1 These requests for a preliminary ruling concern the interpretation of Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ 2007 L 247, p. 21) (‘Directive 93/42’), and of Article 1(2)(a) and Article 2(2) 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 (OJ 2001 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34) (‘Directive 2001/83’).
2 The requests have been made in proceedings between L. GmbH and H. Ltd., respectively, both of which are undertakings governed by German law, and Bundesrepublik Deutschland (Federal Republic of Germany), represented by the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany) (‘the BfArM’), concerning the determination of the scope of EU rules relating to medical devices and medicinal products for human use.
3 Article 1(2)(a) of Directive 93/42 provides: ‘2. For the purposes of this Directive, the following definitions shall apply: (a) “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means’.
4 Article 1(5)(c) of that directive provides: ‘This Directive shall not apply to: … (c) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product’.
5 Article 3 of Directive 93/42, entitled ‘Essential requirements’, states: ‘The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery[, and amending Directive 95/16/EC (OJ 2006 L 157, p. 24),] shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.’
6 Article 4(1) of Directive 93/42 provides: ‘Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.’
7 Article 1(2) of Directive 2001/83 is worded as follows: ‘For the purposes of this Directive, the following terms shall bear the following meanings: (2) Medicinal product: (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’.
8 Article 2(2) of that directive provides: ‘In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.’
9 Recital 7 of Directive 2004/27 states: ‘Particularly as a result of scientific and technical progress, the definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products for human use. In order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. This definition should specify the type of action that the medicinal product may exert on physiological functions. This enumeration of actions will also make it possible to cover medicinal products such as gene therapy, radiopharmaceutical products as well as certain medicinal products for topical use. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a medicinal product but could also fall within the definition of other regulated products, it is necessary, in case of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation.’
10 L. produces various pharmaceutical substances, and, in particular, nasal drops. Since 2011, following the refusal by the competent German authorities to authorise them as a ‘medicinal product’, on the ground that their therapeutic efficacy had not been sufficiently demonstrated, it has distributed those drops as ‘medical devices’.
11 L. also places on the market as a ‘medical device’ the nasal drops at issue in the main proceedings, containing, inter alia, the same active substance as the nasal drops mentioned in the preceding paragraph. According to the package leaflet for those nasal drops, ‘the preparation is suitable for use with irritation of the nasal mucosa caused by viral rhinitis’ and ‘it also soothes irritation of the nasal mucosa and supports its regeneration during a cold’. That preparation is described as ‘supporting the treatment of colds’ and ‘for treating colds’.
12 The January 2011 technical documentation submitted in support of the product’s classification as a ‘Class I medical device’ states that the action of the preparation on the nasal mucosa is achieved by physico-chemical means and causes the outermost cell layer of the nasal epithelium to contract, reducing nasal secretions. According to the referring court, the product concerned has a second physico-chemical effect, preventing the nasal mucosa from drying out by means of an elastic film-like deposit over it, thus supporting its regeneration.
13 By a decision of 16 January 2014, the BfArM determined that the product concerned required prior authorisation as a ‘medicinal product’. It found that it met both the definition of the concept of ‘medicinal product by function’, since the principal intended action was achieved by pharmacological means, and the definition of the concept of ‘medicinal product by presentation’. By a decision of 14 October 2014, it dismissed the objection lodged against that decision.
14 H. is a pharmaceutical undertaking which markets a nasal spray called ‘N.’ as a ‘medical device’ in Germany and in several other Member States of the European Union. The nasal spray contains 50 milligrams (mg) of a freeze-dried plant extract. According to the information on the packaging of that nasal spray, the product is intended to ‘clean and drain nasal cavities filled with mucus and secretions’ and should alleviate the symptoms of nasal congestion. The package leaflet warns users, under the heading ‘precautions to be taken’, not to drive vehicles or use machinery for two hours after use. The English-language version of the product information explains that its use results in intense drainage of secretions that may last up to two hours, which is why users are advised not to drive vehicles on the road or operate machinery during that time.
15 By a decision of 20 June 2013, the BfArM determined that that product required prior authorisation as a ‘medicinal product’. According to the BfArM, the product is a ‘medicinal product by function’, since the desired effect is achieved through the interaction of triterpenoid saponins with membrane components and therefore by a pharmacological action. The mucosa-irritant action of the saponins triggers a reflective hyper-response. Furthermore, H. had provided no evidence of a purely physical action. In higher concentrations, product N. could damage cell membranes. Given that the manufacturer of the product highlights the medical purpose of the preparation concerned, namely alleviating the symptoms associated with rhinosinusitis, it was also a ‘medicinal product by presentation’. By a decision of 22 August 2014, the BfArM dismissed the objection lodged against that decision.
