Union prevention, preparedness and response plan
1. The Commission, in cooperation with Member States and the relevant Union agencies and bodies, and in accordance with the WHO emergency preparedness and response framework set out in the IHR, shall establish a Union health crisis and pandemic plan (‘the Union prevention, preparedness and response plan’) to promote an effective and coordinated response to cross-border threats to health at Union level.
2. The Union prevention, preparedness and response plan shall complement the national prevention, preparedness and response plans established in accordance with Article 6, and shall promote effective synergies between the Member States, the Commission, the European Centre for Disease Prevention and Control (ECDC) and other relevant Union agencies or bodies.
3. The Union prevention, preparedness and response plan shall, in particular, include provisions on joint arrangements for governance, capacities and resources for:
(a)
the timely cooperation between the Commission, the Council, the Member States, the HSC and the relevant Union agencies or bodies. The Union prevention, preparedness and response plan shall take into account the services and support potentially available under the Union Civil Protection Mechanism, and, in particular, the capacities under the rescEU stockpile as laid down in Commission Implementing Decision (EU) 2019/570 ( 30 ) or other mechanisms, the capacities and resources made available for its purposes by the Union and the Member States, and the cooperation with the WHO for cross-border threats to health;
(b)
the secure exchange of information between the Commission, the Member States, in particular the competent authorities or designated bodies responsible at national level, the HSC and the relevant Union agencies or bodies;
(c)
the epidemiological surveillance and monitoring;
(d)
the early warning and risk assessment, especially regarding cross-border interregional preparedness and response;
(e)
the risk and crisis communication, including to health professionals and citizens;
(f)
the health preparedness and response and multi-sectoral collaboration, such as identifying risk factors for disease transmission and the associated disease burden, including social, economic and environmental determinants, following the One Health approach for zoonotic, food and waterborne diseases and relevant other diseases and related special health issues;
(g)
the drawing up of an overview of the production capacities for relevant critical medical countermeasures in the Union as a whole to address serious cross-border threats to health as referred to in Article 2;
(h)
emergency research and innovation;
(i)
the management of the plan; and
(j)
support to Member States for the monitoring of the impact of a serious cross-border threat to health on the provision and continuity of healthcare services, including for other diseases and conditions during health emergencies.
4. The Union prevention, preparedness and response plan shall include cross-border interregional preparedness elements to support aligned, multi-sectoral, cross-border public health measures, in particular considering capacities for surveillance, testing, contact tracing, laboratories, training of healthcare staff and specialised treatment or intensive care across neighbouring regions. The Union prevention, preparedness and response plan shall take into account national respective circumstances and include preparedness and response means to address the situation of citizens with higher risks.
5. In order to ensure the implementation of the Union prevention, preparedness and response plan, the Commission shall facilitate, in collaboration with Member States and, when applicable, with relevant Union agencies or bodies or with international organisations, stress tests, simulation exercises and in-action and after-action reviews with Member States, and update the plan as necessary.
6. The Commission may provide technical assistance, at the Member States' request, to support the development of their staffing plans in order to address specific healthcare needs and facilitate exchange of staff between Member States in the event of a serious cross-border threat to health.
7. The reviews of and any subsequent adjustments to the plan shall be published.
National prevention, preparedness and response plans
1. Without prejudice to Member States’ competences in this area, when preparing national prevention, preparedness and response plans, Member States shall liaise with each other within the HSC and coordinate with the Commission in order to seek coherence with the Union prevention, preparedness and response plan to the largest possible extent.
2. National prevention, preparedness and response plans may include elements relating to governance, capacities and resources laid down in the Union prevention, preparedness and response plan as referred to in Article 5.
3. Member States shall also inform, without delay, the Commission and the HSC of any substantial revision of their national prevention, preparedness and response plan.
4. For the purposes of paragraph 1, Member States may also consult, where relevant, patient organisations, healthcare professionals’ organisations, industry and supply chain stakeholders, as well as national social partners.
Reporting on prevention, preparedness and response planning
1. By 27 December 2023 and every three years thereafter, Member States shall provide the Commission and relevant Union agencies and bodies with an updated report on prevention, preparedness and response planning and implementation at national level and, where appropriate, cross-border interregional levels.
That report shall be succinct, based on agreed common indicators, shall give an overview of the actions implemented in the Member States, and shall cover the following:
(a)
identification of, and an update on, the status of the implementation of the capacity standards for prevention, preparedness and response planning as determined at national and, where appropriate, cross-border interregional level for the health sector, as provided to the WHO in accordance with the IHR, as well as, where available, the interoperability arrangements between the health sector and other critical sectors in emergency situations;
(b)
an update, where necessary, on the elements of emergency prevention, preparedness and response planning, in particular:
(i)
governance: including national and, if appropriate, regional policies and legislation that integrate emergency and preparedness actions; plans for emergency prevention, preparedness, response and recovery; coordination mechanisms, including, where relevant, among national, regional or local administrative levels and in terms of multi-sectoral collaboration;
(ii)
capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; business continuity measures and arrangements aimed at ensuring continuous access to diagnostic services, tools and medicinal products during emergencies, where available; basic and safe gender-sensitive health and emergency services; an overview of the impact of serious cross-border threats to health on the provision and continuity of healthcare services for other diseases and conditions during public health emergencies; risk communications; research development and evaluations to inform and accelerate emergency preparedness; and
(iii)
resources: including financial resources for emergency preparedness and contingency funding for response; essential supplies for health; logistics mechanisms, including for the storage of medical countermeasures; dedicated, trained and equipped human resources for emergencies;
(c)
implementation of national prevention, preparedness and response plans, including where relevant implementation at the regional and, if appropriate, local levels, covering epidemic response; antimicrobial resistance, healthcare-associated infection, and the other serious cross-border threats to health as referred to in Article 2;
(d)
where applicable, consultation with relevant partners on risk assessment and national prevention, preparedness and response plans; and
(e)
actions taken to improve gaps found in the implementation of national prevention, preparedness and response plans.
