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Explainer: EU4Health Programme 2021-2027

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What is EU4Health?

EU4Health is the fourth EU health programme, which will run from 2021-2027. It is the EU’s ambitious health response to the COVID-19 pandemic and the EUs overall health challenges. EU4Health will make €5.1 billion available over the next seven years to improve and foster health in the Union to reduce the burden of communicable and non-communicable diseases by:

  • protecting people from serious cross-border health threats;
  • improving the availability, accessibility and affordability of medicines, medical devices and other crisis relevant products in the EU;
  • strengthening national health systems.

The EU4Health programme will go beyond the COVID-19 crisis, supporting amongst others actions on disease prevention, notably on cancer, the digital transformation of health systems, the reinforcement of the health system and the healthcare workforce. It will pave the way to a strong European Health Union that will improve and safeguard the health of all EU citizens.

What makes EU4Health different from previous health programmes?

Never before has Europe invested more in health. According to a recent EU survey, 66% of EU citizens would like to see the EU given more say over health-related matters. The pandemic has shown that the EU needs greater coordination during health crises and health-systems that are more resilient.

EU4Health is a stand-alone programme with a budget more than ten times that of previous health programmes. Actions like tackling cross-border health threats, making medicines available and affordable, and strengthening and digitalising health systems will be financially supported.

What are the main objectives of the EU4Health Programme?

The EU4Health programme has the following objectives:

  1. Improve and foster health in the Union by:
  • Supporting actions for disease prevention, health promotion and addressing health determinants;
  • Supporting global commitments and health initiatives.
  1. Protect people in the Union from serious cross-border threats to health by:
  • Strengthening the capability of the Union for prevention, preparedness and response to cross-border health threats, including through a new bio-preparedness authority, the European Health Emergency Preparedness and Response Authority (HERA);
  • Supporting actions complementing national stockpiling on essential crisis relevant products;
  • Establishing a structure and training resources for a reserve of medical, healthcare and support staff.
  1. 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 efficient use of medicinal products.
  1. Strengthening health systems resilience and resource efficiency though:
  • Strengthening health data, the uptake of digital tools and services and the digital transformation of healthcare systems, including by supporting the creation of a European Health Data Space;
  • Promoting the implementation of best practices and promoting data sharing;
  • Enhancing access to quality, patient-centred, outcome-based healthcare and related care services;
  • Supporting integrated work among Member States, and in particular their health systems.

How will non-communicable diseases, such as cancer, be addressed in the new programme?

Non-communicable and life style related diseases are among the biggest challenges facing EU health systems. Non-communicable diseases such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, health-related retirement, and premature death in the Union, resulting in considerable social and economic costs. It is key to focus on prevention, combined with efforts to strengthen health systems in order to decrease the impact of non-communicable diseases on individuals and society and to reduce premature mortality towards reaching the Sustainable Development Goals by one third by 2030.

EU4Health will support disease prevention (including screening and early diagnosis for cancer) and health promotion programmes in Member States among others. EU4Health will contribute to the upscaling of the networking through the European Reference Networks, which are virtual networks and aim to facilitate discussion on complex, rare and non-communicable diseases, improving access to diagnosis and the provision of high-quality healthcare.

Will the programme contribute to the EU Beating Cancer Plan?

The pandemic has had a severe effect on cancer care, disrupting treatment, delaying diagnosis and vaccination, and affecting access to medicines. Even before the onset of COVID-19, cancer cases were estimated to increase by almost 25% by 2035, which will make it the leading cause of death in the EU. To reverse this worrying trend, the EU4Health Programme will also finance actions to fight cancer, which is one of the Commission’s main priorities. It will do so by providing funding to eligible legal entities established in Member States, such as health organisations and NGOs. Cancer will already be a strong priority in the first annual work programme for 2021, which will is expected to be adopted soon.

How will EU4Health address cross-border health threats?

The Commission is working to improve prevention, preparedness, surveillance and response to cross-border health threats. EU4Health can finance an EU reserve of medical, healthcare and support staff, and stockpiles of medical equipment.

Cross-border health threats require cross-border cooperation and the EU will play a larger role in supporting capacity and response. Beyond our own borders, the EU will support global cooperation on health challenges to improve health, reduce inequalities and increase protection against global health threats.

Will it also address shortages of medicines and personnel?

EU4Health can finance additional emergency reserves of medicines, medical devices and other health supplies to complement national reserves.

One way to make sure we have enough medical supplies is to use what we have more efficiently, in particular antimicrobials. Another way is to encourage European pharmaceutical production and innovation. EU4health will support the EU’s AMR Action Plan and the Pharmaceutical Strategy.

