The legal situation for the sale of products containing the cannabinoid cannabidiol (CBD) is still unclear in Germany. Cannabis with all its plant parts is subject to the German Narcotics Law (BtMG). Since CBD is not listed as an active substance in the BtMG, it could be assumed that it is therefore not considered a narcotic in the legal sense. However, there are different judgements on this.

However, a recent ruling by the European Court of Justice (ECJ) now provides clarity. In France, the entrepreneurs Sebastien Beguerie and Antonin Cohen-Adad were sentenced by the court in Marseille to 18 and 15 months imprisonment and a fine of €10,000 each for importing CBD-containing liquids for e-cigarettes from the Czech Republic and offering them for sale in France. Only hemp fibres and seeds may be used commercially here.

After the entrepreneurs appealed against the judgement, the proceedings finally reached the ECJ. This was to clarify the question whether the marketing of a CBD product manufactured in an EU Member State from the entire cannabis plant and not only from hemp fibres/seeds is compatible with EU law.

According to a report, the judges of the ECJ decided that the French law discriminates against competitors from other EU Member States. The reasoning stated that it could not refer to the free movement of goods when dealing with narcotics. This is because the marketing of narcotics is prohibited in all member states. An exception is the supervised trade in narcotics for scientific and medical use.

“On the other hand, the Court observes that the provisions on the free movement of goods within the European Union (Articles 34 and 36 TFEU) are applicable, since the CBD at issue in the main proceedings cannot be regarded as a ‘narcotic drug’”, the ECJ stated.

CBD has no harmful effects on health

The judges also stated that the terms “narcotic drugs” and “narcotic substances” are defined in the Convention on Psychotropic Substances and the Single Convention on Narcotic Drugs. While the cannabis plant is not mentioned in the first-mentioned Convention, the second Convention refers to the plant Cannabis Sativa L., which led the European Commission to conclude that the CBD, produced from the flowers and fruit of the plant, should be classified as a narcotic.

According to the ECJ, this interpretation by the EU Commission contradicted “the general spirit of that convention and to its objective of protecting ‘the health and welfare of mankind’”.

„According to the current state of scientific knowledge, which it is necessary to take into account, unlike tetrahydrocannabinol (commonly called THC), another hemp cannabinoid, the CBD at issue does not appear to have any psychotropic effect or any harmful effect on human health “.

For the CBD industry, the ECJ’s ruling is ground-breaking, as both European and national courts will be guided by it in the future.

Source:
https://www.apotheke-adhoc.de/nachrichten/detail/apothekenpraxis/eugh-cbd-ist-kein-betaeubungsmittel/?fbclid=IwAR3t-oEnXrFnJLWrGOZCqCKIE6iuQd_DSzR5BPiXndIHn4OYnpkFkdN2GAM

Fibromyalgia syndrome (soft tissue rheumatism) is a chronic pain disorder. About one to two percent of the German population is affected, with women six to seven times more often than men.

It is a very complex pain syndrome in which the symptoms can occur in both the muscles and the connective tissue of the entire body. Patients frequently complain of pain in the arms, legs and back. Typical for fibromyalgia is a painful pressure over various pain points (tender points). Patients also often suffer from sleep disorders, exhaustion, headaches, abdominal pain and digestive problems.

The causes have not yet been fully clarified. It is assumed that the patients’ perception of pain has changed so that they perceive stimuli more quickly and give them greater significance. Studies also suggest that the nerve fibres in the muscle tissue might also be altered. In many cases, however, no cause or trigger of the disease can be found.

The use of medical cannabis in fibromyalgia has been the subject of many trials. Because the endocannabinoid system is involved in the perception of pain, among other things, this might explain the positive results of the trials. Although the link between medical cannabis and fibromyalgia is not yet clear, the results so far are positive.

