Annexes to COM(2024)206 -

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dossier COM(2024)206 - .
document COM(2024)206
date May 22, 2024
agreement was reached by the co-legislators in March 2024, leading to adoption by the European Parliament in April 2024. The EHDS will introduce clear rules for the use of electronic health data, and will facilitate better healthcare delivery, research, innovation, and policymaking, in full compliance with the EU's data protection standards.

Patients will have immediate, free and easy access to their data in electronic form and will be able to share these data with healthcare professionals across Member States. Healthcare documents, such as patient summaries, e-prescriptions laboratory results, images, image reports, and discharge reports, will be exchanged in a common European format. This will improve the healthcare that patients receive, wherever they are in the EU. It will also reduce needless and costly repetitions of what are at times invasive medical procedures and tests.

In parallel, the EHDS will empower the use of health data for research, innovation, policy-making and regulatory activities, under very strict conditions protecting those personal data. This will advance research and innovation, support the development of important new treatments, identifying side effects of medicines and help to fortify health systems.

The EU invests in novel technologies, including artificial intelligence combining multiple types and sources of health data. To this end the power of data leveraged through the European Health Data Space and specialised data infrastructures (such as 1+Million Genomes, Cancer Image Europe or EOSC- Life), combined with high-performance computing will enhance early detection, prediction and prevention, further improving diagnosis and treatments.

5. Global Health

The COVID-19 pandemic highlighted how, in our interconnected world, health is a global policy area and with a clear geopolitical dimension. The pandemic underscored the urgent need for a more coordinated EU approach to global health, and for greater global cooperation in the face of interlinked health threats like pandemics, the triple planetary crisis (climate change, environmental pollution and biodiversity loss) and antimicrobial resistance. These threats are likely to grow, and the EU – and the world – need to be ready to respond.

The EU played a central role in the rapid development, scale-up and equitable distribution of COVID- 19 vaccines, therapeutics, and diagnostics. Around two-thirds of vaccine doses produced in the EU –

3.1 billion doses – have been exported to the rest of the world saving millions of lives. The EU was a founding member and strong supporter of the Access to Covid Tools Accelerator (ACT-A) and the largest donor to COVAX – the multilateral initiative for global equitable access to COVID-19 vaccine. The EU is determined to continue this path and is committed to preventing and combatting health threats globally, applying a One Health approach.

The EU also seeks to reduce supply chain vulnerabilities resulting from dependencies by promoting diversification. Given the complexity of pharmaceutical products, EU industry needs to have access to a broad range of essential inputs. Trade policy and partnerships aim at opening new markets and diversifying sources of supply and complement enhanced efforts to reduce excessive dependencies for critical supply chains by thorough implementation of preferential trade agreements, as well as of the work within international fora such as the G20, the G7 and the WTO.

The EU Digital COVID Certificate set a global standard for international travel and has been the most widespread system in operation at international level. 51 non-EU countries and territories across four continents have benefited from this system. On 1 July 2023, the EU handed over the system of digital COVID-19 certification to the WHO, in order to develop a system for global verification of health documents to deliver better health for all and protect citizens across the world from health threats.

The EU is continuously working multilaterally to shape a new global health order through a more strategic, and effective engagement. This includes building a robust global governance, prioritising international partnerships and dialogue at multilateral, regional and bilateral level, addressing disinformation, and providing more effective funding. The EU has become increasingly active in multilateral fora, including the G7, G20, the UN General Assembly as well as the WHO, and under its Neighbourhood, Development and International Cooperation Instrument is a major donor to global funds (e.g. the Pandemic Fund, GAVI, Global Fund).

In the current geopolitical context, with the ongoing Russian war of aggression on Ukraine and the conflict in Gaza, the EU has supported the medical evacuation (Medevac) of patients. Since Russia’s war against Ukraine, over 3100 medical evacuation operations were conducted through the Union Civil Protection Mechanism (UCPM). The Commission has been closely cooperating with the WHO, notably in the establishment of the EU Medevac hub in Poland to support Ukraine, and in the deployment of Member States’ medical experts to support WHO operations in Gaza.  

The EU is playing a leading role in the negotiations of the Pandemic Agreement, which aims to strengthen international rules on pandemic preparedness and response.

