Annexes to COM(2020)405 - Establishment of a Programme for the Union's action in the field of health -for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (“EU4Health Programme”)

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dossier COM(2020)405 - Establishment of a Programme for the Union's action in the field of health -for the period 2021-2027 and repealing ...
document COM(2020)405 EN
date March 24, 2021
ANNEX I

LIST OF POSSIBLE ELIGIBLE ACTIONS PROVIDED FOR IN ARTICLE 12

1.   

Actions meeting the objective laid down in point (a) of Article 4
(a)Supporting the establishment and implementation of programmes assisting Member States and supporting the actions of Member States to improve health promotion and disease prevention;

(b)Supporting the implementation and further development of surveys, studies, collection of comparable data and statistics, where relevant including disaggregated data by gender and age, methodologies, classifications, microsimulations, pilot studies, indicators, knowledge brokering and benchmark exercises;

(c)Supporting Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices, to promote healthy diets and regular physical activity, taking into account the needs of vulnerable groups at every stage of their life, with the aim of promoting life-long health;

(d)Supporting Member States in delivering effective responses to communicable diseases, and in the prevention, surveillance, diagnosis and treatment of such diseases;

(e)Supporting Member States’ actions in health promotion and disease prevention throughout the lifetime of an individual and by addressing health risk factors, such as obesity, unhealthy diets and physical inactivity;

(f)Supporting actions to improve mental health;

(g)Supporting actions to complement measures of Member States in reducing damage to health due to illicit drug use and addiction, including information and prevention;

(h)Supporting implementing policies and actions to reduce health inequalities and inequities in relation to healthcare;

(i)Supporting actions to enhance health literacy;

(j)Supporting the promotion and implementation of the recommendations of the European Code against Cancer and supporting the revision of the current edition of that Code;

(k)Actions to support the implementation of cancer registries in all Member States;

(l)Furthering the cooperation among relevant national bodies of participating Member States with a view to supporting the creation of a virtual European network of excellence in order to strengthen research on all types of cancer, including paediatric cancer, and further the collection and exchange of clinical data and the translation of research findings into everyday care and treatment of cancer patients;

(m)Supporting actions to improve the quality of cancer care, including as regards prevention, screening, early diagnosis, monitoring and treatment, supportive and palliative care, in an integrative and patient-centred approach and supporting the establishment of quality assurance schemes for cancer centres or other centres treating cancer patients, including those treating paediatric cancer;

(n)Supporting the establishment of quality assurance schemes for cancer centres and centres treating cancer patients;

(o)Supporting mechanisms for cross-specialty capacity building and continuous education, in particular in the area of cancer care;

(p)Actions supporting the quality of life of cancer survivors and caregivers, including provision of psychological support, pain management and health-related aspects of professional reintegration;

(q)Strengthening collaboration on patient rights, patient safety and quality of care;

(r)Supporting actions regarding epidemiological surveillance, thus contributing to assessment of factors that affect or determine the health of people;

(s)Supporting, in synergy with other programmes, actions to improve the geographical distribution of the healthcare workforce and actions for the avoidance of ‘medical deserts’, without prejudice to Member State competences;

(t)Supporting the development of guidelines for preventing and managing communicable and non-communicable diseases, and of tools and networks for the exchange of best practices in that area;

(u)Supporting Member States’ actions to address health determinants, including reducing alcohol-related harm and tobacco use;

(v)Supporting tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use;

(w)Supporting initiatives to improve vaccination coverage rates in the Member States;

(x)Communication activities addressed to the public and stakeholders to promote Union action in the areas mentioned in this Annex;

(y)Awareness-raising campaigns and communications activities for the general public as well as for targeted groups, aimed at preventing and addressing vaccine hesitancy, misinformation and disinformation as regards prevention, causes and treatment of diseases, in a manner that complements national campaigns and communications activities on those matters;

(z)Communication activities addressed to the public on health risks and health determinants;

(za)Supporting actions to reduce the risk of healthcare-acquired infections.

