Regulation on Medical Marijuana in Germany

The public perception of cannabis is changing. In addition to some of the longer existing islands of legality or at least tolerance, more and more markets and communities are beginning to open up for the product. Of course, this is happening at very different speeds, in different ways and on different levels.

In Germany, marijuana or cannabis – or rather the (active) substances contained in it – remain in principle prohibited substances, they are considered as drugs. An opening of the market for consumption is still not foreseeable. Nevertheless, the possible positive medical effects of cannabis were recognized.

For some time now, cannabis-containing finished medicinal products have been able to be prescribed. Furthermore, an amendment of various acts in 2017 made the state-controlled cultivation of cannabis possible and allowed the production of cannabis-containing medicinal products in pharmacies. This exciting, market-opening development is reason enough to give an overview about the legal framework applicable to cannabis products and especially cannabis-containing medicinal products and to give an update on the current discussions and developments in this matter.

Marketability of Cannabis Products

Cannabis containing products can be classified in different ways: First, it is decisive whether the product is marketable according to the German Narcotics Act (Betäubungsmittelgesetz – “BtMG”). Second, the product can be a foodstuff or a medicinal product.

In detail:

Annex I of the BtMG states that “Cannabis” is a not marketable product. The possession, cultivation or trade with cannabis is therefore illegal. By Cannabis a broad range of products are included: According to Annex I marijuana, plants and parts of plants belonging to the genus cannabis are not marketable. Additionally, certain processing forms and ingredients of cannabis are mentioned in Annex I, eg cannabis resin and cannabinols like Δ9-Tetrahydrocannabinol and other “THCs” (the substance to which particularly psychoactive effects are attributed).

However, there are exceptions made in Annex I of the BtMG regarding the marketability of Cannabis: The seed of cannabis and products thereof, plants and plant parts of cannabis are marketable if they originate from cultivation in countries of the European Union with certified seed or if their THC content does not exceed 0.2% and the trade with them serves exclusively commercial or scientific purposes, which exclude a misuse for intoxication purposes.

Cannabis Product as Novel Food?

The classification of a cannabis-containing product as novel food is not very likely as a lot of circumstances would have to coincide: If cannabis-containing products are not subject to the BtMG according to the requirements set out above, they can in principle be marketed as foodstuffs and – under the requirement that they are novel – as novel food. The classification as foodstuff must be proven by the person that places the product on the market. In particular, the product must not have a pharmacological effect. In this case it would be classified as a medicinal product.

In individual cases – depending on the ingredients of the final product – it may be difficult to deny a pharmacological effect. For example, according to German authorities (German Federal Institut for Drugs and Medical Devices (Bundesamt für Arzneimittel und Medizinprodukte – “BfArM”)) and Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit – “BVL”), the cannabidiol (“CBD”) found in cannabis clearly has pharmacological properties due to its interactions with biological receptors (eg the antipsychotic or sedative effects of CBD). Additionally, CBD was added to the list of prescription medicinal products in 2016 that are stated in the German Drug Prescription Ordinance (Arzneimittelverschreibungsverordnung – “AMVV”).

If the absence of a pharmacological effect can be demonstrated, products that have CBD as an ingredient could be novel foods under the European Regulation (EU) 2015/2283 (“Novel Foods Regulation”) and would then be subject to authorisation. However, not subject to the Novel Foods Regulation are certain products prepared from the cannabis sativa plant or parts of this plant, such as seeds, seed oil, hemp seed flour, defatted hemp seed as these products have a history of consumption in the EU and are therefore not “novel”. As they are not novel, the fact that they may have CBD as an ingredient does not make them a novel food.

