Since March 2017, medical cannabis has been legal in Germany, launching a new domestic industry, and attracting the watchful eye of the global cannabis community.
Previously, the state had only accepted applications from around 1,000 patients who had navigated rigorous regulations in order to legally access cannabis treatments. However, as of March 2018, the number of applications to the health insurance companies has risen to 13,000, with over 60% of requests for reimbursement being approved.
As the Federal Ministry of Health announced earlier this year, eleven applicants have applied to the Federal Institute for Drugs and Medical Devices (BfArM) for an import permit for medical cannabis. In addition, applications are ongoing from existing licence holders looking to increase their import capacity.
But haste makes waste and Germany has experienced its fair share of speed bumps on the road to medical cannabis legislation. Last month, the courts in Düsseldorf ruled that on the basis of the previous tender no cultivating licences can be granted. As a result, a new tender must be arranged, which won’t begin for another six months at least, frustrating both foreign and domestic companies who were keen to cash in on the new program.
The German cannabis market, now the largest in Europe, is clearly taking off, both in terms of the number of medical cannabis patients and the volume of cannabis imported from international market. But the deconstruction of archaic cannabis laws brings a whole new set of commercial rules as Germany aims to import medical cannabis and introduce a domestic cultivation sector. We spoke to German Lawyer and industry expert, Kai-Friedrich Niermann, who ran us through the most recent developments in the German cannabis industry.
On domestic cultivation plans…
In order to meet the further demand for medical cannabis in Germany, the [recent] amendment also provides for the production of medical cannabis in Germany. For this, the cannabis agency within the Federal Institute for Drugs and Medical Devices is responsible. It provides [regulation] the control of the cultivation, harvesting, processing, quality inspection, storage packaging and delivery to wholesalers and pharmacists or manufacturer. However, after harvest is completed, the cannabis is not transported to BfArm, but the distribution is handled by the respective growers and the other contracted companies.
The cultivation of cannabis in Germany is made exclusively for medical purposes. As such, it must also meet the requirements of the Good Agricultural and Collection Practice (GACP), and the German monograph for "cannabis flowers". Then the Cannabis Agency will set a factory price and sell medical cannabis to wholesalers and pharmacies.
On the long and winding road of import applications...
A prerequisite for the import is that the cannabis can be dated back to its original source, which is a licensed medical producer under the exporting states control. These laws are the result of the 1961 single convention on narcotic drugs.
In addition, import applicants must also have permits for cannabis testing, nationwide official permits by the Medicines Act, the import permit, the wholesale licence, and the manufacturing authorisation.
The importing company must appoint a ‘narcotics officer’ who has sufficient expertise. Expertise can include a university degree in biology, chemistry, pharmacy or human / veterinary medicine or the testimony of a vocational training as a wholesale pharmaceutical merchant.
On the possibility of full legalisation…
In July 2017, The Green Party introduced a bill, known as the ‘Cannabis Control Law’, to the German Federal Parliament proposing the complete legalisation of cannabis . The law provided a complete decriminalisation of users, and a regulated market for cultivation, wholesale, speciality shops, processing and import. During the negotiations, the FDP and the Left Party joined forces to create a pro-legalisation coalition. However, the current ruling coalition does not necessarily agree on the issue. Several initiatives for the controlled sale of cannabis have been proposed in the Bundestag but the government is yet to vote.
Most recently, the Federation of German Detectives has advocated for legalisation and it remains an exciting proposition as the Grand Coalition has made significantly more progress than any previous government.
The German cannabis industry is only going one way - international. Medical cannabis patients have grown 1200% in a single year and simultaneously, the government has, albeit hastily, introduced a series of licences for both domestic and international cultivators. Germany has ignited a fire in the heart of the European cannabis community and provided a bright spark of hope for advocates and entrepreneurs alike.
For more reading on the German cannabis industry, check out our country review: https://www.prohibitionpartners.com/european-country-review/2017/6/21/germany-leads-the-european-medical-cannabis-market
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