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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.

Defence investigates cannabis use in PTSD

The Dutch Ministry of Defence is conducting research together with the Leiden University Medical Center into the use of medicinal cannabis by veterans with post-traumatic stress disorder (PTSD). The researchers recently visited one of Bedrocan’s cultivation facilities. There, they received an explanation from our CEO Tjalling Erkelens about the high-quality standards under which medicinal cannabis is produced in the Netherlands.

Minister wants to stop compensation, ombudsman intervenes

At the beginning of 2020, there was a stir when the ministry announced it would stop paying for medical cannabis for veterans with PTSD. PTSD is a disease that consists of reliving a traumatic event through compulsive memories, re-experiences, or nightmares. War veterans mainly use the drug to fight symptoms such as insomnia and nightmares.

The ombudsman intervened and asked the minister to continue the compensation. “In view of the Veterans Act and the special duty of care of the minister for veterans, I find the termination of the reimbursement of medicinal cannabis insufficiently motivated,” said ombudsman Reinier van Zutphen.

Shortly afterwards, the Minister of Defence announced that he would continue with the compensation. She is awaiting the research results led by Prof. Colonel Eric Vermetten for her final decision. The results are expected in 2022.

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

Bedrocan and adult-use cannabis legalisation in Germany

The new German government is set to legalise some form of adult-use cannabis. Bedrocan has been supplying cannabis to German patients for years. Lately, we have often been asked: ‘Will you soon also be supplying German recreational users?’ That is a very understandable question. However, the answer is simple: No.

Bedrocan does not supply cannabis for recreational use. We do not do that anywhere in the world, not even in the Netherlands, and soon also not in Germany.

Why does Bedrocan not want to enter the recreational market?

Bedrocan believes in a strict separation of medicinal cannabis and cannabis for recreational use. We are committed to providing a pharmaceutical product that is available on prescription to patients who benefit from it. We want to focus one hundred per cent on this assignment. This means that we cannot and do not want to be involved with cannabis for recreational use.

In other countries, we have (unfortunately) seen patients that use medicinal cannabis become the victims of the legalisation of recreational use. Not so much because of the legalisation itself, but because of the fact that producers were tempted to jump into this market. The quality requirements are lower, the rules are easier, controls are less strict, and yields (they hoped) higher. Result: medicinal cannabis received less (or no) attention, and patients were left without the product. We want to avoid that at all costs.

Moreover, it is true that there can indeed be adverse effects from the use of cannabis. That’s why we want our products to be available only to patients who use them with a prescription and under the supervision of a pharmacist. We also only want to use our many years of knowledge and experience in the field of cannabis cultivation for this purpose.

Are you approached by companies or users who would like to work with Bedrocan towards the recreational market?

Yes, very often, in fact. The answer is and will always be ‘no.’ At first, that may sound strange. But change the resource and the players. Suppose the government legalises ecstasy pills. Would a pharmaceutical company that now makes antidepressants or rheumatism drugs show up there? No, of course not. They would stay far from it. The same goes for Bedrocan. Medicinal cannabis and cannabis for recreational use are two different products with completely different target groups. You shouldn’t want to mix them up. Also not after legalisation.

Will you continue to supply German patients?

The current supply system via the Dutch Office of Medicinal Cannabis (OMC) will not be impacted. Therefore, German patients will continue to have access to our pharmaceutical-grade products.

Bedrocan shows pharmaceutical API at CPhI 2021

Last week world’s largest pharmaceutical API & raw materials fair: CPhI Worldwide in Milan, Italy. Bedrocan was, of course, present this year again. Our team met a lot of interesting parties during the event who were curious about our standardised medicinal cannabis API. The team had a very fruitful event and spread our message on the importance of pharmaceutical quality standards for medicinal cannabis products.

Bedrocan op CPhI Worldwide 2021
Andrew Kraszewski, Karolina Ostapenko & Varun Arora

Varun Arora represented our organisation and our cannabis products together with Key Account Manager Karolina Ostapenko. In addition, our Director of Product Development & Compliance Naiem Hakiemie, our Manager Legal Affairs Robert Rademaker and our Corporate Strategy Analyst Andrew Kraszewski strengthened the team.

