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. Once difference is the price of the products in different countries. In The Netherlands, patients pay € 5.80 per gram (excluding prescription fee) in the pharmacy, while in some other countries prices can go up to € 25 or more. We often get questions why these prices differ so much. In this article, we explain why.

How come patients in other countries pay more than € 5.80?

Here it gets difficult. 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  € 5.80 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. German pharmacies, for instance, are 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.

How does Bedrocan feel about the huge price difference between the original production cost and the amount patients have to pay?

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.

And what about the oil?  

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

Bedrocan recognised for setting the industry standard

Bedrocan won the Regional Game Changer Award at MJBizCon 2019, a cannabis conference held in Las Vegas. The award recognises Bedrocan as a regional game changer in Europe, the Middle East, Asia and Oceania. The MJBizDaily Award was presented at a major cannabis conference in the US, organised by American cannabis magazine Marijuana Business Daily.

“However, it is quite satisfying to me that we are seen as a different company that has a real impact on setting the industry standard. With our 16 years of experience, we have achieved GMP as the first cannabis company in the world and we will continue to advance these industry standards.”

For the future, Bedrocan is stimulating EU harmonisation: “Nowadays, it is still hard to ship medicinal cannabis from one country to the other. Every country has its own set of rules. We aim for EU legislation so that, regardless of their location, patients in need have easy access to pharmaceutical grade standardised medicinal cannabis.“

The awards were awarded during a gala on Thursday December 12 in Las Vegas, USA.

Italian pharmacist provides doctors with cannabis advice

The Italian pharmacist Dr Marco Ternelli received so many requests from doctors and patients about how to prescribe medicinal cannabis that he decided to put all the information together. Prescribing in Italy is not an easy matter. Doctors have little knowledge, do not know how to dose cannabis, and there are complicated forms a doctor should fill in to prescribe.

By now his clients come from all over Italy, albeit mainly from north and central Italy. For over three years, he saw 10,000 to 15,000 prescriptions for medicinal cannabis (oils, capsules, suppositories, eye drops and creams) pass through his hands for the most wide ranging conditions. He incorporated all those data in a comprehensive brochure (only available in Italian). It contains an overview of all the cannabis prescriptions he has handled over the years. ”It is a sort of personal statistics I decided to share. Reporting the strains prescribed by Italian doctors and what conditions they prescribe them for.”

Besides doctors, other pharmacists and patients benefit from the information in his blog. Dr Ternelli continuedPharmacies and pharmacists understand how a prescription for medicinal cannabis has to be completed by doctors to be accepted and for them to be permitted to proceed with the compounding preparation. In other words, what pharmacists need to check to consider the prescription as valid.”

New edition of booklet on medicinal cannabis

Our brochure ‘A primer to medicinal cannabis’ has been revised by adding the latest research in the area of medicinal cannabis. Ideal for healthcare providers, policy makers and patients who would like to have more insight into the medical and scientific aspects.

Looking for fibromyalgia patients for a new LUMC cannabis study

The Leiden University Medical Center (LUMC) is looking for fibromyalgia patients who wish to participate in a new study into the effects of medicinal cannabis on the medication oxycodon. Patients may register through a special website of the Anaesthesiology Department. Lead researcher Professor Albert Dahan aims to demonstrate that medicinal cannabis in combination with the opiate product oxycodon may have added value in pain relief.

Bediol

The study will use the cannabis product Bediol®, which contains cannabinoids THC (6.3%) and CBD (8% CBD). There will be three study groups – one group is only given oxycodon, a painkiller based on opium; the second Bediol in combination with oxycodon; and the third group just Bediol.  The research is carried out by the Anaesthesiology Department and is partly financed by Bedrocan.

The main purpose of the study is to assess whether co-medication with Bediol reduces the side effects of oxycodon in patients with chronic pain. The study will run for several years. According to the Professor it will be a complex study, because the patients may determine the dose they take. “We will give a maximum, but within that limit patients may determine what they use.” Furthermore, the study takes place in patients’ homes. They will be given a vaporiser that can be used to take the cannabis. “This set-up will definitely succeed, because our researcher will be in continuous contact with the patients.”

