Long-running issue: the distinction between cosmetic products and medicinal products by function

CJEU on the question of whether the thickening and lengthening of eyelashes and the associated effect on the human body in the form of the positive effect on appearance and the increase in self-esteem are sufficient for the classification of the product as a "pharmaceutical product".

In its decision of October 13, 2022 - C-616/20, the Court of Justice of the European Union dealt with three questions referred for a preliminary ruling by the Cologne Administrative Court concerning the classification of the product "M2 Eyelash activating serum" as a "functional medicinal product" within the meaning of Article 1 No. 2 b of Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001 on the Community code relating to medicinal products for human use, as implemented by Section 2 (1) No. 2 a of the German Medicines Act (AMG).

Facts:

In these proceedings, the Federal Institute for Drugs and Medical Devices (BfArM) was of the opinion that the product in dispute - "M2 Eyelash activating serum", a product with a concentration of between 0.001% and 0.302% of the active ingredient "Methylamido-Dihydro-Noralfaprostal" (hereinafter: MDN) - constitutes a medicinal product within the meaning of Article 1 No. 2 b of Directive 2001/83/EC, Section 2 (1) No. 2 a AMG. Accordingly, on April 29, 2014, the authority issued a notice stating that the product was a "functional medicinal product." It based its assumption on the fact that MDN, as a novel synthetic active ingredient belonging to the group of prostaglandin derivatives, is largely identical to bimatoprost (hereinafter: BMP), which is approved as a medicinal product in Germany and marketed under the name "Lumigan" in eye drops for the treatment of glaucoma. A corresponding investigation of the chemical and biological properties of MDN itself does not exist. According to the BfArM, MDN has a pharmacological effect because it interacts with the prostamide receptor, which means that the lengthening of the eyelashes has a significant influence on bodily functions. The presence of a health risk also indicates that the product should be classified as a medicinal product. These health risks are derived from the analogy to BMP.
However, the product was marketed by the manufacturer as a cosmetic product at the time in question. According to the manufacturer, it promotes the growth and density of eyelashes by up to 50%. The manufacturer is of the opinion that the simple influencing of physiological functions, without being suitable to be directly or indirectly beneficial to human health, cannot establish a property as a medicinal product.

The preliminary ruling

In the course of the proceedings, the Cologne Administrative Court referred the following questions to the CJEU:

1. Is a national authority, when classifying a cosmetic product as a medicinal product by function within the meaning of Art. 1 No. 2 lit. b of Directive 2001/83, which includes an examination of all the characteristics of the product, entitled to base the necessary scientific determination of the pharmacological properties of the product and its risks on a so-called "structural analogy" if the active substance used has been newly developed, is comparable in its structure to pharmacological active substances already known and examined, but no comprehensive pharmacological, toxicological or clinical studies of the new substance on its effects and its dosage are submitted by the applicant, which are required only in the application of Directive 2001/83?
2. Is Article 1(2)(b) of Directive 2001/83 to be interpreted as meaning that a product which is placed on the market as a cosmetic and which significantly influences physiological functions by a pharmacological effect is to be regarded as a medicinal product by function only if it has a specific positive effect which promotes health? Is it also sufficient in this regard that the product has predominantly a positive effect on appearance which is indirectly beneficial to health by increasing self-esteem or well-being?
3. Or is it also a medicinal product by function if its positive effect is limited to an improvement in appearance without being directly or indirectly beneficial to health, but if it does not have exclusively harmful properties and is therefore not comparable to an intoxicant?

On Question 1: Assessment of the property as a functional drug by structural analogy - a further development of the case law on pharmacological action.

The CJEU stated with regard to the first question that "Article 1 no. 2 lit. b of Directive 2001/83 is to be interpreted as meaning that, when classifying a product as a 'medicinal product' within the meaning of that provision, a national authority may establish the pharmacological properties of that product by relying on the scientific evidence relating to a structural analogue of that substance, where no scientific studies of the substance , of which the product is composed are available and provided that the degree of analogy, on the basis of an objective and scientifically sound analysis, allows the assumption that a substance present in a product at a given concentration has the same properties as an existing substance for which the necessary studies are available."

In summary, the authority can thus also rely on comparable products and active substances to assess the pharmacological property of a product. With regard to the answer to the second and third questions, however, it should be noted that comparability cannot be the only criterion. Rather, the product must be evaluated in the context of an overall assessment.

On questions 2 and 3: "Influence" includes health-promoting effect

With regard to the second and third questions, the CJEU answered them uniformly by stating that "Art. 1 No. 2 letter b of Directive 2001/83 is to be interpreted as meaning that a product which influences physiological functions can only be classified as a 'medicinal product' within the meaning of that provision if it has specific effects which are beneficial to health. In this respect, an improvement in appearance that brings about an indirect benefit by increasing self-esteem or well-being is sufficient if it enables the treatment of a recognized disease. By contrast, a product which improves appearance without having harmful properties and which has no health-promoting effects cannot be classified as a 'medicinal product' within the meaning of this provision."

The CJEU thus continues its ruling on the interpretation of the term "affect", according to which the product to be assessed must be beneficial to the functioning of the human organism and consequently to human health. The CJEU already followed this direction in rulings such as those of 2012 (CJEU, ruling of September 6, 2012, C-308/11 - Chemische Fabrik Kreussler) and 2014 (CJEU, ruling of July 10, 2014, C-358/13, C-181/14 - Legal Highs). While the potential ability to directly or indirectly cause harm is sufficient, the product is not a medicinal product in the sense of the law. The product is, however, not a medicinal product within the meaning of Art. 1 No. 2 letter b of Directive 2001/83 if that product is not even potentially used for the treatment of a recognized disease. It then lacks the required health-promoting effect. Therefore, products that have an effect on the functioning of the body but result in purely cosmetic effects do not qualify as functional medicinal products.
For the assessment, the specific use must necessarily be taken into account in consideration of all characteristics of the product. The CJEU does not explicitly state what the term "specific use" indicates. However, interpreting the ruling, the CJEU seems to base its decision on the specific use and expectations of the user and the specific concentration and effect.

Conclusion / Takeaway:

The CJEU's view on structural analogy expressed in the answer to the first question referred for a preliminary ruling presents manufacturers of cosmetic products with the challenge that they not only have to keep in mind the mode of action of the ingredients used for their own purposes. Rather, assessments with regard to comparable substances must now also be taken into account, to ensure that a product which actually constitutes a medicinal product is not marketed as a cosmetic product. However, the problem is relativized by the answer to the second and third question, in which the classification as a functional medicinal product is based on the specific use of the product and the health-promoting effect by treating a recognized disease.