OPINION OF ADVOCATE GENERAL

BOT

delivered on 12 June 2019 ( 1 )

Case C‑222/18

VIPA Kereskedelmi és Szolgáltató Kft.

v

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet

(Request for a preliminary ruling from the Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and Labour Court, Hungary))

(Reference for a preliminary ruling — Directive 2011/24/EU — Article 3(k) — Article 11(1) — Prescription-only medicinal products for human use — Definition of ‘prescription’ — Definition of ‘order form’ — Restriction on a pharmacy dispensing prescription-only medicinal products ordered by a doctor who practises in a different Member State for the purposes of that doctor’s own activities — Directive 2001/83/EC — Wholesale distribution of medicinal products — Conditions — Articles 34 and 36 TFEU — Free movement of goods — National rules — Quantitative restriction on exports — Measure having equivalent effect — Justification — Protection of the life and health of humans)

I. Introduction

1. This request for a preliminary ruling concerns the interpretation of Article 3(k) and Article 11(1) 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. ( 2 )

2. The request has been made in proceedings between VIPA Kereskedelmi és Szolgáltató Kft. ( 3 ) and the Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (National Institute of Pharmacy and Nutrition, Hungary) ( 4 ) concerning an administrative decision penalising VIPA for unlawfully dispensing medicinal products subject to a medical prescription to doctors practising in a Member State other than Hungary.

3. This case provides the Court of Justice with an opportunity, in the sensitive area of the sale of medicinal products within the EU internal market, to rule, first, on the scope of Directive 2011/24 and, secondly, on assessment of the justification for the restriction on the free movement of goods imposed by the national legislation in question.

4. On completion of my analysis, I propose that the Court should find that: – the dispensing of medicinal products on the basis of order forms falls outside Directive 2011/24. – in the case of the wholesale distribution of medicinal products, it is regulated by the provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, ( 5 ) as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, ( 6 ) and – the restriction on the free movement of goods imposed by the national legislation in question can be justified by an objective of protecting the health and life of humans, within the meaning of Article 36 TFEU and is appropriate for the purpose of attaining that objective.

II. Legal context

A. EU law

1. Directive 2001/83

5. Article 1(17), (17a) and (19) of Directive 2001/83 provides as follows: ‘For the purposes of this Directive, the following terms shall bear the following meanings: … (17) Wholesale distribution of medicinal products: All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in the Member State concerned. (17a) Brokering of medicinal products: All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. … (19) Medical Prescription: Any medicinal prescription issued by a professional person qualified to do so.’

6. Title VI of that directive, entitled ‘Classification of medicinal products’, contains Articles 70 to 75. Article 70 provides: ‘1. When a marketing authorisation is granted, the competent authorities shall specify the classification of the medicinal product into: – a medicinal product subject to medical prescription, – a medicinal product not subject to medical prescription. To this end, the criteria laid down in Article 71(1) shall apply. 2. The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification: (a) medicinal products on medical prescription for renewable or non-renewable delivery; (b) medicinal products subject to special medical prescription; (c) medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas.’

7. Article 71 of that directive sets out the criteria to be taken into account to determine whether medicinal products should be subject to a medical prescription. According to Article 71(3): ‘Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: … – the medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment.’

8. The rules governing the wholesale distribution of medicinal products are set out in Title VII of that directive, entitled ‘Wholesale distribution and brokering of medicinal products’, which comprises Articles 76 to 85.

9. According to Article 76 of Directive 2001/83, all medicinal products for wholesale distribution are to be covered by a marketing authorisation.

10. Article 77(1) and (2) of that directive provides: ‘1. Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid. 2. Where persons authorised or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorisation provided for in paragraph 1.’

11. Article 81 of that directive states: ‘With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State, any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities. The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.’

2. Directive 2011/24

12. Recitals 10, 11 and 53 of Directive 2011/24 state as follows: ‘(10) This Directive aims to establish rules for facilitating access to safe and high-quality cross-border healthcare in the Union and to ensure patient mobility … (11) This Directive should apply to individual patients who decide to seek healthcare in a Member State other than the Member State of affiliation. As confirmed by the Court of Justice, neither its special nature nor the way in which it is organised or financed removes healthcare from the ambit of the fundamental principle of the freedom to provide services. … … (53) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated health profession within the meaning of Directive 2005/36/EC [of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications] ( 7 ) for an individual named patient, it should, in principle, be possible for such prescriptions to be medically recognised and for the medicinal products to be dispensed in another Member State in which the medicinal products are authorised. …’

13. According to Article 1(1) and (2) of that directive: ‘1. This Directive provides rules for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare. … 2. This Directive shall apply to the provision of healthcare to patients …’

14. Article 2(h) of Directive 2001/24 stipulates that the directive is to apply without prejudice to Directive 2001/83.

15. Article 3(k) of Directive 2011/24 provides: ‘For the purposes of this Directive, the following definitions shall apply: … (k) “prescription” means a prescription for a medicinal product or for a medical device issued by a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive [2005/36] who is legally entitled to do so in the Member State in which the prescription is issued.’

16. Article 11 of Directive 2011/24, entitled ‘Recognition of prescriptions issued in another Member State’, provides as follows in the first and second subparagraphs of Article 11(1): ‘1. If a medicinal product is authorised to be marketed on their territory, in accordance with Directive [2001/83] or Regulation (EC) No 726/2004 [of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,] ( 8 ) Member States shall ensure that prescriptions issued for such a product in another Member State for a named patient can be dispensed on their territory in compliance with their national legislation in force, and that any restrictions on recognition of individual prescriptions are prohibited unless such restrictions are: (a) limited to what is necessary and proportionate to safeguard human health, and non-discriminatory; or (b) based on legitimate and justified doubts about the authenticity, content or comprehensibility of an individual prescription. The recognition of such prescriptions shall not affect national rules governing prescribing and dispensing, if those rules are compatible with Union law, including generic or other substitution. …’

3. Implementing Directive 2012/52/EU

17. According to Article 1 of Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State, ( 9 ) the directive ‘lays down measures for the uniform implementation of Article 11(1) of Directive [2011/24] concerning the recognition of medical prescriptions issued in another Member State.’

18. Article 2 of Implementing Directive 2012/52 states: ‘This Directive shall apply to prescriptions, as defined in point (k) of Article 3 of Directive [2011/24], which are issued further to a request of a patient who intends to use them in another Member State.’

19. Article 3 of Implementing Directive 2012/52 provides that: ‘Member States shall ensure that prescriptions contain at least the elements set out in the Annex.’

20. That annex contains a non-exhaustive list of the information that must be included in prescriptions, which includes, in particular, in respect of ‘identification of the patient’, the following information: ‘Surname(s) First name(s) (written out in full, i.e. no initials) Date of birth.’

B. Hungarian law

21. Paragraph 1(1) of 44/2004. (IV. 28.) ESzCsM rendelet az emberi felhasználásra kerülő gyógyszerek rendeléséről és kiadásáról (Regulation No 44/2004 of the Minister for Health, Labour Affairs and Family on the prescription and dispensing of medicinal products for human use) of 28 April 2004, ( 10 ) as applicable to the dispute in the main proceedings, provides as follows: ‘For the purposes of the present regulation, “medical prescription” means the communication addressed by the medical doctor prescribing the medicinal product to the pharmacist who dispenses or prepares it or, in the cases provided for by the special rules, to the assistant pharmacist. The following shall be considered medical prescriptions: (a) prescriptions stricto sensu; and (b) order forms.’

22. Paragraph 9/A(1) to (3) of that regulation states that: ‘1. Medical doctors shall use order forms in the exercise of their healthcare activities to order medicinal products that they use in the treatment of patients. 2. Order forms shall be used to order medicinal products or medicinal products specially prepared in a pharmacy which are authorised to be placed on the market. … 3. Various types of medicinal product may be ordered at the same time by means of one order form. The name of the medical doctor ordering the medicinal products, his or her identification stamp and handwritten signature, the number of persons for whose treatment the medicinal product is ordered, the name and address of the establishment or company using the medicinal product in question and the date of the order shall be recorded on the order form. The name of the medicinal product ordered, including the pharmaceutical form and — where the product is placed on the market in various dosages — the dosage and total quantity of the medicinal product, shall be recorded on the order form.’

23. Paragraph 12 of that regulation provides that: ‘1. Prescription-only medicinal products may be dispensed only on prescription or on the basis of an order form which meets the requirements established in this Regulation or in the special rules. 2. Only one type of medicinal product may be dispensed per prescription stricto sensu. 3. Various types of medicinal product may be dispensed on the basis of an order form. …’

24. According to Paragraph 20(1) and (3) of that regulation: ‘1. … a medicinal product subject to prescription which has been prescribed by a person not registered on the register of practitioners, but who is legally authorised to do so in another State, may only be dispensed if the identity, quantity and dosage of the medicinal product prescribed can be determined … 3. Medicinal products subject to prescription that are prescribed in accordance with subparagraph 1 shall be dispensed on the basis of a prescription stricto sensu only if: (a) the name of the person prescribing the medicinal product and the address or identification of his or her surgery, in addition to the date on which the medicinal product was prescribed and the signature of the person legally authorised to prescribe that product, may be determined; and (b) the name and date of birth of the patient are included on the prescription.’

III. The facts in the main proceedings and the question referred for a preliminary ruling

25. VIPA is a commercial company incorporated under Hungarian law which operates a pharmacy. During an inspection, the Institute found that VIPA had, on 25 occasions between 1 January 2014 and 15 September 2015, unlawfully dispensed prescription-only medicinal products on the basis of order forms issued by prescribing agents not authorised by the Hungarian health authorities to exercise healthcare activities. That finding concerned 21 order forms issued by a medical company established in the United Kingdom and 4 order forms issued by a doctor practising in Austria.

26. By decision of 31 August 2016, the Institute imposed a fine of HUF 45000000 (approximately EUR 145000) ( 11 ) on VIPA, prohibited any further unlawful supply of medicinal products at the pharmacy in question and withdrew the pharmacy’s operating licence.

27. VIPA brought an action against that decision before the Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and Labour Court, Hungary), the referring court. In support of its action, VIPA contends, in particular, that Directive 2011/24 contains only the term ‘prescription’ and that, according to Hungarian law, both prescriptions stricto sensu and order forms are prescriptions. Accordingly, both those categories of prescriptions should be recognised in Hungary, provided they are issued by a person entitled to issue prescriptions in a Member State other than Hungary (which, VIPA contends, is not disputed in the present case).

28. According to VIPA, the Institute’s position amounts to recognising the qualifications of health professionals of Member States other than Hungary only where they issue prescriptions stricto sensu, as opposed to order forms, for which there can be no justification. That company also relies on the Court of Justice’s case-law on the prohibition of measures having equivalent effect to quantitative restrictions.

29. The Institute argues that medicinal products may be lawfully dispensed only on the basis of an order form where that order form is issued by a healthcare provider authorised by the Hungarian health authorities to exercise a healthcare activity. Article 11(1) of Directive 2011/24, it asserts, relates only to prescriptions issued for a named patient.

