequences which have been witnessed on a large scale in the context of the COVID-19 pandemic – with a view to ultimately safeguarding the economic stability of the Union and of its Member States.

(3) In the event of the recognition of a public health emergency at Union level, it should be possible for the Council, upon a proposal from the Commission pursuant to Article 122(1) of the Treaty on the Functioning of the European Union (TFEU), to decide to activate the framework of measures to the extent that those measures are appropriate to the economic situation, taking into account the need to ensure a high level of protection of human health in accordance with Article 9 TFEU and possible risk of the global disruption of supplies of crisis-relevant medical countermeasures, which could affect the health systems of Member States. The proposal from the Commission should explain the rationale and the need for the proposed activation of an emergency framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency, as established by this Regulation (‘the emergency framework’), including for each of the measures proposed, including an analysis of anticipated impact, subsidiarity, proportionality and financial implications for each of the measures proposed. The use of measures within the emergency framework should be limited in time for a maximum period of six months. It should be possible to prolong the use of such measures in view of the situation. The implementation of such measures should respect the responsibilities of Member States for the organisation and delivery of health services and medical care, including the allocation of the resources at national level, as referred to in Article 168(7) TFEU.

(4) The emergency framework should include the establishment of a Health Crisis Board on crisis-relevant medical countermeasures to ensure the coordination of approaches at Union level. That is of particular importance given the distribution of responsibilities between Union and national level. To support the Health Crisis Board, the Commission should, on its own initiative or on the proposal of the Health Crisis Board, be able to set up subgroups or ad-hoc working groups, including if needed for industrial aspects. In order to ensure the effective and systematic involvement of Member States in the decisions taken for the implementation of this Regulation, rules for the deliberations of the Health Crisis Board should be laid down. When deliberating, the members of the Health Crisis Board should use their best endeavours to reach a consensus. If a consensus cannot be reached, and in order to ensure a smooth deliberation mechanism, the Health Crisis Board should act by a two-thirds majority, where one vote is given to each Member State. Moreover, it is useful for the effective operation and swift decision-making by the Health Crisis Board that it be supported through preparedness and response planning carried out by the Health Emergency Preparedness and Response Authority (HERA) established by a Commission Decision of 16 September 2021. Such preparedness and response planning is to provide an assessment for the purpose of activating measures pursuant to this Regulation, propose the rules of procedure of the Health Crisis Board, draft negotiating mandates and procedural rules for joint procurements, and provide relevant information for the establishment of an inventory of crisis-relevant medical countermeasure production and production facilities. The involvement of Member States should also contribute to the necessary coordination between the implementation of this Regulation and the operations of the HERA. The Health Crisis Board should be able to also coordinate, where appropriate, with the HERA Board referred to in the Commission Decision of 16 September 2021.

(5) Member States and the Commission should appoint their representative and alternate representative in the Health Crisis Board.

(6) The Commission should ensure that a list of crisis-relevant medical countermeasures and raw materials is established and that their supply and demand are monitored. That should provide a comprehensive overview of the needed crisis-relevant medical countermeasures as well as of the Union’s capacity to meet that need and to guide relevant decision-making during public health emergencies.

(7) In view of the mandate of the European Medicines Agency (EMA) and its role as regards monitoring and mitigating potential and actual shortages of medicinal products, medical devices and in vitro diagnostic medical devices, including establishing lists of critical medicinal products and critical medical devices, under Regulation (EU) 2022/123 of the European Parliament and of the Council , close cooperation and coordination between the Commission and EMA should be ensured to implement the measures provided for in this Regulation. When carrying out the tasks set out in Articles 7 to 13 of this Regulation, the Commission, including HERA, should fully respect EMA’s responsibilities. A representative of the Executive Steering Group on Shortages of Medical Devices, as established by Article 21 of Regulation (EU) 2022/123, a representative of the Emergency Task Force, as established by Article 15 of that Regulation, and a representative of the Executive Steering Group on Shortages and Safety of Medicinal Products, as established by Article 3 of that Regulation, should be invited, as observers, to the Health Crisis Board. That should complement the smooth transmission of data and information during public health emergencies at Union level, including via integrated IT systems.

(8) With regard to the monitoring of demand and supply of medical countermeasures in the third countries, the Commission should maintain a dialogue with its counterparts to foster international collaboration.

(9) The measures should also take into account the structures and mechanisms set up by the Union acts on serious cross-border threats to health, namely Regulation (EU) 2022/2371 of the European Parliament and of the Council , and on the extended mandate of the European Centre for Disease Prevention and Control (ECDC) laid down by Regulation (EU) 2022/2370 of the European Parliament and of the Council , in order to ensure response coordination within the Health Security Committee and the Advisory Committee on public health emergencies, as established respectively by Articles 4 and 24 of Regulation (EU) 2022/2371 , taking into account input from the ECDC on epidemiological surveillance and monitoring. The Director of the ECDC and a representative of the Advisory Committee on public health emergencies should be invited to attend the meetings of the Health Crisis Board. A member of the Health Security Committee should also be invited, as an observer, to the Health Crisis Board.

(10) Efficient procurement procedures for crisis-relevant medical countermeasures and raw materials should be ensured. In that regard, the Commission can act as a central purchasing body for participating Member States, under the rules and procedures laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council , and, where appropriate, Council Regulation (EU) 2016/369 as well as joint procurement procedures referred to in Article 12 of Regulation (EU) 2022/2371 . In order to allow for speed and efficient procurement during times of crisis, procedural simplifications might be necessary. Moreover, for the purpose of drawing lessons learned from the procurement experience during the COVID-19 pandemic, better involvement of Member States should be ensured in the preparation and award of contracts. Agreements between the Commission and Member States should ensure that all Member States have equal and timely access to all information and that their needs are duly taken into account. Procurements of crisis-relevant medical countermeasures carried out under this Regulation can be exclusive or non-exclusive depending on the agreement of the participating Member States to such restrictions.

(11) On the basis of the needs of Member States, as advised by the Health Crisis Board, the Commission should seek to ensure that all crisis-relevant medical countermeasures procured or developed under this Regulation meet the relevant Union, and, where applicable, national regulatory requirements, while allowing, as applicable, for any derogations, or other national exemptions.

(12) Those procurement procedures can be supported by any necessary preparatory steps, including on-site visits at the location of the production facilities of crisis-relevant medical countermeasures. That should allow for the timely procurement and purchase of crisis-relevant medical countermeasures across the Union and promote accessibility across Member States, with the primary objective of securing the speediest possible equitable provision and distribution of the crisis-relevant medical countermeasures in the required quantity needed by each Member State and with all necessary guarantees. The possibility of relocation, redistribution, resale, loan and donation should already be taken into account contractually at the time of purchase.

(13) In the cases covered by this Regulation, the immediate award and performance of the contracts resulting from procurement procedures carried out for the purposes of this Regulation could be justified given the extreme urgency of the health crisis and resulting economic difficulties. Also, it could be necessary to make adjustments to the contracts that are strictly necessary to adapt them to the evolution of the public health emergency as well as to add contracting authorities during the performance of the contract. For that specific purpose, it is necessary to allow derogations from specific provisions of Regulation (EU, Euratom) 2018/1046 while duly documented by the contracting authority. As those derogations are introduced for the purpose of the emergency framework, they should be temporary and apply solely for the period of the activation of the measure referred to in Article 8 of this Regulation.