Updates

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Join us at CPhI Frankfurt 2022

Bedrocan is present again at world’s largest pharmaceutical API & raw materials fair: CPhI Frankfurt 2022, Germany. Our team is happy to tell you everything about our standardised medicinal cannabis API. Will we you  see you in Frankfurt?

Register now and receive a FREE Early Access Pass

Book your ticket for this 3-day international pharma industry event by clicking on the below banner.

Advisor Commercial Strategy & Development Varun Arora and Market Research Analyst Thanh Nguyen-Kim will represent our organisation and our cannabis products together with Corporate Strategy Analyst Andrew Kraszewski.

Promoting our products at CPhI Frankfurt 2022

Last year, we focused on our five varieties of standardised cannabis as an API and the trichome powder and placebo product forms.  Although there is no production line for the trichome powder yet, Bedrocan will 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.

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

The importance of a standardised cannabis product

A standardised cannabis product enables doctors to monitor the dose and the effect of medicinal cannabis in the same way as for other certified medication.

Unlike other medication, the cannabis plant does not have a fixed chemical/molecular composition. Cannabis  contains hundreds of different substances and each individual plant is different in terms of its composition. THC and CBD are the best known substances, but there are dozens to hundreds of other known and unknown substances in the plant that may have an effect. No two cannabis plants are the same. Even if the levels of THC and CBD are the same, the substances around them can produce a different effect for the patient; this known as the ‘entourage effect’. There have been various studies of this entourage effect. Ultimately, the complete ‘fingerprint’ of the plant determines its effect.

Four crucial reasons why cannabis should be standardised

Bedrocan produces five medicinal cannabis varieties. Each variety has a unique, fully standardised genetic composition that is and remains the same each time, for every batch, year in, year out, because of the unique production process. The result is that the CBD and THC levels are always the same, but the other substances are also always present in the same ratio. The reproducible chemical profile enables doctors to monitor the dose and the effect on the disorder in the same way as for other certified medication. Furthermore, it makes these varieties suitable for carrying out scientific medical research.

1. PATIENTS

Standardised cannabis is extremely important to the patient

Just like ‘normal’ medication, all patients are ‘set’ on a certain variety. Sometimes it can take a long time to get patients on the right variety with exactly the right dose on the basis of the existing five varieties. The same applies to the use of cannabis oil. Changing the dose or administering medication with a different genetic composition can have adverse consequences for individual patients.

2. DOCTORS

Standardised cannabis is extremely important to the doctor

Quite rightly, doctors want to know exactly what they give to their patients and what its effects are. It takes a lot of time and effort for doctors to become used to prescribing cannabis. The reproducible chemical profile of standardised medicinal cannabis enables doctors to monitor the dose and the effectiveness in the same way as for other certified medication. As this medicinal cannabis is also produced in accordance with pharmaceutical standards (GMP), quality and safety are guaranteed as much as possible. As doctors have prescribed the same products from the Office of Medicinal Cannabis for years, they know what it does and they feel comfortable with it. The same applies to the pharmacists who ultimately hand over the product.

3. RESEARCHERS

Standardised cannabis is extremely important to researchers

For the first time, there is now larger scale serious clinical research into the effect of medicinal cannabis. In December 2018, the first results were published of a placebo-controlled, comparative study of 3 of the 5 varieties available in the Netherlands, carried out by the Leiden University Medical Centre. Different doctors, pharmacists, and study groups are now preparing further clinical research. They prefer to work with standardised medicinal cannabis that has a guaranteed quality, safety and availability.

In order to obtain permission for medical scientific research with humans, you need a detailed statement of the product that is studied. At the end of the study, the outcomes only say something about the specific plant, and its unique genetic composition, that was used in the study. Clinical research that is carried out with an existing product, can only be carried out with that product. Changing variety in the meantime is not possible from a substantive point of view, it is legally impossible, and certainly not desirable. If there were to be a change to a plant variety with only comparable THC and CBD levels, permission for the research would have to be applied for again. THC and CBD may well be comparable, but the chemical and genetic composition of the plant and the presence of other substances changes. So therefore, in essence the product used for the research changes too. It means the outcomes that were gathered up to that point are no longer usable, because they do not apply to this new, different plant.

