Germany sets up new agency to oversee production of medicinal cannabis

BMJ 2017; 356 doi: (Published 08 February 2017) Cite this as: BMJ 2017;356:j706
  1. Ned Stafford
  1. Hamburg

Germany’s Federal Institute for Drugs and Medical Devices, known by the acronym BfArM, is creating an agency to oversee the cultivation of marijuana and the subsequent production of cannabis to be used medicinally, in line with a new law approved by the Bundestag, Germany’s lower house of parliament.

The new law legalises cannabis based medicines to treat pain, nausea from chemotherapy, and other chronic ailments. It mandates that Germany’s massive public health insurance system cover the cost of cannabis medicines prescribed by doctors. Under the previous law cannabis could be used for medical treatment, but the approval process on a case-by-case basis was long and complex, and patient use was negligible.

Under the new law, which was approved on 19 January, BfArM will create a “cannabis agency” within its existing Federal Opium Agency to ensure that cannabis used in Germany for medicinal purposes is of pharmaceutical quality. The cannabis agency’s duties will include contracting farmers to grow marijuana and monitoring for quality control during cultivation, harvesting, and storage. The agency will continue quality control monitoring during the cannabis extraction and production process and distribution to pharmacies.

BfArM is seeking to fill four new job positions related to medicinal cannabis, one of which is for a doctor with experience in pain or palliative medicine.1 The doctor’s duties will include evaluating patient data from doctors who are prescribing cannabis based medicines and guiding development of cannabis for use as a medicine.

A BfArM spokesperson told The BMJ that the doctor position would be based in the Federal Opium Agency, whereas the other three positions will be within the new cannabis agency. Two positions are for pharmacists with several years’ experience in inspection and quality control of medicines. One of those positions is at a higher level and requires fluent English.2

The new law stipulates that doctors should prescribe cannabis only as a last resort if patients cannot be treated in any other way and only “in very limited exceptional cases.” Supporters of the new law have emphasised that it does not legalise recreational use of marijuana or cannabis. The German health ministry said in a statement that doctors prescribing cannabis will be asked to provide anonymous patient information, including diagnosis, cannabis dosage levels, and side effects. The data will be studied in order to improve cannabis treatments.

BfArM said that medicinal cannabis in Germany will be dispensed by pharmacists either as cannabis extract in capsules or liquid form or as dried flower buds from the female cannabis plant. Germany will continue to import medicinal cannabis until German production overseen by BfArM is up and running.

As at 1 February, 1020 patients in Germany had obtained approval to use cannabis extract or dried flower buds, BfArM said. Using dried flower buds was the preferred method of 980 patients.

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