Cannabis extract shows effect in fibromyalgia patients

The Public Health School of the Municipal Ministry of Health in Florianopolis (Brazil) and the Federal University of Santa Catarina have now published the results of their eight-week clinical placebo-controlled trial. The study involved 17 women with fibromyalgia. They were given a daily dose of THC-rich cannabis extract (24.44 mg/mL THC and 0.51 mg/mL CBD).

During the eight-week period, the patients were interviewed regularly and, compared to the placebo group, the cannabis group showed a marked improvement in the values for pain, well-being, fatigue and depression. No serious side effects were reported.

The researchers say that more trials with different cannabinoids need to be done to assess the long-term benefits. This is the only way to improve our knowledge about the effects of medical cannabis in fibromyalgia.

Source:
Chaves C, Bittencourt PCT, Pelegrini A. Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Med. 2020 Oct 1;21(10):2212-2218. doi: 10.1093/pm/pnaa303. PMID: 33118602; PMCID: PMC7593796.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7593796/

According to estimates, over 320,000 people in Germany suffer from chronic inflammatory bowel disease (IBD) such as Crohn’s disease or ulcerative colitis. Several studies have already shown that cannabinoids can have anti-inflammatory and pain-relieving effects in IBD.

In May this year, the Lambert Initiative for Cannabinoid Therapies at the University of Sydney published the results of its survey on chronic inflammatory bowel disease and the use of cannabis. About one quarter of Australians suffering from Crohn’s disease or ulcerative colitis are using illegal cannabis. Only 1.4 per cent of the 838 participants interviewed received legal medical cannabis.

The researchers said that these results indicate that patients cannot adequately treat their disease with drugs and are therefore looking for alternative treatment options. In particular, the use of cannabis helped patients to relieve cramps and pain. In addition, sleep quality and anxiety symptoms improved. In contrast, stool frequency, consistency and urgency improved only slightly.

Latest survey on IBD and cannabis use

The online magazine Medical Tribune reports on a current survey conducted by the Clinic for Integrative Medicine and Naturopathy in Bamberg. A total of 417 IBD patients were asked about their experiences with cannabis.

About 8 percent of the participants stated that they had already used cannabis to relieve their symptoms. 16.7 percent stated that medical cannabis was recommended to them by their doctor and 5.7 percent asked their health insurance companies to cover the costs. 82.4 percent obtained cannabis on the black market.

It is particularly interesting that 40 percent of those interviewed, according to their subjective assessment, stated that they were able to reduce their dose of biologicals by using cannabis. 6.7 percent stopped taking their medication altogether.

It is further stated that the most common reason for stopping cannabis use for symptom relief was the lack of access to legal medical cannabis. For this reason, 62.9 percent were in favour of legalising cannabis.

The researchers concluded that the high level of supply via the black market was a cause for concern. Furthermore, controlled clinical trials of medical cannabis for IBD were necessary.

Sources:
https://www.canpharma.eu/de/studie-medizinalcannabis-bei-chronischen-darmerkrankungen/
https://www.medical-tribune.de/medizin-und-forschung/artikel/cannabis-eigentherapie-bei-chronisch-entzndlichen-darmerkrankungen-weit-verbreitet/

In Germany, chronic back pain in the lumbar spine area (lumbalgia) is one of the most common diseases. The causes can be manifold. Patients suffer particularly frequently from arthrosis of the vertebral joints, osteochondrosis (wear-related changes in the vertebral bodies and intervertebral discs) and disc protrusion.

In many cases, non-drug therapies and the administration of painkillers are not sufficient to effectively relieve the symptoms. If the pain is very severe, opioids are used, which have considerable side effects and a high risk of dependence.

Various studies have already shown in the past that patients taking opioids and additionally medical cannabis have been able to reduce their opioid dose. This is possible because cannabinoids can enhance the effect of opioids. In this respect, opioids and cannabinoids can complement each other in pain management.

New study delivers positive results

The Society of Cannabis Clinicians in Sebastopol (USA) has now published the results of its retrospective cohort study with 61 patients suffering from chronic lumbar spinal pain and taking opioids.

