Bedrocan market leader in Europe

Facts and myths – the MJBizDaily factbook ‘Medical Cannabis in Europe: The Markets & Opportunities’ provides a clear picture of the European medicinal cannabis for the first time. What does the European market for medicinal cannabis look like? Which regulations apply to which country, who produces, who imports and which producers make the largest contribution?

Those questions and many more are answered factually and in detail for the first time by a special edition of Marijuana Business Daily, an American news outlet on the global cannabis industry. What transpires? Bedrocan is the clear market leader in Europe. More than 61% of the medicinal cannabis that is used by patients in Europe comes from our sites in Emmeloord and Veendam.

A special team of journalists and researchers analysed the European market for medicinal cannabis. It produced a diverse picture, both in terms of regulation and figures. Just three countries – the Netherlands, Germany and Italy – have a significant domestic market, whilst all other countries together account for just 3% of the market. Furthermore, the Netherlands is the only country that is able to meet the needs of patients internally, as all other countries depend on import. In contrast to a popular argument, this import does not come from Canada.

Besides the general European figures, the report also provides a good overview of the market and the regulations in more than 20 individual countries. If you are interested, you can download the MJBizDaily factbook free of charge.

Canfusion – No, this title is not an error

Developing new medication is a long and expensive process, marred by uncertainty. On average it takes 10 years before medication is registered officially, but in the world of cannabis it works the other way around. Cannabis and cannabis products are on the market already, be that legal or illegal. “It’s time for governments to get into gear”, argued Bedrocan’s CEO Tjalling Erkelens in a guest article he wrote for the German Hanf Magazine. Politicians and policy makers need to come up with universal regulations that are meaningful to the cannabis industry, the healthcare professional and the patient.

By: Tjalling Erkelens – CEO Bedrocan
Published in Hanf Magazin

No, this title is not an error. However, it certainly has to do with “confusion” and more in particular about confusion surrounding cannabis these days. Aside of all ‘big money’, ‘big pot’ and ‘big pharma’ discussions I do see an immense amount of confusion among doctors, patients, pharmacists, but also scientists, regulators and politicians.

Since cannabis has become ‘hot’ everybody is trying to jump on the bandwagon and be part of the current ride that cannabis is taking in the world. Even worse, everybody nowadays also has an opinion on cannabis. At the numerous conferences and meetings that are now being held on this subject we see so much information either lacking, being false or at least incorrect and certainly not patient-focused.

I am working in the world of cannabis since 1992. So that started only 16 years after fellow Dutchman Harm Dost, was arrested in Kleve (as a tourist). Harm Dost was known for his sales of cannabis in Arnhem, also to German people who he, at that time, treated as patients, calling himself a caregiver. In 1977, after having spent 18 months in a German prison, he was extradited to The Netherlands. In 1986 he was again sentenced in Germany, now to 10 years in prison. In 1987, on appeal the sentence was diminished such way that he was released from prison immediately. Twenty-two years later (2008) Germany imported its’ first medicinal cannabis from The Netherlands and sales through pharmacies, on prescription of a medical doctor started.

So, I have seen the world of cannabis change from a full illicit/grey product and industry, basically without any surrounding scientific knowledge, into one in which science, industry and regulators / politicians have started to see the added (medical) value of cannabis. That doesn’t mean that everything now is perfectly right and ok. As said in the intro, there is still a lot of confusion among many stakeholders. Even today, a lot of politicians and regulators don’t see the difference between cannabis for medical use or recreational use. At the least they are struggling with it. Although the amount of positive scientific evidence is more and more piling up these days, the acceptance of cannabis as a medicine is still highly driven by emotions and (contra-)activism. Lack of consensus among scientists, lack of coherence and harmonization of regulations and an un-unified industry are frustrating development of proper cannabis-based medications, let alone proper access for patients globally.

To unravel this relative complex problem, we have to start with a very basic question: ‘What is cannabis?’ Even till 5 years ago, the general answer was: ‘A plant, well-known for its’ healing, though psychotropic effects due to its’ main constituent THC.’ If you will ask today, a majority will tell you: ‘A plant, well-known for its’ healing and non-psychotropic effect due to its’ main constituent CBD.’ In between you will find people talking about terpenes, minor-cannabinoids, flavonoids, entourage-effect. But in the end, nobody is able to provide all the right answers. The only thing we do know is that cannabis works well for a lot of people in all kinds of suffering and diseases. However, from that point on, we all got stuck in a swamp of so-called expert-opinions, testimonies, n=1 studies and even hearsay.

Solving this problem is not an effort that can be put on the shoulders of industry, research institutions or NGO’s only. The consequences of more than 60 years of global prohibition will have to be borne by the politicians who made that decisions back in the early sixties of last century. So actually, that means all of us, represented by our politicians. If we want proper research, proper products and proper access for patients and that way allow cannabis to become the medicine we all think it is, this is a bigger task than making industry responsible in the traditional pharmaceutical way. Such would have worked 60 years ago, just like it did with other controlled substances producing plants (poppies and coca mainly). Some then would say legalize all cannabis use and thus have the recreational user contribute to the development of cannabis medicines. That is what I call: mixing apples and pears. The 60 years of prohibition were not caused by recreational users or activists and patients neither of course…

Now a number of governments is telling the newly arising cannabis industry to follow the well-known track of pharmaceutical drug development. That would mean in very broad strokes: develop your product, perform your (clinical) research, register your product, get market authorization and have your product into the patient’s hand hopefully reimbursed partially or in full. Following that track will mean another 10 – 20 years of waiting because that is what this ‘royal route’ brings with it. However, that time is not really available. Cannabis and cannabis derive products already are in the market (licit or illicit); efficacy is shown by means of the numbers and experiences. If you can show a 100.000 times or more positive N=1 (research on 1 person) results, is a result that cannot be ignored.

