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(10) In line with the One Health and Health in All Policies approaches, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. It is crucial that the Union support Member States in reducing health inequalities, within and between Member States, in achieving universal health coverage, in addressing the challenges of vulnerable groups and in strengthening the resilience, responsiveness and readiness of healthcare systems as regards addressing future challenges, including pandemics. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, and all relevant stakeholders, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (‘the Euratom Treaty’), whose activities are relevant to prevention, preparedness and response planning, and monitoring, early warning of, and combatting serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (EWRS) set up by Decision No 1082/2013/EU. The EWRS is to implement robust, accurate and interoperable data processes with Member States to ensure data quality and consistency. The ECDC should coordinate with Member States throughout such data processes, from assessing the data requirements, transmission, and collection to updating and interpretation, with a view to fostering strong collaboration between the Commission, the ECDC and national and regional competent bodies.

(11) Prevention, preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ prevention, preparedness and response plans so as to ensure they are compatible within the regional level structures. It is crucial that those Union and national plans be prepared with particular attention paid to cross-border regions in order to enhance their health cooperation. Where appropriate, regional authorities should be able to participate in the drawing up of such national plans. To support Member States in this endeavour, the Commission and the relevant Union agencies and bodies should provide targeted training and facilitate the sharing of best practices for healthcare staff and public health staff to improve their knowledge and necessary skills. Cross-border elements should also, where relevant, be included in the Union plan, in order to foster the sharing of best practices and a smooth exchange of information in times of crisis, such as concerning capacities for specialised treatment and intensive care across neighbouring regions. To ensure the implementation of the Union plan, the Commission should facilitate stress tests, simulation exercises and in-action and after-action reviews with Member States. The Union plan should be functional and updated, and have sufficient resources for its operationalisation. Following reviews of the national plans, proposed recommendations should be addressed in an action plan and the Commission should be kept informed of any substantial revision of the national plans.

(12) Member States should provide the Commission with an update on the latest situation with regard to their prevention, preparedness and response planning and implementation at national level, and where applicable at regional level. Information provided by the Member States to the Commission should include the elements that Member States are obliged to report to the WHO in the context of the IHR. Access to timely and complete data is a precondition for prompt risk assessments and crisis mitigation. To avoid duplication of efforts and diverging recommendations, standardised definitions, where possible, and a secured network are needed between Union agencies and bodies, the WHO and national competent authorities. In turn, the Commission should report to the European Parliament and to the Council, every three years, on the state of play and progress with regard to prevention, preparedness, response planning and implementation at Union level, including on recommended actions, to ensure that national prevention, preparedness and response plans are adequate. In order to support the assessment of those plans, the ECDC should conduct assessments in Member States, in coordination with other Union agencies and bodies. Such planning should include, in particular, adequate preparedness of critical sectors of society, such as agriculture, energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between the health and veterinary sectors for prevention, preparedness and response planning through the One Health approach. The obligations of Member States to provide information under this Regulation do not affect the application of Article 346 (1), point (a), of the Treaty on the Functioning of the European Union (TFEU) pursuant to which no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security.

(13) Experience from the ongoing COVID-19 pandemic has demonstrated that there is a need for further firmer action at Union level to support cooperation and coordination among the Member States, in particular between neighbouring border regions. The national prevention, preparedness and response plans of Member States sharing a border with at least one other Member State should therefore include plans to improve the preparedness for, prevention of and response to health crises in border areas in neighbouring regions, including through cross-border training for healthcare staff and coordination exercises for the medical transfer of patients.

(14) Health literacy plays a fundamental role in preventing and mitigating the impact of cross-border threats to health and contributing to a better understanding on the part of the population of the countermeasures for and risk assessment of different threats. Health education campaigns based on the latest available evidence could help to improve population behaviour in this regard.

(15) Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at Union level. The declaration of a public health emergency at Union level would trigger increased coordination and could enable the timely development, stockpiling and joint procurement of medical countermeasures, under Council Regulation (EU) 2022/2372 .

(16) This Regulation should strengthen the tools to safeguard the security of supply of critical medical countermeasures within the Union, while respecting the proper functioning of the internal market in the event that serious cross-border threats to health arise.

(17) In order to prevent shortages of critical medical countermeasures and protect the security of their supply at Union and national levels, as well as to support an effective and strategic stockpile location, the Commission should ensure coordination and information exchange between the entities organising and participating in any action under the different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the framework of measures adopted under Regulation (EU) 2022/2372, and the strategic rescEU reserve established under Decision No 1313/2013/EU of the European Parliament and of the Council , taking due account of the accessibility of those medical countermeasures for people in remote, rural and outermost regions.

