Provisional text

delivered on 15 May 2025 (1)

Case C‑489/23

AF

Guvernul României,

Ministerul Sănătăţii,

Casa Judeţeană de Asigurări de Sănătate Mureș

(Request for a preliminary ruling from the Înalta Curte de Casaţie şi Justiţie (High Court of Cassation and Justice, Romania))

( Reference for a preliminary ruling – Social security – Cross-border healthcare – Freedom to provide services – Article 56 TFEU – Directive 2011/24/EU – Article 7(7) – Assumption of the costs of treatment incurred by the insured person – Reimbursement – Requirement for a medical assessment to be carried out exclusively by a health professional covered by the public health insurance scheme of the insured person’s Member State of affiliation, which has given rise to a request for hospitalisation )

Introduction

The question referred for a preliminary ruling which is the subject of this targeted Opinion, in accordance with the Court’s request, concerns the interpretation of Article 56 TFEU and Article 7(7) of Directive 2011/24/EU. (2) The Court has been called upon, for the first time, to rule on the question of whether that provision of that directive allows a Member State of affiliation to make the reimbursement of the costs of cross-border hospital healthcare subject to a medical assessment being carried out by a health professional covered by the public health insurance scheme of that State and to the subsequent issuing of a request for hospitalisation.

The request for a preliminary ruling has been made by the Înalta Curte de Casație și Justiție (High Court of Cassation and Justice, Romania) in proceedings between a Romanian resident, AF, on the one hand, and the Guvernul României (Romanian Government), the Ministerul Sănătăţii (Ministry of Health, Romania) and the Casa Judeţeană de Asigurări de Sănătate Mureș (District Health Insurance Fund, Mureș, Romania) [(‘the CJAS’)], on the other, concerning the refusal of the CJAS to reimburse AF for the costs of hospital healthcare he received in Germany.

Legal framework

European Union law

Regulation (EEC) No 1408/71

Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community, in the consolidated version of 7 July 2008, (3) provided, in Article 22 thereof, entitled ‘Stay outside the competent State – Return to or transfer of residence to another Member State during sickness or maternity – Need to go to another Member State in order to receive appropriate treatment’:

1.‘1.

An employed or self-employed person who satisfies the conditions of the legislation of the competent State for entitlement to benefits, taking account where appropriate of the provisions of Article 18, and:

…

(c) who is authorised by the competent institution to go to the territory of another Member State to receive there the treatment appropriate to his condition, shall be entitled:

(i) to benefits in kind provided on behalf of the competent institution by the institution of the place of stay … in accordance with the provisions of the legislation which it administers, as though he were insured with it; the length of the period during which benefits are provided shall be governed however by the legislation of the competent State;

…

The authorisation required under paragraph 1(c) may not be refused where the treatment in question is among the benefits provided for by the legislation of the Member State on whose territory the person concerned resides and where he cannot be given such treatment within the time normally necessary for obtaining the treatment in question in the Member State of residence taking account of his current state of health and the probable course of the disease.’

Regulation (EC) No 883/2004

Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (4) repealed and replaced Regulation No 1408/71 with effect from 1 May 2010.

Article 20 of Regulation No 883/2004, entitled ‘Travel with the purpose of receiving benefits in kind – authorisation to receive appropriate treatment outside the Member State of residence’, provides, in paragraphs 1 and 2 thereof:

1.‘1.

Unless otherwise provided for by this Regulation, an insured person travelling to another Member State with the purpose of receiving benefits in kind during the stay shall seek authorisation from the competent institution.

Regulation (EC) No 987/2009

Under Article 26(4) of Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems, (5) at any time during the procedure granting the authorisation, the competent institution is to retain the right to have the insured person examined by a doctor of its own choice in the Member State of stay or residence.

Directive 2011/24

Article 7(7) of Directive 2011/24 provides that the Member State of affiliation may impose on an insured person seeking reimbursement of the costs of cross-border healthcare, including healthcare received through means of telemedicine, the same conditions, criteria of eligibility and regulatory and administrative formalities, whether set at a local, regional or national level, as it would impose if this healthcare were provided in its territory. This may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient’s entitlement to healthcare. However, no conditions, criteria of eligibility and regulatory and administrative formalities imposed according to that provision may be discriminatory or constitute an obstacle to the free movement of patients, services or goods, unless it is objectively justified by planning requirements relating to the object of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources.

Article 8 of that directive provides as follows:

1.‘1.

The Member State of affiliation may provide for a system of prior authorisation for reimbursement of costs of cross-border healthcare, in accordance with this Article and Article 9. The system of prior authorisation, including the criteria and the application of those criteria, and individual decisions of refusal to grant prior authorisation, shall be restricted to what is necessary and proportionate to the objective to be achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of patients.

…

3. With regard to requests for prior authorisation made by an insured person with a view to receiving cross-border healthcare, the Member State of affiliation shall ascertain whether the conditions laid down in Regulation (EC) No 883/2004 have been met. Where those conditions are met, the prior authorisation shall be granted pursuant to that Regulation unless the patient requests otherwise.

…

Romanian law

The Normele metodologice privind asistența medicală transfrontalieră (Detailed rules on cross-border healthcare) (‘the detailed rules’) are set out in the annex to Hotărârea Guvernului nr. 304/2014 pentru aprobarea Normelor metodologice privind asistența medicală transfrontalieră (Government Decision No 304/2014 approving the Detailed rules on cross-border healthcare) of 16 April 2014 (‘Government Decision No 304/2014’), (6) which approved them.