4. MEDICINE DEVELOPERS

Standardised cannabis is extremely important to developers of medication and medical devices

At the moment, medicinal cannabis only applies as a medical raw material, i.e. an API or Active Pharmaceutical Ingredient. Various companies around the world are working on developing medication or medical devices on the basis of this active pharmaceutical ingredient. One example is an extremely advanced inhaler, which was developed by using standardised products from the Netherlands from the beginning. This inhaler is so advanced that it detects even the slightest change in the form and composition of the product to be administered. For the device to work correctly, the same percentage of THC and CBD and exactly the same genetic and chemical composition of the product are important. Any change in plant will produce high modification costs and months, if not years, of delay in its further development.

Scientific research with standardised cannabis

The importance of standardising the complete chemical composition of the plant is supported by various scientific studies. Below is a list of a number of studies into other substances in the cannabis plant and the entourage effect they cause:

Cannabis - from cultivar to chemovar

The study considered the ‘cultural’ designation of cannabis varieties, how to distinguish them in terms of effect and how they can be separated chemically and scientifically. The chemical difference is expressed in THC and CDB values, but also in other cannabinoids and terpenoids. This means that clinical research and anecdotal evidence could be used to study the various therapeutic effects of cannabis and/or certain varieties of cannabis could be prescribed to patients on the basis of the complete chemical profile.

Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects

This study introduces the ‘entourage effect’, which assumes interaction between cannabinoids and terpenes. This interaction may lead to positive effects regarding treatment of pain, inflammation, depression, anxiety, addiction, epilepsy, cancer, fungal and bacterial infections. Unique therapeutic properties are ascribed to terpenes, the odour and flavour substances in cannabis.

Terpenes and derivatives as a new perspective for pain treatment: a patent review

This study deals with the role of terpenes in pain relief and is particularly focused on the role those terpenes could play in developing new analgesics.

Synergy between cannabidiol, cannabidiolic acid, and Δ⁹-tetrahydrocannabinol in the regulation of emesis in the Suncus murinus

This study demonstrated that a combination of THC, CBD, and CBDA (cannabidiolic acid) produced better control of vomiting and fewer side effects. This combination was administered to shrews. These effects are also expected to occur in humans.

Beyond Cannabis: Plants and the Endocannabinoid System

Not just the substances in cannabis have an effect on the endocannabidoid system. This article deals with a number of other plants that could produce similar effects. It also deals more in-depth with the ‘entourage effect’.

Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads

This article aims to answer the question as to the synergy between cannabinoids and terpenes in the therapeutic treatment of pain, psychiatric complaints, cancer and various other disorders. It also considers the therapeutic effects of substances in cannabis roots, leaves and seeds.

Cannabis constituent synergy in a mouse neuropathic pain model

This animal study demonstrated that CBD strengthens the pain-killing power of THC during the treatment of neuropathic pain. The results suggest that a combined low dose of THC and CBD is the best option for dealing with neuropathic pain.

Single and combined effects of Δ 9 -tetrahydrocannabinol and cannabidiol in a mouse model of chemotherapy-induced neuropathic pain

This study in mice demonstrated that really small doses of CBD or THC – administered separately – do not have an effect on reducing neuropathic pain caused by chemotherapy. However, when THC and CBD are administered in combination, these two substances have a synergetic effect and can be effective in dealing with pain.

Appraising the "entourage effect": Antitumor action of a pure cannabinoid versus a botanical drug preparation in preclinical models of breast cancer

This animal study demonstrated that a full extract of cannabis has a better effect on treating tumours (breast cancer) than pure THC.

The Case for the Entourage Effect and Conventional Breeding of Clinical Cannabis: No “Strain,” No Gain

This article proposes to stop categorising cannabis varieties by strains and to categorise them by chemical properties (‘chemovars’) instead. Furthermore, according to this article it is assumed that the combination of substances has a better therapeutic effect than the active substances alone – the ‘entourage effect’.

An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia

This clinical study demonstrated that administering a combination of THC and CBD demonstrated a synergetic effect in patients, whereby the CBD increased the amount of THC in the bloodstream.

Our endocannabinoid system explained

Like in the case of the opioid system reacting to opioids (morphine, codeine), humans have a distinct receptor system for cannabinoids. The endocannabinoid system contains cannabinoid receptors and influences the activity of many other body systems. The phytocannabinoids of the cannabis plant work in a similar way to our naturally produced endocannabinoids.

