1 This request for a preliminary ruling concerns the interpretation of Article 56 TFEU and Article 20 of Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ 2004 L 166, p. 1, and corrigendum OJ 2004 L 200, p. 1), as amended by Regulation (EC) No 988/2009 of the European Parliament and of the Council of 16 September 2009 (OJ 2009 L 284, p. 43) (‘Regulation No 883/2004’).
2 The request was made in the context of a dispute between TS, UT and VU, the heirs of ZY, and the Casa Naţională de Asigurări de Sănătate (National Health Insurance Fund, Romania) and the Casa de Asigurări de Sănătate Constanţa (Health Insurance Fund, Constanţa, Romania) concerning the latter’s refusal to reimburse them the full cost of medical treatment given to ZY in Austria.
3 Article 1 of Regulation No 883/2004 provides: ‘For the purposes of this regulation: … (j) “residence” means the place where a person habitually resides; (k) “stay” means temporary residence; (l) “legislation” means, in respect of each Member State, laws, regulations and other statutory provisions and all other implementing measures relating to the social security branches covered by Article 3(1); … (p) “institution” means, in respect of each Member State, the body or authority responsible for applying all or part of the legislation; (q) “competent institution” means: (i) the institution with which the person concerned is insured at the time of the application for benefit; … (s) “competent Member State” means the Member State in which the competent institution is situated; … (va) “benefits in kind” means: (i) for the purposes of Title III, Chapter 1 (sickness, maternity and equivalent paternity benefits), benefits in kind provided for under the legislation of a Member State which are intended to supply, make available, pay directly or reimburse the cost of medical care and products and services ancillary to that care. This includes long-term care benefits in kind; …’
4 Article 3(1) of that regulation provides: ‘This regulation shall apply to all legislation concerning the following branches of social security: (a) sickness benefits; …’
5 Article 20 of the regulation, which is headed ‘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. 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. 2. An insured person who is authorised by the competent institution to go to another Member State with the purpose of receiving the treatment appropriate to his/her condition shall receive the 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 it applies, as though he/she were insured under the said legislation. The authorisation shall be accorded where the treatment in question is among the benefits provided for by the legislation in the Member State where the person concerned resides and where he/she cannot be given such treatment within a time limit which is medically justifiable, taking into account his/her current state of health and the probable course of his/her illness.’
6 Article 26 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 No 883/2004 (OJ 2009 L 284, p. 1), headed ‘Scheduled treatment’, provides, in paragraph 4 thereof: ‘At any time during the procedure granting the authorisation, the competent institution shall retain the right to have the insured person examined by a doctor of its own choice in the Member State of stay or residence.’
7 Order No 592/2008 of the President of the National Health Insurance Fund of 26 August 2008 (Monitorul Oficial al României, Part I, No 648 of 11 September 2008) lays down the rules for the use, within the Romanian health insurance system, of the forms issued by Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community, in the version amended and updated by Council Regulation (EC) No 118/97 of 2 December 1996 (OJ 1997 L 28, p. 1) and by Regulation (EEC) No 574/72 of the Council of 21 March 1972 fixing the procedure for implementing Regulation No 1408/71 (OJ 1972 L 74, p. 1). The procedures for the use of the forms are set out in the annex to Order No 592/2008.
8 Article 40(1)(b) and (3) of that annex states: ‘1. Form E 112 is for use by: … (b) employed persons, self-employed persons and members of their families authorised by the competent institution to go to another Member State for the purpose of receiving medical care. … 3. The competent institution shall not refuse to issue a form E 112 for the situation referred to in paragraph 1(b) where the treatment in question is among the benefits provided for by the legislation in the Member State where the person concerned resides and where, taking into account his or her current state of health and the probable course of his or her illness, he or she cannot be given such treatment within the period which is normally necessary for obtaining the treatment in question in the Member State of residence.’
