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Historic cannabis law change in Germany does not yet serve the patient

Germany has gone steps further than the Netherlands when it comes to cannabis policy. Cannabis possession is no longer prohibited under certain conditions, but the door seems wide open for pseudo-medical players. Does the new German legislation, which came into effect on April 1, 2024, mean something for the patient and what are the catches? Bedrocan’s Chairman of the Board Tjalling Erkelens responds to the most important changes.

Cannabis removed from narcotic list

In Germany, cannabis has been removed from the national narcotics list but is still restricted in many ways. Cannabis is still not allowed to be exported or sold and possession is limited to 25 grams per adult (50g at home).

The new law makes some things easier for patients and pharmacies. However, the biggest problem is that the new setup makes privately paid pseudo-medical prescriptions the only legal source of cannabis in Germany. Home cultivation and the new cannabis clubs will only play a role several months down the road. In the meantime, the law has not set strong medical standards as a minimum requirement, hundreds of new products with recreational names are flooding the medical market and telemedical services are offering prescriptions for almost any indication and for marketing prices as low as 1 euro.

Bedrocan's response

Tjalling: “The new law mainly fulfils a promise to voters who are recreational users. We have seen similar effects in Canada – it has created a huge wave of recreational demand. In Germany, medical and pseudo-medical structures are currently the only supply, resulting in a gigantic nationwide misuse. Real patients will be stigmatised even more than in the past. Instead, recreational users should have an easy source to receive recreational cannabis, while real patients, who often have years of treatment behind them, should receive medical treatment.”

Simplified access

Tjalling Erkelens on new German cannabis policy

Access to medicinal cannabis will be simplified, or at least that is the expectation. The German G-BA, which is responsible for amending the Medicines Directive on cannabis medicines, will soon hold a plenary hearing. A new list of specialists will be released who will be allowed to prescribe medicinal cannabis without approval by public health insurance.

Previously, four conditions had to be met: the clinical picture had to be serious enough, the patient had to have tried all standard treatment methods, treatment with medicinal cannabis had to offer the prospect of a positive change and, finally, there was an obligation to participate in anonymous accompanying research.

The best possible outcome would be better access to medical cannabis for patients and a simpler process for doctors and health insurers. However, with the country being hit by a wave of pseudo-medical prescriptions, health insurance providers today have all arguments on their side to open the door for publicly paid prescriptions only as limited as absolutely necessary.

Bedrocan's response

Tjalling: “It remains to be seen what exactly that will look like, but it is an overdue step forward, one that the Dutch Society of General Practitioners (NHG) and the Dutch government should also follow as an example. Real patients with chronic pain, spasms, rheumatism, palliative indications and so on – they can profit heavily from cannabis treatments, and they need easy access. Those patients cannot be faking their symptoms, and no health system should treat them like misusers. To help suffering patients, we need different measures to fight misuse, not restricting access for all. For example, I wonder why the new law in Germany makes it so easy for telemedical services to provide medical cannabis for seemingly recreational users, while it is very difficult for recreational users to legally access recreational cannabis. Potential misuse of the medical system by recreational users in Germany is unavoidable this way.

New THC limit for driving

The ministry’s expert group has agreed on a new THC limit (3.5ng in blood) for driving under the influence of cannabis. This recommendation still needs to go through Parliament, which will draft a law. Until now, there was no legal limit. However, case law has established a threshold of 1 ng above which penalties have been imposed.

Bedrocan's response

Tjalling: “Patients are exempted from these rules in Germany, which is good. Their individual dosage plan, tolerance and body weight means that the question needs to be assessed individually. I hear that the abolition of cannabis in the Narcotics Act makes it difficult for patients to prove their status as patients. But I’m sure the efficient German administration will solve that quickly.”

Removal of health insurance approval

Removal of health insurance approval requirement for medical cannabis is planned for certain specialised doctors. Others are demanding this altogether.

Bedrocan's response

Tjalling: “The approval requirement hits everyone and claims that even patients with years of medical history and unfakable symptoms are only seeking drug misuse. Anything that really fights the misuse of medication for recreational purposes is good for patients. And providing real patients with good access to a medically supervised cannabis therapy is good for patients and actually saves health insurance companies significant money.”