16 The actions which L. and H. brought against those decisions were dismissed. The appeals which they subsequently brought before the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (Higher Administrative Court for the Land of North Rhine-Westphalia, Germany) were also dismissed.
17 That court found that the products concerned were presented as ‘medicinal products’. It pointed out, in that regard, that although the package leaflets for those products presented them as ‘medical devices’, the products were also presented as products for treating irritation of the nasal mucosa, respectively, as a treatment of viral rhinitis in Case C‑495/21 and as a treatment of rhinosinusitis in Case C‑496/21, alleviating symptoms, leading the reasonably well-informed and observant consumer to regard those products as having the efficacy generally associated with medicinal products. In addition, in Case C‑496/21, that court pointed out that the claim of ‘pharmacy-only’ distribution, and the reference, on the English-language version of the relevant producer’s website, to clinically demonstrated efficacy in the treatment of rhinosinusitis would reinforce the consumer’s impression that the product in question is a medicinal product.
18 The same court therefore rejected the arguments put forward by the applicants in the main proceedings, according to which, first, the concept of ‘medicinal product by presentation’ does not apply to medical devices, and, second, the principal mode of action of the product concerned is to be taken into account only for the purposes of assessing the concept of ‘medical device’, thus ruling out the application of the legal framework under Directive 2001/83. In that regard, the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (Higher Administrative Court for the Land of North Rhine-Westphalia) stated that, according to current scientific knowledge, it was impossible to establish a non-pharmacological mode of action in the case of the products concerned, which did not, therefore, satisfy the requisite conditions for classification as a ‘medical device’.
19 The applicants in the main proceedings brought an appeal on a point of law before the referring court, the Bundesverwaltungsgericht (Federal Administrative Court, Germany).
20 That court is uncertain as to the respective scopes of Directive 93/42 concerning medical devices and Directive 2001/83 relating to medicinal products for human use, in the absence of any scientific study demonstrating the non-pharmacological mode of action of the products concerned.
21 Thus, the referring court’s questions arise, first, from the absence of any scientific study capable of proving or ruling out a pharmacological (or immunological or metabolic) action and, second, from the fact that the mutual exclusivity - whereby the definition of the concept of ‘medicinal product by function’ excludes that of ‘medical device’, in respect of which the absence of any pharmacological (or immunological or metabolic) means must be established - appears not to have any consequences in the case of a ‘medicinal product by presentation’.
22 Consequently, the referring court finds that a number of issues merit further clarification, namely, first, the concept of ‘pharmacological means’, referred to in Article 1(2)(a) of Directive 93/42; second, the way in which a product is to be classified where it is not possible to establish, in respect of that product, whether the principal intended action is achieved by pharmacological means; third, the conditions for being able to conclude that a product placed on the market as a ‘medical device’ may be classified as a ‘medicinal product by presentation’, as referred to in Article 1(2)(a) of Directive 2001/83; and, fourth, whether the rule that Directive 2001/83 takes precedence in respect of products which fall within the definition of the concept of ‘medicinal product’ and within that of a product covered by other EU legislation, as provided for in Article 2(2) of Directive 2001/83, also applies to ‘medicinal products by presentation’.
23 As regards, specifically, the question whether the rule that Directive 2001/83 is to take precedence also applies to ‘medicinal products by presentation’, the referring court indicates that only ‘medicinal products by function’ have characteristics that would enable them to be identified as a ‘medicinal product’. In its view, ‘medicinal products by presentation’, in respect of which such characteristics are merely claimed, could be subject to rules that correspond more closely to the specific characteristics of the product concerned, even if those products are covered by other legal rules. If that approach were to be adopted, a product meeting both the definition of the concept of ‘medicinal product by presentation’ and that of the concept of ‘medical device’ could be subject to Directive 93/42 concerning medical devices.
24 In those circumstances the Bundesverwaltungsgericht (Federal Administrative Court) decided to stay the proceedings and to refer the following questions, the wording of which is identical in Cases C‑495/21 and C‑496/21, to the Court of Justice for a preliminary ruling: ‘(1) Can the principal intended action of a substance be pharmacological within the meaning of Article 1(2)(a) of Directive 93/42/EEC even if it is not based on a receptor-mediated mode of action and the substance is not absorbed by the human body but remains on and reacts with the surface of, for example, the mucosa? On what criteria should a distinction be drawn between pharmacological and non-pharmacological means, in particular physico-chemical means, in such a case? (2) Can a product be regarded as a substance-based medical device within the meaning of Article 1(2)(a) of Directive 93/42/EEC if, according to current scientific knowledge, the mode of action of the product is open to debate and it is thus not possible to definitively determine whether the principal intended action is achieved by pharmacological or physico-chemical means? (3) In such a case, is the classification of the product as a medicinal product or as a medical device to be carried out on the basis of an overall assessment of its other properties and all other circumstances, or, in so far as it is intended to prevent, treat or alleviate diseases, is the product to be regarded as a medicinal product by presentation within the meaning of Article 1(2)(a) of Directive 2001/83/EC, irrespective of whether or not a specific medicinal effect is being claimed? (4) Does the primacy of the regime governing medicinal products also apply in such a case in accordance with Article 2(2) of Directive 2001/83/EC?’