9 According to Article 45(1)(b) and (4) of the annex: ‘1. In the situation provided for by Article 40(1)(b) [which concerns employed persons, self-employed persons and members of their families authorised by the competent institution to go to a Member State other than their country of residence for the purpose of receiving medical care], the application [for the issue of form E 112] must be supported by the following documents: … (b) the medical file, containing, in addition to any medical records, the medical report provided for in Annex 10A, setting out the diagnosis and the medical recommendation for carrying out treatment; … … 4. The medical report is to be drawn up by a doctor in a university teaching hospital or, where appropriate, a provincial hospital which has a contractual relationship with a Romanian health insurance fund.’
10 Article 46 of the annex to Order No 592/2008 reads as follows: ‘1. Form E 112 is to be issued prior to the beneficiary’s departure. 2. The form may also be issued after the beneficiary’s departure where, for reasons of force majeure, it could not be issued prior to departure. The form may only be issued if the medical services have not been paid for. Once payment has been made, the form no longer produces any of the legal effects for which it was requested. 3. In the situation referred to in paragraph 2, the insurance fund shall draw up a report explaining and justifying the situation of force majeure, which shall serve as the basis for the issue of the form E 112. 4. The report provided for in paragraph 3 shall set out in detail the circumstances - external, extraordinary, wholly unforeseeable and unavoidable, including circumstances of a medical nature - which resulted in the situation of force majeure.’
11 Order No 729/2009 of the President of the National Health Insurance Fund of 17 July 2009 (Monitorul Oficial al României, Part I, No 545 of 5 August 2009), lays down the rules relating to the reimbursement and recovery of the cost of health care provided under international health care agreements to which Romania is a party.
12 Article 8 of the annex to that order states, in paragraph 1, 2 and 6 thereof: ‘1. If a person insured under the Romanian public health insurance system goes to another Member State of the European Union for the purpose of receiving medical treatment without the prior authorisation of the health insurance fund with which he or she is registered as an insured person, that person shall pay the cost of the medical services provided. 2. Upon the written request, accompanied by supporting documents, of the insured person, a member of his or her family … or an authorised person the health insurance fund shall reimburse the cost of the medical services provided in accordance with paragraph 1 and paid for by the insured person, in accordance with the tariffs set out in paragraph 5. … 6. Reimbursement as provided for in paragraph [2] may be made only if the medical service provided in a Member State of the European Union and paid for by the insured party is included in the basic package of services of the Romanian public health insurance system.’
13 On 28 March 2013, ZY, a Romanian resident covered by the national public health insurance system, was diagnosed at a hospital in that Member State as having cancer of the tongue. Emergency surgical treatment consisting in the surgical removal of two thirds of the tongue was recommended by ZY’s physician.
14 In April 2013, ZY went to Vienna (Austria) to get a second medical opinion from a private clinic. His diagnosis was confirmed, but, given the advanced state of the cancer, surgery was not considered to be appropriate. Treatment consisting of radiotherapy, chemotherapy and immunotherapy and requiring hospital care was recommended. That treatment was regarded as being as effective as surgical intervention and having the advantage of not causing a disability.
15 ZY attended a meeting with the competent institution with a view to obtaining a form E 112 so that the institution would undertake to bear the costs of the medical treatment which he planned to have at the Austrian clinic that had recommended it. He was informed at that meeting that, if he went to Austria without obtaining prior authorisation, the costs of the treatment he would receive there would not be fully reimbursed, in accordance with Regulation No 883/2004, but reimbursed according to the Romanian tariffs, pursuant to Article 8 of the annex to Order No 729/2009. Under the applicable national regulations, in fact, form E 112 may only be obtained in connection with a recommendation for treatment made by a doctor designated by the competent institution. The competent institution did, however, ask ZY to produce a medical opinion indicating that he could not be treated in Romania.