30. Furthermore, according to the Institute, although, in the case of a prescription stricto sensu, the fact that it indicates the patient’s name guarantees the end use to which the medicinal product will be put, that is not true of order forms. The end use of the medicinal product is crucially important, because the case concerns prescription-only medicinal products and the purpose of Directive 2011/24 is to protect health. Therefore, according to the Institute, order forms, whether issued by a Hungarian healthcare provider or by a provider practising in a different Member State, fall outside the scope of EU law.

31. The referring court states that there are two categories of prescription under Hungarian law, that is to say, prescriptions stricto sensu and order forms issued by doctors in order to have available several types of medicinal product when treating patients in the course of their healthcare activities. Nevertheless, Paragraph 20(4) of the Minister for Health Regulation does not contain any reference to the concept of ‘foreign order form’. The medicinal products in question were therefore found to have been dispensed unlawfully on the ground that they were dispensed on the basis of order forms issued by healthcare professionals not entitled to practice in Hungary.

32. The referring court states that it has difficulty in determining whether the Hungarian legislation in question is compatible with the concept of ‘prescription’ as defined in EU law and with the rule that medical prescriptions should be mutually recognised established in Article 11(1) of Directive 2011/24. Neither the definition of ‘medicinal prescription’ in Article 1(19) of Directive 2001/83 nor Articles 70 and 71 of that directive, or the definition of ‘prescription’ in Article 3(k) of Directive 2011/24, can dispel its doubts. The referring court is of the view that, when transposing Directive 2011/24, Hungarian law laid down national provisions on the prescribing and dispensing of medicinal products that are incompatible with EU law, in so far as medicinal products cannot be dispensed under the same conditions for both categories of prescriptions provided for, depending on whether or not the person issuing the prescription is entitled to provide healthcare services in Hungary.

33. It is therefore necessary to ascertain whether the expression ‘prescriptions … for a named patient’ in Article 11(1) of Directive 2011/24 refers only to medicinal products prescribed for patients or whether, in accordance with Article 71(3) of Directive 2001/83, prescriptions by which a specialist orders the preparation but which nevertheless do not contain the details of an individual patient must also be classified as ‘prescriptions … for a named patient’.

34. The referring court states that Hungarian case-law is inconsistent on that point. On the one hand, the Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and Labour Court) has held, by final decision of 5 October 2015, that Paragraph 20(1) of the Minister for Health Regulation contains no prohibition to the effect that doctors who are not entitled to practise in Hungary can order medicinal products subject to prescription only by means of a prescription stricto sensu.

35. On the other hand, the Kúria (Supreme Court, Hungary) ruled, in a judgment of 21 September 2016, that under that provision, persons not registered on the Hungarian register of practitioners, but who are entitled to prescribe medicinal products in another Member State may order medicinal products subject to prescription only by means of a prescription stricto sensu, and not by means of an order form. Therefore, according to the Kúria (Supreme Court) order forms fall outside the scope of EU law.

36. In those circumstances, the Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and Labour Court) decided to stay the proceedings and refer the following question to the Court of Justice for a preliminary ruling: ‘Must Article 3(k) and Article 11(1) of Directive [2011/24] be interpreted as meaning that national legislation, which distinguishes between two categories of prescriptions and, only in the case of one of those categories, allows medicinal products to be dispensed to a doctor who exercises his healthcare activity in a State other than the Member State concerned, [is] contrary to the mutual recognition of prescriptions and to freedom to provide services, and therefore incompatible therewith?’

IV. My analysis

37. The referring court asks the Court of Justice, in essence, whether Article 3(k) and Article 11(1) of Directive 2011/24 and the principle of freedom to provide services must be interpreted as precluding the legislation of a Member State under which medicinal products cannot be dispensed on the basis of order forms that do not contain the name of the patient concerned if they were issued by a doctor authorised to practise only in a different Member State.

A. Admissibility

38. The Institute contends that the question referred is inadmissible on the ground that, first, it relates neither to interpretation of the Treaties nor to the validity and interpretation of acts adopted by the institutions, bodies, offices or agencies of the European Union, but instead seeks a declaration by the Court of Justice that Hungarian law does not comply with fundamental principles protected by EU law, such as the mutual recognition of prescriptions and freedom to provide services.

39. Secondly, the Institute states that the question referred does not reflect the true content of Hungarian law in so far as it appears to suggest that medicinal products are dispensed to doctors in all cases, whereas they are dispensed to patients, in the case of prescriptions identifying the patient, and, in the case of order forms, to the institution that uses the medicinal product.

40. In respect of the first ground of inadmissibility relied upon, it should be noted that, according to settled case-law, while it is not for the Court, in proceedings under Article 267 TFEU, to rule on the conformity or compatibility of national provisions with EU law or to interpret national legislative or regulatory provisions, the Court nonetheless has jurisdiction to give the national court full guidance on the interpretation of EU law in order to enable it to determine the issue of conformity or compatibility for the purposes of the case before it. ( 12 )

41. The Court of Justice must therefore restrict its analysis to the provisions of EU law and provide an interpretation of the national provisions which will be of use to the national court, which has the task of determining the compatibility and conformity of the instruments of national law with EU law, for the purposes of deciding the dispute before it. ( 13 )

42. In the present case, the question referred expressly relates to the interpretation of certain provisions of Directive 2011/24 which may be of use to the referring court in dispelling any doubt as to whether or not the national legislation at issue is compatible with those provisions.