Production and Marketing of Medical Marijuana

Theoretically, the use of medical marijuana has been permitted in Germany for quite some time. Practically, marijuana was used only in the rarest cases and played only a minor role in the pharmaceutical market. Recognizing the medical benefits, the German parliaments passed the act amending narcotics and other regulations (Gesetz zur Änderung betäubungsmittelrechtlicher und anderer Vorschriften). This act, which came into force in 2017, serves to establish the marketability and prescribability of further cannabis medicinal products like dried cannabis flowers and cannabis extracts each in standardised quality. The aim is to enable patients with serious illnesses to obtain these medicinal products for therapeutic purposes by dispensing in pharmacies, if they are indicated in an appropriate way and alternative therapies for the illness are not existent. It is particularly noteworthy that medicinal products containing cannabis may no longer be sold only as finished medicinal products but also after preparation in pharmacies.

On the one hand, the law is intended to improve the care of the patients just addressed. At the same time, the safety of the narcotics traffic is to be maintained. In order to achieve this purpose, the before mentioned Act amended various provisions of the BtMG. According to Annex III of the BtMG, the distribution of cannabis-containing products is now permitted if these products come from a cultivation that is used for medical purposes and is under state control. The state control is performed by the BfArM according to sec. 19 para. 2a BtMG.

In accordance with these provisions, the BfArM approved the applications of three companies to produce cannabis in May 2019. These companies must deliver the first harvest until late November 2020. The harvest must be produced according to and meet the quality standards of Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practice (GMP). A production volume of 10.4 tons was granted, which can be adjusted upwards by 10% if necessary. The harvest will be bought by the BfArM and will then be resold to medical marijuana manufacturers, wholesalers and pharmacies.

Distribution to the Patient

Finished medicinal products may only be placed on the market, if they have been authorised by the BfArM, see sec. 21 para. 1 German Medicial Products Act (Arzneimittelgesetz – “AMG”). It is currently still controversial if the cannabis-containing medicinal products to be produced in pharmacies are subject to this principle. At the moment, nine different formulas for cannabis containing substances that are (finally) produced in pharmacies and then distributed to patients are existent. Depending on the manufacturing process, either on the basis of a doctor's prescription only, or as a bulk-produced medicinal product, i.e. it is produced in small quantities in advance, various exceptions to the approval principle just outlined can be considered. Please note that these bulk-produced medicinal products may not be confused with so called “bulkware”: These are medicinal products in large packages that are already ready for use.

Medicinal products that are manufactured only because of the prescription are not considered finished medicinal products according to sec. 4 para. 1 AMG. Therefore, they do not have to get a marketing authorisation according to sec. 21 para. 1 AMG. Bulk-produced medicinal products are – up to a certain extent – exempt from the marketing authorisation requirement according sec. 21 para. 2 AMG. Decisive for the applicability of the exemption on bulk-produced medicinal products is, whether essential manufacturing stages take place in a pharmacy. This requirement is not part of the wording applicable to prescription medicinal products but is nevertheless also applied to these medicinal products. Therefore, in this context, the fact that cannabis is not planted, harvested and made transportable by pharmacies, but by the companies presented above, seems problematic. Are pharmacies performing essential manufacturing stages when producing cannabis containing medicinal products with the effect that a marketing authorisation is not needed?

The answer to this question cannot yet be given with absolute certainty. However, it seems more reasonable to decline the need for a marketing authorisation: A marketing authorisation for a medicinal product can only be granted, if enough data regarding – inter alia – effectiveness and risks of the product is existent. This is not the case with medical marijuana until today. Since the act of 2017 discussed above was intended to strengthen the supply of cannabis-containing medicinal products to patients, an obligation to obtain a market authorisation would be contrary to the purpose of the nowadays law.

This assessment is also consistent with a judgement by the Higher Regional Court (OLG) of Düsseldorf in 2018. The Court accepted the amendment to the law described in this article to improve the supply of patients with medicinal products containing cannabis. At the same time, however, it insists that, according to the AMG, a distinction must be made between finished medicinal products and those that are prepared on prescription. Without excluding the possibility of manufacturing cannabis-containing medicinal products without a marketing authorisation in pharmacies, the court ruled that a marketing authorisation is required for an industrially manufactured cannabis-containing medicinal product.