Germany has today voted to ban medical cannabis flower from its statutory health insurance scheme, in a controversial move critics say will have an outsized impact on the ‘seriously ill’.
Provisions embedded in a broad health insurance savings package, the GKV-Beitragssatzstabilisierungsgesetz, passed through the Bundestag today (July 10) will mean medical cannabis flower is no longer reimbursed, while patients seeking extract cover must first undergo a mandatory six-month course of an approved cannabis-based finished medicine.
In an attempt to reduce costs for insurance companies, the industry association and the medical profession say the legislation will increase costs in the end, leaving patients without protection and pushing many back onto the illicit drug market.
Christiane Nubaur, Managing director of Verband der Cannabis versorgenden Apotheken VCA, wrote in a LinkedIn post: “Many cannabis prescription medications are not approved for these indications. The blanket priority of six months for completed medicinal products may create significant access barriers, if the finished product is not authorised for that specific indication.
What is happening?
The GKV-Beitragssatzstabilisierungsgesetz is primarily a broad savings package for Germany’s statutory health insurance system, the GKV, which covers approximately 90% of the population. Cannabis appears in one clause, the amendment to §31 Abs. The GKV is defined in Section 6 of Social Code Book V.
It was a conditional provision that allowed patients who had a severe illness to have cannabis, both in flower and extract form, or the pharmaceuticals dronabinol or nabilon. The new §31(6) simply removes flowers. The new SS31(6) does not provide for any transition arrangements and there is no alternative provision.
It is now more difficult for patients to get their hands on what remains, which are extracts and the dronabinol. Before any GKV extract claims are valid, the provision has been amended to state that the treating doctor must prescribe a finished cannabis medicine approved by GKV for a 6-month trial.
Patients can claim reimbursement only if they have completed the test or met all the legal requirements. Conditions for eligibility remain unchanged. There must be an illness that is serious and for which the standard of care cannot or will not work.
Original government bill did not include the six-month window. The Cabinet Draft (BT-Drucksache, 21/6130), removed flowers from the bill but did not address a priority rule for finished medicine. That provision appeared in a coalition Änderungsantrag, an amendment tabled by the governing parties in the Gesundheitsausschuss, and was incorporated into the committee’s final recommendation (BT-Drucksache 21/7016) on 8 July, two days before the Bundestag vote.
The four completed medicines that must be tested in the 6-month test are:
- Sativex approved to treat spasticity associated with multiple sclerosis
- Epidyolex is approved for severe epilepsy
- Canemes approved for nausea and vomiting related to chemotherapy
- Exilby is a Vertanical full spectrum extract approved for chronic backache in June 2026. It’s still being negotiated with the Federal Joint Committee, and hasn’t yet been listed on reimbursement market.
The prescription of one or more of the four approved products for a purpose other than their intended use is an “off-label” usage, which requires separate GKV authorization and clinical support. Most cannabis patients who do not have conditions that match the specific labeling of those products will need to undergo an obligatory trial with a drug they’re not approved for.
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The law of savings may be more expensive
The policy’s logic was directly attacked by the industry. Michael Greif, Managing Director of the Bundesverband Cannabis Wirtschaft (BvCW), said the reform ‘completely misses its actual objective.’
The costs of health insurance will probably rise, not fall. Individual compounded medicines are more cost-effective than finished medications. He explained that the autonomy of doctors in medical cannabis is also severely restricted.
BfArM results from a national survey found that 75.4% of GKV prescriptions were for chronic pain. Exilby, however, is only approved as a treatment option.
Patients would be forced to take a test product off-label. They’d also have to justify their choice with separate GKV approvals and clinical evidence.
Kathrin Konyen said, Medical Cannabis Sector lead at BvCW: The absence of any protection for mid-treatment patients is a major concern. “A blanket prioritization for finished drugs forces doctors into rigid treatment schemes, creates more bureaucracy and threatens to harm the success of the treatments.
“Therapy decisions must be oriented to individual medical needs – not blanket requirements. Medically, a priority is only sensible when there are approved, available, and non-medical objections to the treatment of a specific disease.
GKV expenditure on medical cannabis totalled approximately €205 million in 2025, covering flowers and extracts combined, according to GKV Gamsi quarterly data cited by the BvCW. That figure sits against a projected structural GKV funding gap of up to €40 billion by 2030, making cannabis a marginal line in the savings calculus, while risking cost substitution upwards through higher-priced finished medicines.
Antonia Menzel, Chairwoman of the Bundesverband pharmazeutischer Cannabinoidunternehmen (BPC), told Krautinvest The math does not back up the goal. This amendment does not save one euro, on the contrary. The amendment forces doctors to prescribe six-month preparations that are more costly per month of treatment than the standard formula, and which may not be approved by most medical professionals. “This is totally out of place for a law that aims at stabilising contribution rates.”
What comes next
This legislation is classified as nicht zustimmungspflichtig. Germany’s upper chamber can, however, refer it to a mediation committee (Vermittlungsausschuss), a process that could delay implementation and reopen the cannabis provisions for revision.
The BvCW has written to the Länder urging them to take that route, with three specific demands. The BvCW has written to the Lander urging them to take that route, with three specific demands.
Vertanical’s current price negotiations will also be watched closely. Exilby remains the only approved treatment for most chronic pain patients.
Germany has today voted to ban medical cannabis flower from its statutory health insurance scheme, in a controversial move critics say will have an outsized impact on the ‘seriously ill’.