In the end it means that the ‘royal route’ is not available, simply because we’re already far beyond that point. The combination of allowing cannabis to the market but having no proper or sometimes very ‘creative’ regulations in place is not good for patients, nor their caregivers. It has become time now for regulators on a global, or at least multi-national level, to come together and unify regulations on the basis of safety and efficacy on one hand and immediate, proper and responsible access on the other. Germany (although still struggling as we all know) is a good example of allowing and regulating at least that combination of factors to happen. Maybe instead of all those business conferences, the industry should focus on more regulator conferences. Let’s make 2019 “Year Of The Regulator”.

Medicinal cannabis. Lawful, but still difficult to obtain in the UK

At the end of last year, the rules for using medicinal cannabis in United Kingdom were relaxed substantially, but many patients are still looking for ways to obtain medicinal cannabis or derived products in a lawful, affordable and responsible way. Healthcare professionals are extremely cautious with prescriptions, because of the attached ‘clear published evidence of benefit’ condition. According to Hannah Deacon, mother of epilepsy patient Alfie Dingley, time is of the essence. “There is much more awareness in the UK and important steps have been taken, but the procedures are too bureaucratic and time consuming. Patients can’t wait for those.”

In 2018, the UK government took significant steps in terms of the use of medicinal cannabis. Since the 1st of November 2018, medical specialists have been permitted to prescribe medicinal cannabis in specific situations. For a while, it seemed like the icing on the cake for a large group of patients and supporters in the UK who worked tirelessly to put medicinal cannabis on the political agenda and for the rules to be amended. Young patients Alfie Dingley (7) and Billy Caldwell (13) became the figureheads. Both boys suffer from a serious type of epilepsy, but it had become evident that medicinal cannabis could make an enormous difference to them. After Charlotte Caldwell, mother of Billy, was arrested at Heathrow Airport in June 2018 after purchasing medicinal cannabis oil in Canada, they were given an emergency license so Billy could continue taking his oil. Hannah Deacon, Alfie’s mother, also made the news on a regular basis. She started a campaign, personally met PM Theresa May and asked her to change the rules and allow a license to be issued to Alfie to use the oil he had used so succesfully in Holland. Among other things, they also managed to win actor Patrick Stewart for Alfie’s case. Alfie’s doctors recieved the first medicical cannabis license which was issued on 19th of June 2018 and then they could import and use medicinal cannabis from Holland. Hannah was the first person in the UK to bring in THC oil legally through customs in July 2018.

‘Sensible’ approach

In addition, in June 2018, Home Secretary Sajid Javid announced that the use of medicinal cannabis would be reviewed. He made it clear from the start that this review would not lead to a full legalisation of cannabis, ensuring a clear distinction between recreational use and medicinal applications. The outcome was a strict set of rules that became effective as of the 1st of November. Medicinal cannabis was also moved to a category of drugs (Schedule 2) that is still controlled, but that may be prescribed in certain situations. For example, only specialists in a hospital may issue prescriptions for a limited number of disorders. This concerns children with rare and serious types of epilepsy, adults who are undergoing chemotherapy and adult MS patients. Furthermore, treatment with medicinal cannabis may only start when all the other options have been exhausted, whilst the NHS argues that the treatment method needs to be proven to be effective too. Dr Michael Bloomfield, a leading research fellow in psychiatry at University College London was able to accept this ‘sensible’ approach as, like many other healthcare professionals, he is waiting for scientific evidence. “When we don’t have very strong evidence for any medicine, then it should be hard to prescribe something because we should be prescribing medicines when there’s a very strong evidence base for them”, he told BBC News.

New phenomenon

Hannah Deacon understands that perfectly well, but also sees the practical issues for the nearly 25,000 young patients in the UK with refractory epilepsy who, like Alfie and Billy,  could benefit from medicinal cannabis. “We are of course extremely grateful that the responsible bodies acted and that we received permission to import the oil for Alfie. We also understand that healthcare professionals have responsibilities and want scientific evidence, but in practice the new rules mean that many patients still don’t have access to medicinal cannabis. Medicinal cannabis is a new phenomenon for doctors and everyone is waiting for the outcome of clinical trials. Patients simply don’t have that amount of time to spare. More to the point, the rules are limited and complicated and manu clinicians do not understand them. Or they do not understand medicinal cannabis and how to prescribe it.”

Availability

Yet it cannot be denied that the UK is taking steps in line with other countries in Europe. Up to the 1st of November 2018, Billy, Alfie and many other English patients did not have access to medicinal cannabis at all without a special license. Nearly all medicinal products based on cannabis were Schedule One drugs, that were assigned no medicinal or therapeutic value and the use of which was prohibited. MS patients were allowed to use Sativex®, whilst Nabilone® was given to cancer patients. However, the use of these registered products was subject to conditions. Availability was a general problem for patients for whom regular treatment methods no longer worked, as was the case with Alfie Dingley. So in September 2017, Hannah and Alfie crossed the Channel to the Netherlands to find out whether medicinal cannabis provided relief; in the Netherlands medicinal cannabis has been available on prescription since 2001. Time was of the essence for Alfie.

Hannah, Drew, Alfie, Patrick Stewart and supporters.

Responsible product

Alfie suffers from PCDH19 epilepsy, which is caused by a mutation in the PCDH19 gene that disturbs the production of the protein protocadherin and disrupts the communication between brain cells. This is a serious form of epilepsy that produced clusters of seizures in Alfie; sometimes as many as 30 seizures a day or 150 per cluster. “Initially, the cluster attacks occurred every eight months, but when Alfie was five years old he was in hospital every week”, remembered Ms Deacon. “In the meantime we tried all sorts of different medication, but nothing worked. The situation became more serious as Alfie grew older, so something had to be done.”