43. In respect of the second ground of inadmissibility, even if it were established, the Court has held that ‘questions on the interpretation of EU law referred by a national court in the factual and legislative context which that court is responsible for defining and the accuracy of which is not a matter for this Court to determine, enjoy a presumption of relevance. The Court may refuse to rule on a question referred by a national court only where it is quite obvious that the interpretation of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it’. ( 14 )

44. In the main proceedings, the request for a preliminary ruling contains a description of the factual and legal background of the dispute being heard by the referring court that is in my view sufficient to enable the Court to give a useful answer to the questions referred.

45. It follows from the foregoing that, to my mind, the request for a preliminary ruling is admissible.

B. Substance

1. Interpretation of Article 3(k) and Article 11(1) of Directive 2011/24

46. The issues raised by the referring court concern the requirement in Article 11(1) of Directive 2011/24 that a prescription must have been issued for a ‘named patient’. The doubt seems to arise ( 15 ) when a comparison is made of the wording of that article in Hungarian, which states that the prescription must be ‘nominative’, with that of the third indent of Article 71(3) of Directive 2001/83, which, in the Hungarian version, requires that ‘a specialist order the product’ rather than requiring a ‘prescription drawn up … by a specialist’.

47. The doubts raised by the referring court can be settled without difficulty by analysing the wording of Article 11(1) of Directive 2011/24 in other language versions, and the objectives that the directive pursues.

48. Indeed, it can be seen, first of all, that most of the other language versions of Article 11(1) of Directive 2011/24 that I have been able to check ( 16 ) state that the prescription must be intended for a named patient or a given, specific or particular patient. Secondly, Implementing Directive 2012/52 provides that prescriptions issued further to a request by a patient who intends to use them in another Member State must indicate the surname or surnames and first name or names of the patient and his or her date of birth.

49. Lastly, the wording of Article 11(1) of Directive 2011/24 concurs with the objective of the directive, which is to lay down the conditions under which a patient can go to a different Member State of the European Union to receive safe, high-quality healthcare. ( 17 ) Those conditions include the recognition of prescriptions issued in a different Member State, for which that article makes provision. ( 18 )

50. In those circumstances, it is clear that order forms for medicinal products, which, by definition, are not for named patients, do not serve the same purpose. Order forms therefore fall outside the scope of Directive 2011/24.

51. I infer from the foregoing that Article 11(1) of that directive must be interpreted as meaning that the obligation it imposes to recognise prescriptions applies only to prescriptions that, for the purpose of individual treatment, name the patient for whom the prescription-only medicinal product is intended.

52. Since that article does not apply to order forms, which do not contain the patient’s name because they are intended to ensure that doctors (or institutions) have available a supply of medicinal products with a view to their being used subsequently in the course of their activities, ( 19 ) it cannot in my view preclude national legislation, such as that at issue in the main proceedings, which does not recognise order forms issued by doctors who exercise their healthcare activities in a State other than the Member State where the medicinal products are dispensed.

53. However, that conclusion is insufficient for the purposes of giving an answer that will be of use to the referring court because, given that the national legislation at issue has restrictive effects on the dispensing of medicinal products in a cross-border situation, it must be examined in the light of other rules and principles of EU law that are amenable to interpretation.

2. Examination of the national measure in the light of other provisions of EU law

(a) In the light of Directive 2001/83

54. As a preliminary point, it should be noted, first, that Directive 2001/83 codified all the provisions in force relating to, amongst other matters, the sale and distribution of medicinal products for human use in the European Union. ( 20 )

55. Secondly, the Court has previously highlighted a number of objectives that the directive pursues, as referred to in recitals 2 to 5 and 35 of that directive, that is to say, the protection of public health, the removal of barriers to trade in medicinal products within the European Union and exercising control over the entire chain of distribution of medicinal products. ( 21 )

56. When the national legislation at issue is examined in the light of Directive 2001/83 in the case in the main proceedings, two new characteristics, not present in the situations previously considered by the Court, are apparent, on account of the activity carried on by VIPA. That company, which operates a pharmacy like any other dispensary serving patients, exported a large number of medicinal products on the basis of order forms drawn up by professionals qualified to prescribe medicinal products, for the purposes of their activity in a different Member State.

(1) The order forms

57. As regards requests for the dispensing of medicinal products, it seems appropriate to my mind to recall that Article 1(19) of Directive 2001/83 defines a ‘medical prescription’ as ‘any medicinal prescription issued by a professional person qualified to do so’. The literal meaning of the term ‘prescription’ chosen by the EU legislature makes it necessary to ascertain whether a doctor has named an individual patient as the final consumer.

58. That reading is in line with how Directive 2001/83 uses the term to classify medicinal products and the resulting restriction on dispensing them, depending on whether or not they are ordered by a doctor.

59. Article 3(1) of Directive 2001/83, which states that ‘[this directive shall not apply to] any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as a pharmacy preparation)’, does not undermine that interpretation.

60. The Court has in fact interpreted that provision in a case in which medicinal products were prepared on the basis of orders. ( 22 ) It can be inferred from that case that the expression ‘order form’ is used where a doctor issues an order for a medicinal product to be supplied but does not identify a patient.

61. It can therefore be concluded that the concept of ‘order form’ for medicinal products drawn up by a doctor for his or her own activity is not covered by any specific provision in Directive 2001/83, even though that is the means used to order a supply of medicinal products.

(2) VIPA’s activity

62. As regards the conditions for dispensing the medicinal products in question, whose end use justified the use of order forms, the referring court’s findings raise questions as to how VIPA’s activity is to be classified in the light of Directive 2001/83, in particular given the number of medicinal products sold and their characteristics. ( 23 )

63. That directive establishes a framework to regulate the activities of intermediaries involved in the distribution of medicinal products, and in particular, the activities of wholesale distributors of such products ( 24 ) and brokers. ( 25 )

64. ‘Wholesale distribution of medicinal products’ is defined in Article 1(17) of Directive 2001/83 as ‘all activities consisting of … exporting medicinal products, apart from supplying medicinal products to the public … carried out … with pharmacists and persons authorised or entitled to supply medicinal products to the public in the Member State concerned.’

