Berlin, 11/30/2022: “There is a danger that many seriously ill patients will soon be forced back onto the black market,” is the unanimous opinion of the professional associations of patients, doctors, pharmacists and manufacturers on the new draft guidelines of the Joint Federal Committee (G-BA) on the future handling of cannabis as medicine. Today, the comments of various associations were submitted to the G-BA.
The draft guideline of the G-BA published on 01.11.2022 is proposed, among other things, that dried cannabis flowers may only be prescribed and reimbursed after special justification. At the same time, it is proposed that in the future only certain specialists will be allowed to issue prescriptions for cannabis-based medicines. Family physicians would thus be left out in the care of patients. Furthermore, numerous and additional bureaucratic hurdles are recommended, which would further complicate the prescribing of cannabis in the various forms of application.
In 2017, the German Bundestag passed the Cannabis as Medicine Act, which opened the way for therapies with cannabis on a broad scale and has enabled tens of thousands of patients with serious diseases to significantly improve their quality of life. According to the will of parts of the G-BA, however, the supply of the population with cannabis-based medicines is not to be made easier, but rather more difficult. In the worst case, patients would be forced (back) into illegality or would have to discontinue their therapy if access to therapies is made more difficult for them and they are not able to bear the costs themselves.
According to the assessment of the undersigned associations, the recommendations made by the G-BA contradict the objectives and the will of the legislator, which it pursued with the Cannabis as Medicine Act since 2017.
Furthermore, the proposed new regulations – in view of the planned legalization of cannabis as a stimulant – are a slap in the face of patients:inside, who have been successfully treated with cannabis-based medicines for years. While there is a debate about legalizing cannabis because the dangers to health from the black market with its associated risks are too great, in the worst case patients will be forced to grow their own cannabis.
Furthermore, parts of the G-BA draft guideline are a direct attack on the physicians’ freedom of therapy. While the current legal framework already sets major hurdles for the prescription of cannabis as medicine, in the future even fewer physicians would be able to decide on the right treatment method for their patients.
Last but not least, the current drafts of the new G-BA guideline are based on the findings of the accompanying survey, which on the one hand may not be understood as a scientific study and on the other hand only represents a fraction of the patients and is therefore not representative. Despite this methodological limitation, the authors of the accompanying survey conclude, among other things, that in almost 75% of the cases an improvement of the symptoms was achieved by the use of cannabis medicines. Reported side effects were common but generally not severe. Thus, it is very surprising that the now available drafts of the new G-BA guideline would significantly restrict access for cannabis-based medication, especially for SHI patients.
In the past five years, Germany has been admired as a role model for its pioneering role in the use of cannabis as medicine. Thousands of seriously ill patients have been able to significantly improve their quality of life. Governments in other countries around the world have been encouraged by the German experience to take appropriate steps themselves. But today we are faced with a roll backwards in medical cannabis, while at the same time we want to make three rolls forward in the stimulant sector. And this despite the fact that many patients, who are still unserved and under-served, were hoping for improvements in the Cannabis as Medicine Act, such as the abolition of the authorization requirement.
Patients need medical support and the possibility of reimbursement by health insurance companies. If we now do the roll backwards, we leave the weakest in our society – the seriously ill patients – out in the cold.
The associations have submitted their statements against the planned deterioration in the supply of cannabis medicines to the G-BA in due time and continue to advocate for steps forward in the field of cannabis as medicine as well.
The G-BA’s draft guideline on the future handling of cannabis as medicine can be found here.
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 e.V. (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 vis-à-vis 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 e.V. (BPC)
Contact: Christina Schwarzer, Geschäftsführerin
Phone: 030 235 939 590
The Federal Association of Pharmaceutical Cannabinoid Companies (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 “Medizinal-Cannabis – Health grows!” the German Medizinal-Cannabis Gesellschaft e.V. (DMCG) forms a platform for physicians:inside and connected occupational groups for common work 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 founded in 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: firstname.lastname@example.org / email@example.com
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.