Directive 2011/24/EU of March 9, 2011 on patients' rights in cross-border healthcare aims to guarantee patient mobility and the free provision of healthcare services.
Background information
The European Union's coordination rules guarantee that an insured individual who travels within the European Union will receive the same healthcare as if s/he were a member of the healthcare system of the State in which treatment is provided.
Coordination regulations (EC) Nos. 883/04 and 987/09 entitle insured individuals to receive healthcare elsewhere within the European Union or the European Economic Area (Iceland, Liechtenstein, and Norway), as well as in Switzerland, and be covered for the care received by their home country's healthcare system according to that system's specific guidelines.
Legal precedent from the European Court of Justice has subsequently reinforced patients' rights. Indeed, by taking account of legal precedent (Kohll, Decker, Smits and Peerbooms, and Watts rulings), the directive reaffirms the principle of free movement of people.
This directive includes social security coordination rules which work together with those provided by (EC) regulations Nos. 883 and 987.
The directive is applicable in the European member States and in the European Economic Area (Iceland, Liechtenstein, and Norway). However, it does not apply to Switzerland. It no longer applies to the United Kingdom as of January 1st, 2021.
Content of the directive
The Directive aims to facilitate access to safe, high-quality cross-border healthcare and to promote healthcare-related cooperation between EU and EEA (Iceland, Liechtenstein, and Norway) member States, while maintaining each State's independent authority to organize and provide healthcare services:
- The patient is free to choose a healthcare provider or facility in either the public or the private sector;
- The patient is reimbursed by the member State of affiliation for at least the amount reimbursed for identical care provided in the State of residence, insofar as the treatment received abroad is covered by that State's healthcare system;
- Cross-border prescriptions for medications or medical devices: the patient's home country must provide follow-up care of equal quality, regardless of where treatment was initially provided;
- Creation of a National Contact Point in each country to inform patients of all of their rights. The Cleiss is France's National Contact Point;
- Formation of a network of national authorities in charge of "e-health" to improve continuity of care and guarantee access to high-quality care;
- Establishment of a network of authorities or bodies in charge of assessing healthcare technologies as a way of promoting cooperation among the competent authorities from each State (see questions 42 to 45 of the frequently asked questions);
On this subject, please note that article 15 of Directive 2011/24/EU has been cancelled and replaced by Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU.
- Member States are encouraged to work together to improve treatment of rare diseases by developing new diagnostics and treatment solutions;
- Support for creating European healthcare provider reference networks, promoting mobility of expertise in Europe and access to highly specialized care by concentrating and combining available resources and expertise.
- Facilitation of cooperation in cross-border healthcare provision at regional and local level as well as through information and communication technologies and other forms of cross-border cooperation. Encouragement of Member States, particularly neighbouring countries, to conclude agreements among themselves and to cooperate in cross-border healthcare provision in border regions.
People covered
Directive 2011/24/EU covers all European Union citizens, nationals of the States of the European Economic Area (Iceland, Liechtenstein and Norway), refugees and stateless persons residing in a Member State of the European Union or the European Economic Area, who are or have been subject to the legislation of one or more Member States, as well as their family members and their survivors.
The directive also covers nationals of third countries in relations between Member States of the European Union with the exception of Denmark, which did not ratify Regulation (EU) No 1231/2010 of the European Parliament and of the Council of 24 November 2010.
The directive does not apply to nationals of third coutries in relations between the Member States of the European Union and the States of the European Economic Area (Iceland, Liechtenstein, Norway).
Healthcare covered
The directive covers all healthcare provided or prescribed in a member State that is not the State of affiliation. It also covers the prescription and delivery of medications and medical devices which are supplied as part of the healthcare being received.
The directive does not apply to:
- Long-term care (home care services),
- Organ donations,
- Public vaccination programs.
Healthcare providers covered
The directive covers all healthcare providers legally practicing medicine (public or private, whether or not they charge government-regulated fees), and regardless of whether the services they provide are "reimbursable."
Transposition into French law
The criteria for and details of how medical care is reimbursed, as provided by regulations Nos. 883/04 and 987/09, which currently cover patients who receive care in another European Union or EEA country or Switzerland, remain applicable.
The directive adds on to the current system by incorporating ECJ legal precedent and by bolstering patients' rights when it comes to information and to the quality and safety of care.
The rules for coverage of care are set forth by articles R160-1 et seq of the French social security code:
- Article R160-1 applies to unforeseen or emergency care ("medically necessary during a temporary stay") in another European Union or European Economic Area (Iceland, Liechtenstein, and Norway) member State or in Switzerland: this is covered by the European Health Insurance Card (EHIC) or the provisional replacement certificate. The EHIC is proof of the patient's entitlement to health insurance coverage and to the same coverage in the country being visited as those insured in that country.
- Article R160-2 applies to "scheduled care," where the patient travels to another European Union or European Economic Area (Iceland, Liechtenstein, and Norway) member State or to Switzerland for the purpose of receiving medical treatment. This requires prior authorization for reimbursement from the local health insurance fund to which the patient belongs. Article R160-2 as from decree No. 2015-1865 of December 30, 2015 circumscribes the prior authorization requirement to include only scheduled care that implies overnight hospital accommodation for at least one night, and to that requiring the use of major medical equipment (scanners and MRIs in particular). The list of major medical care and treatments requiring prior authorization has been determined by decree of May 27, 2014.
The provisions of the directive pertaining to the recognition of prescriptions written in another EU member State have been transposed into French law by decrees No. 2013-1216 of December 23, 2013 (medications) and No. 2014-1525 of December 27, 2014 (medical devices).
French Law No. 2014-201 of February 24, 2014, which brings various aspects of French health-related law into line with European law, requires persons authorized to use the titles of "chiropractor" and "osteopath" to take out specific insurance.
Decree No. 2015-223 of February 26, 2015 pertaining to the setup and revised roles of the Cleiss, designates the latter as France's National Contact Point as defined by directive 2011/24/EU.
How the directive works together with regulation No. 883/2004
The directive mainly applies to ambulatory care, whether or not it is scheduled. Unforeseen or emergency care covered by the EHIC remains within the scope of (EC) regulations Nos. 883/04 and 987/09.
This means that the scopes of (EC) regulation No. 883/2004 and directive 2011/24/EU coexist and are complementary. A comparison of the healthcare system in the country of affiliation and that of the country where care is received will determine whether the directive or the regulation applies.
Directive 2011/24/EU does not apply to Switzerland (whereas (EC) regulation No. 883/2004 does).
(EC) regulation No. 883/2004:
- Prior authorization (Form S2, "entitlement to scheduled treatment") is required for coverage of scheduled care in another European Union or European Economic Area (Iceland, Liechtenstein, and Norway) member State or in Switzerland which will include at least 1 night of hospitalization, or for major treatments which appear on a list. Other scheduled care is covered without prior authorization.
- If coverage is granted, the monetary amount covered will be based on the rates set by the Social Security system of the member State where the healthcare was provided. If the insured has paid upfront and has not applied for reimbursement in the country in which the healthcare was provided, the expenses incurred will be reimbursed by the State of Insurance according to the rates applicable in the State in which treatment was provided or, at the insured's request, according to the rates set by the French Social Security system, up to the actual amount incurred.
Directive No. 2011/24/EU:
- France offers a single prior authorization procedure pursuant to the directive and the regulation for certain scheduled treatments (care requiring at least 1 night of hospitalization or the use of major medical equipment).
- Standard ambulatory care (which does not include full hospitalization) is not subject to prior authorization. It is reimbursed based only on the rates set by the French Social Security system, up to the actual amount incurred.
Applicable legislation
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