EUROPEAN COMMISSION EMPL/-/12 - EN

AC 246/12
Guidance note of the Commission services on the relationship between Regulations on the coordination of social security systems and Directive on the application of patients' rights in cross border healthcare
SECRETARIAT – 21.05.2012

Orig. EN

ADMINISTRATIVE COMMISSION
FOR THE COORDINATION OF SOCIAL SECURITY SYSTEMS

Subject: Guidance note of the Commission services on the relationship between Regulations (EC) Nos 883/2004 and 987/2009 on the coordination of social security systems and Directive 2011/24/EU on the application of patients' rights in cross border healthcare

Note from the Commission of 21 May 2012

Delegations will find enclosed the guidance note of the Commission services on the relationship between Regulations on the coordination of social security systems and Directive on the application of patients' rights in cross border healthcare together with a graphical presentation of the scenarios described in the note.

The Administrative Commission has already had a first discussion on the subject in question. The Secretariat, together with DG SANCO, presented a joint note AC 422/11, identifying the main points of inter-relation between Regulations (EC) Nos 883/2004 and 987/2009 and Directive 2011/24/UE. The note was discussed at the Working Party of the Administrative Commission on Patients Mobility on 4 October 2011 (see minutes note AC 332/11) and the delegations subsequently submitted their written observations.

The present document aims at ensuring the coherent application of the Regulations and the Directive by the Member States with regard to social security aspects which are covered by both instruments, and at guiding Member States when transposing Directive 2011/24/EU. The document is intended for lawmakers and experts and will have to be supplemented by further guiding documents for institutions and citizens. The guidance note has been elaborated jointly by DG EMPL and DG SANCO and approved by the Legal Service of the European Commission.

The guidance note will be presented to the Members of the Committee on Cross-Border Healthcare at the meeting on 30 May 2012 and to the Members of the Administrative Commission for the Coordination of the Social Security Systems at the meeting on 12-13 June 2012.

Annexes:

1. Guidance note of the Commission services

2. Graphical presentation of the scenarios described in the guidance note

1

Annex 1

Guidance note of the Commission services on the relationship between Regulations (EC) Nos 883/2004 and 987/2009 on the coordination of social security systems and Directive 2011/24/EU on the application of patients' rights in cross border healthcare[1]

In the field of cross-border healthcare, Regulations (EC) Nos 883/2004 and 987/2009 on coordination of social security systems have put in place a system aimed at ensuring access to healthcare in various situations such as temporary stay abroad and residence outside the competent Member State. The Regulations also include provisions for planned healthcare.

On the other hand, Directive 2011/24/EU on the application of patients' rights in cross-border healthcare was adopted on 24 April 2011 with the aim to facilitate access to safe and high-quality cross-border healthcare. The Directive codifies the abundant jurisprudence of the Court of Justice on the application to healthcare of Article 56 of the Treaty FEU. The Directive has to be transposed by Member States by 25October 2013.

Since both the Regulations and the Directive cover healthcare received in other Member States, the implementation of the Directive must take into account the obligations and requirements laid down by the Regulations. In order to support Member States when transposing Directive 2011/24/EU and to ensure the coherent application of the Regulations and the Directive by the Member States, the European Commission undertook to provide a specific legal analysis of the relationship between these two legal instruments and its practical consequences by way of this interpretative note.


I. Horizontal rules

1. Relationship between the two instruments

When looking at the relationship between Regulations (EC) Nos 883/2004[2] and 987/2009[3] (hereinafter the Regulations) [4] and Directive 2011/24/EU[5] (hereinafter the Directive), it should be clear that both legal instruments are linked to the free movement of workers with respect to the EU fundamental freedoms. The Regulations fall within the framework of the free movement of persons, while the Directive falls within the framework of the freedom to provide services.

The main purpose of the Regulations is to ensure that insured persons – mainly workers - do not lose their social security protection when moving to another Member State.

