Phytocannabinoids from medicinal hemp act on the endocannabinoid system of the human body, which is involved in the regulation of a diversity of physiological functions, while displaying a very favourable safety profile. Many patients use cannabis as a replacement for prescription drugs that have a more unfavourable safety profile. Medicinal cannabis follows strict pharmaceutical quality standards regarding active ingredient content, stability and purity and may be prescribed by any medical doctor since March 2017 in Germany, with the costs covered by the statutory health insurance funds.
The legalisation of cannabis for medicinal purposes has been the subject of controversial discussions for many decades, even though the therapeutic use of cannabis has already demonstrated positive effects in several countries. As an example, the consumption, abuse, as well as mortality due to (accidental) overdose of prescription drugs (e.g. opioids) has verifiably decreased in US states where medicinal cannabis is legally available.1
A 2017 cross-sectional study with 2774 cannabis consumers that was published in the Journal of Pain Research revealed that 46% of those surveyed used cannabis as a replacement for prescription drugs. While these figures only illustrate self-reported data, certain tendencies are observable: the most frequently substituted classes of drugs were narcotics/opiates (35.8%), anxiolytics/benzodiazepines (13.6%) and antidepressants (12.7%).2
The plant cannabinoids contained in cannabis, particularly THC and CBD, modulate the body’s own endocannabinoid system (ECS), which is involved in the regulation of a wide variety of physiological functions (nervous system, immune system, cardiovascular system, gastrointestinal system, muscles, bones, skin). This also explains the broad therapeutic potential of the plant3. Following a 1961 UN Convention, cannabis has been categorised as an illegal drug, on a par with heroin or cocaine, which has hindered research regarding its medicinal properties and controlled clinical application in recent decades. Although cannabis has been used as a medicinal plant for thousands of years4, which in itself should be considered a testimony to its efficacy and safety, numerous doctors and pharmacists oppose cannabis as a medicine with disproportionate scepticism.
According to the World Health Organization (WHO), in 2015 an estimated 183 million adults consumed cannabis world-wide; it is thus the most commonly consumed illegal substance – it was not possible to erase 10,000 years of co-evolution of humanity and this cultivated plant within a few decades. The WHO subsequently responded and reevaluated the risk of (recreational) cannabis consumption in 2018: marihuana is now considered a “relatively safe drug” which, in contrast to heroin, cocaine but also legal substances such as alcohol, nicotine and various medicines, has never led to fatal overdoses. At most, they deliver a warning regarding possible acute side effects, including an impaired short-term memory formation, reduced motor control as well as potential risks for the cognitive development of adolescents.5
Previously, the BfArM (Federal Institute for Phamaceutical Drugs in Germany) had granted certificates of exemption for the treatment with cannabis according to § 3 (2) of the BtMG (German Narcotics Act) for the following diagnoses7: