LeX-Ray

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 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 ( 1 ) 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.

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

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.

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 2022/123 of the European Parliament and of the Council ( 2 ) , 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 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.

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.

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 SCBTHR of the European Parliament and of the Council ( 3 ) , and on the extended mandate of the European Centre for Disease Prevention and Control (ECDC) laid down by Regulation 2022/2370 of the European Parliament and of the Council ( 4 ) , 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 SCBTHR , 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.

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 ( 5 ) , and, where appropriate, Council PESWUR ( 6 ) as well as joint procurement procedures referred to in Article 12 of SCBTHR . 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.

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.

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.

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.

During a public health emergency at Union level, the demand for crisis-relevant medical countermeasures could be greater than the supply. In such a situation, surge production and manufacturing of crisis-relevant medical countermeasures are essential, and the Commission should be entrusted to activate the surge in Union manufacturing capacities for crisis-relevant medical countermeasures, including ensuring resilient supply chains for the needed raw materials and ancillary supplies, such as under the Network of Ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (‘EU-FAB’). As outlined in the Commission communication of 17 February 2021 entitled ‘HERA Incubator: Anticipating together the threat of COVID-19 variants’, an EU-FAB project is a network of ‘ever-warm’, single and/or multi-user, single and/or multi-technology production capacities for vaccine and medicinal products manufacturing at the European level.

Effective mechanisms should be elaborated and agreed upon at Union level in order to ensure redistribution in cases where the surge of manufacturing has resulted in a situation where supply exceeds demand.

Appropriate intellectual property tools are needed to mitigate the risks of abandonment of development efforts, or supply issues, concerning crisis-relevant medical countermeasures during a public health emergency, especially where public authorities have provided financial support for the development and production of such countermeasures. The Commission should therefore be able to require the licensing, under fair and reasonable terms, of intellectual property rights and know-how pertaining to such countermeasures, the development and production of which the Commission has financed, in justified exceptional cases, as a safety net and an incentivising element. When facilitating the licensing of intellectual property and know-how pertaining to such countermeasures, the Commission should take into account the upfront financing by the Union or Member States of the development and the production of such countermeasures.

The activation of emergency research and innovation plans, as well as the repurposing of medicinal products and the activation of clinical trial networks, and conduct of clinical trials, should be ensured to reduce any delays in the development phase of crisis-relevant medical countermeasures. Research and innovation activities should be able to use European digital infrastructures as well as platforms operating under the European Open Science Cloud and other accessible EU digital platforms, in order to get access to (real-world) data for quick analysis. Close coordination of the Commission with the ECDC and the EMA, as the Agency responsible for scientific advice and scientific assessment of new and repurposed medicinal products, should be ensured for those matters, as well as for those related to regulatory aspects concerning the authorisation of medicinal products, including for the establishment of new manufacturing sites for authorised medicinal products, and to guarantee the acceptability of the clinical trials and the evidence they generate for the authorisation of new or repurposed medicinal products. Emergency research can also include diagnostic preparedness. That should allow key actors and relevant infrastructure to be immediately ready for operation in times of public health emergencies, thereby reducing any delays.

During a public health emergency, detailed overviews of the Union’s current and short-term future production capacities of crisis-relevant medical countermeasures are an integral element of demand and supply management. Therefore, an inventory of crisis-relevant medical countermeasure production and production facilities should be established and regularly updated on the basis of the compulsory transmission of information by the relevant economic operators.

Supply shortages of raw materials, consumables, medical devices, equipment or infrastructure could affect the production of crisis-relevant medical countermeasures. Upon identification of a supply shortage or the risk thereof, the inventory should also cover those elements. That complements the detailed overview of the Union’s current and short-term future production capacities, in order to allow for the factoring-in of supply elements that could affect production capacities and to improve demand and supply management of crisis-relevant medical countermeasures at Union level.

On the basis of the detailed overviews of production capacities, raw materials, consumables, medical devices, equipment and infrastructure, it could transpire that further measures to bolster supply chains and production capacities are needed. Where the market does not, or cannot, ensure adequate supply of needed crisis-relevant medical countermeasures, the Commission should therefore be able to implement measures in those areas that serve to increase the availability and accessibility of crisis-relevant medical countermeasures and raw materials.

PESWUR provides for a flexible framework for emergency financial support. It allows for the provision of support that cannot be implemented through the existing spending programmes. Such a tool should become available if there is a recognition of a public health emergency at Union level to the extent that is appropriate to the economic situation, taking into account the need to ensure a high level of protection of human health. Emergency funding should be provided by the emergency support instrument in line with the appropriate budgetary procedures.

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation 2011/182 of the European Parliament and of the Council ( 7 ) . The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the public health emergency, imperative grounds of urgency so require.

Where the activities to be carried out pursuant to this Regulation involve the processing of personal data, such processing should comply with the relevant Union legislation on personal data protection, namely Regulations GDPR ( 8 ) and (EU) 2018/1725 ( 9 ) of the European Parliament and of the Council.

The implementation of the emergency framework should be reviewed by the Commission. During the conduct of the review, the crisis activities of HERA should be considered together with its preparedness activities. Consideration should also be given to relevant learning, from both preparatory and crisis modes, and to the necessity of establishing a distinct entity, such as an agency.

Since the objective of this Regulation to establish a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the measures necessary to ensure the sufficient and timely availability and supply of such medical countermeasures throughout the Member States, be better achieved at Union level, the Union may adopt a framework of measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,