The European Union is above all an economic union, based on the principles of the free movement of goods, services, persons and capital within an internal market. Through the competencies acquired in this framework, it intervenes in almost all sectors of activity, including the hospital and healthcare sectors. Although they do not necessarily measure its impact on a daily basis, hospitals and healthcare services thus exist in an environment that is governed to a great extent by community legislation, whether this concerns the goods and services they purchase or produce, the professionals they employ, the patients they admit, the financial resources they obtain and the investments they make. The EU influence, while not always decisive, is nonetheless significant. Influence may be indirect but progressively becomes very direct, as evidenced by the consequences of the jurisprudence of the European Court of Justice that considered medical care, and then hospital care as services. With the implementation of the directive on cross-border care, the difficulties in reconciling these elements with the provisions of the treaty that restates the Member States’ competency in organising and financing of health systems are now coming to light. In this context, it is all the more important for hospital and healthcare services to be aware of the European mechanisms.
The European Union (EU) is not a federation, like the United States, nor an organisation for cooperation between governments, like the United Nations. The countries that make up the EU (its ‘Member States’) remain independent sovereign nations but they have decided to pool their sovereignty in order to gain strength and world influence none of them could have on their own. Pooling sovereignty means in practice that the member states delegate some of their decision-making powers to shared institutions they have created, so that decisions on specific matters of joint interest can be made democratically at European level. The EU decision-making process involves three main institutions: the European Parliament, the Council of the European Union and the European Commission.
The European Parliament (EP) is elected by the citizens of the European Union to represent their interests. Elections are held every five years, and every EU citizen is entitled to vote, and to stand as a candidate, wherever she/he lives in the EU. Parliament thus expresses the democratic will of the Union’s citizens (more than 500 million people), and represents their interests in discussions with the other EU institutions. The present parliament has 751 members from all 28 EU countries. Members of the European Parliament (MEPs) do not sit in national blocks, but in seven Europe-wide political groups. Between them, they represent all views on European integration, from the strongly pro-federalist to the openly Eurosceptic.
The Council is the EU’s main decision-making body. It represents the Member States, and its meetings are attended by one minister from each of the EU’s national governments. Which ministers attend which meeting depends on what subjects are on the agenda. If, for example, the Council is to discuss health issues, the meeting will be attended by the Health Minister from each EU country and it will be known as the ‘Health Council’. But altogether there are nine different Council configurations and health issues are only one of the topics dealt with by the Employment, Social Policy, Health and Consumer Affairs Council. Each minister in the Council is empowered to commit his or her government. In other words, the minister’s signature is the signature of the whole government. Moreover, each minister in the Council is answerable to his or her national Parliament and to the citizens that Parliament represents. This ensures the democratic legitimacy of the Council’s decisions. Up to four times a year the Presidents and/or Prime Ministers of the Member States, together with the President of the European Commission, meet as the European Council. These ‘summit’ meetings set overall EU policy and resolve issues that could not be settled at a lower level (that is, by the ministers at normal Council meetings). The Council has three key responsibilities: to pass European laws – jointly with the European Parliament in many policy areas; to coordinate the broad economic policies of the Member States; to approve the EU’s budget, jointly with the European Parliament.
The European Commission is independent of national governments. Its task is to represent and uphold the interests of the EU as a whole. It drafts proposals for new European laws, which it presents to the European Parliament and the Council. It is also the EU’s executive arm, responsible for implementing the decisions of Parliament and the Council. The Commission manages the day-to-day business of the European Union: implementing its policies, running its programmes and spending its funds. The term ‘Commission’ is used in two senses. First, it refers to the team of men and women – one from each EU country – appointed to run the institution and take its decisions. Secondly, the term ‘Commission’ refers to the institution itself and to its staff.
Informally, the appointed Members of the Commission are known as ‘commissioners’. Members of the Commission are committed to acting in the interests of the Union as a whole and not taking instructions from national governments.
A new Commission is appointed every five years, within six months of the elections to the European Parliament. The Member State governments agree together on who to designate as the new Commission President. The Commission President-designate is then approved by Parliament. The Commission President-designate, in discussion with the Member State governments, chooses the other Members of the Commission. The Council adopts the list of nominees by qualified majority and communicates it to the European Parliament for approval. Parliament then interviews each nominee and votes its opinion on the whole team. Following Parliaments vote of approval, the new Commission is formally appointed by the Council, acting by qualified majority.
