OPINION OF ADVOCATE GENERAL
SZPUNAR
delivered on 3 March 2015 (1)
Joined Cases C‑544/13 and C‑545/13
Abcur AB
v
Apoteket Farmaci AB (C‑544/13)
Apoteket AB and Apoteket Farmaci AB (C‑545/13)
(Requests for a preliminary ruling from the Stockholms tingrätt (Sweden))
(Directive 2001/83/EC — Article 3(1) and (2) — Medicinal products for human use — Concepts of pharmacy and advertising — Scope of Directives 2005/29/EC and 2006/114/EC)
I – Introduction
1. Apoteket, a State-owned company which until July 2009 enjoyed the sole right in Sweden to retail medicinal products, produces and markets two products without having obtained an authorisation pursuant to Regulation (EC) No 726/2004. (2) Abcur, a company which produces and markets two products similar to those products and which has obtained an authorisation pursuant to Regulation No 726/2004, is suing Apoteket for damages. Abcur’s complaint concerns both the fact that Apoteket manufactures the products without an authorisation and the measures employed by Apoteket to present the products. The case at issue deals with the question whether the medicinal products in question fall within the scope of Directive 2001/83/EC, (3) whether Directives 2005/29/EC (4) and 2006/114/EC (5) are applicable and, if so, whether some of their substantive requirements are fulfilled.
II – Legal framework
A – Directive 2001/83
2. Article 2(1) of Directive 2001/83 (as amended) provides:
‘This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.’
3. Article 3 of Directive 2001/83 is worded as follows:
‘This Directive shall not apply to:
1. Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula).
2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula).
…’
4. Article 5(1) of Directive 2001/83 (as amended) states:
‘A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.’
5. Under Article 87(1) of Directive 2001/83:
‘Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not been granted in accordance with Community law.’
B – Directive 2005/29
6. Article 2(d) of Directive 2005/29 defines ‘business-to-consumer commercial practices’ as meaning ‘any act, omission, course of conduct or representation, commercial communication including advertising and marketing, by a trader, directly connected with the promotion, sale or supply of a product to consumers.’
7. According to Article 3(4) of Directive 2005/29:
‘In the case of conflict between the provisions of this Directive and other Community rules regulating specific aspects of unfair commercial practices, the latter shall prevail and apply to those specific aspects.’
C – Directive 2006/114
8. Pursuant to Article 2(a) of Directive 2006/114:
‘“advertising” means the making of a representation in any form in connection with a trade, business, crafts or profession in order to promote the supply of goods or services, including immovable property, rights and obligations’.
III – Facts and procedure
9. Abcur AB (‘Abcur’) is a pharmaceutical company which manufactures and markets the medicinal products Metadon DnE and Noradrenalin Abcur.
10. Apoteket AB is a company owned by the Swedish State. Until 1 July 2009 it had the sole right in Sweden to retail medicinal products. Before that date, it marketed Metadon APL and Noradrenalin APL.
11. Apoteket Farmaci is a subsidiary of Apoteket AB which deals with the supply of medicinal products to county councils, municipalities and private undertakings, and also to public and private health care providers. Apoteket Farmaci is also responsible for operating around 70 hospital dispensaries.
12. Noradrenalin Abcur 1 mg/1 ml has been authorised for sale as a medicinal product since 3 July 2009. The product has been marketed since October/November 2009. It is sold only in 10x4 ml packs. The product contains noradrenaline infusion solution, a medicinal preparation which is used principally in the treatment of acute low blood pressure in emergency and intensive care. It is a so-called hospital-only medicinal product. Hospital-only medicinal products are not available on prescription to individual patients. They are bought or ordered by companies and public bodies which are responsible for their respective health-care institutions. A prescription from a doctor in a health-care institution is required for noradrenaline to be supplied.
13. Before 3 July 2009, there was no Swedish noradrenaline medicinal product which was authorised for sale. Before that date, needs in Sweden were met by using Noradrenalin APL, which was produced by Apotek Produktion och Laboratorier AB (‘APL’), a wholly-owned subsidiary of Apoteket AB. The product was ordered by health care institutions from Apoteket Farmaci when there were needs which were known in advance and relatively immediate.