25 By its fourth question, which it is appropriate to examine first, the referring court asks, in essence, whether Article 2(2) of Directive 2001/83 must be interpreted as meaning that it applies not only to ‘medicinal products by function’, as referred to in Article 1(2)(b) of that directive, but also to ‘medicinal products by presentation’, as referred to in Article 1(2)(a) of that directive.
26 As a preliminary point, it should be noted that Article 2(1) of Directive 2001/83 provides, in essence, that that directive is to apply to medicinal products for human use which are intended to be placed on the market in Member States and which are manufactured industrially.
27 The scope of Directive 2001/83 is thus limited to products which are industrially manufactured medicinal products, to the exclusion of products which do not correspond to one or other of the definitions of ‘medicinal product’ listed, respectively, in Article 1(2)(a) of that directive, that is, ‘medicinal products by presentation’, and in Article 1(2)(b) of that directive, that is, ‘medicinal products by function’ (see, to that effect, judgment of 13 March 2014, Octapharma France, C‑512/12, EU:C:2014:149, paragraph 30).
28 However, first, the wording of Article 2(2) of Directive 2001/83, which expressly refers to ‘medicinal product’, does not permit a distinction to be drawn between the two definitions of the concept of ‘medicinal product’ adopted in points (a) and (b) of Article 1(2) of that directive, unless the very wording of that provision is to be disregarded.
29 Second, the exclusion of ‘medicinal products by presentation’ from the primacy of application of the legal regime applicable to medicinal products is incompatible with the stated intention of the legislature, which sought, by means of the obligation laid down in Article 2(2) of Directive 2001/83, to reconcile the requirements of legal certainty for economic operators with those of quality, safety and efficacy of medicinal products for human use.
30 Directive 2004/27, which introduced that provision into Directive 2001/83, states, in recital 7, that ‘the definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products for human use’ and that, ‘in order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products’.
31 In that regard, it must nevertheless be pointed out that recital 7 also states that ‘where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, [Directive 2004/27] should not apply’.
32 However, that exception is subject, in accordance with the wording of recital 7, to the conditions laid down by another definition being clearly satisfied, as was submitted at the hearing by the European Commission, according to which the legislature did not in any way intend to call into question the rule on Directive 2001/83 taking precedence.
33 In the present case, it does not seem to be clear that the conditions of the concept of ‘medical device’ are satisfied, which is, however, a matter for the referring court to verify.
34 Thus a product that falls within the definition of a ‘medicinal product’, as referred to in Article 1(2)(a) or (b) of Directive 2001/83, is covered by the legal regime established by that directive and accordingly may not be classified as a ‘medical device’, within the meaning of Directive 93/42 (see, to that effect, judgment of 3 October 2013, Laboratoires Lyocentre, C‑109/12, EU:C:2013:626, paragraph 41).
35 In the light of all of the foregoing considerations, the answer to the fourth question is that Article 2(2) of Directive 2001/83 must be interpreted as meaning that it applies not only to ‘medicinal products by function’, as referred to in Article 1(2)(b) of that directive, but also to ‘medicinal products by presentation’, as referred to in Article 1(2)(a) of that directive.
36 By its second and third questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 1(2)(a) of Directive 93/42 and Article 1(2) of Directive 2001/83 must be interpreted as meaning that, where the principal mode of action of a product is not scientifically established, that product can meet the definition of the concept of ‘medical device’, within the meaning of Directive 93/42, or that of ‘medicinal product by function’ or of ‘medicinal product by presentation’, as referred to in Directive 2001/83.
37 In the first place, it should be noted that it follows from Article 1(2)(a) of Directive 93/42 that a substance may be classified as a ‘medical device’ only where the principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means (see, to that effect, judgment of 3 October 2013, Laboratoires Lyocentre, C‑109/12, EU:C:2013:626, paragraph 44).
38 In that regard, it must be pointed out that Articles 3 and 4 of that directive require a manufacturer wishing to market a product as a ‘medical device’ to demonstrate that that condition has been satisfied.
