The evolving legal framework

Adapting regulations to take account of cross-border cooperation

Some Member States have adapted their planning tools for healthcare services to take account of cross-border cooperation. France, for example, incorporated the cross-border dimension for the first time when it drew up its regional healthcare organisation plans in 2006.

Agreements have also been concluded between countries, regions and the bodies that finance and provide healthcare. As regards the mobility of patients and health professionals, agreements on the reimbursement of treatment costs and authorisations to practice on the other side of the border have been adopted.

In addition, bilateral instruments have been put in place at national level. Their aim is to facilitate or develop pre-existing cross-border cooperation. Thus, two framework agreements have been signed by France – one with Germany in 2005, another with Belgium (signed in 2005 and ratified in 2011), as well as one between France and Spain, adopted in 2008. In the same year, France also signed a bilateral agreement with Hungary on cooperation in healthcare. Framework agreements for healthcare cooperation with Switzerland, Luxembourg and the Principality of Monaco are also being negotiated. However, such agreements do not remove all obstacles to the development of cross-border cooperation. Aside from the fact that they can be used as a means of recentralisation, their implementation involves a certain time lag and does not resolve all the difficulties encountered locally.

Although France and Germany had already enshrined the rules successively laid down by the European Union’s Court of Justice in their respective national laws (Sozialgesetzbuch and Code de Sécurité sociale), there was no regulation common to all European countries that consolidated the principle of the free circulation of patients, enabling them to receive treatment abroad without prior authorisation from their health insurance body and harmonising procedures for the payment for cross-border treatment. This gap has now been filled by the healthcare directive, the rules of which will coexist with those laid down by European regulations 883/2004/EC and 987/2009/EC.

Regulation (EC) 883/2004 lays down the principle of equality of treatment of European citizens with regard to health care: the nationals or residents of an EU country are equal with regard to the rights and obligations stipulated by the national legislation. More practically, it stipulates that a patient receiving emergency care or planned care (with prior authorisation) in a State other than the State where he or she is insured is to be treated under the same conditions as the persons insured in that State. In practical terms this means that the cost of the care will be reimbursed by the social insurance body of the country of affiliation (to the patient or to the social insurance body of the country providing the care, depending on the system) at the rates and on the scales in effect in the country providing the care.

Important bilateral progress was made in July 2016 with the signing of a French-Swiss agreement (in force since October 2016) removing the need for dual affiliation of border workers to the health insurance systems of both countries, and allowing them to choose between the two regimes. With questions remaining on the retroactive effect of this measure, the French Court of Cassation issued a ruling on 15 March 2018 in favour of 9789 border commuters working in Switzerland who had requested their retroactive removal from the French social security system. In March 2018, the French health minister Agnès Buzyn made a commitment to enacting this ruling.

The changing European landscape with respect to healthcare

Initially, healthcare was not taken into account by the European Treaties, from the Treaty of Rome to the Single European Act of 1986. It was considered for the first time in the SEA in the form of legislation intended to protect the health and safety of workers within an integrated single market.
Between 1986 and 1997 Community issues in matters of health developed, through programmes in the fight against cancer and AIDS, and the need for common European policy grew notably in the context of numerous health crises such as the ‘mad cow disease’ crisis.
The Maastricht Treaty of 1992 (article 129) provides the legal basis for the competences of the European Union in public health matters, which was then extended in 1997 by the Treaty of Amsterdam (adoption of binding decisions). Health is defined as a shared competence in article 6 of the TFEU. In 1999 DG SANCO (Directorate General for Health and Consumer Affairs) was established, having now become DG SANTE (DG for Health and Food Safety). These Community competences in health matters were also laid down in article 168 of the Lisbon Treaty (2009), with the aim of taking into account health issues in all EU policy, the development of cooperation in border regions, and it widens the field of these competences.