14. Metadon DnE is a pharmaceutical preparation used to treat opiate addicts. The preparation is classed as a narcotic and can only be prescribed by a doctor with special authority to prescribe medicinal products as narcotics. Before Metadon DnE was authorised on 10 August 2007, there was no authorised methadone product in Sweden and needs in Sweden were met solely by using Metadon APL, which was marketed in Sweden by the Apoteket companies between 2000 and 2011. Metadon DnE and Metadon APL contain the same active substance, have the same strength and pharmaceutical form, are both supplied in bottles and are used in the same way. Metadon DnE and Metadon APL differ in terms of their sugar and alcohol content, and taste.
15. Abcur brought legal proceedings against Apoteket Farmaci claiming that the latter infringed Swedish legislation in having advertised Noradrenalin APL (Case C‑544/13), between 30 October 2009 and 30 June 2010 both dates inclusive, and Metadon APL (Case C‑545/13), between 15 November 2006 and 30 June 2010 both dates inclusive on the basis that Noradrenalin APL and Metadon APL were medicinal products to which Directive 2001/83 (and particularly Article 87) applied. Abcur also claims damages.
16. By orders of 11 October 2013, received at the Court Registry on 21 October 2013, the Stockholms tingrätt decided to stay the proceedings in both cases and to refer questions to the Court of Justice for a preliminary ruling.
IV – Questions referred
A – C‑544/13
17. In Case C‑544/13, the Stockholms tingrätt referred the following questions to the Court for a preliminary ruling:
‘(1) Can a prescription-only medicinal product for human use which is used only in emergency health care, for which no marketing authorisation has been granted by the competent authority in a Member State or pursuant to Regulation (EEC) No 2309/93, [(6)] and which is prepared by an operator such as that involved in the proceedings before the Stockholms tingsrätt (Stockholm District Court) and ordered by health care institutions on the conditions material to the case before the Stockholms tingsrätt, be covered by any of the exceptions in Article 3(1) or (2) of Directive 2001/83 on the Community code relating to medicinal products for human use, in particular in a situation where there is another authorised medicinal product with the same active substance, same dosage and same pharmaceutical form?
(2) If a prescription-only medicinal product for human use such as that referred to in question 1 is covered by Article 3(1), 3(2) or 5(1) of Directive 2001/83, may legislation on advertising measures for medicinal products be regarded as non-harmonised or are the kind of measures which are purported in this case to constitute advertising governed by Directive 2006/114 concerning misleading and comparative advertising?
(3) If Directive 2006/114 concerning misleading and comparative advertising is applicable in accordance with question 2, under what basic conditions do the measures under consideration before the Stockholms tingsrätt (use of a product name, product number and AnatomicTherapeuticChemical code for the medicinal product, application of a fixed price for the medicinal product, supply of information on the medicinal product in the National Substance Register for Medicinal Products (NPL), attachment of an NPL identifier to the medicinal product, dissemination of an information sheet on the medicinal product, supply of the medicinal product via an electronic ordering service for health services and the supply of information on the medicinal product via a publication issued by a national professional organisation) constitute advertising within the meaning of Directive 2006/114?’
B – C‑545/13
18. In Case C‑545/13, the Stockholms tingsrätt referred the following questions to the Court for a preliminary ruling:
‘(1) Can a prescription-only medicinal product for human use which is prepared and supplied in the circumstances at issue in the proceedings before the Stockholms tingsrätt, for which no marketing authorisation has been granted by the competent authority in a Member State or pursuant to Regulation (EEC) No 2309/93, be regarded as constituting a medicinal product within the meaning of either Article 3(1) or Article 3(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, in particular where there is another authorised medicinal product with the same active substance, the same dosage and the same form?
(2) If a prescription medicinal product for human use which is prepared and supplied in the circumstances at issue in the proceedings before the Stockholms tingsrätt is covered by Directive 2001/83, can Directive 2005/29 concerning unfair business-to-consumer commercial practices in the internal market be applicable in parallel with Directive 2001/83 in respect of the purported advertising measures?
(3) If a prescription medicinal product for human use which is prepared and supplied in the circumstances at issue in the proceedings before the Stockholms tingsrätt is covered by Article 3(1), 3(2) or 5(1) of Directive 2001/83, may legislation on advertising measures for medicinal products be regarded as non-harmonised or are the kind of measures which are purported in this case to constitute advertising governed by (i) Directive 2006/114 concerning misleading and comparative advertising and/or (ii) Directive 2005/29 concerning unfair business-to-consumer commercial practices?
