How German pharmacologists are setting the stage for monopolizing the therapeutic properties of cannabis
The President of BfArM called the attitude towards medical cannabis in the country "a systemic gap." This is due to the fact that prescriptions based on the use of the therapeutic properties of psychoactive cannabis are currently allowed in Germany without the same level of effectiveness that is necessary for any other prescription drug.
On the pages of the specialized electronic edition of Ukrainian hemp breeding, more than once the question has been raised of how German and British pharmacological giants are working towards monopolizing the market for the therapeutic properties of cannabis. This material provides an example of how German officials create the conditions for "squeezing" pharmaceuticals from the market for small and medium-sized manufacturers of products rich in drug-free cannabinoids.
Germany may become the largest and fastest growing market for medical cannabis in Europe, but there are signs in the pharmacological and “regular” circles that demonstrate to companies involved in the commercialization of cannabis drugs the need to document the effectiveness of their use.
According to the imposed opinion of various industry experts, enterprises that prioritize science and efficiency in the long term will have a competitive advantage in Germany compared with those companies that are focused on an uncontrolled increase in sales. For example, in an interview with the media, President of the Federal Institute for Drugs and Medical Devices (Federal Institute for Drugs and Medical Devices, BfArM) Karl Broich (Karl Broich) called the attitude to medical cannabis in the country "systemic gap". This is due to the fact that prescriptions based on the use of the therapeutic properties of psychoactive cannabis are currently allowed in Germany without the same level of effectiveness that is necessary for any other prescription drug. Mr. Broich considers the current conditions under which, without clinical conclusions, pharmacological preparations based on the therapeutic properties of psychoactive cannabis can be obtained as transient and claims that the department headed by him “plans to correct this situation as soon as possible”. According to the President, BfArM needs to ensure that hemp pharmacological products are on the market with proven effectiveness. At the moment, this extremely short list includes Sativex and Canemes.
According to Franjo Grotenhermen, Managing Director of the International Association for Cannabinoid Medicines, "It is necessary to create conditions under which interested companies will conduct studies confirming the effectiveness of the use of pharmacological preparations based on the therapeutic properties of cannabis. This is due to the fact that German regulators and doctors "feel more comfortable" using hemp-based medicines with well-studied indications and to use. At the same time, the dependence of German regulators and doctors on Dronabinol and Sativex can be explained by an effective marketing company undertaken by pharmaceutical companies, convincing medical associations that their products have excellent qualities compared to other similar drugs And this is despite the fact that these products play practically no role in the markets of Canada, the Netherlands, the USA and Israel. "
According to Mr. Grotenhermen, “In the near future, synthetic modulators of the endocannabinoid system (FAAH inhibitors, MAGL, selective CB2 receptor agonists) will appear on the German market, which are already under active clinical studies.
According to the medical director of Aphria Germany, Jan Witte, despite the tendency of the Germans to use pharmacological preparations made on the basis of the therapeutic properties of psychoactive cannabis, legal access to the leaves and buds of the plant remains. Mr. Witte emphasizes that in the first half of 2019, BfArM first contracted for the legal cultivation of psychoactive cannabis at home, which will last for the next four years, thus demonstrating a commitment to the use of leaves and inflorescences. "At the moment, a constructive dialogue is needed to increase the level of evidence, as well as to support the understanding by medical staff of the tools at their disposal provided by the therapeutic properties of cannabis," says a high-ranking functionary of Aphria Germany.
More than a dozen associations representing the German medical industry throughout 2019 appealed to the country's specialized community, journalists, insurers and politicians to develop documents suggesting a "more responsible approach to the legal use of the therapeutic properties of psychoactive cannabis. In particular, the signatories of this petition are the German Association Palliative Medicine (German Association of Palliative Medicine), German Association for Psychiatry and Psychotherapy (German Association for Psychiatry and Psychotherapy), Not etskoe Society for Neuroscience (German Neurological Society), as well as the German Society of Pain (German Pain Society).
According to Mr. Witte, “associations that appeal to the public undoubtedly represent the German medical community, therefore this treatment should be taken seriously.”
The appeal is criticized by representatives of the media for the fact that they often represent medical cannabis in the "rainbow light" and do not distinguish between two different categories of cannabis products: cannabis-based drugs that have been given permission to legally sell in the country and other pharmaceutical products drugs, selling OTC in pharmacies. The lack of available and reliable information about the therapeutic properties of cannabis leads to the fact that the medical staff usually do not know what kind of cannabis varieties should be assigned to the patient, under what conditions and in what dosages. Among other things, the signatories of the petition are concerned about the lack of information about the side effects of using cannabis-based prescription drugs. It focuses on the fact that pharmacological manufacturers are actively using therapeutic drugs on hemp-based, while spending enormous resources on marketing and promoting their products. Particularly emphasized is the engagement of "independent" media from the maternal structures, which impose separate commodity groups of pharmacological preparations made on the basis of the therapeutic properties of cannabis. In particular, the German-language Leafly website is mentioned, claiming that it only contains information from independent sources. According to German experts, this statement is absolutely wrong, since the parent company Leafly, among other things, owns the Canadian manufacturer of cannabis Tilray.
Treatment is also intended for doctors who prescribe leaves and inflorescences or preparations based on the therapeutic properties of cannabis in need of patients. According to the signatories of the appeal, medical associations must develop guidelines in accordance with the "Guidelines and Rules of Germany on scientific and medical societies" ("Guidance Manual and Rules for Guideline Development"). In turn, journalists should conduct thorough investigations and re-examine the data they provide in order to clearly distinguish between drugs based on the therapeutic properties of cannabis, with traditional pharmacological preparations and psychoactive hemp. Insurers should develop standardized and understandable guidelines for the criteria used to approve or deny treatment with cannabis. In turn, politicians must make decisions based on reliable data from independent studies conducted in accordance with internationally accepted standards of evidence-based medicine.
In turn, legal producers of psychoactive cannabis invite German doctors to visit their production and meet with industry experts in order to regularly conduct outreach and educational work aimed at providing the full range of information regarding the possibility of using the therapeutic properties of cannabis for medical purposes in the form of pharmacological drugs.
Commentary of the Association "Ukrainian technical hemp"
In early 2017, German legislators adopted a legal act providing for the legal use of the therapeutic properties of cannabis for medical purposes. The aforementioned law obliges state insurance companies to provide compensation subject to the fulfillment of certain requirements to patients, including the possibility of using the plant as the last possible means of treating a disease.
Compared to 2017, sales of leaves and inflorescences rich in cannabinoids in 2018 in Germany will double. In particular, during the first quarter of 2019, 765 kg of psychoactive hemp raw materials were officially imported into the country.
According to statements by a number of German government officials, including BfArM President Karl Broich, a process is starting in Germany, according to which intellectual property patents (primarily pharmacological companies are interested) will eventually play a key role in the market for pharmacological drugs, made on hemp base. In fact, structures with high-quality practices in this branch of business, but not having significant financial resources for their official registration and subsequent promotion in the market, will gradually “leave” the opportunity to work in this sector of cannabis production.