The report shall include, where relevant, cross-border interregional and intersectoral prevention, preparedness and response elements involving neighbouring regions. Such elements shall include coordination mechanisms for the relevant elements of Union and national prevention, preparedness and response plans, including cross-border training and sharing of best practices for healthcare staff and public health staff, and coordination mechanisms for the medical transfer of patients.
2. Every three years, the Commission shall make the information received in accordance with paragraph 1 of this Article available to the HSC in a report prepared in cooperation with the ECDC and other relevant Union agencies and bodies.
The report shall include country profiles for monitoring progress and developing action plans, taking into account national respective circumstances, to address identified gaps at national level. For that purpose, the Commission may issue general recommendations, considering the outcomes of the assessment carried out under Article 8.
Based on the report, the Commission shall, in a timely manner, initiate discussion in the HSC on the progress and gaps in preparedness, thereby allowing for continuous improvement.
An overview of the recommendations of the report on preparedness for and response to serious cross-border threats to health referred to in Article 2(1) shall be published on the websites of the Commission and the ECDC.
3. The Commission shall, by means of implementing acts, adopt templates to be used by the Member States when providing the information referred to in paragraph 1 of this Article, in order to ensure its relevance to the objectives identified in that paragraph and its comparability, while avoiding any duplication of the information requested and submitted.
The templates shall be designed in collaboration with the HSC and shall be, as far as possible, consistent with templates used under the IHR State Parties reporting framework.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
4. When receiving classified information transmitted pursuant to paragraph 1, the Commission, the ECDC and the HSC shall apply the rules on security regarding the protection of European Union classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 ( 31 ) and (EU, Euratom) 2015/444 ( 32 ) .
5. Each Member State shall ensure that its national security regulations apply to all natural persons resident on its territory and all legal persons established on its territory that handle the information referred to in paragraphs 1 and 2, where it is classified as European Union classified information. Those national security regulations shall offer a degree of protection of classified information at least equivalent to that provided by the rules on security as set out in the Annex to Decision (EU, Euratom) 2015/444 and in Council Decision 2013/488/EU ( 33 ) .
Assessment of prevention, preparedness and response planning
1. Every three years, the ECDC shall assess the Member States’ state of implementation of their national prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan. Such assessments shall be based on a set of agreed indicators and carried out in cooperation with the relevant Union agencies or bodies and shall aim to assess prevention, preparedness and response planning at national level with regard to the information referred to in Article 7(1).
2. The ECDC shall, if applicable, present to the Member States and to the Commission recommendations based on the assessments referred to in paragraph 1, addressed to Member States, taking into account national respective circumstances.
3. Member States shall, if applicable, present to the Commission and the ECDC in a timely manner within nine months of the receipt of the ECDC conclusions, an action plan addressing the proposed recommendations of the assessment, together with the corresponding recommended actions and milestones.
If a Member State decides not to follow a recommendation, it shall state its reasons for so deciding.
Those actions may, in particular, include:
(a)
regulatory actions, if necessary;
(b)
training initiatives;
(c)
an overview of good practices.
4. The Commission shall adopt delegated acts in accordance with Article 31 to supplement this Regulation concerning procedures, standards and criteria for the assessments referred to in paragraph 1 of this Article.
Commission report on prevention, preparedness and response planning
1. On the basis of the information provided by the Member States in accordance with Article 7 and the results of the assessment referred to in Article 8, the Commission shall by 27 December 2023 and every three years thereafter, transmit to the European Parliament and to the Council a report on the state of play and progress on prevention, preparedness and response planning at Union level.
2. The Commission report shall include, where applicable, cross-border preparedness and response elements in neighbouring regions.
3. Based on its report, the Commission may support the action of the Member States through the adoption of general recommendations on prevention, preparedness and response planning.
Coordination of prevention, preparedness and response planning in the HSC
1. The Commission, relevant Union agencies and bodies and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for monitoring, early warning and assessment of, and response to, serious cross-border threats to health.