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;

(d)Supporting preventive actions to protect vulnerable groups from health threats and actions to adapt the response to and the management of health crises to the needs of those vulnerable groups such as actions to secure basic care for patients with chronic or rare diseases;

(e)Supporting actions to address the collateral health consequences of a health crisis, in particular the consequences for mental health, on patients suffering from cancer, from chronic diseases and other vulnerable situations, including people living with addiction, with HIV/AIDS, or suffering from hepatitis and tuberculosis;

(f)Supporting, in synergy with other programmes, training and educational programmes for the upskilling of healthcare and public health workforces, and programmes for temporary exchanges of staff, in particular with the aim of improving their digital skills;

(g)Supporting the establishment and coordination of Union Reference Laboratories, Union Reference Centres, and Centres of Excellence;

(h)Auditing Member States’ preparedness and response arrangements, for example regarding health crisis management, antimicrobial resistance and vaccination;

(i)Communicating to the public in the context of risk management and health crisis preparedness;

(j)Supporting upwards convergence of national systems’ performance through health indicator development, analysis and knowledge brokering and the organisation of voluntary stress tests of national healthcare systems;

(k)Supporting investigation, risk assessment and risk management work on the link between animal health, environmental factors, and human diseases, including during health crises.

3.   

Actions meeting the objective laid down in point (c) of Article 4
(a)Supporting actions to strengthen laboratory capacity and the production, research, development, and deployment of health products and crisis-relevant niche products within the Union;

(b)Supporting actions and interoperable IT tools to monitor, prevent, manage, report and notify shortages of medicinal products and medical devices, while contributing to their affordability;

(c)Supporting, in synergy with other programmes, clinical trials to speed up the development, market authorisation and access to innovative, safe and effective medicinal products and vaccines;

(d)Supporting actions to encourage the development of innovative medicinal products and vaccines to meet rising healthcare challenges and patients’ needs, and of less commercially profitable products such as antimicrobials;

(e)Supporting actions to improve the environmentally friendly production and disposal of medicinal products and medical devices and actions to support the development of medicinal products that are less harmful for the environment;

(f)Supporting actions to promote the prudent and efficient use of medicinal products, in particular of antimicrobials;

(g)Supporting actions aimed at stimulating the increase in the production of essential active pharmaceutical ingredients and medicinal products in the Union, including by diversifying supply chain production of active pharmaceutical ingredients and generics within the Union, to reduce Member States’ dependence on certain third countries;

(h)Supporting actions to enhance the availability, accessibility and affordability of medicinal products and medical devices;

(i)Supporting actions to foster innovation in repurposing, reformulation and combining of off-patent medicinal products, in synergy with other programmes;

(j)Actions to strengthen the environmental risk assessment of medicinal products;

(k)Supporting the establishment and operation of a mechanism for cross-sectorial coordination following the One-Health approach.

4.   

Actions meeting the objective laid down in point (d) of Article 4
(a)Monitoring of information on national stockpiling activities regarding essential crisis-relevant products to identify potential needs for additional stockpiling at Union level;

(b)Ensuring consistent management of stockpiling of essential crisis-relevant products at Union level, in a manner that complements other Union instruments, programmes and funds and in close coordination with relevant Union bodies;

(c)Supporting actions for the procurement and supply of essential crisis-relevant products, which contribute to their affordability, in a manner that complements Member States’ stockpiling actions.

5.   

Actions meeting the objective laid down in point (e) of Article 4

Supporting actions for the preparatory work for mobilising and training at Union level a reserve of medical, healthcare and support staff to be mobilised in the event of a health crisis, in close collaboration with the ECDC, in synergy with other Union instruments, and in full respect of Member State competences; facilitating the exchange of best practices between existing national reserves of medical, healthcare and support staff.

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;

(d)Supporting the optimal use of telemedicine and telehealth, including through satellite communication for remote areas, fostering digitally-driven organisational innovation in healthcare facilities and promoting digital tools to support citizen empowerment and patient-centred care;

(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;

(i)Actions to support e-health, such as the transition to telemedicine and at-home administration of medication;

(j)Supporting the establishment of interoperable electronic health records, in line with the European Electronic Health Record Exchange format in order to increase the use of e-health and improve the sustainability and resilience of healthcare systems.

7.   

Actions meeting the objective laid down in point (g) of Article 4
(a)Actions promoting access to health services and related facilities and care for people with disabilities;

(b)Supporting the strengthening of primary care and reinforcing the integration of care, with a view to providing universal health coverage and equal access to good quality healthcare;

(c)Supporting Member States’ actions to promote access to sexual and reproductive healthcare and supporting integrated and intersectional approaches to prevention, diagnosis, treatment and care.

