As is well known, medicinal products and medical devices have, by definition, the same intended purpose. Both serve the purpose of detecting, preventing, monitoring, treating or alleviating diseases. Section 2 AMG defines medicinal products and distinguishes between presentation medicinal products according to subsection 1 number 1 AMG and functional medicinal products according to subsection 1 number 2 a AMG as well as diagnostic products according to subsection 1 number 2 b AMG.
Section 2(5) of the MPG determines, inversely to Section 2(3) of the AMG, what does not belong to the scope of the Medical Devices Act, namely medicinal products as defined in Section 2 of the AMG, whereby the decision as to whether a product is a medicinal product or a medical device is made taking into account, in particular, the principal mode of action of the product, unless it is a medicinal product as defined in Section 2(1)(2)(b) of the Medicinal Products Act (diagnostics).
For years, the case law of the Administrative Court of Cologne and the Higher Administrative Court of North Rhine-Westphalia (OVG NRW) has been that medical devices containing substances are not subject to the medicinal product regime according to objective scientific criteria, but with the argumentation that they present themselves like a medicinal product and since the mode of action cannot be sufficiently clarified, they are to be subject to the medicinal product regime via the rule of doubt.
In fact, the concept of the presentation medicinal product was developed by the ECJ in order to be able to make a distinction in the area of foodstuffs and medicinal products. When differentiating between medicinal products and medical devices, however, the presentation of the therapeutic effect cannot be the decisive factor and a product that is correctly labelled in accordance with the provisions of the MPG cannot be subjected to the medicinal product regime by means of the concept of a medicinal product for presentation. Rather, when differentiating between medicinal products and medical devices, the main effect of the product in dispute must be scientifically clarified.
In an oral hearing on 20.05.2021, the Federal Administrative Court has now decided to suspend the proceedings and to submit the questions to be decided here – 4 in total – on the demarcation of substance-based medical devices from medicinal products to the ECJ for a preliminary ruling.
The subject matter of the present proceedings is a declaratory decision of the Federal Institute for Drugs and Medical Devices (BfArM) pursuant to Section 21 (4) of the German Medicines Act (AMG), according to which the nasal spray marketed by the plaintiff as a medical device was a medicinal product subject to authorisation.
The BfArM regarded the preparation in question as a presentation medicinal product within the meaning of section 2(1)(1) of the AMG and thus subjected it to the medicinal product regime, which in the opinion of the plaintiff was an inappropriate distinction from a medical device within the meaning of section 3(1)(a) of the MPG.
The actions brought against this were unsuccessful both before the Administrative Court of Cologne and the Higher Administrative Court of North Rhine-Westphalia (OVG NRW) on the grounds that the term “presentation medicinal product” under Section 2(1)(1) of the German Medicines Act (AMG) also applies if the product in question is placed on the market as a material medical product under Section 3(1)(a) of the MPG.
The decision of the OVG NRW is based on the finding that the product in dispute is a presentation medicinal product according to its presentation and that the term presentation medicinal product according to § 2 para. 1 no. 1 AMG also applies if the product in question is placed on the market as a material medical product according to § 3 para. 1 letter a) MPG.
III. Decision
Against the background of the questions under European law, the BverwG has now suspended the proceedings in the appeal proceedings and submitted the following four questions to the ECJ:
The ECJ decision can be awaited with anticipation, as there is hope that the long-standing controversial question of the applicability of the presentation medicinal product to medical devices as well as the question of the applicability of the doubtful case regulation in such cases will then be resolved.
It is possible that the ECJ will also deal with a definition of a pharmacological effect, which is still not suitable for finding a uniform and satisfactory solution to numerous borderline cases.
Perhaps there will also be further demarcation criteria for the future if the previous definitions and demarcation criteria do not offer any further help, because the questions will remain relevant under the MDR.