Article 3(1)(b)(i) of those detailed rules, which appears in Chapter II, entitled ‘Methodology for reimbursing prices/rates representing the value of cross-border healthcare, including their level’, provides:

1.‘1.

At the written request of the insured person, a member of his/her family (parent, spouse, son/daughter) or a person authorised by him/her, accompanied by supporting documents, the health insurance fund shall reimburse the consideration for cross-border healthcare provided in the territory of a Member State of the [Union] and paid for by the insured person at the rates provided for in Article 4 if:

…

(b) the following eligibility criteria are met:

(i) hospital medical services were provided in another Member State of the European Union following a medical assessment carried out by a health professional providing health services under the Romanian health insurance system, which gave rise to a request for hospitalisation, with the exception of the situations referred to in Article 1, criterion No 2, and situations falling under the criteria for admission without a request for hospitalisation provided for in the Contractul-cadru privind condițiile acordării asistenței medicale în cadrul sistemului de asigurări sociale de sănătate (Framework contract on the conditions applicable to the provision of healthcare under the social health insurance system).’

Article 3(2) of the detailed rules states that ‘the “supporting documents” referred to in paragraph (1) mean any medical document, including the request for hospitalisation, the medical prescription for the issue of medicinal products and medical devices, the medical certificate mentioning the recommendation for treatment with specific medicinal products in national health programmes for curative purposes which are issued under the Romanian health insurance system in closed pharmacies – in copy – certifying that the insured person has received medical services, medicinal products and medical devices, dated and signed by the health professional who issued it …’

The facts, the dispute in the main proceedings, the questions referred for a preliminary ruling and the procedure before the Court

On 8 March 2018, AF, a Romanian resident, was diagnosed with adenocarcinoma of the prostate by the Clinica de Urologie și Andrologie Endoplus (Endoplus Clinic of Urology and Andrology) in Cluj-Napoca (Romania).

In view of the benefits for the patient’s health and subsequent recovery, the recommended treatment consisted of a prostatectomy using a surgical robot. AF was informed that such a robot existed in the public hospital in Cluj-Napoca (Romania), although it was not operational at that time, and that he could undergo the same procedure in the private system, at a cost of approximately EUR 13 000.

In that context, AF decided to have the operation using the surgical robot, at the same cost, at a specialist clinic devoted exclusively to that pathology, located in Germany.

At the beginning of April 2018, AF requested that the CJAS issue him with a specific form, Form E 112, which is required for treatment in another Member State under Regulation No 1408/71, replaced by Regulation No 883/2004, in order to obtain authorisation to travel to the territory of Germany to receive treatment there. That request was refused.

In parallel with that procedure, AF was offered the opportunity to have the surgery in Germany on 9 May 2018, following the cancellation of another patient’s booking for that date. In the event of his refusal, he would have had to wait for a surgery date for eight weeks after receiving the approval of the CJAS. On 24 April 2018, AF therefore made a payment with a view to reserving the date of 9 May 2018.

After making that payment, AF decided to send a request to be issued with the required form to the CJAS by post with acknowledgement of receipt. He received a reply stating that his request had not been made using the standard request form and was not accompanied by the documents required by national legislation.

The surgery, for which a ‘medical admission’ had been ordered from 8 to 14 May 2018, finally took place on 9 May 2018.

After the surgery, on his return to Romania, AF requested reimbursement from the CJAS of the amount of EUR 13 069, corresponding to the cost of the healthcare he had received in Germany, relying on Regulation No 1408/71, replaced by Regulation No 883/2004, and on the judgment of 5 October 2010 in Elchinov. (7) The CJAS refused payment, stating that Form E 112 had to be issued before the departure of the beneficiary and that AF should have followed the procedure provided for in the annex to Government Decision No 304/2014 in order to be reimbursed.

AF responded that he had also followed that procedure, but that it had been unsuccessful, and submitted that he could not be reimbursed because he had not submitted the request for hospitalisation from a health professional providing health services under the Romanian health insurance system, a condition required by Article 3(1)(b)(i) of the detailed rules.

By another request, AF sought reimbursement of the cost of cross-border healthcare from the CJAS and submitted a copy of certain documents requested in accordance with the detailed rules. That request was refused on the ground that there was no evidence that AF had undergone a medical assessment carried out by a health professional in the Romanian health insurance system which had given rise to a request for hospitalisation.

AF brought an action before the Curtea de Apel Târgu Mureș (Court of Appeal, Târgu Mureș, Romania) seeking partial annulment, inter alia, of Article 3(1)(b)(i) of the detailed rules, as well as reimbursement of the costs associated with the medical treatment he had received in Germany. He claimed, inter alia, that the provisions of Romanian law concerning the conditions for the reimbursement of medical services and the method of calculating the reimbursement of healthcare costs constituted an incorrect transposition of Directive 2011/24 and that he was entitled to reimbursement of the full cost of the treatment carried out in Germany, or at least up to the level of the fees which would have been paid by Romania through the health insurance system for the surgery in question if prior authorisation had been given.

By civil judgment of 30 December 2019 of the Curtea de Apel Târgu Mureș (Court of Appeal, Târgu Mureș), the action brought by AF was dismissed as unfounded.

AF then brought an appeal against that judgment before the Înalta Curte de Casație și Justiție (High Court of Cassation and Justice), which is the referring court.

That court has doubts as to the compatibility with EU law of the provisions of Romanian law which make the assumption of the costs of cross-border medical services subject to (i) a medical assessment being carried out by a health professional belonging to the public health system of the State of affiliation – to the exclusion of a health professional belonging to the private health system of that State – and (ii) a request for hospitalisation being issued by such a health professional, even though the health service at issue is provided in another Member State.

