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German Government Answers Questions on Medical Cannabis

German Government Answers Questions on Medical Cannabis
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Conor O’Brien, George Brown 


 

The questions were posed by MPs of the Die Linke (The Left) party and Prohibition Partners has delivered a full transcribe of the exchange in English with a simplified translation of the question and answer session.

Question 1

What is the maximum quantity of cannabis which could be imported under currently active licences?

Answer

Eighty-seven individual permits to import medical cannabis are currently active, with a total capacity for 191,090 kg/annum.

Prohibition Partners’ comment: 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)

 

Source: BfArM 

Prohibition Partners’ comment:

This is the first time that re-exported quantities of medical cannabis from the country have been published. See the discussion on the growth of imports to the German market here.

Question 3

How many patient records does the BfArM have data on from its official survey?

Answer

We have 13,343 complete records.

Prohibition Partners’ comment: We estimate over 128,000 patients receive medical cannabis in Germany annually.

Question 4

What are the main indications for which medical cannabis is prescribed?

Answer (data translated by Prohibition Partners)

Note, several other conditions were cited at 1% frequency or less. Also note in 33% of cases, the course of medication was discontinued before one year.

Question 5

Can you explain why 40% of applications for reimbursement of medical cannabis are rejected by insurers, considering rejection is only meant for ‘exceptional’ cases?

Answer

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.

Cont..

Q. Does the Federal government think new legislation is necessary to fix this rejection rate?

A. No such legal measures are currently planned.

Q. Has the government discussed these issues with insurers?

A. Not to date.

Q. Why is the rejection rate so high?

A. 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 6

As the government does not know the exact number of medical cannabis patients, how does it estimate how much medical cannabis is needed?

Answer

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 7

When will the first domestic harvest of medical cannabis be made available?

Answer

We expect the harvest to be sent to the BfArM in May 2021.

Prohibition Partners’ comment: See details on the cultivation tender here.

Question 8

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?

Answer

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 9

What steps does the government think should be taken to lower the price of medical cannabis?

Answer

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.

 

See original document published by the Federal Government here

Prohibition Partners will be diving deeper into these issues and the wider supply chain of Europe in their upcoming 6th edition of the European Cannabis Report.

For bespoke research, consulting and sponsorship opportunities, contact: info@prohibitionpartners.com

 


 

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