EU public health policy is under continuous development. While several measures were triggered by the COVID-19 pandemic, the EU delivered by addressing both immediate and future health concerns, building resilience against cross-border health threats, implementing Europe’s Beating Cancer Plan (better screening and preventive measures), advancing the pharmaceutical strategy for Europe (making sure EU patients have timely and equitable access to medicines) and enhancing the digitalisation of health systems.

Legal basis

Article 168 (public health), Article 114 (single market) and Article 153 (social policy) of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the Charter).

Objectives

EU public health policy aims to:

  • Protect and improve the health of EU citizens;
  • Support the modernisation and digitalisation of health systems and infrastructure;
  • Improve the resilience of Europe’s health systems;
  • Better equip EU countries to prevent and address future pandemics.

Context

The Maastricht Treaty of 1992 established a clear legal basis for the adoption of health policy measures. Subsequently, the 1997 Treaty of Amsterdam strengthened these provisions, enabling the EU to adopt measures ensuring a high level of human health protection.

The emergence of major health issues and their socio-economic consequences, coupled with the free movement of patients and health professionals within the EU, mean that public health has attained an ever-more prominent position on the EU agenda. The setting up of specialised agencies such as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) underlined the EU’s growing role in health policy. Other agencies such as the European Chemicals Agency and the European Food Safety Authority further contribute to strengthening European health policies. The Health Emergency Preparedness and Response Authority’s (HERA) mission is to enhance the EU’s capacity to prevent, detect and respond to health emergencies.

The EU4Health programme (2021-2027) was adopted as a response to the COVID-19 pandemic and to improve crisis preparedness in the EU. The COVID-19 crisis intensified efforts, emphasising the importance of collective resilience and cross-border health security, driving the EU towards a robust European Health Union. In March 2025, the Commission proposed the Critical Medicines Act to improve the availability, supply and production of critical medicines within the EU.

The general objectives of the European Health Union for 2021-2027 focus on immediate and enduring health concerns. These include addressing the COVID-19 crisis, fortifying defences against cross-border health risks, implementing initiatives such as Europe’s Beating Cancer Plan and the pharmaceutical strategy for Europe, and advancing digital health. The EU will also persist in collaborating globally to overcome health challenges, including developing vaccines and tackling antimicrobial-resistant infections.

Achievements and current developments

A. Health in All Policies (HiAP)

The EU’s HiAP approach, formulated in 2006 and codified in Articles 9 and 168(1) TFEU and Article 35 of the Charter, addresses the cross-sectoral nature of public health issues and aims to integrate health aspects into all relevant policies to improve people’s health and health equity. For example, the ‘Farm to Fork’ strategy contributes to the production of, not only sustainable, but also healthier food; the zero pollution action plan seeks to create a cleaner and healthier living environment; the EU4Health programme (2021-2027), together with other funds and programmes, helps address health issues from multiple perspectives. Several policies aim to prevent the harmful health effects of climate change, such as the increasing number of deaths due to heatwaves and natural disasters, changing patterns of infection in water-borne diseases, and diseases transmitted by insects, snails or other cold-blooded animals.

B. Disease prevention and health promotion

Prevention activities in the EU encompass a wide range of areas, including initiatives against cancer, communicable and non-communicable diseases (NCDs), and on vaccination and combating antimicrobial resistance (AMR).

1. Cancer

Cancer is the second leading cause of death in the EU. Its impact extends beyond personal and familial spheres, affecting healthcare systems and overall economic productivity. The EU addresses the issue of cancer through several initiatives, including a dedicated Special Committee on Beating Cancer (2020-2022), set up by Parliament, which examined the measures that the EU could implement to combat cancer.

In February 2021, the Commission presented Europe’s Beating Cancer Plan, covering prevention, early diagnosis, treatment and follow-up. In September 2022, the Commission presented a new approach on cancer screening to support Member States’ efforts to boost the uptake of cancer screening and to increase the participation rate of eligible individuals in breast, colorectal and cervical cancer screenings to 90% by 2050.

To support policymakers and help guide investment and contributions towards this goal, the Country Cancer Profiles highlight the achievements, challenges and disparities in cancer care across EU countries. The 2nd edition was published in February 2025. The upcoming fifth edition of the European Code against Cancer (ECAC5) will update and expand current prevention guidelines, integrating the latest scientific evidence and policy recommendations.

