Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Subject matter
This Regulation establishes the EU4Health Programme (the ‘Programme’) for the period of the multiannual financial framework 2021 to 2027. The duration of the Programme is aligned with the duration of the multiannual financial framework. This Regulation also lays down the objectives of the Programme, the budget for the period from 2021 to 2027, the forms of Union funding and the rules for providing such funding.
Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘associated country’ means a third country which is party to an agreement with the Union that allows for its participation in the Programme, in accordance with Article 6; (2) ‘blending operations’ means actions supported by the Union budget, including within blending facilities pursuant to point (6) of Article 2 of the Financial Regulation, combining non-repayable forms of support, and/or financial instruments from the Union budget with repayable forms of support from development institutions or other public finance institutions, as well as from commercial finance institutions and commercial investors; (3) ‘health crisis’ means a crisis or serious incident arising from a threat of human, animal, plant, food, biological, chemical, environmental or unknown origin, which has a public health dimension and which requires urgent action by authorities; (4) ‘crisis-relevant products’ means products, tools and substances that are necessary, in the context of a health crisis, for the prevention, diagnosis or treatment of a disease and its consequences, or for the monitoring and the epidemiological surveillance of diseases and infections, including, but not limited to, medicinal products, such as vaccines and their intermediates, active pharmaceutical ingredients and raw materials, as well as medical devices and hospital and medical equipment, such as ventilators, protective clothing and equipment, diagnostic materials and tools, personal protective equipment, disinfectants and their intermediary products, and the raw materials necessary for their production; (5) ‘One Health approach’ means a multisectoral approach which recognises that human health is connected to animal health and to the environment, and that actions to tackle threats to health must take into account those three dimensions; (6) ‘European Reference Networks (ERNs)’ means the networks referred to in Article 12 of Directive 2011/24/EU; (7) ‘legal entity’ means a natural person, or a legal person created and recognised as such under national, Union or international law which has legal personality and which can, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (8) ‘third country’ means a country that is not a Member State of the European Union; (9) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection; (10) ‘Health in All Policies’ means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity; (11) ‘health determinants’ means a range of factors that influence the health status of a person, such as behaviour-related, biological, socio-economic and environmental factors; (12) ‘emergency support’ means a needs-based emergency response that complements the response of the affected Member States and is aimed at preserving life, preventing and alleviating human suffering, and maintaining human dignity, wherever the need arises as a result of serious cross-border threats to health.
General objectives
The Programme shall have a Union added value and complement the policies of the Member States, in order to improve human health throughout the Union and to ensure a high level of protection of human health in all Union policies and activities. It shall pursue the following general objectives in keeping with the One Health approach, where applicable: (a) improving and fostering health in the Union to reduce the burden of communicable and non-communicable diseases, by supporting health promotion and disease prevention, by reducing health inequalities, by fostering healthy lifestyles and by promoting access to healthcare; (b) protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States in order to cope with serious cross-border threats to health; (c) improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supporting innovation regarding such products; (d) strengthening health systems by improving their resilience and resource efficiency, in particular through: (i) supporting integrated and coordinated work between Member States; (ii) promoting the implementation of best practices and promoting data sharing; (iii) reinforcing the healthcare workforce; (iv) tackling the implications of demographic challenges; and (v) advancing digital transformation.
