Binding implications of notification under German Drug Act and qualification of preparation as presentation drug

Introduction
Facts
Decision
Practical advice

Introduction

The Frankfurt am Main District Court recently examined whether a Federal Institute for Drugs and Medical Devices (BfArM) notification made pursuant to Section 21(IV) of the German Drug Act (AMG) can establish whether a preparation is a medicinal product subject to authorisation.(1) In principle, the courts are bound by the institute's assessment unless the notification is null and void.

When assessing the constituent elements of a notification, the courts may need to review the notification in full. If a partially redacted notification is submitted, the necessary substantiation of the constituent elements may be lacking in summary proceedings.

If a notification is redacted in such a way that its constituent elements are unknown, the court must decide whether a preparation is a functional medicinal product or a 'presentation drug' within the meaning of Section 2 of the AMG.

Facts

The defendant was a pharmaceutical company which marketed Mucosolvan Complete PHYTO as a medical device. The competition association suing for injunction argued that the product in dispute should be qualified as a presentation drug.

The product's active ingredients include two recognised and monographed medicinal plants which have long been used in the treatment of coughs and whose pharmacological effect is undisputed. In addition, the trade name Mucosolvan is identical to that used for the defendant's Mucosolvan cough syrup, whose approval as a medicinal product is undisputed. Finally, Mucosolvan Complete PHYTO is a functional medicinal product because it has both pharmacological and immunological effects. Thus, the product in question was subject to compulsory authorisation under Section 21(I) of the AMG.

The defendant asserted that the BfArM had made a binding determination pursuant to Section 21(IV) of the AMG that the product did not require authorisation, but was rather a medical device. The BfArM's decision effectively established the facts for the civil court, which was thus bound by the decision. In this respect, a claim for injunction was excluded.

Decision

The Frankfurt am Main District Court rejected the defendant's appeal and confirmed the temporary injunction.

The court held that the BfArM's notification had, in principle, binding implications. However, the notification in this case was not sufficiently credible as information which was elementary to its scope had been redacted.

In addition, the court held that Mucosolvan Complete PHYTO was a presentation drug because its specific presentation gave the impression that the product could heal and alleviate diseases. The other Mucosolvan products are known to the public as authorised medicinal products and the effect of an umbrella brand must be taken into account. In this respect, there was an infringement of Section 21(I) of the AMG.

Practical advice

The Frankfurt am Main District Court's decision appears to be the first higher-court judgment to deal with the constituent elements of a notification issued under Section 21(IV) of the AMG in this depth. It provides almost textbook-like explanations that:

• a corresponding notification can have binding implications;
• a notification's unlawfulness may be harmless; and
• in the corresponding application of Sections 133 and 157 of the Civil Code, it is not only the tenor of a notification issued according to Section 21(IV) of the AMG which must be taken into account, but also its justification.

From a procedural point of view, it is notable that a redacted notification may stand in the way of a sufficient prima facie case under Section 294 of the Code of Civil Procedure. This brings into focus the topic of the protection of secrets in proceedings (Sections 172(2) and 174(III)(1) of the Courts Constitution Act).

The court's remarks on the qualification of a product as a presentation drug align with case law. In this respect, it depends on the perception of an averagely informed consumer (see BGH GRUR 2000, 528 [529], L-Carnitin), which can be influenced by:

• the opinions of pharmaceutical or medical scientists;
• the indications and instructions for use enclosed with a product or contained in advertising brochures; and
• the presentation in which a product is generally marketed (see BGH GRUR 1995, 419 [420 f] Knoblauchkapseln).

For further information on this topic please contact Daniel Kendziur or Fabian Huber at Simmons & Simmons LLP by telephone (+49 2 11 4 70 53 0) or email (daniel.kendziur@simmons-simmons.com or fabian.huber@simmons-simmons.com). The Simmons & Simmons LLP website can be accessed at www.simmons-simmons.com.

Endnotes

(1) Frankfurt am Main District Court, 22 May 2020 – 6 U 23/20, GRUR-RS 2020, 12553.