Regulation 2022/2372 - Framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level - Main contents

EN

Official Journal of the European Union

L 314/64

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.

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.

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.

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...