(4) If Directive 2006/114 concerning misleading and comparative advertising is applicable in accordance with question 3, under what basic conditions do the measures under consideration before the Stockholms tingsrätt (use or attachment of a product name, product number and ATC code for the medicinal product, application of a fixed price for the medicinal product, supply of information on the medicinal product in the National Substance Register for Medicinal Products (NPL), attachment of an NPL identifier to the medicinal product, dissemination of an information sheet on the medicinal product and information thereon via an electronic health care ordering service and via an undertakings’ own homepage, supply of information on the medicinal product via a publication issued by a national trade organisation, supply of information on the medicinal product in the Apoteket’s Central Product Register and the associated register (JACA), supply of information on the medicinal product in another national information database for medicinal products (SIL), supply of information via the Apoteket Terminal System (ATS) or similar dispensing system, provision of information on an undertaking’s own or a competing supplier’s medicinal product in correspondence with doctors’ surgeries and patient organisations, marketing of the medicinal product, measures relating to pharmaceutical checks on the medicinal product and competing medicinal products, failure to notify documented and relevant differences between products, failure to notify the contents of an undertaking’s own medicinal product and the assessment of the medicinal product by the Läkemedelsverket (Swedish Medical Products Agency), failure to inform the health care service of the Läkemedelsverket’s scientific advisory board’s assessment of competing products, to maintain a fixed price level for the medicinal product, to set a validity period of three months for a prescription, to dispense the medicinal product from a pharmacy instead of a competing medicinal product despite the fact that the patient has a prescription for that competing product, and to hinder and prevent market transfers of standardised preparations to the competing medicinal product, including local pharmacies refusing delivery of the competing medicinal product, and application of a fixed price as part of the scheme under which medicines are eligible for subsidies without a prior decision from the national authority) constitute advertising within the meaning of Directive 2006/114?’
19. By decision of 12 December 2013, the President of the Court joined the two cases.
20. The defendants in the main proceedings submitted written observations, as did the governments of Portugal and the United Kingdom and the Commission. At the hearing, held on 6 November 2014, oral argument was presented by the parties in the main proceedings, the government of the United Kingdom and the Commission.
V – Legal analysis
A – Preparation of the products in question
21. Question 1 in Cases C‑544/13 and C‑545/13 deals with the preparation of the products in question. This question essentially concerns the scope of Directive 2001/83. The referring court seeks to ascertain whether a prescription-only medicinal product for human use, for which no marketing authorisation has been granted by the competent authority in a Member State or pursuant to Regulation No 726/2004, (7) is covered by either of the exceptions in Article 3(1) or (2) of Directive 2001/83, in particular in a situation where there is another authorised medicinal product with the same active substance, same dosage and same pharmaceutical form.
22. There are further elements specific to the two cases: the absence of a prior medical prescription for Noradrenalin APL and Metadon APL and the preparation of Metadon APL at a separate facility from where it is dispensed.
1. Relationship between Article 2 and Article 3 of Directive 2001/83
23. While the question explicitly refers to Article 3 of Directive 2001/83, the referring court appears to be unclear about the relationship between Articles 2 and 3. It should therefore first be clarified whether the conditions of Article 2 have to be fulfilled in order for Article 3 to come into play.
24. Indeed, the relationship between Articles 2 and 3 of Directive 2001/83 is not as clear as it may appear at first sight. By virtue of Article 2(1), the directive applies to medicinal products prepared industrially or manufactured by a method involving an industrial process. Article 3 states that the directive does not apply to a number of situations. For the case at issue the first two situations are relevant, i.e. medicinal products prepared in a pharmacy, in accordance with either the magistral or the officinal formula.
25. Does Article 2 of Directive 2001/83 imply that as soon as the process of preparation of a medicinal product is not industrial, we are outside the scope of Directive 2001/83, as the defendants in the main proceedings claim?
26. I do not think so.
27. I would submit to the Court that it cannot be inferred from Article 2 that all products not industrially produced automatically fall outside the scope of Directive 2001/83. Otherwise, some parts of Article 3 would appear to be redundant, the work already having been done by Article 2. The list of situations contained in Article 3 is heterogeneous. Thus, just to take a few examples, some situations referred to typically concern non-industrial production (e.g. paragraphs 1 and 2), whereas others typically concern industrial production (paragraphs 3, 4 and 5). (8) Regarding paragraphs 1 and 2, Article 3 does no more than provide concrete expression of Article 2 by means of specific instances. (9)
28. As far as paragraphs 1 and 2 of Article 3 are concerned, I therefore concur with Advocate General Sharpston, who states in Novartis Pharma that Article 3 of Directive 2001/83 defines those medicinal products that can be described as not being prepared as described in Article 2. (10)
29. Moreover, I do not see why the EU legislature should have intended to exclude from the scope of the directive all medicinal products not prepared industrially or by a method involving an industrial process. The overriding aim of the directive being to safeguard public health, the Court should not be too restrictive in determining the directive’s scope. I am therefore of the opinion that Article 3(1) and (2) adds specification to Article 2. In other words, in my reading of the directive, for the case at issue the requirements of Article 3 have to be fulfilled in order for the directive not to be applicable.