The main purpose of the Directive is to facilitate access to safe and high-quality cross border healthcare, to ensure patients' mobility and to promote cooperation on healthcare between Member States, whilst respecting the competence of Member States' for organising their own healthcare systems. The Directive codifies a number of rulings of the Court of Justice of the European Union regarding the freedom of patients to seek medical services abroad and to be reimbursed for such services by their home Member State, and introduces a number of measures to facilitate the implementation of these rulings in practice.

The Regulations and the Directive are two independent instruments that apply within their own respective designated areas. In accordance with Article 1 of the Directive, the Directive clarifies the relationship of these two instruments. To this end, Article 2(m) specifies that the Directive shall apply without prejudice to the Regulations. Furthermore, Recital 30 of the Preamble to the Directive stresses the need for coherence between the two instruments, stating that rights under the two instruments cannot be used simultaneously.

Recital 31 moreover clarifies that patients should not be deprived of the more beneficial rights guaranteed by the Regulations (EC) No 883/2004 and No 987/2009 when the conditions of these Regulations are met. This Recital also provides that where the patient is entitled to cross-border healthcare under both the Directive and the Regulations, and the application of the Regulations is more advantageous to the patient, the patient’s attention should be drawn to this by the Member State of affiliation.

The Directive furthermore clarifies the relationship between the Directive and the Regulations with regard to specific matters, such as granting of prior authorisation (Recital 46 and Article 8(3)), assumption of costs of necessary healthcare (recital 28) or reimbursement of costs of healthcare (Article 7(1) and (2)). The application of the two legal instruments with regard to these matters is examined in the relevant chapters of this note.

Conclusion: The Directive applies without prejudice to Regulations (EC) No 883/2004 and No 987/2009. The coherent application of the two instruments must be ensured by the Member States. As a general principle, when the terms of the Regulations are met, treatment should be delivered under the Regulations, unless a patient, fully informed about his/her rights, requests otherwise.

2. Material scope of application

The Regulations apply to the social security branches referred to in Article3 of Regulation (EC) No 883/2004, which include, inter alia, sickness benefits (Article 3(1)(a)) and benefits in respect of accidents at work and occupational diseases (Article 3(1)(f)). These two branches are relevant for the purpose of this note, in so far as they refer to benefits in kind. When the text of this note refers to sickness benefits, it shall be understood as relevant also to benefits in respect of accidents at work and occupational diseases, for ease of reading. However, in accordance with Article 3(5) thereof, social and medical assistance are excluded from the material scope of the Regulations.

Article 1(va) of Regulation (EC) No 883/2004 provides for a definition of the benefits in kind for the purpose of the two above branches. These cover those benefits in kind which are intended to supply, make available, pay directly or reimburse the cost of medical care and products and services ancillary to that care, including long-term care benefits in kind, and are provided for under the national legislation or under the accidents at work and occupational diseases schemes of the Member States.

The Regulations cover both planned and unplanned treatment.

The material scope of the Directive is defined by the combined provisions of Article 1 and Article 3(a) and (e) thereof. In accordance with Article 1, the Directive applies to the provision of cross-border healthcare to patients, regardless of how it is organized, delivered and financed. Article 3(a) provides for a definition of healthcare which means health services provided by health professionals to patients to assess, maintain or restore their health, including the prescription, dispensation and provision of medicinal products and medical devices. Article 3(e) defines the term "cross-border healthcare" as healthcare provided or prescribed in a Member State other than the Member State of affiliation.

Article 1(3) of the Directive lists the types of care excluded from the application of the Directive. These are long-term care services to support people in carrying out routine, everyday tasks; allocation of and access to organs for transplantation; as well as public vaccination programmes against infectious diseases which aim at protecting the health of the population of a Member State and are subject to specific planning and implementation measures.

Furthermore, it is clear from the above provisions that the Directive, as regards its scope, does not distinguish between planned and unplanned healthcare but applies in principle to all care received by patients in a Member State other than their Member State of affiliation, regardless of the circumstances[6]. This includes therefore both planned and unplanned healthcare.

