Updates

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Bedrocan opens its own cannabis Clinical Research Unit

Bedrocan, which for years has only supported external researchers financially, has opened its own Clinical Research Unit to conduct research into the effects of the cannabis products it produces on behalf of the Dutch government. Dutch cannabis researcher Matthijs Bossong will lead the Clinical Research Unit in Utrecht, Netherlands.

The Clinical Research Unit has long been a wish of Bedrocan’s Chief Scientific Officer Mikael Kowal: “Much research is being done worldwide with these products, but then other scientists decide what is being investigated. Now, we take the lead by conducting our own research.”

The first study has already been approved by a Medical Ethics Committee. Mikael: “We will take a closer look at two products: Bedrocan® and Bediol®. The study will determine the risk factors of cannabis use and hopefully serve as a guide to patients on how to use these products safely, i.e. in a way that does not cause anxiety or psychotic symptoms.”

Clinical Research Unit with Matthijs Bossong & Mikael Kowal
Matthijs Bossong & Mikael Kowal

Chronic pain

The future plan is to put together a cohesive clinical research program that addresses relevant scientific issues, such as chronic neuropathic pain. Matthijs Bossong: “There is scientific evidence that medicinal cannabis can help with certain conditions, including chronic pain. However, the problem with clinical research with cannabis is that there are large differences between studies. For example, the administration route, dosage and cannabis composition may vary, which makes the results difficult to interpret. We will conduct research with the standardised products Bedrocan produces, which will hopefully contribute to the willingness of doctors to prescribe medicinal cannabis.”

Clinical Research Unit

CEO Jaap Erkelens is very pleased with the opening of Bedrocan’s research unit: “Bedrocan can now conduct targeted research into the effects of the cannabis products it produces on behalf of the Dutch government. That is the only way to obtain official recognition of the safety and efficacy of these products by regulatory authorities worldwide. This is a goal the company has always strived to achieve, and now it is one step closer with the opening of the Clinical Research Unit.”

Bedrocan is an EU GMP-certified producer of pharmaceutical-grade medicinal cannabis. The high-quality products are used as pharmaceutical raw materials and active pharmaceutical ingredients (APIs). Bedrocan operates multiple indoor cultivation facilities and an R&D facility in the Netherlands. Soon, a brand new production facility will open in Denmark.

Canadian patients struggle to access consistent cannabis treatment

Since Canada legalised the recreational use of cannabis in 2017, a lot has changed for patients who use medicinal cannabis. While access was expected to be facilitated, patients are actually struggling to get products with consistent quality and content. Here, patients, a doctor, and a patient organisation talk about how they see the current medicinal cannabis system in Canada.

Canadian patients struggle 1
Canadian patient Patricia McGill

Mother of six and grandmother of four, Patricia McGill has been using medicinal cannabis for twenty years. She has been a therapeutic riding instructor in both Quebec and Nova Scotia. In 2003, she suffered an injury which generated a Reflex Sympathetic Dystrophy condition, known for causing chronic pain. She was prescribed other drugs but experienced negative side effects, so her doctor prescribed medicinal cannabis.

Before and after legislation

As a patient from before the legalisation of recreational use in Canada, Patricia sees the differences before and after the legalisation in 2017: “The access to cannabis has been increased, but not in a positive way. The places where you get the cannabis have no qualified personnel, and the quality of the products have significantly decreased once companies started to produce for both recreational and medical markets.”

Patricia also experiences problems with availability: “Sometimes the product I was using is no longer available the next time I go pick it up.” According to her, patients also face the challenge of a shortage of qualified general practitioners in Canada: “The doctor that used to treat me has now retired. My new doctor does not want to prescribe cannabis because he has no knowledge about it. Now, I have to go to a doctor from a specialised company who will give me a prescription based on my condition and history. Prescribing medicinal cannabis should be taught in all medical schools.”

One Canadian doctor who prescribes medicinal cannabis is Dr Andrew Cooper. He is an anaesthesiologist with thirty years of experience in general practice, anaesthesiology, and critical care medicine. He prescribes medicinal cannabis in his clinic in Caledon, Ontario, and believes the priority should be keeping patients away from the illegal market: “Unfortunately, the illegal cannabis industry is winning the price war with the legal cannabis industry. The legal cannabis industry must comply with very stringent standards for security, storage, and quality control, along with all the associated costs. I would like to see the standards relaxed so they can enter into competition with and defeat the illegal industry.”

Dr Andrew Cooper
Dr Andrew Cooper

Recreational and medicinal use

Unlike Patricia, Dr Cooper believes that cannabis for recreational and medicinal use are both suitable for patient use. “Products sold in retail stores are identically analysed and labelled as medical products. They have the necessary labelling of chemovar and milligram (mg) content. I differentiate between non-medical legal and non-medical illegal. If patients source their products from illegal sources, I express concern about quality or adulteration, and I encourage them to source from the legal streams.” However, he believes it would be better to have a traditional pharmacy model for medicinal cannabis in Canada: “A traditional pharmacy model incorporates fewer steps than the current system and would be much more efficient.”

Robert Featherby
Canadian patient Robert Featherby

Patient Robert Featherby, 50, has chosen a different route: home cultivation.
Robert lives in Victoria, British Columbia. In his early twenties, he had a serious ankle injury. After an unsuccessful surgery to repair it, he was left with chronic pain. Doctors prescribed him different medications, but he got all sorts of negative side effects. Robert then decided to “self-medicate” with cannabis meant for recreational use, which also did not generate positive results.

CBD flowers

After many years, his doctor finally prescribed medicinal cannabis to help him cope with the pain: “I discovered the benefits of CBD flowers and oils. Initially, my doctor set me up with a Canadian company that had a very inconsistent supply of CBD products, and the quality of the flowers was questionable. When I spoke to my doctor about the issues of supply and quality, he recommended products from Bedrocan. This is when everything really improved for me. Nothing helped with the pain like the flower that contains higher CBD and little THC. It literally changed my life.”

When Canada legalised recreational use, Robert started cultivating cannabis for his treatment because he did not trust the quality of other products: “At the point that recreational cannabis was legalised in Canada, there were still very few CBD options, and none of them were good quality. This is when I decided to start growing my own cannabis. I am growing mostly CBD plants and have discovered a few that work well.”

While Robert consciously chose to grow cannabis at home, other Canadian patients rely on their doctors. According to Max Monahan-Ellison, Board Chair of patient organisation Medical Cannabis Canada (MCC),  patients in Canada struggle to find support from healthcare professionals (HCPs): “I can say that support from HCPs is minimal. That comes down to a lack of investment in evidence-based training in Canada, and the government’s own healthcare data provided for HCPs is little and out of date.” The patient organisation strives to ensure patients can access medicinal cannabis treatment safely, equitably and with the support of healthcare professionals.

Changing the cannabis legislation

The Canadian government has recently started a review of the cannabis act. Max: “The Cannabis Act is structured to prevent misuse instead of encouraging safe and accessible use with a medical authorisation.” MCC is currently completely focused on the review for the maintenance of a robust medical framework and released a 5,000+ collaborative patient study identifying barriers in the framework, cited by Health Canada’s expert panel: “People who use cannabis as a treatment should be accessing it with the support of a healthcare professional and with needed coverage to ensure affordability, but the system pushes them away. This is our chance to really make a difference, and that is why we have invested all of our energy to push for real patient-driven changes in this review.”

Bedrocan products in Canada

Bedrocan-branded products used to be available in Canada. However, after the legalisation of recreational use and the decision of the licensee Canopy Growth to enter the recreational market, Bedrocan decided to sell its shares and leave the Canadian market. An arbitration also prohibited Bedrocan from returning to Canada until 2019. Bedrocan has always had the ambition to return to the Canadian market and hopes the cannabis legislation in Canada changes in a way that medical and recreational use are clearly separated, and patients are given access to pharmaceutical-quality products with proper healthcare guidance.

Study: Long-term use of medicinal cannabis improves quality of life

The majority of patients say their quality of life has improved since using medicinal cannabis. The Netherlands pharmacovigilance centre Lareb and the Office of Medicinal Cannabis (OMC) have studied Dutch patients’ experience with medicinal cannabis and published the results in the December 2023 issue of Dutch Pharmaceutical Weekly magazine (PW). The article concludes that patients who use medicinal cannabis for more than six months see an improvement in their quality of life. However, some side effects are also mentioned, such as dizziness, drowsiness, dry mouth, headache and increased appetite. A negative side note is that ‘many users find the costs a barrier, as medicinal cannabis is not eligible for reimbursement in the Netherlands.’

