L 314/64 EN Official Journal of the European Union 6.12.

2022

II
(Non-legislative acts)

REGULATIONS

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

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 122(1) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(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
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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 (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.

(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 (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 (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.

(1) Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority (OJ C 393I,
29.9.2021, p. 3).
(2) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European
Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
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(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 (3), 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 (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 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 (5), and, where appropriate, Council Regulation (EU) 2016/369 (6) 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

(3) Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to
health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).
(4) Regulation (EU) 2022/2370 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC)
No 851/2004 establishing a European centre for disease prevention and control (OJ L 314, 6.12.2022, p. 1).
(5) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable
to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU)
No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU
and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(6) Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union (OJ L 70, 16.3.2016,
p. 1).
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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.

(14) 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.

(15) 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.

(16) 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.

(17) 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.

(18) 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.
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(19) 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.

(20) 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.

(21) Regulation (EU) 2016/369 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.

(22) 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 (EU) No 182/2011
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.

(23) 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 (EU)
2016/679 (8) and (EU) 2018/1725 (9) of the European Parliament and of the Council.

(24) 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.

(25) 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,

(7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general
principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55,
28.2.2011, p. 13).
(8) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with
regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (OJ L 119,
4.5.2016, p. 1).
(9) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons
with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of
such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
6.12.2022 EN Official Journal of the European Union L 314/69

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1. This Regulation establishes a framework of measures for ensuring the supply of crisis-relevant medical
countermeasures in the event of a public health emergency (‘the emergency framework’).

2. The emergency framework shall include:

(a) the establishment of a Health Crisis Board;
(b) the monitoring, procurement and purchase of crisis-relevant medical countermeasures and crisis-relevant raw
materials;
(c) the activation of emergency research and innovation plans, including the use of Union-wide clinical trial networks and
data-sharing platforms;
(d) emergency Union funding, including under Regulation (EU) 2016/369;
(e) measures concerning the production, availability and supply of crisis-relevant medical countermeasures, including the
establishment of an inventory of crisis-relevant medical countermeasures production and production facilities, and, as
appropriate, of crisis-relevant raw materials, consumables, medical devices, equipment and infrastructure, and
including measures aimed at increasing their production in the Union.

3. The emergency framework may be activated only to the extent that it is appropriate to the economic situation, taking
into account the need to ensure a high level of protection of human health.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘monitoring’ means monitoring as defined in Article 3, point (6), of Regulation (EU) 2022/2371 ;
(2) ‘public health emergency’ means a public health emergency at Union level recognised by the Commission in
accordance with Article 23 of Regulation (EU) 2022/2371;
(3) ‘medical countermeasures’ means medical countermeasures within the meaning of Article 3, point (10), of Regulation
(EU) 2022/2371, including personal protective equipment and substances of human origin;
(4) ‘raw materials’ means the materials required in order to produce the required quantities of crisis-relevant medical
countermeasures;
(5) ‘real-world data’ means data relating to patient health status or the delivery of healthcare from sources other than
clinical trials.

Article 3

Activation of the emergency framework

1. In the event of recognition of a public health emergency, the Council, upon the proposal of the Commission, may
adopt a regulation activating the emergency framework where that is appropriate to the economic situation, taking into
account the need to ensure a high level of protection of human health.

2. Where the Council activates one or several measures set out in Articles 7 to 13, Article 5 shall apply.
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3. The Council shall set out in the regulation activating the emergency framework which of the measures set out in
Articles 7 to 13 are appropriate to the economic situation, taking into account the need to ensure a high level of
protection of human health, and which measures are therefore to be activated.

4. The emergency framework shall be activated for a maximum period of six months. This period may be prolonged in
accordance with the procedure set out in Article 4.

5. The regulation activating the emergency framework shall be without prejudice to Decision No 1313/2013/EU of the
European Parliament and of the Council (10) and the overall coordination role of the Emergency Response Coordination
Centre under the Union Civil Protection Mechanism (UCPM), both established by that Decision, and the political
coordination role of the Integrated Political Crisis Response (IPCR), established under Council Decision 2014/415/EU (11).