New restrictions for public inhalation

Within pedestrian zones or a radius of 100 meters from schools, playgrounds, children and youth facilities, and publicly accessible sports facilities and in or within 100 meters of any cannabis club.

Bedrocan's response

Tjalling: “Distance regulations should not apply to patients. This discriminates against the dosage form and the patient’s daily medication, and it sets a dangerous precedent for the mistreatment of sick people in Germany. For example, travelling patients, who cannot inhale in their hotel, will need to find public hiding places for their inhalation treatment – that is a shame. If we mistrust all patients to be misusers, soon patients who need insulin will need to hide, too. These types of restrictions have an undue stigmatising effect.”

Follow-up research is started into the effect of cannabis oil on neuropathic pain

The Leiden University Medical Center (LUMC) and the Center for Human Drug Research (CHDR) in the Netherlands have started a study into the efficacy of medicinal cannabis oil and its effects on neuropathic pain. The research involves 200 pain patients who are administered oil made from Bedrocan® cannabis, and it is expected to be completed in two years.

The study is a follow-up to an earlier study, which aimed to establish an the ideal ratio between THC and CBD for pain treatment. That study among healthy volunteers has now been completed, but the results have not yet been published. From the results, however, it has emerged that follow-up research should be started using a cannabis product with high THC. In this case, oil was chosen as the product form. Medical cannabis oil with high THC is available on prescription in the Netherlands at various compounding pharmacies.

Monique van Velzen
Monique van Velzen

Research manager Monique van Velzen from the LUMC is supervising the research.

How important is this research?

“We think this could be an important study to predict which patients might benefit from THC oil for their pain complaints. We want to treat patients in a more targeted manner, and for this, we will have to understand which types of patients have a greater chance of a positive effect from this drug.”

Participants wanted

Participants are still being sought for the research with cannabis oil. Van Velzen: “We are looking for Dutch patients with nerve pain caused by nerve damage or a brain disorder.”

It is difficult to say exactly what conditions a participant must meet: “We prefer to discuss that with the patients themselves, because it is not very easy to summarize. In any case, participants must be adults and diagnosed with chronic neuropathic pain,” says Van Velzen.

It is estimated that 1 in 5 Dutch adults suffer from moderate to severe chronic pain. A significant portion of them suffer from neuropathic pain.

Why was cannabis oil chosen as the administration form and not a vaporizer?

“This has several reasons: oil is easier to dose, easier to use, and more pleasant for patients. In addition, it is a more pharmaceutical approach, it has less stigma and we think patients can integrate this better into their daily lives.”

How high are the expectations of the outcome?

“Naturally, we expect that the outcome may have an impact on treatment recommendations for patients with chronic pain. More targeted treatment is friendlier to the patient, more economically optimal and leads to better quality of care.”

Bedrocan welcomes new European monograph for cannabis flowers

Europe has now the long-awaited quality standard monograph for cannabis flowers. The European Pharmacopoeia Commission officially published the monograph at the beginning of the year, and it will come into force as of July 2024. Many experts and members of the cannabis industry were invited to collaborate on the content. Now that the document has been officially published, Bedrocan welcomes the launch of official quality requirements for medicinal cannabis and hopes it will push more standardised cannabis legislations in Europe and countries that follow European standards.

Quality requirements

The new monograph Cannabis Flower (Cannabis Flower, monograph 3028) describes in detail the required quality of cannabis flowers for patient use. Among other things, the monograph establishes a maximum accepted deviation of 10% from the declared THC and CBD content on the product label. It also mentions the maximum acceptable levels of heavy metals and how to carry out tests that assure the quality of cannabis flowers in milled or ground forms. In general, the EDQM aimed to apply the highest pharmaceutical quality standards to cannabis. Bedrocan Founder Tjalling Erkelens: “It is of the utmost importance for patients and their healthcare providers to be able to rely on more consistent and standardised cannabis and cannabis derivatives. This new monograph is very helpful in that regard.”