2. Non-communicable diseases

In December 2021, the Commission launched the ‘Healthier together – EU non-communicable diseases initiative’ to assist EU countries in reducing major NCD burdens and enhancing citizens’ well-being.

a. Mental health and well-being

It is estimated that more than 84 million people in the EU are struggling with mental health problems. The EU Joint Action on Mental Health and Well-being (2013-2016) led to the creation of the European Framework for Action on Mental Health and Wellbeing, which promotes mental health. With suicide being the second main cause of death among 15-29-year-olds, prevention, awareness, non-stigmatisation and access to help remain of key importance. On 13 September 2022, in a resolution on the impact of COVID-19 closures of educational, cultural, youth and sports activities on children and young people in the EU, Parliament called on the Commission to establish a European Year of Mental Health. The Commission has not expressed support for this initiative so far.

b. Cardiovascular diseases and lifestyle factors

Cardiovascular diseases are the leading causes of death in the EU. Drugs, alcohol and tobacco consumption are lifestyle choices that significantly increase the risk of developing heart-related conditions, which have a serious impact on human health. Addressing these risk factors is a major focus of EU health policy. The Tobacco Product Directive (Directive 2014/40/EU) and the Tobacco Tax Directive (Council Directive 2011/64/EU) were milestones in regulating tobacco use. The use of drugs not only harms individuals, but also public health and safety and carries significant costs. On 16 July 2025, the Commission tabled a proposal for a revision of the Tobacco Taxation Directive to expand the scope of the directive to new products and to increase minimum tax rates to reflect inflation and differences in price levels between Member States.

c. Public health threats

For communicable diseases and cross-border threats to health, the ECDC has put in place an Early Warning and Response System to detect and respond to possible outbreaks. Each Member State’s Health Security Committee coordinates the EU-wide response to outbreaks and epidemics. Cooperation with the UN’s World Health Organization (WHO) is pivotal in these cases, as demonstrated during the COVID-19 pandemic in early 2020. Many ad hoc measures were adopted under urgency procedures (see the dedicated EUR-Lex webpage on COVID-19 and the Commission’s coronavirus response webpage).

In 2022, the EMA’s and ECDC’s mandates were extended, a new regulation on serious cross-border threats to health was adopted, and the HERA was set up to improve preparedness and response to serious cross-border threats in the area of medical countermeasures.

A Parliament Special Committee on COVID-19 (COVI) was also established in 2022 to assess the EU’s response. The Special Committee completed its work on 12 July 2023, delivering a report entitled ‘COVID-19 pandemic: lessons learned and recommendations for the future’. The adopted recommendations aim to enhance EU crisis management and preparedness for future health emergencies.

On 11 April 2025, the Commission launched a public consultation in the context of its strategy to support medical countermeasures against public health threats. The rapid development of security risks means that the EU needs to consolidate its preparedness and response against public health threats (including chemical, biological, radiological and nuclear threats). The strategy aims to strengthen the development and availability of crisis-relevant medical countermeasures.

C. Societal changes and demographic transition

The 2023 Commission report on the impact of demographic change in a changing environment explores challenges arising from ageing, population decline and reduced numbers of working-age individuals. Addressing the EU’s ageing population, ensuring a high quality of life in old age and sustainable healthcare systems are key challenges. In 2020, the WHO launched the Decade of Healthy Ageing, and the Commission published a green paper on ageing in January 2021. In addition, the Commission adopted a communication entitled ‘Demographic change in Europe: a toolbox for action’, which lists EU instruments available to Member States to manage the demographic change in the EU.

In response to the challenges posed by the migration crises, the action plan on the integration of third country nationals (non-EU nationals) was adopted in 2016. The action plan addresses, inter alia, health-related disadvantages experienced by migrants, including access to health services. In 2020, the Commission put forward the European Agenda on Migration and the New Pact on Migration and Asylum, which aim to further streamline EU policies in this area. The regulations entered into force in June 2024 and will be applicable from 1 July 2026.

Back in 2015, Parliament called for action to reduce childhood inequalities in areas such as health, and to introduce a European Child Guarantee in the context of an EU plan to combat child poverty. In June 2021, the Commission’s proposal to establish a European Child Guarantee was adopted by the Council. The objective of the European Child Guarantee is to prevent and combat social exclusion by ensuring that children in need have effective access to a set of key services, including free healthcare and healthy nutrition. As a first step, Member States submitted national plans outlining how they will implement the European Child Guarantee until 2030, with progress to be reviewed every two years.

D. Medicines (2.2.5)

A medicinal product (medicine) is a substance or combination of substances that is used for the treatment or prevention of diseases in human beings. The directive on the Community code relating to medicinal products for human use (Directive 2001/83/EC) and the regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Regulation (EC) No 726/2004) lay down the requirements and procedures for marketing authorisation, as well as the rules for monitoring authorised products. The regulation adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Regulation (EU) 2019/1243) brought changes to this legislation, implementing particular actions aimed at guaranteeing the accessibility of medications and handling shortages across the EU.

