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Is cannabis about to have its moment in Germany?

The highly anticipated Cannabis Act (CanG), which would allow private and club-based cultivation for recreational adult use, is back on the German Bundestag (Parliament) docket. Although the law's proponents are looking toward early April for it to come into effect, other lawmakers are intent on holding it up, citing concerns about increased youth access and crime. Bavarian officials have even gone as far as to caution that if the law is passed in February, Germany would become the "Colombia of Europe."

Latin American comparisons aside, questions remain regarding the effect that cannabis liberalization would have on medical cannabis. "Medical cannabis would no longer be a narcotic," Parissa Hajebi, a spokesperson for Germany's Federal Ministry of Health, told Medscape Medical News. The plan is to regulate cannabis within the framework of a separate act (MedCanG), which "would alter restrictive prescription requirements."

Concurrently, it might also remove a few of the shackles that have restricted research, according to Franjo Grotenhermen MD, executive director of the German Association for Cannabis as Medicine and the International Alliance for Cannabinoid Medicines. "If cannabis is removed from the Narcotics Act, it could make research easier, as the handling of narcotics in clinical research is much more complicated than with normal medicines," he said.

Traversing the Landscape

Because cannabis has been scheduled under the German Narcotic Drugs Act, both researchers and clinicians have had to coordinate cannabis-related disease management and investigations directly through the German Federal Institute for Drugs and Medical Devices (BfArM). On the clinical side, this has meant coordinating with BfArM for narcotic prescription forms that permit patients to visit designated pharmacies to obtain their medicine, ideally on the federal insurers' dime.

But Christian Kessler, MD, senior researcher at the Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, and internal and integrative physician at Immanuel Hospital Berlin, Berlin, Germany, noted that the lane for reimbursement has been narrow. "You have to prove that you have a severe disease burden. And you have to demonstrate, with medical records, that you have tried everything according to conventional clinical guidelines related to your diagnosis and regular treatments have not been sufficiently effective," he explained.

Moreover, approved coverage has mostly been limited to synthetic, pharmaceutically produced tetrahydrocannabinol (eg, dronabinol) vs cannabis flower. And findings from an analysis of data from BfArM and the Barmer Ersatzkasse health insurance fund underscored that certain conditions — namely, noncancer pain and oncology and palliative situations — carry more favor among insurers vs others, especially psychiatric.

The rationale, at least in part, might be due to the dearth of studies in psychiatric vs pain conditions. Not only is "high-quality data missing in the field of depression but so are systematic observational studies," said Michael Specka, a psychiatrist and researcher at LVR-Hospital Essen and the University of Duisburg-Essen, Essen, Germany, speaking to Medscape Medical News.

Specka is the lead author of a recent naturalistic study that examined how outpatients with major depressive disorder were being treated via one of Germany's largest telemedical cannabis platforms — Algea Care GmBH — and their response to vaporized, inhaled cannabis flower.

In this small trial of 59 patients, mean depression scores (measured on a 0-10-point rating scale comparable to the Beck depression scale) decreased from 6.9 points at baseline to 3.8 at 18 weeks; 23.7% (14/59) of the cohort experienced declines by 50% or more. Specka said the team was intrigued by the number of male patients, which may indicate that cannabis could be a means to get more male patients with depression into treatment. "There was also some restraint in dose changes (between 12 and 18 weeks), which we expected to increase more. It remained quite stable," which Specka believed helps validate that many patients who use cannabis to treat depression might do so responsibly.

Grotenhermen, of the German Association for Cannabis as Medicine, noted that when he first started out in cannabis medicine, the focus was on physical not psychological ailments, an important reason why a data desert exists in psychiatric diagnoses. But this does not mean that it doesn't have a place. Researchers are studying a host of conditions ranging from attention-deficit/hyperactivity disorder to anxiety to learn if cannabis can help where other traditional medications have not.

Cannabis Conundrum

Cannabis medicine data gaps have left patients, clinicians, and researchers between a rock and a hard place. Even with the ease in German regulations, it's likely that many primary care practitioners will avoid or even evade patient requests for cannabis prescriptions; reliable, randomized controlled evidence is only available for a few conditions such as chronic pain, multiple sclerosis, and epilepsy.

"I'd like to see more funding from the public and private sectors to get to this next level, a stage where we can take this further based on good evidence," said Kessler. "Until we get on that track, we have to make do with other kinds of evidence, for example, cohort studies, observational studies, etc."

In the interim, researchers like Specka are looking toward telemedicine cannabis companies to provide the data they collect on patients who opt to skip the general practitioner's office and access prescriptions through clinicians. This may raise other issues, like inadequate training in cannabis medicine, depending on the platform.

It's a conundrum that has been 70+ years in the making due to global prohibition, noted Kessler. "I'd like to see a more sober discussion in the medical arena. Cannabinoids are not a golden bullet. But let's try to see where it makes sense, where it doesn't, if the evidence is there, and use it like any other prescription drug based on a regulatory framework."

Quoted sources had no disclosures of interest.