(18) A Joint Procurement Agreement for medical countermeasures was approved by the Commission on 10 April 2014. That Joint Procurement Agreement provides for a voluntary mechanism for participating countries and the Union institutions to jointly purchase medical countermeasures for different categories of cross-border threats to health including vaccines, antivirals and other treatments. It lays down common rules for the practical organisation of joint procurement procedures. This Regulation should strengthen and extend the framework for joint procurement of medical countermeasures, in accordance with measures concerning monitoring, early warning of and combatting serious cross-border threats to health, laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council . In the event of a serious cross-border threat to health, the joint procurement of medical countermeasures laid down in this Regulation should constitute an effective operational instrument at the Union’s disposal, together with other procurement instruments provided for in Union legislation. In particular, contracts under the joint procurement procedure laid down in this Regulation may be concluded or activated in times of crisis, pursuant to Regulation (EU) 2022/2372. In such instances, those contracts should abide by the conditions laid down in the Joint Procurement Agreement, as provided for in this Regulation. The Commission should ensure coordination and information exchange between the entities organising and participating in any action under the different mechanisms established under this Regulation and other relevant Union acts related to procurement and stockpiling of medical countermeasures.

(19) The Commission should support and facilitate the joint procurement of medical countermeasures by providing all relevant information for the negotiation of such joint procurement, such as information on envisaged prices, manufacturers, delivery time frames and modalities of joint procurement. The Joint Procurement Agreement determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU should also be adapted to provide for an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the Union, a strengthened negotiation position and more efficient action to protect the Union's security of supply. Under the exclusivity clause, participating countries commit to not procuring the medical countermeasure in question through other channels and to not running parallel negotiation processes for that countermeasure. The Commission should facilitate the decision of Member States on participation by providing an assessment, inter alia, of the application of the exclusivity clause, its necessity and the conditions thereof, to be jointly agreed with the participating countries. Member States should decide on their participation in the joint procurement procedure once all the necessary information has been provided to them. In any event, limitations to parallel procurement activities and negotiations should occur only when the participating countries have agreed to such restrictions. Due to the sensitive content of the assessment and its relevance for the financial interests of the Union and the participating Member States during a joint procurement procedure, the possibility of making it public should be duly weighed against the exceptions provided for in Regulation (EC) No 1049/2001 of the European Parliament and of the Council , and, in particular, Article 4 of that Regulation.

(20) As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach, characterised by solidarity and responsibility, in combatting such threats. Therefore, joint procurement of medical countermeasures should be extended to include European Free Trade Association States, Union candidate countries, in accordance with applicable Union legislation, 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 and in accordance with Article 3(2) of that Regulation. Joint procurement of medical countermeasures is aimed at strengthening the negotiating position of participating countries, contributing to the contracting authorities’ security of supply and ensuring equitable access to medical countermeasures against serious cross-border threats to health. Joint procurement procedures should abide by high standards of transparency in relation to Union institutions, including the European Court of Auditors, and Union citizens, in accordance with the principle of transparency as referred to in Article 15 TFEU. While taking into account the protection of commercially sensitive information and the protection of essential national security interests, transparency should also be encouraged in relation to the disclosure of information related to the delivery schedule of the medical countermeasures, terms of liabilities and indemnifications and the number of manufacturing locations. A high degree of transparency should be applied in accordance with Regulation (EC) No 1049/2001. This includes the right of citizens to request access to documents regarding jointly procured medical countermeasures in accordance with Article 2 of Regulation (EC) No 1049/2001. When joint procurement is deployed, in addition to cost, qualitative criteria should be considered in the award process.

(21) Prevention is one of the essential steps in the crisis management cycle, according to the WHO. Under the four categories of prevention that have been recognised at the international level, namely primary, secondary, tertiary and quaternary categories, a number of activities constitute a cornerstone for early warning of, monitoring and combatting serious cross-border threats to health. Those activities include the monitoring of vaccination coverage for communicable diseases, surveillance systems for the prevention of communicable diseases and measures to decrease the risk of communicable disease spreading at the personal and community levels, in line with the One Health approach. Investment in prevention activities in relation to serious cross-border threats to health would directly contribute to the objectives of this Regulation. The term ‘prevention’ or ‘disease prevention’ under this Regulation should therefore be understood as covering prevention activities which aim to minimise the burden of communicable diseases and associated risk factors for the purposes of early warning of, monitoring and combatting serious cross-border threats to health.