“Even in a country like America, where a form of cannabis is legalised in most States, pain specialists do not know how to prescribe or dose medicinal cannabis. I know I cannot make any recommendations on the basis of this experimental study, but I can set them on their way.”

If you are interested in participating in the LUMC study, you can register with the online form on the Dutch website Samen tegen Pijn.

1.9 million Euro available for pain research

The Dutch Ministry of Health, Welfare and Sport (VWS) has made 1.9 million Euro available for research into the effectiveness of medicinal cannabis for neuropathic pain. The Ministry instructed ZonMw, a Dutch stimulus fund for healthcare, to look for suitable research. The subsidy will be awarded to one Dutch research organisation, knowledge institute or other type of organisation.

A maximum of 1.9 million Euro is available for the entire project over a maximum period of four years.

Bedrocan stand at CPhI in vogue

Bedrocan was able to answer many questions from international pharmaceutical companies at the world’s largest pharmaceutical trade fair CPhI Worldwide in Frankfurt, Germany. There was a significant amount of interest from companies that aim to use cannabis as raw material for medication.

Bedrocan present at Cannabinoid 2019 Conference

From November 31 to November 2, Berlin is the setting for the Cannabinoid 2019 conference. The conference, organized by the International Association for Cannabinoid Medicines (IACM) aims – just like the IACM itself – to advance the knowledge on cannabis, cannabinoids, the endocannabinoid system and their therapeutic potential.

The biennial conferences – this will be the tenth edition – have grown substantially throughout the years and the IACM is privileged to continuously have world-class scientists and clinicians among their speakers and attendees. But the conference welcomes patients and industry members as well.

‘Throw away your bias, your preconceptions and try’

In Italy, access to cannabis-based medicines is complicated because of the ‘excess of bureaucracy’, according to Dr Marco Bertolotto, an Italian pain specialist. Dr Bertolotto is an experienced prescriber of cannabis-based medicines, having already treated more than 2500 patients. While other Italian doctors do not even consider prescribing. Dr Bertolotto points out: “Every step is complex and insidious. A serious error can be punishable by law. Every step has a trap inside.” Limited prescribing means few patients access medicines they could benefit from. “It is a recurrent story. Patients suffer from the disease and from the lack of therapy.”

Cannabis Business Italy

This week Bedrocan will be present at the Cannabis Business conference, held on October 16th and 17th 2019 in Rome. Bedrocan’s CEO Tjalling Erkelens will talk about standardisation, harmonisation and education. At the same conference Dr Marco Bertolotto will also talk about his experience with medical cannabis.

Dr Bertolotto runs a regional pain clinic and palliative care centre ASL2 in Liguria, Italy. At the end of 2018 he launched a personal website with information about the use of cannabinoids as a medicine. Due to a special Bedrocan cannabis Masterclass in December 2015 in the Netherlands, Dr Bertolotto and a small group of Italian medical experts were trained in depth on the use of medicinal cannabis according to Bedrocan standards. He now considers himself an expert and an Italian pioneer in the field. “My experience started five years ago, at the start of the Italian medical cannabis programme. I found out that there was a group of patients that were suffering and had tried so many drugs, without efficacy. They were looking for an alternative and an expert doctor who could help them.”

Despite the maze of rules, Bertolotto’s motto to doctors starting out prescribing is ‘not to be afraid. Throw away your bias, your preconceptions and try. Choose the dosage by starting low, and continue going slow. Follow the patient day by day.” Bertolotto also provides advice with regards to which administration form to use. “It depends of the patient and the disease. I normally prefer to use oil, because the titration with drops is easy, but I also prescribe cannabis dried flower by vaporization.” As Western medicine is entirely based on scientific evidence that requires randomised, double-blind studies there is unfortunately still not enough evidence. Bertolotto about this issue: “This is a big problem as doctors are therefore reluctant to prescribe. Evidence based medicine is not adapted to studying cannabis-based medicine. We need a different approach. My personal approach, that I will present later this week at the Italian Cannabis Business conference, is called Personalised Medicine. We collect and analyse a lot of data until we have an algorithm to help doctors.”

