An amended law recognising cannabis as medicine and increasing its availability was unanimously adopted by Germany’s Bundestag (lower house of parliament) last Thursday.
The Act comes into force in March 2017 and regulates the use of cannabis medicinal products as a therapeutic alternative of last resort in patients suffering serious conditions.
Doctors prescribing cannabis will also need to submit details of diagnosis, treatment, dosage and side effects anonymously to the Federal Institute for Drugs and Medical Devices (BfArM). This will be compulsory in order for any medicines to be claimable under health insurance.
The aim of this data collection is gauge the impacts and effects on the long-term use of cannabis for medical purposes.
Medicines will only be prescribed if there is prospect of a noticeable positive effect on the course of the disease or on serious symptoms.
Germany is also to make cultivation of cannabis for medical purposes within it borders possible via a yet to be established state-owned “cannabis agency”. The agency will be integrated into the existing structure of the BfArM. A tender will be issued in due course for companies to vie for cultivation contracts.
Until the state-controlled cultivation can take place, the supply of cannabis for medical purposes in Germany will be met by imports. Patients will not be permitted to grow their own plants.
The law will replace the special exemptions system currently in place; a system that has been often criticised over the amount of red tape associated with it. Given the complexity of gaining a permit, just 1,020 patients have received an exemption. Those exemptions will remain valid for the time being after the amended law comes into force.
It was in May last year the German Government initially announced medical cannabis would be available from pharmacies in Germany this year to eligible patients, with health insurance companies and public health system covering the cost of prescription.
Under Germany’s program, cannabis as dried flower or extracts containing tetrahydrocannabinol (THC) and cannabidiol (CBD) will be permitted.
More on the announcement can be viewed here (in German).