Updates

In this Updates section, you will find a selection of articles that appeared in our newsletter. For a complete overview, go to our Archive.

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Real-World Data can help to understand better how medicinal cannabis works

For years, doctors and researchers have been calling out ‘we need more evidence’ regarding the effect of medicinal cannabis. The Dutch-German company MYCB1 says it can now provide this proof by using data from actual patients. It is called Real-World Data (RWD), a new term that is popping up more and more in the medical world.

Real-World Data approach

In a Real-World Data approach, drug efficacy data is not extracted from traditional controlled clinical trials but comes directly from patients. For example, a patient keeps track of his health status via an online app on a daily basis. This data is then processed and made available via an online platform. More and more drug agencies, including the US FDA and the European EMA, are using this type of data to support drug decision-making and approval.

Uruguay-born Ernesto Diringuer started the pharmaceutical technology company MYCB1 five years ago with the aim of collecting scientifically useful data from real patients. The starting point was to demonstrate the effect of medicinal cannabis with the help of patients. To collect the data, MYCB1 has developed the ALETTA platform, named after Aletta Jacobs, the first female doctor in the Netherlands.

High-quality Real-World Data

Doctors and researchers can use ALETTA to gather high-quality Real-World Data on patients under cannabinoid-based treatment. This data can then be used to optimize patient treatment results or for research purposes.

The ALETTA stands out from all other apps in the market. “We are not a purely technological company, because we also produce cannabis oil ourselves from Bedrocan raw materials. This oil is standardised and that is the basis of the whole concept. Without standardised oil, you cannot collect scientifically sound evidence about the effect of medicinal cannabis. The ingredients of cannabinoid-based medicines must always be the same, just like with any other medicine.”

MYCB1 produces three different types of medicinal cannabis oil that doctors can prescribe to patients.

Real-World Evidence and Covid

The Covid-19 vaccines from AstraZeneca, among others, have been developed with evidence collected through Real-World Evidence (RWE) studies. In an article approved by the International Society for Pharmacoepidemiology, scientists state that RWE has “quickly provided compelling evidence on drug safety, vaccine safety and effectiveness.” The European Medicines Agency expects that by 2025 the use of RWE will have become commonplace.

Amsterdam pharmacy

In the Netherlands, the products of MYCB1 are registered with Z-index, the drug database of the Netherlands. The oil is manufactured under GMP in their Amsterdam pharmacy. For the German market, production takes place in Steinheim. Per default, the oil comes with the ALETTA application in which patients indicate any side effects and how they are feeling through a validated, internationally recognised questionnaire. Diringuer: “These are not random questions but standardised questions that are used by scientists worldwide to assess someone’s quality of life, the so-called EQ-5D. It has been used to gather evidence in trials, population studies, and real-world clinical settings for over 25 years.”

The patient plays a crucial role in the concept. Data about his well-being must be captured in the app. Diringuer: “The patient who is prescribed our oil can keep control over their own medication. They can look for the dose that works best and has the least side effects. Side effects can be reported immediately, and the patient gains insight into their own Quality of Life.” Doctors can then use this data to make more informed medical decisions.

Researchers also see the value of the availability of the Real-World Data. “The drug agencies, including the European Medicines Agency, increasingly want to see Real- World Evidence (RWE) studies, which provide insight into medications outcomes on patients’ daily drug use. It is a new development from which there is no escaping, and it seems RWE will be the new gold standard for clinical research in the near future,” says Diringuer.

Real World Data - self reported health status through ALETTA
The Real-World Data management platform ALETTA

How MYCB1 started

“In 2017, it became clear to me that the only way going forward on the cannabis space in the Netherlands was on prescription-only cannabis extracts manufactured only with Bedrocan GMP-grade standardised cannabis flos.

We found out in our journey that, on one side, many patients are benefiting from cannabis. However, there is a serious lack of high-quality scientific evidence on the other side. We also found out that this is not an exclusive problem of cannabinoids, but the insufficient evidence also applies to register medicines when used in the Real-World setting. Control studies results as Randomized Control Trials, with strict exclusion criteria, do not represent the results of the same drug in Real-World use by “real patients”  with varied comorbidities, poor adherence, ethnicities, using many medications with complex interactions, and so on.

