The German government has passed a controversial law to save money that will reimburse tens and thousands of patients who were denied access to medical cannabis flower through the statutory health insurance.
The framework has been further thrown into chaos by a tug-of war between doctors, health funds and patient groups.
The fissures between the country’s statutory insurance physicians and the health funds have opened up after an August move softening the most contested provisions, the mandatory 6-month finished-medicine-trial, which was then reversed.
The decision on how to treat the approximately 65,000 patients who are cannabis users rests now with a minister that has not yet made a ruling.
Chaos for weeks
The Statutory Health Insurance Contribution Rate Stabilisation Act (GKV-Beitragssatzstabilisierungsgesetz), a broad financial bill designed to reduce the country’s ballooning insurance deficit, officially took effect on July 30.
This took dried flowers out of statutory reimbursement, and required a six month trial for finished medicine before extracts such as dronabinol and nabilone can be prescribed.
The KBV-Spitzenverband and the KBV issued a joint statement in August 2006 that softened this rule.
In a press release, they said that the trial period would only be required for indications in which a licensed finished medicine is available. Patients who are already using extracts will not have to undergo this test. Industry and pharmaceutical groups welcomed the move.
In a press statement, Philip Schetter said, “The clarification brings legal certainty to physicians and patients alike.” “Continuity in treatment is essential to reliable medical care.”
In fact, after a closer look, the KBV has changed its position. This week, it said that it now believed a cannabis finished medicine must be tried first in every case, even when it is not approved for the patient’s condition, which would mean prescribing ‘off-label’ medicines.
In practice, the insurers will reimburse this only in extreme cases. Sativex is approved for MS spasticity. Epidyolex is approved for certain epilepsies. Canemes is approved for chemotherapy nausea. And Exilby, for chronic back pain, can be prescribed by insurers.
Two exceptions remain. Patients who already take flower or extracts won’t be affected. The doctor can use an extract if the final medicine does not work or the patient is unable to tolerate it. This allows him to avoid having to go through the entire six-month trial period.
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Pharmacists push back
This policy maelstrom complicates an already difficult situation, which pharmacists say is unworkable. The funds are not covering the costs of high-concentration extracts that can be used to replace flower.
That leaves pharmacies exposed to ‘clawback’. After a pharmacy has purchased and distributed an expensive extract, it can be denied payment by the insurance company and left to bear the cost. This risk makes many pharmacists wary about supplying. Individual funds and regional doctors’ associations have drawn contradictory results from the same rule.
Felix Maertin of the Karlsruhe pharmacy who supplies many cannabis patients with severe illnesses has given KBV-Spitzenverband and KBV a 14-day deadline to answer 15 specific questions and make a public statement, such as whether or not they exclude any extract exceeding 25% THC from reimbursement.
“Patients must have a solution right now, not months later or after the social court rulings,” said he. Another pharmacist has called for a constitution complaint. And a patient-led initiative is gathering video testimony that will be presented to politicians.
Separately the Arbeitsgemeinschaft Cannabis als Medizin is already pursuing an constitutional complaint against the Karlsruhe law.
In order to put the cannabis reimbursement question in context, let’s briefly examine Germany’s GKV financing gap. According to GKV’s latest statistics, the spending on cannabis rose by 8% between 2024-2025. However, contributory income only increased by 5%.
As costs continued to outpace contributions, the central health fund (Gesundheitsfonds) posted a combined deficit of nearly €10 billion in 2024, while reserves fell below the statutory minimum, and the health fund’s liquidity had to be propped up with a federal loan.
By 2030, Germany would be facing a structural gap of up to €40bn. By slashing flower from GKV, the government hoped to save roughly €130m, roughly one three-hundredth of the hole. Even at its most generous reading, which includes the additional reductions to extracts the savings would still only amount to 0.5%.
The window for finished medications
A rule that requires a completed-medicine test first, even if it is off-label will increase the number of patients who are exposed to these products.
Vertanical is launching Exilby (a full-spectrum, non-neuropathic extract) in September. Sativex has only been licensed for spasticity associated with multiple sclerosis.
Exilby was the first choice for only a small percentage of patients with pain under the reading from August 2006. According to the KBV, it is now mandatory that a medicine be used regardless of its indication. Exilby and the Federal Joint Committee have not yet agreed on a reimbursement price.
Pharma Deutschland, Germany’s largest association of the pharmaceutical industry, warned earlier that the law at the heart of the issue was to blame. Its chief executive, Dorothee Brakmann, said the legislation had, ‘through its one-sided focus on short-term savings, caused operational problems that then had to be caught by interpretive notes and subsequent clarifications’, and predicted a further statutory correction would be needed.
Brakmann’s predictions have been confirmed by the chaos of recent weeks.
What happens next?
For the time being, Germany’s medical marijuana framework is based on contested interpretaions rather than established rules. The question is whether BMG will side with KBV or its earlier interpretation and move quickly to prevent patients, prescribers and pharmacists from experiencing more uncertainty.
The constitutional challenge of the ACM continues. And the concern raised by the insurers in the spring that a law intended to save money might not be able to do so as patients move to reimbursed options, is still unresolved.
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The German government has passed a controversial law to save money that will reimburse tens and thousands of patients who were denied access to medical cannabis flower through the statutory health insurance.
The framework has been further thrown into chaos by a tug-of war between doctors, health funds and patient groups.
The fissures between the country’s statutory insurance physicians and the health funds have opened up after an August move softening the most contested provisions, the mandatory 6-month finished-medicine-trial, which was then reversed.
