Evidence, Access and the Future of Cannabinoid Medicine: Key Takeaways from Cannabis Health Symposium Frankfurt — Part 2

A thread running throughout was that legal access to medical cannabis, by itself, is not the same as practical, affordable access. Reimbursement, prescribing rules, pharmacy capacity, product quality, and cross-border consistency all need to work together.

Read Part 1 of our takeaways from Cannabis Health Symposium Frankfurt, exploring the evidence, policy, telemedicine, and clinical practice.

Here are our key takeaways from the afternoon.

 

Prescribing Under Pressure: What Germany’s Cannabis Policy Shifts Mean in Practice

Antonia Menzel, Chair of the Executive Board of the Bundesverband pharmazeutischer Cannabinoidunternehmen (BPC), opened the afternoon with a detailed walk-through of Germany’s recent and incoming cannabis legislation.

The Contribution Rate Stabilization Act (BStabG), which took effect at the end of July, removed cannabis flower from reimbursement under Germany’s statutory health insurance (GKV) system, while keeping extracts, dronabinol, and nabilone potentially eligible under certain conditions. 

Menzel argued that the BStabG’s cannabis clauses were inserted late in a fiscally motivated process that will not actually save the GKV money. The federal government itself, she said, had confirmed on inquiry that it anticipated no cost savings from the changes, prompting the industry to question the basis on which they were made in the first place.

Menzel estimated that approximately 65,000 patients had previously received reimbursed cannabis flower prescriptions.

“Patients who cannot easily switch to a different dosage form will lose their treatment option,” she said. “This is a point we have repeatedly raised with the authorities.”

Social Courts in Munich, Hamburg, Frankfurt and Leipzig have heard early challenges from patients who previously held open-ended reimbursement authorisations, with rulings so far unfavourable but subject to further proceedings.

Looking ahead, Menzel did not see political majorities forming for the reinsertion of flower reimbursement.

The second process, a long-stalled reform of the Medical Cannabis Act, would introduce mandatory in-person prescribing and restrict mail-order dispensing. That reform has been held up by coalition disagreement and concerns about European law, but keeps returning to the table because of pressure from the International Narcotics Control Board on Germany’s rising cannabis import volumes.

Menzel said the industry’s position was that Germany should not create a “lex cannabis” exception to its broader digitisation of healthcare, within which telemedicine is being formalised as standard care. Mail-order restrictions, she noted, also raise European law concerns that had contributed to the collapse of the previous coalition compromise.

She warned that the combination of regulatory uncertainty and price pressure was already visible in market consolidation, bankruptcies and takeovers.

“The most important thing we should avoid is that patients have to emigrate to the illegal market,” she added.

When Does a Standard Become a Rule? ASTM D37, GMP and the Medical Cannabis a German Doctor Prescribes

Ana Serrato, Chair of ASTM International’s Cannabis Human Health Subcommittee (D37.11) and Chairwoman of the European Medicinal Cannabis Association (EUMCA), used her session to argue for voluntary consensus standards as the mechanism through which the medical cannabis sector could define quality, testing and manufacturing practice before regulators imposed their own rules.

D37.11’s immediate priorities include establishing shared terminology (common definitions of medicinal cannabis, cannabinoid-based medicines and related terms), clarifying the GACP to GMP boundary, and raising the standard for analytical testing. 

Many certificates of analysis, Serrato said, have been reduced to THC and CBD content alone, which raised the question of whether this is sufficient for a doctor to prescribe, a pharmacist to dispense or a patient to use the product with confidence. Terpene profiles and minor cannabinoids were, in her view, candidates for the next level of detail.

For all its regulatory density, including the DAB and DAC monographs, the Medical Cannabis Act, the Cannabis Act and the parallel positions of BfArM and state authorities, significant gaps remain, Serrato argued. Existing regulations largely govern herbal products, with medical cannabis sitting between pharmaceutical and herbal classifications. 

The D37.11 subcommittee currently has around 55 members, the large majority US-based, and Serrato emphasised the need for European and specifically German voices to shape standards for European markets. She urged delegates to get in touch with what they would like to see.

Pharmaceutical Quality: Does Europe Need a Common Framework for Medical Cannabis?

Building on her presentation, Serrato moderated a panel discussion with Tjalling Erkelens, Chairman of the Board of Bedrocan International, Silvia von Pistor, Chief Innovation Officer at Canify AG, Sita Schubert, Secretary-General of the European Medicinal Cannabis Association, and Dr Susann Hesse-Bikbaeva, Responsible Person for Wholesale at PharmCann Deutschland AG, exploring whether Europe needs a common framework for medical cannabis.

Panellists identified cultivation and production, the development of genetically stable, reproducible products, proof of clinical effectiveness, and healthcare-professional education as the biggest gaps in European frameworks.

Von Pistor argued that existing knowledge in the sector is not reliably shared.

“Transparency is limited, not merely because of intellectual property but because different countries require different products and publish different information,” she told the panel.

Patients and pharmacists, she added, have different levels of access to information, and even where marketing authorisations exist, the data they publish vary.

The discussion returned repeatedly to the inconsistency in how GACP and GMP requirements are interpreted, within Germany as well as across Europe. 

Hesse-Bikbaeva pointed out that GMP requirements may look similar on paper, but the way flowers are actually grown varies enormously, with microbiological contamination assessed differently depending on the source and the authority. Even within Germany, she noted, companies may choose to do business in one federal state whose authorities accept their cultivation approach rather than another that would not.

But Schubert argued that there is already an established European pharmaceutical framework, and companies looking to enter the market should operate within it.