Bedrocan present at first CECF Conference in Poland

On 22 and 23 October, Warsaw will see the first Central European Cannabis Forum Conference in Poland. Bedrocan will be presenting the company and the latest news on its clinical research. We spoke to the man behind this first time event, Andrew de Roy, to find out why he decided to organise this event in Poland and the goals he wants to achieve.

Andrew de Roy has been a risk consultant and corporate investigation specialist. He has built over the past twelve years Bearstone Global, a risk consultancy with offices in Poland, Berlin and opening in London. Over this time they have increasingly been working in the space of medical cannabis as the industry has developed at such great speed over the past few years.

‘The industry is not only fast moving but obviously also controversial, as the industry goes from Black to White, most visibly in North America, but also in greater frequency in Europe. As the industry has developed, Poland is one of the more interesting countries in Europe in terms of progressive laws and numbers of registered patients. The industry requires the development of a more organised ecosystem and the ability to speak with one voice on issues which are key for the whole industry in general,’ De Roy explains.

‘Patients are the most important here’

He organises the event in order to educate, network and help the industry to speak with one voice in Poland, and to help regional integration within the industry. De Roy: ‘I am convinced that Poland has huge potential to develop businesses, as well as be a leader in an industry which still has such a significant room for innovation and development. We hope that the conference will result in a Memorandum of Understanding for a Polish Medical Cannabis Association. We hope that a more collaborative approach will assist everyone within the ecosystem, from cultivators to companies, and of course right through to the patients, who are the most important here.’

‘Future is promising, but process is difficult’

Looking at the future, De Roy sees huge potential in Poland, but it is not easy: ‘The election on October the 13th will likely show a lot! We have just had four new products registered in Poland raising the overall number to five, and there is a significant pipeline of products in line. There are rumors that all registrations have been halted, but this has not been verified officially, and there is much confusion about this. What is certain is that at present the process is cumbersome and difficult. We also have issues in terms of access for patients and cost, which is very much in line with many others in Europe.’

Vaping vs vaporization

There has been a lot of talk in the media about the risks of vaping. This article discusses the differences between vaping and the administering cannabis flos by vaporization.

Not all vaporizers are the same

Many of us have heard of vaporizers, and instantly we think of ‘e-cigarettes’ or ‘vape-pens’. However, these are not the only types of devices available. Vaporizers (as medical devices) for the administration of cannabis flos [1] are in fact quite different from ‘vape-pens’ or ‘e-cigarettes’.

The vaporizer vapour does not contain nicotine, or carrier agents such as liquid propylene glycol, glycerol, or vitamins and synthetic flavours. [i] [ii] [iii] The large, socially intrusive vapour clouds of ‘e-cigarettes’ do not apply for the medicinal use of cannabis flos by vaporization.

Vaporization devices do not include liquids, rather dry cannabis is heated by precise temperature control, efficiently releasing active ingredients without toxic by-products.

Vaporization devices offer patients an effective, safe, and easy to use delivery system for cannabis flos. [iv] [v] The inhaled vapour contains THC, CBD, and terpenes [2] in consistent, measurable quantities. The use of a high quality vaporizer device avoids the respiratory disadvantages of smoking, [vi] and of the inhalation of compounds from liquid vape-pens.

An efficient administration route

The most efficient administration route of medicinal cannabis is by inhalation. Indeed, administration by inhalation is a rapid way to induce measurable serum levels of cannabinoids. [vii]

A vaporizing medical device, compared to smoking or vaping, [3] dramatically lowers concentrations of toxic compounds such as carbon monoxide, ammonia and polyaromatic carbohydrates (PACs). Compared to smoking, higher therapeutic levels of THC and consistent, reproducible THC extraction and delivery is possible. [viii] [ix]

Vaping Controversy

In the United States the vaping phenomenon hit the headlines this year after the American Centre for Disease Control and Prevention (CDC) reported at least eighteen fatalities and more than 1,000 people with serious lung complaints after vaping. Although almost all of these concerned the use of so-called e-cigarettes and vape pens for recreational use, the use of a vaporizer to administer medicinal cannabis is now being questioned.

