According to Annexe I German Narcotics Act, cannabis is a non-marketable substance. The production, trade, and activities associated with this drug are clearly regulated in German law. Thus, among other things, the acts mentioned above and acquisition and possession are prohibited and, in some cases, punishable by imprisonment or a fine. Nevertheless, there is consideration of legalising the non-trafficable substance in Germany. A survey showed that the votes for and against legalisation are about equal. This consideration now raises the question: by whom and under what conditions could cannabis be produced?
We will go into these aspects and describe the current legal situation in the following. In addition, we will explain the current regulations on the sale and consumption of cannabis for medical purposes and go into more detail on the cultivation of commercial hemp.
For more information on the legalisation of cannabis and the current political debate, take a look at our article “Could Cannabis soon be Legalised in Germany?“. If you have any questions or need individual and personal legal advice, contact the legal team at Schlun & Elseven Rechtsanwälte.
Legal Production of Medical Cannabis in Germany
The non-marketable substance cannabis under Annexe I German Narcotics Act can be legally prescribed since 2017. Provided that the consumption serves a medical purpose, the prescription of the substance in pharmaceutical quality is possible in compliance with the regulations under drug and narcotics law. On the other hand, recreational use remains prohibited, although a change could be imminent here as well.
Legalisation in 2017 raised the question of how the growing demand for medicinal cannabis to date is to be met. Currently, the substance is still imported from various countries for this purpose. The products mainly come from the Netherlands or Canada. However, to be able to legally cultivate the substance in Germany and thus cover the domestic demand, the Federal Institute for Drugs and Medical Devices (BfArM) established the Federal Cannabis Agency. This agency is responsible for the control of cultivation and harvesting as well as the quality testing of medicinal cannabis and all subsequent procedures.
So far, only three companies have been contracted by the Federal Institute for Drugs and Medical Devices (BfArM) for the purpose of producing the narcotic. The Federal Cannabis Agency had selected two Canadian companies and a German start-up from various applicants based on a tendering procedure and contracted them to cultivate the Indian hemp plant in Germany. In June of this year, after initial delays due to the pandemic, the first legal harvest was carried out in Germany. In addition, another company was entrusted with the distribution.
Now, especially given the current discussion on the legalisation of the narcotic, the question arises as to how and under what conditions permission can be obtained from the Federal Cannabis Agency. So far, however, only the three companies mentioned are allowed to cultivate or produce cannabis of various types in Germany. It will only be possible to apply for these processes at the next opportunity to commission a company. Therefore, for the time being, corresponding companies have to hope for the next tendering procedure of the Federal Institute for Drugs and Medical Devices (BfArM).
If a company is selected, it has to comply with several requirements. These include, among others, §§ 15 ff. of the Narcotic Drugs Act (BtMG), which stipulate the obligations to comply with particular safety measures, to keep continuous documentation on the inflow and outflow as well as to report the quantity. Likewise, concerning the quality of the substance, the requirements of the GACP, GMP and monograph “Cannabis Flowers” must be observed.
The lawyers at Schlun & Elseven Rechtsanwälte will be happy to assist you. To obtain the authorisation required for the legal cultivation of cannabis from the Cannabis Agency established by the Federal Institute for Drugs and Medical Devices (BfArM), we will work with you to submit the relevant applications, check compliance with all regulations and will also be available to advise you on other legal issues. Feel free to contact us today via our online form.
The Current Legal Situation regarding the Sale and Consumption of Medicinal Cannabis
Concerning the legalisation of cannabis for medical purposes in Germany, some questions arise concerning the consumption and trade of the product. In the following, we address the sale, ingestion and the possibility of self-cultivation of the prescription drug.
Since 2017, it has been possible for doctors – with the exception of veterinarians and dentists – to prescribe the pharmaceutical-grade substance cannabis, which is considered non-marketable under German law, to seriously ill patients. Patients do not need permission from the Federal Institute for Drugs and Medical Devices (BfArM). A doctor can decide at their own discretion whether it is necessary to use “medical hemp” for the treatment of the patient. It is mainly used when the usual treatment methods do not work. It is prescribed for the following conditions, among others:
- Chronic pain (rheumatism or multiple sclerosis)
- Chemotherapy
- Cancer
- Tourette’s syndrome
- AIDS
The entitlement to the provision of medical cannabis is laid down in § 31 para. 6 SGB V. There, the prerequisites are listed that are linked to the prescription of medical cannabis. Before starting treatment with the narcotic, the approval of the patient’s health insurance fund must be obtained.
Furthermore, the prescribing doctor is obliged to forward to the Federal Institute for Drugs and Medical Devices (BfArM) the data listed in § 1 of the Cannabis Monitoring Ordinance (CanBV) in anonymised form (cf. § 31 para. 6 SGB V, § 4 para. 2 CanBV).
The medicinal product is sold in pharmacies. To obtain it at pharmacies, a “narcotic prescription” is required (cf. § 9 Narcotic Prescription Ordinance (BtmVV)). The pharmacies, in turn, receive the narcotic via the Federal Cannabis Agency, which controls all processes related to the production and the subsequent process. The agency also commissions companies with the cultivation of the plant. Cultivation on its own is generally prohibited. However, the Federal Institute for Drugs and Medical Devices (BfArM) can approve this under certain circumstances. This requires an application on your part and the fulfilment of all requirements. However, a permit for self-cultivation is rarely granted.
Commercial Cannabis – Use and Cultivation
The regulations outlined in Annexes I to III German Narcotics Act (BtMG) distinguish between cannabis for use for medical purposes and cannabis that is not marketable. However, Annexe I German Narcotics Act also regulates exceptions that refer to commercial hemp (also called “industrial hemp”). This Annexe refers to those varieties whose tetrahydrocannabinol (THC) content does not exceed 0.2% and which cannot be used as an intoxicant or medicinal product.
In addition to the THC mentioned, cannabis also contains the ingredient cannabidiol (CBD). This substance is not subject to the Narcotics Act. Nevertheless, it contains regulations that specify the origin of the plant, the THC content, and the substance’s purpose.
Industrial hemp is cultivated for the production of oils and fibre, among other things. Oil, for example, can also be produced from the plant’s seeds. However, the cultivation of industrial hemp in Germany requires a corresponding licence from the Federal Cannabis Agency. If such a licence is not available, one is acting unlawfully. To curb abusive purposes, this licence is only issued to certain companies. In most cases, these are agricultural enterprises within the meaning of § 1 para. 4 Law on Old-Age Insurance for Farmers (ALG).
If you are wondering whether your agricultural enterprise is allowed to cultivate commercial hemp, contact the lawyers at Schlun & Elseven. Our legal team will be happy to support you in applying for the permit and will also advise you on other legal issues.
Legal Support at Schlun & Elseven
The information provided in this article is of a general and informative nature. For legal advice, please do not hesitate to contact the team of lawyers at Schlun & Elseven Rechtsanwälte.
Schlun & Elseven Rechtsanwälte is a multidisciplinary, full-service law firm. With offices in Cologne, Aachen and Düsseldorf as well as conference rooms in Hamburg, Berlin, Stuttgart, Frankfurt and Munich, we operate nationwide and are always at your service. Our lawyers provide their services in German, English and other languages. Call us, send us an email or use our online form – we will be happy to give you an overview of your options as part of an initial assessment.