The problem of lack of scientific evidence also extends into supplements and vitamins, and other OTC drugs, but also into all kinds of behavioral interventions.

MYCB1 is developing tools and technologies such as ALETTA, our Real-World Data management platform, to gather high-quality Real-World Evidence to help optimise patients’ outcomes. Starting with cannabinoids but moving into all prescription medications, OTCs, and also behavioural interventions. ”

MYCB1 Apotheek + ALETTA is ISO27001, NEN7510, ISO9001 and HKZ certified.

Ernesto Diringuer - about Real World Data
Founder & Director Ernesto Diringuer

Bedrocan presents: A clinical primer

Bedrocan is happy to present the new booklet ‘A clinical primer’. Following on from the introductory text ‘A primer to medicinal cannabis’, the ‘clinical primer’ draws on clinical research, clinical observations, and professional experiences to provide useful, real-world insights into the rational use of cannabis-based medicines. It aims to equip prescribers, pharmacists, and nurses with practical, evidence-based guidance to support decision-making and improve communication of these medicines’ benefits and risks with their patients.

clinical primer

About the authors and editor

The authors are Dr Jürgen Fleisch (MD, PhD) and Martin Woodbridge (MPHC, DPH). The editor is Professor Emeritus Dr Carl Burgess (MB ChB, MD, MRCP, FRACP, FRCP).

Dr Jürgen Fleisch (MD, PhD) has practised anaesthesiology and pain therapy since 2007 at the Leiden University Medical Centre (LUMC), Netherlands. His close cooperation with the Department of Oncology of the LUMC allowed him to regularly treat pain and related symptoms in cancer patients using classic medications and interventional pain treatments. He also has considerable experience prescribing cannabis-based medicines.

Martin Woodbridge (MPHC, DPH) is a pharmacologist, policy analyst, and clinical educator. In 2007, he wrote New Zealand’s medicinal cannabis clinical and regulatory guidelines for the Ministry of Health. Since then, he has advised on the development of cannabis medicine programmes in Oceania and Asia and for the United Nations International Narcotics Control Board’s regulatory guidance on cannabis intended for medical and scientific use. He is also the author of the complimentary text ‘A primer to medicinal cannabis’.

Professor Emeritus Dr Carl Burgess (MB ChB, MD, MRCP, FRACP, FRCP) is a member of the New Zealand Order of Merit for Services to Pharmacology. He taught internal medicine and clinical pharmacology from 1982 to 2013 at the University of Otago’s Wellington School of Medicine while also a consultant hospital physician to Capital and Coast Health, New Zealand. He has been involved in clinical pharmacology research since 1976.

Martin has worked with Dr Carl Burgess and Dr Jürgen Fleisch on different projects relating to the rational use of medicines.

Contributions

The clinical primer is also the result of the contribution of several healthcare professionals, who agreed to share their experience with prescribing, handling and working with medicinal cannabis for patients with different conditions.

Bedrocan also proudly supports the development of this brochure under the policy of education without commercial bias.

Go to our Downloads page to download a free copy.

Talking with Lucy Haslam, co-founder of the Australian UIC Medicinal Cannabis Symposium

The Australian  United in Compassion symposium (UIC) started in 2014. UIC is well attended by industry, health professionals, government regulators and patient advocacy groups. Bedrocan Australia caught up with Lucy Haslam – UIC co-founder – to see where it all started and what lies ahead.

Bedrocan Australia first attended UIC in 2016. Then, the industry was fledgling in status. All health practitioners were new to prescribing, and the Australian TGA was preparing to publish TGO93 (quality standard) and SAS prescribing guidance. What did UIC represent back in 2016?

“UIC represented patients struggling not to be forgotten in the political arena. The discussion had changed from exercising compassion to enforcing regulations. We were still very much trying to battle the mantra that harped on constantly about the lack of evidence, and the devaluation of the lived patient experience.”

In 2022 UIC is back! There is strong support from the industry. The speaker line-up is diverse, as are the topics. What role does UIC represent today?