The Commission published a new EU Global Health Strategy in November 2022 to ensure a coherent, effective, and focussed approach worldwide33. First and foremost, the Strategy indicates the EU’s determination to reassert its responsibility and leadership in global health, based on fundamental values like solidarity, equity, and respect for human rights. It positions global health as an essential pillar of EU external policy representing the external dimension of the European Health Union. and a key component of Global Gateway which builds partnerships of equals with partner countries based on joint responsibility and co-ownership. Under the Global Gateway the EU and Member States are helping to tackle inequalities, improve health security and increase health systems’ resilience globally, engage with global partners to ensure equitable worldwide access to diagnostics, vaccines and treatments, pandemic preparedness, prevention, and early detection of health emergencies. The Team Europe initiative on manufacturing and access of vaccines, medicines and health technologies in Africa (MAV+) has mobilised more than EUR 1.3 billion in funding from the EU, Member States and European financing institutions to implement actions through 89 projects at continental, regional and local level. In Rwanda for instance, Global Gateway provides over €103 million support to local manufacturing and access to vaccines, medicines and health technologies including a local plant for manufacturing of vaccines with mRNA technology. The EU is also working to deepen cooperation on manufacturing vaccines, medicine and health technologies, and strengthen health systems in the context of the EU- Latin America and the Caribbean (LAC) Health Partnership. Strengthening global health is an investment in global health security, in the Sustainable Development Goals, and in the protection of the health of all people, wherever they are.

6. Looking ahead

Overall, and thanks to the cooperation between the Commission and the Member States, the EU is in the area of health now in a much stronger position than five years ago. But complacency is not an option. Much work remains to be done to further improve our health policies. Health therefore needs to remain a political priority.

New threats will continue to emerge, and particular attention should be paid to AMR, climate change- induced health threats and CBRN threats. Cooperation is required at multiple levels – European, national, regional, and global to continue to bolster our health security.

The EU faces a multitude of health challenges beyond disease outbreaks. Shortages of medicines across Europe are disrupting treatment plans for chronic illnesses, like cancer and diabetes. Adopting the proposed reform of the EU’s pharmaceutical legislation will be vital to improve access to and availability of medicines, together with other actions addressing shortages of critical medicines such as the work carried out by the European Medicines Agency and the Critical Medicines Alliance. To support Member States in accessing medicines in the area of rare diseases and orphan medicines, instruments such as Joint Procurement could be further explored.

Similarly, Europe would benefit from strengthened medical research, and a boost to biotechnologies and biomanufacturing, in line with the recent Communication “Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU”34. The slow development of new medicines, diagnostics, and therapies leave everyone vulnerable to future diseases and makes it harder to manage existing ones. AMR is a prime example. Investing in research for new antimicrobials, alternatives to antimicrobials, and rapid diagnostics, while tracking the spread of resistant bacteria and identifying emerging threats, is essential. This requires a close cooperation across multiple sectors, according to a One Health approach, promoting research and further advocating a prudent and responsible use of antibiotics. To accelerate research and development for antimicrobials and medical countermeasures for future pandemics, together with Member States, we should continue working to make clinical trials in the EU attractive, efficient, and fast. Strengthening pan-European clinical trials should continue.

At the same time, learning from the experience of the COVID-19 pandemic and conscious of the challenges ahead, health systems should continue to be strengthened, with a resilient, well-trained health workforce at the heart. The Commission will keep up its support to reforming national health systems, by providing advice and financing with EU funds.

Europe’s population is ageing and that comes with consequences for health policy – including on healthy longevity, non-communicable diseases, including neurodegenerative diseases. This requires exploring how to deal with longevity so that our societies stay healthy, even as they age. Finding effective treatments and ultimately cures for debilitating conditions like Alzheimer's and Parkinson's disease requires significant research investment and international cooperation. The future of healthcare will also depend on personalised medicine approaches. Advances in genomics and data technologies, such as artificial intelligence, can enable the tailoring of treatments, improving their effectiveness and reducing side effects.

Non communicable diseases remain a top priority. The EU has shown its commitment to tackling NCDs, with a focus on prevention across a person’s lifetime, promoting healthy lifestyles and policy coordination across sectors, using Europe’s Beating Cancer Plan as a template, and strengthening existing initiatives such as the ‘Healthier Together Initiative’ to tackle key challenges such as cardiovascular diseases. Through the 2023 Mental Health Communication, the Commission will continue to prioritise the most vulnerable groups in our societies, with a focus particularly on children and youth. The European Health Union is already preparing for these challenges. The EHDS has the potential to revolutionise healthcare in the EU by maximising the immense potential of digital health. The current multiannual financial framework which runs until 2027 will continue to provide financial and technical support to Member States and stakeholders in this area, including through EU4Health Programme and the Digital Europe Programme. It is essential to also explore how to integrate artificial intelligence into healthcare and the digital upskilling of healthcare professionals for improved efficiency, accessibility, and sustainability.

Serious health risks – from rising pandemic or epidemic threats to the health impacts of climate change and NCDs – are interlinked and driven by the triple planetary crisis. A strong, innovative, and inclusive European Health Union requires cooperation at all levels in a One Health approach.

Moreover, in the coming years, preparing for a larger Union will require ensuring that a future enlarged EU is resilient to health challenges and that the public health policies are well-coordinated among the Member States, and with countries in the accession process.

