The Greens want to know from the federal government how the priority for cannabis-containing finished pharmaceuticals made it into the law. 28 questions, submitted on August 26, target memos, contacts, and the approval process for Exilby. We have read the inquiry and provide context on what it can and cannot achieve.
📑 Inhaltsverzeichnis
- How the regulation made it into law
- The figure that contradicts the cost-saving rationale
- Why Exilby is at the center
- Two six-month periods that overlap
- Approval and benefit assessment are two different procedures
- What Der Spiegel reported and what we could verify
- The manufacturer’s counterposition
- What a written inquiry can accomplish
- What matters now for those affected
- 💬 Fragen? Frag den Hanf-Buddy!
Since July 30, statutory health insurance no longer covers cannabis flowers, and extracts are only reimbursed after a six-month trial with an approved finished pharmaceutical. On September 1, Exilby came to market—the preparation that practically fills this new rule. A week earlier, the parliamentary group Alliance 90/The Greens submitted a written inquiry addressing the very origins of this regulation.
The document is publicly accessible under Bundestag document 21/7743, dated August 26, 2026. It is signed by, among others, Paula Piechotta, Linda Heitmann, Janosch Dahmen, and Kirsten Kappert-Gonther. We have read the original because the summaries currently circulating truncate the essentials.
How the regulation made it into law
The procedure is the actual core of the inquiry, and it is remarkable. Just days before the final vote on the GKV Contribution Rate Stabilization Act, the governing coalition submitted 64 amendments. Amendment number 52 contained the new wording of Section 31, Paragraph 6 of the German Social Code (SGB V)—the finished pharmaceutical priority. The Bundestag and Bundesrat passed the package on July 10, 2026, and it was published in the Federal Law Gazette on July 29.
A regulation that fundamentally changed therapy for tens of thousands of people thus did not come through the original bill but through one of 64 amendments shortly before the vote. This is permissible under parliamentary procedure and hardly unusual. However, it substantially shortens the time for consultation and hearing, and that is what the inquiry targets. Question 1 asks on whose initiative the amendment was introduced and when it was first proposed. Question 2 requests memos, statements, emails, and meeting notes from the Health Ministry.
The figure that contradicts the cost-saving rationale
The priority was justified on the grounds that approved finished pharmaceuticals represent the more appropriate form of care compared to unlicensed preparations. At a public hearing on June 22, 2026, Josef Hecken, then neutral chair of the Joint Federal Committee, recommended the six-month trial therapy in response to a question from MP Stephan Pilsinger, citing the „very high“ costs of pharmacy-prepared formulations by comparison.
The inquiry counters this rationale with a cost comparison from AOK based on Lauer-Taxe data from March 2025. According to this data, one month of therapy with the finished pharmaceutical Canemes costs approximately €1,372, while the therapeutically equivalent dronabinol formulation costs €92 to €117—less than one-tenth.
This comparison is the document’s strongest point because it tests the cost-saving logic at its foundation. However, it concerns Canemes, not Exilby, and it dates from spring 2025. Anyone reading it as evidence that the priority increases costs overall goes beyond what the figures support. As a question directed at lawmakers, it is nevertheless justified, and that is precisely how the parliamentary group poses it in Questions 3 and 17.
Why Exilby is at the center
Four cannabis-containing finished pharmaceuticals are currently approved in Germany: Canemes, Epidyolex, Exilby, and Sativex. Among these, Exilby is the only full-spectrum extract, and with approval granted on May 30, 2026, for chronic lower back pain with neuropathic component, it covers the broadest indication.
Thus the inquiry describes the exact constellation at issue: at the time the law was changed, precisely one preparation was about to enter the market that could widely fulfill the new priority rule. This does not constitute an accusation, and the parliamentary group formulates none. Instead, it asks about the considerations underlying the regulation.
Two six-month periods that overlap
A detail has gone unnoticed in the debate so far, and it follows directly from the inquiry. Patients must trial a finished pharmaceutical for six months before a formulation is reimbursed. Simultaneously, for a newly approved medicine under the AMNOG procedure, the manufacturer sets the distribution price freely during the first six months after market entry. Only thereafter is a reimbursement amount negotiated.
Both periods run largely in parallel for Exilby. The statutorily mandated trial period thus falls precisely within the window when the price has not yet been negotiated. We have explained how this procedure works in our article on price formation via AMNOG, and what this means for the current price debate is covered in our analysis of why the price is not yet fixed. Questions 18 and 19 are aimed at whether the federal government even knew or based price assumptions for Exilby before passing the law.
Approval and benefit assessment are two different procedures
Here, a distinction is worth making—one that is absent from almost every summary of recent days and without which the debate skews.
- Approval is granted by the Federal Institute for Drugs and Medical Devices. Quality, efficacy, and safety for the requested indication are examined. The question is: Does the drug work and is it sufficiently safe?
- Benefit assessment is subsequently conducted by the Joint Federal Committee. The added benefit compared to appropriate comparative therapy is examined. The question is: Is it better than what already exists, and what should it therefore cost?