 “In some ways, our position hasn’t changed much. We continue to struggle to ensure that barriers to access are removed.

In 2022, we have a rapidly evolving industry where many participants are not even aware of the patient-led campaign that went before the birth of the industry.  Some in the industry have a determined focus on profits; they undervalue the patient as their customers and only give them recognition when it relates to their bottom line.

UIC today tries to remind the industry that patients should come first, and that ethical industry practice will be rewarded in the longer term. UIC still promotes education because that is a void that has remained since the change in legalisation. The regulation around advertising and the lack of public information demonstrate the failure of government to accept the reality of medicinal cannabis use in the broader community.”

Lucy Haslam and son
Lucy Haslam and her son Dan Haslam, who passed in 2015 and inspired her fight for patient access to medicinal cannabis.

Since 2016 you have been in a leadership role and the face of UIC. What have been the key achievements for UIC, and what are you most proud of?

“It has been a hard road. The key achievements would be raising public awareness and acceptance of medicinal cannabis, but with the knowledge that there is still much to be done in removing the stigma and ongoing barriers.

Changing the law in Australia was briefly rewarding until the legislation revealed the potential for many problems. These problems, predicted in 2016, have indeed emerged. These unnecessary obstacles have impacted most heavily on patients, who were the very reason for changing the legislation in the first instance.”

UIC is pretty focused on (a) ensuring access to quality herbal material and full-spectrum extracts medicines, and (b) engagement with health professionals – indeed, UIC has supported health professional education… regarding this:

Are there unmet needs with regard to patient access?

“Many eligible patients still rely on the ‘green market’ [illegal market] because of cost and ease of the process. The price disparity is improving, but cannabis remains outside the reach of many due to the regulatory limbo which sees it  as ‘approved yet unapproved’ in Australia. Consequently, it is not able to be subsidised by the Government.

Paediatric epilepsy patients who are not suitable for Epidiolex (the only registered product) cannot afford the exorbitant costs of the quantities they require. They are frequently still relying on the ‘green market’.

Patients who need to drive still have to choose between ‘driving and risking criminal prosecution’ or ‘not having medicinal cannabis as medicine’. That should never be the reason to make a health determination, and the laws need urgent fixing as they are discriminatory and unscientific. Many cancer patients are using cannabis in ways unapproved by the TGA. The regulations do not reflect reality, which puts patients outside the care of their doctors when that care is most needed.”

Are there unmet needs with regard to medicine quality?

 “Australia opted for allowing cheaper imports to fill the need until the local industry was established. That created a dual system whereby local producers were held to a higher standard than imported products, which is now being addressed following many complaints.”

 Are there unmet needs with regard to education?

“Education is beginning to be sought out, and there is progress in the number of prescribers accessing it.

The roadblocks here seem to be more at the College level [health professional societies], and one can only assume that this is political and based on the vested interests and/or personal biases of individuals.”

Cannabis-based medicines are increasingly being prescribed in Australia. Do you think cannabis is now being seen as a medicine? From your perspective, are we almost there, or are we still on a long path ahead?

“For many people, cannabis is a very valuable medicine. Additionally, for many like me, it represents the battle for truth that seems so readily diluted when vested and commercial interest is involved.

Patients who use cannabis are still largely struggling for respect and recognition that their choice of medicine is validated scientifically.

We are on the road, but far from where we should be – which is where patients can easily access affordable medicine and not be punished or discriminated against for doing so. I still hold the belief that once human interference is removed from the mix, cannabis will one day be considered a wonder drug by the medical community and not just by the patients who use it.”

Find out more

Interested in attending UIC? There are still tickets available for the sunny Queensland symposium.

Bedrocan Australia will host an industry booth, and will also speak at the General Symposium on the topic of ‘quality in cultivation’, Saturday 21 May 2022.

Medicinal cannabis information available at the Floriade

In order to raise awareness of the Dutch medicinal cannabis program, Bedrocan will be present at the Floriade Expo together with the Institute for Medicinal Cannabis Netherlands and the OMC for the next six months. More than two million visitors are expected at this world horticultural exhibition from April to October 2022.