65. The Court has held, first, that ‘pharmacists are included in the wider class of persons authorised or entitled to supply medicinal products to the public within the meaning of Article 77(2) of [Directive 2001/83] and are required, if they are permitted under domestic law to engage in activity as wholesale distributors in medicinal products, to obtain the authorisation prescribed under Article 77(1).’ ( 26 )

66. Secondly, the Court has decided that ‘given that the retail of medicinal products has different characteristics from the wholesale distribution of such products, it cannot be presumed from the simple fact that pharmacists satisfy the conditions governing retail supply in their respective Member States that they also satisfy the conditions laid down by harmonised rules at European Union level [ ( 27 )] for wholesale distribution.’ ( 28 )

67. Accordingly, given the definition of wholesale distribution of medicinal products, the classification of a pharmacy’s activity of dispensing medicinal products, as a dispensary, is only relevant where it supplies retailers — in other words, professionals responsible for dispensing medicinal products to end consumers.

68. In the present case, it is common ground that the medicinal products were sold to doctors who, by definition, were not engaged in the retail sale of medicinal products, for their own use. The fact that the conditions governing wholesale distribution are not met is corroborated by the finding that the unlawful conduct for which VIPA was fined was not based on any infringement of the requirements pertaining to that field. ( 29 )

69. The conditions under which VIPA, as a dispensary, dispensed medicinal products on a cross-border basis to doctors in the course of its healthcare activities, for unnamed patients, therefore fall outside the scope of Directive 2001/83.

70. That being so, it should be noted, first, that those procedures for distributing medicinal products to healthcare professionals who have ordered them on their own behalf in order to administer or supply them to patients are not harmonised under EU law as it currently stands.

71. It should be noted in that regard that that is not the only non-harmonised area in the field of medicinal products. The Court has, on the one hand, previously commented on that lack of harmonisation as regards the conditions to be satisfied in order to be authorised to supply medicinal products to the public, or, in other words, to engage in the retail distribution of medicinal products, and has held that the Member States may impose conditions, within the limits laid down in the FEU Treaty. ( 30 )

72. On the other hand, in relation to the supply of medicinal products to doctors in the course of their professional activities, the Court has held that this must be distinguished from the service provided by internal pharmacies in hospital departments. ( 31 )

73. Secondly, the principle that, where a matter has not been the subject of exhaustive harmonisation at EU level, any national measure relating thereto must be assessed in the light of the provisions of primary law ( 32 ) and, especially, the freedoms of movement, must apply.

(b) In the light of the freedoms of movement guaranteed within the internal market

74. Both the referring court and the Spanish Government referred to the principle of the freedom to provide services. However, the Hungarian and Polish Governments and the European Commission take the view that the national measure may relate to the principle of the free movement of goods. ( 33 )

75. I shall set out the reasons why I propose that the Court should examine the national measure at issue, which may relate both to the free movement of goods and to freedom to provide services, in the light of one only of those two fundamental freedoms, since one of them is of secondary importance in relation to the other and may be considered together with it. ( 34 )

(1) Freedom to provide services

76. Article 57 TFEU and Article 4(1) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market ( 35 ) define ‘service’ as any service normally provided for remuneration not falling within the definition of, inter alia, ‘goods’.

77. In the main proceedings, it is apparent that the national legislation at issue does not have the effect of limiting the provision of services by pharmacists or of refusing to recognise in Hungary the status of a person as a member of a regulated healthcare profession legally authorised to issue prescriptions in a different Member State, as VIPA maintained before the referring court. I do not share the view of the Spanish Government that the legislation at issue casts doubt on whether professionals qualified to carry on healthcare activities in their own Member State, other than Hungary, are able in that Member State to legitimately use and issue a form of medical prescription governed by Hungarian law.

78. However, it may be concluded that, if they cannot freely obtain supplies of medicinal products in a Member State other than that in which they practise, the activity of the doctors concerned will be indirectly hindered.

79. Nevertheless, I am of the view that the case in the main proceedings, which relates to the fine imposed on a pharmacy because it exported medicinal products to another Member State, does not primarily concern freedom to provide services.

80. In the interests of completeness, in the event that the Court does not share that view, I shall make three brief observations. It should be noted first of all that, in Article 2(2)(f) of Directive 2006/123, healthcare services are excluded from the scope of that directive. Recital 22 of that directive states that ‘the exclusion of healthcare from the scope of this Directive should cover healthcare and pharmaceutical services provided by health professionals to patients to assess, maintain or restore their state of health where those activities are reserved to a regulated health profession in the Member State in which the services are provided’.

81. Next, it is therefore necessary to ascertain whether it is possible that the cross-border situation at issue complies with the requirements of primary law. If the effect of the national legislation is to prohibit a cross-border provision of services, the authorities of the Member State must show that the legislation is appropriate and necessary for the purpose of achieving the public interest objective recognised as being a ground for derogation, under Article 52 TFEU, which applies by virtue of Article 62 TFEU, or an overriding reason which will be accepted by the Court.

