EU4Health - Performance

Programme in a nutshell

Concrete examples of achievements

^{(*) Excluding cancer.}

Budget for 2021-2027

Rationale and design of the programme

The EU4Health programme is a key instrument for delivering a comprehensive response to the health needs of EU citizens, reflecting the implementation of priority EU legislative proposals and acts, flagship initiatives such as the Europe Beating cancer plan, preventing non communicable and communicable diseases, lessons learned from the COVID-19 crisis, the consequences of Russia’s unjustified and unprovoked war against Ukraine, and previous health programmes.

Budget

Budget programming (million EUR):

^{(*) Only Article 15(3) of the financial regulation.}

Financial programming:
- EUR 211.9 million (- 9%)
compared to the legal basis *

^{(*) Top-ups pursuant to Art. 5 MFF Regulation are excluded from financial programming in this comparison.}

EU4Health is benefitting from funds under Article 5 of the multiannual financial framework regulation. The overall amount under Article 5 of the multiannual financial framework regulation to be allocated to the EU4Health for 2021-2027 is around 3.3 billion in current prices, where the exact amount to be added to the programme for year N is normally known during the draft budgetary procedure for year N. These amounts however are not included in the financial programming for the subsequent years (2025-2027).

The initial EU4Health envelope has been reduced to take into account the redeployment of funds that were allocated to the extended mandate of the decentralised agencies European Centre for Disease Prevention and Control and European Medicines Agency.

Budget performance – implementation

Multiannual cumulative implementation rate at the end of 2022 (million EUR):

Annual voted budget implementation (million EUR) ⁽¹⁾:

^{(1) Voted appropriations (C1) only.}

Contribution to horizontal priorities

Green budgeting

Contribution to green budgeting priorities (million EUR):

• The EU4Health programme does not contribute directly to the climate, biodiversity and clean air horizontal priorities. Nonetheless, up to seven actions addressing environmental risk factors for health will be included in the upcoming annual work programmes.

Gender

Contribution to gender equality (million EUR) (*):

<sup>(*) Based on the applied gender contribution methodology, the following scores are attributed at the most granular level of intervention possible:
- 2: interventions the principal objective of which is to improve gender equality;
- 1: interventions that have gender equality as an important and deliberate objective but not as the main reason for the intervention;
- 0: non-targeted interventions (interventions that are expected to have no significant bearing on gender equality);
- 0*: score to be assigned to interventions with a likely but not yet clear positive impact on gender equality.</sup>

• The EU4Health programme has no significant bearing on the promotion of gender equality considering that it aims to keep all people healthy and active longer, irrespective of gender and addressing health inequalities and inequities. However, some actions, for example cancer screening for breast cancer and cervical cancer, focus on women’s health and may provide relevant information for the purpose of the gender tracking of EU4Health programme, which for the time being has been assigned a score of 0*. The indicators are under development and the information will be updated in due course.

Digital

Contribution to digital transition (million EUR):

• The EU4Health programme has contributed substantially to the digital transition in 2021 and 2022 according to the specific objective ‘(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’ (Article 4 of the EU4Health regulation).
• The tracking assesses at the action level the past budget commitment appropriations of the programme across the five strands of the annual work programmes. A 100% coefficient was applied to all actions under the digital strand and to similar actions under the other strands which have a prominent digital dimension; a 40% coefficient was applied to the other actions that have a partial digital component irrespective of the strand of the annual work programme; a 0% coefficient was applied to the rest of the actions.
• The 2021 programme activities (budget: EUR 98.97 million) that contribute to the goals of the digital transition are assigned to the following intervention fields: (i) human capital – information technology services and applications for digital skills and digital inclusion; support for the development of digital skills; (ii) digital public services – government information and communications technology solutions, e-services and applications; e-health services and applications (including e-Care, the internet of things for physical activity and ambient assisted living), and digitalisation in healthcare. The actual amount programmed after adjustment (20% flexibility) is EUR 105.67 million, of which EUR 66.61 million have already been committed. The 2022 work programme includes digital transition activities (budget: EUR 76.6 million), however the actual data for 2022 are not yet available.
• Additional investments are planned in the 2023 annual work programme (budget: EUR 26 million) and are expected in subsequent annual work programmes for a total budget that is subject to the negotiation of the European health data space proposal between the European Parliament and the Council.

Budget performance – outcomes

• The implementation of the 2022 annual work programme continued in parallel with the implementation of the annual work programme for 2021. The programme performance is on track and the key achievements highlighted below reflect that.

  The focus of the 2022 annual work programme remained on crisis preparedness, with almost half (45.6%) of the annual budget allocated to this strand by DG Health and Food Safety and HERA. The programme supports the implementation of Regulation (EU) 2022/2371 with an annual budget of EUR 51 million. This support is spent on Member State actions for crisis preparedness, surveillance, European Reference Laboratories as well as early warning and response capacities. In 2023, the programme will support the improvement of Member State surveillance systems for cross border health threats with EUR 97 million.

  One of the most ambitious initiatives in 2022 was the launching of EUFAB that will ensure ever-warm production capacities in the EU for vaccines to respond to cross-border health to threat. The main challenge will be to ensure effective and timely activation of these facilities to supply the relevant countermeasures when there is no certainty of which crisis will come next. The 2022 annual work programme launched a study on mapping of diagnostics, that intends to support HERA’s intelligence gathering function to anticipate and adequate preparedness and response to future emergencies. The regulation on serious cross-border threats to health was adopted in October 2022, and the programme supported and launched related preparatory actions. The programme delivered as expected with regard to prevention, preparedness and response to cross-border health threats, complementing national stockpiling of essential crisis-relevant products and establishing training resources for a reserve of medical, healthcare and support staff. Specific support is being provided to train the health workforce and support Member State capacity building; to develop and implement the national prevention, preparedness and response plans; and to implement activities to strengthen crisis preparedness and surveillance capacities, including the support to public procurement of medical countermeasures and the use of digital tools for cross-border contact tracing. To enhance preparedness and response, HERA will develop its own IT system. Here, the main challenge will be to ensure complementarity and synergy of different systems including interoperability with Member States. Synergies with Horizon Europe programme and rescEU/UCPM are sought to maximise outputs and reduce duplication. Furthermore, the State of Health Preparedness report on medical countermeasures was published in November 2022, and sufficient doses of monkeypox vaccine were made available to the Member States. In collaboration with the European Centre for Disease Prevention and Control, and with support from the EU4Health programme, Member States will reinforce their testing and genome sequencing capacities and consolidate and modernise their wastewater surveillance capacities. Since not all Member States have equal capacities and strategies, a challenge may lay in identifying the right priorities and implementing the action in a way that is meaningful for all involved parties. In addition, an antimicrobial resistance feasibility study on stockpiling identified 32 classes of antibiotics for which continued access might be required by EU Member States. Continued access is necessary to make sure that sufficient therapeutic and prophylactic options are made available on a continuous basis to patients with systemic bacterial infections. The stockpiling budget is below the maximum threshold of 12.5% of the total programme's budget.

  The performance of the programme regarding the health promotion and disease prevention strand implementation (10.8% of the annual budget) is on track to deliver the policy objectives of the ‘Healthier together – EU non-communicable diseases’ initiative, the tobacco legislation and other related EU health initiatives. A total of 21 actions addressing the prevalence of major chronic diseases per Member State and one action on the environmental risk factors for health have been launched successfully. The number of Member States implementing ‘best’ and ‘promising’ practices regarding health promotion, disease prevention and health inequalities is halfway to the target of 15 EU Member States. Several projects and collaborative actions on diabetes, cardiovascular diseases, mental health and neurological disorders, chronic respiratory diseases and health determinants have been rolled out. The vaccination coverage varies across Member States. The Member States’ focus on COVID19 vaccination (30 EU Member States / European Economic Area countries recommended it in 2022) very likely influenced the resources available for other vaccination campaigns. The number of Member States having reached 95% coverage for both the first and the second dose of the measles vaccine for eligible individuals fell to three in 2021 from five in 2020 (the target for 2031 being eight Member States). The coverage of vaccination for human papillomaviruses remained steady. A possible challenge related to the implementation of the health promotion and disease prevention specific objective is the development of synergies between different actions, for example at programming or implementation level. At programming level, in an effort to promote synergies and coordination of support to both national authorities and other stakeholders, some open calls for proposals build on the progress of the related joint actions. If the latter are not timely available, this might affect the calendar of the open calls. At implementation level, contractors’ meetings will be organised to bring together different actions and stimulate synergies.

  The total budget for health promotion and disease prevention in 2022 met the requirement of reserving a minimum of 20% of the total budget for that health prevention purpose.

  The cancer strand implementation (28.4% of the annual budget) is on track to deliver the policy objectives of Europe’s Beating Cancer Plan. A total of 22 actions that address the prevalence of cancer have been launched successfully. All EU Member States (plus Iceland and Norway) published their country cancer profiles, highlighting key achievements and challenges in cancer prevention and care for each country. Several cancer results and impact indicators are under construction, and data is not yet available to assess the performance of relevant actions.

