A company in Munich built what Israel, Canada and the UK never managed. Then a last-minute amendment cleared the ground in front of it.
by Falk Altenhöfer
In 2019 I went to Israel. CannaTech, iCAN, the whole scene in Tel Aviv, which back then was the closest thing this industry had to a serious research culture. That trip is the reason Cannabis-Startups.com exists.
Everybody there was talking about how to get people high. So I went to the researchers to really understand the plant. The solution: a real drug. A proper phase three, a proper regulatory dossier, a marketing authorisation from a serious agency, and an indication big enough that it would change how doctors think rather than how investors pitch. Israel was going to do it. Then Canada was going to do it. Then the UK. For seven years the answer was always eighteen months away.
It happened this year, and it did not happen in Tel Aviv or Toronto. It happened in Munich.
And within days of the launch, the story about how it got there became the more important one.
What Exilby is
Exilby is a standardised full-spectrum cannabis extract, developed as VER-01 by Vertanical GmbH near Munich. The German federal medicines agency, the BfArM, granted it a marketing authorisation at the end of May for chronic low back pain with a neuropathic component. The parliamentary record gives 30 May as the date of grant [1]; it was reported publicly on 9 June [2]. The authorisation itself is retrievable in the agency’s medicines database [3].
The indication is the ambitious part. Chronic low back pain is one of the largest undertreated conditions in Europe, and the incumbent therapy is a class of drugs everyone in medicine would like to prescribe less of. Vertanical has said for years that displacing opioids is the goal [4], and its founder has said he wants Exilby established as the leading therapy for chronic pain by 2030 [5].
Of the four cannabis-containing finished medicines approved in Germany, Canemes, Epidyolex, Exilby and Sativex, Exilby is the only full-spectrum extract and carries the broadest indication of any of them [1].
Vertanical points to two studies in which the product showed a significant reduction in pain [5].
For ten years this industry promised a pharmaceutical outcome and delivered distribution agreements. On paper, this is the outcome.
What Der Spiegel found
On 27 August, Sven Becker and Hannes Munzinger published an investigation in Der Spiegel based on internal documents from the approval procedure [5]. Their reporting describes political interest in the progress of that procedure, and doubts at the technical level of the agency about the drug’s benefit. All of the following comes from that reporting.
A caseworker at the BfArM wrote in February that the proposed approval rested exclusively on a verbal instruction from the agency’s leadership, a “Vorgabe der Hausleitung”, that an authorisation had to be issued in this procedure, and that the decision could not be justified plausibly on scientific grounds. A person familiar with the process told the magazine that on the technical assessment alone the agency would not have granted the licence.
The surrounding timeline as reported: shortly before Christmas 2025 the Bavarian minister president visited Vertanical and praised the group publicly. In October 2025, ahead of that visit, the BfArM president is reported to have told staff that he would have to answer questions about the status of the procedure and that the federal health ministry wanted to be kept informed. In March the then federal health minister visited the company at the invitation of the CSU group in the Bavarian state parliament, and her officials had asked the agency in advance about the status of the application. Two months later the authorisation was granted.
Everyone named denies improper influence. The BfArM says the decisive question in any approval is whether the statutory requirements are met, and that the Exilby decision rests on a comprehensive scientific evaluation of the documents submitted by the applicant. Asked again by the pharmacists’ trade paper Deutsche Apotheker Zeitung, the agency rejected any political influence on the technical assessment or on the decision, and stated specifically that there was no contact during the procedure between its president and the Bavarian minister president or staff of the Bavarian State Chancellery [18]. The Bavarian State Chancellery also denies interference. Vertanical declines to comment on internal assessments at the agency and points to its trial results.
The agency has also said it will publish a Public Assessment Report for Exilby in the coming weeks, setting out the evidence of efficacy and the course of the procedure [18]. That document is now the most consequential thing anyone in this sector will read this autumn.
I have not seen those documents. I am relying on the reporting of two journalists at a publication with the resources to verify them, and I am reporting the denials alongside. But this is now the central question, and it is a different one from what the industry was arguing about a week ago. It is no longer only whether the market was tilted after the licence. It is whether the licence itself was decided on the science.
The part that is almost funny, if you have been here long enough
For as long as I have worked in this field, the standing objection to cannabis as medicine was that it cannot be measured properly.
Too many active compounds interacting at once. Too much variation between plants and between batches. An endocannabinoid system that responds differently in every patient, with feedback loops nobody has fully mapped. Effects that patients describe in language no endpoint captures cleanly, and that are hard to separate from expectation. Every time someone in this sector cited a patient survey, the reply was the same: that is subjective, come back with a trial.