Hannah and her husband Drew Dingley explored the possibilities of medicinal cannabis. “There is a lot of anecdotal evidence. In consultation with our GP we went to the Hague, where a specialist was prepared to treat Alfie and where the Transvaal Apotheek produced oil from medicinal cannabis in a responsible manner”, said Ms Deacon who is familiar with stories about illegal and often contaminated cannabis products. “When it comes to health, a little scepticism is a good thing. We were convinced that we needed to look for a legal, standardised and pharmaceutically responsible product. In the Netherlands that is available on prescription.”

After five weeks of treatment in the Netherlands, Alfie started to respond positively to an oil with a low THC content. After adding another oil (with more THC), Alfie’s situation improved enormously. Ms Deacon said: “After five months we were fairly certain that we had found good medication for Alfie. We returned to the UK and started the campaign that enabled Alfie to be given the license after a fair number of setbacks and other patients taking action. In the end, that license led to a prescription from the National Health Service (NHS), ensuring that Alfie can have lawful access to medicinal cannabis. The only problem is that we need to travel to the Netherlands on a regular basis, because the oil used by Alfie is not yet available in the UK.”

Savior

“All things concerned, Alfie is doing well”, continued Hannah Deacon. “The number of attacks has been reduced to just a handful. When they come, they are also far easier to deal with and Alfie recovers far quicker. He goes to school, rides a bike, rides a horse and is developing like any other child. Previous medication worked less well and made him aggressive too. We can truly say that medicinal cannabis has been a savior for us all. Alfie and the people around him have their life back.”

Unfortunately, this is still not true for all patients in the UK. It is with good reason that Hannah Deacon is concerned. “We did not campaign for Alfie alone. There are so many other patients – with different disorders – who could benefit from medicinal cannabis. Now the government has given consent, the availability of medicinal cannabis should be improved rapidly.”

First batch of medicinal cannabis arrived in the UK

On Thursday the 14th of February, the first bulk batch (800 gram) of medicinal cannabis from the Netherlands reached the UK. The English company Grow Biotech had been given permission to import the batch. This is not cannabis oil, but standardised medicinal cannabis of pharmaceutical quality that is produced under the responsibility of the Dutch government. That first batch of cannabis appears to have opened up a new, official route and possibly puts an end to a system where import is permitted for a select number of patients who then need to organise the import process themselves. The risk is that the import procedure takes longer than the validity of a prescription (28 days), making the bulk import essential according to many of those concerned.
The cost of medicinal cannabis is another threshold for many patients. Some patients spend approximately 700 GBP per month and there is still no set procedure for reimbursement. At the end of 2019,  the National Institute for Health and Care Excellence is due to publish guidelines for medicinal cannabis. The NHS will use those as the basis for possible reimbursement.

Bedrocan is returning to Canada and South America early

An arbitration tribunal rules that the Dutch medicinal cannabis producer Bedrocan International (“Bedrocan”) is allowed to resume commercial activities in Canada as of September 11, 2019, and allowed to engage the same in South America (retroactively) as of March 14, 2019.

A legal settlement agreement containing a moratorium on commercial activities between Canopy Growth Corporation and Bedrocan, prohibited Bedrocan from operating in Canada until 1 January 2020, with the same prohibition applying to South America until 7 June 2019. This moratorium was enforced by Canopy in June 2018 after both parties agreed to terminate their joint licensing agreement.

The arbitrator has now reduced the duration of this moratorium due to Canopy not meeting all the conditions set out for the termination in the license agreement. The arbitrator concluded that the mere fact that Canopy was seriously prejudiced by a reduction of the moratorium is for the account of Canopy and Canopy only. He concluded as well that Canopy could have prevented any damage (i.e. reduction of moratorium) themselves had they simply adhered to the terms of settlement in a timely fashion. Following this ruling Bedrocan will be announcing its next steps within these markets some time later this year.

Bedrocan CEO, Tjalling Erkelens believes that “lifting of the moratorium not only results in an important milestone for Bedrocan as a company, but is also very good news for Canadian and South American patients who rely on the use of medicinal cannabis and who already used medicinal cannabis from Bedrocan before the moratorium commenced.”

‘Cannabis-oil quality should be beyond dispute’

Infinity Pharma in Helmond, the Netherlands, is a pharmacy that works with regular medication as well as ‘new’ medicinal products, such as cannabis oil. It is one of the four pharmacies that compounds medicinal oil from standardised medicinal cannabis under the supervision of the Dutch government, and in accordance with GMP guidelines. The Office for Medicinal Cannabis in the Netherlands oversees the whole process. “The demand for cannabis oil is high and we like to meet it. But it has to be produced responsibly.

Until the 8th of August 2018, Infinity Pharma was known as GMP Apotheek Mierlo-Hout, a well-respected pharmacy with advanced medicinal knowledge and a strong dialogue between prescribers and patients allowing for ‘personalised medicine’. This led to a desire to produce cannabis oil in-house which could be issued to patients on the basis of a prescription. “We saw an increase in the interest in cannabis oil and we did not want to ignore that”, says Key Account Manager Loes Haast.

Medicinal cannabis

“We followed the developments around medicinal cannabis closely and trusted our own knowledge to be able to compound the oil responsibly. The fact that the Dutch government has made medicinal cannabis that is highly standardised and produced under GMP available for some years now provides a responsible basis. On top of that, Transvaal Apotheek in The Hague helped us with setting up the production. They already had the experience and we weren’t looking to reinvent the wheel. Furthermore, it is important to patients and prescribers that the products we offer are of the highest quality with minimum risks.”

Fagron Group

The Helmond pharmacy Infinity Pharma is part of the Fagron Group that has 200 pharmacists in more than 50 sites on 5 continents. Rafael Padilla, CEO of Fagron, used to be a pharmacist and aims to roll out the Infinity Pharma concept in Europe. The site in Helmond is the first of its kind and serves patients and consumers from the Netherlands, Belgium and Germany.

Fully in line with the history of the pharmacy in Helmond and the mission and vision of the parent company, Infinity Pharma offers regular medication alongside ‘personalised’ products. The pharmacy strives to have customised products for each patient and uses its own system of medication control to avoid risks.

