Updates

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.

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.”

“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.

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.

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.

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.”

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.

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, 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.

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.

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).

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.

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.”

Some patients go to the coffee shop rather than to a doctor. Others grow their own cannabis. These are just two examples of how patients obtain cannabis for medicinal use in the Netherlands. According to figures from the Trimbos Institute, more than 130,000 people in the Netherlands use cannabis for medicinal purposes. Of these, fewer than 7,000 patients are prescribed cannabis by a doctor. Therefore, most of them get their cannabis from other sources, such as coffee shops or growing it themselves.

To understand how access to and supply of medicinal cannabis can be improved, the Trimbos Institute is conducting an independent survey among cannabis users. The online questionnaire is already live. The research and knowledge institute in the mental health and substance field hopes to map out patients’ needs and wishes. Bedrocan finances the research.

Patients’ voice

According to Trimbos Researcher and Project Leader Lisa Strada, it is common knowledge that patients use weed, hashish, cannabis oil or other cannabis products to reduce physical or psychological complaints. Strada: “Based on more recent findings, almost half a million people use cannabis-based products for medicinal purposes. Of these people, 50% use CBD products, including CBD products from drugstores.” Strada continues: “With this research, we want to give these patients a voice. Patient-centred care means that the patient’s needs are the driving force behind care decisions. And while this is the norm in other healthcare sectors, medical cannabis treatment is lagging in this regard.”

Since 2003, patients in the Netherlands have been able to obtain cannabis from pharmacies on a doctor’s prescription. Chief Scientific Officer Mikael Kowal of Bedrocan: “Despite the fact that medicinal cannabis has been available in the Netherlands for twenty years, most people do not get their products from a pharmacy. It’s important to understand why so many people choose the unofficial route. What obstacles do they experience? Is cannabis from pharmacies too expensive, do doctors not want to prescribe it, or are specific products missing? It’s guesswork. We don’t know now.”

Kowal hopes the outcome will lead to change: “We will have to come up with strategies to meet the needs of patients who are now using cannabis from non-official sources. The aim should be for more patients in the Netherlands to use standardized, controlled and safe cannabis, instead of products of unverified quality.”

Medusa research

The first part of the Medusa study is an online questionnaire. Filling it in takes 10-15 minutes, and participants can win 200 euros in a sort of lottery. Some sample questions asked:

• For which complaints do you use cannabis?
• What cannabis products do you use?
• How well does cannabis work against your complaints?
• Why don’t you use cannabis on a doctor’s prescription?

After the questionnaire, participants can participate in follow-up studies. They can choose one of these follow-up tests or both, and participation is voluntary. One is an online interview, and for the other, they can send in a bit of their cannabis. Participants receive a reimbursement of 40 euros per follow-up study.

A new study shows that cannabis, and in particular the THC component, has no effect on the breathing system. The Leiden University Medical Center (LUMC) has conducted research into this. The outcome is important safety information when using cannabis for medical purposes.

There is not much knowledge on the effect of cannabis on ventilatory control – the unconscious and automatic process of breathing. The clinical study at the LUMC administered vaporized Bedrocan® to 18 volunteers to study the effect of THC on breathing with and without the addition of an opioid. Since opioids can potentially cause life-threatening respiratory depression, it is important to understand if combining opioids with cannabinoids can intensify this problem. It is possible that such a combination of products will be used in the treatment of chronic pain. Fortunately, the results of the clinical trial suggests that THC has no effect on ventilatory control.

Below you can find the original abstract of the study, executed by the research team of professor dr Albert Dahan.

Can higher CBD levels reduce the harmful effects of cannabis use? That is the question that researchers from King’s College London tried to answer in a psychopharmacological study of forty-six healthy participants, who had little or no experience with cannabis use. The group received various cannabis preparations with 10 mg THC and a varying CBD content (0, 10, 20 and 30 mg) via a vaporizer, in a double-blind and randomised study. The cannabis used for the study originated from Bedrocan and was produced in accordance with Good Manufacturing Practice.

Fifteen minutes after cannabis inhalation, participants completed a series of tasks measuring mental abilities and reported how “pleasant” they experienced the cannabis. They also went on a 15-minute ‘hospital walk’, with the task of buying a £2 item of their choice from a cashier in the hospital shop. They had to ask for a receipt. They were observed from a distance by the research team. After any intoxicating effects had subsided, psychological questionnaires and a semi-structured clinical interview were administered.

No evidence

The researchers found no evidence that CBD reduces the acute adverse effects of THC. In terms of cognition, the adverse effects of THC mainly refer to effects on attention and memory. In terms of mental health, this mostly relates to the emergence of psychotic symptoms.   Also, there was no evidence that it changed the subjective or pleasurable effects of THC. This was the case for all CBD:THC dose ratios used in the study.

Interesting data

Bedrocan’s Chief Scientific Officer Mikael Kowal about the outcome: “This is interesting data which is somewhat contradictory to previous research on the interactions between THC and CBD, in which CBD has been shown to reduce some of the negative effects of THC. It is difficult to say which factors contributed to these different results, however there is a possibility that the differences are related to the use of specific cannabis varieties. Specifically, the current study used Bedrocan® and added various amounts of Bedrolite® to the THC-rich variety, in order to achieve the desirable amounts of CBD. Possibly, using a cannabis variety that already contains both THC and CBD (like Bediol®) would yield different results. This is only speculation, but in such a case it may be possible that other compounds in cannabis, aside of CBD, contribute to modulating the effects of THC.“

Bedrocan is expanding its production capacity with the establishment of a new GMP-approved facility for the cultivation and packaging of medicinal cannabis in Denmark. The new facility will be located in Køge, which is 30 kilometres south of Copenhagen.

Meeting international demand

The main reason for Bedrocan to expand into Denmark is to better meet the growing international demand for its high-quality medicinal cannabis products. Under the current legal framework in the Netherlands, Bedrocan’s products are only available via the Dutch Office of Medicinal Cannabis (OMC), part of the Ministry of Health. Bedrocan expects to significantly improve the availability of its products to vulnerable patients globally. In Denmark, Bedrocan can conduct business directly with other commercial entities.

The new facility will comply with all relevant regulatory requirements (GACP and GMP). Products from this facility are initially meant to supply European medicinal cannabis markets. The facility will employ approximately 40 staff and will be operational by the end of 2023.

Products

The facility starts off by producing some of the currently known Bedrocan varieties, such as Bedrocan® and Bediol®, plus a new high CBD variety. The dried cannabis products are processed in a cut form (sometimes referred to as granulate) in small and large packaging. For the manufacturing of extracts and isolates, it is also possible to obtain whole-plant cannabis from the Danish facility.

If you have any questions regarding this announcement, please contact our business department at business@bedrocan.com.