After the patients received medical cannabis, 50.8 percent were able to stop taking opioids. This lasted a median of 6.4 years (IQR01.75-11 years). Of the 29 patients who could not stop taking opioids, nine patients were able to reduce their opioid dose. Another three patients maintained the dose and 17 patients had to increase the dose.

The authors of the study stated that no variables could be identified to measure which patients stopped taking opioids. However, the authors assume that those who used higher doses of cannabis were also more likely to stop using opioids for pain relief.

In their concluding statement, the authors of the study stated that in this long-term observational study, cannabis use was effective in about half of the clients as an alternative to opioids and as a supplement to reducing use in chronic opioid users.

Takakuwa KM, Hergenrather JY, Shofer FS, Schears RM. The Impact of Medical Cannabis on Intermittent and Chronic Opioid Users with Back Pain: How Cannabis Diminished Prescription Opioid Usage. Cannabis Cannabinoid Res. 2020 Sep 2;5(3):263-270. doi: 10.1089/can.2019.0039. PMID: 32923663; PMCID: PMC7480723
https://pubmed.ncbi.nlm.nih.gov/32923663/

Every woman over 40 will somewhen go through the menopause (menopause). During this time, the interplay of hormones in the body changes, so that symptoms like hot flashes, sweating, severe pain during menstruation, mood swings and sleep disturbances can occur.

For some women, the symptoms are so severe that their quality of life suffers considerably. There are several treatment options available to relieve the symptoms. These include hormone replacement therapy (oestrogens, gestagens), herbal preparations and local hormone preparations. However, many of these drugs are associated with adverse effects, so research is constantly looking at new treatment options.

One such alternative could be medical cannabinoids. It is thought that the endocannabinoid system (ECS) plays an important role in menopause. Among other things, ECS is responsible for regulating pain, mood, memory, appetite and the reproductive organs. Because cannabinoid receptors are found in the female reproductive system, medical cannabinoids might reduce symptoms.

However, there has been little research on the effects of cannabinoids on menopausal symptoms.

Women have been able to relieve complaints of cannabis

During the virtual annual meeting of the North American Menopause Society (NAMS) interesting study results were presented. In a sample of 232 menopausal women, more than half reported symptoms like hot flashes and night sweats, insomnia and urogenital problems.

About 27 percent of the women used cannabis to relieve these typical menopausal symptoms. Another 10 percent of women showed interest in using cannabis. Only 19 percent declared that they were taking traditional treatment (e.g. hormone therapy).

“These findings suggest that cannabis use to manage menopause symptoms may be relatively common. However, we do not know whether cannabis use is safe or effective for menopause symptom management or whether women are discussing these decisions with their healthcare providers […] his information is important for healthcare providers, and more research in this area is needed,” said Carolyn Gibson, PhD, MPH, psychologist and public health researcher at the San Francisco VA Health Care System and lead author of the study.

Dr. Stephanie Faubion, NAMS Medical Director, further explained that the study shows an alarming trend and the need for more research into the benefits and potential risks of cannabis use in the treatment of menopausal symptoms.

Source:
https://www.androidkosmos.de/wachsende-zahl-von-frauen-die-cannabis-zur-behandlung-von-wechseljahrsbeschwerden-konsumieren-studie/

Researchers at the Medical University of Innsbruck have now tested in a randomised controlled trial to what extent the synthetic THC drug nabilone can relieve non-motor symptoms (NMS). The results were published in the renowned journal of the American Neurological Assosiation “Annals of Neurology”.

Approximately two percent of the world’s population over the age of 60 suffers from the neurodegenerative disease Parkinson’s disease. Those affected suffer from a variety of motor disorders such as muscle tremor at rest, lack of movement, slowed movements and stiff muscles. In addition, the upright posture becomes increasingly unstable. Various non-motor symptoms (NMS) can also occur, such as mood swings, perception and sleep disorders, daytime tiredness, reduced performance, depression and anxiety.

