Legal provisions of COM(2021)577 - 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
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| dossier | COM(2021)577 - Framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health ... |
|---|---|
| document | COM(2021)577  |
| date | October 24, 2022 |
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.
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.
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.
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:
| (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).
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; |
| (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.
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.
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.
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.