Med. Cannabis / CBD: How can companies secure themselves?

Since March 2017, physicians have been able to treat their patients with severe illnesses such as
chronic pain, ancillary treatment to cancer therapy, epilepsy, etc., and have been able to provide
them with medical cannabis, which can be prescribed on prescription.
In the area of medical cannabis, high growth rates can be recorded with currently (October 2019)
already approx. 25,000-40,000 patients in Germany, in 1-2 years there could already be approx.
100,000-200,000 patients in Germany, in the longer term the number of patients could rise to
approx. 800,000-1 million patients.
Germany could become one of the largest markets for medical cannabis worldwide, whereby the
good health insurance system also offers advantages.
According to Dr. Späth & Partner Rechtsanwälte mbB, based in Berlin and Hamburg, more and more
companies are trying to enter the lucrative market for medical cannabis or cannabidiol (CBD).
Various venture capitalists, investors and family offices are also increasingly recognising the growth
opportunities in the medical cannabis sector in Germany and, according to Dr. Späth & Partner, are
now becoming more courageous to make an investment in the growth market of medical cannabis.
In a strong growth market they could still benefit from a “first mover” advantage.
In addition to countries such as Canada and the Netherlands, other countries such as Colombia,
Australia, New Zealand, Israel, Macedonia, Portugal or Poland and other countries could also be
available for export to Germany in the future. In some countries there is great interest in exporting
medical cannabis to Germany, and corresponding legislative changes are already in preparation in
some countries.
Countries that want to export medical cannabis to Germany usually have to have a “cannabis agency”
in their country, according to the UN Convention of 1961 only countries that have released cannabis
for medical purposes and not for leisure purposes are allowed to export to Germany.
However, interested companies wishing to import medicinal cannabis should be made aware that
the legal requirements for importing medicinal cannabis must always be taken into account, both in
terms of narcotic law and drug law.
As a rule, for example, the provisions of Section 72-74 of the German Medicines Act (AMG)
concerning the law on medicinal products must be observed alone; in order to apply for an import
licence, a competent person such as a doctor or pharmacist and a suitable warehouse for narcotics
must be proven. In the event of a violation, high fines or, in the worst case, even imprisonment may
be imposed.
Interested companies should also be informed that EU-GMP certification (Good Manufacturing
Practice) is required for the import of medical cannabis in order to ensure export to Germany and to
comply with the high quality requirements.
As a rule, international contracts must also be concluded here with manufacturers from e.g. Canada,
which places high demands on the international drafting of contracts, e.g. with regard to the place of
jurisdiction, because according to the observation of Dr. Späth & Partner, some importers from
Germany had chosen Canada as the place of jurisdiction in the contracts, for example, and in the
meantime have not only had positive experiences with this.
A further hint is also to be given: In various cases, especially if it was produced outdoors, medical
cannabis is treated with radioactive or ionising radiation in order to free it from pests or pesticides,
for example. Importers who import med. cannabis treated in this way should be aware that a special
licence is often required in accordance with the “Ordinance on Radioactive Drugs or Drugs Treated

with Ionising Radiation” (AMRadV). Of the more than 20 importers of medical cannabis in Germany,
Dr. Späth & Partner observes that only a few of them have received this AMRadV licence, although
some of them also import medical cannabis treated in this way. This can also lead to high fines in
some cases, especially since some federal states such as Brandenburg have become more cautious
with the approval according to § 52a AMG.
Companies from Germany and abroad wishing to import medical cannabis or CBD (cannabidiol) into
Germany must therefore comply with numerous civil and criminal regulations and are welcome to
contact Dr. Späth & Partner Attorneys at Law.

Med. Cannabis growing in Germany

In a press release dated July 20, 2018, the Federal Institute for Drugs and Medical Devices announced the requirements for the new tender for the cultivation and purchase of cannabis for exclusively medical purposes in Germany, which is expected to be available from cultivation in Germany from 2020.

According to the tender, a total of 10,400 kg of medical cannabis, spread over four years of 2,600 kg each, will be cultivated.

The new invitation to tender provides for 13 lots with an annual quantity of 200 kg each, and thus 3 lots more than the original invitation to tender, which was limited to a maximum of 10 lots and which had initially been stopped by the Higher Regional Court of Düsseldorf on 28.03.2018 (Ref.: VII-Verg 40/17).

The submission deadline for the offer has now been set for 22.10.2018 at 12.00 noon.

In Dr. Späth & Partner’s opinion, the new tender also brings some advantages especially for German applicants, since, unlike the original tender, cultivation experience with medicinal cannabis is no longer explicitly required and the purely German applicants were massively disadvantaged, as they could not yet have any cultivation experience at all due to the previous ban on cultivation.

Nevertheless, in the opinion of Dr. Späth & Partner, applicants or applicant communities should once again consider whether they can meet the quite high requirements:

A decisive criterion now is the price, because the supplier with the lowest price offer now receives 40 points.

Up to 60 additional points will be awarded for the quality of the technical equipment of the plant, quality of the technical and structural equipment, quality of the concept for cultivation, concept for the selection and training of personnel, as well as for the safety concept to prevent the unauthorized use of cannabis.

Thus, the requirements for a medical cannabis license are quite high.

Companies from Germany and abroad who wish to become active in the field of medical cultivation license or medical cannabis import to Germany can contact Dr. Späth & Partner Rechtsanwälte, we will be pleased to advise you.

We therefore advise you on the following legal issues in the medical cannabis law:

Cannabis cultivation license

Cannabis – Import License

Cannabis pharmacy law

Cannabis-medical and medical law

Cannabis real estate and -Grundstücksrecht (no brokerage)

Cannabis corporate and founding

Cannabis trademark

Cannabis Customs Law

etc.