The vapour is quickly absorbed by the lungs, permitting patients to effectively titrate to optimise their dose based upon symptom severity, tolerability and avoidance of side-effects. The rapid onset of effects of inhaled cannabinoid use allows easier titration of dose, while standardised cannabis products enable patients to administer an exact dose. [vi] [x][xi][xii]

Patient perspectives and providing therapeutic options

Prescribers, pharmacists and patients should be aware of this differences between ‘vaping cannabinoids’ and ‘vaporising cannabis flos’.

The importance of vaporization is underlined in patient use surveys. The majority of survey respondents report higher satisfaction (approval) scores with the inhalation route. In general, whole plant, herbal cannabis-based medicines received higher scores than other products containing isolated cannabinoids. [viii][xiv]

Patients seek a reliable, affordable and portable vaporizer for administering cannabis flos. Presently there is research dedicated to advancing administration technology. Some examples of major developments in vaporizer devices, using standardised cannabis flos, include the Volcano® and Mighty Medic vaporizer (Storz & Bickel) [xv] [xvi] [xvii], and the Syqe® Inhaler [xviii] [xiv].  All devices have relied on Bedrocan standardised cannabis flos for their quality testing and clinical trials.

Vaporizer medical devices, delivering standardised doses, underline quality assurance, safety, and efficacy. With these administration technical advancements, smoking of cannabis flos can soon be a thing of the past. Backed by proper scientific studies, cannabis flos will become an acceptable therapeutic among patients, prescribers, and regulatory authorities. [xx]

Future thinking – critical policy decisions

It should be recognised that vape-pens for inhalation of cannabinoids often are not subjected to any technical or clinical testing. While, by comparison, a number of the devices for administering cannabis flos by vaporisation have robust supporting clinical and technical studies.

With regard to administration, future policy must be clear and obvious. For example, in the Netherlands, Germany, Australia and New Zealand, smoking cannabis flos is actively discouraged and/or not permitted, respectively. While the clinical guidelines support cannabis flos for inhalation administered by vaporization.

While there are similarities between the administration methods – vaping vs vaporisation – a blanket ban on inhalation or on vaporizer devices for administering cannabis flos would be nonsensical. This would have implications for administration options and prescriber-patient choice. It would also impact on their valid use in hospitals and hospices, rest-homes, and home settings.

[1] Fully-standardised, pharmaceutical-quality cannabis flos is the whole, dried flowers of the cannabis plant which is genetically and chemically standardised according to pharmaceutical standards with a defined cannabinoid and terpene composition. Also, it is free of contaminants such as microbial contaminants (molds, fungi, and bacteria) pesticides (residues), aflatoxins, impurities and heavy metals.

[2] Terpenes are a major component of Cannabis sativa. Responsible for the plant’s aroma, terpenes may also act synergistically with the cannabinoids. x

[3] When administering pharmaceutical quality cannabis flos.

References

[i] Douglas, H., Hall, W., Gartner, C. (2015). E-cigarettes and the law in Australia. Australian Family Physician. 44 (6): 415-418.

[ii] Jensen, P., Luo, W., Pankow, J., Strongin, R., Peyton, D. Hidden formaldehyde in e-cigarette aerosols. New England Journal of Medicine. 372 (4): 392-393.

[iii] Editorial and Review (2019). E-Cigarettes and Vaping-Related Disease. New England Journal of Medicine. Online: https://www.nejm.org/vaping

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

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

[vi] Pomaahcova, B., Van der Kooy, F., Verpoorte, R. (2009). Cannabis smoke condensate III: the cannabinoid content of vaporised Cannabis sativa. Inhalation Toxicology. 21(13): 1108-12.