82. Lastly, there could be said to be public health grounds in the present case. The factors to be taken into account in order to examine that derogation are therefore the same as those I shall go on to describe in relation to the free movement of goods. ( 36 )

(2) Free movement of goods

(i) Preliminary remarks

83. Under the Hungarian legislation at issue, the dispensing of prescription-only medicinal products on the basis of order forms is restricted to doctors, who must be registered to practice in Hungarian territory. Article 35 TFEU, according to which ‘quantitative restrictions on exports, and all measures having equivalent effect, shall be prohibited between Member States’, is therefore applicable.

84. According to the Court’s case-law as it currently stands, the prohibition laid down by Article 35 TFEU covers a national measure applicable to all traders active in national territory which has a greater effect on goods leaving the market of the exporting Member State than on the marketing of goods in the domestic market of that Member State. Classification as a ‘measure having equivalent effect to a quantitative restriction on exports’ therefore presupposes the existence of restrictive effects on trade, which may be minor, provided they are neither too indirect nor too uncertain. ( 37 )

85. However, general interest objectives may justify legislation that hinders the free movement of goods. Accordingly, Article 36 TFEU provides that prohibitions or restrictions on imports, exports or goods in transit may be justified on, inter alia, grounds of the protection of health and life of humans but that those prohibitions or restrictions must not, in any event, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.

86. In the present case, since it relates to a national measure falling within the field of public health, it seems to me to be appropriate to refer to the judgment of 19 October 2016, Deutsche Parkinson Vereinigung. ( 38 ) The Court observed that it had ‘on numerous occasions held that the health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for the Member States to determine the level of protection which they wish to afford to public health and the way in which that level is to be achieved. Since that level may vary from one Member State to another, Member States should be allowed a measure of discretion (see judgment of 12 November 2015,Visnapuu, C‑198/14, EU:C:2015:751, paragraph 118 and the case-law cited)’ ( 39 ).

87. The Court stated that ‘in particular, the need to ensure that the country has reliable supplies for essential medical purposes may, so far as Article 36 TFEU is concerned, justify a barrier to trade between Member States if that objective is one of protecting the health and life of humans (see judgment of 28 March 1995, Evans Medical and Macfarlan Smith, C‑324/93, EU:C:1995:84, paragraph 37)’ ( 40 ).

(ii) Justification for restricting freedom of movement

88. In the case in the main proceedings, having regard to the Commission’s general observation that the national provision in question is discriminatory and restrictive, it may, in my view, be concluded, first, should the Court consider it necessary, ( 41 ) that the only requirement imposed on a doctor wishing to purchase medicinal products on the basis of an order form is that he or she must provide healthcare services in Hungary, no distinction being made on the basis of that doctor’s Member State of origin.

89. Secondly, it should be noted that the national legislation at issue restricts the dispensing of medicinal products on the basis of order forms that are used by doctors to cover the needs of more than one patient. In that way, it seeks to control supplies which, in the context of healthcare services provided by doctors, may involve a large number of medicinal products. ( 42 ) That legislation can therefore be justified by the need to ensure that the country has supplies of medicinal products. The observations made by the Hungarian and Polish Governments at the hearing on that point confirmed that this is a pressing, current and constant concern.

90. However, in the case in the main proceedings that legitimate justification based on the desire of the Member State concerned to guard against any risk of a shortage of medicinal products appears to be of less importance ( 43 ) than that based on the need to ensure the quality of the system for the distribution of medicinal products, on which the Hungarian Government relied, in essence, in its written observations and which was examined at the hearing.

91. It must, in my view, be borne in mind that the question referred relates to a specific situation, that is to say, one entailing the supply of prescription-only medicinal products outside the chain of distribution existing in the Member State in which the acquiring doctor practises.

92. The Spanish Government correctly noted at the hearing that this kind of supply of medicinal products could constitute a third method of distribution, after wholesale distribution and distribution by distance selling. ( 44 )

93. The method of dispensing medicinal products at issue cannot, in my view, be accepted, since it causes a shift away from the distribution chain of medicinal products, which is strictly regulated in Directive 2001/83, in particular, by reason of the characteristics of prescription-only medicinal products.

94. The Court has previously highlighted in that respect the importance of the rules imposed by Directive 2001/83, which established a system for the protection, inter alia, of public health, by codifying all the provisions in force for the sale, production, labelling, classification, distribution and advertising of medicinal products for human use in the European Union.

95. In particular, as regards the type of medicinal product that is covered in that field, Directive 2001/83 provided that the competent authorities must indicate the classification of medicinal products when they authorise the marketing of such products. Those authorities must specify whether or not medicinal products are subject to prescription, depending on the potential dangers associated with their use. ( 45 ) The Court has previously referred to the purpose, and the effect, of that classification, ( 46 ) that is to say, the need for stricter control at the time of supply. ( 47 )

96. In its judgment of 28 June 2012, Caronna, ( 48 ) the Court observed that the distribution system for medicinal products, as envisaged in Directive 2001/83, ( 49 ) must be implemented rigorously, in the light of the objectives to be achieved, in particular the protection of public health, the removal of barriers to trade in medicinal products within the European Union and the need to exercise control over the distribution chain of medicinal products, as referred to in recitals 2 to 5 and 35 of that directive. ( 50 )

97. The Court has also observed that the need for high-quality conservation of medicinal products and their proper distribution imposes specific organisational requirements on medicinal product wholesalers as regards premises, equipment and qualified staff, which must be complied with if the special authorisation under Article 79 of Directive 2001/83 is to be granted. ( 51 )

98. Accordingly, the case in the main proceedings affords an opportunity to add that, in this system for the distribution of prescription-only medicinal products, it is vital to circumscribe the role of pharmacists, for two fundamental reasons.

99. First, by participating in that system as retailers, pharmacists contribute to upholding high standards as regards the quality and safety of the supply of medicinal products.