Cannabinoid receptors

The human brain and other organs contain naturally occurring cannabinoid (CB) receptors and the chemicals that bind to them. This is called the human endocannabinoid system (ECS). The system’s role is to maintain our body’s ability to function normally by influencing the functioning of other systems. It plays a critical role in our nervous system, and regulates multiple physiological processes. This includes the adjustment of our response to pain, appetite, digestion, sleep, mood, inflammation, and memory.

The endocannabinoid system also influences seizure thresholds (i.e. in epilepsy), coordination, and other processes such as the immune system, heart function, sensory integration (touch, balance, sense of space), fertility, bone physiology, the central stress response system (the HPAA), neural development, and eye pressure.

Cannabinoid receptors

Endocannabinoids

Humans produce their own cannabinoids, the endocannabinoids. These endocannabinoids act on, or stimulate, the cannabinoid receptors. These compounds act in a similar way to phytocannabinoids which also bind to the receptors. The plant cannabinoids are called phytocannabinoids. They are the unique constituents of the cannabis plant. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main constituents. There are other cannabinoids, but currently far less is known about them.

For example, the CB1 receptor is located in a number of regions of the brain which control various physical and behavioural functions. As a result, cannabinoids influence sensory and motor responsiveness (movement), heart rate, emotional reactions, appetite and nausea/vomiting, sensitivity to pain, learning and memory, and high-level decision making. As our knowledge of the human endocannabinoid system develops so will our understanding of how the phytocannabinoids, THC, CBD and other cannabinoids work. This understanding will lead to better medicines.

Endocannabinoidsystem (EDS)

GPCRs

Cannabinoid receptors are G-protein-coupled receptors (GPCRs). GPCRs are found on the surface of our cells. These receptors are said to ‘act like an inbox for messages, talking with cells and therefore our body’. GPCRs have a great number of functions in the human body. As a result, many medicines, including medicinal cannabis, work on GPCRs. Humans produce endocannabinoids which interact with the GPCRs CB1 and CB2. We know the most about the endocannabinoids anandamide (AEA) and 2-arachidonoylglycerol (2-AG).

Bedrocan develops new practice for cannabis cultivation

Bedrocan has developed a new practice for medicinal cannabis cultivation. The practice is already in use at Bedrocan’s facilities and is called GMCCP: Good Medicinal Cannabis Cultivation Practice. According to Bedrocan, GACP is not sufficient for cannabis intended for medicinal use, hence the need for a special practice for the cultivation of medicinal cannabis.

At the moment, Good Agricultural and Collection Practice (GACP) is the only set of requirements available to companies within the EU for the cultivation of medicinal cannabis. This GMCCP standard exceeds the requirements as defined in GACP. The ultimate purpose is to increase the quality of medicinal cannabis cultivation and to get it as close as possible to GMP, while simultaneously taking into consideration the complexity of cultivating the cannabis plant for medicinal and scientific use.

The introduction of GMCCP has gone smoothly within Bedrocan. Actually, not much has changed because Bedrocan already had strict rules in place for growing cannabis. For example, Bedrocan has a quality management system (QMS) to guarantee product quality and continuous process improvement. It ensures that all cultivation operations are carried out in a correct and consistent manner.

White Paper

A white paper promoting novel standards for the cultivation of pharmaceutical-quality cannabis for medicinal and scientific use.

 

Cannabis cultivation: GMP certificate

Until recently, these stricter cultivation rules were covered by Bedrocan’s GMP certificate, which was obtained in 2017, the first of its kind for a cannabis grower in the world. However, the Dutch inspector then drew a line after the cultivation of plants. Cultivation, including the making of cuttings, the vegetative and generative phase, and the harvest were no longer subject to GMP, but to the less stringent GACP. The reason for this change was that GMP requirements cannot be applied to the cultivation of plants. “Working in cleanrooms is a requirement for GMP, but it is not realistic to grow plants, with all its microorganisms in a GMP cleanroom,” says CEO, Jaap Erkelens, in an explanation. The processing phase, including drying, primary processing, and packaging, remained GMP certified.

GACP is not sufficient

However, growing pharmaceutical grade medicinal cannabis requires a clean and controlled environment. According to Bedrocan, GACP is not sufficient for cannabis intended for medicinal use, especially when inhaled. Erkelens says: “You want to prevent the end product from being contaminated with micro-organisms and other contaminants, such as pesticides that can be harmful to the patient. This is only possible in an environment where everything is checked, validated, and documented.”

