Germany: medical cannabis cultivation postponed

Since June, 118 companies have applied for one of the future licenses authorizing the cultivation of medical cannabis in Germany. The licenses were supposed to have been issued in October by the Federal Institute for Drugs and Medical Devices (BfArM), but a complaint filed by the German company Lexamed against the BfArM delayed the final selection.

In Germany, the BfArM regulates the production of any substance that must meet the criteria of the Single Convention on Narcotic Drugs of 1961, which provides a framework for the supply and production of specific substances, including cannabis.

Companies seeking to produce medical cannabis in Germany must comply with many criteria to demonstrate their ability to grow, process, and supply medical cannabis.

The final selection is based, in particular, on the experience of the companies that have applied. Each producer must be able to supply at least 200 kg of medical cannabis per year. Applicants must demonstrate that they have already produced at least 50 kg of medical cannabis in the past three years and have knowledge in the field of agriculture.

These draconian criteria effectively exclude German companies, which have never legally cultivated cannabis in Germany due to its previous illegality. The only option for these companies is to form partnerships with foreign companies that already legally cultivate medical cannabis, such as those in Canada, the Netherlands, or Israel.

Lexamed’s complaint specifically targets the selection criteria. Until the dispute is resolved, the selection process has therefore been put on hold. If the complaint is upheld, the current selection process will become obsolete, and the BfArM will have to develop new criteria and give companies that have not yet cultivated medical cannabis the opportunity to enter the sector.

The main objection comes from German patients who are already having trouble obtaining their medication at pharmacies and who are seeing the backlog in domestic cannabis production grow.