It also questions whether the national rule which limits the amount of reimbursement of the costs of cross-border medical services significantly as compared with the costs actually incurred by the insured person in the Member State which provided those medical services is consistent with EU law.

In those circumstances, the Înalta Curte de Casație și Justiție (High Court of Cassation and Justice) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Must Article 49 and Article 56 TFEU and Article 7(7) of Directive [2011/24] be interpreted as precluding legislation which automatically makes reimbursement of the costs incurred by a compulsorily insured person in the Member State of residence subject to a medical assessment carried out by a health professional providing health services under the health insurance system of that State and the subsequent issuing of a request for hospitalisation by that professional, without it being permissible to present equivalent medical documents issued by private medical establishments, even in a situation where the hospitalisation has taken place and the health service has been provided in a Member State other than that in which the insured person resides?

(2) Must Article 49 and Article 56 TFEU, Article 22(1)(c) of Regulation No 1408/71, the principles of free movement of patients and services, as well as the principle of efficiency and the principle of proportionality, be interpreted as precluding national legislation which, where prior authorisation is not obtained, sets the amount of the recoverable services at the level of the costs which would have been borne by the Member State of residence, had the medical care been provided in its territory, using a calculation formula which limits the amount of that reimbursement significantly as compared with the costs actually incurred by the insured person in the Member State which provided the health services at issue?’

Written observations have been submitted by the European Commission and the Polish Government.

Analysis

Preliminary observations

I would point out that there is a certain degree of fragmentation of competences in the area of health services, which has certainly created conflict between Member States’ sovereign powers in respect of organising their health services, (8) on the one hand, and the fundamental freedoms, on the other.

According to settled case-law, medical services provided for consideration fall within the scope of the provisions on the freedom to provide services, including situations where care is provided in a hospital environment. The freedom to provide services includes the freedom for the recipients of services, including persons in need of medical treatment, to go to another Member State in order to receive those services there. (9)

It is also apparent from the case-law of the Court that EU law does not detract from the power of the Member States to organise their social security systems. It is for the legislation of each Member State to determine, first, the conditions concerning the right or duty to be insured with a social security scheme and, second, the conditions for entitlement to benefits. Nevertheless, the Member States must comply with EU law when exercising that power, (10) in particular the provisions on the freedom to provide services. (11)

The Court has also repeatedly held that Article 56 TFEU precludes the application of any national rules which have the effect of making the provision of services between Member States more difficult than the provision of services purely within one Member State (12) and that restrictions on the freedom to provide services are national measures which prohibit, impede or render less attractive the exercise of that freedom. (13)

As regards Directive 2011/24, it follows from recital 4 thereof that, notwithstanding the possibility for patients to receive cross-border healthcare under that directive, Member States retain responsibility for providing safe, high quality, efficient and quantitatively adequate healthcare to citizens on their territory.

It also follows from recitals 7 and 8 of Directive 2011/24 that, while respecting and being without prejudice to the freedom of each Member State to decide what type of healthcare it considers appropriate, that directive is intended to achieve a more general, and also effective, application of principles developed on a case-by-case basis by the case-law of the Court concerning certain issues relating to healthcare provided in a Member State other than that in which the recipient of the care is resident, in particular reimbursement of that care.

Pursuant to Article 2(m) of Directive 2011/24, that directive is to apply without prejudice to Regulations No 883/2004 and No 987/2009.

Thus, in Chapter III of Directive 2011/24, which governs the reimbursement of costs of cross-border healthcare, Article 7 thereof, entitled ‘General principles for reimbursement of costs’, lays down, in paragraph 1 thereof, the principle that, without prejudice to Regulation No 883/2004 and subject to the provisions of Articles 8 and 9 of that directive, the Member State of affiliation is to ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation.

The first subparagraph of Article 7(4) of Directive 2011/24 provides that the costs of cross-border healthcare are to be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had that healthcare been provided in its territory, without exceeding the actual costs of healthcare received.

It is also apparent, in essence, from Article 7(7) of that directive that the Member State of affiliation may impose on an insured person seeking reimbursement of the costs of cross-border healthcare the same conditions, criteria of eligibility and regulatory and administrative formalities, whether set at a local, regional or national level, as it would impose if that healthcare were provided in its territory, including an assessment by a health professional, provided that those conditions, criteria of eligibility and regulatory and administrative formalities are not discriminatory and do not constitute an obstacle to the free movement of patients, services or goods, unless this is objectively justified by planning requirements.

Lastly, it follows from Article 7(8) of Directive 2011/24 that the Member State of affiliation is not to make the reimbursement of costs of cross-border healthcare subject to prior authorisation except in the cases set out in Article 8 of that directive. (14)

Thus, in order for a situation such as that at issue in the main proceedings to be capable of falling within the scope of Directive 2011/24, the healthcare in question must form part of the benefits to which the insured person is entitled in the Member State of affiliation. In the present case, it is apparent from the information available to the Court, and in particular from the referring court’s answers to the questions put by the Court, that the medical intervention at issue in the main proceedings is one of the benefits to which an insured person is entitled on Romanian territory.

I would also add that I question why, while the first question referred for a preliminary ruling, which is the subject of this targeted Opinion, concerns Directive 2011/24, the second concerns Regulation No 1408/71, which has been replaced by Regulation No 883/2004, and asks the Court about the limits on the amount of the recoverable services. The Court has already noted ‘the existence of a systemic difference between the reimbursement system established by Regulation No 883/2004 and that provided for by Directive 2011/24’. (15)

In that regard, I would point out, so far as is relevant, that, in accordance with recitals 30 and 31 of Directive 2011/24, the system established by the Union regulations on the coordination of social security systems and the system established by that directive should be coherent for patients, with the result that either one or the other applies. In addition, patients should not be deprived of the more beneficial rights guaranteed by the Union regulations on the coordination of social security systems when the conditions are met. Therefore, any patient who requests an authorisation to receive treatment appropriate to his condition in another Member State should always be granted that authorisation under the conditions provided for in the Union regulations when the treatment in question is among the benefits provided for by the legislation in the Member State where the patient resides and when the patient cannot be given such treatment within a time limit that is medically justifiable, taking account of his current state of health and the probable course of the condition. However, if a patient instead explicitly requests to seek treatment under the terms of Directive 2011/24, the benefits which apply to reimbursement should be limited to those which apply under that directive. Where the patient is entitled to cross-border healthcare under both that directive and Regulation No 883/2004, and the application of that regulation is more advantageous to the patient, the patient’s attention should be drawn to this by the Member State of affiliation.

The first question

The question referred for a preliminary ruling which is the subject of this targeted Opinion concerns the eligibility criterion imposed by the national legislation at issue, which, in essence, makes the reimbursement of hospital services provided in another Member State subject to a twofold condition, namely that those services follow a medical assessment carried out exclusively by a health professional covered by the public health insurance scheme of the Member State of affiliation, and cannot have been provided under the private system, and that the subsequent request for hospitalisation is issued by such a health professional in the Member State of affiliation, even though the hospital service is provided in another Member State.

I consider it appropriate to point out that, although it is apparent from the documents before the Court that the medical intervention at issue in the main proceedings is one of the services for which Romania requires, for the reimbursement of the costs of cross-border healthcare, prior authorisation, which must be issued by the competent institution before the insured person’s departure, the system of prior authorisation is not the subject matter of the question referred.

For the purposes of the present case, I would suggest that the Court reformulate the question referred so that the Court assesses whether Article 56 TFEU (16) and Article 7(7) of Directive 2011/24 are to be interpreted as precluding legislation which automatically makes the reimbursement of the costs of cross-border healthcare incurred by the insured person in the Member State of affiliation (17) subject to a medical assessment being carried out by a health professional providing medical services in the public health insurance scheme of that State and the subsequent issuing of a request for hospitalisation by that professional, without that person being allowed to submit equivalent documents (18) issued by a health professional who is not covered by the public health insurance system of that State.

In order to propose a useful answer to that question, I shall explain, first of all, what, in my view, is to be understood by ‘assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation’ within the meaning of Article 7(7) of Directive 2011/24, and the reasons why I consider that a Member State may rely on that provision in order to require a medical assessment by a health professional covered by the public health insurance scheme of the Member State in question, to the exclusion of a health professional not covered by that system. It will then be necessary to examine more specifically the twofold condition imposed by the national legislation at issue, namely that the cross-border hospital services follow a medical assessment carried out by a health professional covered by the Romanian public health insurance scheme, which has also given rise to a request for hospitalisation issued by such a health professional. The question will then also arise as to whether that eligibility criterion constitutes an obstacle to the free movement of patients or services and, if so, whether it is objectively justified in relation to the objective pursued.

The assessment by a health professional or healthcare administrator providing services for the statutory social security system or the national health system of the Member State of affiliation, within the meaning of Article 7(7) of Directive 2011/24

In accordance with the settled case-law of the Court, when interpreting a provision of EU law, it is necessary to consider not only its wording but also its context and the objectives pursued by the rules of which it is part. (19)

As worded, Article 7(7) of Directive 2011/24 provides that a Member State of affiliation may impose an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient’s entitlement to healthcare.

The French version of that provision expressly refers to the ‘système de sécurité sociale obligatoire’ (statutory social security system) or the ‘système de santé national’ (national health system) of the Member State of affiliation for which the health professional or healthcare administrator provides services. The same applies to other language versions, the wording of which is equally precise. (20)

From a contextual point of view, I note that recital 37 of Directive 2011/24, which refers to the possibility for Member States to maintain general conditions, criteria for eligibility and regulatory and administrative formalities for reimbursement of healthcare costs in relation to patients seeking healthcare in another Member State, specifically mentions, by way of example, the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care.

Article 1(4) of Directive 2011/24 further provides that nothing in that directive obliges a Member State to reimburse costs of healthcare provided by healthcare providers established on its own territory if those providers are not part of the ‘social security system or public health system of that Member State’.

Moreover, as regards the objectives of Directive 2011/24, the proposal for Directive 2011/24 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare stated that it left a wide margin for implementation of the general principles laid down by that directive by the Member States according to their national, regional or local circumstances and, inter alia, did not alter the right of Member States to apply conditions to their benefits, such as going through a general practitioner for referral to specialist treatment. (21)

It is also apparent from various press releases of the Council of the European Union that, during discussions on the draft Directive 2011/24, opinions differed as to whether the scope of the directive should be limited only to healthcare providers contracted to public health insurance or otherwise recognised by the public system, or whether it should also be extended to private healthcare providers not thus recognised. (22)