Promoting our products

The last time Bedrocan participated in CPhI in 2019, we focused mainly on presenting our five varieties of standardised cannabis as an API. This time, Bedrocan could also introduce the trichome powder and placebo product forms. Many pharmaceutical companies showed interest in these products. Although there is no production line for these products yet, this interest certainly encourages Bedrocan to produce them on a larger scale in the future. Especially for companies from countries in which the import of cannabis flos is not allowed, having our products in a different form that can be used as raw material would be very valuable. The placebo also called the attention of those parties involved in clinical trials, as currently, there is no placebo for medicinal cannabis in the form of flos/granulate.

Additionally, Bedrocan team also promoted our unique cultivation techniques and excellent quality management system, which could also be applied to the production of other medicinal plant products.

Next year, we will be present again in CPhI Frankfurt and hope to have another successful event.

IMC Nederland to Copenhagen at the invitation of the Danish government

Together with the Danish Technology Institute, Invest in Denmark recently held the symposium: Medicinal Cannabis, from plant to patient. Invest in Denmark is part of the Danish Ministry of Foreign Affairs and is committed to attracting foreign companies to Denmark. Medicinal cannabis has recently become one of their spearheads. This edition was all about collaboration and partnership. To explain how the Institute for Medicinal Cannabis (IMC) in the Netherlands promotes cooperation and partnership, IMC board member Ole Heil, also director of Communication & Government Affairs at Bedrocan, spoke at this symposium at the invitation of the Danish government.

IMC good example

Heil: “Since 2018, dozens of new companies have started up in Denmark, and research has really taken off. This is largely due to the favorable regulations, but also due to the efforts of the government. It actively supports parties in the sector, which is bearing fruit with dozens of new companies and research projects.”

Bedrocan proud partner of the IMC

Bedrocan has joined the IMC because it allows us to contribute to the knowledge about medicinal cannabis among doctors, pharmacists and patients in the Netherlands and to facilitate medical research.

“Something the Danish government would like to see more of is mutual cooperation. It aims to create a sustainable ecosystem of companies, doctors and researchers. At the moment the cooperation is still relatively limited.”

“We had the same situation in the Netherlands, but within the IMC, Dutch medical researchers, pharmacists, universities and companies, including Bedrocan, are now working together in the field of information and coordination of investigations. The IMC does this independently and on a non-profit basis. We also serve the interests of parties in the medicinal cannabis chain.”

Medicinal cannabis in Denmark

On January 1, 2018, a trial program with medicinal cannabis started in Denmark. This program makes it possible for doctors to prescribe medicinal cannabis and for companies to develop commercial activities with medicinal cannabis. The pilot was extended by the Danish Parliament for a further four years for doctors and patients in March 2021. The commercial activities have even been made possible on a permanent basis. Medical cannabis has rapidly developed into a major industry in Denmark in those four years. Since the start of a trial period, a vibrant sector has emerged in the chain of breeding, production, processing and development of medicinal cannabis products.

UMCG starts scientific research into cannabis oil for chronic pain in Epidermolysis Bullosa

The Dutch University Medical Center Groningen (UMCG) has recently started a study into the effect of cannabis oil in patients with Epidermolysis Bullosa (EB). EB is a serious hereditary blister disease in which patients experience different types of pain. The study is an exploratory, randomised, placebo-controlled and double-blind crossover intervention study, in which 16 patients participate. Within a year, the chief physician of EB patients at the UMCG, Dr Marieke Bolling, and Prof. Dr André Wolff, medical head of the UMCG Pain Center, both principal researchers, want to be able to tell whether medicinal cannabis oil has an influence on the pain experience of these patients.

Together with fellow physician-researcher Nic Schräder from the UMCG, they are working on this unique study: “We are the first in the world to clinically investigate the effect of cannabinoids in EB patients in this way.”

Epidermolysis Bullosa

Epidermolysis bullosa (EB) is an inherited blistering disease of the skin and mucous membranes often associated with intense pain, chronic wounds and scarring. EB patients are treated according to the usual WHO pain ladder, a step-by-step plan developed by the World Health Organization (WHO). Lead researcher Dr Bolling: “What we as doctors have available to fight pain in EB patients is actually not sufficient. The pain starts at birth and lasts for a lifetime because the blisters and wounds keep coming. So, there is no cure. Many pain interventions are not intended to be used for years, but unfortunately, that is necessary for EB patients.”

It is therefore not surprising that patients themselves are looking for methods to fight their pain: “Cannabinoid-based medicines, such as cannabis oil, are of course an example of this. We know that patients use medicinal cannabis with or without medical supervision.”