100. However, where medicinal products are supplied outside the territory in which a pharmacist practises, he or she is no longer in a position to have control over those requirements, though he is responsible for ensuring that they are complied with. ( 52 )

101. Secondly, it must be borne in mind that the requirements imposed on pharmacists as regards the retail distribution of medicinal products are connected with the fact that such distribution forms part of the public health system that each Member State has complete freedom to organise. ( 53 )

102. Under those circumstances, I am of the view that if a doctor were allowed to obtain, hold and dispose of large amounts of prescription-only medicinal products from a Member State other than that in which the doctor practises, that would be likely to foster a solution in which the supply of medicinal products is placed outside the control exercised by the Member State in question not only pursuant to Directive 2001/83, over wholesale distribution in particular, but also as part of the Member State’s discretion in relation to retail supply. ( 54 )

103. It is also important to guard against encouraging the parallel sale of particularly expensive medicinal products, such as those included in the order forms at issue. ( 55 )

104. It is apparent from all the foregoing that, in my view, the national legislation at issue is justified, in essence, by the need to monitor safety and quality standards in the retail supply of medicinal products, in line with the objective set out in recital 35 of Directive 2001/83, and to do so to a greater degree in the case of prescription-only medicinal products.

105. However, ‘legislation which is capable of restricting a fundamental freedom guaranteed by the Treaty, such as the free movement of goods, can be properly justified only if it is appropriate for securing the attainment of that objective and does not go beyond what is necessary in order to attain it’. ( 56 )

(iii) Analysis of whether the measure adopted is appropriate and necessary

106. On the basis of the information given in the order for reference, as supplemented at the hearing, my view is that the Court is in a position to assess whether the national legislation at issue is justified in the light of the requirements of the principle of proportionality. ( 57 )

107. According to the Court’s settled case-law, account must be taken of the fact that the Member States have a wide discretion in determining the degree of protection which they wish to afford public health and the way in which that degree of protection is to be achieved. ( 58 )

108. In that respect, the measure chosen by the Hungarian Government seems to me to be consistent with the objective pursued.

109. As regards whether that measure is necessary, there may be reason to question, as VIPA and the Commission do, whether a less restrictive measure should have been chosen. Indeed, the Hungarian Government could have envisaged rationing the number of medicinal products distributed or establishing a special regime for the sale of medicinal products to healthcare professionals established in other Member States who might be facing, for example, a shortage, large-scale emergency, sudden interruption in supply or an insufficient number of wholesalers.

110. However, in line with the factors which I propose should be advocated as regards the justification for the national legislation at issue, my view is that only that legislation may have the effect of ensuring that the Member State concerned can perform its task of controlling the conditions under which medicinal products are distributed in the territory for which it is responsible.

111. Indeed, any other half-way measure would be likely to complicate those controls and would justify coordinating them with the controls required of the Member State in which a healthcare professional practises, where that professional seeks a supply of medicinal products via channels other than those normally offered to him or her by that Member State.

112. I am therefore of the view that Articles 34 and 36 TFEU do not preclude the legislation of a Member State, such as that at issue in the main proceedings, which does not authorise the dispensing of prescription-only medicinal products on the basis of order forms drawn up by doctors who do not practise in its territory, since that legislation is appropriate for the purpose of attaining the objective of protecting public health and does not go beyond what is strictly necessary to attain that objective.

V. Conclusion

113. In the light of the foregoing, I propose that the Court should reply as follows to the question referred by the Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and Labour Court, Hungary) for a preliminary ruling: (1) Article 3(k) and Article 11(1) 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 meaning that the obligation imposed by Article 11(1) to recognise prescriptions only applies to prescriptions that name the patient for whom the medicinal product prescribed is intended, for the purposes of individual treatment. Article 11(1) therefore does not apply to order forms intended to ensure that doctors (or institutions) have available a supply of medicinal products with a view to their being used subsequently in the course of their activities. (2) Articles 34 and 36 TFEU must be interpreted as not precluding national legislation, such as that at issue in the main proceedings, that does not authorise the dispensing of prescription-only medicinal products on the basis of order forms drawn up by healthcare professionals qualified to draw up prescriptions who practise in a different Member State, since such legislation is justified by an objective of protecting public health and is appropriate for the purpose of achieving that objective.

( 1 ) Original language: French.

( 2 ) OJ 2011 L 88, p. 45.

( 3 ) ‘VIPA’.

( 4 ) ‘The Institute’.

( 5 ) OJ 2001 L 311, p. 67.

( 6 ) OJ 2011 L 174, p. 74, ‘Directive 2001/83’.

( 7 ) OJ 2005 L 255, p. 22.

( 8 ) OJ 2004 L 136, p. 1.

( 9 ) OJ 2012 L 356, p. 68.

( 10 ) Magyar Közlöny 2004/58.(IV.28.) (‘the Minister for Health regulation’).

( 11 ) At the exchange rate on 31 August 2016.

( 12 ) See judgment of 26 July 2017, Europa Way and Persidera (C‑560/15, EU:C:2017:593, paragraph 35 and the case-law cited).

( 13 ) Ibidem (paragraph 36 and the case-law cited).

( 14 ) Judgment of 20 September 2018, Motter (C‑466/17, EU:C:2018:758, paragraph 22 and the case-law cited).

( 15 ) According to what is stated by the translator of the order for reference.

( 16 ) That is to say, the Spanish, German, English, Italian and Polish versions.

( 17 ) See, in particular, Article 1(1) and (2) of that directive, read in conjunction with recitals 10 and 11.

