German company Lexamed has successfully filed a lawsuit against the Federal Institute for Drugs and Medical Devices’ (BfArM) selection process for medical cannabis cultivation in Germany, delaying selection and implementation of the country’s medical cannabis cultivation program.
t the beginning of June, 118 companies had applied for a medical cannabis cultivation-license in Germany. Until Lexamed’s appeal against the application criteria is heard by the Düsseldorf Higher Regional Court Dec. 20, official application evaluations, which should have been decided in October, are suspended.
Criteria Favors Experience
Generally, the BfArM regulates any production that must be done in compliance with the U.N.’s Single Convention on Narcotic Drugs of 1961, an international treaty that set regulations for the supply and production of specific drugs, including cannabis.
Cultivation applicants are required to meet many criteria to prove their capacity in the field of growing, processing, and supplying medical cannabis or growing phytomedicinal products in general. In a staged lottery, ten licenses are distributed by drawing lots among all applicants fulfilling the required criteria. For every hundred kg of cannabis grown, applicants earn 10 points, with a maximum of 40 points. So, if an applicant can prove they’ve already grown 200 kg of medical cannabis within the last three years, they will have already satisfied two-thirds of the minimum criteria. A maximum of 20 additional points is awarded based on references for the other herbal medicinal products.
If fewer than ten companies meet the requirements, licenses will be given to the applicants with the most points. Each cultivator is expected to deliver 200 kg of medical cannabis per year. For the period from 2019 to 2022, around 6.6 tonnes were scheduled for cultivation. To ensure each applicant is able to produce enough cannabis for a period of 65 months, up to seven lots per applicant may be awarded.
In order to achieve the maximum score of 60 points, candidates must demonstrate experience in growing at least 50 kilograms of medicinal cannabis within the last three years and have references in the cultivation field.
Only applicants who could prove they had already made finished drugs from medical herbs could earn the highest score.
Additionally, cannabis “made in Germany” will be subject to some of the strictest standards. In the Netherlands and Germany, test results for THC and CBD content must be within a +/- 10-percent deviation. In Canada and the Netherlands, the allowable deviation is 20 percent. For example, if a product is expected to test at 20 percent THC based on any previous testing, but tests at 35 percent, that’s allowable in Canada or the Netherlands as long as the THC percentage is clearly labeled on the product. In Germany, that crop would fail, so even if producers are awarded licenses to cultivate, they have very little room for error.
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