Since 2015, a cannabinoid-based drug oil (CBM) containing Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) has been prescribed to Dutch patients with Epidermolysis Bullosa with reported relief of pain, itching and reduction in the concomitant use of other medications for these patients’ symptoms.

The idea for the study originated in 2014. Nic Schräder, the driving force behind the research trajectory, became unintentionally involved in the subject as a former medical student. “I went to EB patients’ homes for a small-scale wound examination to test a new kind of bandage. During small talks, it kept coming up that these people were using cannabis to treat pain. As a tea or joint, or in a vaporiser, but also on the wound itself.” His interest was piqued, as the use of cannabis was, even then, a controversial topic. After consultation with Prof. Dr. Marcel Jonkman, head of the dermatology department of the UMCG then, Schräder prepared three case reports. After that, a subsidy application for a placebo-controlled follow-up study was the next step.

cannabisolie voor chronische pijn bij epidermolysis bullosa

Patient association DEBRA

The financial resources for the study were obtained from, among others, the patient organisations DEBRA-UK and Debra Nederland. However, the most challenging obstacle was the methodological exchange between the Medical Ethics Review Committee (METC) and the research team, which took three years. “There are so many variables when you do research with cannabis; which form of administration should you investigate, which cannabinoid composition suits the clinical picture, which dosage is the right one, and which effects do you want to measure as reliably as possible?” Schräder explains.

By involving other specialists from the UMCG and the German Oldenburg, including an epidemiologist, we finally succeeded in drawing up an ethically sound, thorough research protocol. “Epidemiologists are methodologically very well versed. This helped us design the study, and it will help us process statistics and make the right choices,” said Prof. Dr Wolff about this special choice. The knowledge exchange within the UMCG has also borne fruit. Doctors and researchers from the UMCG, who are involved or interested in cannabinoids within a scientific and clinical context, meet regularly in Round Table meetings to exchange knowledge and discuss the subject. It is the second time in a short time that the UMCG has started an investigation into the effect of cannabis oil. Schräder: “We have exchanged a lot of knowledge in this area with the Hepato-pancreato-biliary Surgery Department, who have previously started a study into liver cancer.”

Transvamix®

Medicinal cannabis oil that contains sufficient CBD is used for the study. Schräder: “The literature shows that CBD theoretically suppresses the adverse side effects of THC.” This Transvamix® contains 10 per cent THC and 5 per cent CBD and is prepared by the Dutch Transvaal Pharmacy. This uses the standardised plant varieties Bedrocan® and Bedrolite® as raw materials for the oil. This oil is also used in another scientific study by the UMCG, a study into the effects of cannabis oil in liver cancer.

Crossover design

A crossover design was chosen for the study, a setup in which the participant is administered the cannabis oil, as well as the placebo. So there is no separate control group. Schräder “There is a limited number of patients with EB who are willing and able to participate, and who meet the strict criteria for participation.” In the Netherlands, there are about 500 patients with EB, of which about 90 per cent are registered in the treatment centre for blisters of the UMCG. Sixteen patients were selected to participate in the study. According to Prof. Dr Wolff, the number is less important because the design of the study determines whether something has statistical value. “You have to be able to demonstrate an effect. The right method, that’s what matters.”

Nociplastic pain

The study focuses solely on the experience of pain and not on blistering. Pain in Epidermolysis Bullosa is chronic and difficult to treat and is often experienced as ‘unpleasant’ by patients. This concerns wound and care pain, neuropathic and nociplastic pain, whereby the latter form of pain can appear in various places in the body without being anatomically explained. Prof. Dr Wolff: Pain often has a negative impact on people’s mental state, behaviour and interaction with the people around them. People are often anxious, depressed or unable to work and become socially isolated.”

It remains difficult for science to determine someone’s experience of pain objectively. A scale of 0-10 is often used for this, but the outcome is still a subjective score. A new way to measure objective pain is the use of a functional MRI (fMRI). fMRI creates a 3D image of the brain. The areas, the brain activity, that are responsible for processing pain become visible. Schräder: “For the first time, this gives us a picture of what the pain circuit looks like in EB patients before and after treatment with cannabis oil. We do these scans in addition to the patients’ self-reported pain scores. If you put all that data side by side, you should get a better picture of the pain experience.”

If this combined fMRI method works, it could be of interest for other studies of pain. But according to Prof. Dr Wolff, the primary goal of the study is to demonstrate effectiveness: “You want to show whether cannabis can make a difference and is effective in EB patients with pain because that is not yet clear. The studies on the effect of cannabinoids on other pain syndromes are not always conclusive.”