The researchers explain that the burden on the NMS often increases during the course of the disease. There is little data from controlled clinical trials on treatment and the available treatment options are limited.

“The potential therapeutic effect of cannabinoids on motor function and NMS in Parkinson’s disease is an important issue and is often raised by patients in the treatment room,” said Marina Peball, the study’s lead author.

The neurologist and corresponding author of the study, Klaus Seppi, further explained that the study had examined the effect of nabilone “on the controlled treatment of NMS in Parkinson’s disease in a randomised, double-blind and placebo-controlled manner in a large number of patients”.

Nabilone is a synthetic analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone has similar pharmacological properties to THC.

Results of the study

In the study, a withdrawal design was used after all patients were adjusted to nabilone. The results said that the NMS load decreased under treatment with nabilone. In particular, anxiety decreased and the quality of sleep improved. In addition, the patients tolerated the therapy well.

“Given the data and possible mechanisms of action, we can say that nabilone seems to improve non-motor symptoms in patients with Parkinson’s disease,” the researchers said.

Thus, the results of the study may contribute to a better understanding of the value of cannabinoids in the treatment of NMS. The results may also serve as a basis for larger controlled trials that might lead to approval.

Source:
https://www.i-med.ac.at/mypoint/news/748324.html

The tendering procedure for the cultivation of medicinal cannabis in Germany was bumpy from the start. After the first procedure was stopped, the Federal Institute for Drugs and Medical Devices (BfArM) started the next round in July 2018. But even here there were delays. First the application deadline was extended twice and then the contract was awarded. Nonetheless, the BfArM insisted on being able to bring in the first harvest in Germany this year.

According to a recent report of the pharmacy adhoc, the cannabis producers Aurora, Aphria and Demcan will not be able to harvest German cannabis this year. The blame lies with the corona crisis. As a result, the competent authorities were unable to issue the necessary BtM (narcotics) and GMP certifications in time.

Producers confirm delays

At present Aurora is preparing to start up its production plant in Leuna and made an ad hoc statement according to the pharmacy:

“We look forward to starting production as soon as all necessary steps for production preparation and regulatory approvals have been taken – some of these steps will take longer than originally expected and planned due to the ongoing pandemic. Aurora regularly discusses the progress of the project with the Cannabis Agency and agrees on how to proceed and any delays in the schedule. The first delivery will probably be postponed until next year”.

The Berlin-based start-up Demecan is also planning production near Leuna. In Ebersbach, near Dresden, the company acquired a former slaughterhouse from the insolvent cannabis company Wayland. Now the cannabis production has to be adapted to the new conditions, making a harvest this year impossible.

“Our aim is to start plant cultivation as soon as possible in order to guarantee delivery to the Federal Institute for Drugs and Medical Devices as soon as possible in the new year”, Demecan said ad hoc according to the pharmacy.

The delay in the cannabis harvest was also confirmed by Aphria, whose production plant is located near Neumünster. Delivery is planned for the first quarter of 2021.

No changes on the German cannabis market

The delays in the German cannabis harvest due to the corona crisis are understandable. However, the imported medical cannabis is not sufficient, which is why BfArM had to apply for the approximately 12.4 tons.

But even if German cannabis is available next year, the 2.6 tons per year may still be far from sufficient, so that Germany will probably continue to depend on companies such as CanPharma, which import medical cannabis into Germany.

Source: https://mjbizdaily.com/germanys-first-medical-cannabis-harvests-likely-delayed-until-2021/

https://www.apotheke-adhoc.de/nachrichten/detail/markt/bfarm-cannabis-dieses-jahr-keine-ernte/?tx_aponews_newsdetail%5B%40widget_4%5D%5BcurrentPage%5D=2&tx_aponews_newsdetail%5B%40widget_4%5D%5BitemsPerPage%5D=1&cHash=25c7ab284ce95b6f9449e330a777fc2a

Obsessive-compulsive disorder (OCD) is a mental disorder in which patients suffer from obsessive-compulsive thoughts or actions. Although patients are aware that this compulsion is excessive, they have to give in to the urge. Depending on the severity of the disorder, the patient’s daily life may be considerably impaired.