16 Between April 2013 and April 2014, ZY received medical treatment consisting in radiotherapy, chemotherapy and immunotherapy at two Austrian clinics. He did not, however, produce the medical opinion. In September 2013 and June 2014, he applied for the reimbursement by the competent institution of the costs associated with that treatment.
17 On 14 November 2016, the competent institution reimbursed ZY’s heirs, following ZY’s decease, the sum of 38 370.70 Romanian lei (RON) (approximately EUR 8240), representing the cost of the examinations and medical care which ZY had received in Austria, calculated, pursuant to Article 8 of the annex to Order No 729/2009, on the basis of the tariffs applicable under the Romanian public health insurance system.
18 ZY’s heirs brought an action before the Tribunalul Constanța (Regional Court, Constanța, Romania) seeking the reimbursement, in accordance with Regulation No 883/2004, of all the costs related to the medical treatment ZY received in Austria.
19 By judgment of 24 October 2018, that court dismissed the action, holding that, in the absence of a request for prior authorisation, the costs related to the medical treatment given to ZY in a Member State other than his Member State of residence could not be reimbursed in accordance with Regulation No 883/2004.
20 The referring court, before which ZY’s heirs brought an appeal against that judgment, states that, in order to give its ruling on the appeal, it must establish whether, despite the fact that ZY did not obtain the prior authorisation he had requested from the competent institution, pursuant to Article 20(1) of Regulation No 883/2004, he could be reimbursed by that institution the cost of the treatment carried out in Austria, for the amount that would have be covered by it if ZY had been granted prior authorisation pursuant to the second sentence of Article 20(2) thereof.
21 That court states that, in this instance, the condition that the insured person must be in urgent need of medical treatment is satisfied, as is apparent from the medical and legal expert’s report produced at first instance. On the other hand, the referring court states that, in order to be able to determine whether the condition relating to the possibility of the medical treatment chosen by the insured person being given in Romania within a medically justifiable period was satisfied, taking into account the insured person’s state of health and the probable course of his illness, it must first of all establish whether the fact that ZY was not granted prior authorisation for the treatment he received in Austria was due to exceptional circumstances, within the meaning of the judgment of 5 October 2010, Elchinov (C‑173/09, EU:C:2010:581), that issue being the basis for the questions referred for a preliminary ruling.
22 In that regard, according to the referring court, it is necessary to start from the premiss, first, that ZY was entitled to choose the treatment prescribed in Austria, by virtue, in particular, of his right to privacy and physical integrity, and, second, that the applicable national legislation did not allow him to obtain prior authorisation for that treatment or an undertaking to bear the full cost thereof in Romania, because the treatment in question was not prescribed by a medical practitioner in the public health insurance system of the competent Member State, but was recommended, by way of a second opinion, by a doctor in another Member State after considering the diagnosis made by the first doctor. ZY therefore went to a Member State other than the competent Member State, because the treatment in question had been prescribed for him only in that other Member State and because, that being so, he could not get the treatment in the competent Member State, even though it is among the benefits provided for by the legislation of that Member State.
23 The referring court observes that Article 45(4) of the annex to Order No 592/2008 does not give the insured person any right to have his or her physician actually reconsider, in the light of a second medical opinion given in a Member State other than Romania, the treatment initially prescribed. However, since the treatment recommended to ZY in Austria had the advantage of not causing a disability, he was entitled to choose it, by virtue of the principle of freedom of choice, which is an element of the right to respect for private life, enshrined in Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed at Rome on 4 November 1950, and in Article 7 of the Charter of Fundamental Rights of the European Union, and an element of the right to physical integrity, guaranteed by Article 3 thereof.
24 Against that background, the referring court observes that the fact that ZY did not go back to his own physician in Romania, in order to show him the diverging opinion of the Austrian doctors and try to convince him that that opinion was correct does not appear to be decisive, since there is no provision in the national legislation for any procedure for the consideration of a second medical opinion given in a Member State other than Romania, such as might effectively guarantee the insured person the right to have his or her own physician re-examine an initial recommendation, with a view to possibly revising it.