Quality of life

The researchers write in the PW: “The majority of participants (87%) agree that their quality of life has improved since using medicinal cannabis. This is especially true for patients who use it for more than six months (93%). Of the patients who used it for less than six months, a smaller proportion believe that their quality of life has improved (62%) and 33% are neutral about this. The most frequently mentioned explanation for an improvement in quality of life is that the symptoms are under control, sleep is improved and the number of symptoms is reduced.”

Medicinal cannabis

Medicinal cannabis is an unregistered medicine that can only be prescribed by a doctor. Indications for which cannabis is used include chronic neuropathic pain, palliative treatment of HIV/AIDS and cancer, epilepsy, chemotherapy-related nausea and vomiting, and treatment-resistant glaucoma. However, the Dutch Association of General Practitioners (NHG) does not recommend the use of medicinal cannabis because there is still too little scientific evidence about its effect. In the coming years, Bedrocan will conduct its own research into the effects of medicinal cannabis.

SyqeAir Inhaler approved by the Therapeutic Goods Administration (TGA)

The high-tech, metered-dose SyqeAir Inhaler, which contains Bedrocan® material, has been officially approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG). Bedrocan is thrilled with Syqe’s historic achievement.

CEO Jaap Erkelens: “Syqe has reached an incredible milestone. The TGA’s approval sets a positive example in the global regulatory environment for medicinal cannabis. Bedrocan has always advocated for the proper registration of medicinal cannabis products through official regulatory pathways. Syqe’s achievement needs to be celebrated by everyone who strives for medicinal cannabis to be seen and regulated as a pharmaceutical product.”

SyqeAir is the first metered-dose cannabis inhaler to obtain the ARTG register. The device has been available on prescription in Australia since January this year.

Pharmaceutical-grade device

The Israeli MedTech company has spent eight years developing the device with a strong focus on meeting pharmaceutical standards and dosage precision. The advanced technology developed by Syqe allows the inhaler to deliver metered and consistent doses of THC along with all other cannabinoids and terpenes found in full-spectrum cannabis. The inhaler includes a pre-loaded cartridge containing 60 uniform doses of pharmaceutical-grade, standardised Bedrocan® product.

SyqeyAir 2023

Research-based

There are several real-world evidence publications related to the device. It has also been used in a number of clinical trials. Among other things, the studies demonstrated that with medicinal cannabis administration using the SyqeAir Inhaler, patients experienced a reduction in pain intensity and improved sleep and quality of life, with little adverse effects compared to other routes of administration.

Irradiation does not affect medicinal cannabis

Gamma-irradiation does not cause significant changes in the composition of medicinal cannabis. A recent study has shown that the most important therapeutically active components THC and CBD are not affected by the radiation. Herbal cannabis products, often used by vulnerable patients, are treated by gamma-irradiation to free them from contamination with potentially harmful microbes. Patients have occasionally expressed their concerns about the effects of irradiation treatment on medicinal cannabis. Some have claimed a change of taste or effect, while others worry about changes in the chemical composition or the quality of their medicine.

Irradiation treatment

The study evaluated the effects of irradiation treatment on four different cannabis varieties covering different chemical compositions. Samples were chemically analysed before and after standard gamma-irradiation treatment. In addition, water content and microscopic appearance of the cannabis flowers was evaluated.  The effect of gamma-irradiation was limited to a slight reduction of some terpenes present in the cannabis, but keeping the terpene profile qualitatively the same. No effects on THC or CBD content was observed.

Recommended method of decontamination

Based on the study results gamma-irradiation of herbal cannabis remains the recommended method of decontamination, at least until other more generally accepted methods become available.

How is Bedrocan’s cannabis irradiated?

For twenty years now, medicinal cannabis, which Bedrocan produces in the Netherlands on behalf of the Office of Medicinal Cannabis (OMC), is also irradiated. This process is also called sterilisation. The article How is Bedrocan’s cannabis irradiated? offers an insight into how the irradiation process works.

