Since Germany legalized cannabis for medical use in 2017, we have frequently spoken to Peter Homberg, Partner and Head of the German Life Sciences Practice and the European Cannabis Group at Dentons, a global law firm. Over the years, Peter has provided us with regular updates on the European and German medical cannabis industry.
In this most recent interview, Peter and I discussed the latest developments in the German cannabis market, starting with changes in import quantities, the choice of logistics and wholesale services for German-grown medical cannabis, and what we can expect in Germany and Europe in the future.
Peter, Germany has been in dire need of higher quantities of imported medical cannabis for a while now. What’s the news there?
Every year, the International Narcotics Control Board (INCB), established under the 1961 UN Single Convention on Narcotic Drugs, defines the estimates of the demand for narcotic substances. At the same time, this has an effect on the annual maximum quantities for the import of narcotics.
Looking at the past, the quantities imported into Germany have significantly increased over the years. In 2015, the maximum quantity confirmed by the INCB for the import of cannabis for medical and scientific purposes into Germany was about 1,500 kilograms. When the liberalization of medical cannabis took place in 2017, the quantities increased to 10.38 tonnes. This amount remained stable at approximately 10.69 tonnes in 2018.
In 2019, patient demand increased dramatically and the INCB confirmed a quantity for the import of medical and scientific cannabis of about 20.77 tonnes. Thus, the annual maximum quantity for the import of cannabis to Germany had almost doubled in comparison to the previous year.
The essential question was what was going to happen in 2020? Due to unknown reasons – probably the coronavirus pandemic and the stagnation of new patients in doctors’ practices – the INCB first defined an import quantity of only 16.1 tonnes for 2020. Importers soon noticed that this amount would not be sufficient to meet patient demand.
Recently, the German Federal Institute for Drugs and Medical Devices (BfArM) reacted and filed an application with the INCB to increase the 16.1 tonnes by about 12.36 tonnes, which means we would reach over 28 tonnes of medical and scientific cannabis for import in 2020. The respective application is still pending and has not yet been approved by the INCB.
The estimated quantities by the INCB include cannabis for scientific and medical purposes, cannabis flowers for direct treatment of patients and for the manufacture of dronabinol, and extracts as well as the finished product Sativex® and other prescribable cannabis extracts.
Why is this increase in imported medical cannabis so important for Germany?
Last year, three licensed producers, Aurora, Aphria, and Demecan, started growing medical cannabis in Germany. However, I’ve seen statements from all three producers that it is highly likely we will not see the first harvest in Germany before the end of 2020, and that’s if everything goes well.
Nevertheless, the BfArM has informed the INCB that in 2020 an estimated 650 kg of dried cannabis flowers from cultivation in Germany will be produced for medical purposes.
Furthermore, patient demand is increasing continuously, which is why we still need imports of cannabis to meet the increasing demand. Currently, cannabis for medical purposes is only imported from three countries. These are Canada, the Netherlands, and Portugal. There are imports from other countries, but for research and development purposes only.
A number of European and foreign cultivators are currently looking at the German market and will probably export medical cannabis products to Germany in the near future. Covid-19 is causing some delays in this regard.
Recently, the BfArM was looking for a distributor for cannabis cultivated in Germany. What is the background and which company won the tender?
We are talking about the public tender for providing logistics and services in the wholesale of cannabis flowers for medical purposes for and on behalf of the Cannabis Agency of the BfArM. The Cannabis Agency is going to purchase the cannabis flowers harvested in Germany and will distribute it to the respective pharmacies. They will not distribute the products themselves but will be using a third party, which was the reason for this tender.
The tender process had 18 applicants and the Cannabis Agency recently decided in favor of Cansativa GmbH, a Frankfurt-based startup company. Cansativa is now the respective distribution vehicle providing logistical and wholesale services for the Cannabis Agency once the first cannabis flowers are harvested in Germany.
German cultivation of cannabis flowers includes a total volume of 10.4 tons for a period of four years. This quantity can increase by up to 150% of the annual planned requirement of 2.6 tonnes.
There has been a lot of discussion in Germany and on a European level about running clinical trials for medical cannabis. What are the latest developments there?
In Germany, physicians are actually obliged to inform the BfArM about the prescriptions for medical cannabis and the respective results on the patient side. They must document information concerning the indications they have prescribed cannabis for, the concentration of the prescribed product, and how patients responded to the therapy.
In other words, the BfArM conducts a large non-interventional observational study by collecting all of this data. Recent results showed that there is an overwhelming prescription of medical cannabis for chronic pain patients.
What developments can we expect in the future?
Currently, the German industry focuses on cannabis flowers. In the future, we will definitely see the development of alternative cannabis products, such as vaporizers or gel capsules.
The major obstacle at the moment is that cannabis for medicinal purposes is defined as an extemporaneous mixture, which means the pharmacist has to take a certain manufacturing step before selling the product. Without this manufacturing step, the product would qualify as a ready-made pharmaceutical, which would require marketing authorization.
As such, the industry is now looking at product options that will include the manufacturing step for the pharmacist to define the product as an extemporaneous mixture and not a ready-made pharmaceutical.
There are many different ideas of what can be done and we see an increasing intention to develop new products which may be even safer to consummate, easier to prescribe by physicians or have a higher active ingredient stability.
In our last articles, we have frequently discussed the harmonization process regarding cannabis in the European Union. What can we expect of this process in the future?
The harmonization process for medical cannabis in the European Union has somewhat stagnated. Together with two colleagues, I have therefore founded a new Brussels-based association, the European Cannabis Association.
We will work to influence the European harmonization process through the European Commission in favor of the medical cannabis industry. We will fulfill a number of tasks, but essentially, represent the European medical cannabis industry in Brussels.
Would you like to learn more about recent developments regarding the medical cannabis industry? Get in touch with Peter and his expert team at Dentons or check out the brand new European Cannabis Association here!
Or read our past interviews with Peter and follow the development of cannabis regulations in Germany and the EU since 2017: