G-BA RESOLUTION SHOWS IMPORTANCE OF MEDICAL CANNABIS – BUT ALSO COMPLEXITY AND NEED FOR FURTHER REFORMS
Berlin, 03/17/2023: “The intensive referral to the Federal Joint Committee (G-BA) and yesterday’s decision on the Medicinal Products Guideline regarding medical cannabis shows how relevant safe care for patient:s is, but also the complexity of the issue. We call on the legislator and the federal government to ensure legal and supply security for the patient:inside by revising the “cannabis as medicine” law still this year”, so the first joint conclusion of professional associations of patient, doctors, pharmacists and the cannabis industry on the results of the meeting of the G-BA on March 16, 2023.
In this context, the explicit orientation towards the legal text should be emphasized. The legislator’s intention with the “Cannabis as Medicine” Act of 2017 was to make access to medical cannabis for patients with serious illnesses as unbureaucratic and safe as possible. From the point of view of the professional associations, the G-BA has taken this into account.
In the text of the resolution, however, one formulation remains unclear (§44 para. 2).¹ While it was conveyed in the meeting of the G-BA that the use of cannabis as dried flowers and as standardized extracts is not to be subordinated, the final text now includes a general subordination in the prescription of prescription drugs compared to cannabis-based finished drugs, which was not intended by the legislator. This is further exacerbated by the last sentence of the paragraph, which, despite plenary discussion to the contrary, only addresses the rationale for prescribing flower. Clarification is needed here to avoid creating additional hurdles in practice.
In the run-up to yesterday’s meeting, an extensive hearing procedure was conducted, which, according to the impartial chairman Prof. Hecken, was very valuable. The professional associations are very grateful for the opportunity to participate in this process and for the professional discourse.
Above all, it is to be welcomed that the care of patients has been at the center of the discussion at all times and that a regulation corresponding to the law has been found here.
The revision of the law is appropriate after six years of experience
At the same time, it has once again become clear in this process that after six years of “cannabis as medicine” in Germany, the legal regulations are in great need of optimization. For example, the approval proviso continues to lead to rejection rates of 30-40%, although the law provides for rejections only in exceptional cases. We fear that the medicament guideline submitted now does not lead to a Entbürokratisierung for patient:in and physician:in, but also by additionally created uncertainties rather against that runs.
The professional associations contributed intensively to the G-BA’s commenting procedure and are also available to the legislator for discussions on an amendment of the law at any time. The associations are currently developing concrete proposals in a joint position paper, which is to be published within the next few weeks.
“In the past six years, we have achieved a great deal for seriously ill patients in Germany and have created an exemplary legal framework for access to medical cannabis that is a model worldwide. To develop this further must be the common goal of politics, patients, physicians, pharmacists, science and industry.”
The resolution of the G-BA on the future handling of cannabis as medicine can be found here: Link
Contact person for the press:
Vice President BvCW, Vice President External Affairs Aurora Europe GmbH
Phone: 0170 64 00 306
Dr. Franziska Spitzner
Member of the Board and Head of the Research WG at the BPC, Lead Medical Affairs DEMECAN
Phone: 0151 25815804
About the associations:
Working Group Cannabis as Medicine e.V. (ACM)
Contact: Dr. med. Franjo Grotenhermen & Prof. Dr. med. Kirsten Müller-Vahl
Phone: 05233 953 72 46
The working group Cannabis as medicine registered association (ACM) was created 1997 in Cologne. In it physicians:inside, Apotheker:inside, patient:inside, Jurist:inside and other interested ones from Germany and Switzerland organized themselves. Over the past 25 years, the ACM has been instrumental in improving the medical use of cannabis and cannabinoids in Germany. For example, a constitutional complaint initiated by the ACM and subsequent test cases before the administrative courts paved the way for exemption permits for the use of cannabis from pharmacies in 2007 and finally for the 2017 law.