Portfolio

The portfolio has been subdivided into the product groups: ‘pharmaceuticals’, ‘nutriceuticals’ and ‘cosmeceuticals’. Digital Transformation Manager Dimitri Lambrecht informs us that all are produced state of the art and are offered in clearly recognisable packaging. “We keep our eyes open for new products to serve patients and consumers in the best possible way. We make a clear distinction between products that may only be issued on prescription and products that may be sold over the counter or online. That distinction is reflected in the packaging. Under the flag of nutraceuticals we also offer a self-care product based on CBD. This oil can be produced responsibly and in contrast to most CBD oils, the consumer can check the ingredients exactly. Cannabis oils are of the product group pharmaceuticals, thus available on prescription, and are produced using Bediol®, Bedica®, Bedrocan® and Bedrolite®, the latter exists in two versions.”

FTO module

Apart from serving patients and consumers, Infinity Pharma also aims to share knowledge. This happens at the pharmacotherapeutic meeting (FTO), with one module solely focussed on medicinal cannabis and cannabis oil. During the FTO, doctors and colleagues receive comprehensive information from pharmacist Joris Cornelissen. “We base ourselves on scientific facts and not on anecdotal evidence”, said Loes Haast. “Our profession requires an enormous amount of responsibility and we take that extremely seriously. That applies to the information we provide to patients, doctors and colleagues, but also to the parties we work with, such as the suppliers of raw materials and equipment.”

‘We must bring the plant to the physician’

Although he has retired, Rudolf Brenneisen’s mission – the re-medicalisation of cannabis – has not come to an end. Mr Brenneisen gives lectures, talks to the press and leads the Swiss Taskforce for Cannabinoids in Medicine (STCM), for which he himself organises a biannual congress. His motto is to develop, interpret and share scientific knowledge. “We must bring the plant to the physician.”

“This is the last time I’ll be doing this on my own”, said Rudolf Brenneisen on the eve of third STCM congress around the middle of January.

“I really enjoy organising a congress and the previous ones demonstrated that scientific meetings about medicinal cannabis meet a need, but it is too much work for one person.

Furthermore, I’m retired and need to focus on my hobbies. There is more to life than cannabis.”

Rudolf Brenneisen

That wasn’t always the case. The curriculum of Rudolf Brenneisen (Bern, 1949) comes down to nearly 40 years of acquiring and sharing knowledge of the medicinal potential of cannabis. It began and ended at the University of Bern, where he started as a researcher at the Institute of Pharmacy in 1975 and where he retired as Professor of Phytochemistry and Pharmacognosy of the Department of Research in 2014. Not surprising, because Mr Brenneisen’s country of birth has a rich tradition in the area of phytotherapy and cannabis was one of the plants that was offered as being beneficial way back in the last century.  “My first research was focused on the pharmaceutical potential of blueberries”, remembers Mr Brenneisen. “At some point in my Pharmacy study I was allowed to compose a cannabis preparation for corns and that generated my interest in the cannabis plant. I wondered whether the qualities of this ‘folk medicine’ could be translated to pharmacy. At the same time, I was extremely aware of the controversy surrounding cannabis and the risks of excess consumption. It became clear to me that you to have maintain a strict separation between medicinal and recreational use of cannabis – and the discussion about it.”

From forensic to medical

In the 1970s, Mr Brenneisen took his first steps as a cannabis scientist, but in the forensic sphere. On the instructions of the Swiss Drogenpolizei he was at the cradle of a reliable method for determining the THC content of cannabis, and then moved to the Research Institute of Pharmaceutical Sciences in Oxford Mississippi, where together with Professor Mahmoud ElSohly he worked on the chemical fingerprint (terpenoids profiling) of the cannabis plant and its active components (cannabinoids). This knowledge brought Mr Brenneisen to the laboratory of the Drug Enforcement Administration (DEA) in McLean, Virginia around the middle of the 1980s. A beautifully framed certificate on the wall in Mr Brenneisen’s office in Bern serves as a daily reminder of that period. In the end, a pilot study with muscle-spasm patients brought the Swiss cannabis specialist back to his country of birth.

“That was a definite move from forensic to medical science”, said Mr Brenneisen. “That study, where initially two patients were treated with THC, proved to be a milestone in cannabis research. The study was scaled up to several patients and actually opened the door to clinical studies of cannabis in Switzerland. Perhaps even in the rest of the world, because after that many trials were started up in the area of neurological disorders, such as Amyotrophic Lateral Sclerosis (ALS) and pain.”

Remedicalisation

With nearly 40 years of forensic and medical-scientific research, Rudolf Brenneisen has been referred to as the ‘cannabis papst’ (cannabis pope) more than once. Perhaps because he has fervently expressed his belief in the medicinal potential of cannabis, albeit a little unorthodox at times. Perhaps because he had an unchanging mission; making sure that cannabis returned to the pharmacies, where it deserves a place alongside all other prescription medication. Therefore Mr Brenneisen prefers to talk about the ‘re-medicalisation’ of cannabis. “It cannot be right that patients who benefit from cannabis have to go to the street or the internet to buy their ‘medication’ from the illegal circuit. For patients, who suffer enough as it is, it constitutes a possible criminal offence as well as a health risk. Practice has demonstrated time and again that you simply do not know what you are using. In my view, quality and safety are paramount and therefore a scientific, pharmaceutical approach is essential. I’m not a ‘cannabis pope’. I do not belong to the group of people who believe that everything from nature is good for your health by definition. And I’m not a catholic either (laughs). However, I do believe in medicinal cannabis and by now there is scientific information to support that belief.”