To strengthen medicine supply and production, the Commission proposed the Critical Medicines Act in March 2025. It seeks to improve the availability of critical medicines and expand access to treatments for rare diseases and underserved markets. Currently, Parliament and the Council are ready to start negotiations on the act. Alongside this, the Critical Medicines Alliance was established in January 2024 under the HERA as a consultative platform. The Alliance brings together stakeholders from Member States, industry, civil society and the scientific community to identify priority areas and propose solutions to prevent and manage medicine shortages.

The EMA is responsible for facilitating the development of medicines and monitoring their safety, for evaluating marketing authorisations and for providing information to healthcare professionals. Clinical trials investigate the effectiveness and safety of medicines in humans. The regulation on clinical trials on medicinal products for human useestablished harmonised rules for the authorisation and conduct of clinical trials in the EU.

As part of its ongoing revision of the general pharmaceutical legislation, the Commission presented the Pharmaceutical Package in April 2023, aiming to make medicines more available, accessible and affordable. At the same time, it proposed a Council recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach, which was adopted on 13 June 2023. The Commission defines it as ‘an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, and ecosystems’. Parliament and the Council have adopted their positions on the two proposals and are currently negotiating in trilogue discussions.

The Medical Devices Regulation (Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746) set the rules for placing medical and in vitro diagnostic devices on the market and for conducting related clinical investigations. These regulations on medical devices came into force in May 2021 and May 2022 respectively. Devices are grouped according to their risk category, each of which has a specific set of rules. In October 2024, Parliament adopted a resolution on the urgent need to revise the Medical Devises Regulation to address regulatory challenges and improve patient access to essential medical devices.

In July 2024, a new regulation on standards of quality and safety for substances of human origin intended for human application was adopted. It sets quality and safety standards for human-derived substances used in healthcare. The regulation will apply from 7 August 2027.

E. eHealth

In 2025, a regulation for a European Health Data Space (EHDS) was adopted, which seeks to empower EU citizens to manage their health data, and enabled cross-border use for research and innovation while ensuring data protection compliance. This is a major achievement in the EU’s eHealth agenda.

The EU is in the middle of a digital transformation of its healthcare systems. The digitalisation of health refers to the integration of digital technologies and information management systems into various aspects of the healthcare industry. It involves the use of electronic health records, telemedicine, wearable devices, mobile apps, data analytics and other digital tools. The digitalisation of the healthcare sector is part of the EU’s digital single market strategy, which aims to achieve closer digital harmonisation between the Member States.

The eHealth Network is a voluntary network set up under Article 14 of the directive on the application of patients’ rights in cross-border healthcare (Directive 2011/24/EU) which provides a platform for Member States’ competent authorities dealing with eHealth. The 2018 Commission communication on enabling the digital transformation of health and care in the Digital Single Market prioritises secure access to health data (including cross-border) for citizens, personalised medicine, better research through shared EU data infrastructure and the empowerment of citizens through digital tools for user feedback and person-centred care (mobile health solutions). The eHealth Digital Service Infrastructure ensures the continuity of care for European citizens while they are travelling abroad in the EU.

F. Health Technology Assessment (HTA)

HTA aims to offer evidence-based data on health technologies to ensure safe, effective, patient-focused and cost-efficient health policies. National authorities also use HTA findings to guide decisions on which technologies should be reimbursed at the domestic level. HTA assesses the added value of health technologies, including medicines, medical devices, diagnostic tools, surgical procedures, and measures for disease prevention, diagnosis or treatment. A new regulation for assessing health technologies was adopted in December 2021 and has been gradually applied since January 2025.

G. Biotechnology

In July 2024, the Commission proposed a series of targeted actions to boost biotechnology and biomanufacturing in the EU through its communication entitled ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’. The upcoming European Biotech Act aims to accelerate innovation in HTA, clinical trials and biomanufacturing, strengthening Europe’s competitiveness and advancing healthcare solutions. The proposal for the Biotech Act is mentioned in the 2026 Commission work programme.

Role of the European Parliament

From 2023 to 2025, the Public Health Committee (SANT) operated as a subcommittee of the Committee on the Environment, Public Health and Food Safety. In February 2025, it became a standalone committee, responsible, among other things, for programmes and actions in public health, pharmaceutical and medical devices, health crisis preparedness and response, and mental health and patients’ rights. SANT also oversees the work of the EMA and the ECDC and liaises regularly with the WHO.

For more information on this topic, please see the website of the Committee on Public Health.

 

Leila Jouini / Ioana-Alice POSTU