On 25 October 2022, the Federal Joint Committee (Gemeinsamer Bundesausschuss - G-BA) issued a decision on the initiation of a commenting procedure on the amendment of the Pharmaceutical Guideline (Arzneimittel-Richtlinie), which could fundamentally change prescription practice in the field of medical cannabis in particular.
The role of the Federal Joint Committee
The G-BA is the highest decision-making body of the joint self-administration in the German health care system. It is composed of representatives of the statutory health insurance funds and service providers as well as impartial members and an impartial chairperson. Patient representatives have the right to participate in consultations and submit proposals, but do not have the right to vote. The G-BA determines, in the form of guidelines, which medical services the approximately 73 million insured persons in Germany can claim. In addition, it decides on quality assurance measures for practices and hospitals.
In the area of medicinal cannabis, the prescribability of which was established in 2017 by the Act Amending Narcotics Law and Other Regulations (Gesetz zur Änderung betäubungsmittelrechtlicher und anderer Vorschriften), the G-BA is mandated, among other things, pursuant to Section 31 para. 6 p. 9 of the Social Code Book (Sozialgesetzbuch Buch V - "SGB V"), to "regulate the details of the granting of benefits in the guidelines" within six months of the transmission of the results of a non-interventional accompanying survey conducted by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - "BfArM"), based on these very results.
On 6 July 2022, the BfArM published the final report of this accompanying survey, so that it is now the G-BA's turn to react to these results in the form of a guideline.
Content of the decision
First, it should be mentioned that the decision is about the initiation of a commenting procedure, i. e. its content is not yet final or legally binding (more on this under "Procedure"). Also, several positions are taken within the resolution on many aspects of content, so that concrete details are still being worked out in any case. However, it can be assumed at this point that the final resolution will not fall below the minimum of the most liberal position.
A future amendment of the Pharmaceutical Guideline will cover cannabis in the form of dried flowers or extracts as well as medicinal products with the active substances dronabinol or nabilone, to which patients with a serious disease will continue to be entitled, provided that an alternative, generally recognized service is not available and there is a not entirely remote prospect of a noticeable positive effect on the course of the disease or on serious symptoms. If necessary, a special obligation to justify the prescription of dried flowers could exist in the future. Physicians will be subject to additional documentation and verification obligations with regard to the appropriateness of cannabis therapy.
Furthermore, the service will be subject to the approval of the statutory health insurance; however, the approval will usually only have to be obtained once, even if the cannabis medicine is changed.
The necessary qualification of the prescribing physician will probably be significantly tightened. While general practitioners have been able to prescribe cannabis as a medicinal product up to now, this could be reserved exclusively for specialists in the future. The respective specialty would be defined in an annex to the amended Pharmaceutical Guideline, linked to the respective clinical picture. For example, in future only specialists in gastroenterology for the treatment of intestinal complaints; neurology for the treatment of epilepsy; neurology or psychiatry/psychotherapy for the treatment of ADHD could be allowed to prescribe medicinal cannabis. Irrespective of these stipulations, however, specialists in anesthesiology, neurology or those with relevant further training in the field of pain medicine/palliative medicine should be able to initiate cannabis therapy, provided that the treatment of the symptom complex of pain is in the foreground.
Motives
Within the framework of this decision, the G-BA has published the supporting reasons. In this, with consideration of the mandate in Section 31 para. 6 p. 9 SGB V, in particular the results of the companion survey of the BfArM are dealt with.
While the conclusion of the accompanying survey was on the whole rather positive, the BfArM had expressed concerns in the final report, especially with regard to the prescription of cannabis flowers. Compared to other cannabis medicines, the patients were significantly younger, and the THC content was higher. There was a lack of scientific publications dealing with the effectiveness and safety of such high doses. Also, the proportion of male patients was strikingly high in comparison. The obvious concern: a lack of differentiation between therapeutic effects and a temporary feeling of well-being induced by the consumption of cannabis flowers, which has a potential for dependence.
The G-BA will probably react to these aspects with the special obligation to justify the prescription of cannabis flowers and additional documentation and verification obligations.
The most significant change, namely the specification of the necessary specialist medical qualification, is also a reaction to a potential for abuse identified by the BfArM. By limiting the ability to prescribe to persons with specific specialist qualifications and experience, the aim is to ensure that the lack of therapeutic alternatives for the specific clinical picture can be safely assessed.
Procedure
With its decision of 25 October 2022, the G-BA initiated a commenting procedure. A number of affected organizations and authorities, such as the Federal Association of the Pharmaceutical Industry e. V. (Bundesverband der Pharmazeutischen Industrie e. V.), the Federal Association of German Pharmacy Associations e. V. (Bundesverband Deutscher Apothekenverbände e. V.), the Cannabis Industry Association (Branchenverband der Cannabiswirtschaft), the Federal Association of Pharmaceutical Cannabinoid Companies (Bundesverband der pharmazeutischen Cannabinoid-Unternehmen), the Federal Medical Association (Bundesärztekammer) and the Cannabis Agency at the BfArM (Cannabisagentur beim BfArM), have the opportunity to comment within a four-week period. After evaluating the comments, the subcommittee of the G-BA prepares a reasoned draft resolution for the plenum. The plenum then adopts a resolution if at least seven votes are cast in favour of it and submits it to the Federal Ministry of Health (Bundesministerium für Gesundheit) for a review of its legality. If the Ministry has no objections to the decision within the two-month period, it is published in the Federal Gazette (Bundesanzeiger) and becomes legally binding.
Conclusion and outlook
The decision of the G-BA of 25 October 2022 provides for a significant restriction of the prescription practice of medical cannabis. This follows as a reaction to the results of the accompanying survey conducted by the BfArM.
It could be criticized that those results, according to the BfArM's own reporting, depict a possibly non-representative data set. Despite the reporting obligation, only 21,000 therapies were reported by prescribing physicians in the period 2017-2022 (the BfArM itself estimates the number of therapies carried out between 2017 and 2020 alone at approx. 70,000), of which in turn only 16,809 were included as complete entries in the companion survey. However, the legislative mandate to regulate more details on the granting of benefits in the guidelines based on this monitoring survey was clearly defined in 2017.
The law does not provide for direct legal protection against the G-BA's guidelines, with the exception of the non-applicable special provision of Section 92 para. 3 SGB V. Affected SHI-accredited physicians can only have these reviewed incidentally within the framework of an action for annulment against onerous administrative acts. Insured persons can also only obtain an incidence check of the guidelines. If the health insurance fund refuses to grant a service on the basis of a guideline, insured persons can procure the service themselves in accordance with Section 13 para. 3 SGB V and then file a claim for reimbursement of the costs incurred. In future, however, it may be unavoidable for those affected to visit a specialist practice.