Bedrocan at CPhI Worldwide 2021 in Milan

Bedrocan will be present at the world’s largest pharmaceutical exhibition, CPhI Worldwide. A pioneer in the medicinal cannabis industry, Bedrocan began its journey more than three decades ago. The company has been a reliable supplier of pharmaceutical-grade cannabis to the medicinal cannabis programme in the Netherlands since its inception in 2003. Over the last five years, the industry has grown exponentially and there is increasing interest from pharmaceutical companies seeking high quality cannabis raw material and APIs for drug development.

At CPhI, Bedrocan is looking to engage with some of these companies and also share its vast knowledge about the industry and regulations.

Global trend

A global trend has arisen: Prescribers are becoming more familiar with cannabis-based medicines and prescribing them. The increasing demand for pharmaceutical quality cannabis-based medicines has resulted in greater need for reliable and consistent APIs.

Meet us in Milan

CPhI Worldwide 2021 will be held in Milan from Tuesday November 9th until Thursday November 11th.

You can visit our booth and meet our Business Development team at stand number 18H24.

 

In their quest for a reliable source of API, pharmaceutical companies are increasingly finding their way to Bedrocan. This is unsurprising given Bedrocan was the first EU GMP-certified producer of standardised medicinal cannabis in the world. Varun Arora (Advisor Strategy & Development) and Karolina Ostapenko (Key Account Manager) will be present at CPhI Worldwide. We talk to them about the medicinal cannabis industry and Bedrocan’s product offerings.

Meet the Bedrocan CPhI Team

Varun Arora & Karolina Ostapenko

CPhI Worldwide

Karolina

I began my journey at Bedrocan in February 2019. I am a pharmacist by trade. As Key Account Manager, I am the point of contact at Bedrocan with regards to the Dutch medicinal cannabis system and possibilities of ordering Bedrocan products from the Office of Medicinal Cannabis. I am well-versed with the regulatory aspects of medicinal cannabis worldwide and can provide detailed information on Bedrocan products and the manufacturing process, which is compliant with EU GMP guidelines for pharmaceutical products.

Varun

I joined Bedrocan a little over three years ago in what can be described as an interesting moment for the medicinal cannabis industry in Europe. My background is actually in investment research. I worked as an equity research analyst for almost seven years, with three of those focused on the life sciences industry. Since joining Bedrocan, I have focused mainly on formulating the company’s commercial strategy and taking the lead with regard to commercial development.

Feel free to contact Varun Arora and Karolina Ostapenko via the Meet Bedrocan page.

Tell us about the Dutch medicinal cannabis program

Varun: “The Netherlands began a cannabis program more than two decades ago. The need for such a program was driven by the fact that there were a large number of self-medicating patients in the Netherlands and the Dutch government ‘s intent was to bring them under prescriber/pharmacist supervision and move them away from the illicit market to procure their medicines. In line with the requirements under the UN Single Convention, the Dutch set up a cannabis agency, the OMC, which then tendered out different parts of the supply chain to different companies. For the last nearly twenty years, Bedrocan has been handling cultivation, with the entire harvest sold to the OMC, which has monopoly over trade of cannabis in the Netherlands. The programme has largely been successful, with around 9,000 patients in the Netherlands and around 90% of our total capacity of approximately 5.4 tons is actually exported through the OMC.”

Karolina: “Interestingly, the programme was never set up with the intent to export, a mistake that several countries in Europe that legalised medicinal cannabis in the last few years made. Because the Netherlands implemented a cannabis programme many years before the hype in the industry, its interpretation of the Single Convention is quite strict. Under the current framework in the Netherlands, the actual vendor of Bedrocan products is the OMC. We are essentially a contract manufacturing organisation, or CMO. However, regulators in the country have obviously noticed the changes in the industry, especially since Germany, one of biggest medicinal cannabis market outside North America, legalised access to medicinal cannabis in March 2017. And given these changes, a review of the Dutch cannabis policy began in the summer of 2020 and some changes are expected in the coming years that would provide more freedom, especially when it comes to product development activities and engaging in business-to-business supplies.”

What are your current product offerings?