How is Bedrocan’s cannabis irradiated?

All Bedrocan’s cannabis products manufactured in the Netherlands are gamma-irradiated by an external company. This has been contracted by the Dutch government. We have written before about how gamma radiation does not change the medicinal cannabis’ composition and how irradiation is necessary to ensure a sterile product for patient use. However, this is the first time we offer an insight into how the irradiation process works.

Gamma radiation, so-called ionising radiation, is the same type of radiation used in X-rays. Gamma rays are deadly to microorganisms, including fungi, viruses and bacteria. Gamma radiation, generated by Cobalt-60 isotopes, is also very harmful to humans. That is why an irradiation company must have a special room, a type of bunker with walls of 2.5 to 3 meters thick concrete, where the products are irradiated. Employees and visitors are not allowed to enter it.

Cannabis Flos Lr 42

In the Netherlands, mainly medical and hospital equipment is irradiated with gamma rays, such as heart valves, baby bottles, knee prostheses, and contraceptive implants. For twenty years now, medicinal cannabis, which Bedrocan produces in the Netherlands on behalf of the Office of Medicinal Cannabis (OMC), is also irradiated. Sterilisation, as the process is euphemistically called, is done 24 hours a day, seven days a week, and is fully automated. All kinds of medical products go into the bunker inside a box through a conveyor belt. Cannabis is treated in the bunker for about 1 to 1.5 hours.

In addition to medical equipment and medicinal cannabis, food is also irradiated in some countries. This is done to reduce microorganisms in food and extend shelf life. The EU tracks which foodstuffs are irradiated annually in the European Union. According to the latest figures from 2019, the three most commonly irradiated products are frog legs (65.1%), poultry (20.6%) and dried aromatic herbs, spices and vegetable seasoning (14.0%). In the EU, the irradiation of foodstuffs is limited and must certainly not replace hygienic conditions. Irradiated food or ingredients must be labelled as such.

However, in America and Asia, food irradiation is more common. This mainly concerns meat and fruit. According to the US Food and Drug Administration (FDA), irradiation does not affect nutritional quality or change the taste, texture or appearance of food.

Nuclear cannabis

Still, patients are concerned. This is mainly due to the lack of clarity on how cannabis is irradiated. While most European countries have clear regulations, American cannabis growers, for example, have unclear rules. Cannabis that has failed a contamination test can be subsequently irradiated so it can still be sold, according to an article by MJBiz Daily. “Generally because of bad microbial growth due to poor sanitation in the grow and processing stages – growers will have to nuke it.”

Cannabis medicinal

“Nuke” suggests that irradiation is associated with nuclear contamination or radioactive danger. But is that so? Is nuclear energy released? The answer is clear: Gamma irradiation has nothing to do with radioactive contamination. Some people have negative associations with the word ‘radiation’, but the gamma irradiation process is entirely safe. The process kills microorganisms and cleans the products. Products sterilised in this way are entirely free of radiation after treatment. In fact, these products are safer after the irradiation process and also have a longer shelf life.

Why to irradiate?

As a natural product, cannabis cannot be 100% free of microorganisms, even when grown in a strict-controlled environment. Non-irradiated cannabis may contain traces of microbes or fungal spores. These can be harmful to health. For example, some Aspergillus fungi, present all around us, can cause severe illnesses. Patients with reduced resistance are particularly more vulnerable. Therefore, governments that make medicinal cannabis available require some form of sterilisation.

The effects of gamma-irradiation for decontamination of medicinal cannabis

The blue glow of cobalt

Cobalt is a crucial part of batteries in, for example, a smartphone. This mineral is mainly mined in African cobalt mines. In only a limited number of locations in the world, cobalt is converted into Cobalt-60, the isotope that generates the final gamma rays. The largest reactor is in Canada. Cobalt-60 is supplied in granular form in long metal rods. An irradiation company has hundreds of such rods in use. When the irradiation installation is out of operation, these rods are submerged in water, giving off the well-known cobalt blue colour. Water, like the thick walls, blocks the radiation. The bunker is built like a labyrinth so the radiation cannot leak.