It will not be enough to have sufficient medicine and medical supplies. We also need a strong healthcare workforce, equipped with the necessary skills to face cross-border health threats. That is why EU4Health will also support healthcare workforce training in specific areas.

How will it improve health systems?

By making health systems more resilient, EU4Health will not only help prepare the EU to face future health crisis, but will also get Member States ready to face long-term challenges like an ageing population and health inequalities. Vulnerable groups need to have access to health services and healthcare, and inequalities between Member States and between regions in those Member States must be addressed.

When will the programme start?

Now adopted by the co-legislators, the EU4Health regulation will enter into force on the day of its publication in the Official Journal of the European Union and will apply retroactively from 1 January 2021. Next up is the preparation and adoption of the 2021 annual work programme, which is expected to prioritise crisis preparedness, disease prevention, health systems and digitalisation, as well as cancer as a transversal priority.

How much funding will be available under the EU4Health Programme and how will it be spent?

EU4Health will invest €5.1 billion over seven years to address health challenges. About €316 million are allocated to the first annual budget. Over its 7 year-lifetime, the programme will respect a number of provisions on total expenditure:

  • a minimum of 20% for health promotion and disease prevention;
  • a maximum of 12.5% for stockpiling crisis-relevant products at Union level;
  • a maximum of 12.5% for supporting global commitments and health initiatives;
  • a maximum of 8% for administrative expenses.

The programme should also contribute to mainstreaming climate action in the Union’s policies and the achievement of an overall expenditure target of at least 30% of the total amount of the Union budget and the EU Recovery Instrument on climate action.

How will EU4Health be implemented?

EU4Health will be implemented mainly by the Commission through direct management, including delegation to the executive agency. It will be implemented with eligible legal entities from Member States and third countries who will receive EU funding in the form of grants, prizes and procurement as well as indirect management by the relevant EU agencies such as European Medicines Agency or European Centre for Disease Control.

The new Health and Digital Executive Agency (HaDEA), that will be operational from 1 April, will be tasked with the roll-out and management of the annual work programmes.

The EU agencies – the European Centre for Disease Prevention and Control, and the European Medicines 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. The programme’s actions will enhance the work of these EU Agencies as well as of the European Food Safety Authority and the European Chemicals Agency.

To prepare the annual work programmes and monitor results, the EU4Health Regulation also sets up the consultative EU4Health Steering Group bringing together the European Commission and Member States. The Steering Group will be consulted on the annual priorities, contribute to ensure consistency and complementarity with Member States’ health policies, follow up the implementation of EU4Health and propose any necessary adjustments based on evaluations.

In addition, the Commission will consult with relevant stakeholders, including representatives of civil society and patient organisations, to seek their views on the needs to be addressed through the annual work programme, annual priorities and results.

The results of the stakeholder consultation and steering group discussions will be presented once a year to the European Parliament before the last Steering Group meeting.

Will the Commission continue to provide health funding through the European Social Fund + and other EU funds?

Whilst the EU4Health is the most ambitious health programme ever, important investments in health in the next long-term budget will also be made through other funding instruments working in synergy with EU4Health:

  • the European Social Fund Plus (ESF+) to support vulnerable groups in accessing healthcare;
  • the European Regional and Development Fund to improve regional health infrastructure;
  • Horizon Europe for health research and innovation;
  • rescEU to create emergency medical supplies;
  • the Digital Europe Programme for creating the digital infrastructure needed for digital health tools;
  • the Recovery and Resilience Facility for a stronger and more resilient EU from the current crisis.

Working across programmes and having shared objectives between policies will be key.

With the adoption of the EU4Health programme, the health strand of the proposal for the European Social Fund Plus (ESF+) is fully integrated into the EU4Health Programme.

How will the programme support research and innovation?

The EU4Health programme is an implementation tool for EU health policy and may support and encourage innovation regarding medicinal products and medical devices, and crisis-relevant products in the Union.

EU4Health will work closely with the European Commission’s main research programme, Horizon Europe, which includes a health cluster. Horizon Europe will finance research and innovation on topics such as life-long good health; environmental and social health determinants; non-communicable and rare diseases; infectious diseases; tools, technologies and digital solutions for health and care and healthcare systems. It will also include a Horizon Europe research & innovation mission on cancer, one of the Commission’s top priorities in health policy. 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.

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EU Politics

Coronavirus: EU Strategy for the development and availability of therapeutics

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The European Commission is today complementing the successful EU Vaccines Strategy with a strategy on COVID-19 therapeutics to support the development and availability of much-needed COVID-19 therapeutics, including for the treatment of ‘long COVID’. Today’s Strategy covers the full lifecycle of medicines: from research, development and manufacturing to procurement and deployment.

