On March 16, 2023, the Federal Joint Committee (Gemeinsamer Bundesausschuss (G-BA)) amended the German Medicinal Products Guidelines (Arzneimittelrichtlinie (AM-RL)). The newly adopted regulations of the G-BA already largely reflect the requirements of Section 31 VI of the German Social Code V (Sozialgesetzbuch V (SGB V)), which allows the G-BA to provide the framework for further regulations on the granting of medical treatment. The regulations will enter into force if the Federal Ministry of Health does not legally object to them, and they are published in the Federal Gazette (Bundesanzeiger).

The changes in detail

To subsection B. of the AM-RL— which sets out the legal basis for the scope and limits of the entitlement to benefits for pharmaceuticals—Section 4a was added, which regulates entitlement for insured persons with a serious illness to the provision of cannabis in the form of dried flowers (THC content of at least 0.2 percent) or extracts in standardized quality and the provision of pharmaceuticals with the active substances dronabinol or nabilone (cannabis pharmaceuticals).

Before a physician may prescribe cannabis in the form of dried flowers or extracts, it must be ascertained that cannabis-containing finished pharmaceuticals are suitable for the treatment. The prescription of dried flowers must be justified. The term “serious illness” is already defined in the AM RL. A disease is serious if it is life-threatening or permanently impairs the quality of life of the patient. According to the new Section 44, the prescription of cannabis pharmaceuticals is permissible if a generally accepted treatment that meets medical standards is not available or cannot be used in the individual case, and the likelihood of the cannabis product having a noticeable positive effect on the course of the disease or of severe symptoms is not entirely remote. The physician must specify the cannabis pharmaceutical product when prescribing it. The appropriateness of further treatment with the cannabis pharmaceuticals must be reviewed regularly.

In Section 45, the G-BA also regulates the approval requirement for prescribing a medicinal cannabis product. The approval required for the first prescription may only be refused in justified exceptional cases. If a patient is treated as an inpatient or is receiving general outpatient palliative care with cannabis pharmaceuticals, the health insurance provider has three days to decide whether to approve it. In the case of specialized outpatient palliative care no approval is required. Subsequent prescriptions, dose adjustments or changes to other varieties of dried cannabis flowers or other extracts in standardized form do not require renewed approval.

The G-BA did not set out any requirement in the AM-RL allowing only specialized physicians to prescribe medicinal cannabis products. Hence, all physicians remain entitled to prescribe.

Statement

The main difference from the previous regulatory situation is in the prescription procedure, in which the doctor must first consider whether finished pharmaceuticals containing cannabis should be prescribed. A preferred use of dried flowers must be justified in this context.

It remains to be seen whether this justification requirement will reduce the rejection rates of the health insurance companies from the current 30-40% with regard to approval. However, this seems unlikely, since even before the new regulation, the health insurer could only refuse approval in justified exceptional cases.