Bedrocan sponsors young researchers at Gordon Research conference on cannabinoids

Bedrocan supports two young researchers to participate at the Gordon Research Conference on ‘Cannabinoid Functions in the CNS, Charting the Course to Novel Therapeutics’. Bedrocan is a proud sponsor of the event and has given its entrance tickets to Nadia Leen en Jan van Dam. Nadia en Jan will share their recent studies on cannabinoids through a poster presentation. The conference is being held from 16 to 21 July in Castelldefels, Spain. The event gathers researchers from all over the world to share the most recent studies in the field of cannabinoid research.

About the researchers

Nadia Leen

PhD student at the Brain Research and Innovation Centre

Nadia works as a PhD student at the Brain Research and Innovation Centre, part of the Military Mental Healthcare and Defence Healthcare Agency of the Dutch Ministry of Defence. Her research focuses on the role of the endocannabinoid system in stress, anxiety and sleep.

During the conference, she will give a poster presentation about her recent research. The research investigates the role of an enzyme present in endocannabinoid metabolism (FAAH) and its interaction with specific genes in the brain. Brain endocannabinoids play an important role in stress regulation, which is also vital to protect against the development of anxiety and trauma, especially during military deployment.

Bedrocan supports young researchers
Bedrocan sponsors young researchers

Jan van Dam

Physician-Researcher at LUMC

Jan works as a Physician-researcher at the Anesthesiology department of the Leiden University Medical Center (LUMC), Netherlands. At the LUMC, he works together with colleagues on research into the effect and side effects of medicinal cannabis with and without Oxycodone. They also conducted a study into the use of inhaled Bediol®, Oxycodone or the combination in patients with fibromyalgia.

At the conference, he will present the results from a study with inhalation of  Bedrocan®  with and without Oxycodone in healthy subjects (M/F). The study looked at the effects on breathing and vital functions such as heart rate and blood pressure. An interesting finding in the study was that the respiratory depressant effects of Oxycodone do not seem to increase when used simultaneously with cannabis.

Brain scans show effects of CBD on psychosis

What happens in the brain of psychiatric patients when they are given CBD? And especially patients with psychosis? Lead Researcher Matthijs Bossong, who works for Bedrocan, was so fascinated by this question that he spent three years collecting data at the University Medical Center Utrecht to gain more insight into the effects of cannabidiol (CBD) on the brain.

During the study, 31 patients received a capsule containing 600 milligrams of either CBD or  placebo every day for four weeks. Before and after treatment, MRI scans were performed and compared. From the scans, it emerged that CBD has a positive effect on the brain connections involved in psychosis. Bossong: “After use, connectivity between brain regions normalised. Previous studies had already shown that CBD may have a positive effect on the complaints and symptoms of patients. We have shown for the first time which mechanisms in the brain are involved.”

Scan Bossong 1

Why did you find it important to show what CBD does to the brain?

I have always been fascinated by deviant behaviour, and in this study, I also spoke to patients who could hardly distinguish truth from fiction. A psychotic disorder is a very serious brain disease in which people suffer from delusions and hallucinations. However, the available medication has limited effectiveness in a significant group of patients with psychosis. There is, therefore, an urgent need for new medication. After concluding in my PhD research that the administration of THC, the psychoactive substance in cannabis, to healthy volunteers, results in a ‘psychosis-like’ brain function, I came up with the idea of checking whether the treatment with CBD for patients with psychosis might lead to the normalisation of abnormal brain function.

What happens in the brain of someone with psychoses?

We know that a number of brain functions are altered in patients with a psychotic disorder. For example, the connection, the connectivity between a number of important brain areas is disrupted in patients in the so-called ‘default mode network’. This is a network of brain regions that are active when your attention is directed inward, on your own thoughts and perceptions. Disrupted connectivity in the default mode network is therefore implicated in the experience of delusions and hallucinations.

How can you see on an MRI scan if connectivity in the brain normalises after CBD use?

Functional connectivity means that certain brain regions are active at the same time. For example, when you dream away in your own thoughts, certain brain areas become jointly active, while other areas show activity when performing a difficult memory task. You can measure this coherence in activity by performing a number of calculations on the functional MRI scans that have been performed.

Did the patients participating in the study also feel better?