25 Consequently, the referring court has doubts about the conformity with Article 56 TFEU and Regulation No 883/2004 of the provisions of national legislation which apply to the case before it. It questions, in particular, whether, as a result of those provisions, an insured person who merely has a medical opinion from a doctor in a Member State other than his or her Member State of residence, prescribing a different treatment from that initially recommended, is to be regarded as having been prevented, by objective reasons similar to those mentioned in paragraph 45 of the judgment of 5 October 2010, Elchinov (C‑173/09, EU:C:2010:581), from obtaining authorisation for the reimbursement of the costs related to of health care provided in that other Member State.
26 It was in those circumstances that the Curtea de Apel Constanţa (Court of Appeal, Constanța, Romania) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) May the situation be treated as an emergency, as described in paragraph 45 of the judgment [of 5 October 2010, Elchinov, C‑173/09, EU:C:2010:581], or does it constitute a case in which it is objectively impossible to seek the authorisation required under Article 20(1) and (2) of Regulation [No 883/2004], which may justify a claim for full reimbursement of the expenses incurred in obtaining appropriate medical treatment (hospital treatment) in a Member State other than that in which the insured person resides, where the therapeutic treatment to which the latter consented was prescribed only by a doctor of a Member State other than the State in which the insured person resides, given that the diagnosis and the need to administer the treatment as a matter of urgency were confirmed by a doctor belonging to the health insurance scheme of the Member State of residence but who recommended a different therapeutic treatment from that to which the insured person consented, for reasons which may be deemed appropriate on the part of the latter, and which has at least the same degree of effectiveness but the advantage of not creating a disability? (2) If the answer to the first question is in the affirmative, where the insured person, having been given a diagnosis and recommended a therapeutic treatment by a doctor within the health insurance scheme of the Member State of residence which, for reasons which may be deemed appropriate, that person does not accept, goes to another Member State to seek a second medical opinion, that opinion being that a different therapeutic treatment should be administered, which has at least the same degree of effectiveness but the advantage of not creating a disability, and the insured person accepts that treatment, which satisfies the requirements laid down in the second sentence of Article 20(2) of Regulation [No 883/2004], is that person also required, in order to be eligible for reimbursement of the costs incurred as a result of the latter therapeutic treatment, to seek the authorisation referred to in Article 20(1) of that regulation? (3) Do [Article 56 TFEU and Article 20(1)] and (2) of Regulation No 883/2004 preclude national legislation which, first, makes authorisation by the competent institution to receive appropriate medical treatment (hospital treatment) in a Member State other than that of residence conditional on the drawing up of a medical report only by a doctor who practi[s]es within the health insurance scheme of the Member State of residence, on the recommendation of the head physician of the competent institution of that State, also where the therapeutic treatment to which the insured person consented, for reasons which may be deemed appropriate, given that it has the advantage of not creating a disability, is prescribed only by a doctor of another Member State, by way of a second medical opinion, and, second, does not guarantee, under accessible and predictable procedure, actual analysis, from a medical perspective, within the health insurance scheme of the Member State of residence, of the possibility of applying the second medical opinion given in another Member State? (4) If the answer to the first and third questions is in the affirmative, is the insured person, or [his/her] heirs respectively, entitled, subject to fulfilment of the two requirements laid down in the second sentence of Article 20(2) of Regulation [No 883/2004], to obtain from the competent institution of the State in which the insured person resides full reimbursement of the expenses incurred as a result of therapeutic treatment received in another Member State?’
