資料由法律人 LawPlayer整理提供·EU law / curated by LawPlayer from EUR-Lex
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.
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.
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.
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.
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.
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.
1. The Programme shall be implemented in direct management in accordance with the Financial Regulation or in indirect management with the bodies referred to in point (c) of Article 62(1) of that Regulation.
2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular in the form of grants, prizes and procurement.
3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and may be considered as a sufficient guarantee under the Financial Regulation. The Commission shall lay down specific rules for the operation of the mechanism.
4. Where the Commission implements emergency support operations through a non-governmental organisation, the criteria concerning financial and operational capacity shall be deemed to be satisfied if there is a framework partnership agreement in force between that organisation and the Commission pursuant to Council Regulation (EC) No 1257/96 ( 28 ) .
1. Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation.
2. Grants may be used in combination with financing from the European Investment Bank, from national promotional banks or from other development or public financial institutions, as well as in combination with financing from private-sector finance institutions and from public-sector or private-sector investors, including through public-public or public-private partnerships.
3. Grants paid by the Union shall not exceed 60 % of eligible costs for an action relating to an objective of the Programme or for the functioning of a non-governmental body. In cases of exceptional utility, the contribution by the Union may be up to 80 % of eligible costs. Actions with a clear Union added value shall be considered to have exceptional utility, inter alia, where:
(a)
at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average; or
(b)
bodies from at least 14 participating Member States participate in the action, of which at least four are Member States whose GNI per inhabitant is less than 90 % of the Union average.
4. In the case of the direct grants referred to in Article 13(6) and (7), such grants may be up to 100 % of eligible costs.
1. In cases where the emergence or development of a serious cross-border threat to health has been notified under Article 9 of Decision No 1082/2013/EU, or where a situation of public health emergency has been recognised under Article 12 of that Decision, procurement under this Regulation may take any of the following forms:
(a)
joint procurement with the Member States as referred to in Article 165(2) of the Financial Regulation whereby Member States may acquire, rent or lease fully the jointly procured capacities;
(b)
procurement by the Commission on behalf of the Member States on the basis of an agreement between the Commission and the Member States;
(c)
procurement by the Commission acting as wholesaler by buying, stocking and reselling or donating supplies and services, including rentals, for the benefit of Member States or partner organisations selected by the Commission.
2. In the event of the procurement procedure referred to in point (b) of paragraph 1 being used, the ensuing contracts shall be concluded by either of the following:
(a)
by the Commission, where the services or goods are to be provided or delivered to Member States or to partner organisations selected by the Commission;
(b)
by the participant Member States, where they are to directly acquire, rent or lease the capacities procured for them by the Commission.
3. In the event of the procurement procedures referred to in points (b) and (c) of paragraph 1 being used, the Commission shall comply with the Financial Regulation for its own procurement.
Blending operations under the Programme shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation.
1. An action that has received a contribution under the Programme may also receive a contribution from any other Union programme, including Funds under shared management, provided that the contributions do not cover the same costs.
2. The rules of the relevant Union programme shall apply to the corresponding contribution to the action.
3. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support.
Only actions that implement the objectives listed in Articles 3 and 4, in particular the actions set out in Annex I, shall be eligible for funding.
1. In order to be eligible for funding, legal entities shall, in addition to the criteria set out in Article 197 of the Financial Regulation:
(a)
be established in any of the following:
(i)
a Member State or an overseas country or territory linked to it;
(ii)
a third country associated to the Programme; or
(iii)
a third country listed in the annual work programme established in accordance with Article 17 (‘annual work programme’) under the conditions specified in paragraphs 2 and 3; or
(b)
be a legal entity created under Union law or an international organisation.
2. Legal entities that are established in a third country which is not associated to the Programme may in exceptional cases be eligible to participate in the Programme where such participation is necessary for the achievement of the objectives of a given action. The assessment of that necessity shall be duly reflected in the funding decision.
3. Legal entities that are established in a third country which is not associated to the Programme shall bear the cost of their participation.
4. Natural persons shall not be eligible for grants under the Programme.
5. Under the Programme, direct grants may be awarded without a call for proposals to fund actions, if such grants are duly justified, and if those actions have a Union added value that is explicitly provided for in the annual work programmes and are co-financed by the competent authorities that are responsible for health in the Member States or in third countries associated to the Programme, by relevant international health organisations, or by public sector bodies or non-governmental bodies that are mandated by those competent authorities, regardless of whether those bodies act individually or as a network.
6. Under the Programme, direct grants shall be awarded without a call for proposals to ERNs. Direct grants may also be awarded to other transnational networks set out in accordance with Union law.
7. Under the Programme, direct grants may be awarded without a call for proposals to fund actions of the WHO where financial support is necessary for the implementation of one or more of the specific objectives of the Programme that have a Union added value that is explicitly provided for in the annual work programmes.
8. Under the Programme, grants may be awarded without a call for proposals to fund the functioning of non-governmental bodies where financial support is necessary for the implementation of one or more of the specific objectives of the Programme that have a Union added value that is explicitly provided for in the annual work programmes, as long as those bodies fulfil all of the following criteria:
(a)
they are non-profit-making and independent of industry, commercial and business or other conflicting interests;
(b)
they work in the public health area, pursue at least one of the specific objectives of the Programme and play an effective role at Union level;
(c)
they are active at Union level and in at least half of the Member States, with a balanced geographical coverage of the Union.
The Commission shall duly reflect the analysis of the fulfilment of those criteria in the funding decision.
1. Subject to Article 186 of the Financial Regulation, and point (a) of the second subparagraph of Article 193(2) of that Regulation, costs incurred prior to the date of submission of the grant application shall be eligible for funding with respect to actions:
(a)
implementing the objective referred to in point (b) of Article 3 of this Regulation; or
(b)
implementing objectives other than those referred to in point (a) of this paragraph, in duly justified exceptional cases, provided that those costs are directly linked to the implementation of the supported actions and activities.