It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19.

The Strategy includes clear actions and targets, including authorising three new therapeutics to treat COVID-19 by October 2021 and possibly two more by end of the year. Concretely:

  • Research, development and innovation
    • Invest €90 million in population studies and clinical trials to establish links between risk factors and health outcomes to further inform public health policy and clinical management, including for long-COVID patients.
    • Set up a ‘therapeutics innovation booster’ by July 2021 to support the most promising therapeutics from preclinical research to market authorisation. It will build on current initiatives and investments in therapeutic development, working in a close cooperation with the European Health Emergency Preparedness and Response Authority (HERA) preparatory action on mapping therapeutics. It will therefore ensure the coordination of all research projects on COVID-19 therapeutics, stimulating innovation and boosting therapeutic development.
  • Access to and swift approval of clinical trials
    • Invest €5 million under the EU4Health programme to generate better, high-quality safety data in clinical trials, which will help produce robust results in a timely manner.
    • Provide EU countries with financial support of €2 million under the EU4Health 2021 work programme for expedited and coordinated assessments to facilitate approval of clinical trials.
    • Explore how to support developers of therapeutics to build capacity to produce high-grade material for clinical trials.
  • Scanning for candidate therapeutics
    • Invest €5 million to map therapeutics and diagnostics to analyse development phases, production capacities and supply chains, including possible bottlenecks.
    • Establish a broader portfolio of 10 potential COVID-19 therapeutics and identify five of the most promising ones by June 2021.
  • Supply chains and delivery of medicines
    • Fund a €40 million preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, which in turn will become over time an important asset for the future the European Health Emergency Preparedness and Response Authority (HERA).
  • Regulatory flexibility
    • Authorise at least three new therapeutics by October and possibly two more by the end of the year and develop flexible regulatory approaches to speed up the assessment of promising and safe COVID-19 therapeutics.
    • Start seven rolling reviews of promising therapeutics by end-2021, subject to research and development outcomes.
  • Joint procurement and financing
    • Launch new contracts for the purchase of authorised therapeutics by the end of the year.
    • Secure faster access to medicines with shorter administrative deadlines.
  • International cooperation to make medicines available to all
    • Reinforce engagement for the therapeutics pillar of the Access to COVID-19 Tools Accelerator.
    • Boost ‘OPEN’ initiative for international collaboration.

Next Steps

The Commission will draw up a portfolio of 10 potential COVID-19 therapeutics and by June 2021, identify the five most promising ones. It will organise matchmaking events for industrial actors involved in therapeutics to ensure enough production capacity and swift manufacturing. New authorisations, rolling reviews and joint procurement contracts will be up and running before the end of the year.

The therapeutics innovation booster, matchmaking events and preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, will feed into the HERA, for which a proposal is due later in the year. The pilot project on access to health data will feed into the European Health Data Space proposal expected later this year.

Members of the College said:

Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “The situation in many intensive care units across the continent remains critical. We need to focus both on vaccines and therapeutics, as two powerful and complementary ways to combat COVID-19. But currently we have only one authorised medicine to treat COVID-19. By acting on better availability of medicines today, we are making sure patients receive the treatments they need while also preparing our future biomedical preparedness. A coordinated strategy on quick access to therapeutics will boost our strategic autonomy and contribute to a strong Health Union.”

Commissioner for Health and Food Safety, Stella Kyriakides, said: “Vaccinations save lives, but they cannot yet eradicate COVID-19. We need a strong push on treatments to limit the need for hospitalisation, speed up recovery times, and reduce mortality. Patients in Europe and across the world should have access to world-class COVID-19 medicines. This is why we have set a very clear goal: by October, we will develop and authorise three new effective COVID-19 therapeutics that can have the potential to change the course of the disease. We will do so by investing in research and innovation, the identification of new promising medicines, ramping up production capacity and supporting equitable access. Our Therapeutics Strategy is a strong European Health Union in action.”

Commissioner for Innovation, Research, Culture, Education and Youth, Mariya Gabriel, said: “By increasing vaccine availability across Europe, more and more Europeans are now protected against COVID-19. In the meantime, the development of innovative medicines to treat coronavirus patients remains a priority when it comes to saving lives. Research and innovation is the first step to finding effective and safe therapeutics, which is why we are proposing to establish a new COVID-19 ‘therapeutics innovation booster’ and will invest € 90 million in population studies and clinical trials.

Background

The Strategy on COVID-19 therapeutics complements the EU strategy for COVID-19 vaccines from June 2020 and builds on ongoing work by the European Medicines Agency and the Commission to support research, development, manufacturing and deployment of therapeutics.

