Explanatory Memorandum 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”) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| 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 ... |
|---|---|
| source | COM(2020)405  |
| date | 28-05-2020 |
1. CONTEXT OF THE PROPOSAL
This proposal provides for a date of application as of 1 January 2021 and is presented for a Union of 27 Member States.
• Reasons and objectives
“We will stop at nothing to save lives,” said President von der Leyen, speaking to the European Parliament on 26 March 2020, the COVID-19 crisis is the biggest challenge the European Union (EU) has faced since the Second World War, and it has demonstrated that if each country tries to tackle pandemics on its own, the EU will be as weak as the weakest link. Every health system has struggled in tackling this crisis, and this has affected every citizen in one way or another.
Europe needs to give a higher priority to health, to have health systems ready to provide state of the art care, and to be prepared to cope with epidemics and other unforeseeable health threats in line with the International Health Regulations (IHR) 1 . Whilst the overall framework for preparedness, early warning and response is already in place under Decision 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health, COVID-19 has shown the need to significantly boost the EU’s capability to respond effectively to such major health threats. An ambitious self-standing Programme, to be called the EU4Health Programme, will be the key instrument for delivering it.
The new Programme will be essential in making sure that the EU remains the healthiest region in the world, has all possible tools available to address health challenges at national and EU level and is prepared for any new emerging health threat that may endanger the population of the EU.
Embedded in the ‘One health’ approach, which recognises the interconnection between human health and animal health and more broadly with the environment, the EU4Health Programme can support Member States in the transition to better preparedness and the reinforcement of their health systems and support them in achieving the health-related United Nations Sustainable Development Goals (SDGs). It provides for new actions, which will fill in gaps that this pandemic has revealed in terms of the development and manufacturing of medicinal products, the adequate supply of equipment in hospitals and sufficient medical human resources, the uptake of digital tools and services that enable continuity of care, and the need to maintain access to essential goods and services in times of crisis. This will allow the EU to have more tools to take quick, decisive and coordinated action with the Member States in both preparing for and managing crises.
Beyond the required level of preparedness and response, there are a number of further challenges in the areas of health security and health systems impeding their overall functioning, and rendering an adequate crisis response overall more demanding, in particular:
●inequalities in health status among population groups, countries and regions, and access to affordable, preventive and curative health care of good quality;
●burden from non-communicable diseases, including cancer, mental health, rare diseases and risks from health determinants;
●uneven distribution of health care systems capacity, including health care workers;
●obstacles to the wide uptake and best use of digital innovations as well their scaling up;
●growing health burden from environmental degradation and pollution, in particular air, water and soil quality, and also from demographic changes.
The EU4Health Programme will set out key action areas such as improvement of national health systems, measures against communicable and non-communicable diseases, availability and affordability of medicines and other crisis relevant products. As many of the new and innovative suggestions are closely related to the functioning of health systems, the Commission will work closely with the Member States to make sure that the support provided by the EU4Health Programme is based on national needs. The Commission will also work with third countries and international partners in the implementation of the EU4Health Programme actions.
The Programme will need to be dynamic and flexible to adapt to emerging new challenges, and to serve the EU and the Member States in their evolving needs and priorities. It needs to address inequalities by benchmarking, providing support and closing identified gaps between countries, regions, population groups and citizens. It should help reduce gaps in life expectancy and access to care and services. It will provide tools for enhanced solidarity in preparedness and crisis response, as well as in finding common ground to improve prevention and in addressing non-communicable diseases, and in particular cancer, and for better coordinating between different policies, tools and financial instruments. Finally, it will contribute to tackling the negative impact of climate change and environmental degradation on human health.
Funding for health under the next Multiannual Financial Framework (MFF) includes several instruments such as the European Social Fund Plus (ESF+), the European Regional Development Fund, and Horizon Europe, the Digital Europe Programme, and the Connecting Europe Facility 2. Working across programmes, and having shared objectives between policies will be key considerations to channel health funds across policies and support the achievement of their objectives more effectively than before.
Article 168 of the Treaty on the Functioning of the European Union (TFEU) provides the legal basis for the EU’s actions in the field of health. Whilst the Member States are responsible for the functioning of their health systems, there are specific areas where the EU can legislate, and others where the Commission can support Member States’ efforts. There is already a comprehensive regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as on tobacco legislation, patients' rights in cross-border healthcare and serious cross-border health threats.
The EU4Health Programme will support actions to enable the Commission to complement the necessary regulatory framework and contribute to addressing the significant structural needs identified in the COVID-19 crisis.
