Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(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 (4) and No 1350/2007/EC (5) of the European Parliament and of the Council and by Regulation (EU) No 282/2014 of the European Parliament and of the Council (6), 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.

(9) This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (7), for the European Parliament and the Council during the annual budgetary procedure. This financial envelope comprises an amount of EUR 500 000 000 in 2018 prices in line with the joint declaration by the European Parliament, Council and Commission on the reinforcement of specific programmes and adaptation of basic acts of 22 December 2020 (8).

(10) In order for the Programme to be balanced and focused, minimum and maximum shares of the overall budget should be laid down in this Regulation, for certain areas of action, with a view to providing guidance for the allocation of resources in relation to the implementation of the Programme.

(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 (9) 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.

(18) In synergy with other Union programmes, such as the Digital Europe programme established by a Regulation of the European Parliament and of the Council establishing the Digital Europe programme and repealing Decision (EU) 2015/2240, Horizon Europe - the Framework Programme for Research and Innovation established by a Regulation of the European Parliament and of the Council 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 (‘Horizon Europe’), the European Regional Development Fund (‘ERDF’) established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund, the European Social Fund Plus (ESF+) established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+), the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (10), and the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (11), actions that advance the digital transformation of health services and increase the interoperability of such services, including the development of a European health data space, could be supported under the Programme.

(19) Health is an investment, and the Programme should have this concept at its core. Keeping people healthy and active longer and empowering them to take an active role in managing their health by improving their health literacy will have positive effects on health, health inequalities and inequities, access to sexual and reproductive healthcare, quality of life, workers’ health, productivity, competitiveness and inclusiveness, while reducing pressures on national healthcare systems and national budgets. The Programme should also support actions to reduce inequalities in the provision of healthcare, in particular in rural and remote areas, including in the outermost regions, for the purposes of achieving inclusive growth. The Commission has committed to helping Member States to reach the sustainable development targets set in the UN resolution of 25 September 2015 entitled ‘Transforming our world: the 2030 Agenda for Sustainable Development’(the ‘UN 2030 Agenda’), in particular Sustainable Development Goal 3 ‘Ensure healthy lives and promote well-being for all at all ages’. The Programme should therefore contribute to the actions towards reaching those targets.

(20) Non-communicable diseases are often the result of a combination of genetic, physiological, environmental and behavioural factors. Non-communicable diseases such as cardiovascular disease, cancer, mental illness, neurological disorders, chronic respiratory disease and diabetes represent major causes of disability, ill-health, health-related retirement, and premature death in the Union, and cause a considerable social and economic impact. To decrease the impact of non-communicable diseases on individuals and society in the Union and to reach Goal 3 of the UN 2030 Agenda Sustainable Development Goals, in particular but not exclusively Target 3.4 of that Goal, namely to reduce premature mortality from non-communicable diseases by one third by 2030, it is essential to provide an integrated response that focuses on health promotion and disease prevention across relevant sectors.

(21) The Programme therefore should support health promotion and disease prevention and improve mental health throughout the lifetime of an individual by addressing health risk factors, and health determinants, which would also contribute to the attainment of Goal 3 of the UN 2030 Agenda Sustainable Development Goals. The Programme should also therefore contribute to the objectives set out in the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ (the ‘European Green Deal’).

(22) The Programme should continue to support actions in the area of reducing and preventing alcohol-related harm, with particular emphasis on protecting the young.

(23) The burden of chronic diseases is significant in the Union. It is well acknowledged that prevention and early detection are important in that regard. The Programme should support actions in those areas and should support the development of specific Union preventive and disease management guidelines and therefore aim to reduce the burden of Member States by working together to achieve better and more effective management of chronic diseases. Demographic changes, in particular the ageing of society, challenge the sustainability of health systems. Age-related diseases and disorders, such as dementia, and age-related disabilities, necessitate specific attention.

(24) Cancer is the second leading cause of mortality in the Member States after cardiovascular disease. It is also one of the non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. Poor nutrition, physical inactivity, obesity, tobacco use and harmful use of alcohol are risk factors common to other chronic diseases, such as cardiovascular disease, and therefore cancer prevention programmes should be implemented within the context of an integrated approach to preventing chronic diseases. Relevant measures in the ‘Europe’s Beating Cancer Plan’ set out in the communication of the Commission of 3 February 2021 should benefit from the Programme and from Horizon Europe’s mission on cancer, and should contribute to fostering an integrated approach that covers prevention, screening, early diagnosis, monitoring, treatment and care, as well as improving the quality of life of patients and survivors.

(25) It should be possible to support studies on the influence of gender on the characteristics of diseases in order to contribute to improving knowledge and education in that area, thereby improving prevention, diagnosis, monitoring and treatment.