The Medical Cannabis Act at a Glance: Legalization with conditions

The new Cannabis Act (CanG) came into force in Germany on April 1, 2024. Article 1 of the CanG contains the Consumer Cannabis Act (KCanG), which regulates the handling of cannabis for personal use, while Article 2 contains the Medical Cannabis Act (MedCanG), governing the supply of cannabis for medical and scientific purposes. 

As a result, cannabis has been removed from the scope of the Narcotic Drugs Act. The reclassification of cannabis from a narcotic drug to a regulated substance and its partial decriminalization mark a significant shift in German drug policy. The goal is to curb the black market and reduce health risks, such as contamination.

While the handling of cannabis was previously subject to a Europe-wide tender by the Federal Institute for Drugs and Medical Devices (BfArM), authorization is now granted through a licensing procedure. This is intended to create more flexible market conditions and expand production capacity in Germany.

Permit for the handling of medicinal cannabis under Section 4(1) MedCanG

Companies that intend to cultivate, produce, trade, import, export, dispense, retail, otherwise place on the market, obtain, or acquire cannabis for medical or medical-scientific purposes require a permit under Section 4 MedCanG. This permit is issued by the BfArM upon application.

Exceptions apply to the sale of medical cannabis by doctors and pharmacies, which fall under the supervision of the respective state authorities.

The costs incurred are regulated by a special fee ordinance and generally fall within the five-digit range (see BMGBGebV Chapter 15). Licenses issued under the BtMG before the CanG came into force remain valid. Pharmaceutical wholesalers holding a permit under Section 3 BtMG for domestic trade will also be granted a permit under Section 4 MedCanG. However, an application is required, though it does not need to specify the type of cannabis, as a full permit has already been issued.

Application and scope of the permit

The permit application must include details of the responsible person and supporting documents, such as a certificate of good conduct and proof of the required expertise in handling cannabis. The required proof of expertise is governed by Section 7(3) MedCanG. Depending on the intended activities, applicants must provide evidence of a medical license to practice as a pharmacist, a degree in biology, chemistry, pharmacy, human or veterinary medicine, or proof of training as a wholesale and foreign trade clerk, along with confirmation of at least one year of experience in the pharmaceutical trade.

The permit includes details about the location of the business premises, whether handling for medical or medical-scientific purposes is permitted, the specific activities allowed, and the type of cannabis with which these activities may be carried out. It should be noted that for cultivation, multiple business premises of a company can only be combined under a single permit if they are located in neighboring municipalities.

It is therefore important for companies to apply for a permit under Section 4 MedCanG and to comply with the documentation requirements (e.g., for business premises or the type of cannabis). Violations may result in fines of up to EUR 30,000.

Storage of cannabis products

According to Section 21 MedCanG, companies must take appropriate measures and safety precautions, such as storing cannabis in sealed containers or rooms. Logistics companies that transport, store, or hold cannabis on behalf of authorized participants do not require a permit under Section 4 MedCanG, but the shipments may not be stored for longer than necessary for onward transport. If longer storage is required, a separate permit must be obtained.

Distribution of medicinal cannabis

Medicinal cannabis may only be dispensed by pharmacies with a doctor's prescription, according to Section 3(2) MedCanG. Pharmacies are not subject to the licensing requirement (see Section 5(1) No. 1 MedCanG), as they are already regulated and monitored under pharmaceutical and pharmacy laws.

According to Section 3(1) MedCanG, medicinal cannabis may only be prescribed by doctors or administered as part of a medical treatment and is subject to the general requirements for prescription-only medicines. The prescription does not have to be linked to a specific diagnosis; rather, the doctor alone decides whether treatment with medicinal cannabis is necessary. Private prescriptions can be issued for self-payers, or reimbursable prescriptions can be issued through statutory health insurance in accordance with social insurance regulations.

Accordingly, seriously ill health insurance policyholders are entitled to a supply of medicinal cannabis if no generally recognized treatment is available or cannot be used, based on the doctor's decision, and there is a (not entirely implausible) prospect of a positive effect. This must be assessed on a case-by-case basis. Until now, the prescription had to be approved by the health insurance fund. Since October 2024, exceptions have been made for doctors holding certain additional qualifications; initial approval by the health insurance fund is no longer required in these cases. This aims to reduce administrative hurdles and prevent delays, enabling patients to obtain cannabis for medical purposes more easily and quickly. However, the dispensing of medicinal cannabis for consumption purposes remains excluded.

Excursus: Telemedicine

Telemedical treatment refers to the prescription of medicines through remote treatment using audiovisual communication methods or video consultations. Section 3(1) MedCanG does not provide further detailed regulations on this matter; therefore, a physical separation between doctor and patient is not excluded and may be permissible depending on the individual case.

Caution should be exercised with business models where operators of an online platform offer cannabis while simultaneously connecting doctors and a mail-order pharmacy to the platform. Typically, after completing a questionnaire, the user is either offered a video consultation or a prescription for medicinal cannabis is immediately issued after submitting the data. This prescription is then forwarded to the connected mail-order pharmacy, which sends the medicinal cannabis to the patient.

It is doubtful whether the evaluation of a questionnaire without personal contact can truly be regarded as medical treatment. If there is no proper prescription, this does not legitimize the dispensing of medicinal cannabis. In such cases, both doctors and pharmacists may be liable to prosecution under Section 25(1) No. 2, (4) sentence 2 No. 1 MedCanG, while the operators of the platform may generally be liable for incitement. However, if a video consultation takes place, these risks do not typically arise, as it can be considered medical treatment, although this still depends on the individual case.