  Under the health systems and healthcare workforce strand (15.1% of the annual budget), the EU4Health programme supports policies that aim to harmonise work practices across Member State health systems, including by transferring best practices in primary care, implementing high-impact prevention practices, supporting work on health technology assessment and enhancing access to healthcare, with the aim of  achieving universal health coverage. The very successful European reference networks continued to facilitate access to diagnosis and provide high-quality healthcare to patients with rare conditions, and continued to be focal points for medical training and research and the dissemination of information. The number of healthcare units involved in European reference networks increased by more than 40% in 2022 in comparison with the preceding year; the ecosystem is now entering its optimisation phase, with the goal of optimising the geographical and disease coverage with the minimum possible number of healthcare units involved. The number of patients referred to European reference networks whose cases were reviewed amounted to 0.8 million in 2020 and 1.3 million in 2022. The development of guidelines or recommendations for Member States on how to assess and improve access to healthcare services was supported by one action financed by the EU4Health programme in 2021 and in 2022. The programme continues to support Member States in addressing health workforce challenges related to shortages and skills mismatches, including through health workforce planning and forecasting, and skill building (e.g. via training projects with a focus on digital skills). The implementation of the cancer related actions is on track, but the performance monitoring and data collection is expected to be delayed as several indicators are under development. The Commission expects to recover the delay incurred and collect the data by the end of 2023.

  The health systems work well if medicinal products, medical devices and crisis-relevant products are readily available to patients. The number of medicines authorised centrally by the European Commission and valid across the EU has increased by around 10% in 2022. This was mostly due to increased industry output of COVID-19 vaccines and therapies. Likewise, the number of medical devices placed on the market has more than tripled (in comparison with the year 1990), while the number of in vitro diagnostic medical devices was multiplied by 8.6 from 2021 to 2022. Nonetheless, this was only partly influenced by the actions funded under the EU4Health programme, given that the causal link between the challenge and those actions is very weak. It should be also acknowledged that, while the relative increase of the availability of medical devices and in vitro diagnostic medical devices is a positive development, more efforts have to be made to meet the needs of healthcare systems to make devices available and avoid shortages. With this objective, co-legislators adopted a regulation (Regulation (EU) 2023/607) as an urgent measure to facilitate the transition to the legal framework set out in Regulation (EU) 2017/745. It is expected that these measures (applicable as from 20 March 2023) will have an impact on the indicators. This will be considered in upcoming reporting. The data for 2021 and 2022 are not available for several indicators and will be assessed in upcoming reporting. This strand might be negatively impacted by external shocks, such as the pandemics or monetary and fiscal shocks. This is because these might negatively affect the capacity of the Member States public authorities to commit human and financial resources to the on-going or planned actions.

  The digital strand, with 9.2% of the annual budget, aims to strengthen the use of health data, digital tools and services for the digital transformation of healthcare and the implementation of the European health data space. The EU4Health financial support allowed Member States to accelerate their digital transition in the health sector and to continue to invest in cross-border digital health infrastructures. The number of Member States participating in the European health data space has increased, with four new countries in 2021 and 2022, bringing the total number of Member States connected to MyHealth@EU and/or to the cross-border infrastructure for secondary uses (e.g. for research) to 11. In 2021, five Member States had set up or were in the process of setting up health data access bodies. In 2022, the number remained stable, as Member States focused on preparing the ground to launch new projects in 2023 to set up or strengthen these bodies, thanks to substantial support from EU4Health. The number is subsequently expected to grow further in 2023, with the launch of these projects. The timely implementation of the digital strand will depend on the conclusion of the negotiations between the European Parliament and the Council on the proposal for a Regulation on the European Health Data Space. The implementation of this strand depends on the availability of resources and specialised technical expertise in Member States, which could affect the performance of some actions. This will be addressed by stimulating the sharing of knowledge between Member States, within and between relevant projects, and in the relevant fora.

  The international health initiatives and cooperation cuts across several areas and namely implements the global health strategy adopted in November 2022. The total budget supporting global commitments and health initiatives is below the maximum threshold of 12.5% of the programme's total budget. The EU global health strategy is already supported by a total investment of about EUR 21 million under the 2021, 2022 and 2023 work programmes and delivered to a large extent by international organisations such as the World Health Organization and the Organisation for Economic Co-operation and Development. Following its association to the EU4Health programme in July 2022, Ukraine successfully engaged in all joint actions, and a considerable number of the actions launched under the 2022 work programme have been addressing health challenges related to the consequences of the Russian war of aggression against Ukraine. The unpredictable current geopolitical context dominated by the war of aggression may trigger new jeopardising factors that will need to be addressed as timely as possible. The implementation of the global commitments and health initiatives also depends to a large extent on the performance of the international organisations entrusted by the Commission to deliver through indirect management. Adequate monitoring and regular contacts are necessary to ensure a good implementation.

