Questions and answers on medical cannabis issues as published from the German government
Recently, the German Bundestag published the following parliamentary questions on the topic of medical cannabis along with the government’s responses.
The questions were posed by MPs of the Die Linke German party to the German government.
Question 1: What is the maximum quantity of cannabis which could be imported under currently active licenses?
Answer: Eighty-seven individual permits to import medical cannabis are currently active, with a total capacity for 191,090 kg/annum.
The permits allow for different quantities, ranging from 10 to 23,240kg per annum with the average being 2,196kg per annum.
Question 2: What quantities of finished medicinal cannabis products have been imported to Germany since 2017?
Answer (see table)
Question 3: How many patient records does the BfArM have data on from its official survey?
Answer: BfArM has 13,343 complete records.
According to Prohibition Partners it is estimated that over 128,000 patients receive medical cannabis in Germany annually.
Question 4: What is the current price per gram of cannabis medicine for patients with a private prescription? Will domestically produced cannabis be sold at a lower price?
The price for unprocessed flower is set under §4 of the Drug Price Regulation whereby a fixed surcharge of 100% is applied to the pharmacy purchase price of cannabis flowers plus packaging and sales tax. The Federal Government does not have any other information on the predicted pricing of flowers.
Question 5: What are the main indications for which medical cannabis is prescribed?
Question 6: What is the reason why 40% of applications for reimbursement of medical cannabis are rejected by insurers, considering rejection is only meant for ‘exceptional’ cases?
Reimbursement is meant for cases where no standard and approved medicine is effective for the given patient’s condition and where there is a reasonable chance of efficacy of the cannabis medication.
Question 7: Has the government discussed these issues with insurers?
Not to date.
Question 8: Why is the rejection rate so high?
The approval rate is at 60%. Some may be rejected for incorrect filing of applications. Also, we do not know the approval rate for any follow-up applications, which might be granted after an initial refusal.
Question 9: As the government does not know the exact number of medical cannabis patients, how does it estimate how much medical cannabis is needed?
The Federal Government does not see its role as guaranteeing the supply of medical cannabis, as this is guided by the free market in Germany and further afield. We do not expect any supply difficulties, as imports and domestic production combined should be sufficient.
Question 10: Does the Federal government think new legislation is necessary to fix this rejection rate?
No such legal measures are currently planned.
Question 11: When will the first domestic harvest of medical cannabis be made available?
The German government expects the harvest to be sent to the BfArM in May 2021.
Question 12: What steps does the government think should be taken to lower the price of medical cannabis?
New regulations on pricing came into effect in March 2020 whereby a fixed price of €9.52/gram is applied to all medical cannabis varieties. In addition, pharmacies can apply a fixed surcharge based on the quantity of medical cannabis flowers being prescribed. The government does not see a need for further action on this point.
Source: Prohibition Partners
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