The causes have not been definitively clarified. Psychological explanatory models are being discussed, as well as disorders involving neurotransmitter metabolism as risk factors. There is also evidence of the involvement of various other signalling pathways, such as the glutamatergic, dopaminergic or GABAergic system.

OCD: involvement of the endocannabinoid system

Various studies, in particular a small number of animal experiments, suggest that the endocannabinoid system may be involved in the pathophysiology of OCD.

In 2019, researchers from Columbia University published a review on whether the endocannabinoid system could be a new treatment target for OCD. In addition to a comprehensive review of endocannabinoids and phytocannabinoids, the researchers also presented data from different trials.

In two case reports, the researchers said that treatment with dronabinol had positive results in two patients with OCD who were refractory to treatment. Data from a small open-label, uncontrolled trial also showed that the combination of nabilone and psychotherapy was more effective than any treatment on its own.

In summary, the researchers stated the following:

“Is there a place in psychiatry for cannabinoid-based drugs? Studies in animals and humans have shown that the endocannabinoid system is an important emotional regulator. But how can we use this knowledge for therapy? This review article offers a critical evaluation of the evidence focusing on obsessive-compulsive disorders and provides pointers for future research.”

Medical cannabis in the treatment of Tourette’s syndrome

Patients with Tourette’s syndrome suffer from chronic vocal and/or motor tics, often associated with comorbid obsessive-compulsive behaviour. Various studies and clinical trials have shown in the past that patients with Tourette’s syndrome can benefit from treatment with medical cannabis. After taking various cannabis-based medicines (Sativex, medical cannabis flowers), patients reported an improvement in tics.

Recent case report of a patient with OCD

In a case report, a 22-year-old patient was presented suffering from a severe obsessive-compulsive disorder since childhood. The treatment with medical cannabis significantly reduced the symptoms of OCD. His depression also improved, leading to a significant improvement in his quality of life.

Source:
https://www.eurekalert.org/pub_releases/2019-05/mali-cch053119.php
https://pubmed.ncbi.nlm.nih.gov/32848902/

The Federal Institute for Drugs and Medical Devices (BfArM) has set out to tender a quantity of 10.4 tonnes of medical cannabis over four years in Germany. However, this quantity is far from sufficient to cover demand. Import dependency is expected to remain.

In the German government’s response to a minor enquiry from the FDP parliamentary group, it was stated that the import demand for medical cannabis has grown to 14 times its size between 2015 and 2019. This year, as in previous years, the BfArM had to apply retroactively for an increase in the import volume, namely of 75 percent. According to the Federal Government, however, supply bottlenecks are not to be expected.

The use of a complicated import procedure instead of strengthening domestic production

The German government regulates the supply of medical cannabis by means of an import procedure requiring approval. In advance, the Federal Opium Agency must report the expected demand to the BfArM and the International Narcotics Control Board (INCB) by the 30^th of June.

The estimation of the demand includes medical cannabis flowers for direct delivery to the patient as well as cannabis flowers for the production of extracts, dronabinol and finished drugs. The quantities of cannabis needed for clinical trials and research must also be considered.

“The estimate is based on the consumption data available up to the 30^th of June of a given year, their development within the previous year and taking into account the quantities of stocks held by participants in the legal narcotics trade,” says the Federal Government.

The demand for medical cannabis is constantly increasing

The FDP criticises the above-mentioned approach because the demand for medical cannabis is constantly increasing and the estimated quantities are not adjusted. According to the online magazine Apotheke Adhoc, the authorised import volume was 1485 kilograms in 2015, 1500 kilograms in 2016, 10,380 kilograms in 2017, 10,688 kilograms in 2018 and 20,774 kilograms in 2019. In all these years, a re-estimate had to be made because the imported quantity was not sufficient.