Clinical facts

There continues to be a massive call for scientific evidence. Not just for patients and doctors, but for health insurance companies, regulatory bodies and politicians – they are all waiting. Mr Brenneisen commented “It starts with patients. Over the years, plenty of anecdotal evidence has been gathered and although that is promising, ultimately the doctor or specialist need to understand it and believe in it, because they are closest to the patient. Therefore we need hard, clinical facts and everybody knows that is not easy because it costs time and money. Back to me; whether I will live to see the actual re-medicalisation of cannabis remains to be seen, but steps are being taken across the globe.”

Mystification

The attention for the medicinal use of cannabis has taken flight worldwide, and more and more countries are considering legal use by patients or are working on setting up a programme. The European Parliament recently made some statements, the World Health Organisation formulated recommendations, and medical-scientific research of cannabis has taken off. The retired Swiss Professor turns 70 this year and according to pension law he no longer has to worry, but he still does. “I simply still find it absolutely incredible to see how versatile a cannabis plant is and how many scientific questions medicinal cannabis produces, although I do struggle with the wholesale mystification that is taking place. That has been the case for CBD for quite some time. It is marketed aggressively as a food supplement or lifestyle product, and consumers go for it en masse. That is simply the result of a lack of knowledge. Cannabis – and I’m talking about the entire plant here – is a natural product with medicinal potential, it is not a panacea. We also know it carries risks. We need to get rid of stigmatization, but also of glorification. At the same time there are so many questions to answer, and that demands a scientific approach. What is the ideal formula of cannabis as medication and what does the endocannabinoid system do? Should we be looking for medication with an isolated active substance or is it actually the combination of cannabinoids that is making the difference? What is the ideal administration method? There is plenty of research of all those questions and I still find it fascinating and useful to bring all that knowledge together and to share it with the world.”

Stay involved

In order to stay involved Rudolf Brenneisen is still linked with the Swiss Task Force for Cannabinoids in Medicine (STCM) and the Schweizerische Akademie der Pharmazeutischen Wissenschaften, for which he organises the biannual scientific congress himself. This year (2019) is the third congress and is quite a job, barely leaving time for other hobbies, such as exploring the American highways on a Harley Davidson or listening to the famous twelve bar blues of the English rock band Status Quo. “On one Saturday we try to get as many healthcare professionals, scientists, patients, politicians and other stakeholders together and this year they come from 19 different countries. It underlines massive global interest,” said Mr Brenneisen. “Continuing to develop, interpret, and share objective, scientific knowledge of real importance is something I like to contribute to. This also motivated me to act as editor in chief of the new open access journal ‘Medical Cannabis and Cannabinoids’.”

Austria prohibits CBD products

Some countries permit products containing CBD either as food supplements or by turning a blind eye, but the reverse applies in Austria. The country recently prohibited CBD because the government believes that the product is uncontrolled and sales are out of hand. The Austrian Ministry of Health is of the opinion that patients need to be protected, but according to the patients organisation Arge Canna, this measure will only harm patients’ interests.

The CBD prohibition in Austria became effective at the end of 2018, just before the recent recommendation from the World Health Council (WHO) to deregulate CBD. CBD, together with THC, is one of the most important active components of cannabis, whereby THC being known particularly for its psychoactive effect.

Advice WHO

The WHO recently recognised the therapeutic benefits of cannabis, and no longer considers the plant as dangerous, recently proposing to move cannabis from the strict schedule 4 to the more permissive schedule 1 in the Single Convention on Narcotic Drugs from 1961.

According to the Austrian patient organisation Arge Canna, patients do not benefit from a prohibition on its own. There has to be more regulation and improved quality control of CBD products.

Spokesperson Klaus Hübner of Arge Canna commented on the prohibition by saying “In Austria you can still buy cannabis flowers, extracts and hash with CBD and less than 0.3% THC. They’re just no longer sold as a food supplement or medication, but as an aroma product or as raw plant material extract, because that is still allowed.” According to Mr Hübner, there is absolutely no quality control from the government, even though these CBD products are used by patients. It is a thorn in the side of the patients organisation, who call themselves a quality guard. “We now have the worst of both worlds – CBD is not permitted for medicinal use and there are no controls of any kind. Patients are in danger because of it.”

Due to the lack of quality control, Arge Canna, a non-profit NGO, has been testing various Austrian CBD products on their content substances since 2016, through an independent laboratory. On request of the manufacturer they check every product for the presence of cannabinoids, the active ingredients of cannabis (THC content must not exceed 0.3%), as well as whether the product contains heavy metals, pesticides, micro-organisms (fungi), residual solvents or PAHs (polycyclic aromatic hydrocarbons). Hübner: “Products that pass the test receive a mark of approval from us and the product gets the predicate safe. We do not publish bad results, they just do not get our seal of approval and they will not be listed on our website.” There are now five companies that have their products tested and approved.

Arge Canna mainly certifies CBD oil. This year cannabis flos, sprays and crystals have been added.

Reimbursement

Despite the CBD prohibition, you don’t hear many complaints from Austrian patients. It is standard practice for the Austrian government to reimburse medicinal cannabis, and that is something the average European patient can only dream of. However, there are downsides. Cannabis flos containing THC, the dried cannabis flowers, are not permitted in Austria, a doctor may only prescribe THC in the form of dronabinol concentrate where the THC is processed by the chemist into a tablet, oil or cream. This is just one active component. For patients who benefit from THC and CBD, this is far from ideal. It is presumed that those patients now collect their uncontrolled CBD product from the aforementioned aroma shops.

Experts see no benefits

Briefly it seemed like the law might be amended at the end of 2018 and that dried cannabis flowers with THC could be used as an alternative medication. However, following expert advice from the Austrian Health Council (Oberster Sanitätsrat) and the association of chemists and doctors (Apothekerkammer and Ärztekammer) the status quo remains. There is insufficient scientific evidence that cannabis flos works better than the dronabinol that is already available. Furthermore, with cannabis-based drugs it is possible to produce exact doses, whilst it is believed that this cannot be achieved with flos. In Austria, Sativex® has been the only other approved cannabis-based medication since 2012, not including synthetic cannabinoids like Nabilone.