The Association of German Cannabis Patients (Bund Deutscher Cannabis-Patienten e.V., BDCan) is a non-profit association that works to ensure that patients are provided with high-quality cannabis medicines in various dosage forms by local pharmacies in private practice and at the expense of the statutory health insurers when a therapy with cannabinoids is indicated. In addition, we offer our members support in the establishment of self-help groups and provide advice in these groups as well as via our hotline and e-mail on all questions relating to therapy with medical cannabis.
German Cannabis Business Association (BvCW)
Contact & V.i.S.d.P.: Jürgen Neumeyer, Managing Director
Phone: 0163 9860 888
Professional contact: Dr. Armin Prasch, department coordinator medical cannabis
The BvCW is the voice of the cannabis industry in Germany and represents all industry segments and company sizes to politics and administration. Our specialist areas are divided into “stimulant regulation”, ” industrial hemp & food”, “medicinal cannabis”, “CBD et al.” and “technology, trade & services”. We bundle industrial policy, technological, scientific and economic expertise and advocate for better political framework conditions.
Federal Association of Pharmaceutical Cannabinoid Companies (BPC)
Contact: Christina Schwarzer, Managing Director
Phone: 030 235 939 590
The Federal Association of Pharmaceutical Cannabinoid Companies e.V. (BPC) guarantees patients the best possible supply of quality-assured medical cannabis in Germany. The association promotes a sustainable further development of cannabinoid therapies and thus simultaneously strengthens the position of the pharmaceutical cannabinoid industry in Germany and in the international market.
The aim of the BPC is the security of supply of patients with quality-assured medical cannabis. The BPC bundles the expertise of its members and is instrumental in promoting ideal cultivation and supply structures for medical cannabis. This unique combination enables the BPC to represent the interests of the German cannabinoid industry in the best possible way and to position itself clearly vis-à-vis decision-makers.
With our visionary guiding principle ” Medical cannabis – health grows!” the German Medical Cannabis Society e.V. (DMCG) forms a platform for physicians:inside and connected occupational groups for the common work approximately around the topic Cannabis in the medicine. Founded in September 2020, the purpose of the still young professional society is to promote and support scientific and practical work on research into the mode of action as well as the fields of application of cannabis-containing medicines for the prevention, treatment and aftercare of diseases, disease-like impairments or conditions as well as the holistic use in patients in the public health system. The DMCG is patron of the annual Medicinal Cannabis Congress in Berlin.
Interdisciplinary Working Group of Brandenburg Pain Therapists and Palliative Physicians e.V. (IABSP)
Contact: Dr. med. Christoph Wendelmuth & Dr. med. Knud Gastmeier
Phone: 0331 743070
The working group IABSP was created 1993 in Kleinmachnow. In it physicians and psychotherapists from Brandenburg organized themselves, which concern themselves with the regional problems in connection with the pain and Palliativmedizin and look constructively for solutions. The IABSP has been instrumental in various ways since 2000 in bringing about improvements in the medical use of cannabis and cannabinoids in Brandenburg.
Patient Association Self-Help Network Cannabis Medicine (SCM)
Contact: Gero Kohlhaas & Maximilian Plenert
Phone: 05233 953 72 46
E-Mail: email@example.com & firstname.lastname@example.org
The self-help network Cannabis as Medicine (SCM) is by far the largest and oldest association of cannabis patients in Germany. It is a network of affected persons within the ACM. Together with its trained patient advisors, the local self-help groups and a patient telephone, the Arbeitsgemeinschaft Cannabis als Medizin and its self-help network of cannabis patients is the leading point in Germany for those seeking advice and those interested. SCM and ACM e. V. offer information, advice, organizational opportunities and support, and thus foundations for milestones that have been fought for, such as the “Cannabis as Medicine” law.
The avowed goal of the VCA is it to ensure in Germany an efficient and affordable supply of Patient:innen with medical Cannabis. This supply obligation sees the federation completely clearly with the pharmaceutical Expert:innen in the pharmacy. According to § 1 of the German Pharmacy Act, pharmacies are responsible for ensuring the proper supply of medicines to the population in the public interest. This is the point of contact for patients before, during and after receiving a prescription from a doctor. The pharmaceutical staff can provide optimal advice and therapeutic support.