Karolina: “As noted above, the actual vendor of all Bedrocan products is the OMC. Through the OMC, Bedrocan currently offers five different strains of dried cannabis flowers, with the Bedrocan variety accounting for almost 80% of our total production. Current regulations in the Netherlands do not allow manufacturing cannabis extracts for commercial purposes but in anticipation of a change in regulation down the line, we have stepped up our product development activities and one of the pipeline products is the trichome powder or dry extract. We have developed a technique to separate trichomes from the plant material. Trichomes have the highest concentration of cannabinoids. By separating trichomes from plant material, what you get is a much cleaner product. Moreover, no solvents are used in the extraction process and this is important as it means the integrity of the product is maintained and what we offer in the end is a true herbal product. We have done proof-of-concept work with our Bedrocan variety and the THC concentration for this variety goes up to 45% (from 22%).”

Varun: “There are two ways to look at our product offering. One as Karolina explained is the five standardised varieties that are currently supplied through the OMC and their derivatives such as the solventless extract, which subject to regulatory changes we would be able to offer commercially. But as a CMO and an accomplished cannabis raw material producer, what we are essentially offering is three things; our unmatched capabilities when it comes to cultivation techniques, our quality management system and finally stable genetics. The first two can be replicated for other cannabis cultivars and as a CMO we are always open to such opportunities. In fact, our cultivation techniques and QMS can even be replicated for other medicinal plants and this is the company’s mid-to long-term goal in terms of expanding product offerings.”

Can you define standardised medicinal cannabis?

Varun: “Standardised medicinal cannabis is consistent in terms of its active ingredients – the cannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD), but also the terpenes. which are the aromatic compoundsAll our products are produced in accordance with pharmaceutical quality requirements, because our production sites comply with the requirements imposed by EU GMP.”

Karolina: “Each variety shows a constant composition of cannabinoids and terpenes; batch-to-batch, year after year. That’s what we call standardised medicinal cannabis. We have been doing this for over two and a half decades now.”

Why standardisation?

Karolina: “Standardisation is the essence of our mission and vision. The patient is at the heart of all this. Prescribers, pharmacies and patients expect a safe product that works. The same applies to pharmaceutical companies, which do not want a discussion about the composition of their raw materials. The industry needs an API that is consistent in its composition to develop and manufacture novel cannabis-based medicines. So, from pharma to patient; they all expect a product that complies with all the pharmaceutical production requirements, and that starts with high quality starting materials.”

How do you achieve pharmaceutical standardisation with cannabis?

Varun: “Over the past 27 years we have developed and refined a unique method that has taken cannabis to the level of a pharmaceutical API. It starts with stable plant genetics, followed by a series of processes that are fully standardised and controlled. Furthermore, Bedrocan was the first medicinal cannabis producer to be compliant with the European Medicines Agency’s GMP standards. We set the bar high.”

Can you tell us more about your cannabis placebo product?

Karolina: “Cannabis placebo is of particular interest to researchers. A high-quality placebo is essential for thorough scientific research. We already had a placebo product for years. This has served science well, but is no longer available. Work is currently underway on a new, improved placebo product.”

International research shows: No genetic distinction between ‘Sativa’ and ‘Indica’ cannabis

The cannabis industry needs to look more critically at its own disclosures. According to researchers at Canada’s Dalhousie University and the Wageningen University & Research, the Indica and Sativa labels on cannabis are often wrong and misleading. Patients and consumers would benefit from a more scientific approach. The researchers analysed hundreds of cannabis samples. The study shows that the genetic and chemical composition of the cannabis tested often does not correspond to the typical cannabis label Indica or Sativa.

Cannabis labels are often wrong and misleading

The results were recently published in the leading international journal Nature Plants. Robin van Velzen, plant expert scientist at Wageningen University and also affiliated with Bedrocan, contributed to the research.

The terms Indica and Sativa are often used to categorise cannabis. These different strains are generally believed to be associated with certain psychoactive effects. Often the effect of a Sativa strain is described as mentally stimulating and energising, while that of an Indica strain is described as relaxing and soothing. In addition, it is often suggested that the labels say something about the genetic background.

However, the research shows that plants with the Sativa label are no more genetically similar than plants with an Indica label. Also, chemically there is mainly overlap between these two labels.

“Growers worldwide label their cannabis strains quite subjectively with the terms ‘Indica’ and ‘Sativa’. There’s nothing scientific about that. Unfortunately, retailers and consumers cannot rely on the labels that are stuck to the jars,” says Dr Sean Myles, Associate Professor at Dalhousie University‘s Faculty of Agriculture and lead author of the study.