A preparation can thus be approved yet lack demonstrated added benefit. This is not a contradiction but the normal division of labor between two procedures. Anyone who conflates the two and immediately concludes a scandal from scientific doubts in the approval process undermines their own criticism. Conversely, however, anyone citing the granted approval has said nothing about added benefit.
What Der Spiegel reported and what we could verify
Der Spiegel, citing internal documents, reported that the professional staff at the Federal Institute expressed substantial scientific doubts about Exilby’s benefit; a case officer noted that the approval recommendation relied exclusively on a verbal directive from senior management. Prior to this, Bavarian Prime Minister Markus Söder and then-Federal Health Minister Nina Warken had visited the company.
At this point we are obliged to be transparent. The article is behind a paywall, and we do not have access to the internal documents. We therefore could not independently verify these claims and report them exclusively as Spiegel reporting. This is a serious allegation against a federal authority, and such allegations deserve careful source attribution rather than being repeated as established fact.
What is verifiable, however, is that the written inquiry addresses exactly this complex officially and considerably more precisely than the public debate does:
- Question 25 asks whether the Federal Institute informed the Health Ministry of open scientific or regulatory questions during the approval process, and if so, when and what they contained.
- Question 26 asks whether approval was conditional or subject to special provisions under Section 28 of the Medicines Act and on what grounds.
- Question 23 requests information about conversations and contacts between department, division, or higher management levels with representatives of Vertanical GmbH and FUTRUE GmbH, including names, timing, and key topics.
- Question 28 asks whether, given the particular market position of individual manufacturers, special transparency or compliance measures were considered to avoid conflicts of interest.
Should there be substance to Der Spiegel’s account, it should emerge in the answers to these questions. This makes the inquiry the actual test, regardless of how one evaluates the reporting.
The manufacturer’s counterposition
Vertanical founder Clemens Fischer rejects the allegations. He states that his party donations had no influence on legislation because the priority for finished pharmaceuticals had been decided by authorities years earlier. Regarding the donations themselves, we conducted research in July, distinguishing what is documented from what remains speculation: Fischer donated a total of €560,000 before the 2024 federal election—€200,000 to the CSU, €200,000 to the FDP, €100,000 to the SPD, and €60,000 to the CDU. The donations were legal and properly reported in financial statements. A causal link to the legislative change, however, is not documented. The details are in our article about who profits from the finished pharmaceutical advantage.
For Exilby itself, a substantive argument can be advanced: the preparation underwent a regular approval procedure and is based on randomized controlled trials. Whether this justifies the specific design of the priority is a different question—and it is the one the inquiry asks.
What a written inquiry can accomplish
Here too, sober assessment is worthwhile, as expectations are often too high. A written inquiry obligates the federal government to respond, typically within two weeks, and the response is published as a Bundestag document. It thus compels disclosure and creates a citable document.
What it cannot do: change a law, review an approval, or force the disclosure of internal memos. The government can also limit information under reference to ongoing procedures, trade secrets, or the core realm of executive responsibility. For Questions 2, 23, and 25 especially, such limitations are to be expected. The gain in knowledge often lies in what the government does not answer.
At editorial deadline, a response from the federal government had not yet been published. We will analyze it as soon as it is made public.
What matters now for those affected
Two of the 28 questions directly concern access to care. Question 13 asks about provisions for people already well-established on cannabis extracts—specifically about grandfathering, and explicitly why such provisions may not exist. Question 10 asks what applies when no suitable or tolerable finished pharmaceutical is available for an indication.
This is precisely the point on which the Frankfurt Social Court ruled in August when it rejected an emergency appeal without transitional provisions. Specialist associations for pain medicine also sharply criticize the regulatory situation, and the Working Group Cannabis as Medicine is collecting signatures for a petition to the Bundestag. The parliamentary inquiry is thus not the only route available, but it is the only one that compels the federal government to respond.
This changes nothing about the legal situation in the short term. For ongoing treatment, what matters is what is discussed with the treating physician.
Note: This article reflects the status as of September 2, 2026, and does not constitute medical or legal advice. Information about internal documents of the Federal Institute for Drugs and Medical Devices comes from Spiegel reporting and could not be independently verified by us; we report it as third-party information. A causal link between party donations and the legislative change is not established. It does not replace medical consultation. Decisions about therapy in individual cases are made by the treating physician; ongoing treatments should not be changed without medical advice.
Sollten Cannabisblüten weiterhin von der Kasse bezahlt werden?
Sources: Written inquiry of the parliamentary group Alliance 90/The Greens, Bundestag document 21/7743 from August 26, 2026 (advance version, evaluated in original); GKV Contribution Rate Stabilization Act, Bundestag document 21/6130 and committee document 21(14)97; Federal Law Gazette from July 29, 2026; public hearing of the Health Committee from June 22, 2026; AOK cost comparison based on Lauer-Taxe, March 2025 status, cited after document 21/7743; Drug information system AMIce of the Federal Institute for Drugs and Medical Devices; Spiegel from August 27, 2026 (behind paywall); APOTHEKE ADHOC; own reporting.
Branchen-Update
News, Analysen und Reportagen — mehrmals im Monat direkt in dein Postfach.
Folge uns