The Commission remains politically accountable to Parliament, which has the power to dismiss the whole Commission by adopting a motion of censure. Individual members of the Commission must resign if asked to do so by the President, provided the other commissioners approve. The Commission attends all the sessions of Parliament, where it must clarify and justify its policies. It also replies regularly to written and oral questions posed by MEPs. The day-to-day running of the Commission is done by its administrative officials, experts, translators, interpreters and secretarial staff. There are approximately 23,000 of these European civil servants, fewer than the number of staff employed by a typical medium-sized city council.
The Commission meets once a week, usually on Wednesdays in Brussels. Each item on the agenda is presented by the commissioner responsible for that policy area, and the whole team then takes a collective decision on it. The Commission’s staff is organised in departments, known as ‘Directorates-General’ (DGs) and ‘services’ (such as the Legal Service). Each DG is responsible for a particular policy area and is headed by a Director-General who is answerable to one of the commissioners. Overall coordination is provided by the Secretariat-General, which also manages the weekly Commission meetings. It is headed by the Secretariat-General, who is answerable directly to the President. It is the DGs that actually devise and draft legislative proposals, but these proposals become official only when ‘adopted’ by the Commission at its weekly meeting. Once the proposal is fully ready, it will be put on the agenda of the next Commission meeting. If at least 15 of the 28 commissioners approve the proposal, the Commission will ‘adopt’ it and it will have the whole team’s unconditional support. The document will then be sent to Council and the European Parliament for their consideration.
The European Commission has four main roles: to propose legislation to Parliament and the Council; to manage and implement EU policies and the budget; to enforce European law (jointly with the Court of Justice); to represent the European Union on the international stage, for example by negotiating agreements between the EU and other countries.
Decision-making at European Union level involves various European institutions, the main ones being the European Commission, the European Parliament, and the Council of the European Union. In general, it is the European Commission that proposes new legislation and the Council and the Parliament that pass the laws. In some cases, the Council can act alone. The rules and procedures for EU decision-making are laid down in the treaties. The main forms of EU law are directives and regulations. Every proposal for a new European law is based on a specific treaty article, referred to as the ‘legal basis’ of the proposal. This determines which legislative procedure must be followed. The three main procedures are ‘consultation’, ‘assent’ and ‘co-decision’.
Co-decision is the procedure now used for most EU law-making. In the co-decision procedure, Parliament does not merely give its opinion: it shares legislative power equally with the Council. If Council and Parliament cannot agree on a piece of proposed legislation, it is put before a conciliation committee, composed of equal numbers of Council and Parliament representatives. Once this committee has reached an agreement, the text is sent once again to Parliament and the Council so that they can finally adopt it as law. Conciliation is becoming increasingly rare. Most laws passed in co-decision are, in fact, adopted either at the first or second reading as a result of good cooperation between the three institutions. The diagram shows the procedure in greater detail.
The Commission plays a central role. It has the ‘right of initiative’. In other words, the Commission alone is responsible for drawing up proposals for new European legislation, which it presents to Parliament and the Council. As the European Union’s executive body, the Commission is responsible for managing and implementing the EU budget. Most of the actual spending is done by national and local authorities, but the Commission is responsible for supervising it – under the watchful eye of the Court of Auditors. Only if it satisfied with the Court of Auditors’ annual report does the European Parliament grant the Commission discharge for implementing the budget. The Commission also has to manage the policies adopted by Parliament and the Council, such as the Common Agricultural Policy. The Commission also has to make sure that EU countries do not subsidise their industries in such a way as to distort competition. Examples of EU programmes managed by the Commission range from the ‘Interreg’ (creating cross-border partnerships between regions and helping regenerate declining urban areas) to the ‘Erasmus’ programme of Europe-wide student exchanges.
