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Germany / Deutschland

Source: Franjo Grotenhermen

Last update: Juli 2018

Laws

Cannabis is listed in annex I of the Betäubungsmittelgesetz (narcotics law) of substances that cannot be prescribed and marketed. Substances listed in annex I are cannabis, mescaline, heroine, LSD (Lysergic acid diethylamide), methoxyamphetamine, PCP (phencyclidine), psilocybine, among others. Cannabis produced for medicinal purposes are listed in annex III.

Substances listed in annex I can only be used for "scientific and other purposes of public interest." 

The cannabinoids nabilone and dronabinol as well as the cannabis extract Sativex(R) are listed in annex III of the Betäubungsmittelgesetz of substances that can be prescribed on a special prescription for narcotics. 

Also listed in annex III Cannabis (marijuana, plants and parts of plants belonging to the genus Cannabis), only those grown for medicinal purposes under State control in accordance with Articles 23 and 28 (1) of the 1961 Single Convention on narcotic drugs, and in preparations authorized as finished medicinal products.

The current law on the medical use of cannabis and cannabinoids, which came into effect on 10 March 2017, includes amendments to various laws, including the Narcotics Act and the Social Code (German Bundestag of 18 and 19 January 2017). In detail, the following changes have occurred:

● Cannabis flowers and pharmaceutical grade cannabis flower extracts have become prescription medicines by rescheduling into schedule III of the Narcotic Law. This means that there is no longer a need for requesting approval by the Federal Institute for Drugs and Medical Devices.

● Cannabis flowers and extracts may be prescribed on a narcotic prescription by any general practitioner for any indication where the doctor and patient anticipate potential benefit. However, physicians must clarify the question of reimbursement by the health insurance provider. A private prescription, where the patient bears the cost of the drug itself, is also possible at any time. Veterinarians and dentists do not have the authority to prescribe these preparations.

● The maximum amount for prescription for a 30 day period was set at 100 grams of cannabis flowers without restriction to any particular variety. It is up to a doctor to prescribe several varieties at the same time. If the demand is higher, the maximum levels may be exceeded by using an exceptional mark, which also allows other narcotics to exceed the maximum level.

● The cost of cannabis-based  medicines such as nabiximols (Sativex®), nabilone and dronabinol as well as cannabis and cannabis extracts should be covered by the health insurance companies  subject to conditions. A permit from the health insurance provider has to be obtained before the first prescription is issued. Insurance providers need to make their decisions within 3 weeks of receiving the application, and can only turn them down if they have strong justification. If the insurer decides to obtain expert advice (medical service of health insurance), the decision period is extended to 5 weeks. In the case of planned prescription in the context of specialized outpatient palliative care, the decision must be made within 3 days after receipt of the application.

● The first requirement for the prescription of a cannabis-based medicine is that a generally accepted form of  treatment is either not available or, in the individual case according to the reasonable assessment of the physician, cannot be applied, taking into account the expected side effects and the disease state of the insured. Furthermore, there must be a serious illness and a not altogether remote prospect of a noticeably positive effect on the course of the disease or on serious symptoms.

● The doctor must participate in an anonymous survey and inform the patient in advance. This companion survey will take place over a period of 5 years. The Federal Ministry of Health determines which data a doctor must send to the Federal Institute for Drugs and Medical Devices (BfArM) and how. The data are used by the BfArM in an anonymous form and used and stored exclusively for scientific monitoring.

● Controlled cultivation of cannabis will be organized in Germany: There should be a state-controlled cultivation of cannabis in Germany in order to better respond to future needs and not be completely dependent on imports. Until the implementation of cultivation in Germany, the need for cannabis flowers must be covered by imports, currently from Canada and the Netherlands. For this purpose, a corresponding office for medical cannabis was set up at the Federal Institute for Drugs and Medical Devices.

● Patients may bring cannabis and flower extracts, as well as other narcotics, abroad for a maximum of 30 days accompanied by a certified attestation, if permitted by the country visited.

Problems 

Several issues emerge that prevent seriously ill German citizens, who could benefit from cannabis or cannabis-based therapy, from receiving such treatment.

Cannabis has since doubled in price. For cannabis flowers, this is due to a new review by the pharmacy, although flower material has already been tested several times in advance. Cannabis flowers were not considered a medicinal drug before the law came into force. The pharmacies had taken the doses of 5 grams of cannabis from the importer and delivered them to the patients generally at a modest premium. At purchase prices of about 9-10 € per gram, the selling prices were generally at 12-15 € per gram, about 60-75 € per can of 5 grams. This was already relatively expensive by international standards. After the prescription of the cannabis flowers, these are considered medicinal products. Since cannabis is not a finished medicinal product, pharmacies must automatically treat it as an extemporaneous  mixture, meaning that pharmacists need to ensure that the content really is cannabis. The patient is then obliged to pay 100% on the purchase price, which leads to sales prices of 20-25 € per gram,  causing significant problems for those who require a large doses and whose treatment costs are not covered by their health insurance.

Many doctors who prescribe cannabis are worried about recourse claims, which is compounded by inappropriate price increases for cannabis products after the law came into force. Excessive warnings from some medical associations have even lead to some doctors who were previously prescribing cannabis to cancel the treatment again. Regressions are penalties that physicians have to pay if they have not acted economically in their medical expenses at the expense of health insurance companies. A recourse claim is determined by a board of examiners and threatens whenever physicians have high drug costs compared to other physicians.

The prescription of cannabis or cannabis-based medicines is also associated with a bureaucratic overhead for physicians, since for each patient a cost transfer application must be made to the health insurance. In addition, the physician will also have to fill in a form of 14 questions for every patient covered by public but not private health insurance. The objective is to collect data on the efficacy and side effects of cannabis treatment.  Though efforts have been made not to impose any undue burden on medical professionals, the filling in of each form is estimated to take between 15-20 minutes at the end of each course of treatment. The shift from one medicine to another is assessed, as the termination of one course treatment and the beginning of another, will therefore have to be recorded. Though, a switch from the buds of one cannabis strain to another are not.

Although the law only allows health insurers to refuse the reimbursement of medically prescribed cannabis in exceptional cases, it is common practice to submit applications for reimbursement to the competent medical service of the health insurers for review. These are external assessors who, on behalf of health insurances, check the need for a particular therapy. According to published figures of some health insurance companies, so far about 60% of the applications are granted positive and 40% rejected often for reasons that are not taking account of the patient's welfare. The number of rejections cannot be called exemptions as written in the law. 

In spite of the accompanying research, which should take into account the fact that there is currently insufficient clinical data on the efficacy of cannabis treatment for many indications, health insurance companies often require physicians and patients to cite such studies as a prerequisite for reimbursement.

Overall, treatment with cannabis or cannabis-based medicines is unattractive to physicians in Germany, which means that many patients can not find a doctor and continue to have to treat themselves illegally.

 

 

 

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