An amendment to the MedCanG has been planned for some time, but it is still a long time coming. Partly – or perhaps precisely – because it remains unclear when and in what form the amendments to the MedCanG will ultimately come into force, the debate surrounding remote prescriptions, mail-order pharmacies and digital care models is highly topical and therefore reason enough to take a look at the current state of play.
The reform efforts were triggered in particular by sharply rising import figures for medicinal cannabis and the increasing prevalence of telemedicine-based prescribing models. The draft bill aims to address this development and re-establish a stronger link between care provision and face-to-face contact between doctors, pharmacies and patients.
With the draft amendment to the Medical Cannabis Act (MedCanG-E), the legislator is therefore focusing on a particularly practice-relevant aspect of the still relatively new medical cannabis legislation: the prescription and dispensing of cannabis flowers for medical purposes. In particular, the draft provides for stricter requirements regarding contact with a doctor prior to prescribing, as well as a ban on posting cannabis to end users.
The amendment does not, therefore, aim to comprehensively restructure the market for medical cannabis. Issues relating to authorisation, quality certificates, manufacture, storage and the import and export of medical cannabis are not the focus of the planned changes. Rather, the amendments primarily target doctors and pharmacies – and, indirectly, business models that rely on telemedical prescriptions or postal delivery systems. The new regulations thus concern the interface between medical treatment, pharmaceutical advice and digital care models.
At the heart of the draft bill is the planned tightening of the prescription requirements. Section 3(2), first sentence, of the MedCanG-E stipulates that cannabis flowers for medical purposes may only be prescribed following a face-to-face consultation between the patient and the prescribing doctor. This contact must take place in the doctor’s surgery or as part of a home visit.
This is intended to prevent prescriptions being issued exclusively remotely via video consultations or telemedicine platforms without prior face-to-face contact between doctor and patient. The legislator is thus responding to concerns that cannabis flowers could become too readily available via purely digital ordering and questionnaire systems, and that the medical indication is not assessed with the necessary care.
According to Section 3(2), second sentence, of the MedCanG-E, repeat prescriptions shall remain permissible without further face-to-face contact only on condition that face-to-face contact involving a prescription has taken place within the last four quarters, including the current quarter. In practice, it will therefore be crucial to document the initial face-to-face consultation, the date of the prescription and the periods between prescriptions in a reliable manner.
The amendment is intended to bolster traditional local high-street pharmacies, as the draft bill also aims to strengthen in-person procurement when it comes to the supply of medical cannabis to end-users. Section 3(3), second sentence, of the MedCanG-E restricts the supply of cannabis flowers to end-users to high-street pharmacies upon presentation of a corresponding prescription and prohibits dispatch in accordance with Section 43(1), first sentence, of the AMG.
In practice, this represents a significant restriction on postal delivery models specialising in cannabis flowers for medical purposes. By contrast, pharmacies’ delivery services under Section 14(7) of the ApoG remain expressly unaffected. In this respect, the draft distinguishes between anonymised or remote postal dispensing on the one hand, and a pharmacy-based delivery service on the other, where the responsibility of the dispensing pharmacy and the provision of pharmaceutical advice are retained.
From the pharmacies’ perspective, this places greater emphasis on advice, identity verification, safe dispensing and documentation. Particularly in the case of cannabis flowers, which do not have marketing authorisation under pharmaceutical law in the traditional sense and are regularly used as part of an individual therapeutic decision, the draft attaches particular importance to personal pharmaceutical assessment.
The question of how to deal with EU prescriptions deserves particular attention. The Bundesrat had suggested declaring Section 2(1a) of the AMVV inapplicable. This would mean that EU prescriptions for cannabis flowers would no longer be treated as equivalent to German prescriptions. However, the Federal Government has rejected this proposal.
According to the current draft, Section 2(1a) of the AMVV therefore remains applicable. EU, EEA and Swiss prescriptions are, in principle, treated as equivalent to German prescriptions, provided they contain the formal details specified in Section 2(1) of the AMVV. German pharmacies must, in principle, accept such prescriptions provided the formal requirements are met.
In practical terms, it is important to note that, as things stand, pharmacies are not required to carry out a substantive check as to whether a personal doctor-patient contact within the meaning of Section 3(2) of the MedCanG-E has actually taken place abroad. This may give rise to a practical issue. Telemedicine platforms based in other EU countries could continue to issue prescriptions that are dispensed in Germany, provided they formally meet the requirements. It remains to be seen whether and how the legislator will address this scenario in the further legislative process.
For doctors, the face-to-face initial assessment will become increasingly important when prescribing cannabisflowers. Practices should assess at an early stage how they will organise and document initial consultations, home visits, patient education and repeat prescriptions. This applies in particular to care models that have so far relied heavily on video consultations or digital medical history forms.
Due to the changes outlined, pharmacies must review their processes for dispensing cannabis flowers, providing in-store advice and operating a delivery service. In addition, there is the formal verification of foreign prescriptions, where, as things stand, the focus is on the information required under the AMVV. However, no additional substantive checks on the foreign treatment contact are envisaged.
For companies and platform providers, the amendment may have economic implications if distribution channels are restricted or prescription volumes decline. However, it is not currently possible to make reliable statements regarding specific impacts on turnover. As long as the timing and final version of the new regulations remain unclear, business models should be analysed carefully and scenarios developed without drawing hasty conclusions.
The amendment to the MedCanG is a targeted but practically significant readjustment. It shifts the focus regarding cannabis flowers for medical purposes more strongly towards personal medical examination and in-person dispensing by a pharmacist. Access is not to be blocked in principle, but is to be more closely tied to medical and pharmaceutical accountability structures.
Practitioners are currently advised, above all, to closely monitor the further development of the legislative process and to review existing processes in good time to identify any need for adaptation. Doctors, pharmacies and digital providers should, in particular, keep a close eye on the requirements regarding initial prescriptions, repeat prescriptions, dispensing channels, delivery services and EU prescriptions. The critical issues will lie less in the areas of manufacturing or importation, and more at the interface between treatment, prescriptions, pharmacies and patient access.
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