Article 4

Prolongation, deactivation and expiry of the period for which the emergency framework is activated

1. No later than three weeks before the expiry of the period for which the emergency framework was activated, the
Commission shall submit to the Council a report, drawn up in consultation with the Health Crisis Board, assessing
whether that period should be prolonged. The report shall in particular analyse the public health situation and the
economic consequences of the public health crisis in the Union as a whole and in Member States, as well as the impact of
the measures previously activated under this Regulation.

2. The Commission may propose prolongation to the Council, specifying which of the measures are appropriate for
prolongation, when the assessment referred to in paragraph 1 concludes that it is appropriate that the period for which
the emergency framework is activated be prolonged. The prolongation shall be for up to six months. The Council may
repeatedly decide to prolong the period for which the emergency framework is activated where that is appropriate in view
of the economic situation, taking into account the need to ensure a high level of protection of human health.

3. The Commission may propose to the Council to adopt a regulation activating additional measures or deactivating any
activated measures set out in Articles 7 to 13, in addition to those measures that it had already activated, where that is
appropriate in view of the economic situation, taking into account the need to ensure a high level of protection of human
health.

4. Upon expiry of the period for which the emergency framework is activated, the measures taken in accordance with
Articles 7 to 13 shall cease to apply.

5. The measures set out in Articles 7 to 13 shall be automatically deactivated where the public health emergency is
terminated in accordance with Article 23(2) of Regulation (EU) 2022/2371 .

Article 5

The Health Crisis Board

1. Where the Council activates one or several measures set out in Articles 7 to 13 in accordance with Article 3, the
Health Crisis Board shall be established and shall ensure coordination of action by the Council, the Commission, the
relevant Union bodies, offices and agencies and Member States to ensure the supply of and access to crisis-relevant medical
countermeasures.

(10) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection
Mechanism (OJ L 347, 20.12.2013, p. 924).
(11) Council Decision of 24 June 2014 on the arrangements for the implementation by the Union of the solidarity clause (2014/415/EU)
(OJ L 192, 1.7.2014, p. 53).
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The Health Crisis Board shall assist and provide guidance to the Commission in the preparation and implementation of
measures to be taken pursuant to Articles 7 to 13. To that effect, the Commission shall maintain a constant supply of
information to the Health Crisis Board on any planned measures or measures that have been taken.

2. The Health Crisis Board shall cease to operate when all of the measures set out in Articles 7 to 13 are deactivated or
expire.

3. The Health Crisis Board shall be composed of the Commission and one representative from each Member State. Each
Member State shall nominate its representative and alternate representative. The secretariat of the Health Crisis Board shall
be ensured by the Commission.

4. The Health Crisis Board shall be co-chaired by the Commission and the Member State holding the rotating presidency
of the Council.

The Health Crisis Board shall ensure the participation of all relevant Union institutions, bodies, offices and agencies,
including the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), and the
Advisory Committee on public health emergencies, as observers. The Health Crisis Board shall invite, as observers, a
representative from the European Parliament and a Member State representative of the Health Security Committee and,
where relevant, and in line with its rules of procedure, a representative of the World Health Organization (WHO).

5. The Health Crisis Board shall ensure coordination and information exchange with the structures established under:

(a) Regulation (EU) 2022/123 during the period of the public health emergency, related to medicinal products and medical
devices;

(b) Regulation (EC) No 851/2004 of the European Parliament and of the Council (12) during the period of the public health
emergency;

(c) Regulation (EU) 2022/2371 , in particular the Health Security Committee and the Advisory Committee on public
health emergencies;

(d) Decision No 1313/2013/EU, and in particular the Emergency Response Coordination Centre, for the purpose of
bridging operational gaps in accessing crisis-relevant medical countermeasures and raw materials and ensuring, where
necessary, corresponding on-site monitoring and coordination tasks.

6. The Health Crisis Board shall ensure information exchange with the IPCR.

7. The co-chairs of the Health Crisis Board may invite experts with specific expertise to take part, as observers, in the
work of the Health Crisis Board or subgroups on an ad-hoc basis, with regard to a subject matter on the agenda. Such
experts may include: representatives of Union bodies, offices and agencies; representatives of national authorities,
including central purchasing bodies and healthcare organisations and associations; representatives of international
organisations such as WHO, the Food and Agriculture Organization of the United Nations (FAO) and the World
Organisation for Animal Health (WOAH); and experts from the private sector and from other stakeholders.