The authorised import quantity for 2020 is 16,100 kilograms. This is over four tonnes less than in 2019.

“As this figure is expected to be exceeded before the end of 2020, BfArM has already applied to the INCB for an increase in the quantity as part of a reassessment of the expected additional medical and scientific need for 2020 totalling 12,355 kilograms,” explained the Federal Government.

The INCB has yet to reply.

The Government also stated that there were no plans to increase the quantities cultivated in Germany. According to Apotheke Adhoc, FDP health policy expert Dr. Wieland Schinnenburg criticised that this was a missed opportunity. At the same time, he called for a strengthening of cannabis cultivation in the country.

“The planned harvests in Germany cover only a fraction of the actual demand. We must minimise our dependence on imports and increase production volumes in Germany. The lucrative export market should also be opened up to German companies. There is no reason to discriminate against German companies and exclude them from the world market,” said Dr Schinnenburg.

Sources:
https://dip21.bundestag.de/dip21/btd/19/214/1921416.pdf
https://www.apotheke-adhoc.de/nachrichten/detail/politik/cannabis-bfarm-verschaetzt-sich/

According to the online magazine DAZ.online, the Association of Cannabis Supplying Pharmacies (VCA) is now advocating a prescription requirement for CBD products. However, the VCA believes that the classification of cannabidiol (CBD) as a narcotic is not necessary.

In many pharmacies the demand for CBD products is increasing, because it is said that they have a calming, sleep-inducing and pain-relieving effect. However, it is problematic that CBD products are not produced according to standardized procedures and that therefore no studies according the long-term effect exist. In addition, the legal situation in Germany is unclear. Some products are available as food supplements and others as medicals.

The report further says that “CBD preparations according to NRF prescription (Oily Cannabidiol Solution 100 mg/mL NRF 22.10. and Oily Cannabidiol Solution 50 mg/mL NRF 22.10.) are not available only on prescription. The CBD-drug Epidyolex is, however, only available on prescription, which unsettles pharmacists and raises the question whether the marketing of CBD products is permissible.

CBD products: No classification as narcotic

In a statement, the VCA said that it is not necessary to classify CBD as a narcotic because it does not have a psychedelic effect. Nor is there any danger of addiction. Instead, it would be necessary to make products containing CBD available only on prescription.

“CBD is an important ingredient of the cannabis plant, which both influences the effect of THC and can itself trigger significant effects through its ability to activate specific receptors of the body’s endocannabinoid system,” the VCA said according to the media report.

According to the VCA, CBD has great therapeutic potential. That’s why they say that the cannabinoid has to be classified as a drug substance – just like the CBD drug Epidyolex. The VCA is critical of the classification as a food supplement.

“The initially consistently positive reporting in various magazines and sales-promoting announcements on countless manufacturer sites on the Internet aroused people’s curiosity about this potential panacea,” the association says. “CBD is more than just a hope for patients and has very good pharmacological effects. Even if the long-term effects have not yet been researched, it deserves the chance to be perceived as an effective drug,” the VCA said.

CBD products: Prescription requirement as a solution?

The VCA sees a solution in the fact that CBD products are sold through pharmacies as prescription-only preparations or finished drugs.

“A classification of CBD as a standardized prescription-only substance, whether as a prescription preparation or as a ready-to-use drug such as Epidyolex, supplemented by its eligibility for reimbursement under the statutory health insurance system, is completely sufficient in the eyes of the VCA to give CBD the opportunity to develop where it really needs to arrive: For the sick person who needs help,” the VCA concludes in its statement.

Sources: https://www.deutsche-apotheker-zeitung.de/news/artikel/2020/08/26/cannabis-apotheker-fordern-rezeptflicht-fuer-cbd-produkte/chapter:1, https://vca-deutschland.de/stellungnahme-des-vca-zur-angedachten-einstufung-von-cannabidiol-cbd-als-betaeubungsmittel-btm/