The Commission acts as ‘guardian of the treaties’. This means that the Commission, together with the Court of Justice, is responsible for making sure EU law is properly applied in all the Member States. If it finds that an EU country is not applying an EU law, and therefore not meeting its legal obligations, the Commission takes steps to put the situation right. First it launches a process called the ‘infringement procedure’. This involves sending the government an official letter, saying why the Commission considers this country is infringing EU law and setting it a deadline for sending the Commission a detailed reply. If this procedure fails to put things right, the Commission must then refer the matter to the Court of Justice, which has the power to impose penalties. The Court’s judgments are binding on the Member States and the EU institutions.
In principle, it is up to the Commission President to decide which commissioner will be responsible for which policy area, and to reshuffle these responsibilities (if necessary) during the Commission’s term of office.
Two other institutions have a vital part to play: the Court of Auditors that checks the financing of the Union’s activities and the Court of Justice that upholds the rule of European law. The Court of Justice of the European Communities is based in Luxembourg. Its job is to make sure that EU legislation is interpreted and applied in the same way in all EU countries, so that the law is equal for everyone. It ensures, for example, that national courts do not give different rulings on the same issue. The Court also makes sure that EU Member States and institutions do what the law requires. The Court has the power to settle legal disputes between EU Member States, EU institutions, businesses and individuals. The Court is composed of one judge per Member State, so that all 28 of the EU’s national legal systems are represented. For the sake of efficiency, however, the Court rarely sits as the full court. It usually sits as a ‘Grand Chamber’ of just 13 judges or in chambers of five or three judges. The Court is assisted by eight ‘advocates-general’. Their role is to present reasoned opinions on the cases brought before the Court. They must do so publicly and impartially. To help the Court of Justice cope with the large number of cases brought before it, and to offer citizens better legal protection, a ‘Court of First Instance’ was created in 1988. This Court (which is attached to the Court of Justice) is responsible for giving rulings on certain kinds of case, particularly actions brought by private individuals, companies and some organisations, and cases relating to competition law. This court also has one judge from each EU country.
In addition to its institutions, the EU has a number of other bodies that play specialised roles: the European Economic and Social Committee represents civil society, employers and employees; the Committee of the Regions represents regional and local authorities; the European Investment Bank finances EU investment projects, and helps small businesses. In addition, specialised agencies have been set up to handle certain technical, scientific or management tasks.
The EU institutions have used consultation as a policy-making tool very early on. Since the beginning they have consulted the key interest groups in each policy area. And as more and more public policy is decided at the EU level, the interest groups have grown in Brussels. There are now thousands of lobbying organisations, professional or interest groups. This expansion went together with an institutionalisation of this consultation. It changed the political nature and structure of domestic groups with increased cross-border activity and the formation of coalitions. Some say that democracy is strengthened by group participation in the policy process, providing a link between citizens and policy-makers. It is true that the EU is one of the most transparent lobbying systems in Europe. The degree of group mobilisation is so important that there is a real competitive market for influence. In some sectors, the representation is structured and formalised. This is the case for health.
The EU Health Policy Forum serves as an information and consultation mechanism to ensure that the aims of the Community’s health strategy are made clear to the public and respond to their concerns. It provides an opportunity to representative organisations of patients, health professionals and other stakeholders, such as health service providers, to make contributions to health policy development, its implementation and the setting of priorities for action.
The aim of the Health Policy Forum is to bring together umbrella organisations representing stakeholders in the health sector to ensure that the EU health strategy is open, transparent and responds to the public concerns. The intention is to provide an opportunity to organise consultations, to exchange views and experience on a wide range of topics, and to assist in implementation and follow-up of specific initiatives.
The EU Health Policy Forum currently has 52 member organisations, including HOPE. Membership was revised in 2006 and in 2011. The EU Health Policy Forum meets regularly in Brussels. The meetings review the EU work in various areas of public health and adopt recommendations on them. The Forum seeks to evenly cover four groups of organisations: non-governmental organisations in the public health field and patients’ organisations; organisations representing health professionals and trade unions; health service providers and health insurance; economic operators with an interest in and commitment to health promotion, protection and improvement. The NGOs, which are members of the EU Health Policy Forum all cover a broad range of issues and have members in all or most of the EU Member States.