So the whole field agreed on what the answer had to look like. Standardise the extract. Fix the dose. Run a randomised, placebo-controlled trial with a hard endpoint in a serious indication. Submit the dossier. Then let an independent regulator, with no interest in the outcome, decide whether the data holds.
That was the knighthood. Not a commercial win, an epistemic one. The moment cannabis stopped being a matter of opinion.
Exilby was supposed to be that moment.
And now the part of the process that was designed to be immune to subjectivity, the scientific assessment inside the agency, is the part reported to have been overridden by an instruction from above. If the reporting holds, the science was the one thing this company could have won on cleanly, and it is the political route that is in question instead.
Here is what I have had to accept after seven years of covering this. A finished medicine does not automatically mean a different kind of company. The donations are documented. The political attention around the approval is documented. The questions about political contacts remain unanswered. Which makes this, in the end, another cannabis story rather than the one that ended them, and the disappointment is not that a pharmaceutical company behaved like a pharmaceutical company. It is that we had all agreed this was the route out.
Amendment No. 52
The second part of the story is about reimbursement, and it is documented in full in the public record.
On 22 June the Bundestag health committee held its hearing on a health insurance cost-containment bill. The Munich CSU member of parliament Stephan Pilsinger asked how the priority of finished medicines could be underlined more strongly and made binding. Josef Hecken, at the time chairman of the Federal Joint Committee, answered by proposing a minimum six-month treatment attempt with a finished medicine before pharmacy preparations are used, and referred to full-spectrum extracts among the preferred products. The hearing is on the record [6].
The health ministry’s own draft contained no such rule [5]. Days before the vote, the coalition tabled a package of 64 amendments. Number 52 rewrote section 31(6) of the social code. On 10 July both chambers passed it, and it entered into force on 30 July [1] [7].
Dried cannabis flower is now out of statutory reimbursement entirely, affecting around 65,000 patients according to the Association for Cannabis as Medicine [8]. And a new patient must complete a six-month trial on an approved finished medicine before an extract or a compounded preparation is reimbursed.
Hecken left office on 30 June, eight days after the hearing [9].
The number that breaks the official reasoning
Amendment No. 52 was justified on the grounds that approved finished medicines are the more appropriate form of care and that compounded preparations are expensive.
The Green parliamentary group has put that against the payers’ own figures. In a parliamentary question tabled on 21 August, they cite a cost comparison published by the statutory insurer AOK, based on the official German drug pricing database as of March 2025. A month of therapy with the finished medicine Canemes costs 1,372 euros. The compounded dronabinol preparation with the identical active ingredient costs between 92 and 117 euros [1] [10].
Less than a tenth. Inside a law whose stated purpose is to cut statutory health insurance spending.
What everyone says
Pilsinger says he had no contact with Vertanical at any point, that his question reflected his own professional position, and that he had no knowledge of the party donation [5].
Hecken says the staged therapy concept was his own idea and is common practice in many areas, including on economic grounds. He says he took part in two meetings with Vertanical during the approval procedure, that this is normal, and that it did not change the position of his committee [5].
Vertanical has left questions about political contacts unanswered, and responsibility for the passage is disputed between the health ministry and the governing parliamentary groups [5].
The founder’s holding company donated 200,000 euros to the CSU during the federal election campaign, along with 200,000 to the FDP, 100,000 to the SPD and 60,000 to the CDU. The company says the donations were transparent, made in accordance with the law, and intended to support the parties of the political centre [5] [11].
Georg Wurth of the German Hemp Association has said publicly that it looks as though someone bought a monopoly for their product from the parties for half a million euros, at the expense of the insured. That is his assessment and not an established fact [9] [11]. The Green member of parliament Paula Piechotta has said that thousands of patients are losing their pain medication while a single entrepreneur with conspicuous party donations benefits [5].
Vertanical’s own argument, which deserves to be heard
On 20 August the company published the donation figures itself, before the Spiegel investigation appeared: 560,000 euros from FUTRUE GmbH ahead of the 2025 federal election, 200,000 each to the CSU and the FDP, 100,000 to the SPD, 60,000 to the CDU, described as support for the parties of the political centre [18].
On the substance of the new rule, the company’s position is that it continues a long-standing regulatory direction rather than breaking with one. It points to the BfArM’s own 2022 evaluation of cannabis prescribing, in which the agency described the reimbursement of unapproved preparations as a break in the logic of the medicines system, a “Systembruch in der Arzneimittelversorgung”, and argued that the goal must be to make approved finished medicines available in order to repair it [18].
That is a serious argument and it is not new. Anyone who has sat through a German pharmacy or regulatory conference in the last five years has heard it. A system that reimburses a plant preparation with no marketing authorisation, while requiring full dossiers of everything else, is genuinely anomalous, and people who have no connection to Vertanical have been saying so for years.