“There is now a broad scientific consensus that the current use of the Indica and Sativa labelling is misleading: these labels do not provide reliable information about the genetic or chemical makeup of the plant,” Myles continues.

Terpenes

The research shows that genetically it is impossible to prove whether a cannabis plant is an Indica or Sativa. There is no difference in the genes. “What our study mainly shows is that you should not just rely on those labels, but that you should look at the specific terpene profile,” says Van Velzen. “For example, cannabis labelled as Sativa often contains higher concentrations of single terpenes with tea-like and fruity aromas, while Indica samples generally contain higher concentrations of terpenes with an earthy smell such as myrcene, guaiol, gamma-elemene and gamma-eudesmol.”

But the distinction that the researchers found is not convincing: “It really is about these specific, individual terpenes that make the difference. The overall chemical profile, like the genetics, shows no apparent difference between the labels. We also found only a small number of regions in the cannabis genome that likely contribute to the earthy aroma associated with the Indica label,” said Van Velzen.

It is also striking that different cannabis samples sold under the same name such as ‘Lemon Haze’ or ‘OG Kush’ could be genetically just as different from each other as samples with different names.

Van Velzen: ‘Unlike other valuable plant species, the labeling of cannabis is very unreliable. This is particularly undesirable for patients who use cannabis as a medicinal product”.

Indica variant Bedica

Bedrocan shows the terpene profiles per product on the website and makes a distinction between Indica and Sativa per cannabis product because many patients need this information. The product Bedica is marketed as an Indica variant. Van Velzen: “The typical terpenes such as myrcene and gamma-eudesmol are also found in Bedica. In that respect, the labelling is therefore in line with our findings.”

According to the researchers, the industry should be more open about the chemical composition. “Show the terpene profiles for real instead of an unreliable name like Indica or Sativa. Fortunately, a number of companies already do this, but a standardised measurement and naming convention is still lacking. Reliable information is of great importance; certainly for medicinal applications,” concludes Van Velzen.

Sophie Watts at Bedrocan Series

On Friday, November 5,  Sophie Watts of the Dalhousie University research team will be our guests at Bedrocan Series. During this webinar she will explain more about the research and its results.
Do you want to know more? Or already reserve a spot at the webinar? Click here.

Well-known Belgian travel program ‘Reizen Waes’ visiting Bedrocan

Welcome to our website. You probably found us as a result of the Travel program Reizen Waes.

Last summer, presenter Tom Waes filmed us in Emmeloord for the new season of Reizen Waes. This episode was shown on Sunday 31 October at 8.50 pm on NPO 3 and will be broadcast on Monday 06 December on Eén.be.

Missed the broadcast? Then watch it again via this link.

In this broadcast, you get a first look at our company while our CEO Tjalling Erkelens takes Tom Waes and his film crew for a tour.

Tom makes it seem as it is very exciting to visit Bedrocan. Of course, you can’t just walk into our facilities, that’s not allowed at other production companies either, but we don’t want to call ourselves a secret. Commissioned by the Dutch Ministry of Health, we have been the only producer of medicinal cannabis in the Netherlands for almost 20 years. Our medicinal cannabis is prescribed to thousands of patients at home and abroad by doctors and is only available at pharmacies.

Medicinal cannabis is subject to very strict guidelines, just like other pharmaceutical companies are. Tom notes that Tjalling is very strict about the hygiene guidelines in order to prevent possible contamination of the plants. This is not without reason. Bedrocan is GMP certified by the Health and Youth Care Inspectorate (IGJ). GMP stands for Good Manufacturing Practice. This is a quality assurance system for the pharmaceutical industry that guarantees the quality of medicine or raw material. Medicines and active substances for use in medicines may only be produced by companies that have such a GMP certificate. Bedrocan was the first cannabis company in the world to receive such a certificate, and we are still proud of it. Since then, we are actually no longer a cannabis grower but a pharmaceutical raw material producer.

Tjalling is not alone in producing and monitoring our quality. Together with a high-quality team of almost 100 professionals and the necessary quality systems, we turn a vegetable product into a reliable medicinal product.

Do you want to know more about Bedrocan? Take a look around our website.

Here you can read more about our method, the GMP certificate and the people behind the company. If you want to know more about medicinal cannabis and an overview of our products, click here.

If you are a patient and have questions about the use of medicinal cannabis, please contact your GP or pharmacist.

If you have a question that is not answered on our website, please contact us using this form.

Tom Waes van het bekende reisprogramma bezoekt Bedrocan
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