Cannabis-based medicine law and policy in Germany
Abstract
Background
Since 15 years a new discourse about therapeutic effects of psychoactive substances started in Germany in public and in scientific journals. For several years a political movement worked outside of parliament to fight for permission of the use of Cannabis for medical purposes. Also initiatives of the Opposition Parties (Green Party and Left Party) struggled to create the legal basis for Cannabis as Medicine. Opinion Polls (2014) showed that 82% of German population are in favour of Cannabis as Medicine. Since 2014 an initiative of the Federal Drug Commissioner started. The Ministry of Health and she got several hunderts of letters and emails of patients and relatives (no access to treatment, expensive medication (600 – 900 € per month, dependend on the black market, several cases of prosecutions against patients).
Results
For these reasons the Ministry of Health launched a Draft Bill of the Federal Government from 4th May 2016. Which got on 19 January 2017 a 100% Approval in the Parliament (!!!). This Law came into force on 11 March 2017: Recognition of medical therapy responsibility: No licenses required for physicians (large area supply: by GPs), No statutory limitation on the patients (i.e.: no exclusion of treatment of children), At the level of the narcotics law no indication restriction. Physician decides whether the conditions are given in individual cases after exhausting other therapies for treatment (that does not mean years of suffering!). The insurance service demand in the first regulation the approval of the insurance company, to be given before the start of delivery. A scientific survey is carried out and the history of therapy, diagnostic, dosage and side effects data has to be delivered to the Federal Institute for Drugs and Medical Devices (BfARM). More and more patients in Germany are turning to their health insurance companies to reimburse the costs of cannabis: the number of applications has increased to more than 13,000 according to a report of the health insurances companies (end of 2017). Approx. 64% had been approved. But there are still obstacles: - many doctors are not willing (not educated) to prescribe – price of Cannabis dried flowers is very expensive – not enough medication (dried flowers) available in pharmacies – health insurance deny payment). There is a State Control of cultivation and diversion (Cannabis Agency at BfARM): public tender procedure and narcotics legal permission procedures (Published on 4 April 2017); mandatory deposit requirement for the farmers to deliver all the cannabis to the state agency; placing on the market by Cannabis Agency. There had been 107 applications for participation submitted within the time limit. But: there was a decision of the higher Regional Administration Court in Duesseldorf (March 2018): BfAM had to retell the tendering procedure because of lack of time to submit applications. A renewed tender took place (July 2018). Decisions are not taken yet. It is to start with plantation in 2019 and first harvest in 2020. There are still other aspects of „Cannabis as Medicine“ i.e. application models for the patient: oral by smoking or inhaling or eating; effects only through heating?; application through smoking in combination with tobacco is risky; standardisation through regulations for medical application.