The EU agencies, the European Centre for Disease Prevention and Control, the European Medicines Agency, the European Food Safety Authority, the European Chemicals Agency, and the European Safety and Health at Work Agency have a key role to play in Europe’s defence against serious cross border health threats and pandemics, both on the prevention and on the crisis management front.
• Consistency with existing policy provisions
The EU4Health Programme supports policies and priorities which aim to promote health. It will support the implementation of the principles of the European Pillar of Social Rights 2 , the European Semester as far as the health area is concerned to ensure that the Union and Member States reach the targets of the 3rd SDG, to ‘Ensure healthy lives and promote well-being for all at all ages’ and other SDGs related to health. In the areas of national competence, the Commission and the Member States will need to collaborate more closely, earlier, and more inclusively in setting priorities for this EU4Health Programme, defining the best ways to use the instruments and in the subsequent implementation of the Programme.
• Consistency with other Union policies
The EU4Health Programme, while much larger than its predecessor, still represents only about one third of all health investments of the next MFF. In many cases, health expenditure under different programmes and funds needs to be implemented in a closely co-ordinated way to be fully effective and avoid duplication. The Commission is committed to ensure operational synergies with other Union programmes, notably to address policy needs and to enable the pursuit of common objectives and common areas for activities. Building on the principle of ‘Health in all Policies’, these programmes 3 will provide financial support to reforms and investments that will have a lasting impact on the growth potential and resilience of the economy of the Member States. They will also address challenges identified in the European Semester and contribute to the objectives of the EU4Health Programme. The EU4Health Programme will also contribute to the Commission’s priorities, including responding to the challenges from migration and the Green Deal.
Complementary to and in synergy with the EU4Health Programme other programmes may provide support for health policy actions, including the implementation of solutions tailored to specific national/regional contexts/needs, as well as bilateral and interregional initiatives. In particular:
●Through the enhanced Union Civil Protection Mechanism (UCPM/rescEU) capacities, the EU and the Member States will be better prepared for and able to react quickly and flexibly in a future crisis. The upgraded UCPM and in particular its emergency rescEU capacities will also endow the Union with enhanced preparedness and a proficient logistic infrastructure that can cater for different types of emergency, including those with a medical emergency component. Where the UCPM will focus on the direct crisis response capacities which will have to be immediately ready and available in case of an emergency, the EU4Health Programme will include structural, large-scale reserves, including a reserve of ready medical staff and experts, and the underlying resilience of the health care systems and necessary structures. Those resources will be crucial for a coordinated crisis response at Union level
●The European Regional Development Fund (ERDF) will support the health care systems capacity in the regions in terms of infrastructures, modernisation of the public and private healthcare sectors, and (inter)regional cooperation networks. The ERDF also provides investments in research and innovation, uptake of advanced technologies and innovative solutions, and in digitalisation, including in health. Further, it supports capacity building, technical assistance and cross-border cooperation.
●The European Social Fund Plus (ESF+) will create synergies and complementarities with the EU4Health Programme by supporting, among other, skills development for health staff and improved access to health care for people in socio-economic vulnerable situations, and long term care. The challenges identified through the European Semester will be particularly relevant.
●The Recovery and Resilience Facility will provide financial support to reforms and investments that will have a lasting impact on the growth potential and resilience of the economy of the Member States and will address challenges identified in the European Semester.
●Horizon Europe will finance research and innovation in health: health throughout the life; environmental and social health determinants; non-communicable and rare diseases; infectious diseases; tools, technologies and digital solutions for health and care and healthcare systems are the areas of intervention in the Commission’s proposal for a ‘Health’ cluster. The EU4Health Programme will help to ensure best use of research results and facilitate the uptake, scale-up and deployment of health innovation in healthcare systems and clinical practice.
●The Digital Europe Programme will support the deployment of digital infrastructure underpinning the wide use of digital technologies in areas of public interest. The programme will support, amongst other elements, tools and data infrastructures supporting data spaces in different sectors. Building on that infrastructure and pilot implementations in different sectors supported by the DEP Programme, the EU4Health Programme will focus on delivering data sharing and citizen platform applications covering areas such as secure and effective management of personal health data across borders; better data for research, disease prevention and personalised health and care; and use of digital tools for citizen empowerment and for person-centred care, in compliance with data protection rules.