The problem is not the argument. The problem is the timing, and the fact that the mechanism chosen was not a debated reform of the framework but a single amendment inserted days before a vote, with no transition period for 65,000 patients and no hearing on the point itself. A good argument does not become a bad one because a company benefits from it. It does become harder to trust when it arrives that way.
Questions were already being asked before any of the reporting appeared. In mid-July the Berlin pharmacist Melanie Dolfen, who specialises in supplying cannabis patients, publicly demanded clarification of what influence the pharmaceutical industry had had on the new restrictions [18].
The 28 questions
The parliamentary question tabled on 21 August contains 28 of them, and the sharpest are not about health policy [1].
Question 23 asks whether officials in the health ministry, at any level, had contacts with representatives of Vertanical GmbH or its parent FUTRUE GmbH during the legislative deliberations or during the approval procedure, with names, dates and subjects.
Question 24 asks for every official contact between the ministry and the medicines agency during the Exilby approval.
Question 25 asks whether the agency informed the ministry of open scientific or regulatory questions during that approval.
Question 26 asks whether the approval was granted subject to conditions under section 28 of the Medicines Act.
Questions 18 and 19 ask what the government knew about the price Vertanical expected to charge, and whether that expectation was factored into the cost assessment of the new rule.
Question 28 asks whether anyone considered that the market position of a single manufacturer might require specific transparency or compliance measures.
Read alongside the Spiegel reporting, questions 24 and 25 are no longer routine.
Why this costs the whole industry
Market access created by legislation is as durable as the legislation. Six weeks after the law took effect, Germany’s two central bodies for statutory care still disagree about what one sentence means. On 6 August the physicians’ association and the insurance association published a joint reading: the prior six-month trial applies only where an approved product exists for that indication [12]. On 20 August the physicians’ association revised its own position and now holds that a first prescription must always begin with a finished medicine, including outside its approved indication [13] [14]. The insurers do not accept that reading, and the health ministry has been asked to clarify and has not [15]. Physicians must choose an interpretation and carry the liability. Pharmacies risk clawbacks. Patients find out at the counter.
A national framework can be rewritten in one legislative cycle with no transition period. No grandfathering process, no dedicated hearing on the point, tabled as one of 64 amendments days before a vote. If your fundraise underwrites German revenue, that is a live regulatory risk.
And the achievement is now inseparable from the process. Somebody in Europe finally ran a large trial in a serious indication and obtained a licence. That should have been the story of the year for this sector. Instead the first question any US regulator, investor or journalist will now put to Vertanical is about the internal documents. The company has more to lose from that than anyone, and it is the only party that could address it directly.
About the price, which is now known
When Exilby launched, Vertanical put daily treatment costs at around eleven euros and compared that to commonly used pharmacy preparations.
The list price is now published. According to the German drug pricing database, the N2 pack of two 28 millilitre bottles costs 1,478.69 euros, and that is the quantity needed for one month at the maximum daily dose of 32.5 milligrams [18].
Those two figures are hard to reconcile without knowing which dose the company’s number refers to. Eleven euros a day comes to roughly 330 euros a month. A month at the maximum dose costs more than four times that. Vertanical should be asked directly which daily dose produces the eleven euro figure, and what proportion of patients in its trials needed more.
The comparison the law is built on has also now been tested. Deutsche Apotheker Zeitung worked out what a standardised pharmacy extract with the same THC content would cost for the same quantity, including all surcharges. An exact comparison is difficult because the THC and CBD content of the starting material varies, but on average prices the pharmacy preparation comes to between one fifth and one half of the finished medicine [18].
So the rule that requires patients to start on the finished medicine requires them to start on the more expensive option, in a law written to reduce spending. That is the second independent calculation to reach that conclusion, after the insurer figures cited by the Greens.
On Saturday, on Heumarkt
Two days before the launch I stood at a rally in Cologne, held under the slogan that the health insurance reform makes people sick and poor. It was not an industry crowd. It was patients, a few association people, and a speaker from the satirical party Die PARTEI, which has been one of the more consistent voices on cannabis policy in this city.
People were standing in a square asking to keep the therapy they already had. The Association for Cannabis as Medicine is collecting signatures for a parliamentary petition until 30 October and is examining further legal steps, up to a constitutional complaint [8].
What would settle this
The Public Assessment Report. The BfArM says it will publish one for Exilby in the coming weeks, covering the evidence of efficacy and the course of the procedure. If the dossier carries the approval on its own, that document will show it, and the agency has every reason to want it read. If it does not address why an internal note described the proposed approval as resting on an instruction from the leadership, that absence will be the story instead.