2. Interpretation of Articles 3(1) and (2) of Directive 2001/83
30. Let us therefore turn to the examination of Article 3(1) and (2) and analyse the factual circumstances raised by the referring court.
31. Article 3(1) contains the following three conditions: first, the product must be medicinal, secondly, it must be prepared in a pharmacy and thirdly, it must be prepared in accordance with a medical prescription for an individual patient. These conditions clearly follow from the text of Article 3(1). Article 3(2) also contains three conditions, deriving from its wording: the first two are similar to the first two in Article 3(1). In addition, the medicinal product in question must be prepared in accordance with the prescriptions of a pharmacopoeia and be intended to be supplied directly to the patients served by the pharmacy in question. The main difference between Article 3(1) and Article 3(2) is, therefore, that paragraph 2 does not require a medical prescription. (11)
32. A medicinal product is defined in Article 1(2) as (a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings or (b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. It is beyond doubt that the products in question constitute medicinal products under that definition.
33. The criteria of preparation in a pharmacy and either medical prescription for an individual patient or direct supply of a product prepared in accordance with the prescriptions of a pharmacopoeia to patients served by the pharmacy in question appear more problematic. I shall examine them in turn.
a) Concept of ‘pharmacy’ in Article 3(1) and (2)
34. Directive 2001/83 does not define what a pharmacy is. Neither, to my knowledge, do other acts of EU secondary law.
35. During the hearing, the question arose whether one could have recourse to Directive 2005/36/EC on the recognition of professional qualifications. (12) I do not think that one can. First, given that that directive is about professional qualifications and training, it deals with pharmacists rather than pharmacies. Secondly, it does not even attempt to define what a pharmacist is. (13) In this respect the Court has held that neither Directive 2005/36 nor any other measure implementing the freedoms of movement guaranteed by the Treaty lays down conditions governing access to activities in the pharmacy field that specify the category of persons who are entitled to operate a pharmacy. (14)
36. This raises the question of the normative value of the term ‘pharmacy’ in Article 3 of Directive 2001/83: is this term to be interpreted, by the Court, in an autonomous and, logically therefore, uniform manner throughout the European Union or does this term simply refer to the concept of ‘pharmacy’ in each and every Member State of the European Union?
37. The defendants in the main proceedings take the view that it is for the referring court to determine, on the basis of national law, what is to be regarded as a pharmacy.
38. I do not believe that the matter is as straightforward as the defendants in the main proceedings might wish.
39. According to settled case-law of the Court, the need for a uniform application of EU law and the principle of equality require the terms of a provision of EU law which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope normally to be given an independent and uniform interpretation throughout the European Union; (15) that interpretation must take into account the context of the provision and the objective of the relevant legislation. (16) The situation is, however, different, if the EU legislature has expressly limited its harmonisation exercise.
40. Concerning the concept of ‘pharmacy’ under Directive 2001/83, the EU legislature has acknowledged that specific conditions for retail supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty on the Functioning of the European Union (TFEU). (17) In Caronna the Court has explicitly referred to this finding in the context of an interpretation of the provisions of Title VII (18) of Directive 2001/83. (19) The Court went on to state that, consequently, the regime applicable to persons entrusted with the retail supply of medicinal products varies from one Member State to another. (20) Moreover, in an infringement procedure where a Member State sought to derogate from the fundamental Treaty provisions on freedom of establishment and the free movement of capital, the Court has held that EU law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions intended to govern the organisation of health services such as pharmacies. (21)
41. I infer two things from the above: first, the concept of ‘pharmacy’ is not harmonised at Union level in an abstract and all-encompassing manner and secondly, the case-law just cited does not help us for the purposes of interpreting the term ‘pharmacy’ in Article 3 of Directive 2001/83.