●The Connecting Europe Facility Programme 2 Digital (CEF Digital) will fund highly resilient Gigabit networks to connect socio-economic drivers, including hospitals and medical centres, in areas where no such networks exist or are planned to be deployed in the near future; this will enable critical applications such as tele-operated surgery as well as the sharing of medical data. It will also bring connectivity to households to enable remote patient monitoring in a secure manner and in compliance with data protection legislation.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The legal basis for the proposal is Article 168 i TFEU, which provides for the adoption of incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol.
Under Article 168 TFEU the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of the Member States for the definition of their health policies and the organisation and delivery of health services and medical care.
The EU4Health Programme laid down in the proposal, implemented under direct and indirect management, covers actions and incentive measures aimed at preventing health risks and protecting and improving human health.
• Subsidiarity (for non-exclusive competence)
Pursuant to point (a) of Article 6 TFEU, the Union shall have competence to carry out actions to support, coordinate or supplement the actions of the Member States for the protection and improvement of human health. Under Article 168 TFEU the Union is to complement and support national health policies.
The objectives of this Regulation are to protect people in the Union from serious cross-border threats to health; to contribute to a high level of protection of public health by supporting actions which promote health, prevent diseases, strenghten health systems,improve availability and affordability in the Union of medicines and other crisis relevant products and support integrated and cordinated work and exchange of best practices in this respect.
Given the measures envisaged under the proposal, the objectives of the EU4Health Programme cannot be sufficiently achieved by the Member States alone but rather can better be achieved at Union level, and therefore the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
The EU4Health Programme will be implemented with full respect to the responsibilities of the Member States, for the definition of their health policy and for the organisation and delivery of health services and medical care as stated in Article 168 TFEU.
The subsidiarity principle is therefore respected.
• Proportionality
In accordance with the principle of proportionality, this proposal does not go beyond what is necessary to achieve its goals. The principle of proportionality has guided the Commission's design of the EU4Health Programme, which proposes to identify and enable synergies with other programmes and to strengthen collaboration with the Member States in defining priorities for it.
The proposal is proportionate and seeks to increase participation of Member States in the actions it supports by lowering as much as possible the barriers to participation, and provides for a reduction of administrative burden on the Union and on the national authorities that has been limited to what is necessary for the Commission to exercise its responsibility for implementing the Union budget.
• Choice of the instrument
The choice of instrument is a Regulation of the European Parliament and of the Council to establish the EU4Health Programme.
3. RESULTS OF RETROSPECTIVE EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
–The Health Programme 2014-2020
Strengths: The mid-term evaluation confirmed the EU added value of actions, notably in the form of:
(i)increased capacity in the Member States to address serious cross-border health threats;
(ii)technical guidelines and recommendations for cancer, HIV/AIDS and TB prevention;
(iii)additional support for EU health legislation on medicinal products and medical devices, as well as the eHealth Network activities and Health Technology Assessment.
The evaluation also recognised the added value of tools to control healthcare-associated infections and to step up coordinated efforts to fight against antimicrobial resistance, and of the extensive groundwork pursued through Joint Actions to identify and transfer best practices for the prevention and management of diseases. It also recognised the positive contribution of actions to increase the interoperable and standardised cross-border exchange of health data, and of those efforts to set up EU-wide digital infrastructures for that purpose.
Weaknesses: In non-legislative areas where actions can be more open-ended or broadly defined, the mid-term evaluation revealed that there is a danger of those actions being less focused. There is scope to streamline the added-value criteria to focus on three key areas: addressing serious cross-border health threats, improving economies of scale, and fostering the exchange and implementation of best practices. There were also some inefficiencies and inadequacies with the monitoring of implementation of data, which can make it harder for programme managers to keep an up-to-date overview of the programme's achievements.
• Stakeholder consultations
Under the initial proposal for the next MFF, health was included under the European Social Fund Plus (ESF+). A series of stakeholder consultations were carried out at the time with the main organisations and institutions in the EU working in the field of social and employment policy and relevant public authorities at all levels of government, social partners, civil society organisations, funding beneficiaries and end-users as well as citizens across the EU. The general conclusions, which are also relevant for the new programme, were related to the need for streamlining the exchange of knowledge between countries and regions, simplifying and reducing the administrative burden on beneficiaries including less burdensome requirements on collecting data from participants. There was a call to strengthen synergies and avoid duplication and overlaps between EU instruments.
Notably, it was concluded that public health issues could only be effectively dealt with through collaboration at EU level. It was stated that there is an added value in the EU addressing common challenges such as health inequalities, migration, an ageing population, patient safety, high quality health care, tackling serious health threats including non-communicable diseases, infectious diseases and antimicrobial resistance.