27 By its questions, which it is appropriate to consider together, the referring court is asking, in essence, whether Article 20 of Regulation No 883/2004, read together with Article 56 TFEU, must be interpreted as meaning that an insured person who has received, in a Member State other than his or her Member State of residence, a treatment which is among the benefits provided for by the legislation of the Member State of residence is entitled to full reimbursement of the cost of that treatment, under the conditions laid down in that regulation, where he or she has been unable to obtain authorisation from the competent institution, in accordance with Article 20(1) of that regulation, on the ground that, although the diagnosis and the urgent need for treatment were confirmed by a doctor belonging to the health insurance system of the Member State of residence, that doctor had prescribed a different treatment from the one which the insured person chose following a second medical opinion given by a doctor in another Member State, the treatment chosen, unlike the treatment initially proposed, not causing a disability.
28 As a preliminary point, it must be recalled that, in order for a situation such as that at issue in the main proceedings to come within the scope of Regulation No 883/2004, the health care in question must have been dispensed in accordance with the social security legislation of the Member State where it was received, which it is for the referring court to verify (see, to that effect, the judgment of 23 September 2020, Vas Megyei Kormányhivatal(Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraphs 36 and 37).
29 In accordance with Article 20(1) of Regulation No 883/2004, unless the regulation provides otherwise, an insured person travelling to a Member State other than his or her Member State of residence with the purpose of receiving benefits in kind during the stay must seek authorisation from the competent institution.
30 In accordance with the second sentence of Article 20(2) of that regulation, such authorisation must be given by the competent institution where the two conditions laid down in that sentence are satisfied (see, to that effect, judgment of 23 September 2020, Vas Megyei Kormányhivatal (Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 42 and the case-law cited).
31 To satisfy the first of those conditions, the treatment in question must be among the benefits provided for by the legislation of the Member State of residence of the insured person. To satisfy the second condition, it must be impossible for that treatment to be given in the Member State of residence within a medically justifiable period of time, taking into account the insured person’s current state of health and the probable course of the illness.
32 The applicability of Article 20 of Regulation No 883/2004 to the situation in the present case does not, according to Court’s case-law, mean that provisions on the freedom to provide services and, in this instance, Article 56 TFEU, cannot apply at the same time (judgment of 5 October 2010, Elchinov, C‑173/09, EU:C:2010:581, paragraph 38), and so Article 20 must be interpreted in the light of Article 56 TFEU and the Court’s case-law relating to it.
33 It is clear from that case-law that the freedom to provide services involves not only the freedom of the provider to carry out services for recipients established in a Member State other than that in which the provider is established but also the freedom to receive or to benefit, as recipient, from the services carried out by a provider established in another Member State, without being hampered by restrictions (see, inter alia, judgment of 15 June 2010, Commission v Spain, C‑211/08, EU:C:2010:340, paragraph 49).
34 A medical service provided for consideration, including care provided in a hospital environment, does not cease to be a supply of services within the meaning of Article 56 TFEU merely because the patient, after paying the supplier established in a Member State other than his or her Member State of residence for the treatment received, seeks reimbursement of that treatment from a national health service (see, to that effect, judgment of 16 May 2006, Watts, C‑372/04, EU:C:2006:325, paragraphs 86 and 89).
35 The Court has also held 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 dispensed in a different Member State constitutes, both for patients and for service providers, a restriction of the freedom to provide services enshrined in Article 56 TFEU, since 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 (see, to that effect, judgment of 23 September 2020, Vas Megyei Kormányhivatal(Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 58 and the case-law cited).