The decision on how to treat the approximately 65,000 patients who are cannabis users rests now with a minister that has not yet made a ruling.
Chaos for weeks
The Statutory Health Insurance Contribution Rate Stabilisation Act (GKV-Beitragssatzstabilisierungsgesetz), a broad financial bill designed to reduce the country’s ballooning insurance deficit, officially took effect on July 30.
The dried flower was removed from the statutory reimbursement and a six-month trial of finished medicines like dronabinol, or nabilone were required before they could be prescribed.
The KBV-Spitzenverband and the KBV issued a joint statement in August 2006 that softened this rule.
In their statement they said that the six-month mandatory trial would only apply to indications where a finished medicine is actually licensed. Patients already taking extracts will be exempted. The industry and pharmaceutical bodies praised the move.
In a press statement, Philip Schetter said, “The clarification brings legal certainty to physicians and patients alike.” The continuity of treatment is essential to a reliable medical service.”
The KBV’s position has been altered again after a closer look. This week, it said that it now believed a cannabis finished medicine must be tried first in every case, even when it is not approved for the patient’s condition, which would mean prescribing ‘off-label’ medicines.
In practice, the insurers will reimburse this only in extreme cases. Sativex, for MS spasticity; Epidyolex, for certain epilepsies; Canemes, for chemotherapy nausea; and Exilby, for chronic back pain, are the four cannabis-based medicines that have been approved by the FDA for specific indications.
There are still two exceptions. Patients who already take flower or extracts won’t be affected. If the medicine is not working or the patient cannot tolerate it, then the doctor can switch to an extract without having to wait the six-month period or try another finished product.
READ MORE…
Pharmacists push back
This policy maelstrom complicates an already difficult situation, which pharmacists say is unworkable. The funds are not covering the costs of high-concentration extracts that can be used to replace flower.
That leaves pharmacies exposed to ‘clawback’. After a pharmacy has purchased and distributed an expensive extract, it can be denied payment by the insurance company and left to bear the cost. This risk makes many pharmacists wary about supplying. In the meantime, regional doctors’ associations and individual funds are drawing different conclusions from the rules.
Felix Maertin is a pharmacist in Karlsruhe who supplies cannabis to many seriously ill patients. He has given KBV and GKV a deadline of 14 days for them to answer 15 questions, and provide a public explanation, including if they consider any extracts above 25% THC excluded from reimbursement, and on what basis.
“Patients must have a solution right now, not months later or after the social court rulings,” said he. Another pharmacist has called for a constitution complaint. And a patient-led initiative is gathering video testimony that will be presented to politicians.
Separately the Arbeitsgemeinschaft Cannabis als Medizin is already pursuing an constitutional complaint against the Karlsruhe law.
It’s important to briefly review the funding gap of Germany’s GKV in order to place cannabis reimbursements into perspective. According to GKV-Spitzenverband’s latest figures, both in 2024 and in 2025, expenditures rose by around 8%, but contributory income only grew about 5%.
As costs continued to outpace contributions, the central health fund (Gesundheitsfonds) posted a combined deficit of nearly €10 billion in 2024, while reserves fell below the statutory minimum, and the health fund’s liquidity had to be propped up with a federal loan.
By 2030, Germany would be facing a structural gap of up to €40bn. By slashing flower from GKV, the government hoped to save roughly €130m, roughly one three-hundredth of the hole. Even at its most generous reading and including the additional reductions to extracts the savings would still have only amounted 0.5% to the total deficit.
The window for finished medications
A rule that requires a completed-medicine test first, even if it is off-label will increase the number of patients who are exposed to these products.
Vertanical is launching Exilby (a full-spectrum, non-neuropathic extract) in September. Sativex has only been licensed for spasticity associated with multiple sclerosis.
Exilby was the first choice for only a small percentage of patients with pain under the reading from August 2006. According to the KBV, it is now mandatory that a medicine be used regardless of its indication. Exilby and the Federal Joint Committee have not yet agreed on a reimbursement price.
Pharma Deutschland, the largest association in the pharmaceutical industry of Germany, has already stated that the underlying legislation was the problem. Its chief executive, Dorothee Brakmann, said the legislation had, ‘through its one-sided focus on short-term savings, caused operational problems that then had to be caught by interpretive notes and subsequent clarifications’, and predicted a further statutory correction would be needed.
Brakmann’s predictions have been confirmed by the chaos of recent weeks.
What happens next?
Rather than a set of rules, Germany’s medical marijuana framework is based on contested interpretations. The key question is whether or not the Federal Ministry of Health will support the KBV’s stricter interpretation of the law, or the earlier joint reading, and if it will act quickly enough to avoid another round of uncertainty for patients, prescribers, and pharmacies.
The constitutional challenge of the ACM continues. And the concern that the insurers raised in spring that a law intended to save money might not be able to do so as patients move to reimbursed options, is still unresolved.
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This informative article is brought to you by Gen-Europa →
Cannabis Law Resources for Poland
Discover essential legal pages on cannabis cultivation, medical products, and sales in Poland. These resources guide you through certification, compliance, and permission requirements.
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Polish News Registration and Interests of Cannabis Businesses
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Permissions for Cannabis Sales in Poland
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Authorization for Importing or Manufacturing Medical Products
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Permission for Manufacturing or Importing Medical Products
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Certificate of Good Manufacturing Practices (GMP)
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Registration of Medical Products in Poland