Healthcare essentially falls under the competence of the Member States. They are responsible for organising, financing and providing healthcare services. Nevertheless, by virtue of the principle of subsidiarity, the EU is increasingly being called upon to play an active role in healthcare, by embarking on actions that round out national policies while adding European value. This is especially the case in the field of major trans-national health threats, such as food safety, as well as in issues with a cross-border impact or those relating to the free movement of goods, services and persons. Since the early 1990s, a true EU health policy has been progressively formed, legitimised by a legal framework put in place during that same decade (Treaties of Maastricht and Amsterdam).
The health policy is not the only deciding policy in terms of healthcare. Other EU policies, such as those on the environment, research, and the regulation of pharmaceutical products are also essential. The EU has given itself the objective of integrating health in as many of its policies as possible.
In the European integration, health policy is essentially guided by the principle of national sovereignty. In keeping with the principle of subsidiarity, the EU only intervenes in areas that do not fall under its exclusive competency, such as public health, when and if its objectives can be better achieved at community level because of the breadth or effects of the planned action. As such, a function’s appropriate level of administration is the most decentralised one, except in special cases.
Member States have thus decided that the national or regional level was the most appropriate for decision-making in terms of the organisation and financing of healthcare services. As a result, EU actions in these areas are only legitimate if they round out and/or reinforce those that are carried out at a national level. On this account, and up to now, a large portion of EU legislation in the area of healthcare has not fundamentally changed the way that healthcare systems function in the EU Member States, as the different treaties have provided the EU with very limited competencies in terms of healthcare systems.
Threats to health security stemming from the free movement of goods in the internal market were brought to light in spectacular fashion during the bovine spongiform encephalopathy (“mad cow disease”) crisis in the late 1980s. They paved the way for an initial delegation of competencies to the Community when intervention in public health matters seemed more appropriate at a European scale.
The 1992 Treaty of Maastricht, in article 129, was the first to structure the European Union’s approach to health issues, providing for the Community to “contribute towards ensuring a high level of human health protection”. Nonetheless, community intervention in this framework remained limited. It favoured the prevention of diseases, major health threats and their transmission, and health information and education.
Article 152 of the Treaty of Amsterdam (1997) expanded the Union’s competencies in public health by conferring decision-making powers in certain areas. This is the case, for instance, in setting standards for the quality and safety of organs and substances of human origin, blood and blood derivatives. The treaty also made public health a specific common objective of the Community, and a complementary element of other common policies, namely agriculture, industry and consumer protection. The EU is no longer enjoined to “contribute”, but to ensure “a high level of human health protection (…) in the definition and implementation of all Community policies and activities.”
Later, the Charter of Fundamental Rights of the European Union (appended to the Treaty of Nice, 2000) would refer to health protection. Article 35 of the charter states that “everyone has the right of access to preventive healthcare and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.”
With a legal basis at its disposal for public health intervention, the EU establishes a public health policy and attempts to integrate it in all Community policies and activities.
The Lisbon Treaty adopted in 2009 is providing important changes in the article 168 that replaces article 152. It is now the ordinary legislative procedure that will deal with the quality and safety of organs and substances of human origin, blood and blood derivatives. Another remarkable change is that pharmaceuticals and medical devices are now part of this article, which was not the case previously.
EU public health policy
The Commission initially presented in 1993 a notice on its policy framework for health. A policy was truly established in 2000, when the Commission adopted a new strategy for a more coherent approach of public health issues.
The strategy focused on three priorities: improving health information and knowledge, responding rapidly to health threats, and addressing health determinants, particularly lifestyles and the environment.
Consumer health and food safety were taken into consideration in a single approach. The Commission reorganised its services, combining the consumer policy and health portfolios, and creating the Directorate-General for Health and Consumer Protection (DG SANCO) in 1999.
Other tools, including a number of agencies, were put in place for health. One of the most important ones was the European Centre for Disease Prevention and Control (ECDC), created in 2005. To improve EU capacity to cope with communicable disease and bioterrorism, its mission is to coordinate the laboratories of Member States. The purpose of the ECDC is to play a defining role in the prevention of serious health threats such as avian flu and HIV/AIDS, as well as infections associated with health services.