It was thus agreed that Member States may adopt provisions aimed at ensuring that patients enjoy the same rights when receiving cross-border healthcare as they would have enjoyed if they had received healthcare in a comparable situation in the Member State of affiliation. Member States may manage the outgoing flows of patients by requiring prior authorisation for certain healthcare (which involves overnight hospital accommodation, requires a highly specialised and cost-intensive medical infrastructure or which raises concerns with regard to the quality or safety of the care) or via the application of the ‘gate-keeping principle’, for example by the attending physician. (23)

During the discussions surrounding the adoption of Directive 2011/24, the Commission also expressed the view that the exclusion of certain providers, whether public or private, on grounds of objective, concrete and legitimate concerns over quality and safety, is compatible with EU law, in so far as it does not affect the Professional Qualifications Directive. (24)

Therefore, although Directive 2011/24 harmonised, inter alia, certain principles applicable to the reimbursement of the costs of cross-border healthcare, it did not harmonise social security law and the social security systems established by each of the Member States. The dual structure of a statutory social security system or a national health system which distinguishes between public and private medicine is not open to criticism in the light of the case-law of the Court, provided that it is not discriminatory and does not constitute an obstacle to the free movement of patients, services or goods which is not objectively justified.

Nevertheless, I feel it is important to make it clear that, ultimately, Directive 2011/24 is intended to enable EU citizens to receive both private or contracted healthcare and public healthcare in all Member States (25) and that the scope of that directive has not in itself been limited only to healthcare providers contracted to public health insurance or otherwise recognised by the public system. (26) However, the range of healthcare covered and the conditions for accessing reimbursement may in practice differ from one State to another, as the freedom to provide services does not bring about any entitlement in principle to a certain organisation of the national healthcare system. (27)

I therefore consider that a ‘statutory social security system’ or ‘national health system’, within the meaning of Article 7(7) of Directive 2011/24, must be understood to mean the public health system established and organised by each State. As the Member States have established different national systems, it is their responsibility to determine which health professionals are covered by their health system, it being specified that some systems include private providers under contract.

Article 7(7) of Directive 2011/24 thus allows Member States to maintain a system of gatekeeping whereby, where appropriate, a health professional providing services for the public health system determines a patient’s entitlement to certain healthcare.

Accordingly, I consider that it is apparent from the wording of Article 7(7) of Directive 2011/24, as well as from the context and the objectives pursued by that directive, that the Member States may require their insured persons who wish to be reimbursed for the costs of cross-border healthcare to undergo an assessment by a health professional covered by the public health insurance scheme of the Member State of affiliation and may refuse reimbursement where such an assessment is carried out by a health professional who is not covered by that scheme.

The reference made by the national court to the case-law of the Court relating to the judgment of 6 October 2021 in Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa (28)

) does not undermine that conclusion. Admittedly, ruling in the context of the system of prior authorisation under Article 20 of Regulation No 883/2004, read in conjunction with Article 26(4) of Regulation No 987/2009, the Court held that national legislation which requires that a request for authorisation for treatment outside the Member State of residence should be accompanied by a medical report, establishing the diagnosis and the treatment to be carried out, issued by a doctor in the national public health insurance system, imposes a condition beyond those already laid down in Article 20 of Regulation No 883/2004. (29)

However, contrary to the wording of Article 26(4) of Regulation No 987/2009, which provides that the competent institution may, during the procedure granting prior authorisation, have the insured person examined by a doctor of its own choice in the Member State of stay or residence, Article 7(7) of Directive 2011/24 expressly provides that this may be a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation.

The twofold condition relating to the assessment by a health professional covered by the Romanian public health insurance scheme which has given rise to a request for hospitalisation

63.Article 7(7) of Directive 2011/24 does not contain an exhaustive list of the conditions, criteria of eligibility and regulatory and administrative formalities which the Member State of affiliation may impose on insured persons who wish to be reimbursed for the costs of cross-border healthcare. Only the assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, is cited as an example. However, it is apparent from that provision that those conditions, criteria of eligibility and regulatory and administrative formalities must be the same as those imposed for healthcare provided in the territory of the Member State of affiliation, and may not be discriminatory or constitute an obstacle to the free movement of patients, services or goods, unless objectively justified.

64.In that regard, it is apparent from the documents before the Court that the eligibility criterion set out in Article 3(1)(b) of the detailed rules, according to which reimbursement of cross-border healthcare is subject to a medical assessment being carried out by a health professional covered by the public health insurance scheme of the insured person’s Member State of residence, leading to the issuing, by that health professional, of a request for hospitalisation, is also applicable to medical care provided on Romanian territory. It follows that the eligibility criterion set out in Article 3(1)(b) of the detailed rules applies both to cross-border care and to medical care provided on Romanian territory.

65.Nevertheless, does that eligibility criterion constitute an obstacle to the free movement of patients or services?

66.It is apparent from settled case-law that national legislation constitutes an obstacle to the freedom to provide services where, although it does not directly prevent persons affiliated to the public health insurance system from approaching providers of medical services established in another Member State, it has a deterrent effect on the use of cross-border healthcare services. (30) That national legislation therefore has the effect of making the provision of services between Member States more difficult than the provision of services purely within one Member State, within the meaning of the case-law cited in point 32 of this Opinion.

