Turnaround of Medical Cannabis in Germany? – Draft bill by new German Government to address alleged missteps

Background: Partial legalization of cannabis in Germany

The German Cannabis Act (Cannabisgesetz – CanG), which came into force on April 1, 2024 under the former German Federal Government (a coalition between the political parties SPD, Green Party, and FDP), has essentially reorganized the legal framework for cannabis in Germany. This reform was a central promise of the coalition, intending to represent the next step in the German drug policy after the initial legalization of prescribing medical cannabis in 2017. Since then, physicians were permitted to prescribe cannabis for medical purposes in pharmaceutical quality, in accordance with narcotics regulations, and at the expense of the statutory health insurance (SHI) funds (ref. Sec. 31 para. 6 of the German Social Code, Book V (SGB V)). In excess to what is normally required for the prescription of a medicinal product, Section 31, para 6 SGB V sets out specific requirements for the prescription of medical cannabis at the expense of the SHI fund: (1) the patient must suffer from a severe medical condition; (2) conventional treatments must either be unavailable or, in the profound view of the treating physician, not reasonably applicable in the individual case; (3) there must be a plausible chance that the therapy will positively impact the course of illness/recovery; and finally, (4) the prescription requires prior approval from the relevant SHI fund when it is applied for the prescription the first time or for a subsequent change in dosage.

Under the Cannabis Act from 2024 cannabis has been declassified from its former status as a narcotic and has been removed from the list of narcotic substances under the German Narcotic Drugs Act (Betäubungsmittelgesetz – BtMG). As a result, cannabis is no longer classified as a narcotic drug in Germany with further wide-ranging implications for criminal law, pharmaceutical regulation, pharmacy operations, and drug trafficking law. In particular, the medical sector and patients have benefited from reduced bureaucracy, for example through simplified prescription via regular medicinal product prescription forms (and no longer as a narcotics prescription), reduced security measure requirements, and expanded access options. Furthermore, the possession of small quantities of cannabis for recreational use and the private at-home as well as the non-commercial cultivation of cannabis plants in licensed cannabis clubs have been decriminalized.

While recreational cannabis is regulated by the newly enacted German Consumer Cannabis Act (Konsumcannabisgesetz – KCanG), medicinal cannabis is now regulated by the German Medicinal Cannabis Act.

Cannabis legalization under review by the newly formed Federal Government

When the new Federal Government – formed by the political parties CDU/CSU and SPD under Chancellor Friedrich Merz (CDU) – took office in May this year, it was clear that the partial legalization of cannabis initiated under the previous cabinet will undergo critical review. Even before the federal election took place, several representatives within the now majority party CDU/CSU have repeatedly emphasized their intention to reverse the partial legalization of cannabis.

So far, however, these plans have remained rather vague. The coalition agreement between the governing parties merely states that an “open-ended evaluation of the cannabis legalization law is scheduled for fall 2025”. The now introduced draft bill by the BMG may mark the first step of the new government to adjust the partial legalization of cannabis.

The draft bill in a nutshell

According to the Federal Ministry of Health (BMG), the draft bill is a response to the significant rise in imports of medical cannabis: Since the partial legalization of cannabis in April 2024 the imported quantities of cannabis for medical use have reportedly exceeded the anticipated volume already in 2024. This increase, however, did not correlate with an increase of prescriptions in the mandatory health insurance fund system, which covers approximately 90% of the German citizens. The BMG attributes the increase in imports to a growing number of privately paid prescriptions, often issued through telemedicine platforms. These telemedicine service providers often facilitate prescriptions solely on the basis of an online questionnaire, filled out by the patient, without direct contact between patient and prescribing physician. In many cases, the telemedicine platforms collaborate with postal-order pharmacies, without any face-to-face interactions with pharmacists as well.

To counter the aforementioned alleged misdevelopments, the draft proposes a ban on online prescriptions of medical cannabis without a prior in-person doctor-patient consultation, as well as a prohibition of the postal-order dispense of medical cannabis by pharmacies. The justification provided in the draft refers to the specific risk profile of cannabis for medical purposes, referring to the potential for addiction and broader health concerns, in particular for younger people. Given their classification under pharmaceutical law, without being examined in a clinical setting nor having undergone an authorization procedure, the BMG argues that a heightened level of medical diligence is reasonable, meaning a diligence that, according to the draft, cannot be ensured without direct personal interaction between the patient and the prescribing physician. Every patient is to receive a full physical examination, duly information, and give informed consent.

In more detail, the key aspects of the proposed changes are:

• Mandatory in-person appointment with a physician:

The main component of the draft is the already proposed restriction of prescribing practices for medical cannabis via telemedicine platforms. According to the proposed framework, initial prescriptions would require a mandatory in-person consultation between the physician and the patient. This could be either at the medical practice or through an at-home visit by the physician. The current possibility to receive medical cannabis via a simple online questionnaire, reviewed by a physician, or a teleconsultation with a physician via video, would vanish. In addition, for any subsequent prescription the patient must have undergone at least one physical consultation at the same doctor's office within the preceding twelve months.

• Proposed ban on postal-order dispense:

Another notable shift compared to the current given pathway is the proposed ban on postal-order dispense of cannabis for medical purpose to patients. According to the BMG, such dispense of cannabis by mail undermines the important role of pharmacists in providing essential face-to-face guidance. Patients should receive in-person guidance on how to use the product correctly, what side effects or interactions might occur, and how to store and dispose of it safely – especially to prevent misuse by children and teenagers. To ensure such proper consultation and oversight, the draft mandates that all medical cannabis products may only be dispensed directly and exclusively in person in the pharmacy.

• Subject to criminal liability:

To strengthen the proposed changes and to ensure adherence, both the prescription of medical cannabis against the proposed legislation and its dispense through postal-order services shall be subject to criminal liability.

Outlook

Should the draft be implemented in its current version, it would likely have substantial impacts on several business models within the medical cannabis industry, especially on those engaged in patient supply and dispense. Some stakeholders have already expressed their over-all disappointment, particularly for creating new barriers for patients who depend on access to medical cannabis. In addition, also potential negative effects are expected on the further development of telemedicine and digital health care services in Germany, including postal-order pharmacies.

At the same time, the draft bill and its justification already raise legal concerns. The proposed changes would significantly limit the constitutionally protected business activities and autonomy of telemedicine platforms and pharmacists. Furthermore, the current draft bill does not adequately consider the revised risk assessment of cannabis and its recent declassification as narcotic drug. For example, despite the known risks of misuse also associated with other medicinal products, the draft narrows its focus solely to medical cannabis, limiting both its prescription and postal-order dispense.

However, the draft bill is currently in the public hearing and consultation phase of the legislative process. This phase allows industry associations, innovators, and experts to submit their feedback on the proposed draft. It presents the opportunity to suggest other improvements on the existing legal framework.

For now, it remains to be seen how the legislative process will unfold and whether the concerns raised by affected stakeholders will have an impact on the proposed draft bill.

Authored by Arne Thiermann, LL.M. (LSE), Dr. Tina Welter-Birk, and Dr. Philipp Glockemann.