Specific objectives
The general objectives referred to in Article 3 shall be pursued through the following specific objectives, ensuring a high level of human health protection in all Union policies and activities in keeping with the One Health approach, where applicable: (a) in synergy with other relevant Union actions, supporting actions for disease prevention, for health promotion and for addressing health determinants, including through the reduction of damage to health resulting from illicit drug use and addiction, supporting actions to address inequalities in health, to improve health literacy, to improve patient rights, patient safety, quality of care and cross-border healthcare, and supporting actions for the improvement of the surveillance, diagnosis and treatment of communicable and non-communicable diseases, in particular cancer and paediatric cancer, as well as supporting actions to improve mental health, with special attention given to new care models and the challenges of long term care, in order to strengthen the resilience of the health systems in the Union; (b) strengthening the capability of the Union for prevention of, preparedness for, and rapid response to, serious cross-border threats to health in accordance with relevant Union legislation, and improving the management of health crises, particularly through the coordination, provision and deployment of emergency healthcare capacity, supporting data gathering, information exchange, surveillance, the coordination of voluntary stress testing of national healthcare systems, and the development of quality healthcare standards at national level; (c) supporting actions to enhance the availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products by encouraging sustainable production and supply chains and innovation in the Union, while supporting the prudent and efficient use of medicinal products, in particular antimicrobials, and actions to support the development of medicinal products that are less harmful for the environment, as well as the environmentally friendly production and disposal of medicinal products and medical devices; (d) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences, and in close cooperation with relevant Union bodies, supporting actions complementing national stockpiling of essential crisis-relevant products, at Union level, where needed; (e) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences and in close cooperation with the ECDC, establishing a structure and training resources for a reserve of medical, healthcare and support staff allocated voluntarily by Member States for its mobilisation in the event of a health crisis; (f) strengthening the use and re-use of health data for the provision of healthcare and for research and innovation, promoting the uptake of digital tools and services, as well as the digital transformation of healthcare systems, including by supporting the creation of a European health data space; (g) enhancing access to quality, patient-centred, outcome-based healthcare and related care services, with the aim of achieving universal health coverage; (h) supporting the development, implementation and enforcement and, where necessary, the revision of Union health legislation and supporting the provision of valid, reliable and comparable high-quality data for evidence-based decision-making and monitoring, and promoting the use of health impact assessments of other relevant Union policies; (i) supporting integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, supporting work on HTA, and strengthening and scaling up networking through ERNs and other transnational networks, including in relation to diseases other than rare diseases, to increase the coverage of patients and improve the response to low prevalence and complex communicable and non-communicable diseases; (j) supporting global commitments and health initiatives by reinforcing the Union’s support for actions by international organisations, in particular actions by the WHO, and fostering cooperation with third countries.
Budget
1. The financial envelope for the implementation of the Programme for the period 2021 - 2027 shall be EUR 2 446 000 000 in current prices. 2. As a result of the Programme-specific adjustment provided for in Article 5 of Council Regulation (EU, Euratom) 2020/2093 ( 27 ) , the amount referred to in paragraph 1 of this Article shall be increased by an additional allocation of EUR 2 900 000 000 in 2018 prices as specified in Annex II to that Regulation. 3. The amounts referred to in paragraphs 1 and 2 may also be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems. 4. The distribution of the amounts referred to in paragraphs 1 and 2 shall comply with the following: (a) a minimum of 20 % of the amounts shall be reserved for health promotion and disease prevention actions as referred to in point (a) of Article 4; (b) a maximum of 12,5 % of the amounts shall be reserved for procurement complementing national stockpiling of essential crisis-relevant products at Union level as referred to in point (d) of Article 4; (c) a maximum of 12,5 % of the amounts shall be reserved for supporting global commitments and health initiatives as referred to in point (j) of Article 4; (d) a maximum of 8 % of the amounts shall be reserved for covering administrative expenses as referred to in paragraph 3. 5. Appropriations related to activities under point (c) of Article 9(1) of this Regulation, shall constitute assigned revenue within the meaning of point (a) of paragraph 3, and paragraph 5, of Article 21 of the Financial Regulation. 6. Budgetary commitments extending over more than one financial year may be broken down over several years into annual instalments. 7. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, for a limited period in duly justified cases specified in the financing decision, activities supported under this Regulation and their underlying costs may be considered eligible as of 1 January 2021, even if those activities were implemented and those costs were incurred before the grant application was submitted. 8. If necessary, appropriations may be entered in the budget beyond 31 December 2027 to cover the expenses referred to in paragraph 3 to enable the management of actions not completed by 31 December 2027.
Third countries associated to the Programme
1. The Programme shall be open to the participation of the following third countries: (a) members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country in any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programme; (ii) lays down the conditions of participation in the Union programme, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country a decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. 2. The contributions referred to in point (d)(ii) of paragraph 1 shall constitute assigned revenue in accordance with Article 21(5) of the Financial Regulation.
Articles on this page are reproduced verbatim from official open data. See the attribution line.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.