The first legislative measure to take advantage of the new Community competence granted by the Treaty of Amsterdam (1997) involved blood products. Inspired by the work of the Council of Europe, the directive required laboratories, hospitals and other establishments collecting, handling and processing blood and blood components to introduce quality management systems. The main requirements of this system are defined at European level on the basis of best practices, in view of the application of equivalent standards of management and safety throughout the Union. Staff working in these establishments and participating directly in the collection, testing, processing, storage and distribution of blood are required to undergo training that meets Community standards. It was followed by a directive on human tissues and cells and more recently on organ donation and transplantation.
European Union public health programmes
Article 129 of the Treaty of Maastricht (1992) made it possible to create or pursue the progressive development of European public health programmes, especially joint activities on smoking, HIV/AIDS, drug abuse, the surveillance of communicable diseases, and health promotion.
In 1993, the Commission presented a communication on the framework for action in the field of public health. On this basis, eight action programmes on health promotion, cancer, drug dependence, AIDS and other communicable diseases, health monitoring, rare diseases, accidents and injuries, and pollution-related diseases were adopted.
Later, as part of a new strategy, the Commission decided to bring together all public health initiatives in an integrated public health programme, adopted in 2002 and with an initial budget of €312 million for the 2003–2008 period. This programme was based on a very critical evaluation of previous programmes. EU health action is now subject to three key principles that were not previously considered: integration of budget issues, sustainability, and concentration on priority issues. The need for European added value, mainly through the involvement of a large number of Member States and candidates, is also reinforced, as are large-scale, multi-year and multidisciplinary projects.
The three general objectives of the programme were closely tied to those of the Community public health policy: improving health information in order to promote public health, reinforcing the capacity for rapid and coordinated reaction to health threats, and promoting health and preventing disease by addressing health determinants through Community policies and actions.
These objectives provided a framework of reference for annual work plans and determined the priority actions for the tasks to be undertaken, as well as the resources allocated to them. That said, only 0.5% of the Community budget is slated annually for calls for tender.
The second programme of community action in the field of public health for the 2008–2013 period with a financial envelope of €321.5 million fell short of the Commission’s ambitions.
This programme was intended to continue the actions of the previous one. Its major thrust was to support the integration of health goals in all community policies and activities. It especially hopes to undertake joint actions with other programmes, such as research, structural funds and consumer protection. A new one has been set up for the period 2014–2020.
The new EU Health Programme is aimed at encouraging innovation in healthcare, increasing the sustainability of health systems, improving the health of EU citizens and protecting them from cross-border health threats. The programme will have up to €449.4 million at its disposal.
More precisely, the new EU Health Programme seeks to complement Member States’ health policies in the following four areas:
- Promotion of good health and prevention of diseases; eligible actions include for instance the exchange of good practices for addressing risk factors such as smoking, harmful use of alcohol, unhealthy dietary habits and physical inactivity;
- Protection from cross-border health threats, which might be improved via an increase of the capacities for scientific expertise;
- Innovative and sustainable health systems where the new EU Health Programme could provide support of the voluntary cooperation between Member States on health technology assessment (HTA);
- Increased access to better and safer healthcare; eligible actions include support for Member States and patient organisations to help patients affected by rare diseases and the reduction of practices that increase antimicrobial resistance.
Other European policies
Many EU policies and activities have an impact on health, healthcare systems, healthcare services, and, consequently, hospitals. They are often devised according to a policy rationale outside of health, without necessarily knowing all the potential effects. Article 168 of the treaty may well clearly require the European Union to make sure that EU policies and activities contribute to ensuring a high level of health protection, but health policy cannot influence alone health determinants. Coordinated action with other policies – environmental, social and economic – is needed. There are ongoing partnerships, especially in the following areas: the pharmaceutical sector; demographic changes and ageing; the use of structural funds for health, and health in the information society.
The 2020 strategy is the EU main policy for economic growth and productivity. Integration of health concerns in the programme is one of the most significant results obtained as part of the integration of health concerns in other EU policies.
The link between health and economic prosperity is more and more widely recognised, particularly in relation to the ageing population. As such, the ‘Healthy life years’ indicator, which measures the number of years lived in good health, is one of the European Structural Indicators of the Lisbon Agenda.