We have shown in this study that normalisation in brain function after CBD is associated with a decrease in complaints and symptoms. Patients who showed an improvement in brain function after CBD treatment also experienced fewer psychotic symptoms. This indicates that the effects of CBD on brain function are involved in the clinical improvement of patients.

Cannabis use can also trigger psychoses. Does your research also say anything about this fact?

The substance in cannabis responsible for the relationship between cannabis use and the onset of psychosis is THC. CBD is, as it were, the counterpart of THC. While THC can trigger psychosis, our research contributes to the idea that CBD, on the other hand, has antipsychotic properties.

The results of the study have now been published in the Journal of Psychiatric Research.

Great change in the Dutch medicinal cannabis policy

The Netherlands will change its medicinal cannabis policy drastically. Among the expected changes is the removal of the current export cap that limits Bedrocan’s products’ availability abroad. With the cap gone, the Dutch Office of Medicinal Cannabis (OMC) can meet more international requests for Bedrocan’s pharmaceutical-quality cannabis. In March 2023, the Dutch health minister Ernst Kuipers proposed the changes and has given a green light for further implementation.

 Growing international demand

Currently, the OMC cannot meet all requests from abroad due to the export cap. This cap is part of an export guideline in force since 2012. Since then, the international medicinal cannabis market has developed. Many countries have legalised the medicinal use of cannabis but cannot supply their internal markets. Not only due to a lack of domestic cultivation capacity but often due to the difficulty of cultivating at a pharmaceutical quality level. As Bedrocan is known for its high-quality cannabis, there is a growing international demand for Bedrocan products. This demand is what most motivated the change.

No more production capacity limitation

Currently, there is also a limitation imposed on Bedrocan’s production capacity. The limitation will now also be removed from the policy and the current tender procedure. This means there will be room for production expansions that can help meet international demand even further.

Cannabis policy, the next steps

The cannabis policy changes are expected to take effect still in 2023. However, the pace at which the changes will be implemented must still be outlined by the OMC and the Health and Youth Care Inspectorate (IGJ). Additionally, as supply orders are usually placed much in advance, availability abroad can take a bit longer to increase.

‘Closed’ chain remains

The supply chain overseen and controlled by the OMC will remain. In this “closed” chain, only parties the OMC has contracted via tender can operate. This way, the Dutch government keeps control of the cannabis trade and respects the Single Convention on Narcotic Drugs. This means international requests for Bedrocan’s products still need to be sent to the OMC after the policy amendment.

MYCB1 brings full-spectrum extracts from Bedrocan varieties to Germany

MYCB1, a pharmaceutical company headquartered in the Netherlands, is launching full-spectrum, GMP-certified extracts from Bedrocan varieties in Germany. Initially, the company will market two products made from Bedrocan® and Bediol®, named BDR and BDO.

Both products are already registered in Germany and ready for distribution. MYCB1 CEO, Ernesto Diringuer, is excited about this new development and the opportunity to meet German patients’ needs for high-quality cannabis products: ” We see this as an unprecedented achievement in the cannabis industry. It also marks a significant milestone for MYCB1 as we strive to provide patients with access to the highest quality cannabis-based medicines.”

Full-spectrum extracts in Germany

According to insurance reimbursement data, the German market for cannabis extracts has been growing in the past years. However, there are still limited options of full-spectrum extracts for German doctors to prescribe. Now, pharmaceutical-quality, full-spectrum extracts made from Bedrocan’s raw materials can be added to the list.

Bedrolite®

The company expects to be able to supply a high number of German pharmacies, clinics and hospitals. Initially, only extracts from Bedrocan® and Bediol® are available. But a full-spectrum extract from Bedrolite® will also be added to their portfolio in the near future. This would be meant for export, mainly to supply patients with intractable epilepsy in the UK.

Real-World Evidence platform

MYCB1 is also known for its efforts to collect scientifically useful data from real patients. For this purpose, it has developed the ALETTA platform. “Bedrocan’s high-quality cannabis is the most researched in the world, with a robust body of literature supporting its use. By combining our full spectrum extract with ALETTA, our Real-World Evidence platform, we are poised to advance the scientific understanding of cannabis therapy even further”, Ernesto says.

