I. Introduction
As already reported in our July 2021 newsletter, the BVerwG referred four questions to the ECJ for a preliminary ruling after the oral hearing on 20.05.2021:
II. Facts of the case
The subject of the proceedings is a declaratory decision of the Federal Institute for Drugs and Medical Devices pursuant to Section 21 (4) AMG from 2013, according to which the nasal spray marketed by the plaintiff as a medical device is said to be a medicinal product subject to authorization.
The BfArM considered the disputed preparation as a presentation medicinal product in the sense of Section 2 (1) No. 1 AMG and thus subject to the medicinal product regime.
The action brought against this was unsuccessful before both the Cologne Administrative Court and the North Rhine-Westphalia Higher Administrative Court (OVG NRW), on the grounds that the concept of a presentation medicinal product under Section 2 (1) no. 1 AMG also applies if the product in question is marketed as a material medical device under Section 3 (1) a) MPG.
As is well known, medicinal products and medical devices have, by definition, the same purpose. Both serve the purpose of detecting, preventing, monitoring, treating or alleviating diseases. § Art. 2 AMG defines medicinal products and distinguishes between presentation medicinal products according to para. 1 no. 1 AMG and functional medicinal products according to para. 1 no. 2 a) AMG as well as diagnostic products according to para. 1 no. 2 b) AMG.
Also relevant is Art. 2 Para. 2 of Directive 2001/83, the so-called case of doubt regulation. According to this provision, in so-called cases of doubt, in which a product may fall under both the definition of a medicinal product and the definition of another product, the medicinal product regime shall apply.
III. The decision of the ECJ
The ECJ adressed the 4th question first and stated in paragraph 35 that Art. 2 (2) of Directive 2001/83 must be interpreted as applying to both functional and presentation medicinal products.
The ECJ justified this on the one hand with the argument of wording. The text of Art. 2(2) of Directive 2001/38, which explicitly refers to “medicinal products”, does not allow to distinguish between the two definitions of the term “medicinal product” set out in Art. 1 No. 2 a) or b) of the Directive without this being contrary to the wording itself.
Furthermore, an exclusion of presentation medicinal products from the priority of application of the legal regulation applicable to medicinal products would not be compatible with the intention expressed by the legislator to harmonize, by means of the obligation provided for in Art. 2 (2) of Directive 2001/83, the requirements of legal certainty for the economic operators with the requirements of quality, safety and efficacy of medicinal products for human use.
Next, the ECJ answered the 2nd and 3rd questions together. Firstly, it stated that in the absence of scientific evidence on the principal intended effect of a product, this product can neither be classified as a medical device according to Art. 1 Para. 2 a) of Directive 93/42 (para. 41) nor as a functional medicinal product according to Art. 1 No. 2 b) of Directive 2001/83 (para. 44).
Going further, the ECJ is then of the opinion that a product which, due to its presentation, is “intended as a product with curative or preventive properties” – which is the definition of a presentation medicinal product – gives the impression to the averagely informed consumer that this product, in view of its presentation, must have the properties in question. However, this ignores the fact that the definition of medical device differs only marginally in this respect to “the detection, prevention, treatment or alleviation of disease.”
The ECJ then goes on to state that, in this respect, account must be taken of the attitude of an averagely well-informed consumer, for whom the form given to a product may inspire a particular confidence, such as that which medicinal products normally inspire by virtue of the guarantees associated with their manufacture and marketing (paras. 45-47).
In this regard, the ECJ also stated that the manufacturer who wishes to market a product as a medical device must prove compliance with these requirements in accordance with Articles 3 and 4 of Directive 93/42 (para. 38), because Directive 93/42 does not provide the same level of consumer protection as Directive 2001/83. This difference in the level of protection is justified by the negative requirement for medical devices according to Art. 1(2)(a) of Directive 93/42, according to which the main intended effect is achieved neither by pharmacological or immunological means nor metabolically. The presumption of the lesser danger of these products justifies the marketing of goods on a declaratory basis, in contrast to the legal regulation that applies to functional or presentation medicinal products, the marketing of which requires the prior granting of a marketing authorization according to Art. 6 of Directive 2001/83 (para. 39).
In this decision, the ECJ completely disregarded the fact that medicinal products and medical devices have an identical intended purpose and are therefore equally suitable for curing, treating and preventing diseases. The only difference between the two product classes is the way in which the product acts – pharmacologically on the one hand; physically on the other. In its decision, the ECJ dealt with recital 7 of the amending Directive 2004/27/EC regarding so-called “borderline products” in paragraph 30, but completely omitted the decisive passage. The quoted passage in the ECJ ruling is followed by a decisive further sentence, which the court ignored:
“…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…”
In view of the practically identical intended purpose, it is extremely regrettable against this background that the ECJ did not address the first question raised by the referring court regarding the specification of the term “medicinal product” and instead considered the term “presentation medicinal product” to be applicable to medical devices purely on the basis of the wording argument of the doubtful case provision and disregarding the identical intended purpose.
The ECJ thus circumvented the actually decisive questions – namely how medicinal products and medical devices are to be distinguished on the basis of their presentation (if not via the CE mark and the labeling typical of the product class) and returned this to the referring court with reference to features such as pharmacy distribution, which is also not suitable for distinguishing. The ECJ also circumvented an urgently needed concretization of the indeterminate legal concept of pharmacological effect, which would have been more than desirable both to distinguish between borderline products in the class of medicinal products and medical devices and in terms of EU-wide harmonization (but perhaps it is better that way after this decision).
With this decision, the national regulatory authorities can claim the existence of a pharmacological effect, while the medical device manufacturer is obliged to prove the absence of a pharmacological effect. At the very least, it would have been helpful to provide a clear definition of the pharmacological effect in order to differentiate between the two product classes, instead of simply leaving question 1 open.
The ECJ has affirmed the classification of the material medical device as a presentation medicinal product solely on the basis of the wording argument of the doubtful case regulation and in the sense of the precautionary principle. Whether the product marketed as a medical device presents itself as a medicinal product in its entirety due to its presentation for the purpose of curing or alleviating a disease, the reference to interactions with medicinal products and to undesirable effects, as well as with regard to any pharmacy exclusivity, must then again be examined by the referring court.
The BVerwG has already correctly pointed out in the question referred that a product that has a medical purpose and bears the CE marking presents itself as belonging to the product group of medical devices.
With this decision, the ECJ has unfortunately made things too easy for itself and, in particular, missed the opportunity to concretize the undefined legal concept of pharmacological effect.
IV.
As the BVerwG correctly stated, a product bearing the CE mark that is marketed with the purpose of curing and preventing diseases does not present itself as a medicinal product to the consumer addressed. On the German market, medical devices and medicinal products are sold equally in pharmacies, so that this feature is also not suitable for classification as a presentation medicinal product. Accordingly, a product presented in accordance with the specifications of the medical device regime cannot actually be regarded as a presentation drug.
As long as a manufacturer cannot present proof of a non-pharmacological main effect accepted by the federal authority responsible in Germany, he must bow to the blanket assessment of the competent authority if no clear scientific determination is possible, which the authority agrees with, and submit an application for marketing authorization as a medicinal product, or refrain from placing the product on the market.
It is to be hoped that the ECJ will be given another opportunity to revise its opinion. On the other hand, it is to be hoped that in the future case law will attribute a higher degree of legal and product safety to the MDR and recognize the role of the Notified Bodies as a scientific authority – after all, the legislator has expressly excluded the product group of medical devices from the medicinal product regime and subjected it to its own regulatory regime.
