Will the UN point of view on cannabis be modified or not?

Will it come to a vote in March or not? To date it is unclear whether the Commission on Narcotic Drugs (CND) will adopt the six recommendations from the World Health Organization (WHO) regarding the reclassification of cannabis. The European Commission advises EU Member States to reject one of the recommendations and to postpone the vote on other two recommendations. Does this mean the loss of an historic moment, where cannabis is ascribed medicinal value by the highest health organisation for the first time in history?

The Dutch expert on UN Drugs Conventions, Martin Jelsma, associated with the Transnational Institute, doesn’t think so. “In case one or several WHO recommendations are not adopted, countries may continue with medicinal cannabis. That happens anyway.” In addition, member states should not question the scientific opinion of the Expert Committee on Drug Dependence (ECDD), the advisory body of the WHO. “The WHO’s recognition and scientific substantiation of medicinal applications remain in force, even if the recommendations are not adopted.“

  1. Extracts and tinctures are removed from Schedule I of the 1961 Convention.
  2. THC (dronabinol) is added to Schedule I of the 1961 Convention under the category Cannabis & Resin. Subsequently, THC is removed from Schedule II of the 1971 Convention.
  3. THC isomers are added to Schedule I of the 1961 Convention under the category Cannabis & Resin. Subsequently, THC isomer is removed from the 1971 Convention.
  4. Pure CBD and CBD preparations with maximum 0.2% THC are not included in the international conventions on controlling drugs
  5. If they comply with certain criteria, pharmaceutical preparations that contain delta-9-THC should be added to Schedule III of the Convention of 1961, recognising the unlikelihood of abuse and for which a number of exemptions apply.
  6. Cannabis and cannabis resin are removed from Schedule IV, the category reserved for the most dangerous substances, in the 1961 Convention.

Back in 2018, the WHO issued an historic recommendation to reclassify cannabis at international level. In doing so, the WHO gave a clear signal that cannabis has therapeutic value. The final link in this process of change, where 53 countries may vote on the recommendations, was postponed last year. Now the official vote by the UN body that determines which drugs come under international control, is planned for the first week of March.

One of the recommendations is the removal of cannabis from list IV, intended for dangerous drugs without relevant medicinal usages. According to Mr Jelsma, this recommendation is not at all as “ground-breaking” as is supposed. “The WHO still sees cannabis as a public health hazard. That is why the WHO recommends removing it from Schedule IV only and not from Schedule I, the same list for cannabis, opium, heroin and cocaine. Even if the WHO recommendations are adopted cannabis is still on the same list as heroin and cocaine and all criminal treaty provisions remain in force for cannabis. So the WHO does not in any way follow the distinction between “hard” and “soft” drugs such as in the Netherlands and explicitly confirms with this package of recommendations that cannabis should be kept as strictly controlled as cocaine.”

Lack of clarity

Mr Jelsma, who keeps a close eye on the change process of the UN Drugs Conventions, said there are many critical questions regarding the consequences of the new classification. “There is still lack of clarity about the annual reporting obligations. Each year, every member state should report the use and trade in all types of drugs, including medicinal cannabis, to the INCB (International Narcotics Control Board, ed). The recommendation to transfer the substance THC from the 1971 Convention to the 1961 Convention doesn’t make that process any easier.”

Administrative problems

Another important WHO recommendation is to remove products with cannabidiol (CBD) and less than 0.2 percent THC from the Schedule completely. Mr Jelsma fears that the control on cannabis will actually become more stringent and that this will generate administrative problems. He said “Not everyone is aware of this. Indirectly, transferring THC to the 1961 Convention means that even the plant material that contains THC will have to be controlled in the same way. The Convention does not distinguish between the content and the materials they were extracted from. It means that more will have to be controlled, including leaves and stems. The recommendation was supposed to be an improvement, but if you scrutinize it, it actually deteriorates the situation.” Countries with a major hemp industry, don’t need that at all. Hemp is cultivated for its low THC content and high CBD concentrations. With the extremely low threshold criterion of 0.2%, many hemp products and derivatives are likely to fall under the stricter control regime. “I believe that this is one of the possible consequences that was overlooked by the ECDD. This was never the intention”, according to Mr Jelsma.