For more information

Research into the effects of medicinal cannabis (Bedrolite®) in children with epilepsy

The UMC Utrecht Brain Center, in collaboration with various organisations in the Netherlands, will conduct research into the effects of adding medicinal cannabis to the treatment of children with treatment-resistant epilepsy. The study drug to be administered is the Bedrolite® oil from the  Dutch Transvaal pharmacy. This medicinal oil is made from Bedrocan’s cannabis. The research group has been allocated 1.4 million euros from ZonMW s Good Use of Medicines programme, which funds research in the Netherlands. The research will take about four years.

Floor Jansen
Floor Jansen

A total of 50 patients can participate in the study. Importantly, the patients have not previously used CBD oil to treat epileptic seizures. In the first instance, the medicine’s effect on the attacks is examined, which is why participants must have a minimum of eight attacks every four weeks. Otherwise, the effectiveness cannot be assessed.

The study will start in the summer of 2023, and the first patients are expected to be treated by the end of 2023.

Lead researcher Floor Jansen hopes that after the research, neurologists can better predict for which patients CBD (cannabidiol) is an effective treatment. You can read more about this on the UMC’s website. Jansen: “Our research focuses on the individual. Instead of looking at a group, we look at whether the drug is effective per patient. We want to investigate whether the number of attacks decreases, but we also pay attention to other important outcomes for a patient. Think of less use of emergency medication against prolonged attacks, a change in alertness or a better night’s sleep.”

Practitioners of children with epilepsy who would like to know more about the study can contact Floor Jansen, pediatric neurologist at UMC Utrecht (via the secretariat of pediatric neurology at UMC Utrecht, Netherlands).

Bedrolite® and epilepsy

Although epilepsy can be treated well with existing medication, there are forms in which the drugs, registered and reimbursed, do not help. For the treatment of these treatment-resistant patients, the use of cannabis-based products can be a good alternative. According to the Dutch Epilepsy guideline (June 2020), CBD oil (Bedrolite®) from the pharmacy can be prescribed for children (from 2 to 18 years old) with a therapy-resistant Dravet syndrome or for patients (from 2 years old) with a therapy-resistant Lennox Gastaut syndrome.

From different experiences of individual patients, CBD, sometimes also in combination with THC, appears to reduce both the frequency and intensity of epileptic seizures. Partly because CBD has no psychoactive effect, this substance has great potential as a therapeutic agent for various types of epilepsy.

However, the scientific evidence for the effect of medicinal cannabis is still limited. This means that doctors are reluctant to prescribe it and that health insurers in the Netherlands do not reimburse it. More scientific research is therefore needed. The legal (medicinal) cannabis of the Office for Medicinal Cannabis (OMC, part of ministry of health) meets strict quality requirements and is cultivated by Bedrocan under standardised conditions.

German restrictions of patient’s access off the table

Bedrocan highly welcomes that drastic restrictions of patient’s access to medical cannabis discussed in Germany are off the table. The German G-BA (Federal Joint Committee, a decision-making body regulating reimbursements for patients with public health insurance in Germany) decided on March 16 to cancel plans to tighten the currently applicable rules for prescribing medical cannabis. According to the original G-BA draft, most doctors could have lost their right to prescribe medical cannabis and health insurances could have refused a larger proportion of prescriptions. As the largest supplier of medical cannabis in the EU and the only purely pharmaceutical market player with an exclusive focus on patients, Bedrocan is pleased with the fact that the initially proposed restrictions are not being implemented.

Jaap Erkelens
Jaap Erkelens

Bedrocan CEO Jaap Erkelens comments: “Our experiences from Canada and the Netherlands show that such restrictions would have led to shortcomings for suffering patients. They would have been forced into the black market and into medically unaccompanied self-medication. We are relieved that decision makers in Germany understand this danger, which increases even further with the planned liberalisation of recreational cannabis. Before that liberalisation, patients’ access to medicinal cannabis should not become more difficult but easier.”

G-BA regulates the prescription of medical cannabis in the case of serious illnesses

No additional requirements that go beyond the legally mandatory prescription requirements that are binding for the G-BA

You can find more details in German on the website of G-BA.

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CBD effect on psychosis