The CJEU dealt with the categorisation of products as either pharmaceuticals or medical devices in its judgement of 19 January 2023 (Ref.: C-495/21, C-496/21). Products can neither fall under both categories nor do they have the same requirements whatsoever.
This judgement was preceded by four questions for a preliminary ruling from the German Federal Administrative Court in two similar cases:
Two German manufacturers had placed nasal drops on the market and classified them as medicinal products.
One of the products was advertised as having the effect of caring for irritated nasal mucous membranes and regenerating these during the common cold, while the other product was advertised with claims about the effect of cleansing and draining the nasal cavities filled with mucus and secretions, whereby this could lead to heavy secretion discharge.
In both cases, the German Federal Institute for Drugs and Medical Devices had objected to the marketing of these nasal drops as medicinal products because they were lacking a marketing authorisation, since the nasal drops were "functional medicinal products". The companies appealed against this decision unsuccessfully in the first two instances.
The German Federal Administrative Court then referred the following questions to the CJEU at third instance:
- 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?
- 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?
- 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?
- 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?
The CJEU answered the questions of the Federal Administrative Court as follows:
On the fourth question referred:
“Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, and Article 1(2) of Directive 2001/83, as amended by Directive 2004/27, 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, as amended by Directive 2007/47, or that of ‘medicinal product by function’, as referred to in Directive 2001/83, as amended by Directive 2004/27. 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 Directive 2001/83, as amended by Directive 2004/27, are satisfied.”
Art. 2 para. 2 of Directive 2001/83 stipulates that, in cases of doubt, this Directive shall apply. Art. 2 para. 2 of Directive 2001/83 stipulates that this directive applies in cases of doubt about the classification as a medicinal product or as a product. Art. 2 para. 2 of Directive 2001/83 does not distinguish in its wording between medicinal products by presentation and medicinal products by function, therefore the regulation is applicable to both types of medicinal products. In contrast to medicinal products by function, which are to be classified as medicinal products due to their pharmacological, immunological and metabolic effect on humans, medicinal products by presentation are characterised by the fact that such an effect has not been established, but is suggested by the presentation of the product. An exclusion of medicinal products by presentation from the scope of application would not correspond to the legislative intention, which intended to create legal certainty with regard to the requirements for quality, safety and efficacy of medicinal products for human use by means of this provision. According to the 7th recital, the Directive should not apply if " where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics". For this to be the case, however, the requirements of the respective definition would have to be definitely fulfilled. If it is uncertain whether a product is to be classified as a medical device, it is subject to Directive 2001/83.
The second and third questions referred:
“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, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that it applies not only to ‘medicinal products by function’, as referred to in Article 1(2)(b) of Directive 2001/83, as amended, but also to ‘medicinal products by presentation’, as referred to in Article 1(2)(a) of that directive.”
In summary, the question raised was whether a product was to be classified as a medical device or as a medicinal product if it had not been scientifically established which type of main effect was at hand. According to Articles 3 and 4 of Directive 93/42/EC, in order to be classified as a medical device, the manufacturer must prove that there is no pharmacological, immunological or metabolic effect, cf. Article 1(2)(a) of Directive 93/42/EC. If this proof cannot be provided scientifically, the product cannot be classified as a medical device. However, in the absence of available scientific evidence, a product could not fall under the definition of a medicinal product by function according to Art. 2 para. 2 lit. b of Directive 2001/83, since the definition presupposes an established pharmacological, immunological and metabolic effect.
At last, however, such products could be classified as "presentation medicinal products" if they were intended and recommended as products with properties "for healing or prevention", thus creating the impression of similarity with "classical" medicinal products. This would need to be assessed on a case-by-case basis.
The first question referred:
The CJEU does not answer the first question referred as a result of the answers to the other questions.
This is unfortunate in view of the unresolved legal situation with regard to such borderline products, but is no longer relevant to the decision as a result of the question that has already been answered. It remains to be seen whether the CJEU will deal with this issue again.
Conclusion:
This ruling of the CJEU shows that borderline products will regularly have to be classified as medicinal products, since by the very nature of the matter there will often be a lack of scientific determination of the absence of pharmacological, immunological and metabolic effects. In this respect, manufacturers of such products are recommended to check whether such borderline products have been placed on the market as medicinal products and whether the absence of such effects can actually be proven.
