WHAT IS THE AIM OF THE REGULATION?
It establishes the EU4health programme which, like the European Union (EU)’s multiannual financial framework, runs from 2021 to 2027. It sets out the programme’s:
- general and specific objectives;
- forms and rules of EU funding.
KEY POINTS
The programme brings EU added value, creating efficiency gains and value-added impacts that could not be achieved by measures taken only at the national level. It supports and complements national policies to promote and improve human health in the EU and ensures human health protection in all EU policies and activities in line with the One Health approach1.
The four general objectives are to:
- improve and foster health in the EU;
- protect people from serious cross-border health threats;
- improve medicines, medical devices and crisis-relevant products;
- strengthen health systems by improving their resilience and resource efficiency.
These are expanded into 10 specific objectives as follows.
- To improve and foster health in the EU, the programme will support:
- disease prevention and health promotion;
- international health initiatives and cooperation.
- To reinforce EU Member States’ and the EU’s abilities to tackle cross-border health threats, the programme will support:
- prevention, preparedness and response to cross-border health threats;
- complementing national stockpiling of essential crisis-relevant products;
- setting up a reserve of medical, healthcare and support staff.
- To contribute to responding to the rising demand for healthcare, and to fairer public health protection, by:
- supporting the improved availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products.
- To improve the resilience and resource efficiency of health systems, EU4health will support measures that contribute to:
- strengthening health data, digital tools and services and the digital transformation of healthcare;
- enhancing access to healthcare;
- developing and implementing EU health legislation and evidence-based decision-making;
- integrated work among Member States’ health systems.
Annex I to the regulation lists the many different activities eligible for EU funding under each of the 10 specific objectives. Recipients must acknowledge and ensure the visibility of the EU finance they receive.
In cases of a serious cross-border threat to health or a public health emergency, the European Commission may:
- jointly procure with Member States when they acquire, rent or lease fully the items procured;
- carry on procurement on behalf of Member States on the basis of an agreement;
- procure as a wholesaler, buying, stocking and selling or donating supplies and services for the benefit of the Member States and selected partner organisations.
The 7-year programme’s budget is €2,446,000,000 (current prices). This is increased by an additional €2,900,000,000 (2018 prices) from the multiannual financial framework. The total €5.3 billion of funds is distributed according to the following criteria:
- health promotion and disease prevention receive a minimum of 20%;
- procurement to complement national stockpiling of essential crisis products receives a maximum of 12.5%;
- global commitments and health initiatives receive a maximum of 12.5%;
- administrative expenses receive a maximum of 8%.
The programme may provide funding in any of the forms laid down in the financial regulation (Regulation (EU, Euratom) 2018/1046 – see summary), in particular in the form of grants, prizes and procurement. Grants should not exceed 60% of a project’s eligible costs, but this may rise to 80% where there is ‘exceptional utility’, as defined in Article 8 of the regulation. The grants may finance 100% of the eligible costs for projects of European reference networks or other transnational networks defined by EU law and, under certain conditions, for projects of the World Health Organization.
Non-EU countries may take part in the programme under certain conditions and only if they are associated with the programme. Non-EU countries associated with the programme and legal entities that are established in a non-EU country associated with the programme are eligible for all funding opportunities under the EU4health programme. At latest record (August 2022), Iceland, Norway and Ukraine were associated with the EU4health programme.
Governance rules provide for a consultative EU4health steering group composed of Commission and national representatives. This group:
- ensures consistency and complementarity between national health policies, and between the programme and other EU measures;
- follows the programme’s implementation, proposing any necessary adjustments;
- meets at least three times a year so Member States can exchange views.
The Commission is assisted by the EU4health Programme Committee, which gives an opinion prior to the adoption of the annual work programme by the Commission. If the committee has no opinion or a negative opinion, the Commission cannot adopt the work programme.
The Commission:
- consults the steering group when preparing the annual work programmes and informs the European Parliament before the last meeting of the steering group on the outcome of those meetings;
- seeks the views of relevant stakeholders, including civil society and patient organisations, on the annual work programme’s priorities and strategic orientation, on the needs to be addressed and on the achieved results;
- implements EU4health through annual work programmes, which it adopts after a positive opinion of the Member States in the programme committee;
- will present an interim evaluation of the programme no later than 31 December 2024 and a final evaluation no later than the end of 2031 to the Parliament, the Council of the European Union, the European Economic and Social Committee and the European Committee of the Regions;
- implements information and communication campaigns about the programme;
- has the power to adopt implementing and delegated acts.
Annex II sets out the 23 indicators used to evaluate the programme’s progress.
The regulation repeals Regulation (EU) No 282/2014 from 1 January 2021 with transitional rules to cover the transition to EU4health.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2021.
BACKGROUND
- EU4health is the EU’s response to the COVID-19 pandemic, which has had a major impact on patients, medical and healthcare staff and health systems in Europe.
- The programme goes further than crisis response, to strengthen the resilience of healthcare systems with a strong focus on long-term health issues.
- For further information, see:
KEY TERMS
- One Health approach. An approach which recognises that human health is closely linked to that of animals and the environment.
MAIN DOCUMENT
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 (OJ L 107, 26.3.2021, pp. 1–29).
RELATED DOCUMENTS
Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, pp. 45–65).
Successive amendments to Directive 2011/24/EU have been incorporated into the original text. This consolidated version is of documentary value only.
