The Treaty on the Functioning of the European Union (TFEU) enhanced the importance of health policy by stipulating that ‘a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities’ (Article 168(1) of the TFEU). Primary responsibility for health protection and, in particular, healthcare systems continues to lie with the Member States. However, the EU has an important role to play in improving public health, preventing and managing diseases, mitigating sources of danger to human health, and harmonising health strategies between Member States. The EU has successfully implemented a comprehensive policy, through the ‘Health for Growth’ strategy and its third programme for the Union’s action in the field of health (2014-2020), as well as a body of secondary legislation. The EU4Health programme will continue to provide funding during the 2021-2027 programming period.
Article 168 of the TFEU and Article 114 of the TFEU. The Court of Justice of the European Union has ruled on numerous occasions on how the EU can pursue public health objectives through the integration of the internal market, using Article 114 as the legal basis.
The three strategic objectives of EU health policy are:
EU health policy originated from health and safety provisions, and later developed as a result of the free movement of people and goods in the internal market, which necessitated the coordination of public health issues. In harmonising measures to create the internal market, a high level of protection formed the basis for proposals in the field of health and safety. Various factors, including the bovine spongiform encephalopathy (‘mad cow disease’) crisis towards the end of the twentieth century, put health and consumer protection high on the political agenda. The setting-up of specialised agencies such as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) exemplified the EU’s increasing commitment to health policy. Public health has also benefited from actions in policy areas such as the environment and food, among many others. The establishment of the European Chemicals Agency (ECHA) under the REACH framework for the evaluation and registration of chemical substances, and the creation of the European Food Safety Agency (EFSA) were also indicators of the multidisciplinary efforts aimed at improving the health of EU citizens.
A. Past actions and context
Despite the absence of a clear legal basis, public health policy had developed in several areas well before the TFEU was adopted. Legislation on medicines had already been introduced in 1965 to ensure high standards of research into and manufacturing of medicines, to ensure the harmonisation of national drug licencing procedures, and to introduce rules on advertising, labelling and distribution. Medical and public health research programmes date back to 1978, covering subjects such as ageing, environment- and lifestyle-related health problems, radiation risks and human genome analysis, with a special focus on major diseases. Member States also agreed to offer mutual assistance in the event of disaster or extremely serious illness: ‘mad cow disease’ offers a prominent example of such cooperation and assistance.
The past actions that led to the configuration of the current EU health policy took stock of several focused initiatives. The emergence of drug addiction, cancer and AIDS/HIV (among others) as major health issues, coupled with the constant increase in the free movement of patients and health professionals within the EU, mean that public health now occupies an ever more prominent position on the EU agenda.
The Maastricht Treaty of 1992, which created the European Union, introduced public health into the founding treaty. The scope is rather limited, but it did create a clear legal basis for the adoption of health policy measures. The Amsterdam Treaty of 1997 further strengthened the provisions, and while the primary competence for health matters remained with the Member States, the role of the EU became more prominent. The EU could now adopt measures aimed at ensuring (rather than simply ‘contributing to’, as before) a high level of human health protection, and Member States could cooperate in relation to any causes of danger to human health.
In 1993, the Commission published a communication on the framework for action in the field of public health, which identified several areas for action and covered topics ranging from health promotion through cancer and drugs to rare diseases. This was the forerunner of the later multiannual public health programmes. The evaluation of that first programme concluded that a more horizontal, interdisciplinary approach was needed in future so that EU action could produce added value. This approach was taken on board for the design of the subsequent programmes, i.e. the EU Public Health Programme (2003-2008), the Health Programme (2009-2013), and the Third Health Programme (2014-2020).
B. Recent developments
In recent years, the EU institutions have focused on three key dimensions that have direct implications for public health policies:
1. Consolidation of the institutional framework
The role of Parliament as a legislator (through codecision with the Council) has been reinforced with regard to health, the environment, food safety and consumer protection issues. The way in which the Commission launches legislative initiatives has been fine-tuned, with standardised inter-service consultation procedures, new comitology rules, and dialogue with civil society organisations and experts. Finally, the role played by the relevant agencies (the EMA, ECDC, ECHA, EFSA) has been enhanced, more specifically with the creation in 2005 of the Executive Agency for Health and Consumers (EAHC), which implements the EU Health Programme. A proposal for the establishment of a new European Health Emergency preparedness and Response Authority (HERA) is expected to be made in the fourth quarter of 2021.