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;

(b)Supporting the implementation, enforcement, monitoring of Union health legislation and action; and providing technical support for the implementation of legal requirements;

(c)Supporting studies and analysis, health impact assessment of other Union policy actions and the provision of scientific advice to support evidence-based policymaking;

(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;

(e)Supporting national contact and focal points in providing guidance, information and assistance related to the promotion and implementation of Union health legislation and of the Programme;

(f)Auditing and assessment work in accordance with Union legislation, where appropriate;

(g)Supporting the implementation and further development of the Union’s tobacco control policy and legislation;

(h)Supporting national systems as regards the implementation of legislation on substances of human origin, and as regards the promotion of the sustainable and safe supply of such substances through networking activities;

(i)Supporting Member States to strengthen the administrative capacity of their healthcare systems through cooperation and exchange of best practices;

(j)Supporting knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience of health systems, while linking available Union funding;

(k)Supporting capacity building for investing in and implementing health system reforms, including strategic planning and access to multi-source financing.

9.   

Actions meeting the objective laid down in point (i) of Article 4
(a)Supporting the transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States, and in particular providing country-specific tailor-made assistance to the Member States, or groups of Member States, with the greatest needs, through the funding of specific projects including twinning, expert advice and peer support;

(b)Supporting cross-border collaboration and partnerships, including in cross-border regions, with a view to transferring and upscaling innovative solutions;

(c)Strengthening cross-sectoral collaboration and coordination;

(d)Supporting the functioning of ERNs and the establishment and operation of new transnational networks as provided for in Union health legislation, and supporting Member States’ actions to coordinate the activities of such networks with the operation of national health systems;

(e)Supporting further the implementation of ERNs in Member States and fostering their strengthening, inter alia, by continuous assessment, monitoring, evaluation and improvement;

(f)Supporting the creation of new ERNs, to cover rare, complex and low prevalence diseases, where appropriate, and supporting collaboration among ERNs to address the multi-systemic needs arising from low prevalence diseases and rare diseases and to facilitate diagonal networking between different specialities and disciplines;

(g)Support Member States to improve and further develop and implement ERN registries;

(h)Stakeholder consultation activities.

10.   

Actions meeting the objective laid down in point (j) of Article 4
(a)Supporting actions contributing to the objectives of the programme presented by the WHO, as the directing and coordinating authority for health within the United Nations;

(b)Supporting collaboration among Union institutions, Union agencies, and international organisations and networks, and supporting the Union’s contribution to global initiatives;

(c)Supporting collaboration with third countries as regards the areas covered by the Programme;

(d)Supporting actions to foster international regulatory convergence on medicinal products and medical devices.


ANNEX II

INDICATORS FOR THE EVALUATION OF THE PROGRAMME

Programme indicators:

1.Preparedness and response planning of the Union and of Member States for serious cross-border threats to health

2.Access to centrally authorised medicinal products, for example the number of existing and new orphan authorisations, advanced therapy medicinal products (ATMPs), medicinal products for paediatric use or vaccines, for unmet needs

3.Number of actions contributing to the reduction of avoidable mortality in the area of non-communicable diseases and risk factors

4.Number of Member States implementing best practices regarding health promotion, disease prevention and addressing health inequalities

5.Number of Member States participating in the European health data space

6.Number of Member States with improved preparedness and response planning

7.Vaccination coverage by age for vaccine-preventable-diseases such as measles, flu, HPV and COVID-19

8.EU Laboratory capacity index (EULabCap)

9.Age-standardised five-year net survival rate for paediatric cancer by type, age, gender and Member State (to the extent available)

10.Screening coverage for breast, cervical and colorectal cancer screening programmes, by type, target population, and Member State

11.Percentage of population covered by Cancer Registries and number of Member States reporting information on cervical, breast, colorectal and paediatric cancer stage at diagnosis

12.Number of actions addressing the prevalence of major chronic diseases per Member State, by disease, gender and age

13.Number of actions addressing the age prevalence of tobacco use, if possible differentiated by gender

14.Number of actions addressing the prevalence of harmful use of alcohol, if possible differentiated by gender and age

15.Number of shortages of medicinal products in the Member States as reported through the single point of contact network

16.Number of actions aimed at increasing the security and continuity of the global supply chains and addressing dependence on imports from third countries for the production of essential active pharmaceutical ingredients and medicinal products in the Union

17.Number of audits conducted in the Union and in third countries to ensure good manufacturing practices and good clinical practices (Union control)

18.Antimicrobial consumption for systemic use ATC (group J01) per Member State

19.Number of healthcare units involved in ERNs and of patients diagnosed and treated by the members of ERNs

20.Number of HTA reports jointly carried out

21.Number of health impact assessments of Union policies

22.Number of actions addressing the fight against communicable diseases

23.Number of actions addressing environmental risk factors for health