Klaus Hübner

Exception

Despite the prohibition of CBD, the Austrian government makes an exception for a small group of patients. Children with a rare type of epilepsy may be administered CBD to suppress seizures and they are reimbursed. Mr Hübner said “This CBD-containing juice is only prepared by the pharmacist, is of pharmaceutical quality, and cannot be compared to the CBD that is available for sale in the aroma shops.” However, adult epilepsy patients miss the boat, as do people who suffer from Parkinson’s disease because they are not eligible for reimbursement. Patient organisation Arge Canna, which is now active in four Austrian cities, provides the answer in those cases. “Our network of patients and our knowledge of scientific studies is enormous. We help until reimbursement has been organised”, continued Mr Hübner.

Where we speak

As the global cannabis market continues to grow so does the number of conferences about this subject. Bedrocan has selected the following conferences to speak. Our message during these events will always be our focus on the company’s core values: separation of markets (medical vs recreational), global harmonisation of laws and regulations to ease patient access, and allow for easier transfer of products around the world.

 

Event Date Place
Fibromyalgia2019 March, 4 -5 Vienna
International Business Conference Cannabis March, 14 Barcelona
International Business Conference Cannabis March 31 – April 2 Berlin
Cannabis Business France April, 9 -10 Paris
MJBIZDAILY’s European Cannabis Symposium May, 6 Copenhagen

Fibromyalgia study proves effectiveness of Bedrocan’s products

Pharmaceutical-grade cannabis with THC relieves pain in fibromyalgia

A recent study shows that Bedrocan’s standardised pharmaceutical-grade cannabis with a high tetrahydrocannabinol (THC) content is effective in treating pain in fibromyalgia. However, cannabis with only cannabidiol (CBD) did not show relief at all. The study was conducted by the Dutch Leiden University Medical Centre (LUMC) in cooperation with Bedrocan International BV, world’s most experienced producer of legal medicinal cannabis. Principal Investigator, Professor Albert Dahan, head of the Anaesthesia & Pain Research Unit of the Department of Anaesthesiology at the LUMC, believes this is the first real scientific proof that at least two of Bedrocan’s products are effective for fibromyalgia.

Reimbursement

It is the first time a randomised, placebo-controlled four-way cross-over study is conducted into the therapeutic effects of inhaling Bedrocan’s medicinal cannabis products. Tjalling Erkelens, founder and CEO of Bedrocan is especially delighted for patients: “The outcome is very important for patients who suffer from fibromyalgia. Now we have the serious clinical evidence that medical doctors are asking for when prescribing our products and that health insurance companies want to have, to legitimise reimbursement.”

Now we have the serious clinical evidence that medical doctors are asking for”

Tjalling Erkelens, CEO Bedrocan

What is fibromyalgia?

Fibromyalgia is a disorder characterised by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.

A total of twenty patients participated in the study. They were treated at four distinct moments. Administration of three different cannabis products (Bedrocan®, Bediol®, Bedrolite®) and placebo (cannabis without the main active substances THC and CBD) was done by means of a vaporizer.

All subjects were exposed to externally inflicted pain by applying increasing pressure. With the Bedrocan and Bediol products, patients experienced significantly less pressure pain compared to the placebo. Furthermore, many respondents noted they experienced relief in their spontaneous pain after using Bediol.

Furthermore, the Principal Investigator, Professor Dahan, reached the following conclusion about THC: “Fibromyalgia patients experience pressure pain on muscles and tendons especially. Because only Bediol and Bedrocan show good results and the CBD product Bedrolite not at all, it means that especially THC is effective in this specific condition.”

Investigators conducted a series of measurements and tests before and after the cannabis was administered in order to systematize the variables. In one test, a weight was placed on the muscle between the thumb and forefinger. Dahan: “Healthy people can handle ten kilograms. For a fibromyalgia patient, one kilogram is already painful. But after administering Bedrocan products with THC, we saw that the same patient could suddenly bear ten kilos.”

Both Bedrocan and the Principal Investigator believe that investigation is now required to determine whether the same results on pain relief can be reproduced in a long-term study with fibromyalgia patients. “The next study takes place with patients at home. I want to investigate whether THC can be used as an opiate-saving drug. Many people use, and abuse opiates, such as oxycodone. We think that you do not have to prescribe much oxycodone if you also allow patients to use THC,” said Professor Dahan.

Bedrocan® Bediol® Bedrolite®

THC 22%

CBD <1.0%

THC 6.3%

CBD 8%

THC <1.0%

CBD 9%

Overview of used products and their THC and CBD levels

History is made: from flos to cannabis oil

The Dutch Transvaal Apotheek is a pharmacy with a history. The library contains books from 1889 and according to the website one of the clients has been coming here for more than seventy years. Under the leadership of Paul Lebbink and Arwin Ramcharan, in 2015 they made medicinal cannabis oil available in the Netherlands for the first time.

With this, the pharmacy from The Hague made headlines both in the Netherlands and abroad, much to the surprise of the Transvaal Apotheek staff. “The impact was larger than expected”, Arwin Ramcharan, chemist and QA at Transvaal Apotheek, remembers.

OMC

Since 2003 Dutch patients have access to medicinal cannabis flos. The cannabis programme is run by the Office for Medicinal Cannabis (OMC) on behalf of the Dutch government. Ramcharan about this time: “As pharmaceutical chemist we were already well acquainted with the dried product and many of the users. But once we had refined the production process and the oil was released onto the market, the demand proved to be much greater than expected.” The pharmacy currently serves patients throughout the Netherlands and sometimes even abroad. The oil, which is available in five different varieties, is used for a multitude of conditions, with pain, epilepsy, glaucoma, migraines, nausea, infections, restlessness and insomnia, spasms and decreased appetite being the most common.