This time, Bedrocan has a special bond with the location of the Floriade, as it will be held in the province of Flevoland. Bedrocan’s largest production location is also located in Flevoland.

Floriade banner

Great need for good information

More than ever, there appears to be a need for good and reliable information about the medicinal cannabis program. This program has been running in the Netherlands since 2003. Patients can obtain medicinal cannabis on a doctor’s prescription at the pharmacy. This concerns dried cannabis, cannabis oil or CBD oil. These cannabis products are safe to use and are produced under pharmaceutical regulations. It recently emerged that Dutch people who use cannabis for medicinal reasons often do so on their own and do not consult a doctor or pharmacist. The Trimbos Institute has investigated this for the first time (see box below). CBD oil, which is freely available in the Netherlands, is particularly popular. Dutch patients apparently do not know that they can be prescribed medicinal cannabis, including this CBD oil, through their doctor.

Cannabis distribution in the Netherlands

In the Netherlands, the distribution of medicinal cannabis is strictly separated from the tolerated sale of cannabis for recreational use through coffee shops. Medicinal cannabis is only available on a doctor’s prescription and is grown by Bedrocan under strict guidelines on behalf of the Dutch Office for Medicinal Cannabis (OMC). In addition, numerous products with CBD are also freely available at drugstores and via the internet. CBD is a non-psychoactive component of cannabis that does not fall under the Dutch Opium Act.

Interactive booth with virtual tour

The presence at the Floriade is part of a campaign to inform people about the medicinal cannabis program. At the Floriade, there will be an interactive booth about medicinal cannabis. The visitor can click on different videos and learn more about the subject. There is also a space where visitors can test their knowledge about the subject through a quiz. On special days, a Bedrocan team will be present, and it will be possible to take a virtual tour through our production location.

The Floriade Expo opens its doors on April 14 and closes on October 9, 2022.

Trimbos

  

Only 1 in 14 people who use cannabis for medicinal reasons go to a doctor for this. The Trimbos Institute asked about the use of different types of cannabis products for medicinal purposes. Half of the users reported taking CBD oil (49.4%). Just over one third used cannabis (37.5%), and less than one fifth used THC oil (18.7%). Other products were less common. Also striking is that 2.3% of the respondents who used a cannabis product for medicinal purposes do not know whether their product contained THC and/or CBD.

Check out the latest numbers on cannabis for medicinal purposes (available in Dutch only).

Risks for patients with the legalization of recreational cannabis in Germany

In an interview for the Handelsblatt newspaper, published on March 5th, 2022, Tjalling Erkelens warns of the possible negative consequences of legalizing recreational cannabis in Germany. While Bedrocan has specialized in a highly standardized medicinal product for 20 years, Bedrocan‘s CEO expects many companies to turn their backs to medicinal cannabis. “Countries like Canada are showing that, if fully legalized, patients who rely on medicinal cannabis will be disadvantaged,” he says. “This has created supply shortages for patients as many growers have shifted away from medicinal cannabis to embrace the larger recreational cannabis market. There, the quality requirements are lower, the regulations are less strict, and the profits are higher”. Data from Statistics Canada, among others, proves this.

In addition to the supply situation, there is a risk that patients will switch to recreational cannabis,  which is much more easily available, as long as medicinal cannabis can only be obtained in Germany with considerable bureaucratic hurdles. “Then the patients no longer have regular contact with their doctor or pharmacy, and there is no medical care,” says the founder of the family business. Incorrect dosages or the lower quality of recreational cannabis would then be dangerous for patients, especially if they have little or no experience with cannabis.

The Handelsblatt article explains how Bedrocan has become the largest manufacturer of medicinal cannabis in the EU over the years and how the conscious decision to focus on medicinal cannabis shapes the company’s philosophy. Erkelens also justified his exit from Canopy Growth in Canada in 2016: “You can’t do both at once.” The requirements for the plants, cultivation, production and regulation are fundamentally different. “For us, cannabis is not a lifestyle product. It is a medicine that should be efficient, safe and affordable for everyone,” Erkelens said.

