Australia’s drug regulator is taking another look at the medical cannabis access pathway. This time, the focus isn’t on advertising or telehealth consultation times, but on the ownership structures behind prescription services. Under scrutiny are providers that control prescribing, dispensing, and delivery in a single integrated operation. For Germany’s debate on reforming the Medical Cannabis Act, this represents an alternative regulatory model worth examining.
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Understanding Closed-Loop Prescribing
In Australia’s regulatory discussion, „closed loop“ refers to vertically integrated providers. A single platform operates the telehealth consultation, a connected pharmacy dispenses the product, and a connected delivery service brings it to the patient. Revenue is generated at every point in this chain by the same company. Prescribing thus becomes more than a medical decision—it becomes the starting point of an internal distribution network.
Doctors have documented to the Therapeutic Goods Administration how this plays out in practice. Clinics charged fees simply to release already-issued prescriptions. Patients were systematically directed to preferred pharmacies. Both practices are not isolated incidents from bad actors, but follow logically from the integrated business model.
A Special Access Scheme That Became the Standard Pathway
Medical cannabis reaches Australian patients almost exclusively through the Special Access Scheme (SAS), originally designed for justified individual cases involving unapproved products. The numbers reveal what has happened. In the first eight months of 2026 alone, there were at least 148,388 SAS-B decisions. For all of 2025, the total was 207,980, compared to 177,762 in 2024.
Month by month, 2026 runs roughly seven percent ahead of the previous year. Approximately half of all prescriptions are for THC-dominant products containing less than two percent CBD. Patients are predominantly treated for pain, anxiety disorders, and sleep problems. An exception mechanism now carries an entire mass market. For those wanting to understand Australia’s cannabis development from the beginning, our article on cannabis reform in the Australian Capital Territory provides essential background. This is particularly noteworthy because the market has contracted in the interim. We reported in May on the 28 percent revenue collapse and the TGA’s enforcement action. Current prescription data confirm that this correction has not permanently arrested the growth trajectory.
The Regulator Is Running Two Parallel Processes
In August 2025, the TGA opened a consultation on the regulatory framework for unapproved cannabis products. Nearly 800 submissions came from industry, medical associations, and patient organizations. The agency published its response on February 20, 2026. In its 2026/27 business plan, it has now explicitly committed to examining reform options for this framework. In parallel, the health professions regulator AHPRA monitors prescribing behavior through a rapid-response unit established specifically in 2024.
Additional pressure comes from the calendar. Australia’s Narcotic Drugs Regulations automatically expire on April 1, 2027, unless Parliament re-enacts them. A fundamental policy decision is therefore inevitable. Whoever rewrites the framework will struggle to avoid the question of ownership structures. On advertising oversight, the agency has already demonstrated seriousness, issuing warnings totaling more than 2.3 million Australian dollars and working toward a 65 percent closure rate on enforcement actions.
What Germany Can Learn
Germany’s proposed Medical Cannabis Act reform takes a different approach. It aims to tie initial prescriptions to in-person doctor contact and to ban mail-order sales of cannabis flower. Germany regulates the channel; Australia targets the owner. The difference is substantial. A shipping ban affects all providers equally, including those operating fairly, and hits patients in sparsely populated regions hardest. A rule separating prescribing from dispensing, by contrast, directly targets the conflict of interest at stake.
A precedent for this already exists in German law. The Pharmacy Act prohibits arrangements between doctors and pharmacies regarding prescription referrals, and medical ethics rules include a similar prohibition. The question is less whether such rules exist than whether they are consistently applied to platform structures with affiliated companies. How contentious the field remains is evident from our coverage of political demands for stricter rules on online prescriptions. How much current care is under pressure can be seen in the petition against the flower ban in the Petitions Committee.
For the industry in German-speaking markets, Australia’s discussion is therefore far more than a footnote. It provides the argument that has been missing from public hearings on Germany’s reform. Not every telehealth service is problematic, and not every mail-order operation is abusive. Problems arise only when the same corporation prescribes, dispenses, and delivers.
Frequently Asked Questions
What exactly does closed-loop prescribing mean?
It refers to vertically integrated providers where prescribing, dispensing, and delivery all belong to the same corporate group. The patient moves through a closed chain where a single corporation profits at every step. Australian regulators see this as a structural conflict of interest.
Why is the Special Access Scheme facing criticism?
The Special Access Scheme was designed as an exception pathway for justified individual cases. With more than 148,000 decisions in just the first eight months of 2026, it has become a regular supply channel. The regulator is therefore examining whether existing oversight is still proportionate to actual volume.
When might Australian changes take effect?
No specific date has been announced. The TGA’s 2026/27 business plan only indicates that reform options will be examined. A hard deadline, however, is April 1, 2027, when the Narcotic Drugs Regulations automatically expire unless re-enacted by Parliament.
Does this directly affect German patients?
Not legally, since Australian regulations apply only there. Practically, yes—because Germany’s Medical Cannabis Act reform addresses the same questions. Australia provides empirical evidence from a market that experienced its telehealth boom several years earlier.
Would separating prescribing from dispensing be permitted in Germany?
The legal foundations already exist. The Pharmacy Act prohibits arrangements regarding prescription referrals, and medical ethics rules include a corresponding prohibition. The open question is primarily how consistently these rules are applied to platforms with affiliated pharmacies and internal delivery operations.
Sollten Ärzte an Apotheken für Cannabis beteiligt sein dürfen?
Sources: Therapeutic Goods Administration (Medical Cannabis Consultation, response of February 20, 2026, 2026/27 Business Plan, SAS-B prescription data), Australian Health Practitioner Regulation Agency, Business of Cannabis (September 4, 2026), draft amendments to the Medical Cannabis Act.
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