[CODATA-international] [risk_list] European Union - Establishing a Programme for the Union's action in the field of health ('EU4Health Programme') for the period 2021-2027

Horst Kremers office at horst-kremers.de
Sat Mar 27 14:04:54 EDT 2021

On March 26, the European Union (European Parliament and 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

there is a similar need for general Safety&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 in the current
Regulation on the EU4Heath Programme. The goal might be a "European RISK

Please note that I do not refer to specific RISK domains (like Civil
Protection, Critical Infrastructure or NaTech Hazards), it is the general
"Safety&Security" RISK domains that are in need for a regulation aiming at
joint cross-organizational, cross-domain and cross-border solutions in
technical, administrative, operational and financial terms for the benefit
of an all-stakeholders' public interest for the benefit of society.


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 , cf. my message to RISK_List
of Feb.22, 2021, also available in RIMMA Community Blog


Indeed, the current regulation is an important step forward, showing the
direction where general European Safety&Security RISK governance needs to go
in the near future.


Horst Kremers



p.s.:  this complete message is also available in and may be referenced from
our RIMMA Community Blog





Official Journal of the European Union 

L 107 English edition 

Volume 64,  26 March 2021


also available in all 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


(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





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


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


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 yea

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



2. 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;


6. 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;


8. 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 


mobile        +49 172 3211738   (also on WhatsApp)

FAX             +49 30 3728587 

FON            +49 30 20878902


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