monograph cannabis flowers

More harmonisation

The monograph is an important milestone towards the harmonisation of quality requirements for medicinal cannabis. Currently, cannabis legislations vary a lot between countries. Many countries in and outside the European Union (EU) use the European guidelines as a standpoint for their local legislation regarding the quality of medicines. The standards of the European Pharmacopoeia are legally binding in thirty-nine states, not only in the EU. Many other countries, including the US and Canada, also use it as a reference. The harmonisation of standards on such a scale is beneficial to any conventional pharmaceutical product, but it was urgent for medicinal cannabis. Now, Bedrocan hopes there will be more convergence in quality requirements for medicinal cannabis products worldwide. Tjalling: “I hope and expect the global industry and legislators in various countries to embrace this important step forward now set by the EDQM.”

European Pharmacopoeia

The European Pharmacopoeia is the main source document for quality control of medicines. It is elaborated by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which aims to ensure the harmonisation of quality standards for medicines in the European continent and beyond. Since its first version in 1969, the pharmacopoeia has been constantly updated. The document consists of a number of monographs, each describing in detail the expected quality of different categories of medicines, pharmaceutical preparations and their ingredients. The guidelines in the European Pharmacopoeia become mandatory on the same date in all countries part of the convention. This means that all pharmaceutical companies active in these countries must meet the quality requirements described in the monographs in order to market their products.

 

Smoking cannabis vs vaporization

Around the world, people administer medicinal cannabis in various ways. Inhalation is one option. While vaporization continues to be a notable mode of consumption, it is smoking cannabis that remains number one. But why smoke cannabis when vaporization is an option?

Why would you smoke cannabis?

Imagine smoking. Inhale… Exhale… Big inhale! Cough, cough, cough! Lungs filled with smoke, tar, toxins.

We have been warned off about smoking for years, mainly from our collective knowledge of the risks of smoking tobacco. But we know smoking cannabis brandishes harms, too. [1]

Looking at Canada, among survey respondents who used cannabis in the past year, the majority used cannabis flower. Despite over half (53%) being exposed to health warnings, increasing their knowledge of the harms related to cannabis use, the majority continued to smoke. Indeed, smoking (84%) was the most common method of consumption in Canada among non-medical users. While not identical, there are similar trends for Canadian medical users (using on average 1.5 gram/day cannabis flower). [2] And, indeed, this use profile is mirrored among respondents in previous ‘use’ surveys. [3]

So, why are people not vaporizing?

Is it the cost? Is accessing and using a vaporizer prohibitive? Is it people not being used to vaporizing technology? Is it faster to roll and smoke a joint? [4]

cannabis roken
Zak met gedroogde medicinale cannabis

The benefits of vaporizing cannabis

We know that the use of a high-quality vaporizer device avoids the respiratory disadvantages of smoking. [5]

A vaporizing medical device, compared to smoking cannabis, dramatically lowers concentrations of toxic compounds such as carbon monoxide, ammonia and polyaromatic carbohydrates (PACs). Compared to smoking, higher therapeutic levels of THC and consistent, reproducible THC extraction and delivery is possible. [6] [7]

It has been established that inhalation via a vaporizer is an efficient route of administration. The vapour is quickly absorbed by the lungs, resulting in measurable cannabinoid serum levels rapidly (reaching Tmax within minutes). [8]

The rapid onset of effects of vaporized and inhaled cannabinoids allows easier titration of the dose based upon symptom severity, tolerability and avoidance of side-effects. [9] While fully standardised, pharmaceutical-quality cannabis flos enables the administration of an exact dose – assured dose composition and dose repeatability. It also means it is free of contaminants such as microbes, pesticides, heavy metals and other toxic compounds. From a patient safety perspective, these qualities make the vapour safer for inhalation into the lungs.

Over the past years, more and more patients have vaporized cannabis flos without reports of serious adverse reactions. It is now time to start exploring ways to move patients away from smoking toward less harmful modes of administration.

Given patients seek a reliable, affordable and portable vaporizer for administering cannabis flos, perhaps more attention is required here?

Is adept, well-timed policy the way forward?