The important role of pharmacists and medicinal cannabis

The role of pharmacists is as important as prescribers. Pharmacists discuss the risks of a drug with patients and help to minimize drug harm. They also provide information about safety, effectiveness and side effects.

As a pharmacist Salma Boudhan dispenses cannabis flos, and oil extracts (with CBD and THC) for named patients throughout the Netherlands. She dispenses high quality whole cannabis oil, including CBD oil Bedrolite®, for sublingual use since 2015. A typical patient arriving at her pharmacy are those suffering from cancer pain, nausea and vomiting, neuropathic pain or epilepsy.

Dutch pharmacist Salma Boudhan
Salma Boudhan

What is the safest cannabis oil and CBD oil dose?

“In accordance with their doctor’s prescription, we suggest that patients start low and go slow. As a starting dose for oil (e.g. Bedrolite), we recommend to use two drops (0,05ml) under the tongue, three times a day and increase the dose until the desired effect is achieved. The maximum dosage is ten drops (0,25ml), three times a day.

The ‘steady state’ concentration of THC/CBD and the active metabolite is reached after one or two weeks. This time span should be taken into account for the assessment of the medicines effectiveness for the patient.”

What is your dosing advice on vaporization?

“We recommend patients inhale one or two times a day until the desired effect is achieved or until (psychotropic) side effects occur. This means they have had too much. Per inhalation, we recommend patients wait at least five minutes between the inhalations.

Patients should take into account that inhaling cannabis results in a higher uptake than when using other administration routes. Patients have to dose carefully when changing to a different variety, especially if they have previously used cannabis with a lower content of THC/CBD.

The ‘steady state’ concentration of THC/CBD and the active metabolite is reached after one to two weeks. Like oral dosing, this time span should be taken into account for the assessment of the medicines effectiveness for the patient.”

A primer to medicinal cannabis

This is an abridged version of the interview taken from the booklet A primer to medicinal cannabis. Interested in the full version and more information about the use of medicinal cannabis? Then download the booklet A primer to medicinal cannabis.

Does cannabis interact with other medicines?

“We know that cannabis is metabolised by CYP450 enzymes. When taken together with other medicines metabolised by the same enzymes, there may be the potential for drug-drug interactions. We discuss with patients about the risk of using such medicines concurrently, or recommend alternative medications.”

What are the actual and potential complications with medicinal cannabis?

“The biggest risk is getting high and triggering psychoses (especially with psychiatric patients) or worsening current depression. There are risks in prescribing in the elderly, and the potential long-term effects on children are still unknown.”

What are the key risks of patients who have other conditions, and are using cannabis as a therapeutic product?

“The only known contra-indications include schizophrenia, arrhythmia and other heart conditions. We work closely with prescribing doctors and also provide adequate instructions to patients about the benefits and risk of their medicines.”

Bedrocan at the Australian United in Compassion Medicinal Cannabis Symposium

The Australian United in Compassion symposium is a highly publicised medicinal cannabis conference attended by industry, health professionals, government regulators and patient advocacy groups. Bedrocan will host a booth and present at the Symposium from Friday 20 to Sunday 22 May 2022.

United in Compassion symposium

The United in Compassion (UIC) began five years ago as a patient-led movement that actually managed to change the law in Australia. Where are we now?

The Australian federal law changed in 2016, permitting the prescribing of pharmaceutical-quality medicinal cannabis. Quickly, State legislators – Australian states set their own laws – quickly followed suit.

Currently, most medicinal cannabis products in Australia are unregistered, meaning prescriptions require a rapid online application (i.e. 24–48 hours) under a Special Access Scheme (SAS) and medicines must be dispensed by a pharmacy. Data from the Therapeutic Goods Administration reveals that in 2017, 248 applications were approved for medicinal cannabis products. That number soared toward 123,131 approved applications by the end of 2021.

Prescribing occurred among more than 2,700 doctors, with most prescribing in General Practice (Family Medicine). The prescriptions are mainly for chronic non-cancer pain, anxiety, cancer-related symptoms, epilepsy, sleep disorder and other neurological disorders.

