Since 30 July 2026, dried cannabis flower is no longer prescribable at the expense of German statutory health insurance. Under Section 31(6) of the German Social Code Book V (SGB V), extracts of standardised quality as well as medicinal products containing dronabinol or nabilone remain reimbursable. Many patients must therefore be switched to an extract.

In this situation, one question has moved to the fore with considerable consequences for patient care: are cannabis extracts with a THC content above 25 per cent reimbursable? The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) says they are not, in its circular 2026/234; the National Association of Statutory Health Insurance Physicians (KBV) has adopted the same view. Individual health insurance funds are currently deciding inconsistently.

We have examined the pharmacopoeial classification of standardised cannabis extracts in a statement, and we are making our legal position transparent.

Two levels within the pharmacopoeias

The general monograph “Herbal Drug extracts” (Ph. Eur. 0765) of the European Pharmacopoeia defines the types of herbal extracts. Standardised extracts are adjusted to a defined content of one or more constituents with known therapeutic activity. This level does not provide for any upper or lower limit for that content.

The monograph “Eingestellter Cannabisextrakt” (standardised cannabis extract), specifying a range of 1 to 25 per cent THC, is by contrast a monograph of the German Pharmacopoeia (DAB). It describes one individual extract of that type. No European monograph for cannabis extracts exists to date; one is in preparation under the designation “Cannabis extractum spissum”.

Our legal position

Section 31(6) SGB V requires an “extract of standardised quality” and thus refers to a standardised extract as defined in the general monograph, not to the specification of one individual monograph. The Federal Joint Committee (G-BA) has moreover regulated the active-substance content independently: Section 44(2) of the Pharmaceuticals Directive sets a minimum content of 0.2 per cent THC; no upper limit is specified there.

In our legal view, a THC content above 25 per cent therefore does not preclude reimbursement. A conclusive legal determination is still outstanding. As a manufacturer, we are an interested party. Our analysis therefore rests solely on the pharmacopoeias and the relevant provisions; all references are set out in full in our statement.

Our request

We welcome the aim of establishing legal certainty for patient care, and we ask for a timely, technically substantiated clarification. Until then, we recommend applying for coverage from the health insurance fund in advance.

Documentation for healthcare professionals

We provide our full statement, including all references and suggested wording for applications and appeals, to members of the healthcare professions on request: service@becanex.com