The coalition is rolling back one of the most controversial cannabis regulations from the summer. The amendment has now been released in full text: CDU/CSU and SPD are limiting the priority of cannabis-containing finished pharmaceuticals to approved indications and removing the rigid six-month deadline for the preliminary therapy trial. The Health Committee recommended approval on October 14, and the Bundestag will decide on October 15. Until publication, the previous rule applies.
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What the coalition wants to change in the cannabis initial prescription rule
The amendment appears as amendment 11 from the CDU/CSU and SPD parliamentary groups in committee document 21(14)107 from October 5, 2026. It affects § 31 paragraph 6 of the German Social Code (SGB V) as amended by the GKV-Beitragssatzstabilisierungsgesetz, which has been in effect since July 30, 2026. Since then, statutory health insurance no longer covers cannabis flowers. Extracts, dronabinol, and nabilone remain reimbursable, but only after a therapy trial with an approved finished pharmaceutical.
The amendment replaces sentence 2 of the paragraph entirely. The new wording reads: „Outpatient medical care must initially be provided with a cannabis-containing finished pharmaceutical in the indication for which it is approved under pharmaceutical law, as part of a therapy trial.“ The decisive sentence in the justification states: the priority applies „thus only within the approved indication.“ Because the old sentence 2 is replaced, the six-month deadline disappears with it. The length of the therapy trial then lies within the physician’s discretion.
Meanwhile, the regulation has moved beyond the proposal stage. The Health Committee presented its recommendation for a resolution on October 14, 2026, document 21/8629, and the cannabis provision is included as item 2a. The committee recommends approval of the bill as amended, with the votes of CDU/CSU, SPD, and Alliance 90/The Greens, with AfD and Die Linke abstaining. Noteworthy is the Greens‘ approval, who have previously criticized the exclusion of flower reimbursement most sharply. They are thus supporting the correction to the prescription order, not the flower exclusion itself.
The obligation now explicitly applies only to so-called in-label use. This means use within an indication for which a finished pharmaceutical is approved. Outside the approval, meaning off-label use, physicians would retain their treatment freedom. Before writing a custom prescription, they would only need to check whether a suitable finished pharmaceutical is an option. The six-month minimum duration of the therapy trial is to be removed, so that physician discretion decides here too.
A response to the interpretation dispute between KBV and insurers
Politically, the step is primarily a reaction to the chaos following implementation. In early August, the German Medical Association and the GKV umbrella association jointly declared that the therapy trial applies only where a finished pharmaceutical is approved for an indication at all. Twelve days later, the KBV retracted this interpretation. We described how this happened in the article KBV withdraws its own cannabis clarification. Since then, the KBV demanded a finished pharmaceutical first in every case, even off-label, and called on lawmakers for clarification.
The planned wording essentially adopts the original joint interpretation from August. This is significant for the large group of pain patients. Sativex, Canemes, and Epidyolex are approved for narrowly defined indications; chronic pain is not among them. Under the previous KBV interpretation, practices would have had to prescribe one of these products off-label first, with all the liability questions that entails. Criticism of this situation came early from the expert community, such as from pain physicians calling for an end to regulatory chaos with prescription cannabis.
What won’t change for cannabis patients
As important as the correction would be for prescribing practice, the flower exclusion remains untouched. Dried cannabis flowers and preparations made from them have not been reimbursable by insurers since the end of July, and the amendment does not change this. Older approvals don’t help either, as the Leipzig Social Court ruled on old insurance approvals. Those hoping for a return of flower reimbursement will find no reason for it in the new plans.
One detail is worth examining closely. The justification exempts existing patients from the priority requirement with an indication-specific formulation: it applies only to patients who „have not yet been prescribed cannabis-containing medications for their current indication.“ Someone receiving a cannabis medication for years but developing a new indication would fall under the rule for that new indication. Protection of existing status is tied not to the person but to the indication.
The health insurance approval requirement also remains. The planned clarification does not provide free choice among all cannabis medications. It only specifies the order in which physicians must proceed. What role THC content plays in reimbursement is explained in our overview Extracts instead of flowers. The tension between treatment freedom and cost pressure is far from new, as our earlier text on Cannabis in law and health already shows.
The timeline: Hearing on October 7, vote on October 15
The correction is part of a larger package. The coalition is looking for additional savings to finance commitments from the protocol statement on the savings law. These include surcharges for university hospitals and changes in psychotherapy reimbursement. The Health Committee heard twelve amendments in total with expert testimony at its 58th session on October 7, 2026. They are not decided independently but attached to emergency care reform, document 21/6808. The Bundestag will decide on this on October 15 after a one-hour debate.
In the hearing, the GKV umbrella association and the German Medical Association welcomed the indication-based priority. The Association of Pharmaceutical Manufacturers called for standardized cannabis extracts as well as preparations with dronabinol and nabilone to remain available and for existing patient status to be explicitly anchored in the law rather than only in the justification. The German Hemp Association and the Association of German Cannabis Patients also submitted statements.
The procedure is nonetheless noteworthy. The coalition would be loosening a requirement that it itself wrote into a savings package via amendment just in the summer. When asked by the Greens, the federal government did not cite a study justifying exactly six months. It also expects no significant savings according to its own information. For practices and patients, the wording that actually appears in the Federal Law Gazette is what ultimately counts.
Frequently asked questions
Does the new rule on cannabis initial prescription already apply?
No. The amendment was heard in the Health Committee on October 7, 2026, the committee recommended approval as amended on October 14. The plenary vote is scheduled for October 15, 2026, together with the emergency care reform. Until publication in the Federal Law Gazette, § 31 paragraph 6 SGB V applies in its current form.
What does in-label use mean for cannabis medications?
In-label use means that a finished pharmaceutical is used precisely in the indication for which it is approved. Sativex, for example, is approved for spasticity in multiple sclerosis. Only in such cases should the preliminary therapy trial become mandatory in the future.
Must the therapy trial with a finished pharmaceutical last six months?
Under current law, a six-month trial is provided, but it can end earlier in cases of ineffectiveness or intolerance. The amendment removes the fixed duration. The treating physician then decides how long a trial makes sense. The justification explicitly states that continued prescription of an ineffective or intolerable preparation is „not appropriate.“
Will patients get cannabis flowers on insurance prescription again because of this?
No. The elimination of flower reimbursement is a separate intervention and will not be reversed by the planned amendment. The correction affects only the order for extracts, dronabinol, and nabilone.
What applies to existing patients?
Anyone already receiving dronabinol, an extract, or a custom preparation does not need to switch to a finished pharmaceutical. The amendment’s justification makes this clear, but formulates protection of existing status on an indication-specific basis: the priority requirement applies only to patients who have not yet been prescribed a cannabis medication for their current indication. If a new indication is added, the rule applies to that one. Comprehensive documentation of ongoing therapy therefore remains important.
Sollten Ärzte Cannabis frei verschreiben dürfen oder Fertigarzneimittel bevorzugen?
Sources: German Bundestag, Health Committee, committee document 21(14)107 from 05.10.2026, amendments 1 through 12 from CDU/CSU and SPD parliamentary groups to the bill for emergency care reform (document 21/6808), including amendment 11; public hearing of the Health Committee, 58th session from 07.10.2026; recommendation for resolution and report from the Health Committee, document 21/8629 from 14.10.2026 (advance version); German Bundestag, document 21/8148 from 23.09.2026; Deutsches Ärzteblatt, 29.09.2026.
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