Research on cannabis-based medicine is still lagging behind in Germany, despite the fact that the country has one of the most developed regulatory frameworks for medical marijuana in the European Union.
Over the past 20 years, patient interest in the use of cannabinoids to treat a variety of conditions has increased, according to the EU Monitoring Center on Drugs and Drug Addiction (EMCDDA). These include chronic and cancer pain, depression, anxiety disorders, sleep disorders, and neurological disorders.
Marijuana is also used to treat glaucoma while some people with Parkinson’s disease have had less tremors, but more clinical studies are needed in this regard.
The European Medicines Agency (EMA) Plant Committee has initiated some discussions on cannabis-based substances for medicinal purposes in order to agree on a common understanding of terms and definitions.
Some cannabis-based medical devices have already been approved in the EU and in some Member States are also available on an individual prescription or as part of pilot projects.
Germany is considered to be one of the most advanced European markets for hemp products for therapeutic purposes.
According to Franjo Grotenhermen, Managing Director of the International Association for Cannabinoid Medicines (IACM), there is no noteworthy public research on this topic in Germany.
The only ongoing publicly funded research in Germany is the clinical study on the efficacy of Cannabidiol CR (Arvisol), which began in 2015 and has a funding period of eight years.
Grotenhermen told EURACTIV that “a major problem in research into cannabis-based medicines” remains as clinical research can be carried out successfully with patented cannabis extracts.
However, as research on cannabis-based drugs often involves unpatented substances, additional resources need to be found. Grotenhermen said it was difficult to find a pharmaceutical company willing to fund research on unpatented substances “which cost millions of euros per study”.
He added that in the coming years, the use of unpatented cannabis-based drugs could possibly only be replaced by patented substances.
Legalization helps with research
In 2017, German law legalized the medical use of cannabis and cannabis-based drugs, making it easier to access cannabis products for therapeutic purposes.
Before the law was changed, only 1,000 patients were prescribed medical cannabis. In 2018, after the law was passed, doctors wrote about 142,000 prescriptions for medical marijuana only.
Following Germany’s example, a number of other European countries – including the Czech Republic, Italy and Malta – have developed guidelines that make it easier for patients to access medical cannabis.
According to Grotenhermen, the bureaucratic hurdles for carrying out clinical research have been significantly reduced, as cannabis and cannabinoids such as cannabis flowers, cannabis extracts and individual cannabinoids such as THC and nabilone can be prescribed by a doctor and thus prescribed as medicinal products.
“It is much more expensive to research with narcotics if they are not allowed to be used clinically, ie are not drugs,” says Grotenhermen.
Practitioners still have prejudice
The prescription of medical cannabis is only picking up speed in Germany, while in other countries there are still “entrenched prejudices” that are slowing down changes.
For Grotenhermen, all countries that have legalized the medical use of cannabis, such as Canada, the Netherlands and Israel, have gradually experienced widespread acceptance of these substances by doctors.
“There are always first pioneers who are very open. Then there are doctors who are approached by their patients and, over time, persuaded to try it out. Broad acceptance takes time, ”he said.
In the meantime, some patients do not benefit from the 2017 law as the research situation for some medicinal cannabis products is difficult. In addition, “most doctors are very skeptical and the health insurance companies do not cover the therapy costs,” said Grotenhermen.
[Edited Gerardo Fortuna]