42. My view is that, even though Directive 2001/83 does not define in an abstract way what a pharmacy is, the term ‘pharmacy’ in Article 3(1) and (2) still has an autonomous and uniform meaning for the purposes of determining what sort of entities are allowed to produce medicinal products in accordance with either the magistral or the officinal formula. If this were not so, the scope of the whole directive would be subject to differing interpretations across the European Union and the uniform application of the directive would be compromised. This cannot have been the intention of the EU legislature.
43. In this context, for the purposes of Article 3(1) and (2), I would like to draw the Court’s attention to the Commission’s definition, in its written observations, of a pharmacy as a physical facility with the right to sell, supply, monitor and prepare (in small quantities) medicinal products. Supply could be made directly to patients (retail pharmacy) or to ‘competent people in the domain of health’ (retail or hospital pharmacies). Such a definition appears to me compelling, as it is based on provisions of Directive 2001/83 which refer to various functions of a pharmacy: retail supply, (22) verification of authenticity of medicinal products (23) and preparation of medicinal products. (24) The definition therefore finds the defining elements in the directive itself.
44. Whilst it is for the national court to determine whether APL constitutes a pharmacy, I would nevertheless express my doubts that this is the case. It appears to me rather that APL is a simple production unit. (25)
b) Concept of ‘prescription for an individual patient’ in Article 3(1)
45. Regarding the interpretation of Article 3(1) of Directive 2001/83 with regard to the product Noradrenalin APL, the referring court seeks guidance on how to evaluate the fact that orders are made by hospitals before an individual patient is identified. Likewise, concerning Metadon APL, the referring court wonders whether, under Article 3(1) of Directive 2001/83, this product can be supplied on subscription, i.e. without an individual prescription in every instance.
46. Clearly, in the situations just mentioned, a medical prescription for an individual patient in the sense of Article 3(1) of Directive 2001/83 occurs after delivery of the products in question. Regarding the product Noradrenalin APL, one might argue that, given that medicinal products containing noradrenaline are typically resorted to in emergency situations and, as a consequence, for this type of product a medical prescription will typically arise after the delivery of the product to a hospital, Article 3(1) should be interpreted broadly so as to include such a situation.
47. I would, however, rather be cautious here. The wording of Article 3(1) implies for me that the patient must be identified before the medicinal product is produced. Article 3(1) should not be interpreted more widely than this, even if the consequence of such an interpretation is that certain products such as Noradrenalin APL will typically not fall under Article 3(1) of Directive 2001/83.
48. Finally, I should like to stress that I see the very purpose of Article 3(1) in the fact that each individual situation is different. The purpose of that provision is to enable pharmacies to produce on a small scale tailor-made products for individual patients. (26) As a consequence, a strict interpretation of the wording of Article 3(1) appears to me to be necessary and I do not see any possibility for a broad interpretation of this provision.
c) Concept of direct supply in Article 3(2)
49. How is the fact that Metadon APL is prepared at a separate geographical site from that where it is dispensed to be evaluated in this context? The referring court raises this circumstance only regarding the interpretation of Article 3(2) of Directive 2001/83. It wonders whether this circumstance excludes the application of Article 3(2) of Directive 2001/83.
50. The Commission believes that the main phases of preparation of a pharmaceutical product must take place in a pharmacy. A laboratory cannot as such be considered as a pharmacy, though it could well constitute a part of a pharmacy.
51. The United Kingdom contends that Article 3(1) or (2) only requires the products in question to be prepared by or under the supervision of a pharmacist and that there is no requirement that the preparation should occur at the same place as the product which is supplied to the patient. It believes that there is, moreover, no reason why there should be such a requirement as it will frequently be convenient, and may be safer and more secure, to prepare medicinal products at a separate location from that at which they are supplied to patients.
52. For me the wording of Article 3(2) of Directive 2001/83 is very clear: the medicinal product is intended to be supplied directly to the patients served by the pharmacy in question. If it cannot be established that both the production site and the dispensing site are situated in the same pharmacy, this criterion is not fulfilled. I do not consider the mere presence of a pharmacist sufficient. (27) A more flexible reading, even for reasons of practical convenience, as the United Kingdom seems to propose in its written observations should not, therefore, be accommodated.
d) Existence of another authorised product with the same active substance, dosage and form
53. The referring court refers to Article 5(1) of Directive 2001/83. It recalls that this article can be relied on to exclude a medicinal product from the provisions of Directive 2001/83 where there is no authorised equivalent on the national market, or where none is available. It speculates that a similar restriction may apply in relation to the exceptions in Article 3(1) and (2).
54. I do not think so.
55. Such an assumption cannot be deduced from the wording of Article 3(1) and (2). Moreover, as the United Kingdom rightly points out, the exclusion in Article 5(1) of Directive 2001/83 permits a Member State to exclude medicinal products from the provisions of that directive in order to fulfil special needs. That situation is not characteristic of Articles 3(1) and (2) of Directive 2001/83. Those latter provisions allow for the preparation of pharmaceutical products, irrespective of whether other suitable equivalent products are authorised for production other than in pharmacies. Furthermore, the Court has previously held that where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market, there cannot in fact be a question of ‘special needs’, within the meaning of Article 5(1) of Directive 2001/83, necessitating a derogation from the requirement for a marketing authorisation under Article 6(1) of that directive. (28)
56. I therefore propose that the Court should reply to question 1 that for the purposes of Article 3(1) of Directive 2001/83 a medical prescription for an individual patient must, in every case, precede the preparation of a medicinal product in a pharmacy. For the purposes of Article 3(2) of Directive 2001/83 a medicinal product is not supplied directly to a patient if the production site and the dispensing site are not both part of the same pharmacy. It is immaterial for the application of either Article 3(1) or (2) whether there is another authorised product with the same active substance, dosage and form on the market.
B – Presentation of the products in question
57. By question 2 in Case C‑545/13, the referring court would like to know whether Directive 2005/29 is also applicable to a medicinal product falling under Directive 2001/83, in respect of the purported advertising measures. The question is therefore whether Directives 2001/83 and 2005/29 can apply in parallel.
58. My view is that the two directives can apply, in principle, in parallel.
59. Directive 2005/29 constitutes a horizontal directive which fully harmonises (29) the potentially conflicting interests between the provisions of the internal market in goods and services and consumer protection. (30) This means that no deviating national provisions can be adopted by Member States in areas within the scope of the directive. (31)
60. As regards the relationship with other norms of European Union secondary law, in its Article 3(3), the directive states that the directive is without prejudice to Community (32) or national rules relating to health and safety aspects of products. (33) Also, Article 3(4) of the directive states that in the case of conflict between its provisions and other Community rules regulating specific aspects of unfair commercial practices, the latter shall prevail and apply to those specific aspects. As the Commission correctly points out in its written observations, this provision establishes a hierarchical relationship between the directive and sector-specific EU unfair trade provisions. (34)
61. Moreover, a combined reading of Article 7(5) of and Annex II to Directive 2005/29 demonstrates the complementary character of the two directives: by virtue of these provisions information required by EU law in relation to commercial communication including advertising or marketing is to be regarded as material information for the purposes of defining a misleading omission.
62. Finally, it should be noted that the referring court’s question is confined to the applicability of Directive 2005/29 and does not relate to the substantive requirements of the directive.
63. In my view, the referring court should, however, be aware of the considerations that follow. (35)
64. The underlying rationale of Directive 2005/29 is that commercial practices by traders are lawful as long as they are not prohibited by the directive. (36)
65. The directive’s scope is limited to business-to-consumer commercial practices. (37) For the case at issue, this implies that only information accessible to consumers can be regarded as falling within the scope of the directive. Against this background, all the elements cited by the referring court not accessible to a consumer are not covered by the directive.
66. Moreover, I should like to recall that, as pointed out by recital 7 in the preamble to the directive, the directive ‘addresses commercial practices directly related to influencing consumers’ transactional decisions in relation to products’.
67. As regards the last two points, which relate to questions of fact falling within the remit of the national court, given that the product in question, Metadon APL, can only by ‘acquired’ by a person through a prescription by a doctor, I admit to having difficulty in seeing room for the application of the directive. This directive is about consumer protection. I would submit that the consumer, in casu the patient, is adequately protected through the doctor who prescribes the product.
68. That said, it may be that the referring court, for instance, finds that there is a connection between the information provided and influence on the doctor to prescribe the product at the instigation of the consumer/patient. Likewise, it may be that, under national law, a pharmacist enjoys a degree of discretion with regards to the prescription in the sense that he can hand out to the consumer/patient a product with the same active substance. In such situations, Directive 2005/29 can be said to apply.
69. I would therefore propose that the Court should reply to question 2 in Case C‑545/13 that when it is to be ascertained whether marketing measures concerning a prescription-only medicinal product, which has been prepared in the circumstances of the case at issue, fall within Directive 2005/29, it must be borne in mind that the directive’s scope is limited to business-to-consumer commercial practices and that the directive addresses commercial practices directly related to influencing consumers’ transactional decisions in relation to products.
