As predicted in December, the cultivation of medical cannabis in Germany will be delayed. On Wednesday, the Düsseldorf Higher Regional Court issued a ruling on a 2017 lawsuit, VII-Verg 40/17, that challenged the process of issuing cultivation licenses for medical cannabis, saying the licensing process was too short for cultivators to be able to prove they had the experience necessary to meet Germany’s cultivation requirements.
The Higher Regional Court stopped the procurement process for the cultivation and delivery of the first 6.6 tonnes of cannabis. The Federal Institute for Drugs and Medical Devices (BfArM) may no longer follow through with the permissions as scheduled, a court spokesman confirmed after the verdict was spoken. The first harvest under state supervision was planned for 2019. In his prelude, presiding judge Heinz-Peter Dicks criticized the BfArM had set the deadline for the award procedure too short.
“That deadline should have been extended,” said Dicks.
The application process was poorly prepared
The applying process was conducted by a staged lottery in which 10 licenses were to be distributed by drawing lots among all applicants that fulfilled the required criteria.
For every hundred kilograms of cannabis grown, applicants earned 10 points, with a maximum of 40 points. So, if an applicant could prove they’ve already grown 200 kg of medical cannabis within the last three years, they had already satisfied two-thirds of the minimum criteria. A maximum of 20 additional points were awarded based on references for production of other herbal medicinal products.
For the period from 2019 to 2022, around 6.6 tonnes of cannabis were scheduled for cultivation. To ensure each applicant would be able to produce enough cannabis for a period of 65 months, up to seven lots per applicant could be awarded. If fewer than 10 companies met the requirements, licenses would have been given to the applicants with the most points. Each cultivator was expected to deliver 200 kg of medical cannabis per year.
The recent verdict means the schedule for the medical cultivation program remains unclear. Attorney Heike Dahs, who represented the BfArM in the process, said the ban was “very bad” for the care of patients. “Of course it will not hold the 2019 deadline,” said Dahs.
The BfArM now has two options: either the application deadline will be extended or a completely new application procedure has to be presented soon. In the best case, production will be delayed for at least one year if the BfArM properly addresses the licensing issues. Until then, Canadian companies will have to supply the majority of German patients to bridge the resulting supply gaps.