( 18 ) See, also, recital 53 of Directive 2011/24, concerning the rights of individual named patients, to be read in conjunction with recital 16 thereof, concerning the reimbursement of the costs of cross-border healthcare.

( 19 ) For similar circumstances, see the judgment of 16 July 2015, Abcur (C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 63).

( 20 ) See recital 1 of that directive.

( 21 ) See judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 48).

( 22 ) See judgment of 16 July 2015, Abcur (C‑544/13 and C‑545/13, EU:C:2015:481, paragraphs 61, 62 and 64).

( 23 ) VIPA stated at the hearing that 6493 boxes of medicinal products were sold over a 21-month period. The Institute confirmed that sales volume and stated that the medicinal products ordered were capable of causing very serious side effects, such as multiple sclerosis or psychological or physical complications that justify strict controls. It also emphasised that these medicinal products are ‘blockbusters’ used in epidemics and they may vary significantly in price within the European Union, for example by nearly a third for certain products.

( 24 ) Judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 37).

( 25 ) See Article 1(17a) of Directive 2001/83. That article is not applicable here, in view of the circumstances of the present case.

( 26 ) Judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 37).

( 27 ) In its judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 44), the Court stated that ‘the minimum requirements to be satisfied by applicants for and holders of authorisation for the wholesale distribution of medicinal products are harmonised by [Directive 2001/83], in particular in Articles 79 to 82 of the Directive.’

( 28 ) Judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 47).

( 29 ) See, in that respect, judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 37).

( 30 ) Judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 43).

( 31 ) See judgment of 19 May 2009, Apothekerkammer des Saarlandes and OthersC‑171/07 and C‑172/07, EU:C:2009:316, paragraph 48).

( 32 ) See, to that effect, judgment of 1 July 2014, Ålands Vindkraft (C‑573/12, EU:C:2014:2037, paragraph 57).

( 33 ) As regards the fact that I am not prevented from analysing that question simply because the referring court did not mention the free movement of goods, see, in particular, judgments of 16 July 2015, Abcur (C‑544/13 and C‑545/13, EU:C:2015:481, paragraphs 33 and 34 and the case-law cited), and of 21 June 2016, New Valmar (C‑15/15, EU:C:2016:464, paragraphs 28 and 29).

( 34 ) See, in particular, judgment of 4 October 2011, Football Association Premier League and Others (C‑403/08 and C‑429/08, EU:C:2011:631, paragraphs 78 to 83 and the case-law cited).

( 35 ) OJ 2006 L 376, p. 36.

( 36 ) See points 88 to 111 of this Opinion.

( 37 ) See, in particular, to that effect, judgments of 21 June 2016, New Valmar (C‑15/15, EU:C:2016:464, paragraphs 36, 37, 42 and 45 and the case-law cited), and of 28 February 2018, ZPT (C‑518/16, EU:C:2018:126, paragraphs 43 and 44).

( 38 ) C‑148/15, EU:C:2016:776. In that case, the national legislation provided that uniform prices were to be fixed for the sale by pharmacies of prescription-only medicinal products for human use.

( 39 ) Judgment of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776, paragraph 30). See, also, judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 19 and the case-law cited).

( 40 ) Judgment of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776, paragraph 31).

( 41 ) The Court’s case-law appears to have abandoned that requirement for non-discrimination in relation to the free movement of goods, unlike the requirement in respect of the freedom to provide services. See, to that effect, Van Cleynenbruegel, P., Droit matériel de l’Union européenne, Libertés de circulation and marché intérieur, Larcier, Brussels, 2017, p. 274, and Blumann, C., and Dubouis, L., Droit matériel de l’Union européenne, 7th ed., Librairie générale de droit et de jurisprudence, Paris, 2015, paragraph 523, p. 387.

( 42 ) See footnote 23 of this Opinion.

( 43 ) Were that justification nevertheless to be upheld, the Court would then, in my view, have to bear in mind the requirements it set out in paragraphs 35 and 36 of the judgment of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776).

( 44 ) By way of illustration, see judgment of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776, paragraph 32).

( 45 ) See Articles 70 and 71 of that directive. See, also, as regards that characteristic which distinguishes medicinal products from other goods, the judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 31).

( 46 ) See judgment of 11 December 2003, Deutscher Apothekerverband (C‑322/01, EU:C:2003:664, paragraph 108).

( 47 ) Ibidem (paragraph 117).

( 48 ) See, in that respect, the reference to ‘public service obligations’ in Article 81 of that directive, as they are defined in Article 1(18).

( 49 ) C‑7/11, EU:C:2012:396.

( 50 ) See judgment of 28 June 2012, Caronna (C‑7/11, EU:C:2012:396, paragraph 48).

( 51 ) Ibidem (paragraph 45). See, also, the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (OJ 2013 C 343, p. 1).

( 52 ) See judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 37). See, also, as regards the activities pursued by pharmacists, Article 45(2) of Directive 2005/36.

( 53 ) See judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 34).

( 54 ) See judgments of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 19 and the case-law cited), and of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776, paragraph 30).

( 55 ) See footnote 23 of this Opinion. Concerning the regard to be had to the risk to public health of the pursuit of profit by non-pharmacists, see the judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 39). This should also be read in the light of the concept of ‘a reasonable quantity of medicinal products’ for personal use, in recital 30 of Directive 2001/83.

( 56 ) Judgment of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776, paragraph 34 and the case-law cited).

( 57 ) See, by way of illustration, judgment of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776, paragraph 37 et seq.).

( 58 ) See, inter alia, judgment of 9 December 2010, Humanplasma (C‑421/09, EU:C:2010:760, paragraphs 32 and 39 and the case-law cited).