67.Ruling in the context of the system of prior authorisation established by the Member States on the basis of Regulation No 883/2004 or Regulation No 1408/71, the Court has stated that the mere requirement of prior authorisation in order for the competent institution to assume responsibility, in accordance with the rules governing cover in force in the Member State to which that institution belongs, for the cost of medical care provided in a different Member State constitutes, both for patients and for service providers, an obstacle to the freedom to provide services enshrined in Article 56 TFEU, given that, in so far as the costs incurred in the Member State of affiliation are not subject to such prior authorisation, such a requirement deters, or even prevents, patients from approaching providers of medical services established in Member States other than their Member State of residence in order to obtain the treatment in question. (31)

68.Although that case-law concerns the interpretation to be given to Regulation No 883/2004 or Regulation No 1408/71, it is relevant mutatis mutandis to the present case. (32) The question thus arises as to whether the Romanian legislation at issue, in so far as it requires an assessment by a health professional covered by the Romanian public health insurance scheme and the subsequent issue by such a health professional of a request for hospitalisation, makes it more difficult for a Romanian insured person to use services in a Member State other than Romania.

69.From reading the request for a preliminary ruling, it is apparent that the request for hospitalisation, which is required by Article 3(1)(b)(i) of the detailed rules, is a document intended to certify that a medical assessment has been carried out by a health professional covered by the Romanian public health insurance scheme and which recommends specific hospital treatment.

70.First, it is apparent from Article 3(1)(b)(i) and Article 3(2) of the detailed rules that the request for hospitalisation is one of the medical documents intended to certify that the insured person has received, inter alia, medical services. Secondly, in the request for a preliminary ruling, the referring court states that, according to the applicant, the request for hospitalisation is akin to proof that an insured person is admitted to the healthcare system in order to undergo hospital treatment. (33)

71.The criterion of eligibility for reimbursement of cross-border healthcare, as laid down in Article 3(1)(b)(i) of the detailed rules, is therefore not comparable to the example cited in Article 7(7) of Directive 2011/24, which, in essence, allows Member States to impose the obligation to consult a general practitioner before consulting a specialist or before receiving hospital care, as is apparent from points 50 and 52 of this Opinion.

72.If access to specialised or hospital care often depends on obtaining a certificate of clinical necessity issued by the health professional treating the patient, in the present case it is difficult to see how the condition imposed by the national provision at issue can be satisfied in practice in the case of cross-border care. I understand from the information provided by the referring court that, if the hospital service is provided in a Member State other than the Member State of affiliation, the hospitalisation does not take place in a hospital in the Member State of affiliation, just as a request for hospitalisation from a health professional in the Member State of affiliation would not be used for the purposes of hospitalisation in the Member State of destination.

73.That fact leads to the conclusion that the national provision at issue, in so far as it imposes a twofold condition, relating to an assessment by a health professional covered by the Romanian public health insurance scheme and a request for hospitalisation from such a health professional, constitutes an obstacle to the free movement of patients and services as regards hospital medical services provided in another Member State.

74.More specifically, in so far as the national provision at issue requires every insured person to obtain a request for hospitalisation from a health professional covered by the Romanian public health insurance scheme, even though such a request for admission, in the case of cross-border hospital treatment, will traditionally be drawn up by the hospital in the Member State of destination, it deprives the insured person, who has only a request for hospitalisation issued in a Member State other than the Member State of affiliation, of the possibility of obtaining reimbursement for such hospital treatment, which results in insured persons wishing to travel abroad for such treatment being placed at a disadvantage. In those circumstances, the national legislation at issue is likely to make it more difficult for insured persons to exercise their freedom of movement.

75.Therefore, even though that rule applies in the same way and imposes the same conditions on the reimbursement of cross-border and domestic hospital healthcare without distinction, it nevertheless constitutes, for every insured person, an obstacle to the exercise of the freedom to provide services. (34)

76.Consequently, I am of the view that the twofold condition laid down in Article 3(1)(b)(i) of the detailed rules discourages insured persons from approaching healthcare providers established in Member States other than the Member State of affiliation and makes the exercise of the freedom to provide services guaranteed by Article 56 TFEU less attractive. It therefore constitutes an obstacle to the free movement of patients and services.

Justification for the obstacle to the free movement of patients and services

77.In the present case, the Romanian Government has not provided any justification for the applicable Romanian legislation. However, the referring court has doubts as to whether the national legislation at issue is consistent with the objective pursued, which is to ensure the financial balance of the social security system, and as to the proportionality of the condition imposed in the light of the objective pursued.

78.I consider that the case-law of the Court relating to the system of prior authorisation and the freedom to provide medical services on the basis of Article 56 TFEU provides relevant guidance in this area.

79.The Court has held, in particular, that the number of hospitals, their geographical distribution, the mode of their organisation and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning, generally designed to satisfy various needs, must be possible. First, such planning seeks to ensure that there is sufficient and permanent access to a balanced range of high-quality hospital treatment in the territory of the Member State concerned. Secondly, it assists in meeting a desire to control costs and to prevent, as far as possible, any wastage of financial, technical and human resources. Such wastage would be all the more damaging because it is generally recognised that the hospital care sector generates considerable costs and must satisfy increasing needs, while the financial resources which may be made available for healthcare are not unlimited, whatever the mode of funding applied. (35)

80.Accordingly, it cannot be excluded that the risk of seriously undermining the financial balance of the social security system may constitute an overriding reason in the general interest capable of justifying an obstacle to the principle of the freedom to provide services. (36)

81.In that regard, the Court has already held that, in view of the difference between the reimbursement system established by Regulation No 883/2004 and that provided for by Directive 2011/24, in the context of that directive and by contrast with situations governed by that regulation, the Member State of affiliation will not, as a rule, be exposed to any additional financial costs with respect to cross-border healthcare. (37)