Dried cannabis flower and whole extracts

The UIC’s primary mission is advocating for ‘patient access to full-spectrum herbal medicinal cannabis extracts and dried herb cannabis’. There are currently over 200 different cannabis products available on prescription. Most are full-spectrum oral preparations (oils) containing THC or CBD, or the dried cannabis flower. Last year, around 26% of SAS applications were for herbal dried products for pulmonary administion (inhalation).

The full range of Bedrocan products are available on prescription to Australian patients. Novachem, the distributor, faces fierce competition, despite that other companies cannot guarantee pharmaceutical-quality products on an ongoing basis.

Bedrocan Australia attends UIC

This year Bedrocan will host an information booth at the United in Compassion Medicinal Cannabis Symposium. Bedrocan’s booth is a viewing window to our newest services for health professionals, regulators, industry, and patient advocacy groups. At the booth, delegates can:

  • Take a 3D interactive tour of our first-in-class cultivation facilities (Oculus 3D googles),
  • Learn more about our Australian health professional guidance, and the education resources we support.
  • Gain access to our regular, enlightening articles on diverse topics on cannabis-based medicines.

Bedrocan will also present at the symposium on the topic ‘GACP, GMP and Quality in cultivation’. This presentation will discuss Bedrocan’s draft ‘White Paper’ on standards for the cultivation of pharmaceutical-quality medicinal cannabis. Bedrocan’s Good Medicinal Cannabis Cultivation Practices (GMCCP) standards align with current global thinking on clearly separating pharmaceutical from recreational.

Cost to patients and education for health professionals

The UIC continues the push for affordable medicines as cost to patients remains the biggest issue in Australia. Like many countries, there is no pharmaceutical subsidy for cannabis products, meaning patients pay out-of-pocket for all of their medication.

Another hurdle is education. Prescribers are the gate keepers. The recent and rapid introduction of cannabis-based medicines to modern practice means there is still a lot to understand and discover. Australian prescribers and pharmacists are concerned about the correct dosing regimens for the condition being treated, the quality of the medicines themselves, and accountability for treatment-related decisions.

According to Bedrocan, high quality, easy to access, free education is therefore required. Bedrocan is supporting the production of a Clinical Primer text which provides health professionals valuable insights to the rational use of cannabis-based medicines. This compliments the text A primer to medicinal cannabis, an other free text written for health professionals, regualtors, and policy makers. See download button below.

Bedrocan makes Vietnamese translation available on medicinal cannabis

Bedrocan provides a Vietnamese translation of the informative booklet on medicinal cannabis: Nhập môn về cần sa y tế. A request for a Vietnamese version came from the Vietnamese community in North America because accurate information on this subject in the Vietnamese language is scarce. Bedrocan’s goal is always to provide scientific information about medicinal cannabis in as many languages as possible.

Initially drafted in English, the booklet is now available in German, Thai and Vietnamese. It aims to provide doctors, regulators and policy makers with an understanding of the medical and scientific aspects of Cannabis sativa L. and how this plant fits into the range of therapeutic options. As in many other Asian countries, Vietnam currently does not allow medicinal cannabis. This translation is expressly not intended to change or influence the Vietnamese government policy.

Enjoy reading!

Nhập môn về cần sa y tế

Một văn bản giới thiệu về các ứng dụng trị liệu của cần sa

Hiện trạng về khả năng tiếp cận nguồn thông tin đáng tin cậy, dựa trên bằng chứng vẫn còn gây trở ngại cho hoạt động kê đơn cần sa đạt chất lượng dược phẩm vì mục đích trị liệu.

Cuốn sách nhỏ này bàn luận về ứng dụng trị liệu của cần sa. Tức là chúng ta sẽ không bàn về cần sa ở góc độ sử dụng cho mục đích giải trí để đạt được trạng thái ‘phê’. Sách chỉ hoàn toàn hướng đến cần sa y tế. Mục đích của sách là cung cấp cho các chuyên gia y tế, cơ quan quản lý và bệnh nhân những hiểu biết chi tiết từ khía cạnh khoa học và y tế của loài cây Cannabis sativa L., cũng như vị thế của nó trong chuỗi các lựa chọn trị liệu.

