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’. This objective is to be achieved through Community support to Member States and by fostering cooperation. Primary responsibility for health protection and, in particular, the 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 Strategy ‘Health for Growth’ and its action programme (2014-2020) and a body of secondary legislation. The current institutional set-up to support implementation includes the Commission’s Directorate-General for Health and Food Safety (DG SANTE), as well as specialised agencies, notably the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA).
Article 168 TFEU.
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 (BSE) crisis towards the end of the twentieth century, put health and consumer protection high on the political agenda. In response, the Commission’s Directorate-General for Health and Food Safety (DG SANTE) assumed the coordination of all health-related areas, including pharmaceutical products. The consolidation of specialised agencies such as the European Medicines Agency (EMA) and the creation of the European Centre for Disease Prevention and Control (ECDC) exemplify the EU’s increasing commitment to health policy. Public health also benefits 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) are also good 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 prior to the current Treaty. These included:
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. Major initiatives launched have included the ‘Europe against Cancer’ and ‘Europe against AIDS’ programmes (1987 and 1991 respectively). In addition, several key resolutions have been adopted by health ministers in the Council, on health policy, health and the environment and the monitoring and surveillance of communicable diseases. In 1993 the Commission published a communication on the framework for action in the field of public health, which identified eight areas for action, thereby providing the basis for the first multiannual public health programme and its successors:
The above eight programmes were implemented between 1996 and 2002. The evaluation of the programme found that the overall design could have limited their effectiveness owing to the dilution effect of the ‘disease-by-disease approach’ taken. It was felt that a more horizontal, interdisciplinary approach was needed by means of which EU action could produce added value. The initial eight separate programmes were replaced in 2003 by a single integrated horizontal scheme, the EU Public Health Programme 2003-2008, which was adopted by codecision. The second phase was the Programme of Community Action in the field of Health and Consumer Protection 2007-2013, which had a budget of EUR 312 million. The current programme, which is the third phase, is called Health for Growth and spans the period 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.
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, including: EU health strategy; radiation; protection for patients undergoing medical treatment or diagnosis; health information and statistics; respect for life and care of the terminally ill; a European charter for children in hospital; health determinants; biotechnology, including cell, tissue and organ transplants and surrogate motherhood; rare diseases; safety and self-sufficiency in the supply of blood for transfusion and other medical purposes; cancer; hormones and endocrine disruptors; electromagnetic fields; drugs and their impact on health; tobacco and smoking; breast cancer and women’s health in particular; ionising radiation; the ‘European health card’ (carrying essential medical data which can be read by any doctor); nutrition and diet and their impact on health; BSE and its aftermath, and food safety and health risks; e-health and telemedicine; antibiotic resistance; biotechnology and its medical implications; medical devices; cross-border healthcare; Alzheimer’s disease and other dementias; complementary and alternative medicines (CAM); H1N1 pandemic influenza preparedness; antimicrobial resistance; and advanced therapies.
The Programme of Community Action in the field of Health and Consumer Protection 2007-2013 was based on the strategy ‘Healthier, safer, more confident citizens: a health and consumer protection strategy’, which was adopted in 2007 and based on four principles: ‘A strategy based on shared health values’; ‘Health is the greatest wealth’; ‘Health in all policies (HIAP)’; and ‘Strengthening the EU’s voice in global health’. Its objectives were: to foster good health in an ageing Europe; to protect citizens from health threats; and to support dynamic health systems and new technologies. This programme was allocated a budget of EUR 321.5 million, which clearly shows the importance attributed to this area (despite the fact that the final figure represented a considerable reduction on the amounts proposed by Parliament).
The Committee for Environment, Public Health, and Food Safety (ENVI) is Parliament’s main actor on health matters. It is responsible for over one third of Parliament’s total legislative activity. The Health Working Group within ENVI has, in the past and current legislative terms, played an active role in promoting exchanges between MEPs and professional experts on the most topical health issues, through the organisation of thematic workshops.
In 2013 Parliament approved the revision of the EU framework in the field of clinical trials, which had been shown over time not to favour the development of new treatments owing to unduly stringent rules.
The EU Health Strategy ‘Together for Health’ supports the overall Europe 2020 strategy, which aims to turn the EU into a smart, sustainable and inclusive economy promoting growth for all – one prerequisite of which is a population in good health. In 2014 the third health programme started, aimed at fostering health in Europe by encouraging cooperation between EU countries in order to improve the health policies that benefit their citizens and also encouraging the pooling of resources. The title of the programme is Health for Growth and its time frame is 2014-2020. The final programme approved is the result of successful negotiations between the Commission, Parliament and the Council on three main issues: the budget envelope, the modalities for the adoption of annual work programmes, and co-financing for joint actions aimed at creating incentives for improving the participation of the less affluent Member States. The overall budget is almost EUR 450 million.
In 2016 Parliament is currently working on an own initiative report on ‘EU options for improving access to medicines’, which relates to the fundamental rights of citizens to medical treatment, the escalating prices of medicines and barriers to patients in accessing some products owing to shortages of essential medicines and other distortions in the pharmaceuticals market.
Another clear trend in the field of health is the growing adoption of information technologies, the widespread use of mobile devices (smartphones and tablets) and intelligent applications, which allow all actors in the field to benefit from 24/7 ubiquitous connectivity. Parliament is an active partner in the debates concerning the emerging scenarios of eHealth and mHealth.
Marcelo Sosa Iudicissa / Purificación Tejedor del Real