[vii] Grotenhermen, F. (2003). Pharmacokinetics and pharmacodynamics of cannabinoids. Clinical Pharmacokinetics. 42: 327-360. Also, Grotenhermen, F. (2004). Clinical pharmacodynamics of cannabinoids. Journal of Cannabis Therapeutics. 4(1): 29-78.

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

[ix] Gieringer, D., Laurent, J., Goodrich. (2004). Cannabis Vaporizer Combines Efficient Delivery of THC with Effective Suppression of Pyrolytic Compounds. Journal of Cannabis Therapeutics. 4(1)

[x] Hazekamp and Heerdink (2013). The prevalence and incidence of medicinal cannabis on prescription in The Netherlands. The European Journal of Clinical Pharmacology.

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

[xii] Russo, E. (2011). Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. British Journal of Pharmacology. 163: 1344–1364.

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

[xiv] de Hoop, B., Hazekamp, A., Kopsky, D., Wijnkoop, L. (2016). Experiences and motives of medicinal cannabis patients: A cross-sectional questionnaire. Radboud Universiteit Nijengen, the Netherlands. (Unpublished work)

[xv] The Volcano® Medic vaporizer medical device is listed on the Medical Devices Active Licences Listing (Health Canada), licence No.: 82405.

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

[xvii] Pomahacova, B., Van der Kooy, F., Verpoorte, R. (2009). Cannabis smoke condensate III: the cannabinoid content of vaporised Cannabis sativa. Inhalation Toxicology. 21(13):1108-12.

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

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

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

Bedrocan at CPhI Worldwide 2019 in Frankfurt

Bedrocan will be present at the world’s largest pharmaceutical exhibition, CPhI Worldwide. At the fair we will present ourselves as the first GMP supplier of plant-based full-spectrum cannabis APIs. CPhI gathers over 45,000 pharma professionals from around the globe with more than 2,500 international exhibitors. It is the place for Bedrocan to network and meet pharmaceutical companies that are interested in cannabis as an active pharmaceutical ingredient. (API).

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.

Text continues below the announcement.

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CPhI Worldwide 2019 will be held in Frankfurt from Tuesday November 5th until Thursday November 7th.

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In their quest for a reliable source of API, pharmaceutical companies are increasingly finding their way to Bedrocan.

This is unsurprising given Bedrocan is the only fully GMP-certified producer of standardised medicinal cannabis in the world. Founder and CEO Tjalling Erkelens talks about standardised pharmaceutical quality medicinal cannabis.

Can you define standardised medicinal cannabis?
“It refers to cannabis products that are consistent in terms of its active ingredients – the cannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD), but also the terpenes which are the aromatic compounds. Bedrocan produces five different varieties of medicinal cannabis. They are produced in accordance with pharmaceutical quality requirements, because our production sites comply with the requirements imposed by GMP – from cultivation to packaging. 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. And we’re only getting better.”

Why standardisation?
“To us standardisation is a core concept. It is the essence of our mission and vision that were defined years ago but that are still relevant today. The patient is at the heart of all this. Prescribers, pharmacies and patients expect a safe product that works. They expect a product that complies with all the pharmaceutical production requirements, and that starts with high quality starting materials. The pharmaceutical industry needs an API that is consistent in its composition to develop and manufacture novel cannabis-based medicines.”

Tjalling Erkelens

How do you achieve pharmaceutical standardisation with cannabis?
“Over the past 25 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. Our cannabis is produced under climate-controlled conditions, with minimised external influences. Furthermore, Bedrocan was the first medicinal cannabis producer to be compliant with the European Medicines Agency’s GMP standards, covering the whole production process.”

How does the pharmaceutical industry benefit from this?
“Bedrocan is the world’s first GMP producer of standardised, full-flower medicinal cannabis. Consequently, our API offers seamless GMP finished product manufacturing. We offer both blended and genetically distinct herbal preparations suitable to develop novel, cannabis-based medicines.”

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