7. Conclusion

The COVID-19 pandemic was a global health crisis that turned our world upside down. It challenged, our societies, our economies, and our very own European way of life. It also highlighted the weak points in our health systems and left us with some clear lessons. The innovative working methods used during and after the COVID-19 pandemic show that the EU can deliver in a strong and united way, applying creatively the rules, for the benefit of its citizens. The most powerful lesson was also the simplest – we are stronger and more resilient when the Commission and all EU Member States collaborate in solidarity, and when with like-minded international partners we bring together our strengths for a better global response.

During this mandate, the Commission and the Member States came together to deliver a comprehensive response to the greatest health threat in a century. In parallel, they took unprecedented steps to go beyond merely firefighting the pandemic. Drawing on the solidarity and resolve shown during the crisis, the EU has built a strong and resilient European Health Union for all its citizens. The European Health Union seeks to ensure that all Member States are better prepared and respond together to future health crises. To promote European innovation and competitiveness in the healthcare sector, so that the needs of patients can be addressed with the support of all necessary actors. Solidarity and cooperation go hand in hand with resilience, with hope, with security, with meeting citizen expectations across all territories, including rural and remote ones, when it comes to delivering optimal health care. This is the European Health Union in action, answering to the needs of citizens, putting equity in access and care at the heart of the European Union.

Over the coming years, the European Health Union will continue to evolve and grow to further promote the health and wellbeing of people across the EU and beyond.

The world has changed irrevocably since 2019. And it will continue to change. Thanks to a robust European Health Union, the EU is now better prepared for what tomorrow brings for our citizens’ health.

1 mission-letter-stella-kyriakides_en.pdf (europa.eu)

2 EU Vaccines Strategy (europa.eu)

3 https://www.who.int/europe/news/item/16-01-2024-covid-19-vaccinations-have-saved-more-than-1.4-million-lives-in-the-who-european-region--a-new-study-finds

4 EP Autumn 2021 Survey: Defending Democracy | Empowering Citizens - February 2022 - - Eurobarometer survey (europa.eu)

5 Public opinion in the EU in time of coronavirus crisis 2 (europa.eu)


6 Opinion of the Health Security Committee on zoonotic avian influenza - European Commission (europa.eu)

7 Antimicrobial resistance (AMR) in bacteria; vector borne viral pathogens; emerging, rodent-borne and zoonotic viral pathogens; high-risk, emerging and zoonotic bacterial pathogens; Legionella; and diphtheria and pertussis.

8 https://single-market-economy.ec.europa.eu/coronavirus-response/task-force-industrial-scale-covid-19-vaccines_en

9 https://ec.europa.eu/commission/presscorner/detail/en/ip_22_4363

10 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0577

11 Launching GLOWACON: A global initiative for wastewater surveillance for public health - European Commission (europa.eu)

12 Disease X represents the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease. Disease X is part of the WHO list of priority pathogens (World Health Organization definition).

13 https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en

14 In the group of National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (NCAPR)

15 https://ec.europa.eu/commission/presscorner/detail/en/IP_23_5190

16 https://ec.europa.eu/commission/presscorner/detail/en/ip_23_6377

17 https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/critical-medicines-alliance_en

18 eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52019DC0128

19 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/european-partnerships-horizon-europe/health_en

20 A political agreement was reached in December 2023

21 https://www.thcspartnership.eu/

22 Figure as of 28 February 2024. Data are based on the pillar tagging methodology for the Recovery and Resilience Scoreboard and correspond to the measures allocated to the policy area ”Healthcare: Resilience, Sustainability, Adequacy, Availability, Accessibility and Quality, including digitalisation and infrastructure”.

23 https://ec.europa.eu/social/BlobServlet?docId=27472&langId=en

24 The project – JA HEROES | Health Workforce Planning Project

25 BeWell – Blueprint alliance for a future health workforce strategy on digital and green skills (bewell-project.eu)

26 https://pact-for-skills.ec.europa.eu/about/industrial-ecosystems-and-partnerships/health_en

27 https://knowledge4policy.ec.europa.eu/health-promotion-knowledge-gateway/eu-burden-non-communicable-diseases-key-risk-factors_en

28 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en

29 https://environment.ec.europa.eu/strategy/zero-pollution-action-plan_en

30 See, for example, https://www.eea.europa.eu/publications/harm-to-human-health-from-air-pollution/

31 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/eu-missions-horizon-europe/eu-mission-cancer_en

32 Council Recommendation of 9 December 2022 on strengthening p... - EUR-Lex (europa.eu)

33 https://ec.europa.eu/commission/presscorner/detail/en/ip_22_7153

34 https://ec.europa.eu/commission/presscorner/detail/en/ip_24_1570

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