“Companies need to recognise that entering the European medicinal market means operating in the pharmaceutical sector and complying with pharmaceutical rules,” she said. 

“Looking for loopholes may generate a short-term sale but cannot support a sustainable business, particularly where companies have committed to future harvests and long-term production.”

Erkelens highlighted how Bedrocan had spent more than two decades demonstrating that a standardised process could produce standardised plant material and yields. A GMP audit early in that work had accepted the cultivation process, before a later inspector concluded that EU guidance meant cultivation could not formally be classified as GMP. 

Even so, Erkelens argued, GMP principles can be applied to cultivation as far as possible, making it a properly industrial process with documented procedures, audits, consistent outputs and a product that producers, pharmacists and patients can rely on.

Panellists warned that falling prices could lead to companies making cuts in quality assurance, and Schubert warned that governments may be largely indifferent to the commercial survival of individual companies, with a single quality scandal having the potential to trigger a political reaction restricting the whole market. 

“The solution is to join forces,” she said. “Through national and international associations, including pharmacist and patient organisations. Individual companies, even large ones, cannot achieve everything alone.”

The Pharmacists’ Role in Safe Treatment

Dispensing medical cannabis involves more than handing over a prescription, Dr Christiane Neubaur, managing director of the Cannabis-Dispensing Pharmacists’ Association (VCA, told attendees in the penultimate session, explaining that pharmacists need both specialist knowledge and time to check product quality and help patients understand how to use their medicine.

That means explaining how to adjust the dose, use a vaporiser, store the medicine and respond to side effects. Pharmacists also need to check for interactions with other medicines and discuss any concerns with the prescribing doctor. If a prescribed product is unavailable, pharmacists cannot necessarily replace it without consulting the doctor.

She stressed that certificates accompanying cannabis products need proper scrutiny, with threshold values on microbiological testing being particularly consequential for inhaled products. 

Among the dosage formats currently available in pharmacies, Neubaur highlighted inhalable extracts as a safer and easier-to-dose alternative to flower from a microbiological and administration standpoint, and argued for health insurers to extend reimbursement to them.

She also called for better training for pharmacy teams, pointing to a joint continuing-education programme developed with the BPCN, and questioned whether pressure to supply cheaper products was undermining quality.

“It’s a medicine,” said Neubaur. “We need good, standardised quality.”

Legal Treatment, but Can Patients Get It?

The day’s final panel, Medical Cannabis in Europe: What Other Markets Can Teach German Practice, examined the gap between making treatment legal and making it affordable and straightforward to obtain.

Moderated by Dirk Heitepriem, President of the Branchenverband Cannabiswirtschaft e.V. (BvCW), the panel brought together José Tempero, Director International Medical Affairs at Tilray Medical, Nitin Makadia, a UK pharmacist of 35 years and Director of Clinical Service Development at The Digital Health Assurance Company, and Panos Papatheologou, Co-Founder and CEO of the Greek telemedicine platform ReliefTime.

Heitepriem framed the discussion around what Germany, often described as the world’s largest medical cannabis market, could learn from its European neighbours.

Tempero opened by sketching the two broad regulatory paths European markets have taken over the past decade. The first, exemplified by Portugal and the UK despite their very different frameworks, treats medical cannabis as a finished product. 

The second, seen in Germany, Poland and Italy, is the compounding or magistral model, where the pharmacy performs a step that transforms the product into a medicine. These two regulatory landscapes bring consequences for access, pricing and reimbursability, he said.

The challenge in the UK, Makadia said, was that legislation written in 2018 had not anticipated the current clinic model, which was pushing clinics to find workarounds.

“If you can exploit a loophole to deliver best practice for the patient, absolutely you should do it. If you’re looking for a loophole just to try and take advantage of something, that’s more questionable.”

The structural challenge, Makadia said, was that smaller and newer clinics were often obliged to follow patient expectations rather than regulations or best practice, which was where the UK market had developed its most persistent problems.

Papatheologou described Greece’s late and tightly controlled market. Although the law was first passed in 2017, no facility had products on the market until 2024. Greek regulation requires vertical production inside a domestic GMP facility, with no imports permitted. 

The introduction of telemedicine in 2025 changed the trajectory. The market now has three operational GMP facilities, around 50,000 patients, six approved indications, and six flower SKUs plus a tincture oil, with vaporiser cartridges due to launch. 

Portugal was among the first in Europe to encourage companies to establish production, but approval requirements for products are, Tempero said, among the strictest in Europe, probably surpassed only by France.

Asked whether a joint European framework was possible, Makadia was sceptical that legislation could drive the change and argued for collaborative best-practice adoption instead. 

The UK’s Medical Cannabis Clinicians Society had developed best-practice guidelines that the Care Quality Commission had unofficially adopted, he said, and that model of cross-European sharing was more likely to work than attempting a single statutory framework.

The panel also returned to the question of medical cannabis education, which remains largely absent from undergraduate curricula in the UK, Germany, Greece and Portugal, the panellists noted, though early steps are visible. 

Brandenburg’s new Cottbus medical university is incorporating the subject, Greek universities have begun including it on the curriculum, and Makadia teaches a module in two UK medical schools.

European medical cannabis access is currently characterised by as many models as there are markets, Heitepriem noted, with a loose pattern that extracts dominate reimbursed systems and flower dominates self-paid ones.

However, he noted, evidence generation remains the universal gap the industry must now address.

Continue the conversation in London

These conversations will continue at the Cannabis Health Symposium at Conway Hall, London, on 26 November, with sessions on pain treatment, women’s health, prescribing standards and the evidence behind cannabis-based medicines.

Explore the London programme and book your place here.