82.The Court thus found that, in contrast to Article 20(2) of Regulation No 883/2004, the first subparagraph of Article 7(4) of Directive 2011/24 provides, as has been recalled in point 37 of this Opinion, that the costs of cross-border healthcare are to be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by that Member State, had that healthcare been provided in its territory, without exceeding the actual costs of healthcare received. (38)

83.The reimbursement provided for by Article 7 of Directive 2011/24 may, therefore, be subject to a twofold limit. First, it is calculated on the basis of the fees for healthcare in the Member State of affiliation. Secondly, if the cost of the healthcare provided in the host Member State is lower than that of the healthcare provided in the Member State of affiliation, that reimbursement does not exceed the actual costs of the treatment received. (39)

84.Given that reimbursement of that healthcare under Directive 2011/24 is subject to that twofold limit, the healthcare system of the Member State of affiliation is not liable to be faced with a risk of additional costs linked to the assumption of the cross-border healthcare costs, as may be the case under the reimbursement system established by Regulation No 883/2004. The Court added that that interpretation is indeed supported by recital 29 of Directive 2011/24, which expressly states that that assumption of costs cannot have any significant effect on the financing of the national healthcare systems. (40)

85.It follows from the foregoing that, in circumstances such as those in the main proceedings, such an objective cannot, in principle, be relied on in order to justify the condition requiring a medical assessment to be carried out by a health professional providing medical services in the Romanian health insurance system, giving rise to a request for hospitalisation, under Article 7(7) of Directive 2011/24.

86.In the event that the Court does not share that view, the following brief observations must be made concerning the question of the proportionality of the system requiring a prior assessment and a request for hospitalisation from a health professional covered by the public social security scheme of the Member State of affiliation.

87.In the present case, the automatic nature of the eligibility criterion established by the national legislation at issue and the absolute nature of the terms of the twofold condition to which reimbursement of cross-border hospital healthcare is subject do not seem to me to be appropriate to the objective pursued, as measures which are less restrictive and more in keeping with the free movement of patients and services could be taken, such as the implementation of a procedure which would, where appropriate, seek to accept equivalent medical certificates or reports, accompanied by a check on the plausibility of the diagnosis and the treatment proposed. Such an eligibility criterion cannot therefore satisfy the requirement of proportionality.

Conclusion

88.In the light of the foregoing considerations, I propose that the Court’s answer to the first question referred by the Înalta Curte de Casaţie și Justiţie (High Court of Cassation and Justice, Romania) for a preliminary ruling should be as follows:

Article 56 TFEU and Article 7(7) of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare

must be interpreted as precluding legislation which automatically makes the reimbursement of the costs of cross-border healthcare incurred by the insured person in the Member State of affiliation subject to a medical assessment being carried out by a health professional providing medical services in the public health insurance scheme of that State and the subsequent issuing of a request for hospitalisation by that professional, without that person being allowed to submit equivalent documents issued by a health professional who is not covered by the public health insurance system of that State.

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1Original language: French.

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2Directive of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ 2011 L 88, p. 45).

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3OJ 1997 L 28, p. 1 (‘Regulation No 1408/71’).

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4OJ 2004 L 166, p. 1.

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5OJ 2009 L 284, p. 1.

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6Published in the Monitorul Oficial al României, Part I, No 318, of 30 April 2014.

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7C‑173/09, ‘the judgment in Elchinov’, EU:C:2010:581.

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8See Article 168(7) TFEU; see also Opinion of Advocate General Trstenjak in Commission v Germany (C‑562/10, EU:C:2012:210, point 54).

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9See the judgment in Elchinov (paragraphs 36 and 37 and the case-law cited).

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10See judgment of 12 July 2001, Smits and Peerbooms (C‑157/99, ‘the judgment in Smits and Peerbooms’, EU:C:2001:404, paragraphs 44 to 46 and the case-law cited).

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11See, inter alia, judgments of 16 May 2006, Watts (C‑372/04, EU:C:2006:325, paragraph 92), and of 15 June 2010, Commission v Spain (C‑211/08, EU:C:2010:340, paragraph 53).

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12See, inter alia, judgment of 5 October 1994, Commission v France (C‑381/93, EU:C:1994:370, paragraph 17); the judgment in Smits and Peerbooms (paragraph 61); and judgment of 19 April 2007, Stamatelaki (C‑444/05, EU:C:2007:231, paragraph 25).

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13See judgment of 26 September 2024, Nord Vest Pro Sani Pro (C‑387/22, EU:C:2024:786, paragraph 40 and the case-law cited).

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14The system of prior authorisation which Member States may establish under Directive 2011/24 is therefore exceptional in nature (see, to that effect, Opinion of Advocate General Hogan in Veselības ministrija (C‑243/19, EU:C:2020:325, point 65)).

15See judgment of 29 October 2020, Veselības ministrija (C‑243/19, ‘the judgment in Veselības ministrija’, EU:C:2020:872, paragraph 72).

16There is nothing in the documents before the Court to suggest that the legislation at issue in the main proceedings relates to the exercise of freedom of establishment, as enshrined in Article 49 TFEU.

17While the words ‘Member State of residence’ are used in Regulations No 883/2004 and No 987/2009, Directive 2011/24 uses the expression ‘Member State of affiliation’.

18The wording ‘equivalent documents’ is preferred to ‘equivalent medical documents’ as it is broader and capable of encompassing all types of documents issued by health professionals or medical institutions.

19See judgment of 18 September 2019, VIPA (C‑222/18, EU:C:2019:751, paragraph 34 and the case-law cited).

