By Dr. Kokularajah Paheenthararajah and Pia Riemenschneider
In a landmark preliminary injunction of 2 August 2018 (docket no. 15 U 21/18), the Düsseldorf Higher Regional Court ruled that, under the circumstances of the individual case, a medical cannabis product may, due to the way it is objectively presented, trigger the marketing authorization requirement for so-called “finished medicinal products” (“Fertigarzneimittel”). This may particularly be the case if the product, in its specific form, can objectively be used as a finished medicinal product, even though it is only intended as a component for the manufacture of magistral medicinal preparations (“Rezepturarzneimittel“) in pharmacies. As a consequence, the placing of such a cannabis product on the German market may be prohibited as an unfair competition practice in case there is no marketing authorization for the specific product in place.
This decision has been quite unique so far and of particular relevance for the rapidly growing medical cannabis market in Germany since it implies that cannabis products intended only as components for the manufacture of magistral medicinal preparations, e. g. cannabis extracts, may nevertheless have to go through the entire marketing approval process and, hence, extensive clinical trials like any other finished medicinal product prior to placing them on the German market if they are objectively presented as a finished medicinal product.
Das OLG Düsseldorf hat in einer wegweisenden einstweiligen Verfügung am 2. August 2018 (Az. 15 U 21/18) entschieden, dass ein medizinisches Cannabisprodukt im Einzelfall aufgrund seiner objektiven Aufmachung die Zulassungspflicht für sogenannte “Fertigarzneimittel” auslösen kann. Dies kann insbesondere dann der Fall sein, wenn das Produkt in der konkreten Gestalt objektiv als Fertigarzneimittel verwendet werden kann, obwohl es nur als Bestandteil für die Herstellung eines sogenannten “Rezepturarzneimittels” in Apotheken bestimmt ist. Das Inverkehrbringen eines solchen Cannabisprodukts in Deutschland kann als unlautere Wettbewerbshandlung untersagt werden, wenn es arzneimittelrechtlich nicht zugelassen ist.
Diese Entscheidung ist bislang einzigartig und für den rasant wachsenden Markt für medizinisches Cannabis in Deutschland von erheblicher Bedeutung, da sie impliziert, dass Cannabisprodukte, die nur als Komponenten für Rezepturarzneimittel bestimmt sind, wie z.B. Cannabisextrakte, dennoch aufgrund ihrer objektiven Aufmachung als Fertigarzneimittel das gesamte Zulassungsverfahren und damit insbesondere umfangreiche klinische Studien durchlaufen müssen, bevor diese in Deutschland in den Verkehr gebracht werden dürfen.
In the case at hand, units of bottles containing cannabis full extracts for medical use (inter alia, THC 10 mg: CBD 10 mg) were imported from Canada and placed on the German market. The intended use of the products was as a component for the manufacture of magistral medicinal preparations on the pharmacy level. An import licence under Sec. 72 of the AMG (German Medicinal Products Act) as well as under Sec. 3 of the BtMG (German Narcotic Drugs Act) was in place. However, there was no marketing authorization according to Sec. 21 para. 1 of the AMG.
As regards marketing approval requirements, German pharmaceutical regulatory laws differentiate between finished medicinal products (Sec. 4 para. 1 of the AMG) and magistral medicinal preparations (Sec. 1a para. 8 of the ApBetrO − German Regulation on the Operation of Pharmacies). Accordingly, finished medicinal products are medicinal products that are manufactured beforehand and placed on the market in packaging intended for distribution to the consumer, or other medicinal products intended for distribution to the consumer in the preparation of which any form of industrial process is used, or medicinal products that are produced commercially, except in pharmacies. In contrast to that, magistral medicinal preparations are individual medicinal formulations that are manufactured in pharmacies in accordance with a doctor’s prescription and not beforehand. While both types of products qualify as medicinal products under German pharmaceutical laws (Sec. 2 paras. 1 and 2 of the AMG), only finished medicinal products require a marketing authorization according to Sec. 21 para. 1 of the AMG.
Decision of the Düsseldorf Higher Regional Court
The Düsseldorf Higher Regional Court emphasized that the legalization of, inter alia, cannabis blossoms and extracts in standardized quality for medical use in Germany on 9 March 2017 does not suspend the differentiation between finished medicinal products and magistral medicinal preparations under the German drug laws. Thus, cannabis products have to be marketing-authorized according to Sec. 21 para. 1 of the AMG in case they objectively qualify as finished medicinal products.
Against this background and by virtue of the particular circumstances of the individual case, the Düsseldorf Higher Regional Court, inter alia, ruled that the respective cannabis full extracts qualified as finished medicinal products under Sec. 4 para. 1 of the AMG since they were objectively presented as such. The court qualified the products as finished medicinal products rather than only components for the manufacture of magistral medicinal preparations particularly based on the following objective criteria:
- the general language of the package leaflet;
- the concentrations of the cannabis extracts offered were exactly the same as the therapeutic target concentration of the respective magistral medicinal preparations;
- the package leaflets and marketing components suggested the undiluted use of the cannabis extracts;
- child-resistant bottle cap; and
- syringe provided for the dosing of the cannabis extracts.
In the view of the Düsseldorf Higher Regional Court, the overall picture of the specific form of the cannabis extract and the way it was presented implied that the product could objectively be used as a finished medicinal product by patients. In particular the fact that there was no further step required in the pharmacy to transform the cannabis extracts into a magistral medicinal preparation was decisive for the qualification of the product as a finished medicinal product. For example, the concentration of the cannabis extracts were exactly the same as the therapeutic target concentration of the respective magistral medicinal preparations so that there was no need to further dilute the cannabis extracts in the pharmacy prior to dispensing the product to patients. Furthermore, the fact that the cannabis extracts were primarily packed in bottles with child-resistant caps and that an additional syringe was provided for the dosing of the cannabis extracts indicated to the court that the products in any case had not been intended for use by pharmacists only. As a consequence, the marketing authorization requirement pursuant to Sec. 21 para. 1 of the AMG was automatically triggered.
Even though the intended purpose of a cannabis product may be the use as a component for the manufacture of magistral medicinal preparations on the pharmacy level, the product may still objectively qualify as a finished medicinal product due to the way the product is objectively presented. Thus, the marketing authorization requirement pursuant to Sec. 21 para. 1 of the AMG may be automatically triggered. The aforesaid criteria developed by the Düsseldorf Higher Regional Court for the classification of cannabis products as finished medicinal products which are subject to marketing authorization are not conclusive but rather based on the particular circumstances of the individual case and the overall objective picture of the products.
In order to prevent the triggering of the marketing authorization requirement it is essential to carefully assess the way not only the cannabis product itself but also its packaging, labelling and marketing materials are objectively presented prior to placing such product on the German market. Particularly, it should be ensured that a cannabis product, of which the intended use is as a component for the manufacture of magistral medicinal preparations in pharmacies, is not more or less identical to the actual magistral medicinal preparation. There should be an actual manufacturing step required at pharmacy level in order to transform the cannabis component into a magistral medicinal preparation. In this context, according to the Düsseldorf Higher Regional Court, merely an identity control by the pharmacist prior to dispensing the cannabis extract to patients would not be sufficient to constitute a manufacturing step under Sec. 4 para. 14 of the AMG.
It should be noted that placing a cannabis product on the German market which can be objectively used as a finished medicinal product without holding a valid marketing authorization may not only constitute an unfair competition practice prohibited under Sec. 3 para. 1, 3a of the UWG (German Act Against Unfair Competition) in conjunction with Sec. 21 para. 1 of the AMG but even a criminal offence under Sec. 21 para. 1, 96 no. 5 of the AMG.