German drug agency president says: Cannabis flowers are only a temporary fix
From the point of view of the Federal Institute for Drugs and Medical Devices (BfArM), the current situation is also not optimal. BfArM President Professor Karl Broich told the Reuters that the long-term goal is to allow more cannabis-based drugs, not the flower.
Last week, German cannabis cultivation has progressed: on April 17, the Federal Institute for Drugs and Medical Devices (BfArM) awarded nine out of 13 contracts to Canadian companies Aurora and Aphria. This gives the green light for the cultivation of 7200 kilograms of the 10400 kilograms originally planned, over four years.
The BfArM not only regulates German culture, but also the current supply through imports. Critics such as Green and Left politicians find it too restrictive. But how does the “eye of the authorities” see the supply of cannabis in Germany?
"Cannabis is a systemic rupture"
Professor Karl Broich, director of the Federal Institute for Drugs and Medical Devices (BfArM), found clear words in an interview with Handelsblatt on Easter Sunday. The fact that cannabis is available as a drug under the law and not on the basis of evidence of efficacy is a “systemic break” for the physician. From the perspective of the licensing authority, however, this current “special approach” is only a temporary solution. The long-term goal is to allow more finished cannabis-based drugs.
Some studies on standardized cannabis preparations are already underway. However, it may be years before they become available. Mr Broich says pharmaceutical companies that develop cannabis-based solutions will be supported in this process.
“Economic concerns have taken precedence over the interests of patients,” Broich said. On the current call for tenders, the President of BfArM regrets that economic interests have taken precedence over those of patients. “For me, as president of the competent authority, this is an untenable situation. How many requests do you think we have received from farms and nurseries that have taken big business by storm but have no experience in growing medicinal plants?
There will likely not be a German cannabis harvest until the end of 2020. Until then, the supply will be exclusively through imports. Here, too, the authorities set high standards. Because cannabis has serious side effects, like psychosis. “Any regularly approved drug that exhibits such side effects would be immediately taken off the market. This is why it is important that we set high standards when it comes to the quality of our products, ”says Broich. However, the president of BfArM did not address whether these side effects would also occur with finished drugs made from isolated pure substances.
Whether due to the high demands placed on foreign producers or other factors that play a role: In everyday practice, the current import situation for pharmacists and patients is in any case sub-optimal. The only problem is that patients felt they needed a certain strain, especially a strain that was high in THC. "It can happen that flowers, from one pharmacy to another, grow differently and therefore not the same content", suggested the head of the authorities.
The Federal Ministry of Health had a similar idea last summer because pharmacies rarely keep large quantities of flowers in stock, delivery times are short and favorable return regulations are rare.
In addition, it is now recognized internationally scientifically that varieties differ not only in their THC content, but also in their entire spectrum of substances and therefore in their effect - in other words, that they are these are practically different drugs. And the fact that prescriptions of THC-dominant strains are frequent probably has a medical justification: THC, for example, has a strong analgesic effect and the proportion of the indication "pain" in the cannabis therapies currently approved by the funds. disease is relatively high.