36 While Article 56 TFEU does not, in principle, preclude the right of a patient to receive hospital care or health care involving the use of highly specialised and cost-intensive medical equipment in another Member State at the expense of the system in his or her Member State of residence from being subject to prior authorisation, it is nevertheless necessary that the conditions attached to the grant of that authorisation should be justified in the light of overriding public interest requirements - such as preventing the possible risk of seriously undermining the financial balance of a social security system, maintaining a balanced medical and hospital service open to all, making it possible to create a plan seeking, first, to ensure that there is sufficient and permanent access to a balanced range of high-quality hospital treatments in the Member State concerned and, second, to ensure cost control and to prevent, as far as possible, any wastage of financial, technical and human resources - and that those conditions do not exceed what is objectively necessary for that purpose and that the same result cannot be achieved by less restrictive rules. Such a system must, in addition, be based on objective, non-discriminatory criteria, which are known in advance, in such a way as to circumscribe the exercise of the national authorities’ discretion, so that it is not used arbitrarily (see, to that effect, judgments of 5 October 2010, Elchinov, C‑173/09, EU:C:2010:581, paragraphs 41 to 44, and of 23 September 2020, Vas Megyei Kormányhivatal (Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraphs 59, 61 and 62).
37 It must be borne in mind, in this connection, that the Court has already identified two situations in which an insured person, even without an authorisation issued before the provision of scheduled treatment begins in the Member State of stay, is entitled to be reimbursed directly by the competent institution in an amount equivalent to that which would ordinarily have been reimbursed by that institution if the insured person had been granted such authorisation (judgment of 23 September 2020, Vas Megyei Kormányhivatal(Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 46).
38 In the first situation, the insured person is entitled to be reimbursed when, having made an application for authorisation, that application has been refused by the competent institution and it is subsequently established, either by the competent institution itself or by a court decision, that that refusal was unjustified (judgment of 23 September 2020, Vas Megyei Kormányhivatal(Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 47 and the case-law cited).
39 In the second situation, an insured person is entitled to be reimbursed directly by the competent institution in an amount equivalent to that which it would ordinarily have reimbursed if the insured person had had such authorisation when, for reasons relating to his or her state of health or to the need to receive urgent treatment in a hospital, that person was prevented from applying for such authorisation or was not able to wait for the decision of the competent institution on the application for authorisation submitted. The Court has held in that respect that legislation which excludes, in all cases, reimbursement in respect of hospital treatment given in another Member State without authorisation deprives the insured person of reimbursement in respect of such treatment even if all other conditions for reimbursement are met. Such legislation, which cannot be justified by public interest requirements and, in any event, does not satisfy the requirement of proportionality, therefore constitutes an unjustified restriction of the freedom to provide services (judgment of 23 September 2020, Vas Megyei Kormányhivatal (Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 48 and the case-law cited).
40 In the present case, Article 40(1)(b) and (3) of the annex to Order No 592/2008 makes the grant of authorisation pursuant to Article 20(1) of Regulation No 883/2004 subject to the fulfilment of two conditions which, in essence, correspond to those laid down in the second sentence of Article 20(2) thereof. In addition to that, in accordance with Article 45(1)(b) and (4) of the annex to that order, a person insured under the Romanian public health insurance system is required to append to the request for authorisation to receive appropriate treatment outside Romania a medical report setting out the diagnosis and the treatment to be carried out, drawn up by a doctor in a university teaching hospital or, where appropriate, a provincial hospital which has a contractual relationship with a Romanian health insurance fund.
41 It must be observed in that regard, in the first place, that, although the wording of the second sentence of Article 20(2) of Regulation No 883/2004 contains no express requirement regarding the production of a medical report, the question of whether the conditions mentioned in the preceding paragraph are fulfilled implies, as the defendants in the main proceedings, the Romanian and Polish Governments and the European Commission have emphasised in their written submissions to the Court and in their replies to the written questions put by the Court, an assessment, first, of the insured person’s state of health, the probable course of his or her illness and the medical treatments appropriate to his or her condition and, second, the availability of those treatments under the social security system of the insured person’s Member State of residence and the period of time within which they could be provided in that Member State.
42 Moreover, while the assessment of the last two aspects would normally require knowledge that only a doctor or other health care professional in the public health insurance system of the insured person’s Member State of residence would have, the same is not true of the assessment of the first two aspects, which concern the diagnosis of the insured person’s state of health and the appropriate medical treatments.
43 That is confirmed by Article 26 of Regulation No 987/2009, which lays down the procedure for implementing Article 20 of Regulation No 883/2004, paragraph 4 of which states that, at any time during the authorisation process, the competent institution is to retain the right to have the insured person examined by a doctor of its choice in the insured person’s Member State of stay or residence. That provision does not, therefore, limit the competent institution’s choice to doctors within the public health insurance system of the insured person’s Member State of residence.
44 It follows that Article 20 of Regulation No 883/2004, read together with Article 26(4) of Regulation No 987/2009, does not require that the medical opinion supporting a request for prior authorisation for treatment in a Member State other than the insured person’s Member State of residence should be issued by a doctor in the public health insurance system of the person’s Member State of residence, nor does it preclude a second medical opinion from a doctor practising in the Member State where the insured person intends to go for treatment from being taken into account during the course of the authorisation procedure.
45 Consequently, 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.
46 What is more, such a condition is liable to deprive an insured person who merely has a medical opinion issued in a Member State other than the Member State of residence, prescribing an alternative treatment, of the possibility of obtaining prior authorisation in order for the competent institution to bear the cost of that treatment. As the referring court has pointed out, an authorisation procedure of such kind does not ensure that such an opinion will actually be taken into account or, consequently, that the competent institution will be able to determine whether the conditions laid down in the second sentence of Article 20(2) of Regulation No 883/2004, referred to in paragraph 30 of this judgment, are fulfilled.
47 It must be observed, in the second place, that the requirement to which a provision of national law such as Article 45(1)(b) and (4) of the annex to Order No 592/2008 makes the grant of an authorisation pursuant to Article 20(1) of Regulation No 883/2004 subject, is a further deterrent to the use of cross-border health care services over and above the requirement for prior authorisation, which, according to the case-law mentioned in paragraph 35 of the present judgment, is itself a restriction of the freedom to provide services.
48 Although rules such as those at issue in the case in the main proceedings do not directly prevent persons affiliated to the public health insurance system from approaching providers of medical services established in another Member State, the lack of any guarantee that a second medical opinion prepared by such a provider of services and recommending an alternative treatment will actually be taken into account during the authorisation procedure, together with the prospect of financial loss in the event that the national health system does not bear the medical cost of that alternative treatment, following a refusal decision, clearly has a deterrent effect on the use of cross-border health care services (see, by analogy, judgment of 27 October 2011, Commission v Portugal, C‑255/09, EU:C:2011:695, paragraph 62 and the case-law cited).
49 In the present case, as regards the justification for the restriction of the freedom to provide services flowing from the requirement to produce a medical report drawn up by a doctor in the public health insurance system of the insured person’s Member State of residence, the Romanian Government maintains, first, that that requirement is designed to make it possible to verify that the conditions laid down in the second sentence of Article 20(2) of Regulation No 883/2004 are fulfilled.
50 Nevertheless, as was made clear in paragraph 44 of the present judgment, neither that provision nor Article 26(4) of Regulation No 987/2009 precludes the competent institution from taking into account, in the course of the authorisation procedure, a second medical opinion from a doctor practising in a Member State other than the Member State of residence of the insured person.
51 The Romanian Government also mentions the need to ensure the financial balance of the national health care system and to control costs, as well as prevent as far as possible any wastage of financial, technical and human resources. Be that as it may, even assuming the requirement laid down in Article 45(1)(b) and (4) of the annex to Order No 592/2008 to be suited, in the context of hospital care and non-hospital care requiring expensive equipment, to maintaining those public interest objectives, it does not in any event appear to comply with the principle of proportionality, mentioned in paragraph 36 of the present judgment.
52 It would be possible to achieve the objective mentioned by implementing an authorisation procedure that ensured, for the purpose of the preparation of the medical report by a doctor practising in the public health insurance system of the insured person’s Member State of residence setting out the diagnosis and recommended treatment, that account would actually be taken of a second medical opinion prepared in another Member State recommending an alternative treatment equally appropriate to the insured person’s state of health and without the disadvantages of the first treatment.
53 The foregoing considerations are not called into question by the argument of the defendants in the main proceedings and the Romanian Government that the case at issue in the main proceedings is covered by Article 46(2) of the annex to Order No 592/2008, which would have allowed the insured person in question to obtain an a posteriori authorisation, the issue of which is not subject to fulfilment of the requirement laid down in Article 45(1)(b) and (4) of that annex.
54 Even assuming that Article 46 - pursuant to which the issue of that authorisation is subject, first, to ‘reasons of force majeure’ resulting from ‘external, extraordinary, wholly unforeseeable and unavoidable, including circumstances of a medical nature’, which must be detailed in a report prepared by the competent institution and, second, the condition that the cost of the medical services received in those circumstances has not been paid - were applicable to a case such as that at issue in the main proceedings, in which the insured person went to a Member State other than his or her Member State of residence, in a planned fashion, for therapeutic treatments, as the referring court itself established, that fact in no way alters the conclusion that making the issue of the authorisation pursuant to Article 20 of Regulation No 883/2004 subject to the production of a medical report from a doctor in the public health insurance system of the insured person’s Member State of residence constitutes a disproportionate restriction of the freedom to provide services enshrined in Article 56 TFEU, which also amounts in practice to preventing the competent institution from verifying compliance with the conditions for the mandatory issue of that authorisation, as noted in paragraphs 45 and 46 of the present judgment.
55 It follows from all of the foregoing considerations that Article 20(2) of Regulation No 883/2004, read together with Article 56 TFEU, must be interpreted as precluding national legislation which makes the issue of an authorisation for treatment in a Member State, other than the applicant’s Member State of residence, conditional on the production of a medical report setting out the diagnosis and the treatment to be carried out, prepared by a doctor belonging to the national health insurance system, and which offers no guarantee that the competent institution will take into account a second medical opinion given in that other Member State and prescribing an alternative treatment.
56 In those circumstances, it must be held, in the third place, that an insured person who has been unable to obtain an authorisation pursuant to Article 20(1) of Regulation No 883/2004 as a result of the application of rules such as those identified in the preceding paragraph and who, while in possession of a medical report issued in a Member State other than the Member State of his or her residence setting out the diagnosis and the urgent need for a treatment which, unlike the treatment prescribed in the Member State of residence, does not cause a disability, has received that treatment in the other Member State, is in a situation similar to those described in paragraphs 37 to 39 of the present judgment.
57 It follows, in the present case, that if the conditions for issuing an authorisation pursuant to Article 20 of Regulation No 883/2004, as referred to in paragraph 30 of the present judgment, were fulfilled in ZY’s case and the only reason he was not given authorisation was that the medical report prescribing the treatment which he underwent was prepared by a doctor in a Member State other than ZY’s Member State of residence, which it is for the referring court to ascertain, ZY’s heirs are entitled to be reimbursed by the competent Romanian institution such sum as that institution would normally have paid if ZY had been in possession of the authorisation.
58 In light of the foregoing, the answer to the questions referred is that Article 20 of Regulation No 883/2004, read together with Article 56 TFEU, must be interpreted as meaning that an insured person who has received, in a Member State other than his or her Member State of residence, a treatment which is among the benefits provided for by the legislation of the Member State of residence is entitled to full reimbursement of the cost of that treatment, under the conditions laid down in that regulation, where he or she has been unable to obtain authorisation from the competent institution, in accordance with Article 20(1) of that regulation, on the ground that, although the diagnosis and the urgent need for treatment were confirmed by a doctor belonging to the health insurance system of the Member State of residence, that doctor had prescribed a different treatment from the one which the insured person chose following a second medical opinion given by a doctor in another Member State, the treatment chosen, unlike the treatment initially proposed, not causing a disability.
59 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.