Future thinking – policy angles

Given patients indicate a preference for vaporizers, sensible policy and practical education might be the way to usher in positive change.

With regard to administration, the future policy must be clear and obvious. For example, in Germany, Australia, New Zealand, and The Netherlands smoking cannabis flos is not permitted and/or actively discouraged. The clinical guidelines only support cannabis flos for inhalation administered by vaporization. These types of policies need support from the health sector, industry, and must achieve buy-in from patients and their careers.

Some other approaches might include:

  • Setting a positive regulatory environment, focusing on and enabling rapid developments in the vaporizer industry. The aim is to usher in vaporizers which are more affordable, portable, easy to use, environmentally and consumer friendly.
  • Ensuring that a blanket ban on inhalation is not pushed into law. Excluding quality vaporizer devices from the market would be nonsensical. It would:
    • Eliminate their valid use in hospitals and hospices, rest-homes, and home settings.
    • Have implications for administration options; limiting therapeutic options and prescriber-patient choice.
    • Confine administration to oral dosing only (i.e. excluding the inhalation option).

Policy focused to support education is another, including:

  • Educating prescribers, pharmacists and patients to be aware of the differences between ‘vaping cannabinoids’ and ‘vaporising cannabis flos’, and fully understand why smoking should be avoided.
  • Educating the consumer (i.e. patients) on the benefits of using a vaporizer, compared with smoking. This requires really clever social-advertising – getting people to change, often embedded, behaviours and the accepted culture of smoking a joint.
  • Educating the consumer (i.e. patients) on what makes a good vaporizer – what quality aspects to look for.

For more on administration, see the article The risks of vaping cannabis.

References

[1] Tashkin, D. P. (2013). Effects of marijuana smoking on the lung. Annals of the American Thoracic Society, 10(3), 239-247.

Tetrault, J. M., Crothers, K., Moore, B. A., Mehra, R., Concato, J., & Fiellin, D. A. (2007). Effects of marijuana smoking on pulmonary function and respiratory complications: a systematic review. Archives of Internal Medicine, 167(3), 221-228.

[2] Health Canada (2019). The Canadian Cannabis Survey 2019.

[3] Sexton, M., Cuttler, C., Finnell, J., Mischley, L. (2016). A cross-sectional survey of medical cannabis users: Patterns of use and perceived efficacy. Cannabis and Cannabinoid Research; 1: 131-138.

Hazekamp, A., Ware, M., Muller-Vahl, K., Abrams, D., Grotenhermen, F. (2013). The medicinal use of cannabis and cannabinoids: An international cross-sectional survey on administration forms. Journal of Psychoactive Drugs. 45 (3), 199–210.

[4] Aston, E., Scott, B., and Farris, S. (2019). A qualitative analysis of cannabis vaporization among medical users. Exp Clin Psychopharmacol. 2019 Aug; 27(4): 301–308.

[5] Loflin, M., and Earleywine, M. (2015). No smoke, no fire: What the initial literature suggests regarding vapourized cannabis and respiratory risk Can J Respir Ther. 2015 Winter; 51(1): 7–9.

Hazekamp, A., Ruhaak, R., Zuurman, L., van Gerven, J., Verpoorte, R. (2006). Evaluation of a vaporizing device (Volcano) for the pulmonary administration of tetrahydrocannabinol. Journal of Pharmaceutical Sciences. 95(6):1308-17.

[6] When administering pharmaceutical quality cannabis flos.

[7] Abrams, D., Vizoso, H., Shade, S., et al. (2007) Vaporization as a smokeless cannabis delivery system: a pilot study. Clinical Pharmacology and Therapeutics. 82 (5): 572 – 8.

Gieringer, D., Laurent, J., Goodrich. (2004). Cannabis vaporizer combines efficient delivery of THC with effective suppression of pyrolytic compounds. Journal of Cannabis Therapeutics. 4(1)

Eisenberg, E., Ogintz, M., Almog, S. (2014). The pharmacokinetics, efficacy, safety, and ease of use of a novel portable metered-dose cannabis inhaler in patients with chronic neuropathic pain: A Phase 1a study. Journal of Pain & Palliative Care Pharmacotherapy. 28:216–225.

