The German Federal Ministry of Health, under the leadership of Minister Nina Warken (CDU), is proposing significant revisions to the Medicinal Cannabis Act, according to a draft bill reported by the Mediengruppe Bayern. The proposed changes aim to tighten regulations surrounding the prescription and dispensing of medical cannabis.
A key element of the draft legislation mandates that prescriptions for cannabis flowers can only be issued following direct patient contact, either during an in-person appointment at a physician’s practice or through a home visit. The proposed text stipulates: “The prescription of the flowers mentioned in § 2 number 1 may only be issued after personal contact between a physician and the patient in the physician’s practice or during a home visit”. This requirement extends to subsequent prescriptions, which must be preceded by such direct contact within the previous four quarters.
Currently, prescriptions are often issued via video consultations, with physicians sometimes located outside of Germany and providing private prescriptions. The draft bill acknowledges a significant increase in cannabis flower imports for medical purposes, noting that imports have surged since the enactment of the Cannabis Act.
Data from the Federal Institute for Drugs and Medical Devices (BfArM) reveals a 170 percent increase in cannabis flower imports between the first and second halves of 2024. While prescriptions have increased, the proportion borne by statutory health insurance (GKV) providers has only risen by nine percent during the same period. This discrepancy suggests that the increasing import volumes are primarily fulfilling the needs of a growing number of private-paying patients outside the GKV system.
The draft legislation also introduces stricter regulations concerning the dispensing of medical cannabis. It stipulates that distribution will be limited to pharmacies only, prohibiting delivery via mail order as outlined in § 43 Paragraph 1 Sentence 1 of the Drug Law.
The proposed changes are framed within the context of addressing the potential for cannabis dependency and related health risks. The draft emphasizes that medical cannabis flowers possess an inherent risk of addiction and other health concerns, particularly regarding brain development in young people. Highlighting the unique regulatory status of cannabis – lacking the rigorous scientific evidence required for fully approved pharmaceuticals – the draft argues that these factors necessitate specific measures to ensure both the safety of the medication supply and patient safety.