8. The Health Crisis Board shall meet whenever the situation requires, upon request from the Commission or a Member
State.

9. In the course of the preparation and implementation of the measures set out in Articles 7 to 13, the Commission
shall act in close coordination with the Health Crisis Board. In particular, the Commission shall consult the Health Crisis
Board in a timely manner, whenever possible before taking action, and shall take the utmost account of the result of
deliberations within the Health Crisis Board. The Commission shall report back to the Health Crisis Board on the action
taken.

(12) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European centre for
disease prevention and control (OJ L 142, 30.4.2004, p. 1).
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10. The Health Crisis Board may issue opinions, upon the request of the Commission or on its own initiative. Where the
Commission does not follow the opinion of the Health Crisis Board, it shall explain the reasons for its action to the Health
Crisis Board, without prejudice to the Commission’s right of initiative.

11. As far as possible, the Health Crisis Board shall deliberate by consensus. If consensus cannot be reached, the Health
Crisis Board shall deliberate by a majority of two thirds of the Member State representatives. Each Member State shall have
one vote.

The Health Crisis Board shall adopt its rules of procedure on the basis of a proposal submitted by the Commission. The
rules of procedure shall detail when observers are, and are not, to be invited to participate in the deliberations of the
Health Crisis Board and how potential conflicts of interest are to be managed.

12. The Commission may, on its own initiative or on the proposal of the Health Crisis Board, set up working groups on
an ad hoc basis to support the Health Crisis Board in its work for the purpose of examining specific questions on the basis
of the tasks referred to in paragraph 1. The working groups shall deliberate in accordance with the rules set out in
paragraph 11. Member States shall nominate experts for the working groups.

13. The Commission shall ensure transparency and provide all Member State representatives with equal access to
information, in order to ensure that the decision-making process reflects the situation and the needs of all Member States.

Article 6

Declaration of interest

1. The members of the Health Crisis Board shall undertake to act in the public interest.

2. The members of the Health Crisis Board, as well as observers and external experts participating in the meetings, shall
make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might
be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to
their independence. Those declarations shall be made in writing on the establishment of the Health Crisis Board and at each
meeting in order to declare any interests which might be considered prejudicial to their independence in relation to any
item on the agenda. If there are interests which might be considered prejudicial to their independence in relation to any
item on the agenda, the person concerned shall be excluded from relevant discussions and decisions.

Article 7

Mechanism for monitoring crisis-relevant medical countermeasures

1. Where this measure is activated, the Commission shall, after seeking the advice of the Health Crisis Board, draw up
and regularly update, by means of implementing acts, a list of crisis-relevant medical countermeasures and raw materials,
as well as a template for monitoring their supply and demand, including production capacity, stockpiles, possible critical
aspects or the risk of disruption in the supply chains and purchasing agreements.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2) and,
on duly justified imperative grounds of urgency, in accordance with the procedure for immediately applicable
implementing acts referred to in Article 14(3).

2. The list referred to in paragraph 1 shall include a shortlist of specific crisis-relevant medical countermeasures and raw
materials for the preparation of measures to be taken in accordance with this Article and Articles 8 to 13, taking into
account the information obtained pursuant to:
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(a) Regulation (EU) 2022/123, and in particular Articles 3 to 14 and 21 to 30 thereof, concerning the monitoring and
mitigation of shortages of medicinal products and medical devices included in the critical medicines lists and public
health emergency critical medical devices list, respectively;

(b) Regulation (EC) No 851/2004, and in particular Article 3(2), point (f), thereof, concerning available data on Member
States’ health system capacity necessary to the management and response to communicable disease threats.

3. Without prejudice to national security interests, Member States shall, where appropriate, provide the Commission with
additional information not already collected by Union agencies on the basis of the template referred to in paragraph 1.

4. Without prejudice to national security interests and the protection of commercially confidential information resulting
from agreements entered into by Member States, where a Member State intends to adopt at national level measures for the
procurement, purchase or manufacturing of crisis-relevant medical countermeasures or raw materials from the list referred
in paragraph 1, it may inform the Health Crisis Board in a timely manner.

5. Upon request of the Commission, including on behalf of the Health Crisis Board, EMA shall provide it with
information with regard to monitoring of medicinal products and medical devices, including their demand and supply, in
accordance with Article 9(2), points (c) and (d), and Article 25(2), points (c) and (d), of Regulation (EU) 2022/123.