Majority

Fate is in the hands of 53 countries with voting rights. If they proceed to a vote in March, the question remains as to how those 53 countries will vote. This will depend strongly on whether a country has a medicinal-cannabis programme or not. A total of 24 of the 53 countries have legislation on this issue or have plans to issue legislation. That is just not enough to achieve the necessary 50% majority required for an amendment to the 1961 treaty. The further complicating factor is that an amendment to the 1971 treaty requires a majority of at least two thirds. Although the EU*, including the United Kingdom, represents nearly a quarter of the total number of countries with voting rights, a majority is not guaranteed. Mr Jelsma is concerned, as there is a significant chance that EU countries will vote as one block and the voting advice of the European Commission has quite a few flaws. “The vote will be extremely important, because some WHO recommendations can worsen the current situation.”

UN Conventions

The CND, the Commission on Narcotic Drugs, is a UN body that determines which drugs come under international control. The CND regularly amends the schedules of substances that are included in the drugs conventions on the basis of recommendations from the World Health Organization (WHO), which in turn is advised by its Expert Committee on Drug Dependence (ECDD).

There are three important UN Conventions that control drugs throughout the world:

In the current 1961 treaty, cannabis and cannabis preparations are in Schedule IV. The drugs in this Schedule are a partial selection of the drugs in Schedule I that are considered the most dangerous and have the least medicinal value. Heroin is therefore placed on both lists.

In recent years, the WHO has started up a quiet but powerful change process behind the scenes. The process started in 2016 with the scientific assessment of cannabis by ECDD as its highlight.

Office of Medicinal Cannabis

Internationally it was agreed that countries undertake to protect their citizens against cannabis abuse, production is only permitted for medical or research purposes and marketing only by a cannabis agency managed by the government. In the Netherlands that is organised through the Office of Medicinal Cannabis.

*) As of 1 January 2020, the following 13 EU Member States have a voting right on the CND: Belgium, Germany, France, Hungary, Italy, Croatia, the Netherlands, Austria, Poland, Spain, the Czech Republic, Sweden and the United Kingdom.

Important dates

  • CND intersessional in Vienna on Monday 17 February where the basic decision must be made about the vote in March
  • Horizontal Working Party on Drugs (HDG) in Brussels on 19 February, where the EU must determine the joint position
  • The final vote of the CND from 2 to 6 March 2020 in Vienna

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.

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

What dose should I give my patients?

What dose should I give my patients? The most difficult thing for a doctor is to determine the dosage for medicinal cannabis. Leading Maltese doctor advocating for a better understanding of the medicinal properties of cannabis, Dr Andrew Agius, knows how. In his pain clinic on Malta he treats patients with challenging chronic pain conditions, like fibromyalgia, who have tried many different types of medications and have not found relief from their symptoms.

What are the key benefits of cannabinoids as a therapeutic product?

“It provides very effective relief from pain symptoms with very little side effects compared to the other available medications. Most side effects are positive unlike most other medications. This could include less anxiety, better sleep, better mood and better control of chronic conditions such as diabetes, asthma and eczema.”

Which form of administration do you advise?

“I advise vaporizing the dried flower that is available in pharmacies as this provides legal, quick, safe and effective relief of symptoms. They can also combine it with a safe CBD oil product which has been recommended from a trusted supplier, taken as sublingual drops.”

Most doctors are not trained in the use of medicinal cannabis. How did you familiarise yourself?

“I learnt by reading a lot from the internet. I enrolled into online educational courses and went overseas to conferences and educational meetings. When I felt confident enough, I prescribed and recommended various types of medicines to my patients and through the feedback they provided, I learnt more and more on how various cannabinoids effect different patients and relieve various symptoms. This kind of patient feedback helped me improve on various treatment strategies to obtain better results.”

Western medicine is entirely based on scientific evidence that requires randomized, double-blind placebo-controlled studies. Unfortunately, there is still not enough evidence. And that’s why doctors are reluctant to prescribe. What would be your comment on that?

“I fully agree that there are not enough randomized, double-blind studies to provide the same evidence that backs the use of other types of medication. However, cannabis has been used over 5,000 years and we know that it is extremely safe and it has shown to be very effective in many different types of medical conditions, especially conditions where conventional medication was not effective. From my experience over the last two to three years, I have very strong observational evidence that medical cannabis is very effective for most of my patients, especially patients suffering from disabling chronic pain conditions such as fibromyalgia which are very difficult to manage by using available registered medicines.”

Do you have any advice for doctors starting out prescribing?

“Since it is very safe to use and it is now legally available, if you have a patient that has tried medications to relieve chronic pain or other disabling symptoms with minimal effect, start by prescribing a low dose to these patients and see how grateful they will be that you have made a significant improvement in their quality of life.”

