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(1) According to Article 3(1) of the Treaty on European Union (TEU), among the aims of the Union is the promotion of the well-being of its peoples.

(2) According to Articles 9 and 168 of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities.

(3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of Member States for the definition of their health policies and for the organisation, management and delivery of health services and medical care.

(4) Actions have been taken in particular under the previous programmes of Union action in the field of public health, namely those provided for by Decisions No 1786/2002/EC and No 1350/2007/EC of the European Parliament and of the Council and by Regulation (EU) No 282/2014 of the European Parliament and of the Council , to meet the requirements set out in Article 168 TFEU.

(5) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, which particularly affect people with chronic conditions. In addition, staff in health care settings, who have been essential during the COVID-19 crisis, have been exposed to great health risks.

(6) While Member States are responsible for their health policies, they should protect public health in a spirit of European solidarity, as called for in the communication of the Commission of 13 March 2020 on coordinated economic response to the COVID-19 outbreak. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for further action at Union level to support cooperation and coordination among the Member States. That cooperation should improve preparedness for, and the prevention and control of, the spread of severe human infections and diseases across borders in order to combat other serious cross-border threats to health and to safeguard and improve the health and well-being of all people in the Union. Preparedness is the key to improving resilience to future threats. In that regard, Member States should be given the possibility of carrying out stress tests on a voluntary basis to improve preparedness and increase resilience.

(7) It is therefore appropriate to establish a new and reinforced programme for Union action in the field of health, called the ‘EU4Health Programme’ (the ‘Programme’), for the period 2021-2027. In line with the goals of the Union’s action and the Union’s competences in the area of public health, the Programme should emphasise actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level, and actions that have an impact on the internal market.

(8) The Programme should be a means of promoting actions in areas where there is a Union added value that can be demonstrated. Such actions should include, inter alia, strengthening the exchange of best practices between Member States, supporting networks for the sharing of knowledge or for mutual learning, addressing cross-border threats to health so as to reduce the risks of such threats and to mitigate their consequences, addressing certain issues relating to the internal market in relation to which the Union can achieve Union-wide high-quality solutions, thereby unlocking the potential of innovation in health, and improving efficiency by avoiding the duplication of activities and optimising the use of financial resources. The Programme should also support capacity-building actions to strengthen strategic planning, access to multisource financing and the capacity to invest in and implement actions of the Programme. In that respect, the Programme should provide country-specific tailor-made assistance to the Member States, or groups of Member States, with the greatest needs.

(11) Due to the serious nature of cross-border threats to health, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage any future health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council and other relevant mechanisms and structures referred to in the communication of the Commission of 11 November 2020 entitled ‘Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats’, including actions directed at strengthening preparedness planning and response capacity at national and Union level, at reinforcing the role of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and at establishing a health emergency preparedness and response authority. Such actions could include building capacity for responding to health crises, preventive measures related to vaccination and immunisation, strengthened surveillance programmes, provision of health information, and platforms to share best practices. In this context, the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness and surveillance, and the management capacity and response capacity of actors at Union and Member State levels, including contingency planning and preparedness exercises, in keeping with the ‘One Health’ and ‘Health in All Policies’ approaches. The Programme should facilitate the setting up of an integrated cross-cutting risk communication framework for all phases of a health crisis, namely prevention, preparedness and response.

(12) With a view to strengthening capabilities in the Union to prevent, prepare for, respond to and manage health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under relevant Union legislation. That support could include capacity building in health crisis response, including contingency planning and preparedness, preventive measures such as those related to vaccination and immunisation, strengthened surveillance programmes and improved coordination and cooperation.

(13) In the context of public health crises, clinical trials and health technology assessment (HTA) can contribute to speeding up the development and identification of effective medical countermeasures. It should therefore be possible for the Programme to provide support to facilitate actions in those fields.

(14) With a view to protecting people in vulnerable situations, including those suffering from mental illness and those living with or most affected by communicable or non-communicable diseases and chronic diseases, the Programme should also promote actions which address and prevent the collateral impact of health crises on people belonging to such vulnerable groups and actions which improve mental health.

(15) The COVID-19 crisis has highlighted many challenges, including the dependence of the Union on third countries in ensuring the supply of raw materials, active pharmaceutical ingredients, medicinal products, medical devices and personal protective equipment needed in the Union during health crises, in particular pandemics. The Programme should therefore provide support to actions that foster the production, procurement and management of crisis-relevant products within the Union to mitigate the risk of shortages, while ensuring complementarity with other Union instruments.

(16) In order to minimise the public health consequences of serious cross-border threats to health, it should be possible for actions supported under the Programme to improve the interoperability of Member States’ health systems through cooperation and the exchange of best practices and also by increasing the number of joint actions. Those actions should ensure that Member States are able to respond to health emergencies, including by undertaking contingency planning, preparedness exercises and the upskilling of the healthcare and public health workforce as well as the establishment, in accordance with national strategies, of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in times of crisis.

(17) The provision of information to individuals plays an important role in preventing and responding to diseases. The Programme should therefore support communication activities addressed to the general public or to specific groups of people or professionals, in order to promote disease prevention and healthy lifestyles, to counter misinformation and disinformation as regards the prevention, cause and treatment of diseases, to address vaccine hesitancy and to support efforts to strengthen altruistic behaviour, such as organ and blood donations, in a manner that complements national campaigns on those matters.