C – On a hypothetical basis: Further questions on presentation of the products in question
70. On the basis of my reply to question 1, the remaining questions are hypothetical. The analysis to follow is therefore only in the eventuality that the Court should not follow my reasoning thus far and find that Directive 2001/83 is not applicable because the criteria of Article 3(1) or (2) are fulfilled.
1. Question 3(ii) in Case C‑545/13
71. By this question, the referring court asks whether, in case of non-applicability of Directive 2001/83, Directive 2005/29 is applicable to the case at issue and if the measures of the case at issue are covered by this directive. The referring court therefore wishes to ascertain whether the rules applicable to advertising measures for Metadon APL may be regarded as non-harmonised or whether Directive 2005/29 is applicable.
72. I do not see why Directive 2005/29 should not be applicable: if Directive 2005/29 is, as outlined above, in principle, applicable in parallel with Directive 2001/83, a fortiori is it applicable in situations outside the scope of Directive 2001/83.
73. As regards the substantive requirements of Directive 2005/29, I should like to refer to the considerations in points 63 to 69 above.
2. Question 2 in Case C‑544/13 and question 3 in Case C‑545/13
74. While the referring court is aware of the fact that Titles VIII and VIIIa of Directive 2001/83 only apply in situations covered by Directive 2001/83 and constitute full harmonisation of advertising measures, (38) it wonders which rules are applicable in situations in which Directive 2001/83 is not applicable because of Articles 3(1), 3(2) or 5(1) of that directive.
75. The Court has not, as yet, been called upon to determine the relationship between Directives 2001/83 and 2006/114 in situations in which Directive 2001/83 is not applicable.
76. The referring court appears to lean towards the view that the total harmonisation as regards advertising of medicinal products under Directive 2001/83 implies that Directive 2006/114 is not applicable even to the advertising of medicinal products which, pursuant to Article 3 of Directive 2001/83, fall outside the scope of that directive. In other words, national legislation on advertising of medicinal products falling under Article 3 of Directive 2001/83 would not have been harmonised. In this respect, the referring court points to a series of cases of the Court, above all Ludwigs-Apotheke. (39)
77. I do not agree with such an approach.
78. In Ludwigs-Apotheke, the Court held that medicinal products covered by a provision of the German law on medicinal products were excluded from the scope of Directive 2001/83 and that, accordingly, the provisions of Title VIII, on advertising, of that directive were not applicable to them. (40) The Court then went on to examine whether a prohibition on advertising such as that laid down in the German law on the advertising of medicines was compatible with the Treaty provisions on the free movement of goods. (41)
79. In my view, the fact that the Court did not examine the German law in the light of the then applicable directive on misleading advertising (42) does not imply that EU legislation on misleading advertising is not applicable to medicinal products falling outside the scope of Directive 2001/83. (43)
80. Directive 2006/114 has been interpreted by the Court on a few occasions only. (44) I should therefore like to set out a few principles with regard to this directive. First, Directive 2006/114 applies to two distinct sets of situations: misleading advertising, as defined in Article 2(b), and comparative advertising, as defined in Article 2(c). Secondly, as can be inferred from Article 8(1) of Directive 2006/114, with respect to misleading advertising, the directive lays down minimum rules, allowing Member States to retain or adopt provisions with a view to ensuring more extensive protection for traders and competitors, while as regards comparative advertising it fully harmonises Member States’ rules. Thirdly, as is apparent from Article 1 of the directive, its scope is confined with respect to misleading advertising to business-to-business relations while that does not hold good for the provisions on comparative advertising, which also apply in the context of advertising directed at consumers. (45) Regarding misleading advertising, business-to-consumer relations fall under Directive 2005/29.
81. In my view, Directive 2006/14 is an act of a horizontal nature in the sense that it applies to any particular sector of economic activity, unless there are specialised rules governing such a sector. In the absence of an explicit exclusion of Directive 2006/114, it should therefore be considered applicable.
82. This finding does not, however, imply that there is no interaction between the chapters on advertising in Directive 2001/83 and Directive 2006/114 in a situation where Directive 2001/83 is not applicable. In particular, as will be seen below, I think there are good reasons for excluding from the scope of Directive 2006/114 the type of measures referred to in Article 86(2) of Directive 2001/83.
