Medical use of cannabis products. Lessons to be learned from Israel and Canada
J. Ablin, P.A. Ste-Marie, M. Schäfer, W. Häuser, M.-A. Fitzcharles
Der Schmerz, 2016, 1-10
© Deutsche Schmerzgesellschaft e.V. Published by Springer-Verlag Berlin Heidelberg – all rights reserved 2015
Introduction : The German government intends to reduce the barriers for the medical use of cannabis products. A discussion on the indications and contraindications of the medical use of cannabis and on the changes of the regulatory framework has already begun in Germany. It is useful to draw from the experiences of other countries with a more liberal medical use of cannabis.
Methods : The Israeli and Canadian experience is outlined by physicians who have been charged with expertise on the medical use of cannabis by their jurisdiction.
Results : In Israel, only the plant-based cannabinoid nabiximol (mixture of tetrahydrocannabinol/ cannabidiol) can be prescribed for spasticity/chronic pain in multiple sclerosis and for cancer pain. The costs of nabiximole are reimbursed by some, but not by all health maintenance organizations. The medical use of marijuana is permitted; however, it is strictly regulated by the government. Selected companies are allowed to produce marijuana for medical use, and only certain physicians are licensed to prescribe marijuana as a therapeutic drug for specific indications such as chronic neuropathic, and cancer pain, inflammatory bowel diseases, or posttraumatic stress disorder if conventional treatments have failed. The costs of marijuana are not reimbursed by health insurance companies.
In Canada, synthetic cannabinoids and the plant-based (nabiximol) are licensed for neuropathic and cancer pain, HIV-related anorexia and chemotherapy-associate nausea. The costs of these synthetic cannabinoids are covered by health insurance companies. The medical use of marijuana as a treatment option is allowed for individual patients suffering from any medical condition when authorized by a medical practitioner or nurse. Licensed producers are the only source for patients to newly access medical cannabis, although those with previous permission to grow may continue cultivation at the present time. The costs of marijuana are not reimbursed by health insurance companies. There are multiple contraindications for the medical use of cannabis products in both countries.
Conclusions : The use of standardized, synthetic, and plant-based cannabis products should be allowed in Germany for defined medical conditions when high-level evidence of efficacy and safety exists. The costs should be reimbursed by the health insurance companies. Contra-indications for the medical use of cannabis should be defined. Growing marijuana by patients for their medical use should not be allowed.
Keywords : Cannabinoids · Herbal cannabis · Medical use · Israel–Canada · Regulatory framework
In Germany, the only manufactured drug containing cannabinoids is a nabiximol containing oromucosal spray which isv approved for the management of severe spasticity in multiple sclerosis refractory to conventional treatment. In addition, dronabinol and nabilone can be provided off-label by physicians with a narcotic prescription on a single patient basis, for palliative care and chronic pain . In principle, reimbursement of costs is possible by health statutory institutions if conventional treatments have failed. In most cases, German health statutory institutions refuse the cost transfer of between 300 and 600 €/month. In addition, patients can receive extracts or flowers of cannabis by a pharmacy after receiving an exceptional permission according to §3 Absatz 2 of the German Narcotics Act (Betäubungs mittelgesetz) by the Federal Institute of Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) . The costs of up to 1500 €/month are not covered by the health insurance companies. On July 22, 2014 the administrative court in Köln ruled that three severely ill patients could grow marijuana for medicinal purposes. The court determined that growing cannabis plants is allowed if conventional treatments have failed, if there is no therapeutic alternative to cannabis, and if the pharmaceutical cannabinoid preparation is prohibitively expensive for the patient . All patients suffered from chronic pain and had received permission from the Federal Opium Agency to use cannabis flowers . In 2014, the medical use of cannabis was approved for only 109 patients .
The German government has lodged an appeal on points of law against the decision of the court in Köln and has announced a legislative project. According to the federal drug representative Marlene Mortler and the federal minister of health Hermann Gröhe the barriers for the medical use of cannabis as medication should be reduced. The costs should be covered by the health insurance companies .
The Drug Commission of the German Medical Association (Arzneimittelkommission der Deutschen Ärzteschaft) currently does not recommend the use of medical cannabis because the concentrations of cannabinoids can vary widely and contaminations, for example, pesticides can harm the patient . The German Pain Society has recommended the use of synthetic cannabinoids for specific indications after established treatment options have failed, and when potential contraindications, comorbidities, and patient preferences have been taken into account .
While discussing potential indications for cannabis and changes of the regulatory framework it might be useful to consider the experiences of countries with a previous and often more liberal prescription practice of cannabinoids. Although medicinal cannabis has been available in various states in the USA over the years, each with unique health-care regulations, we will confine this review to the experience of two countries that have overreaching health-care policies applicable throughout the country and likely more applicable to the German context. Therefore, we will examine this issue from the Canadian and Israeli perspective. Canadian and Israeli physicians who were charged by their jurisdictions with a medical expertise on medical cannabis in pain medicine and rheumatology will outline their viewpoint with regard to the following points in their countries:
-The historical background
-The legislative framework
-The indications and contraindications of natural and synthetic cannabinoids
-The problems associated with medical cannabis
They discuss which lessons could be learned by German physicians and the German government from the Canadian and Israeli experience.