Bedrocan, therefore, applies the strictest possible hygiene regulations for cultivation, and checks and validates all steps to ensure that the end product is free of pesticides, molds, and other contaminants. “These are more demanding requirements than those that are defined within the GACP, the practice used by the big majority of other medicinal cannabis growers worldwide. Although GACP is intended for the cultivation of medicinal plants, it allows outdoor cultivation and does not require advanced and high-quality indoor cultivation, which Bedrocan has been applying for years. As a result, the global market is overloaded with cannabis products of questionable quality that often have to be recalled because they are contaminated with pesticides and other types of contaminants”, says Erkelens.

To prevent this contamination, Bedrocan is advocating for a new, better quality practice that applies to the entire sector.

What is the difference between GACP and GMCCP?

The main difference is that GACP leaves far too much room for interpretation. It does mention many things which we also mention in GMCCP but does not clearly state what are the exact requirements and how extensive their implementation must be. In that sense, GMCCP is a much stricter practice because it leaves little to no room for interpretation and flexibility.

 

GMCCP GACP
Indoor Outdoor / Greenhouse
GMP QMS Basic QMS
Training performed and documented Training performed but not necessarily documented
Gowning procedure must be established Workers should wear protective clothing to prevent contact with toxic and potentially allergenic substances
Cleaning and sanitation must be recorded, validated, and performed according to established procedures and cleaning schedules Buildings used in the processing of harvested medicinal plants/herbal substances must be clean
Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents also must be defined and justified n/a
Cleaning validation n/a
Validation procedures documented n/a
Calibration of equipment involved in the cultivation process n/a
Critical Quality Attributes and Critical Process Parameters should be identified n/a
Batch Records n/a
Good Documentation Practice n/a
Cultivation process has to be standardised in order to ensure reproducible results n/a
Deviation, CAPA & Change Control n/a
Vendor and Material Qualification n/a
Risk Management n/a

Documentary ‘The Doctor- Franjo Grotenhermen’ to be premiered

On 3 June, the documentary The Doctor – Franjo Grotenhermen will be premiered. It’s about the life of a pioneering physician in Germany and the first in the healthcare sector to foster the therapeutic potential of medicinal cannabis in Europe.

Meet Franjo Grotenhermen in person

The premiere will be held in Amsterdam, at the LAB111 cinema at 7.30 pm. Franjo Grotenhermen will also be present at the event, offering a unique opportunity to meet The Doctor in person.

Do you want to go to the premier? You can use this discount code to get 50% off tickets.

Discount Code: MYCB1DS

Franjo Grotenhermen

The documentary takes place during the 10th Conference on Cannabinoids in Medicine in Berlin in 2019, organised by the International Association for Cannabinoids in Medicine (IACM), which Franjo co-founded and directed for several years.

This award-winning documentary is a journey through his life and work over the last 30 years with interviews with his colleagues and fellow scientists like Raphael Mechoulam, Mark Ware, Kirsten R Müller-Vahl and Manuel Gúzman. Our CEO Tjalling Erkelens is also featured in an interview as one of the people Franjo met in his journey.

About the film director

Edu Hernández, born in Spain, is a filmmaker and photographer focused on journalism and documentaries.

With a passion for journalism, it is his obsession to tell what happens in social conflicts and to reflect true stories of almost unlikely characters. One of his documentaries, Refugees, has already won awards at five film festivals. It has also been nominated at six other festivals, and it was also selected to raise awareness among the world leaders during the World Government Summit 2017 in Dubai.

Since 2017 he has been working as an independent filmmaker. As a photographer, he worked for local as well as international artists, such as Concha Buika, Miguel Poveda, Fuel Fandango and Nynke Laverman.

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 cannabis-based medicines 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 United in Compassion

In Australia, many eligible patients still rely on the illegal market because of the cost and ease of the process. “The price disparity is improving, but cannabis remains outside the reach of many due to the regulatory limbo”, says Lucy Haslam. Lucy is the co-founder of the United in Compassion (UIC) advocacy group and organiser of the UIC medicinal cannabis symposium. The symposium, which started in 2014, took place last 20 to 22 May this year and was well attended by industry, health professionals, government regulators and patient advocacy groups.

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.”

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.

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The selling price per gram may vary if your pharmacy dispenses different quantities.