The other important element is the introduction of the ‘open method of coordination’ (OMC) in the area of health, and more specifically, long-term stays. The OMC is one of the instruments that aiming at achieving the objectives of the 2020 strategy for growth and employment. But the strongest instrument is now the European Semester, the EU’s annual cycle of economic policy guidance. Each European Semester the European Commission analyses the fiscal and structural reform policies of every Member State, provides recommendations, and monitors their implementation and the Member States implement the commonly agreed policies. and surveillance.
Joint strategies and initiatives with other health-related policy areas are also important tools to ensure that health concerns are being properly addressed. Such joint approaches have been developed, for instance, on health and the environment, health and social policy, eHealth, research on life sciences and on health policy, and health and pharmaceuticals policy. A health Inter-Service Group involving representatives from most Commission Directorate-Generals is chaired by the Directorate-General on Health and Food Safety (DG SANTE), and meets every six months, to improve coordination and integration of health protection within the Commission services. This group allows different Commission services to present work in their areas of responsibility, which could have a health impact, and also allows DG SANTE to share its own work with other Commission’s Directorate-Generals.
In the field of information systems, the eHealth initiative of the Commission, along with the action programme for public health, form part of the European Union’s strategy to provide European citizens with access to reliable, high quality information. The eEurope 2020 action plan adopted on 14 June 2000 sought to:
- Ensure that primary and secondary healthcare providers have healthcare telematics infrastructure in place, including regional networks;
- Identify and disseminate best practice in electronic health services in Europe and set benchmarking criteria;
- Establish a set of quality criteria for health related websites;
- Establish health technology and data assessment networks;
- Publish a communication on ‘Legal aspects of health on the internet’.
eHealth is now part of the Digital Single Market Strategy adopted in May 2015 that includes a set of targeted actions. It is built on three pillars: better access for consumers and businesses to digital goods and services across Europe; creating the right conditions and a level playing field for digital networks and innovative services to flourish; maximising the growth potential of the digital economy.
Evidently, the other major aspect in this area is data protection, which has been the subject of directives that, while not specific to the health sector, integrate its issues.
Today, actions in this area focus not only on interoperability, but also on telemedicine and innovative technologies for chronic disease management.
Research policy is also an area where community policies cross each other, and raises questions in terms of clinical trials or advanced therapy, even if the latter, like medicines, follow an internal market rationale.
The new research framework programme “Horizon 2020” for the period 2014–2020 has a total budget of €70.2 billion.
Simplification has been one of the main goals in the design of Horizon 2020. This will have a simpler programme architecture based on three pillars: excellent science (32% of the total budget); industrial leadership (22%); societal challenges, which addresses major concerns shared by citizens in Europe and will focus in areas such as health, climate, food, security, transport and energy (39%).
But the European Union is above all economy-oriented, founded on the principles of the free circulation of goods, services, persons and capital, as well as on the rules of competition. These rules and principles apply one way or another to almost all sectors, including the hospital and healthcare one. Although they do not necessarily measure its impact on a daily basis, hospitals thus live in an environment that is governed to a great extent by community legislation. As purchasers of goods and services, hospitals and healthcare services have been affected by the removal of barriers to free movement of all kind of goods and services. Within this framework, a special attention has been directed to pharmaceuticals and medical devices, leading to specific legislation in this field. The European Court of Justice even confirmed that medical care and hospital care were themselves services and as such falling under the scope of the free movement principles. Mobility is also meant for workers as well as for other persons.
For health professionals, several European directives, then a single one revised in 2013, have harmonised the minimum conditions of training and provided for mutual recognition of professional qualifications and introduced some specificities for health professions (doctor, nurse, midwife, dentist and pharmacist). More generally other measures have been adopted in the social sphere to avoid social dumping, following in particular the coordination of social protection. All of this had an impact of the hospital and healthcare workforce. At the same time European rules on competition are also growingly interfering with the healthcare sector and as the major part of hospital and health financing are public, various questions of their position regarding the community legislation on state aid are currently raised.
In conclusion, the European Union has very limited direct competences in the healthcare field and has only been able to develop a rather constrained public health policy. According to the principle of subsidiarity, the organisation and financing of healthcare remains a Member State’s competence. However, the European Union has developed other policies that have been influencing hospital and health services. In addition to these interventions, European integration is taking place by cooperation activities developed within the remit of European programmes as well as outside them.