• External expertise
N.A.
• Impact assessment
The proposal for the European Social Fund Plus (ESF+) programme under the next Multiannual Financial Framework, including health, was supported by an impact assessment examined by Regulatory Scrutiny Board under the Single Market MFF Programme on 18 April 2018 and issued a positive opinion. All health objectives from the initial proposal are retained with priority given to the EU’s and Member States’ response and crisis preparedness to future health crises in the aftermath of COVID-19 pandemic. The general and specific objectives have been aligned with the political priorities of the Commission regarding pharmaceuticals and cancer.
• Simplification
N.A.
• Fundamental rights
The EU4Health Programme will contribute to the Charter of Fundamental Rights of the European Union as it aims to improve access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. The new Programme is also aligned with the Charter’s objective that a high level of human health protection is to be ensured in the definition and implementation of all the Union's policies and activities.
4. BUDGETARY IMPLICATIONS
The total budget allocated for the EU4Health Programme amounts to EUR 10 397 614 000 (in current prices) for the 2021-2027 period.
1. EUR 1 946 614 000 shall derive from heading 5 “Resilience, Security and Defence” of the MFF 2021-2027;
2. EUR 8 451 000 000 shall derive from proceeds of the European Union Recovery Instrument [/Regulation xxx], constituting external assigned revenues according to Article 21.5 of the Financial Regulation.
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
The proposed EU4Health Programme will be mainly implemented by direct management, using in particular grants, prizes and procurement, as well as indirect management.
Part of the EU4Health Programme is expected to be implemented by executive agencies.
The Programme’s results and outputs will be assessed regularly through defined indicators for the specific work plans to monitor the implementation. Special focus will be put on monitoring the coordination of relevant health spending programmes to ensure there will be no double funding and that synergies will be made.
The Commission will carry out a mid-term and a final evaluation of the Programme in order to assess its efficiency, effectiveness, relevance, coherence and value added, in conformity with Article 34, paragraph 3, of the Financial Regulation.
• Detailed explanation of the specific provisions of the proposal
Contents
The Regulation establishes the EU4Health Programme for Union action in the field of health for the period 2021-2027.
The Programme’s general objectives are laid down in Article 3 of the Regulation and are as follows:
protect people in the Union from serious cross-border threats to health;
the availability in the Union of medicines, medical devices and other crisis relevant products, contribute to their affordability, and support innovation;
strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
Article 4 provides for the Programme’s specific objectives.
The budget of the Programme and rules on resources coming from amounts made available through Regulation [European Union Recovery Instrument] are laid down in Articles 5 and 6.
Participation to the Programme is open to legal entities established in a Member State or in a participating non-EU country, with no further restrictions on access to the Programme.
The Programme will be implemented through direct or indirect management and will make use of the most commonly used spending mechanisms of the Union budget, including public procurement, prizes and grants. Specific provisions for emergency procurement, the possibility of blending, and rules on cumulative funding are provided in Articles 8 and 9.
This Chapter lays down rules on eligible actions, entities and costs.
A non exhaustive list of actions that may be funded through the Programme is provided in Annex I to the Regulation. Actions are deemend to be eligible insofar as they implement the objectives laid down in Articles 3 and 4.
As regards costs, Article 15 provides for the possibility, under conditions, to consider as eligible costs incurred prior to the date of submission of the grant application, in the case of actions contributing to the protection of people in the Union from serious threats to health and in other exceptional cases. In similarly exceptional cases, and again under conditions, costs incurred in relation to a cross border crisis by entities established in non-associated countries can also be considered as eligible.
In order to achieve maximal simplification, the Regulation stipulates either additional conditions or derogations from the Financial Regulation concerning eligibility requirements for entities, exceptions from the requirement of call for proposals, co-financing rules, eligible costs, etc.
Chapter IV – Governance
This Chapter provides for an obligation for the Commission to consult the health authorities of the Member States on the work plans for the Programme, on its priorities and strategic orientations and on its implmentation.
Chapter V – Programming, monitoring, evaluation and control
A list of Programme indicators is included in Annex II to the Regulation, complemented by a list of more specific indicators to be used to monitor the performance of the Programme. The Commission will be empowered to adopt delegated acts in order to amend the list of indicators where necessary.
Interim and final evaluations will be carried out.
This Chapter requires the Commission to implement communication and information activities directed at multiple audiences on the programme and on its actions (as also specified in Annex I).