83. The reply to this question should therefore be that Directive 2006/114, in principle, is applicable to the advertising of medicinal products in situations in which Directive 2001/83 is not applicable.
3. Question 3 in Case C‑544/13 and question 4 in Case C‑545/13
84. Finally, the referring court wishes to know whether the measures employed by the defendants in the main proceedings constitute advertising within the meaning of Directive 2006/114. In essence, the referring court is asking whether the labelling, pricing and providing of purely factual information about the products at issue constitutes advertising within the meaning of Directive 2006/114. The referring court, which appears well acquainted with the Court’s case-law on the interpretation of Directive 2006/114 stresses that the concept of advertising has not been interpreted with respect to the type of measures at issue in the proceedings before it.
85. It appears that the referring court needs an interpretation of the term ‘advertising’ so as to determine whether the measures employed by Apoteket can be termed as misleading advertising.
86. By virtue of Article 2(a) of Directive 2006/114, ‘advertising’ means the making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services. As has been confirmed by the Court, this is a ‘particularly broad definition’, (46) meaning that ‘forms which advertising may take are very varied’. (47)
87. Article 86(2) excludes from the application of Title VIII of Directive 2001/83 a range of measures such as labelling and accompanying package leaflets and factual, informative announcements, and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided that they include no product claims.
88. I would submit to the Court that such measures cannot constitute ‘advertising’ for the purpose of Article 2(a) of Directive 2006/114, given that the general rule on advertising to which economic operators are subject should not be stricter than a special rule. To argue the contrary would lead to the odd situation in which the rules on advertising for a medicinal product falling under Directive 2001/83 are less strict than those for a medicinal product outside the scope of that directive.
89. As the Commission correctly points out in its written observations, the crucial element is whether it can be objectively determined that the representation has been made with a view to promoting the supply of a good or service.
90. Moreover, in MSD Sharp & Dohme the Court held that Article 86(1) of Directive 2001/83 did not, in principle, preclude the possibility that published or distributed material which includes only objective information could be regarded as advertising. (48) The Court held that ‘[i]f the message is designed to promote the prescription, supply, sale or consumption of medicinal products, it is advertising for the purposes of that directive. However, material which is purely informative, without promotional intent, (49) is not covered by the provisions of that directive relating to advertising of medicinal products.’ (50)
91. In my view, such reasoning should be transposed also to Directive 2006/114.
92. It is for the referring court to establish these factual matters so as to determine whether and to what extent the activities at issue in the main proceedings constitute advertising within the meaning of Directive 2006/114.
93. I therefore propose that the Court’s reply to this question should be that when it is to be ascertained whether marketing measures concerning a prescription-only medicinal product, which has been prepared in the circumstances of the case at issue, fall within the scope of Directive 2006/114, it must be borne in mind that the directive’s scope is limited to business-to-business situations as far as misleading advertising is concerned and that the determining criterion is whether a representation has been made with a view and intent to promoting the supply of the good in question.
VI – Conclusion
94. In the light of all of the foregoing considerations, I propose that the Court answer the questions referred by the Stockholms tingsrätt (Sweden) as follows:
(1) For the purposes of Article 3(1) 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 a medical prescription for an individual patient must, in every case, precede the preparation of a medicinal product in a pharmacy.
(2) For the purposes of Article 3(2) of Directive 2001/83 a medicinal product is not supplied directly to a patient if the production site and the dispensing site are not both part of the same pharmacy.
(3) It is immaterial for the application of either Article 3(1) or (2) whether there is another authorised product with the same active substance, dosage and form on the market.
(4) When it is to be ascertained whether marketing measures concerning a prescription-only medicinal product, which has been prepared in the circumstances of the case at issue, fall within Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’), it must be borne in mind that the directive’s scope is limited to business-to-consumer commercial practices and that the directive addresses commercial practices directly related to influencing consumers’ transactional decisions in relation to products.
95. Should the Court not follow the interpretation proposed under (1) to (3) above, I would propose that the remaining questions be answered as follows:
(5) Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (codified version), in principle, is applicable to advertising of medicinal products in situations in which Directive 2001/83 is not applicable.
(6) When it is to be ascertained whether marketing measures concerning a prescription-only medicinal product, which has been prepared in the circumstances of the case at issue, fall within the scope of Directive 2006/114, it must be borne in mind that the directive’s scope is limited to business-to-business situations as far as misleading advertising is concerned and that the determining criterion is whether a representation has been made with a view and intent to promoting the supply of the good in question.