  The EU4Health programme finances studies to support the preparation of impact assessments and the evaluation of health policy initiatives. However, the data and knowledge generated by the studies is not always up to the needs of the Commission. This requires in some cases (e.g. pharmaceutical and medical devices policies) development of new framework contracts to identify the most suitable data providers. In principle, all the actions funded by the EU4Health programme include action-specific indicators. The data will be collected and reported by the beneficiaries and proper monitoring was put in place by the HaDEA to avoid any delays or low quality of data. The preparatory work to launch a study financed by the 2022 annual work programme and which supports the upcoming midterm evaluation of the Europe Beating Cancer Plan is ongoing. To date, there are no published EU health impact assessments or studies supporting the evaluation of health policies.

  The annual work programmes for 2021 and 2022 were each amended on two occasions. The amendments were necessary to address the evolving COVID-19 pandemic and the health consequences of Russian war of aggression against Ukraine. The implementation of related actions may be influenced by the specific conditions on the field of action as well as the absorption capacity of the potential beneficiaries.

  The budget of the Programme increased almost ten-fold in comparison to the previous multi-financial framework. Based on implementation experience acquired until now by the HaDEA and the Commission, the financial absorption capacity of some entities (e.g. non-governmental organisations and some public authorities) is limited. The Commission and HaDEA will continue addressing this type of challenges in the same way as in implementing the previous two annual work programmes by reallocating unspent budget to other actions. The issue remains, however, that the co-funding rate of EU4Health programme is limited to 60% contribution of the EU. Only in exceptional utility cases, it may reach up to 80%, making the contribution from some beneficiaries, in particular the non-governmental organisations, difficult to achieve. The regulation includes the provision for blending of funds from different EU funding programmes. However, the associated administrative and financial burden mainly falling upon the beneficiary allows only to a limited extent to resolve the absorption capacity concerns.

MFF 2014-2020 – Health programme

The third programme for EU action in the area of health (2014-2020) is a financial instrument for policy coordination at EU level. It aims to complement, support and add value to Member States' policies for improving the health of their citizens, reducing health inequalities, encouraging innovation in health and increasing the sustainability of their health systems.

Budget implementation

Cumulative implementation rate at the end of 2021 (million EUR):

Performance assessment

According to the midterm evaluation of 2017, the third health programme has been performing well and has been implemented effectively, contributing to better health protection through its policies and activities. The programme has efficiently addressed the Commission’s priorities on the implementation of best practices for health promotion and disease prevention, crisis preparedness and risk management, the production and communication of relevant information within the framework of the EU semester, the fostering of mental health, and health and innovation.

In the 2014-2020 period, the European Court of Auditors published several reports assessing the implementation of the health programme. In EU Actions for Cross-border Healthcare – Special report 07/2019, the Court found that ‘EU actions in cross-border healthcare enhanced cooperation between Member States. The Commission has overseen the implementation of the Cross-border Healthcare Directive well.’ The special report also identified certain shortcomings and improvements that were necessary in terms of reducing administrative burden and the long-term financial sustainability of the European reference networks. In Addressing Antimicrobial Resistance – Special report 21/2019 the Court emphasised: ‘Fighting against antimicrobial resistance is complicated. The Commission and [European Centre for Disease Prevention and Control] support to strengthen Member States One Health approach to [antimicrobial resistance] was valuable’. However, it also pointed out some challenges, particularly with regard to the sustainable implementation of the results in the Member States. These were addressed in the new EU4Health programme.

While reorienting and gearing a proportion of its resources towards fighting the COVID-19 pandemic, the third health programme continued to implement its main actions with a view to enhancing and further consolidating key achievements over the 2014-2020 implementation period.

With regard to objective 1 ‘promote health, prevent diseases and foster supportive environments for healthy lifestyles’, the targets were reached in all respects except the number of Member States involved in the European accreditation scheme for breast cancer.

With regard to objective 2 ‘protect EU citizens from serious cross-border health threats’, the target of 28 Member States integrating coherent approaches in the design of their preparedness plans was achieved in 2020.

With regard to objective 3 ‘support public health capacity-building and contribute to innovative, efficient and sustainable health systems’, 41 notices of advice were produced and 23 Member States used the tools and mechanisms identified in order to contribute to effective results in their health systems.