2. Costs eligible under point (a) of paragraph 1 that relate to measures aiming to address suspected occurrences of a disease that could trigger a cross-border threat to health shall be eligible from the date of notification of the suspected occurrence of that disease to the Commission, provided that the occurrence or presence of that disease is subsequently confirmed.
3. In exceptional cases, during a health crisis caused by a serious cross-border threat to health as defined in point (g) of Article 3 of Decision No 1082/2013/EU, costs incurred by entities established in non-associated countries may be considered eligible if those costs are duly justified for reasons concerning countering the spread of the risk for the protection of the health of people in the Union.
1. A EU4Health Steering Group shall be established.
2. The Members of the EU4Health Steering Group shall be the Commission and the Member States. Each Member State shall appoint one member and one alternate member to the EU4Health Steering Group. The Commission shall provide the secretariat of the EU4Health Steering Group.
3. The Commission shall consult the EU4Health Steering Group:
(a)
on the Commission’s preparatory work for the annual work programmes;
(b)
each year, at least 6 months in advance of the presentation of the draft of the annual work programme to the committee referred to in Article 23(1), on the priorities and strategic orientations of the annual work programme.
4. The EU4Health Steering Group shall:
(a)
work towards ensuring that there is consistency and complementarity between the Member States’ health policies as well as between the Programme and other policies, instruments and actions of the Union, including those relevant to the Union agencies;
(b)
follow up the implementation of the Programme and propose any necessary adjustments based on evaluations;
(c)
adopt its rules of procedure, which shall contain provisions to ensure that the group will meet at least three times a year, in person where appropriate, thus allowing for a regular and transparent exchange of views among Member States.
1. The Commission shall consult with relevant stakeholders, including representatives of civil society and patient organisations, to seek their views on:
(a)
the priorities and strategic orientation of the annual work programme;
(b)
the needs to be addressed through the annual work programme and the results achieved through it.
2. For the purposes of paragraph 1, the Commission shall organise the consultation and information of stakeholders at least once a year, in the six months preceding the presentation of the draft work programme to the committee referred to in Article 23(1).
3. The Commission may at any time seek the views of relevant decentralised agencies and of independent experts in the field of health on technical or scientific matters of relevance for the implementation of the Programme.
4. Each year, prior to the last meeting of the EU4Health Steering Group, the Commission shall present to the European Parliament the outcomes of the proceedings of the EU4Health Steering Group and the consultation of stakeholders referred to in paragraphs 1 and 2.
1. The Commission shall implement the Programme by establishing annual work programmes in accordance with the Financial Regulation.
2. The Commission shall adopt, by means of implementing acts:
(a)
the annual work programmes, which shall set out, in particular:
(i)
the actions to be undertaken, including the indicative allocation of financial resources;
(ii)
the overall amount reserved for blending operations;
(iii)
eligible actions falling under Article 7(3) and (4);
(iv)
eligible actions by legal entities referred to in point (b) of Article 13(1);
(v)
eligible actions by legal entities from a third country not associated to the Programme but listed in the annual work programme under the conditions laid down in Article 13(2) and (3);
(b)
decisions approving actions with a cost of EUR 20 000 000 or more;
(c)
rules establishing:
(i)
the technical and administrative arrangements necessary for the implementation of the actions of the Programme;
(ii)
uniform templates for the collection of data necessary to monitor the implementation of the Programme.
3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).
In managing and implementing the Programme, the Commission and the Member States shall ensure that there is compliance with all relevant legal provisions regarding personal data protection and, where appropriate, that mechanisms are introduced to ensure that such data remain confidential and safe.
1. Indicators to report on progress of the Programme towards the achievement of the general and specific objectives listed in Articles 3 and 4 are set out in Annex II.
2. The Commission is empowered to adopt delegated acts in accordance with Article 25 to amend Annex II with regard to the indicators where considered necessary.
3. The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner. To that end, the Commission shall adopt implementing acts establishing proportionate reporting requirements for recipients of Union funds and, where appropriate, for Member States.
1. Evaluations provided for in Article 34(3) of the Financial Regulation shall be carried out by the Commission in a sufficiently timely manner to feed into the decision-making process.
2. The Commission shall present an interim evaluation of the Programme no later than 31 December 2024. The interim evaluation shall be the basis for adjusting the implementation of the Programme as appropriate.
3. The Commission shall present a final evaluation at the end of the Programme and no later than four years after the end of the period referred to in Article 1.
4. The Commission shall publish and communicate the conclusions of both the interim and final evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Audits of the use of Union contributions, including audits carried out by persons or entities other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance referred to in Article 127 of the Financial Regulation.
Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF, and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013.
1. The Commission shall be assisted by a EU4Health Programme Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
The Commission and the Member States shall ensure that there is overall consistency, synergy and complementarity between the Programme and other Union policies, instruments and actions, including those relevant to the Union agencies, including through their common work in the EU4Health Steering Group.
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission for a period of seven years from 26 March 2021.
3. The delegation of power referred to in Article 19(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 19(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public.
2. The Commission shall implement information and communication actions related to the Programme, to actions taken pursuant to the Programme and to the results obtained.
3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Articles 3 and 4.
Regulation (EU) No 282/2014 is repealed with effect from 1 January 2021, without prejudice to Article 28 of this Regulation.
1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) No 282/2014 which shall continue to apply to those actions until their closure.
2. The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the measures adopted under Regulation (EU) No 282/2014 and the Programme.
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
It shall apply from 1 January 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
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 (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32021R0522
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
本頁資料來源：EUR-Lex·整理提供：法律人 LawPlayer· lawplayer.com