Vulfsons S, Ognitz M, Bar-Sela G, Raz-Pasteur A, Eisenberg E (2019). Cannabis treatment in hospitalized patients using the SYQE inhaler: Results of a pilot open-label study. Palliative and Supportive Care, 1–6.

[8] Tmax: the time it takes to reach the maximum concentration (Cmax) of an exogenous compound or drug in the plasma or a tissue after a dose is administered.

[9] Van de Donk, T., Niesters, M., Kowal, M., Olofsen, E., Dahan, A., van Velzen, M. (2019). An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. Pain; 160: 860–869.

Research into the role of the endocannabinoid system in anxiety

How can soldiers and civilians experiencing PTSD best be treated, and can medicinal cannabis play a role in this? The Brain Research and Innovation Centre of the Military Mental Healthcare has been dealing with this question for some time and researcher Nadia Leen has obtained her PhD for several substudies. Nadia currently works for Bedrocan and will contribute to research into gender differences in the acute effects of the products Bedrocan® and Bediol®.

Studies have long shown that the endocannabinoid system, the mechanism in the human body that regulates stress, among other things, plays an important role in fear extinction. Childhood trauma can also permanently disrupt the endocannabinoid system. However, forty per cent of patients with anxiety-related disorders do not respond to standard treatments such as cognitive behavioural therapy. An alternative treatment could be medicinal cannabis. In this specific case, treatment with CBD, because it would have an acute anxiolytic effect and stimulate fear extinction. CBD (cannabidiol) is a component of the cannabis plant that affects the endocannabinoid system after ingestion. Anandamide is one of the body’s own cannabinoid that is broken down less quickly after CBD use. Anandamide controls all kinds of processes in the human body.

Anandamide

Anandamide has an anxiolytic effect and plays an important role in extinguishing fear. Nadia Leen: “In our study, we wanted to know whether the level of Anandamide in blood plasma was associated with treatment success in veterans with PTSD. We thought: the higher the level, the better they respond to treatment because increased Anandamide levels are related to better fear extinction. However, the blood samples showed that there was no difference between healthy people and veterans.” Was that a disappointment? Nadia: “Yes, it certainly was, because we thought that Anandamide levels would be lower in veterans and that they would therefore benefit from boosting these levels. In fact, it was the opposite. Some veterans actually had increased Anandamide levels, which was associated with anxiety symptoms.”

Research team - Nadia Leen
Nadia Leen

PTSD

Post-traumatic stress disorder (PTSD) is a trauma and stressor-related disorder that has a disruptive impact on family life, work, and can lead to general social exclusion. Isolation and PTSD can result in self-destructive behaviour, such as excessive use of alcohol or drug abuse. PTSD occurs after a traumatic event. The patient experiences nightmares and lifelike memories (flashbacks). Treatment often consists of a combination of medication, such as antidepressants, and cognitive behavioural therapy.

There is limited clinical data to support the prescription of medicinal cannabis for PTSD. Medical cannabis (oil, or floss) can be tried as a complementary therapy, in low doses (microdosing) and in combination with physical and psychological therapies.

Endocannabinoid system

“It seems, but that is purely hypothetical, that the endocannabinoid system will adapt to the long-term high levels of Anandamide after a while” Nadia continues, “which means that if the stress level is too high, the system becomes overactive and can no longer regulate the levels properly. We actually still have a lot to learn about the precise mechanism of action of the endocannabinoid system.”

Follow-up research has now started and Nadia is hopeful: “The endocannabinoid system is a promising candidate in understanding and treating anxiety, stress and trauma. I am therefore pleased that the Brain Research and Innovation Centre is continuing clinical research into the effects of CBD (cannabidiol) in veterans with an anxiety disorder and/or PTSD. Hopefully, it will contribute to reducing the burden that military personnel and veterans in particular experience in their daily lives due to PTSD.” The follow-up research is being conducted by PhD candidate Remco van Zijderveld.

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.

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.

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irradiation
quality of life