With regard to objective 4 ‘facilitate access to better and safer healthcare for EU citizens’, 24 European reference networks were established in accordance with Directive 2011/24/EU, more than 1500 healthcare providers and centres of expertise joined European reference networks and all 28 Member States used the tools developed.

The final evaluation of the third programme for the EU's action in the field of health (2014-2020) (the programme) has been completed. It assesses the performance of the programme, its main outcomes and achieved results and identifies the main problems and solutions with regard to its implementation.

The main achievements of the programme are the following.

1. The establishment of a portal for the exchange and implementation of best practices in health promotion and disease prevention.
2. An ‘EU compass for action on mental health and wellbeing’, a web-based mechanism used to collect best practices and analyse information on policy and stakeholder activities in mental health.
3. On cancer, the European quality assurance scheme, a harmonised and evidence-based way to grant equal and quality-benchmarked treatment to patients, and the European network of cancer registries coordinated by the Joint Research Centre (128 cancer registries from 29 European countries, with more than more than 25 900 000 records).
4. A feasibility study was carried out for the development of a common EU vaccination card. The resulting template was tested by a sample of 10 000 citizens in 10 Member States.
5. In 2018, the joint action on efficient response to highly dangerous and emerging pathogens at EU level (EMERGE joint action) delivered on its work for the improvement of capabilities for rapid laboratory diagnosis of new or emerging pathogens (e.g. sample sharing). The joint action also contributed to combating the outbreaks of ZIKA and Ebola.
6. During the Ebola and Zika outbreaks, part of the funds of the programme were used to support interventions to limit the spread of these threats by strengthening Member States preparedness and response through the actions of the Health Security Committee.
7. The European health data space joint action, with 25 participating countries, facilitated the establishment of a European health data space, by developing principles for the cross-border secondary use of health data. The Commission published its proposal for the establishment of the European health data space in 2022.
8. The joint actions for EU cooperation on health technology assessment (EUnetHTA) enabled to produce 41 joint reports (joint assessment and early dialogues). These led to the adoption of legislation, securing EU cooperation on health technology assessment in the long-term.
9. In 2019, the joint action on market surveillance of medical devices enabled the reinforcement of the market surveillance system for medical devices and the improvement of coordination and cooperation among all Member States.
10. A total of 24 European reference networks – virtual networks involving healthcare providers across Europe – were established. They aim to tackle complex or rare medical diseases or conditions that require highly specialised treatment and a concentration of knowledge and resources. More than 1 500 healthcare providers are a part of European reference networks across the EU.

Key findings per evaluation criterion, lessons learned and recommendations

Effectiveness

The evaluation found that knowledge produced by the programme was used in policy making and the programme contributed to the improvement of health and healthcare policy developments in the EU (e.g. in the areas such as anti-microbial resistance, health technology assessment, health inequalities, alcohol, tobacco control, European reference networks for rare diseases).

Funded actions helped achieve the programme’s objectives to a good extent, in particular for objective 1 (promote health, prevent diseases, and foster supportive environments for healthy lifestyles) and objective 4 (facilitate access to better and safer healthcare for EU citizens). This is demonstrated by the positive trend of the quantitative indicators associated with each of the 4 specific objectives of the programme.

However, the participation of countries with low gross national income (low-GNI Member States) in the programme did not increase significantly, despite the exceptional utility criteria designed to do so.

Efficiency

The programme was relatively cost-effective. In particular, its functioning costs (administrative costs plus the costs allocated to the functioning of the executive agency CHAFEA) were found reasonable, moreover on decreasing trend and comparable with those of other EU programmes of similar size.

The introduction of electronic tools, SYGMA-COMPASS for the submission of proposals, management of grants, monitoring and reporting mechanisms (also used by the Horizon 2020 Framework Programme for Research and Innovation), enabled, along with other simplifications measures (e.g. the introduction of framework partnership agreements for operating grants), to improve the efficiency of the programme implementation. However, according to some beneficiaries, there was some scope to further simplify the processes, especially in relation to funding applications, monitoring and reporting.

Administrative costs were found heavy by some stakeholders involved in actions, increasing workload and potentially putting countries with low GDP or smaller organisations off becoming involved, or being involved in future work.

Cost-effectiveness of actions could have been improved with a more centralised information system (either using existing systems in place within the programme portal; or a new addition) dedicated to disseminating information about EU funding, ensuring synergies across projects, and further communicating on the results of the implemented actions.

Contribution to the sustainable development goals