Medicinal cannabis on Malta

In Malta, every registered doctor can prescribe medical cannabis. If a patient suffers from a chronic illness and has tried at least one medication which hasn’t been effective, they are eligible to try medical cannabis. The doctor makes an application to the Superintendent of Public Health requesting her permission for the patient to use the medicine. If the patient has never attended an opiate detoxification program in the past, the application is approved for thirty days. Following this thirty-day trial, the patient needs to go back to their doctor who prepares a medical report and another application which is then approved for six months. The patient needs to be reviewed every six months and each time a new approval is granted by the Superintendent of Public Health. There are four medicinal cannabis products available on Malta, this includes Bedrocan® (THC 22% | CBD <1.0%)  and Bediol® (THC 6.3% | CBD 8%).

Your pain clinic is an integrative medical centre for the holistic management of persistent pain. What do you mean by that?

“Persistent pain is chronic pain for more than three months which greatly effects patients’ quality of life. Holistic management means integrating a biopsychosocial approach to managing such patients and supporting them in all areas of their life not just by providing medication. We give advice on lifestyle changes, improving sleep routines, increasing physical activity, adjusting the diet and reducing stress through mindfulness meditation and yoga and also psychotherapy when indicated.”

Logo of Pain Clinic Malta

What makes your approach special?

“We adopt a very conservative approach and start by prescribing physical activity, a healthy diet and mindfulness-based stress reduction before considering medication or more invasive measures. When prescribing drugs, we opt for the safest, most natural alternatives that promote natural healing and effective relief from symptoms with minimal side effects.”

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.

Infographic explains why people in other countries pay more for medicinal cannabis

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.

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.

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 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.

Meet us in Frankfurt

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

You can visit our booth and meet our Business Development team at stand number 41B46.

Should you wish to make an appointment, please fill in the form below and we will get in touch with you.

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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.”

Three misconceptions about medicinal cannabis

What are we talking about when we talk about medicinal cannabis?

The term ‘medicinal cannabis’ leads often to faulty assumptions and misconceptions. That’s why we think it’s important to make clear what medicinal cannabis actually is. In a series of short articles we present the most common misconceptions about medicinal cannabis, in order to speak the same language in discussions, news articles and so on.

All cannabis is suitable for medicinal use

There is a great difference between ‘medicinal cannabis’ and ‘cannabis for medicinal use’. That difference is all about the manner in which and the purpose for which the cannabis is produced. Medicinal cannabis is intended solely for patients and the production process is fully attuned to that purpose.

Production takes place in a fully standardised manner, in a pharmaceutical environment, and is subject to those stringent quality and safety standards. The production processes are designed so that the cannabis is genetically consistent, the proportion of active ingredients is consistent, and there is minimum risk of contamination (microorganisms, heavy metals, and no pesticides). The cannabis quality is tested by an independent laboratory. This way quality is guaranteed. Both the patient and doctor clearly know what is being prescribed.

Industrial hemp is medicinal too

Hemp belongs to the family of Cannabis sativa L. It contains cannabinoids and is sometimes used for ‘recreational’ or ‘medicinal’ purposes, although it is never produced under pharmaceutical conditions. When referring to hemp, this typically concerns ‘industrial hemp’; a sturdy agricultural crop with long, strong fibres.

It differs genetically from the medicinal cannabis species. Mainly used in clothing, paper, (animal) feed, and automobile industries, industrial hemp contains negligible or zero levels of THC (the psychoactive component of cannabis). This is why it may be legally grown in many countries under more relaxed regulations. Industrial hemp does however contain CBD. As a result it is sometimes also used for the production of CBD rich oils which are not for medical use.

Medicinal cannabis is expensive

The production of medicinal cannabis requires considerable investment. The production process must continuously comply with the applicable quality and safety requirements of medicines. Nonetheless, in the Netherlands – a programme designed to provide patients with acceptably priced pharmaceutical quality medicines was initiated in 2003 – it has proven possible to gradually reduce the price.

Indeed, the price for one gram of medicinal cannabis has remained below the average price for recreational cannabis in the Netherlands for some time. This was made possible due to industrial efficiencies, scalable production process, and – in more recent years – income from exports.

In 2018, the Minister for Public Health, Welfare and Sport – who is ultimately responsible for the Dutch medicinal cannabis programme – further reduced the price per gram. A patient today pays € 5.80 (net) at the pharmacy.

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