20By way of example, the Spanish version refers to the ‘sistema de seguridad social o el sistema nacional de sanidad obligatorio’ (social security system or national statutory healthcare system), the German version to ‘die gesetzliche Sozialversicherung oder das nationale Gesundheitssystem’ (legal social security system or national health system), the English version to the ‘statutory social security system or national health system’, the Italian version to the ‘sistema obbligatorio di sicurezza sociale’ (statutory social security system), the Dutch version to ‘het wettelijke socialezekerheids- of gezondheidszorgstelsel’ (legal social security or healthcare system), and the Romanian version refers to the ‘sistemului obligatoriu de securitate socială sau sistemului național de sănătate’ (statutory social security system or national health system).

21Proposal of 2 July 2008 [SEC(2008) 2163] [SEC(2008) 2164] [SEC(2008) 2183] /* COM/2008/0414 final – COD 2008/0142, point 4(c), and point 7.1.

22Press release, 2947th Council meeting – Employment, Social Policy, Health and Consumer Affairs – Luxembourg, 8 and 9 June 2009, 9721/2/09 REV 2, Presse 124, p. 12. See also Press release, 2980th Council meeting – Employment, Social Policy, Health and Consumer Affairs – Brussels, 30 November and 1 December 2009, 16611/2/09 REV 1, Presse 348, p. 13: the intention was to fully respect the case-law of the Court while preserving the Member States’ right to organise their healthcare system.

23Press release, 3019th Council meeting – Employment, Social Policy, Health and Consumer Affairs – Luxembourg, 7 and 8 June 2010, 10560/10, Presse 156, p. 16; see also Press release, 2916th Council meeting – Employment, Social Policy, Health and Consumer Affairs – Brussels, 16 and 17 December 2008, 16825/08, Presse 358, p. 9.

24Communication from the Commission to the European Parliament pursuant to Article 294(6) [TFEU] concerning the position of the Council at first reading on the adoption of a Directive of the European Parliament and of the Council on the application of patients’ rights on cross-border healthcare, COM(2010) 503 final, 2008/0142 (COD), 20 September 2010, pp. 6 and 9, which refers to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ 2005 L 255, p. 22).

25Thus, Article 3(a) of Directive 2011/24 defines ‘healthcare’ as ‘health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices’, without distinguishing between public and private health services. See also the Council’s draft statement of reasons of 3 September 2010, Interinstitutional File 2008/0142 (COD), p. 4; ‘The Top Ten Mistakes Patients make in Cross-border Healthcare’, European Commission 2018, available at: https://health.ec.europa.eu/document/download/b2a023c2-2af5-4ef7-b886-2b9203d355c1_en?filename=2018_10mistakes_en.pdf&prefLang=fr.

26Article 3(f) of Directive 2011/24 defines ‘health professional’ as ‘a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of [Directive 2005/36], or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of [Directive 2005/36], or a person considered to be a health professional according to the legislation of the Member State of treatment’. As has been mentioned in point 51 of this Opinion, it is for the Member States to determine whether they wish to reimburse the costs of healthcare provided by healthcare providers which are outside their social security system or public health system.

27See, to that effect, Opinion of Advocate General Trstenjak in Commission v Germany (C‑562/10, EU:C:2012:210, point 55).

28C‑538/19, ‘the judgment in Casa Naţională de Asigurări de Sănătate’, EU:C:2021:809.

29The judgment in Casa Naţională de Asigurări de Sănătate (paragraphs 41 to 45).

30See the judgment in Casa Naţională de Asigurări de Sănătate (paragraph 48 and the case-law cited).

31See, to that effect, inter alia, judgments of 28 April 1998, Kohll (C‑158/96, EU:C:1998:171, paragraphs 34 and 35); of 12 July 2001, Vanbraekel and Others (C‑368/98, EU:C:2001:400, paragraph 45); of 19 April 2007, Stamatelaki (C‑444/05, EU:C:2007:231, paragraphs 26 and 28); the judgment in Elchinov (paragraph 41 and the case-law cited); and the judgment in Casa Naţională de Asigurări de Sănătate (paragraph 35 and the case-law cited).

32I note that, in the present case, the question of reimbursement for cross-border healthcare provided to AF is part of a system of prior authorisation, together with the requirements of a prior assessment by a health professional covered by the public health insurance scheme of the Member State of affiliation and a request for hospitalisation issued by such a health professional.

33According to the CJAS, the fact that a medical assessment has been carried out can be proved only by the request for hospitalisation.

34The Court has already held that national legislation which, although applying to nationals and to operators or providers of services from other Member States in exactly the same way, leads to a result whereby providers from another Member State are placed at a disadvantage compared with nationals, constitutes a restriction on the freedom of establishment and the freedom to provide services (see, inter alia, judgments of 13 December 2007, Commission v Italy (C‑465/05, EU:C:2007:781, paragraphs 46 to 48), and of 21 December 2023, (Cofidis, C‑340/22, EU:C:2023:1019, paragraphs 40 and 41)).

35See the judgment in Smits and Peerbooms (paragraphs 76 to 79); judgment of 16 May 2006, Watts (C‑372/04, EU:C:2006:325, paragraphs 108 and 109); and the judgment in Elchinov (paragraph 43).

36See judgment of 27 January 2011, Commission v Luxembourg (C‑490/09, EU:C:2011:34, paragraph 43 and the case-law cited).

37See the judgment in Veselības ministrija (paragraphs 72 to 77).

38The judgment in Veselības ministrija (paragraph 73).

39The judgment in Veselības ministrija (paragraph 74).

40The judgment in Veselības ministrija (paragraphs 75 and 76).