2. The need to strengthen rapid response capacity
It is now seen as essential for the EU to have a rapid response capacity to enable it to react to major health threats in a coordinated manner, especially given the threat of bioterrorism and the potential for worldwide epidemics in an age in which rapid global transport makes it easier for diseases to spread.
3. The need for improved coordination of health promotion and disease prevention
The aim is to tackle the key underlying causes of ill health related to personal lifestyles and to economic and environmental factors (pollution from pesticides, heavy metals, endocrine disruptors). This entails, in particular, close coordination with other EU policy areas such as the environment, transport, agriculture and economic development. In addition, it means closer consultation with all interested parties and greater openness and transparency in decision-making. A key initiative is the setting-up of a public consultation mechanism on health matters.
C. Current issues and upcoming challenges[1]
1. Health in all policy areas
Synergies across various policy areas allow health issues to be tackled in their wider context. The Farm to Fork Strategy will contribute to the production of not only sustainable, but also healthier food; the Zero Pollution Action Plan will create a cleaner and healthier living space; the proposed EU4Health Programme (2021-2027), together with other funds and programmes, will help to address health issues from different viewpoints. Mitigating the impact of climate change also includes tackling the health problems brought, or exacerbated, by climate change, such as the increasing number of deaths due to heatwaves and natural disasters, and changing patterns of infection for water-borne diseases and diseases transmitted by insects, snails or other cold-blooded animals.
The Health in All Policies (HIAP) approach, codified in the TFEU and the Charter of Fundamental Rights of the European Union (the Charter), responds to the cross-sectoral nature of public health issues and aims at integrating health aspects in all relevant policies (Articles 9 and 168(1) of the TFEU; Article 35 of the Charter).
2. Disease prevention and health promotion
Cancer is the second leading cause of death in the EU. Its consequences are felt not only at the individual and family levels, but also at the level of national healthcare systems, budgets and economic productivity. A comprehensive approach, called the Europe’s Beating Cancer Plan, was presented in February 2021 and covers prevention, early diagnosis, treatment and follow-up.
In addition to new initiatives, there is also a need for proper implementation of existing measures and possibly for revision of existing initiatives. For example, there are EU-level recommendations in force about the national screening programmes for breast, cervical and colorectal cancer, but outreach to the target population, attendance of screening examinations, and follow-up on uncertain or positive results vary greatly across the Member States. There are also ongoing discussions on whether the scope of the screening programme should be expanded to include other cancer types, and on broadening the target population.
The EU Joint Action on Mental Health and Well-being ran from 2013 to 2018, and created the European Framework for Action on Mental Health and Wellbeing. Though the lifetime of the joint action was limited, mental health awareness continues to be an important issue. With suicide being the second main cause of death in the 15-29 age group, prevention, awareness, non-stigmatisation and access to help when it comes to depression, self-harm and suicide remain of key importance. Mental health at schools and at the workplace also requires special attention.
As for communicable diseases, legislation is in force (Decision No 1082/2013/EU) that provides a framework for dealing with cross-border threats to health: the ECDC has put in place an Early Warning and Response System, and the EU Health Security Committee coordinates the response to outbreaks and epidemics. Cooperation with the UN’s World Health Organization (WHO) is pivotal in those cases, as was seen with the recent outbreak of the coronavirus pandemic (Sars-CoV-2 virus; 2019 coronavirus disease, COVID-19) in late 2019/early 2020. Countless ad hoc measures were adopted under urgency procedures and can be followed on a dedicated EUR-Lex webpage, as well as on the coronavirus response webpage of the Commission. The following documents deserve specific mention:
Drugs, alcohol and tobacco use are lifestyle factors with a serious impact on human health, and the fight against them is a major factor in public health policy. The Tobacco Product Directive (Directive 2014/40/EU; applicable from 2016) and the Tobacco Tax Directive (Council Directive 2011/64/EU) were milestones in this fight.