The coordination shall, in particular, aim to:
(a)
share best practice and experience in prevention, preparedness and response planning;
(b)
promote the interoperability of national prevention and preparedness planning and the multi-sectoral dimension of prevention, preparedness and response planning at Union level;
(c)
support the implementation of capacity requirements for surveillance and response as referred to in the IHR;
(d)
support the development of the prevention, preparedness and response plans referred to in Articles 5 and 6;
(e)
monitor and discuss progress for gaps identified and actions to strengthen prevention, preparedness and response planning, including in the field of research, at cross-border regional, national and Union levels; and
(f)
facilitate the exchange, outside the joint procurement procedure laid down in Article 12, of information on medical countermeasures, including, where appropriate, on pricing and delivery dates.
2. The Commission and the Member States shall, where appropriate, conduct a dialogue with stakeholders, including health and care workers’ organisations, industry and supply chain stakeholders, and patient and consumer organisations.
3. The HSC shall also coordinate, where relevant, response to public health emergencies with the Health Crisis Board, where it is established in accordance with Regulation (EU) 2022/2372, and contribute accordingly to the coordination and information exchange within that body.
Training of healthcare staff and public health staff
1. The Commission may organise training activities, in close cooperation with the relevant Union agencies and bodies and professional health organisations and patient organisations, for healthcare staff, social service staff and public health staff in the Member States, in particular interdisciplinary One Health training, including on preparedness capacities under the IHR.
The Commission shall organise those activities in cooperation with the Member States concerned, as well as with the ECDC, in particular the EU Health Task Force, and in coordination, where possible, with the WHO. The Commission shall make the fullest use of the potential of distance learning to increase the number of trainees.
In cross-border regions, joint cross-border training, sharing of best practices and familiarity with public health systems for healthcare staff and public health staff shall be promoted.
2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with the knowledge and skills necessary, in particular, to develop and implement the national prevention, preparedness and response plans, and implement activities to strengthen crisis preparedness and surveillance capacities, especially regarding the gaps identified, including in relation to the use of digital tools, and shall be consistent with the One Health approach.
3. The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union in coordination, where possible, with ECDC activities in this area.
4. Bodies whose staff participate in the training activities referred to in paragraph 1 shall ensure that the knowledge acquired through those activities is disseminated as necessary and is appropriately used in the staff training activities they organise.
5. The Commission and relevant Union agencies and bodies may support the organisation of programmes, in cooperation with the Member States and Union candidate countries, for the exchange of healthcare staff and public health staff, as well as for the temporary secondment of staff between Member States, Union candidate countries or Union agencies and bodies. In organising those programmes, account shall be taken of the contribution made by professional health organisations in each of the Member States.
6. The Commission may, by means of implementing acts, lay down rules on the organisation of the training activities referred to in paragraph 1, and of the programmes referred to in paragraph 5.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Joint procurement of medical countermeasures
1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame.
2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the parties determining the practical arrangements governing that procedure and the decision-making process with regard to the choice of the procedure, the joint procurement assessment as referred to in paragraph 3, point (c), the assessment of the tenders and the award of the contract.
3. The joint procurement procedure referred to in paragraph 1 of this Article shall comply, where it is used to procure medical countermeasures in accordance with this Regulation, including in the framework of Article 8(1) of Regulation (EU) 2022/2372, with the following conditions:
(a)
participation in the joint procurement procedure is open to all Member States, European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046;
(b)
the rights and obligations of the countries referred to in point (a) that do not participate in the joint procurement are respected, in particular those relating to the protection and improvement of human health;
(c)
before the launch of a joint procurement procedure, the Commission prepares a joint procurement assessment which shall indicate the general envisaged conditions of the joint procurement procedure, including as regards possible restrictions to parallel procurement and negotiation activities by the participating countries for the countermeasure in question during the specific joint procurement procedure; that assessment shall take into account the need to ensure security of supply of medical countermeasures concerned to the participating countries. Based on the joint procurement assessment and the relevant information provided therein, such as on envisaged price ranges, manufacturers, delivery time frames and the proposed deadline for decision on participation, the parties to the Joint Procurement Agreement shall express their interest in participating at an early stage. Those parties to the Joint Procurement Agreement which have expressed their interest shall subsequently decide on their participation in the joint procurement procedure under the conditions jointly agreed with the Commission, taking into account the information proposed in the joint procurement assessment;
(d)
the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade and does not cause distortion of competition; and
(e)
the joint procurement does not have any direct financial impact on the budget of the countries referred to in point (a) that do not participate in the joint procurement.
4. The Commission shall, in liaison with the Member States, ensure coordination and the exchange of information between the entities organising and participating in any action, including, but not limited to, joint procurement procedures for and development, stockpiling, distribution and donation of medical countermeasures, under different mechanisms established at Union level, in particular under:
(a)
stockpiling under rescEU referred to in Article 12 of Decision No 1313/2013/EU;
(b)
Regulation (EU) 2016/369;
(c)
the Pharmaceutical Strategy for Europe;
(d)
the EU4Health Programme established by Regulation (EU) 2021/522;
(e)
Regulation (EU) 2021/697 of the European Parliament and of the Council ( 34 ) ; and
(f)
other programmes and instruments supporting biomedical research and development at Union level for enhanced capacity and readiness to respond to cross-border threats and emergencies, such as measures adopted under Regulation (EU) 2022/2372.
5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of medical countermeasures and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