This directive, which was proposed in 2008, is the result of the gradual meshing of European interests with those of healthcare players, with the health sector being affected by the construction of the internal European market. This impact occurred indirectly, i.e. on fundamentals other than those of healthcare. For example, the expansion of the internal market for goods determined the adoption of directives on medicines and medical devices.

The jurisprudence of the Court of Justice of the European Union (CJEU) has also in a way speeded up this process by defining healthcare (Kohll and Decker decisions in 1998) and hospital care (Smits and Peerbooms decisions in 2001) as services and applying the principle of free circulation to them. The latter takes precedence over the need for prior authorisation to receive care abroad, at least with regard to non-hospital care. Raising doubts with these decisions about the coordination of social protection policies defined by regulation 1408/1971, the European Court of Justice had introduced some legal uncertainty.

On the basis of this jurisprudence, the Commission initially proposed to include health services and the jurisprudence of the Court on patient mobility in the 2004 services directive (the Bolkenstein directive). The exclusion of health services at the near-unanimous request of the member States, the European Parliament and civil society led the European Commission, after a consultation from September 2006 to January 2007, to propose a health initiative which resulted in a draft directive, adopted on 19 January 2011.

Meanwhile, the extension of the EU’s competences introduced by the Lisbon Treaty in 2009 gave the European Union shared competence1 in respect of public health issues.

The European directive on cross-border healthcare

The EU Directive of March 2011, transposed by the Member States in 2013, codifies the jurisprudence of the CJEU2  and guarantees patient mobility and the freedom to provide health services. It defines (clause 29 of the recitals) the necessity to guarantee to patients the assumption of the costs of healthcare (in a State other than the State of affiliation) at least at the level as would be provided for the same healthcare had it been provided in the Member State of affiliation. The directive is applicable only to planned care, not to emergency care, which is always governed by the regulation.
The systems created by regulation 883/2004 and directive 2011/24/EC thus coexist and are complementary. According to the comparison between the system of the country of affiliation and that of the country providing the care (most beneficial system), either the directive or the regulation is applicable. 

Member States must therefore set up national contact points (in consultation with patient associations, healthcare providers and insurers) charged with informing patients about their rights and providing them with the details of the contact points in other Member States. EU patients’ lack of awareness of the directive is one of the European Commission’s major preoccupations with regard to healthcare. In France, the Cleiss (Centre for European and International Liaison for Social Security) is the National Contact Point for cross-border healthcare.

The directive also provides for the creation of a network of national authorities responsible for “online healthcare” in order to increase the continuity of treatment and ensure access to high-quality healthcare. Lastly, the creation of a network of authorities or bodies responsible for the evaluation of healthcare technologies is aimed at facilitating cooperation between the competent national authorities in this area.

In 2015 the European Commission published a report addressed to the European Parliament on the functioning of the 2011 Directive relating to cross-border healthcare. The Commission also published another report in October 2016, taking stock of the Member States’ application of the Directive.


Other instruments for actions in the field of health have developed at the EU level, such as the multi-annual healthcare programmes beginning in 2003, specific recommendations by country in the context of the European Semester, and the Open Method of Coordination (OMC) in order to collect data on healthcare, beginning in 2004. Other instruments exist, including the European Food Safety Authority, the European Medicines Agency, and the European Centre for Disease Prevention and Control.

  1. Under Article 4 of the TFEU. Find out more about European legislation in the area of health. "Community action complements national policies, and the Union encourages cooperation between Member States in the field of health. However, defining national health policies remains an exclusive competence belonging to Member States. Consequently, EU action shall not include the definition of health policies, nor the organisation and provision of health services and medical care. European health policy therefore consists in developing a shared competence with Member States and complementing national policies."

  2. This concerns in particular the Van Braeckel ruling (12 July 2001). The CJEU considered that, for a procedure carried out in another country, the reimbursement must be at least as favourable as that stipulated in the Member State of affiliation. In consequence, an insured person who has received treatment in another country can claim a “differential supplement” from his or her social insurance body, if the coverage in the State of affiliation is higher.