Medicinal Properties

Thanks to regulatory changes, Germany is now the third-largest market for medical cannabis in the world. There are lots of legitimate opportunities for international investors in this lucrative growth market, from growing to ready-made medications.

June 2020

© REA/laif

It’s a growth industry. Prior to 2017, only around a thousand patients received treatment with medical cannabis, obtained through special permits. But in March 2017 the German government made medical cannabis more readily accessible, and patient numbers have skyrocketed ever since. In 2018 some 60,000 patients had been prescribed medical cannabis, and public health insurers covered almost 200,000 products.

With insurance companies in Germany now required to cover the cost of cannabis prescriptions, and health insurance being mandatory, the market is booming. London-based researchers Prohibition Partners reported in October 2019 that the German sector was worth almost EUR 74 million in 2018. By the end of 2019, public health insurers had covered over EUR 100 million of medical products. And the market volume is likely to be even bigger. Private health insurers also reimburse patients and patients can opt to pay out of their own pockets.

Regulation

Federal Cannabis Agency

The German government has had its own special department for cannabis since March 2017. The new cannabis agency is part of the Federal institute for Drugs and Medical Devices, the organization tasked
with licensing drugs and medical products, known as BfArM for short.

BfArM is responsible for licensing cannabis growers inside Germany – they started issuing permits for the first time in April 2019. The new agency is part of the Department for Special Therapies and will eventually be responsible for monitoring planting, harvesting and packaging, as well as the quality of cannabis in Germany. Until Germany harvests its first crop, most cannabis will continue to be imported from countries like Canada and the Netherlands, and the importation of drugs remains the responsibility of another department at BfArM, the Federal Opium Agency.

Germany’s first harvest

Thanks to the spike in demand, there are a number of opportunities for international companies. For example, before 2017, doctors were only allowed to prescribe proprietary medical products containing cannabinoids such as capsules or sprays. Thanks to the regulatory changes, they can now prescribe cannabis flowers and extracts of pharmaceutical quality as well.

Also in 2017, the German government established a special agency to issue the first call for tenders for the cultivation of medical cannabis in Germany. In 2019, three companies were given licenses – Canadian companies Aphria and Aurora and German start-up Demecan.

“In virtually all developed markets we see an incredible demand,” a spokesperson from Aphria told Markets Germany. “So we believe that there are tremendous opportunities ahead. To us, it is not only the size of the market, but also the mentality and level of sophistication that will drive the demand.”

Aside from pain management, cannabis has potentially many other medical uses especially in the field of psychiatric therapy, for example in treating ADHD and PTSD. © REA/laif

The three companies’ first German harvest is expected at the end of 2020. But because of the German government’s conservative approach to issuing licenses, local supply will probably cover less than 40 percent of current market demand. Presently the country’s entire supply is being imported, mainly from Canada and the Netherlands. Importers must go through a rigorous approval process to obtain licenses.

Dr. Marcus Schmidt, director of chemicals and healthcare at Germany Trade & Invest, believes that Germany’s supply issues are now a thing of the past – even if the market continues to grow as rapidly as it has been. “In addition to local production beginning later this year, there is now an established distribution system,” he explains, “with ample supply from other EU countries as well as from facilities overseas that have been certified according to EU guidelines for good manufacturing practice. And we expect the medical cannabis market in Germany to continue to grow at a very lucrative rate.”

At the same time, he is worried about a boom-and-bust scenario potentially hanging over the sector. “With hundreds of production licenses being issued overseas, and many companies focusing on rapid expansion and international investment more than they are on generating cash flow and ensuring their long-term viability, it won’t be surprising if a number of international suppliers go out of business in the next few years,” Dr. Schmidt cautions. “The key to success will not only be to guarantee product safety and the highest quality, but to develop a sustainable business model.”

More research, more education

That is why, says Schmidt, the medical cannabis industry now needs to shift its focus to more research and to educating medical professionals on the subject. “Both patients and doctors prefer clear guidelines regarding dosage, just as with any other pharmaceutical product,” he says. “Better research will provide more clinical evidence as well as a wider range of delivery options – such as pills, capsules, and tinctures – and will in turn support physicians with better knowledge about treatment options”.

Inside View

Cannabis: a legitimate medicine

Long-time cannabis advocate Franjo Grotenhermen is the founder of the International Association for Cannabinoid Medicines and a practicing doctor in the state of North Rhine-Westphalia. He talks about the potential and the pitfalls of the German cannabis market.

Which areas need more research and development in this growth market?

Many people think of cannabis as just pain medication, but that’s not the full picture. Even before the 2017 legislation, it was used to treat 50 different kinds of medical issues. There are several promising areas of research such as psychiatric therapy. We have seen good results in neurodevelopmental disorders like attention deficit hyperactivity disorder (ADHD) and compulsive disorders, as well as in post-traumatic stress disorder (PTSD). This has relieved concerns that cannabis could worsen psychiatric problems. I have over 200 patients with ADHD I’m successfully treating with cannabis, and there are also patients with compulsive disorders who have had success with the cannabinoid tetrahydrocannabinol (THC). That is supported by research done in other countries.

There are other areas such as autoimmune disorders like Crohn’s disease or rheumatic disorders where cannabis can be used as an anti-inflammatory. And certain dermatological conditions like psoriasis have been treated successfully as well. But for many other conditions – from restless legs syndrome to tinnitus – we have very little scientific research so far.

Is there a reason for the lack of R&D?

We have some cannabis companies in Germany that have capital but no apparent desire to do research. You can understand why. If they spend EUR 10 million on research that becomes publicly available, their competitors also profit from it. However, we do need more research. I am always trying to encourage this. In my opinion, it would be great if more companies worked together to support research projects.

At the end of the day, products backed up with research will be prescribed more often by doctors, who prefer to work on a scientific basis. And patients want to know the facts as well – does cannabis help 5 percent of patients with a particular condition, or 50 percent?

Which kinds of cannabis products do you think have the most potential? For example, should Germany be investing in more ready-made medications?

I believe everything has its place. Physicians usually prefer standardized, ready-made medications. They are more familiar with these kind of drugs that are also traditionally more likely to be covered by insurance companies.

On the other hand, the more familiar you become with cannabis the more you understand how the various extracts and strains work. If doctors and patients are more experienced with cannabis, they can more carefully calibrate treatments, for example by using a combination of oral preparations and flowers. The German market certainly needs more information on things like which strain and which active ingredient is good for which condition.

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