EU - Establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027

On March 26, 2021 the European Union (European Parliament and of the Council ) by legal act established the EU4Heath Programme for the period 2021-2027.

The main principles specified in this regulation certainly not only apply to Health,
there is a similar need for general Safety and Security domains and you note the broad equivalence of regulations and measures when you replace the term “Health” by the more general term “RISK”.

This is why I recommend members of RISK_List to read the Regulation (see link below) with regard to your own action fields.

Local, regional, national and european experts groups and professional societies involved in RISK domains should work together with administrative bodies of various levels as well as with corresponding members of parlaments to prepare for joint European action in a much similar way as the current Regulation on the EU4Heath Programme. The goal might be a “European RISK Programme”.

Please note that I do not refer to specific RISK domains (like Civil Protection, Critical Infratsructure or NaTech Hazards), it is the general “Safety&Security” RISK domains that are in need for a regulation aiming at joint cross-domain and cross-border solutions in technical, administrative, operational and financial terms for the benefit of an all-stakeholders public interest.
I selected a few paragraphs from the Regulation’s text (see below).

These selected aspects address some of the important issues concerning RISK governance as well as RISK Stakeholder involvement (and there are a lot of deficits in these issues considering the (slow) implementation of the UN Sendai Framework)

  • (6) – for a long time there was a discussion that EU cannot make rules for domains that are under member states “sole” responsibility”. The current Regulation shows that really a lot can be accomplished in harmonizing definitions, content, techniques and organization cross-Europe for the benefit of our citizens
  • (16) – “improving interoperability” does not get the adequate attention in this Regulation. While knowing about the absolute essential role of Information Interoperability in all the actions detailed in that Regulation (and much more when extending these principles to the wider RISK domains) a perspective for a EU Directive on RISK Information Interoperability (Safety&Security) would have been adequate to be pointed out as an expected outcome of that programme.
  • (17) – as we all know, communication in RISK certainly is not only a one-way information stream. Considering all phases of RISK management (including prevention planning as well as audit and post-event aftermath) such regulations should be worded more to address the complex communication of all stakeholders in Safety&Security domains (not only in the “RISK-as-a-Service” one-way command/instruction modus).
  • (26) – gives a very useful overview of the complex legal/organizational embeddedness of such a regulation. Colleagues without much administrative background may get a slight idea of administrative consequences and workload not much visible to the science domains but essential for the functioning of the complex fundaments of our societies.
  • (43) – Outreach, audit and reporting are key management instruments needed for adequate information towards good (recursive, participative) governance
  • (50) – The all-of-society approach of the European Union calls for “equal opportunities for all, and the mainstreaming of those objectives should be taken into account and promoted throughout the assessment, preparation, implementation and monitoring of the Programme”.  (here we are still lacking the adequate all-of-society Information Management principles definition, deficits compilation, strategy, roadmap, implementation and participative audit governance aiming at a common Regulation for setting up a European Common RISK Information Space ECRIS    my message to RISK_List of Feb.22, 2021 also available in RIMMA Community Blog

Indeed, an important step forward, showing the direction where general Safety&Security RISK governance need to go in the near future.

Horst Kremers


Official Journal of the European Union
L 107 English edition
Volume 64,  26 March 2021
also available in other EU languages, see 

Regulation (EU) 2021/522 of the European Parliament and of the Council, establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027

(6) While Member States are responsible for their health policies, they should protect public health in a spirit of European solidarity

(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

(26) The Programme should work in synergy with and in a manner that complements other Union policies, programmes and funds, such as the Digital Europe Programme, Horizon Europe, the rescEU reserve under the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council(12) (the ‘rescEU reserve’), the Emergency Support Instrument established by Council Regulation (EU) 2016/369(13), the ESF+, of which the Employment and Social Innovation strand forms part, including as regards synergies in relation to better protecting the health and safety of millions of workers in the Union, the InvestEU Programme, the Single Market Programme established by a Regulation of the European Parliament and of the Council establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014, the ERDF, the Recovery and Resilience Facility, Erasmus+ established by a Regulation of the European Parliament and of the Council establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013, the European Solidarity Corps Programme established by a Regulation of the European Parliament and of the Council establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014, and external action instruments of the Union, such as the Neighbourhood, Development and International Cooperation Instrument established by a Regulation of the European Parliament and of the Council establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009, and the Instrument for Pre-accession Assistance III established by a Regulation of the European Parliament and of the Council establishing the Instrument for Pre-accession Assistance (IPA III). Where appropriate, common rules should be established with a view to ensuring that there is consistency and complementarity between Union policies, programmes and funds, while ensuring that the specificities of those policies are respected, and with a view to aligning with the strategic requirements of those policies, programmes and funds, such as the enabling conditions under the ERDF and ESF+. The Commission and the Member States should ensure that such synergies and complementarities are duly taken into consideration when drafting the annual work programmes as provided for in this Regulation.