6. The Commission shall gather additional information not already collected by Union agencies through a secured IT
system and monitor, on the basis of the template referred to in paragraph 1, all relevant information concerning the
supply and demand of crisis-relevant medical countermeasures and raw materials within and outside the Union. The
Commission shall ensure the interoperability of the IT system with the electronic monitoring and reporting systems
developed by EMA pursuant to Article 9(1), point (c), of Regulation (EU) 2022/123.

7. The Commission shall regularly provide information on the results of the monitoring of crisis-relevant medical
countermeasures and raw materials to the European Parliament and to the Council.

The Commission shall make available to the European Parliament, to the Council and to the Health Security Committee
modelling and forecasts regarding the needs for crisis-relevant medical countermeasures and raw materials with, where
appropriate, the support of relevant Union agencies.

The Commission shall subsequently inform the Health Crisis Board of the monitoring and its results.

Article 8

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).

(13) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the
Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing
Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1).
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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:

(a) 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;

(b) 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;
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(c) 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;

(d) 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.

Article 9

Emergency research and innovation aspects of the preparedness and response plans and the use of clinical trial
networks and data-sharing platforms

1. Where this measure is activated, the Commission and Member States shall, after consulting the Health Crisis Board,
activate the emergency research and innovation aspects of the Union prevention, preparedness and response plan referred
to in Regulation (EU) 2022/2371 .

2. The Commission shall support access to relevant data from clinical trials, but also to real-world data. If possible, the
Commission shall build upon existing preparedness research initiatives such as Union-wide and international networks for
clinical trials as well as observational studies including strategic cohorts, supported by digital platforms and infrastructures,
such as high performance computing, enabling the open sharing of findable, accessible, interoperable and reusable (FAIR)
data, as well as the activities of the national competent bodies supporting availability and access to data, including health
data, in accordance with Article 15.
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3. In setting up actions on clinical trials, the Commission shall involve the EMA Emergency Task force established by
Regulation (EU) 2022/123 as well as existing networks, such as the European Clinical Research Infrastructure Network,
while ensuring compliance with Regulation (EU) No 536/2014 of the European Parliament and of the Council (14) as well
as coordination with ECDC.

4. The participation and contribution of the Union, and that of the Member States, in the emergency research and
innovation aspects of the Union prevention, preparedness and response plan shall be in accordance with the rules and
procedures of the Multiannual Financial Framework programmes.

Article 10

Inventory of crisis-relevant medical countermeasure production and production facilities

1. Where this measure is activated, the Commission may, by means of implementing acts, draw up and regularly update
an inventory of crisis-relevant medical countermeasure production and production facilities and a template for monitoring
of production capacity and stocks.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2) and,
on duly justified imperative grounds of urgency, in accordance with the procedure for immediately applicable
implementing acts referred to in Article 14(3).

2. The Commission may, using the template referred to in paragraph 1, request the producers of crisis-relevant medical
countermeasures to inform the Commission, within five days, of the actual total production capacity, and possible existing
stocks of the crisis-relevant medical countermeasures and components thereof, in their Union production facilities and the
third-country facilities which they operate, with which they have contracts, or from which they purchase supplies, while
fully respecting trade and business secrets. The Commission may also request those producers to transmit to it a schedule
of the expected production output for the following three months for each Union production facility.

3. Upon request of the Commission, each producer of crisis-relevant medical countermeasures shall inform the
Commission, within a maximum of five days, of any Union crisis-relevant medical countermeasure production facility it
operates, including information on its production capacity as regards such countermeasures by means of regular updates.
For medicinal products, that information shall comprise facilities related to both finished products and active
pharmaceutical ingredients.

4. The Commission shall regularly inform the European Parliament and the Council about the production of crisis-
relevant medical countermeasures and the expected production rate within the Union and the production of supplies from
third-country facilities, whether the products are finished, intermediates or other components, as well as about the capacity
of Union and third-county crisis-relevant medical countermeasure production facilities, while adequately protecting
commercially sensitive information of the producers.