39 That approach is further reinforced by the general scheme of Directive 93/42, which does not provide for the same level of consumer protection as that provided for by Directive 2001/83. The reason for that difference is the negative requirement to which medical devices are subject, in the sense that the principal intended action is not to be achieved by pharmacological, immunological or metabolic means, in accordance with Article 1(2)(a) of Directive 93/42. The presumption that those products are less dangerous justifies the release of goods on a declaratory basis, unlike the legal rules applicable to medicinal products, whether by function or by presentation, in respect of which Article 6 of Directive 2001/83 requires the prior grant of marketing authorisation.
40 In the second place, Article 1(5)(c) of Directive 93/42 specifically requires the competent authorities to take ‘particular’ account of the principal mode of action of the product concerned. Such wording cannot, however, be interpreted as allowing the national authorities to take account of other criteria, since it follows from Article 1(2)(a) of that directive that the mode of action of any ‘medical device’ must necessarily be other than pharmacological, immunological or metabolic.
41 Therefore, in the absence of scientific knowledge that would make it possible to establish that the principal intended action in or on the body is not achieved by pharmacological, immunological or metabolic means, Article 1(2)(a) of Directive 93/42 does not enable a product to be classified as a ‘medical device’.
42 In the third place, as regards classification as a ‘medicinal product by function’, as referred to in Article 1(2)(b) of Directive 2001/83, it must be noted that, according to settled case-law, unlike the concept of ‘medicinal product by presentation’, as referred to in Article 1(2)(a) of that directive, a broad interpretation of which is intended to protect consumers from products that do not have the efficacy which they would be entitled to expect, the concept of ‘medicinal product by function’ is intended to encompass products whose pharmacological properties have been scientifically established (see, to that effect, judgment of 6 September 2012, Chemische Fabrik Kreussler, C‑308/11, EU:C:2012:548, paragraph 30 and the case-law cited).
43 In addition, as regards determining that a product is a ‘medicinal product by function’, as referred to in Directive 2001/83, it must be recalled that the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product concerned, in particular its composition, its pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail (judgment of 15 January 2009, Hecht-Pharma, C‑140/07, EU:C:2009:5, paragraph 39).
44 However, in the absence of available scientific knowledge, a product cannot meet the definition of the concept of ‘medicinal product by function’, which requires, in accordance with Article 1(2)(b) of Directive 2001/83, a pharmacological, immunological or metabolic action.
45 In the fourth place, as regards classification as a ‘medicinal product by presentation’, as referred to in Article 1(2)(a) of Directive 2001/83, it must be recalled that a product is ‘presented [as having properties] for treating or preventing disease’ within the meaning of Directive 2001/83 when it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation.
46 A product is also ‘presented [as having properties] for treating or preventing disease’ whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, having regard to its presentation, have the properties concerned (judgment of 15 November 2007, Commission v Germany, C‑319/05, EU:C:2007:678, paragraph 46 and the case-law cited).
47 In that regard, account should be taken of the attitude of an averagely well-informed consumer, in whom the form given to a product may inspire particular confidence similar to that normally inspired in him or her by proprietary medicinal products, having regard to the safeguards normally associated with their manufacture and marketing. Although the external form given to the product may serve as strong evidence of its classification as a medicinal product by presentation, the ‘form’ must be taken to mean not only the form of the product itself but also that of its packaging, which may, for reasons of marketing policy, tend to make it resemble a medicinal product (see, to that effect, judgment of 15 November 2007, Commission v Germany, C‑319/05, EU:C:2007:678, paragraphs 44, 46 and 47 and the case-law cited).
48 Thus, the factors referred to by the referring court, such as the presentation of the product concerned as having properties for treating or alleviating disease, references to medicinal interactions and adverse effects, and pharmacy-only distribution, are factors which, taken as a whole, are capable of making the products concerned appear to an averagely well-informed consumer to have the properties of a medicinal product, which will, however, be for the referring court to verify.
49 Having regard to all of the foregoing considerations, the answer to the second and third questions is that Article 1(2)(a) of Directive 93/42 and Article 1(2) of Directive 2001/83 must be interpreted as meaning that, where the principal mode of action of a product is not scientifically established, that product cannot meet the definition of the concept of ‘medical device’, within the meaning of Directive 93/42, or that of ‘medicinal product by function’, as referred to in Directive 2001/83. It is for the national courts to assess, on a case-by-case basis, whether the conditions relating to the definition of the concept of ‘medicinal product by presentation’, as referred to in the latter directive, are satisfied.
50 By its first question, the referring court asks, in essence, whether Article 1(2)(a) of Directive 93/42 must be interpreted as meaning that a principal intended action of a substance can be ‘pharmacological’, and thus falls outside the scope of that directive, in situations where that mode of action is not based on a receptor-mediated action and the substance concerned is not absorbed by the human body but remains on its surface, for example, on the mucosa.
51 In view of the answers given to the second, third and fourth questions referred for a preliminary ruling, the first question referred does not require an answer.
52 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.