Cuốn sách này được thực hiện với sự tài trợ của Bedrocan International – đơn vị giữ bản quyền.

A fully standardised product, but with different prices. How come?

Since 2006, medicinal cannabis produced by Bedrocan for the Dutch Office of Medicinal Cannabis has become available to patients in various countries. Bedrocan is the only company in the world that has the proven capability of producing standardised cannabis flos (whole, dried flower) – containing consistent levels of cannabinoids, every time. Products used by patients in Australia or Italy are identical to the products used by patients in the Netherlands or Germany. However, one difference is the price of the products in different countries. In the Netherlands, patients pay €5.50 per gram (excluding prescription fee and VAT, price as of September 1, 2021) in the pharmacy, while in some other countries prices can go up to €25 or more. Why do these prices differ so much. In this article, we explain why.

How come patients in other countries pay more than €5.50?

The Dutch OMC sells all products for the same price to anyone. However, the rules and regulations in other countries differ a lot, resulting in very different prices in each country. The price difference (from €5.50 per gram) for which the product is sold in another country is caused by the cost of transportation and import fees, permits and licensing fees, taxes and additional regulatory steps in the chain. Until March 2020, for instance, German pharmacies were obliged by German law to increase the price of their raw (cannabis) material by 100% in order to be allowed to deliver a final product to patients. This is just one of many examples showing Bedrocan and the OMC have no control over the final price of the product in other countries.

Prices for medicinal cannabis in the Netherlands

How does Bedrocan feel about the huge price difference?

We do not like it. It is our mission to produce affordable, constantly available, high quality, safe and standardised medicinal cannabis for patient use. In The Netherlands, we have succeeded in this mission. It is now our goal to improve patient affordability worldwide. We feel that it is not fair to patients that such high prices are set in other countries. With the harmonisation of international rules and regulations, we hope prices will become more equal and, most importantly, more affordable for patients.

What about the price for cannabis oil?

Bedrocan does not produce or sell cannabis oil. Nor does the OMC. Medicinal cannabis oil extracted from Bedrocan’s standardised products is currently available in the Netherlands, Italy and Germany among others. It is extracted by third parties for patient’s use only. The companies extracting and producing an oil dose form, like compounding pharmacies, decide the final price to patients. Bedrocan therefore has no control over the prices of oils based on our products, currently.

Whole-plant medicinal cannabis reduced epileptic seizures in children by 86%

A case series published in the open-access journal BMJ Paediatrics Open reveals that whole-plant cannabis extracts can reduce epileptic seizures in children by 86%. The study looked into the effects of whole-plant medicinal cannabis in 10 children with severe epilepsy who did not respond to conventional treatments, including CBD extracts that are currently mainly prescribed for their condition.

The study “Medical cannabis for severe treatment-resistant epilepsy in children: a case-series of 10 patients”, was published by Rayyan Zafar, PhD at the Centre for Psychedelic Research and Neuropsychopharmacology, Department of Brain Sciences, Imperial College London, his Imperial College colleagues Anne Schlag, David J Nutt, and Lawrence Phillips, from the London School of Economics and Political Science. They also list their affiliation with the public institution DrugScience, which was founded by professor Nutt in 2010.

According to the authors, the study “establishes the feasibility of whole-plant medical cannabis as an effective and well-tolerated medicine for reducing seizure frequency in children suffering from intractable epilepsies.” They also mention in the paper that substantial anecdotal evidence on the value of medicinal cannabis for treating childhood epilepsy has been accumulating since the 1800s. However, there has not been much evidence on the efficacy of whole-plant medicinal cannabis so far.

The authors also expose UK patients’ challenges to access cannabis-based products (CMBPs). As in many other countries, doctors in the UK are reluctant to prescribe CMBPs to patients. “Many patients are thus forced to resort to private treatment which costs up to £2000 per month”, the authors write.