The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve the resilience of Europe’s health systems.

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EU Politics

EU defence gets a boost as the European Defence Fund becomes a reality

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Commission welcomes the adoption of the European Defence Fund (EDF), following the European Parliament’s approval. The EDF, with a budget of €7.9 billion, is the Commission’s flagship instrument to support defence cooperation in Europe. EDF will co-finance collaborative research and capability development projects amplifying national investment. It will also foster an innovative and competitive defence industrial base. In doing so, it will enhance Union’s technological sovereignty and therefore its open strategic autonomy.

Margrethe Vestager, Executive Vice-President for a Europe Fit for the Digital Age, said: “This is an important step for a stronger Europe. The Fund will play a key role to enable SMEs to participate in defence supply chains and widen cross-border industrial cooperation. Providing opportunities to companies all sizes helps achieving more innovative solutions, to foster an open internal market. So besides a stronger defence cooperation it contributes to our competitiveness.”

Thierry Breton, Commissioner for Internal Market, said: “Today marks a historic day for Europe. The idea of working together for promoting our Defence Union and for the security of EU citizens is now a tangible reality.  In a global context where Europe needs to be stronger, more resilient and more autonomous in strategic areas, the European Defence Fund is a milestone and will significantly contribute to the security of EU citizens.”

A Fund to deepen EU defence industrial cooperation

Without substituting Member States’ efforts, the Fund will promote cooperation between companies of all sizes and research actors throughout the EU, in research and development of state-of-the-art and interoperable defence technology and equipment.

The Fund will support competitive and collaborative defence projects throughout the entire cycle of research and development, focusing on projects that have the potential to be game-changers for the armed forces of Member States. The Fund will foster innovation and incentivise the cross-border participation of SMEs. Projects will be defined based on defence capability priorities agreed by Member States within the framework of the Common Security and Defence Policy and particularly in the context of the Capability Development Plan. The projects will aim at contributing to the security and defence interests of the Union.

The EDF allows for the participation of European subsidiaries of third country companies and also for the cooperation with third country companies provided that their involvement  ensure the security and defence interests of the EU, and meet the rigorous security conditions as set in the EDF Regulation.

A strong budget for ambitious and inclusive defence programmes

2021 constitutes the first year of the rollout of the new EDF, which will be operational for the period 2021-2027, in alignment with the Multiannual Financial Framework.

It will be endowed with a budget of €7,953,000,000 in current prices. This financial envelope will be divided into two pillars: €2,651,000,000 will be allocated to funding collaborative defence research to address emerging and future security threats and €5,302,000,000 to co-finance collaborative capability development projects.

Up to 4%-8% of the Fund budget is devoted to development or research for disruptive technologies (i.e. technologies that have the potential to create game-changing innovations). This budget represents an unprecedented opportunity to contribute to the development of a competitive and innovative European defence industry.

Next Steps

The complete establishment of the Fund both legally and financially will now allow the Programme Committee (PC), chaired by the Commission and composed of Member States representatives, to discuss priorities and confront topics with the aim to open calls for proposals in summer 2021. The Commission will directly manage the programme. The European Defence Agency (EDA) is invited to participate as observer and the European External Action Service (EEAS) will assist in the Committee.

Background

The creation of a European Defence Fund was first announced in 2016. The Commission presented the first version of the European Defence Fund in June 2017, which has allowed defence cooperation at EU level to embark thanks to   two pilot projects, the Preparatory Action on Defence Research (PADR) for 2017-2019 and the European Defence Industrial Development Programme (EDIDP) for 2019-2020.

The Fund is part of the priorities of the von der Leyen Commission for a ‘Stronger Europe in the World’.

A political agreement between the Member States and the European Parliament was found in December 2020 and today’s decision gives legislative effect to the EDF that will operate for the next 7 years.

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EU Politics

Dual-use goods: what are they and why are new rules needed?

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The EU is working on new export rules for so-called dual-use goods to prevent them being misused in human rights violations.

What are dual-use goods?

Dual-use products are goods designed for civilian use that in the wrong hands could be used to supress human rights or launch terrorist attacks. They can be anything from drones to chemicals.

Although these goods can improve people’s lives, they can be misused. Authoritarian regimes might use them to keep the population under control, while terrorist groups could use them to stage attacks.

Why are new rules needed?

To prevent dual-use goods being repurposed in ways that violate human rights , the EU wants to make sure strict export rules prevent them being sold to people or organisations wanting to misuse them.

The EU is currently working on an update of the existing rules to take into account recent technological developments, including new cyber surveillance tools, and beef up protection of human rights.

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