Read it when it appears. Not the press release about it, the report.
The government could answer all 28 questions in full, starting with the first: on whose initiative amendment No. 52 entered the process, and when.
And Vertanical could stop leaving questions about political contacts unanswered. It published its donation figures on its own initiative, which was the right call. The contacts are the remaining gap, and silence is now the only part of this story the company still controls.
The people who designed and ran that trial did the work this industry said it wanted. They deserve to have it judged on the data. So does everyone who comes after them.
Sources
- Deutscher Bundestag, printed paper 21/7743, Kleine Anfrage of Bündnis 90/Die Grünen, tabled 21 August 2026, published 26 August 2026. https://dserver.bundestag.de/btd/21/077/2107743.pdf
- Pharmazeutische Zeitung, report on the Exilby marketing authorisation, June 2026. https://www.pharmazeutische-zeitung.de/cannabis-medikament-gegen-rueckenschmerzen-erhaelt-zulassung-165972/
- BfArM, AMIce medicines information system. https://portal.bfarm.de/amguifree/
- APOTHEKE ADHOC, interview with Vertanical on the phase three programme. https://www.apotheke-adhoc.de/nachrichten/detail/markt/vertanical-wir-wollen-die-opioide-verdraengen/
- Der Spiegel 36/2026, “Hat sich die CSU für diesen Parteispender aus der Cannabis-Branche starkgemacht?”, by Sven Becker and Hannes Munzinger, 27 August 2026. https://www.spiegel.de/politik/deutschland/cannabis-investitionen-profitieren-csu-spender-von-neuer-cannabis-regelung-a-4438334d-e2a6-4df4-97a3-041bab25710f
- Deutscher Bundestag, public hearing of the health committee, 22 June 2026. https://www.bundestag.de/ausschuesse/gesundheit/anhoerungen/1184692-1184692
- Bundesgesetzblatt 2026 I No. 228, promulgated 29 July 2026. https://www.recht.bund.de/bgbl/1/2026/228/VO.html
- Hanfjournal, on the ACM petition and the number of affected patients, 29 August 2026. https://hanfjournal.de/2026/08/29/65-000-patienten-ohne-blueten-jetzt-zieht-die-cannabis-petition-in-den-bundestag/
- Deutscher Hanfverband, statement on the reimbursement decision. https://hanfverband.de/hanfverband-skandaloese-entscheidung-zu-gkv-cannabis
- AOK, cost comparison for cannabis prescriptions based on the LAUER-Taxe, as of March 2025, cited in source 1. https://www.aok.de/gp/fileadmin/user_upload/Arzt_Praxis/Wirtschaftliche_Verordnung/Sachsen-Anhalt/san_wv_canabis.pdf
- Hanf Magazin, on the donations and the committee process. https://www.hanf-magazin.com/politik/deutschland/gkv-cannabis-lobbying-spenden-fertigarzneimittel/
- KBV, joint interpretation with the GKV-Spitzenverband, 6 August 2026. https://www.kbv.de/praxis/tools-und-services/praxisnachrichten/2026/08-06/neue-regelungen-zur-verordnung-von-cannabis-kbv-und-gkv-spitzenverband-schaffen-klarheit
- KBV, revised legal assessment, 20 August 2026. https://www.kbv.de/praxis/tools-und-services/praxisnachrichten/2026/08-20/bei-cannabis-erstverordnung-immer-ein-fertigarzneimittel-kbv-bewertet-gesetzliche-regelung-neu
- Deutsches Ärzteblatt, 21 August 2026. https://www.aerzteblatt.de/news/cannabis-erstverordnungen-kbv-bewertet-gesetzliche-regelung-neu-ba765493-b07d-4ebc-bdf7-24681deb56e6
- KV Baden-Württemberg, on the divergence between the two interpretations. https://www.kvbawue.de/kvbw/aktuelles/news-artikel/was-gilt-in-der-versorgung-mit-cannabis-1
- APOTHEKE ADHOC, on the September launch and the price talks, cited in source 1. https://www.apotheke-adhoc.de/rubriken/detail/medizinisches-cannabis/zulassung-fuer-exilby-cannabis-fertigarzneimittel-ab-september/
- Krautinvest, on price formation for a cannabis finished medicine. https://krautinvest.de/wie-entsteht-der-preis-fuer-ein-cannabis-fertigarzneimittel/
- Deutsche Apotheker Zeitung, “Ein fragwürdiger Vorrang”, by Kirsten Sucker-Sket, 1 September 2026, including the BfArM’s statement to the paper, the published list price and the DAZ cost comparison. https://www.deutsche-apotheker-zeitung.de/news/artikel/2026/09/01/ein-fragwuerdiger-vorrang