(43) The implementation of the Programme should be supported by extensive outreach activities to ensure that the views and needs of civil society are duly represented and taken into account. To this end, the Commission should seek feedback on the Programme’s priorities and strategic orientations and on the needs to be addressed through its actions from relevant stakeholders once a year, including from representatives of civil society and patients’ associations, academics and organisations of healthcare professionals. Each year, before the end of the preparatory work for the work programmes, the Commission should also inform the European Parliament about the progress regarding such preparatory work and on the outcome of its outreach activities towards stakeholders.

(50) According to Article 8 TFEU, in all its activities, the Union shall aim to eliminate inequalities and to promote equality between men and women. Gender equality, as well as rights and equal opportunities for all, and the mainstreaming of those objectives should be taken into account and promoted throughout the assessment, preparation, implementation and monitoring of the Programme.


Chapter I, Article 3

(d) strengthening health systems by improving their resilience and resource efficiency, in particular through:
(ii) promoting the implementation of best practices and promoting data sharing;

Chapter I, Article 4

(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;

Chapter IV, Article 15
Joint policy implementation

A EU4Health Steering Group shall be established.

Chapter IV, Article 16

Stakeholder consultation and information of the European Parliament
The Commission shall consult with relevant stakeholders, including representatives of civil society and patient organisations
Commission shall organise the consultation and information of stakeholders at least once a year
Each year, … the Commission shall present to the European Parliament the outcomes of the proceedings of the EU4Health Steering Group and the consultation of stakeholders


  1. Actions meeting the objective laid down in point (b) of Article 4

(a) Strengthening the critical health infrastructure to cope with health crises, by supporting the setup of tools for surveillance, forecast, prevention and management of outbreaks;

(b) Supporting actions to foster Union-wide health crisis prevention and preparedness, and the management capacity and response capacity of actors at Union and national level, including voluntary stress tests, contingency planning and preparedness exercises; supporting the development of quality health standards at national level, mechanisms for the efficient coordination of preparedness and response, and the coordination of those actions at Union level;

(c) Supporting actions for setting up an integrated cross-cutting risk communication framework covering all phases of a health crisis, namely prevention, preparedness, response and recovery;

  1. Actions meeting the objective laid down in point (f) of Article 4

(a) Supporting a Union framework and the respective interoperable digital tools for cooperation among Member States and cooperation in networks, including those needed for HTA cooperation;

(b) Supporting the deployment, operation and maintenance of mature, secure and interoperable digital service infrastructure and data quality assurance processes for the exchange of, access to, and use and reuse of, data; supporting cross-border networking, including through the use and interoperability of electronic health records, registries and other databases; developing appropriate governance structures and interoperable health information systems;

(c) Supporting the digital transformation of healthcare and health systems, including through benchmarking and capacity building, for the uptake of innovative tools and technologies such as artificial intelligence, and supporting the digital upskilling of healthcare professionals;

(e) Supporting the development, operation and maintenance of databases and digital tools and their interoperability, including already established projects, where appropriate, with other sensing technologies, such as space-based technologies and artificial intelligence;

(f) Supporting actions to strengthen citizens’ access to and control over their health data;

(g) Supporting the deployment and interoperability of digital tools and infrastructure within and between Member States and with Union institutions, agencies and bodies;

(h) Supporting preparatory activities and projects for the European health data space;

  1. Actions meeting the objective laid down in point (h) of Article 4

(a) Supporting the establishment and operation of a health intelligence and knowledge infrastructure;

(d) Supporting expert groups and panels providing advice, data and information to support health policy development and implementation, including follow-up evaluations of the implementation of health policies;

(f) Auditing and assessment work


Horst Kremers, Engineering Management and Information Sciences
P.O. Box 20 05 48, 13515 Berlin, Germany
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FAX             +49 30 3728587
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