Cystic fibrosis

The Dutch pharmacist made history again in 2017. The Transvaal Apotheek started to fight big pharma with their own cost-effective alternative to exorbitantly priced medication for cystic fibrosis.

Patients in the Netherlands can only get the oil on doctor’s prescription. They can obtain it at the counter or have it delivered to their home by ‘medical post’. The number of patients who come to The Hague from neighbouring countries to take home oil is gradually increasing. They need a doctor’s prescription and – of course – permission to bring the cannabis oil home. Ramcharan: “We mainly see patients who have tried all other types of medication and who have become more or less therapy resistant. They have heard of medicinal cannabis, but they also want a product with known contents and a traceable origin. And they often appreciate receiving guidance from their physician and the chemist. The price of the oil is sometimes the subject of a debate, but most patients understand that the production requires investing in equipment and knowledge and that this is a labour-intensive and strictly-controlled pharmaceutical production process.”

Magistral preparations

Cannabis oil is a commonly used form among patients who administer their medication themselves because it is easy to dose. Transvaal Apotheek is one of the last Dutch pharmacies that still make magistral preparations so it came as no surprise that Ramcharan and his colleagues were asked to produce cannabis oil. “The request for oil came from the BMC and was initially aimed at young patients”, Ramcharan says. “In approximately nine months time we, in collaboration with (then still) pharamcist-in-training Svenja Laarhuis and researcher Arno Hazekamp, created a standardised process for the preparation of oil with mainly CBD, based on the then new Bedrolite® brand. After a large number of trial runs and tests we were able to start supplying oil to our patients in 2015. We were lucky to have good active pharmaceutical ingredient.” Bedrocan products are being used for the production of the oils. Ramcharan: “The medicinal cannabis available through pharmacies in the Netherlands is standardised and extensively tested on contents and the absence of contamination. It is also produced in compliance with GMP which prevents unnecessary discussions. And… our oil is also extensively tested. Because if you supply a medicinal product while being unsure about its quality and safety, you are on the wrong track, to put it mildly. The responsibility is simply too great.”

Other pharmacies

Transvaal Apotheek is no longer the only pharmacist in the Netherlands that is allowed to produce cannabis oil. Three other chemists also received permission and have started production and deliveries in the last few years. Two of these received guidance from Ramcharan and his colleagues. “These pharmacies thought it was unnecessary to re-invent the wheel and wanted to start production of medicinal cannabis oil as quickly as possible, while also assuring top quality”, Ramcharan says, who thinks a standardised way of working is important. “We think it is important to work in a standardised way and to use the same ingredients. This way you produce the exact same product every time, which means you can make statements about the effects and possible side effects in the long run.”

In the meantime the pharmacists exchange information and thus collect clinically relevant information. Ramcharan says: “Especially in the case of medicinal cannabis, everyone is waiting for clinically relevant information. Collaborating with other dispensers can also reveal information about the application of medicinal cannabis for other conditions. We therefore have collected information about migraine patients.”

According to Ramcharan, more patients can be followed by the collaboration: “In collaboration with a specialist, our chemist is currently monitoring a group of approximately 20 epilepsy patients. We are seeing, for example, positive effects from the administration of CBD. But we can now also provide information about possible side effects. As soon as we are able to broaden and deepen the scope of this type of research, we will gain access to incredibly valuable data. Not just for patients and professional care providers, but also for researchers.”

Is medicinal cannabis on the rise in Australia?

Medicinal use of cannabis has been legal in Australia since 2016. There are currently an estimated one thousand patients who have been granted permission. That is a very small number in a population of 24 million. Indeed,  it is assumed that one hundred thousand patients still obtain their medicine from illegal sources. How is that possible? We talked about this with Professor Iain McGregor, Academic Director of the Lambert Initiative for Cannabinoid Therapeutics, an Australian research institute within the University of Sydney.

Since its establishment in 2015, McGregor and his team have been researching the effects of medicinal cannabis, among other things. This year they published the results of two surveys from both physicians and patients. This was the first time both target groups were surveyed about the medicinal use of cannabis. And it showed hidden populations.

High price

According to McGregor, the high price of medicinal cannabis is a major reason why Australian patients still depend on the black market: “Most of the people are extremely poor because they live on social welfare or pensions. People cannot afford pharmaceutical products that are on offer in the federal scheme. It would cost 60,000 Australian dollars a year to treat an epileptic child with 1,000 milligrams of CBD a day.”

Medicinal cannabis is not covered by health insurance or government pharmaceutical subsidies in Australia. Therefore, McGregor is not surprised that patients are looking for cheaper alternatives. “Our research even shows that a quarter of the patients sometimes don’t pay anything at all for their cannabis. They get it for free or grow it themselves.”

Iain McGregor

The same research shows that Australian patients do not want it to be this way. “The same as with other medications, patients want a standardised product of pharmaceutical quality that is available at the chemist. This wish does not comply with the current programme”, says McGregor.

General Practitioners

The Australian GP is not to blame. The majority of GPs think that medicinal cannabis should be available on prescription. The Lambert Initiative surveyed 640 General Practitioners (family physicians) last year and the results astounded even researcher McGregor: “We knew pain doctors and specialists are very negative about medicinal cannabis. But the majority of the GPs, the family doctors, are in fact in favour of medicinal cannabis. This was quite surprising.”

GPs also say they support the use of cannabis for conditions such as chronic pain, epilepsy (intractable epilepsy) and palliative care, but less for depression or anxiety disorders. According to McGregor, the problem with the Australian system is that GPs are not allowed to prescribe medicinal cannabis, although they would like to. This task is reserved for specialist physicians (neurologists, oncologists and palliative care physicians) only. McGregor: “In Australia it is very difficult to get access to specialised medical care, let alone to find a specialist who is interested in cannabis-based medication.”

Research inspired by the Lambert family

Despite the medicinal cannabis programme, parents in Australia are still treating their children who suffer from epilepsy with cannabis products of unknown composition. This often includes severely sick children for whom regular medication barely works or does not work at all.