Participants profile

The children that participated in the study were recruited through two charities, MedCann Support and End Our Pain, that represent children who use medicinal cannabis to treat their intractable epilepsies. In total, 10 children participated in the study. Their average age was 6 years old, although ages varied from 1 to 13 years old. The children had different types of epilepsy, and three of them had other concurrent issues, including infantile spasms, learning disabilities, and global developmental delay. All the participants received whole-plant extract cannabis-based medicinal products either through private prescription or through the NHS.

Products used

Among the CBMPs used in the study, there were extracts made of Bedrolite (<1% THC and 9% CBD) and Bedica (14% THC and <1% CBD), two Bedrocan products. The study also compared other CMBPs to Bedrocan products’ extracts. “One patient saw a significant worsening of symptoms including an increase in seizure frequency when switching from Bedrolite and Bedica products to other whole-plant CBMPs. The other three patients that changed CBMPs from Bedrolite and Bedica to other products noted the burden of cost as the primary reason for switching products, though all these patients reported the efficacy of Bedrolite and Bedica in reducing seizure frequency”, the team reported.

Study limitations

Although the study brings hope and valuable data for the treatment of children with severe epilepsy, it also reports its limitations that require further research on the subject. Among the limitations of the study are the use of retrospective data based on parental recall (though these often maintained seizure diaries), no randomisation or use of placebo, the possibility of biased information given by parents of children that had had the largest clinical impact from using medicinal cannabis, and, finally, the small number of participants.

Bedrocan products officially available in Ireland

Ireland is getting two new medicinal cannabis products: Bedrocan and Bedrobinol. Recommended by the Health Products Regulatory Authority (HPRA) and approved by the Department of Health, an Irish company Oleo was successful in adding these two medicinal cannabis products to the Medical Cannabis Access Programme.  This makes it possible to import Bedrocan medicinal cannabis products directly from the Netherlands. Both products can be prescribed for intractable nausea and vomiting associated with cancer chemotherapy, despite the use of standard anti-emetic regimens.

Bedrolite oil

Oleo will also produce a chemical free cannabis oil solution using Bedrocan trichome powder. It is not yet known when this oil will be available in Ireland but Oleo is confident it will be sometime in 2022.
Medicinal cannabis oil is mainly used by children with a severe form of epilepsy. Bedrocan’s cannabis products, including Bedrolite oil, have not been on the list of approved dosage forms since the start of Ireland’s medicinal cannabis programme. This is to the great indignation of parents of children with epilepsy, who have had to get the oil from the Netherlands for years.

Irish Medical Cannabis Access Program

In Ireland, only products listed under the Medical Cannabis Access Program can be prescribed by a doctor. The following specified medicinal products (cannabis-based products) have been accepted as suitable for use:

  • Aurora CBD drops
  • CannEpil
  • Tilray oral solution

Bedrocan products have, therefore, recently be added to this.

The couple Shirley and Richard Creagh are the people behind Oleo. They have been committed to making Bedrocan available in Ireland for almost three years.  Richard Creagh: “Many parties have tried, but it is very difficult to get cannabis products, including oil, into Ireland under current legislation. Having an import license now opens new doors. Without this approval, we couldn’t even sit down with the Dutch OMC or Bedrocan. It is really a big step forward. Not just for us as a start-up company, but especially for Irish patients.”

The products are supplied directly by the OMC, packaged by Oleo in Ireland, distributed to retail and hospitals pharmacies around the country.

Bedrocan products officially available in Ireland
Richard & Shirley Creagh

Online application

The company has also developed a mobile application OleoCare that allows Irish patients to monitor dosage, symptoms and any adverse affects. With a QR code on the Oleo box, the patient can log in and keep track of which doses have been used and what effect they have had. The patient indicates on a sliding scale how he feels at a certain dose. Shirley: “Not only does it give the patient insight, but this data is also useful for the healthcare provider  because they’re always looking for information about the effects of medicinal cannabis.”

Disease indications approved for treatment

The Irish Medical Cannabis Access Programme is to provide access for patients with the following medical conditions which have failed to respond to standard treatments:

  • Spasticity associated with multiple sclerosis
  • Intractable nausea and vomiting associated with chemotherapy
  • Severe, refractory (treatment-resistant) epilepsy
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The selling price per gram may vary if your pharmacy dispenses different quantities.
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