Finally, under the Directive all providers, including non-contracted or private providers, are covered.

In the light of the provisions set out above, the material scope of the two instruments is very similar. Sickness benefits in kind and benefits in kind for accidents at work and occupational diseases covered by Article 3(1) (a) and (f) of Regulation (EC) No 883/2004 fall under the definition of healthcare provided in Article 3(a) of the Directive and therefore, within the material scope of application of the Directive defined in Article 1(1) and (2).

Conclusion: The material scope of Regulation (EC) No 883/2004 and the Directive overlap, except in the field of long-term care benefits, which are not covered by the Directive. Both the Regulations and the Directive apply to planned and unplanned healthcare. The Directive covers all providers, including non-contracted or private providers, while Regulation (EC) 883/2004 does not impose any obligation on the Member States with regards to treatment given by providers who are not subject to the national legislation of the Member State of treatment, such as certain non-contracted or private providers.

3. Personal scope of application

The personal scope of the Regulations is defined in Article 2 of Regulation (EC) No 883/2004. In accordance with this provision, the Regulations apply to nationals of a Member State, stateless persons and refugees residing in a Member State who are or have been subject to the legislation of one or more Member States, as well as to the members of their families and to their survivors[7]. They also apply to the survivors of persons who have been subject to the legislation of one or more Member States, irrespective of the nationality of such persons, where their survivors are nationals of a Member State or stateless persons or refugees residing in one of the Member States.

Regulation (EU) No 859/2003, for United Kingdom, and Regulation (EU) No 1231/2010, for all the Member States except United Kingdom and Denmark, extend the application of the Regulations to nationals of third countries who are not already covered by these Regulations solely on the ground of their nationality as well as to members of their families and to their survivors, provided that they are legally resident in the territory of a Member State and are in a situation which is not confined in all respects within a single Member State[8].

In accordance with Article3(b) of the Directive, the personal scope of the Directive covers persons, including members of their families and their survivors, who are covered by Article 2 of Regulation (EC) No 883/2004 and who are insured persons within the meaning of Article 1(c) of that Regulation. The Directive also covers nationals of a third country who are covered by Regulation (EU) No 1231/2010 (all Member States except for United Kingdom and Denmark) or Regulation (EC) No 859/2003 (United Kingdom), or who satisfy the conditions of the legislation of the Member State of affiliation for entitlement to benefits (e.g. Denmark). Therefore, nationals of a third country and their family members legally residing in any of the Member States or, in the case of Denmark, who satisfy the conditions of the legislation of the Member State of affiliation for entitlement to benefits are covered by the Directive, provided they are in a situation which is not confined in all respects within a single Member State.

Conclusion: The Directive applies to persons covered by Regulation (EC) No 883/2004 as well as to the third country nationals and their family members who are legally resident in the territory of a Member State or, in the case of Denmark, who satisfy the conditions of the legislation of the Member State of affiliation for entitlement to benefits and are in a situation which is not confined in all respects within a single Member State.


II. Planned healthcare

1. Request for prior authorisation

As a rule, under the Regulations prior authorisation is a necessary requirement for receiving planned treatment in another Member State. In accordance with Article 20(1) of Regulation (EC) No 883/2004, the insured persons and members of their family travelling to another Member State with the aim of receiving benefits in kind during the stay must seek an authorisation from the competent Member State[9].

Article 1(s) of Regulation (EC) No 883/2004 defines the competent Member State as the Member State in which the institution with which the person concerned is insured or from which the person is entitled to benefits is situated.

If an insured person does not reside in the competent Member State, a request for prior authorisation for the planned treatment in a third Member State is made in the Member State where the person resides. Theprior authorisation is then issued by the competent Member State on the basis of an assessment made by the Member State of residence (Article 26(2) of Regulation (EC) No 987/2009). The procedure applicable to planned treatment in a third Member State is described in detail in Chapter IV of this note.