In December 2020, the Council approved the new 2021-2025 EU Drugs Strategy. The document establishes an overarching political framework and sets out strategic priorities for EU policy on illicit drugs under three main strands: drug supply reduction, drug demand reduction and addressing drug-related harm. Efforts to revise the 2006 EU Alcohol Strategy seem to currently be stalled.
The 2014-2020 EU Action Plan on Childhood Obesity was an important step for streamlining the various measures tackling obesity. Although the mid-term evaluation showed further potential to strengthen the scheme, and the Council found that it was not sufficiently effective, it has not yet been updated
3. Societal changes, demographic transition
Recent demographic trends have brought up further issues to be focused on in health policy. The ageing population of the EU, the demand for quality of life in old age, and the sustainability of healthcare systems all require a response. In 2020, the WHO is launching the Decade of Healthy Aging, and the Von der Leyen Commission has committed to a green paper on ageing.
The recent migration crises and the arrival of a large number of non-EU migrants prompted the adoption of an Action Plan on the Integration of Third-Country Nationals. The action plan addresses, inter alia, health-related disadvantages experienced by migrants, including access to health services. The European Agenda for Migration and the New Pact on Migration and Asylum proposed by the new Commission are expected to further improve the situation.
Back in 2015, Parliament called for action to reduce childhood inequalities in areas such as health, and for the introduction of a Child Guarantee in the context of an EU plan to combat child poverty. The von der Leyen Commission is expected to deliver on this, while the European Court of Auditors is also looking into the effectiveness of the Commission’s support to Member States in reducing child poverty.
4. Medicines[2]
The new clinical trials regulation of 2014 will become applicable early 2022. In the field of medical devices and in-vitro diagnostic devices, two new regulations will progressively replace the three existing directives in the coming years (by 2022). Access to affordable medicines and the tackling of medicine shortages will feature on the political agenda in the coming years, in particular in the light of Brexit. The evaluation of the legislation on medicines for children and rare diseases, and the blood, tissues and cells directives will pave the way for possible future changes. Parliament has already raised concerns about vaccine hesitancy and the dropping vaccination rates[3], and expressed its view on the European One Health Action Plan on Antimicrobial Resistance[4]; these issues will also remain pivotal in the coming years.
5. eHealth
Information and communication technologies improve the whole life cycle of health issues, from prevention through diagnosis to treatment, monitoring and management of health and lifestyle. The digitalisation of the healthcare sector forms part of the EU’s digital single market strategy and has enormous potential; to make it work, several measures are being prepared.
The 2018 Commission communication on the Digital Transformation of Health and Care in the Digital Single Market identifies as priorities secure access by citizens to their health data, also across borders; personalised medicine through shared EU data infrastructure, allowing researchers and other health professionals to pool resources across the EU; and empowering citizens with digital tools for user feedback and person-centred care (mobile health solutions, personalised medicine). The eHealth Digital Service Infrastructure will provide the physical network for that. A legislative proposal for a European health data space is being drawn up for the end of 2021.
Parliament has consistently promoted the establishment of a coherent public health policy. It has also actively sought to strengthen and promote health policy through numerous opinions, studies, debates, written declarations and own-initiative reports on a wide range of issues.
The Committee for Environment, Public Health, and Food Safety (ENVI) is Parliament’s main actor on health matters and is responsible for over 10% of Parliament’s total legislative activity[5].. Several parts of the upcoming European Green Deal package will also have a direct or indirect impact on health, such as the strategy for a clean and circular economy, the zero pollution goal, the food chain sustainability goal, and the climate neutrality goal. Related legislation will be adopted with Parliament as co-legislator. Parliament also exercises its right of scrutiny by checking and possibly objecting to delegated and implementing acts proposed by the Commission in relation to previously adopted legislation; preparatory work in that field is done by the ENVI Committee. The Health Working Group within ENVI is, as in the past, playing an active role in promoting exchanges between MEPs and professional experts on the most topical health issues, through the organisation of thematic workshops and the provision of written expertise (studies, analyses[6]).
In September 2020, Parliament established a Special Committee on Beating Cancer (BECA).
Christian Kurrer