Setbacks In Germany Due to Delays on Forward Reform

The regulatory mishmash that currently exists in Germany is putting both patients and other projects on hold, if not in limbo.
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There was much excitement in Germany last September in the German cannabis industry, in particular, when the new “Traffic Light Coalition” announced that they would finally tackle the particulars of full recreational cannabis legalization.

As spring begins to think about arriving, however, excitement has begun to fade in Germany with the repeated statements from government officials of late that there were more pressing priorities (from COVID to presumably the Russian-Ukraine crisis). 

In the meantime, the significant problems on the ground for both the industry and patients continue.

This is why, according to Kai-Friedrich Niermann, an industry specialist lawyer now pursuing a legal case against the German government on behalf of his clients to clarify rules on the importing of hemp: “The case for full and final reform is made every day, right now. In the courts, at the regulatory agencies, in the marketplace. There are many issues that will only be addressed by normalization of this market.”

Industry Setbacks

No matter that Cansativa in Frankfurt, the firm that won the BfArM issued (monopoly) contract to distribute German grown medical cannabis is suddenly proclaiming their excitement about the advent of the recreational market (particularly after their recent cash injection from Snoop Dogg) the reality is that recreational pot is still a few miles away yet. Beyond this, the medical industry is suffering from several big issues, starting with the expense of cannabinoid treatments, not to mention the government and health insurers’ reluctance to pay for them. 

In a case decided in Karlsruhe on Monday that is no doubt going to generate challenges rather than set case law, the Social Court ruled, unconvincingly and actually just repeating the 2017 statute, that patients may only receive such medicines in exceptional cases and under strict conditions. This is also discounting the fact that presumably the justices know how much danger and risk still exists for doctors.

Ärzte, as they are called in Germany, face footing the bill for the drug they prescribe to their patients in a situation of non-coverage by the insurers and government agency behind them. One presumes that any doctor taking that risk would be well-versed in the “last option” discussion already.

The plaintiff filed suit against the Medizinische Dienst Krankensicherung or MDK (the state-by-state arm of the public/private coalition that ultimately decides on medical cannabis approvals) and the patient’s health insurance company after he was denied compensation for an oral cannabis spray. 

The doctor wrote that his 27-year-old patient suffered from chronic pain syndrome (the most common reason medical cannabis is prescribed and approved in Germany). He also wrote that the patient could not alleviate the pain in his back and legs with other treatments. This is supposedly the test that is used in such cases, at least according to the 2017 law.

However, the court ruled that other treatments should also be tried.

The response from the cannabis industry here has been swift. “There are several things that need a dire update,” said Lisa Haag. Haag is a Berlin-based consultant, patient advocate, and CEO of of MJUniverse GmbH, which organizes educational events around cannabis and helps pharmaceutical companies understand the plant better. 

“These are awfully high if not contradictory barriers,” said Haag. “Why can’t the other suggested treatments happen in combo with cannabis? Beyond this, the direction is contradictory. As suggested by the court, they make you stop cannabis treatment. This is ridiculous. The expensive bureaucratic processes are still prohibiting access.” 

Haag also noted that this is just one court ruling, and others have put emphasis on the therapy responsibility of the doctor. It is widely expected that the patient will appeal to the tongue-twisting Landessozialgericht in Baden-Wurttemberg.

In addition to this decision on the medical discussion, there has been another setback for the industry—this time on the industrial hemp side. A German energy company, Leag, just announced this week that it was putting its two year experiment with hemp cultivation on open cast mining areas on hold. Leag was conducting the cultivation experiment to determine if new lines of business could be derived from cultivation of the plant, including products that might be made of industrial hemp.

The company also stated that it would revisit its decision if there was a “changed framework conditions or new developments that make the new line of business attractive and economically profitable again.”

“It is precisely these kinds of problems we report to the government, as it needs to know about them and begin to prioritize the passing of the law,” said Kai-Friedrich Niermann. “I won’t have as much litigation work of this kind, but for that I will not be sorry.”

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