The Treaty of Lisbon has enhanced the importance of health policy, stipulating that ‘a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities’. 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’ health strategy and its action programme (2014-2020) and a body of secondary legislation. The European Social Fund Plus (ESF+) will continue to provide funding during the 2021-2027 programming period.
Article 168 TFEU and Article 114 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, evoking 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, amongst many others. The entry into force of 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 Europe’s 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 current Treaty. Legislation on medicines had already been introduced in 1965 to ensure high standards of research into and manufacturing of medicines and the harmonisation of national drug licensing 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 have taken stock of several focused initiatives. The emergence of drug addiction, cancer and AIDS (among others) as major health issues, coupled with the constant increase in the free movement of patients and health professionals within the EU, have meant that public health now occupies an ever more prominent position on the EU agenda.
The Maastricht Treaty of 1992, creating 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[1], 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 institutions have focused on three key dimensions having direct implications for public health policies:
1. Consolidation of the institutional framework
The role of Parliament as a decision-making body (in 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-services consultation procedures, new comitology rules, and dialogue with civil society and experts. Finally, the role played by the agencies (EMA, ECDC, 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.
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[2]
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[3] will contribute to the production of not only sustainable, but also healthier food; the Zero Pollution Action Plan[4] will create a cleaner and healthier living space; the integration of public health funding into the European Social Fund Plus (ESF+)[5], 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[6], 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 EU Treaty and the Charter on Fundamental Rights, responds to the cross-sectoral nature of public health issues and aims at integrating health aspects in all relevant policies[7].
2. Disease prevention and health promotion
Cancer is the second leading cause of death in the EU whose consequences are felt not only at individual and family level, but also at the level of national healthcare systems, budgets, and economic productivity. A comprehensive approach, called the Europe’s Beating Cancer Plan[8], is currently being draw up 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 possible 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, turnout at screening examinations, and the follow-up to 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 as well, and on broadening the target population.
The EU Joint Action on Mental Health and Well-being[9] ran from 2013 to 2018, and created a European Framework for Action on Mental Health and Wellbeing[10]. 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)[11] to provide the framework for dealing with cross-border threats to health: the ECDC has put in place an Early Warning and Response System, and a Health Security Committee coordinates the response to outbreaks and epidemics. Cooperation with the UN’s World Health Organisation is pivotal in those cases, as could be seen with the recent outbreak of the novel coronavirus (nCov-2019) in early 2020[12].
Drugs, alcohol and tobacco use are lifestyle factors with a serious impact on human health, and the fight against them is a major concern for public health policy. The Tobacco Product Directive (Directive 2014/40/EU[13]; applicable from 2016) and the Tobacco Tax Directive (Council Directive 2011/64/EU[14]) were milestones in this process. The possible follow-up to the EU’s Drug Strategy 2013-2020[15] and the EU Alcohol Strategy 2006-2012 (COM(2006)0625)[16] is subject to discussion and further evaluation.
The EU Action Plan on Childhood Obesity 2014-2020[17] is an important step for streamlining the various measures tackling obesity, although the mid-term evaluation showed further potential to strengthen the scheme, while the Council found that the programme was not sufficiently effective.
3. Societal changes, demographic transition
Recent demographic trends have brought further issues into the focus of health policy. The aging population of the Union, 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 aging.
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 (COM(2016)0377)[18]. 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, the European 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 a European plan to combat child poverty[19]. The new 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[20]
The new clinical trials regulation and legislation on medical devices and in-vitro diagnostic devices will become applicable in 2020. Monitoring the practical application of those regulations will be important to see whether they bring the expected results. Access to affordable medicines and tackling 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. The European Parliament has already signalled its concerns about vaccine hesitancy and the dropping vaccination rates[21], and expressed its view on the European One Health Action Plan on Antimicrobial Resistance[22]; 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[23] and has enormous potential; to make it work, several measures are under way.
The 2018 Communication on the Digital Transformation of Health and Care in the Digital Single Market (COM(2018)0233[24]) identifies as priorities secure access by citizens to their health data, also across borders; personalised medicine through shared European 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[25] will provide the physical network for that.
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[26]) is Parliament’s main actor on health matters and is responsible for over 10 % of Parliament’s total legislative activity[27]. Recently adopted key legislative files[28] include, for example, the new regulation on clinical trials, medical devices and in-vitro diagnostic devices, and cross-border healthcare, the directive on tobacco products, and decisions to establish the health funding programmes. A substantial part of the upcoming European Green Deal package (COM(2019)0640) will also have a direct or indirect impact on health, such as the strategy for a clean and circular economy, the zero pollution ambition, achieving the sustainability of the food chain and climate neutrality. 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[29]).
Zsuzsanna Laky