Article 11

Inventory of crisis-relevant raw materials, consumables, medical devices, equipment and infrastructure

Where this measure is activated, the Commission shall extend the inventory and template provided for in Article 10 to
crisis-relevant raw materials, consumables, medical devices, equipment and infrastructure, if it considers that there is a risk
of a shortage in supply of crisis-relevant raw materials, consumables, medical devices, equipment or a risk of any problems
with infrastructure.

(14) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal
products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
6.12.2022 EN Official Journal of the European Union L 314/77

Article 12

Measures to ensure the availability and supply of crisis-relevant medical countermeasures

1. Where this measure is activated, the Commission may, when it considers that there is a risk of a shortage of crisis-
relevant raw materials, consumables, medical and other devices, equipment and infrastructure, implement, as quickly as
possible, in agreement with the Member States concerned and after consultation with the economic operators concerned,
specific measures to ensure the efficient reorganisation of supply chains and production lines and utilise existing stocks to
increase the availability and supply of crisis-relevant medical countermeasures.

2. In particular, the measures referred to in paragraph 1 may include:

(a) facilitating the expansion or repurposing of existing, or the establishment of new, production capacities for crisis-
relevant medical countermeasures;

(b) facilitating the expansion of existing, or the establishment of new, capacities related to activities and the introduction of
measures ensuring regulatory flexibility, in order to support the production and placing on the market of crisis-relevant
medical countermeasures, while respecting the responsibilities of EMA and national medicines authorities with regard
to the evaluation and supervision of medicinal products;

(c) implementing procurement initiatives, reserving stockpiles and production capacities to coordinate approaches, and
providing critical supply, services and resources for the production of crisis-relevant medical countermeasures;

(d) facilitating the collaboration of relevant companies in a joint industry effort to ensure the availability and supply of
crisis-relevant medical countermeasures; and

(e) facilitating the licensing of intellectual property and know-how pertaining to the crisis-relevant medical
countermeasures.

3. The Commission may provide timely financial incentive mechanisms necessary to ensure the rapid implementation
of the measures referred to in paragraph 2.

Article 13

Emergency funding

Where this measure is activated and the requirements laid down in Regulation (EU) 2016/369 are met, emergency support
under that Regulation shall be activated to finance expenditure necessary to address the public health emergency.

Article 14

Committee Procedure

1. The Commission shall be assisted by a Health Crisis Implementing Committee. That Committee shall be a committee
within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4),
third subparagraph, of Regulation (EU) No 182/2011 shall apply.

3. On duly justified imperative grounds of urgency relating to the public health emergency, the Commission shall adopt
immediately applicable implementing acts in accordance with the procedure referred to in Article 8 of Regulation (EU)
No 182/2011.
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Article 15

Personal data protection

1. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal
data under Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council (15), or the
obligations of the Commission and, where appropriate, other Union institutions, bodies, offices and agencies, relating to
their processing of personal data under Regulation (EU) 2018/1725, when fulfilling their responsibilities.

2. Personal data shall not be processed or communicated except in cases where it is strictly necessary for the purposes of
this Regulation. In such cases, the conditions of Regulations (EU) 2016/679 and (EU) No 2018/1725 shall apply as
appropriate.

3. Where processing of personal data is not strictly necessary for the fulfilment of the mechanisms established in this
Regulation, personal data shall be rendered anonymous in such a manner that the data subject is not identifiable.

4. The Commission, by means of an implementing act, shall adopt detailed rules to ensure that the requirements
provided for by Union legislation concerning the roles of the actors involved in the collection and processing of personal
data are fully complied with.

Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 14(2).

Article 16

Review

By 2024 at the latest, the Commission shall carry out a review of this Regulation and present a report on the main findings
of that review to the European Parliament and to the Council. That review shall include an evaluation of the work of the
Health Preparedness and Emergency Response Authority (HERA) under the emergency framework established by this
Regulation, and its relation to the preparedness activities of HERA.That review shall also include an assessment as regards
the need to establish HERA as a distinct entity considering relevant agencies or authorities active in the field of health
crisis. Member States shall be consulted and their views and recommendations on the implementation of the emergency
framework shall be reflected in the final report. The Commission shall, if appropriate, present proposals based on that
report in order to amend this Regulation or make further proposals.

Article 17

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Luxembourg, 24 October 2022.

For the Council

The President
A. HUBÁČKOVÁ

(15) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and
the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201,
31.7.2002, p. 37).