Provisions embedded in a broad health insurance savings package, the GKV-Beitragssatzstabilisierungsgesetz, passed through the Bundestag today (July 10) will mean medical cannabis flower is no longer reimbursed, while patients seeking extract cover must first undergo a mandatory six-month course of an approved cannabis-based finished medicine.
Despite the fact that it was designed to reduce costs for insurance companies, medical associations, along with industry groups, say the legislation will increase costs in the end, leaving patients without any protection and pushing many of them back onto the black market.
Christiane Nubaur, Managing director of Verband der Cannabis versorgenden Apotheken VCA, wrote in a LinkedIn post: “Many cannabis prescription medications are not approved for these indications. If there are no approved finished products for a specific indication, then a blanket six-month prioritisation of finished medicines can create substantial access barriers.
What is happening?
The GKV-Beitragssatzstabilisierungsgesetz is primarily a broad savings package for Germany’s statutory health insurance system, the GKV, which covers approximately 90% of the population. Cannabis appears in one clause, the amendment to §31 Abs. The GKV is defined in Section 6 of Social Code Book V.
The prior version of this provision allowed patients who had a serious disease to have cannabis, both in flower and extract form, along with the nabilon and dronabinol pharmaceutical ingredients, provided they met certain conditions. The new §31(6) simply removes flowers. The new SS31(6) does not provide for any transition arrangements and there is no alternative provision.
It is now more difficult for patients to get their hands on what remains, which are extracts and the dronabinol. According to the amended provisions, before an extract claim can be valid under GKV a treating physician has to prescribe a cannabis-containing medicine that is approved for six months of therapeutic trials.
Patients can claim reimbursement only if their trial has been completed or the legal conditions have been met. Conditions for eligibility remain unchanged. There must be an illness that is serious and for which the standard of care cannot or will not work.
The government did not originally propose the gateway of six months. The Cabinet Draft (BT-Drucksache, 21/6130) did away with flowers and said nothing of a completed-medicine rule. That provision appeared in a coalition Änderungsantrag, an amendment tabled by the governing parties in the Gesundheitsausschuss, and was incorporated into the committee’s final recommendation (BT-Drucksache 21/7016) on 8 July, two days before the Bundestag vote.
Four finished drugs are being tested for the trial of six months.
- Sativex approved to treat spasticity associated with multiple sclerosis
- Epidyolex is approved for severe epilepsy
- Canemes approved for nausea and vomiting related to chemotherapy
- Exilby is a Vertanical full spectrum extract approved for chronic backache in June 2026. It’s still in negotiations over price with the Federal Joint Committee, and hasn’t yet been listed on reimbursed markets.
The prescription of one or more of the four approved products for a purpose other than their intended use is an “off-label” usage, which requires separate GKV authorization and clinical support. Most cannabis patients who do not have conditions that match the specific labeling of those products will need to undergo an obligatory trial with a drug they’re not approved for.
READ MORE…
The law of savings may be more expensive
The policy’s logic was directly attacked by the industry. Michael Greif, Managing Director of the Bundesverband Cannabis Wirtschaft (BvCW), said the reform ‘completely misses its actual objective.’
The costs of health insurance will probably rise, not fall. Individual compounded medicines are more cost-effective than finished medications. He explained that the autonomy of doctors in medical cannabis is also severely restricted.
BfArM conducted a national survey to determine the prescription of GKV marijuana. The results showed that 76.4% patients had chronic pain, for whom Exilby is approved, but it has not yet been reimbursed.
Patients would be forced to take a test product off-label. They’d also have to justify their choice with separate GKV approvals and clinical evidence.
Kathrin Konyen said, Medical Cannabis Sector lead at BvCW: The absence of any protection for mid-treatment patients is a major concern. “A blanket prioritization for finished drugs forces doctors into rigid treatment schemes, creates more bureaucracy and threatens to harm the success of the treatments.
“Therapy decisions must be oriented to individual medical needs – not blanket requirements. Priority would be medically sensible only if there is an available and approved preparation for the particular illness and no objections are made.
GKV expenditure on medical cannabis totalled approximately €205 million in 2025, covering flowers and extracts combined, according to GKV Gamsi quarterly data cited by the BvCW. That figure sits against a projected structural GKV funding gap of up to €40 billion by 2030, making cannabis a marginal line in the savings calculus, while risking cost substitution upwards through higher-priced finished medicines.
Antonia Menzel, Chairwoman of the Bundesverband pharmazeutischer Cannabinoidunternehmen (BPC), told Krautinvest The math does not back up the goal. This amendment does not save one euro, on the contrary. The amendment forces doctors to prescribe six-month preparations that are more costly per month of treatment than the standard formula, and which may not be approved by most medical professionals. It is totally out of place for a law that aims to stabilize contribution rates.”
What comes next
This legislation is classified as nicht zustimmungspflichtig. Germany’s upper chamber can, however, refer it to a mediation committee (Vermittlungsausschuss), a process that could delay implementation and reopen the cannabis provisions for revision.
The BvCW has written to the Länder urging them to take that route, with three specific demands. The BvCW has written to the Lander urging them to take that route, with three specific demands.
Vertanical’s current price negotiations will also be watched closely. Exilby remains the only approved treatment for most chronic pain patients.
Cannabis Law Resources in Poland
Discover essential legal information about the cultivation of cannabis, its sale, and regulations governing medical products in Poland. These guides will help you understand the legal requirements, such as certifications and permissions.
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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