This is a big concern for the Lambert Initiative because the organisation is closely involved with families with children who suffer from epilepsy. The establishment of the research institute was made possible by a large donation from the prosperous Lambert family. Their grandchild Katelyn suffers from Dravet Syndrome, a rare and severe form of epilepsy affecting young children. Her family fought for years to legalise medicinal cannabis in Australia after discovering that cannabis oil reduced their daughter’s epileptic seizures. Katelyn is currently being treated successfully with approved medicinal cannabis oil. But at one time Katelyn’s father was standing in front of a judge himself because he grew cannabis illegally to treat his daughter.

Katelyn and Barry Lambert

The Lambert Initiative was curious to know if more Australian families were breaking the law to treat their children. In the end they found 65 families who were willing to participate in a study. Most of the parents are using cannabis oil obtained through the illegal circuit. They think they are administering CBD oil to their child. CBD is an active ingredient in cannabis. However, analysis showed that a considerable number of samples also contained THC. Iain McGregor, Academic Director of the Lambert Initiative, was very surprised: “Families were surprised as well. There are a whole lot of families that think that CBD has a fantastic effect. But we found out that there was no or low doses of CBD in their oils, but quite a lot of THC.”

The study was not designed in such way to provide any definitive conclusions on how effective these cannabis extracts are for childhood epilepsy. McGregor: “However, the study does throw a spotlight on the world of families who are resorting to the use of illicit cannabis products to treat their child’s epilepsy when conventional treatments have failed.”

Therapeutic Goods Administration

Over the past two years the Australian drug agency the Therapeutic Goods Administration (TGA) has approved 1,442 applications. The number of patients who actually use cannabis is lower than the number of applications because some physicians submit multiple applications for the same patient. McGregor and his team estimate there are about one thousand patients who actually make use of the programme legally. But he thinks there could be many more: “Our opinion is that people that are suffering should have the benefit of medicinal cannabis if it is going to have a favourable effect. It is very simple: if the doctor wants to prescribe it and the patient wants it then the politicians and regulations should probably get out of the way.”

Another obstacle is the complex application procedure for the Australian medicinal cannabis programme. The physician must first submit an application to the Federal Department of Health. This application must clearly show that alternative treatments are not effective and that an extensive literary study has been carried out.

Paperwork

Until recently the same application also had to be sent to the Department of Health in the state where the patient lives. McGregor: “The paperwork was just terrible. There were also a lot of refusals because both the state health and federal departments were really looking for evidence that cannabis products were better than existing medication.”

The procedure has been adapted so physicians only have to fill out one online form and most applications are now assessed within 48 hours. Still McGregor is not satisfied and advocates for expanding the number of permitted conditions: “Patients are using cannabis for quite different conditions to the ones that you can get an approval for from the government. Most of the conditions are not acknowledged by the Therapeutic Goods Administration. For example, fifty percent of the patients are using cannabis for controlling their back pain and back pain is not on the TGA list. There is no evidence or clinical study that shows back pain is a condition that cannabis treats. But people are doing it anyway.”

Medicinal cannabis chewing gum in clinical phase

Nicotine gum is probably the most well-known medicinal application. But chewing gum containing medicinal cannabis is something new. So new that the first batch has not even been made yet. AXIM Biotechnologies developed the product and is waiting to start the first clinical trials in the Netherlands, Israel and Canada.

Earlier this month they uncorked the champagne bottles at both the American head office in New York and in the Netherlands. The company that is listed on the American stock market (AXIM U.S.: OTC) received a GMP certificate from the Dutch government to produce samples for clinical trials. This test medication may now be used worldwide as a research resource. This is a huge milestone for the company that has been trying to bring medicinal cannabis gum onto the market since 2007.

MedChew Rx

MedChew Rx, a type of gum produced by AXIM looks very promising. It contains 5 milligrams of CBD – a non-psychoactive component of cannabis – and 5 milligrams of THC – a psychoactive cannabinoid. The cannabis for this chewing gum is supplied by Bedrocan. The medication was developed to treat pain and spasms in Multiple Sclerosis (MS) patients. The Dutch VU University Medical Center in Amsterdam will carry out the clinical trials.

Motion sickness, pain, quitting smoking, dental decay and middle ear infections are all well-known or lesser-known medical conditions for which medicinal chewing gum is available. AXIM consciously chose chewing gum as a method of administration.

Lekhram Changoer

According to Lekhram Changoer, Chief Technology Officer, it is a socially accepted and user-friendly method. Much more so than smoking or inhaling cannabis. And does it work? Changoer: “Chewing has a considerable effect. Chewing activates your brain. Scientists at the Vrije Universiteit in Amsterdam have proven that the medication has a greater effect when chewed, especially for pain.”

More clinical trials

AXIM Biotechnologies will be carrying out more clinical research next year. QPS, a medication research company based in Groningen (Netherlands), will conduct a study on chewing gum with synthetic dronabinol (THC). This gum should, among other things, prevent nausea and vomiting (chemotherapy) or stimulate the appetite (anorexia, AIDS). The University of British Columbia in Canada will carry out clinical trials for treating drug-related psychoses with cannabis chewing gum. A double-blind, randomised, phase 2 study with 30 RLS patients will start in Israel next year.

Restless Leg Syndrome

AXIM Biotechnologies developed a chewing gum containing CBD to help patients suffering from Restless Leg Syndrome (RLS). RLS patients suffer from muscle spasms in their lower legs, knees and sometimes arms during the night. This leads to sleep disorders and the condition is also often accompanied by excruciating pain. The gum contains 1,000 milligrams of CBD and gabapentin, an anticonvulsant.

Just like a pill

According to Changoer, physicians have responded positively to this administration method: “It is not entirely new. They are already familiar with nicotine gum. Physicians don’t want their patients to smoke cannabis because it is unhealthy. Some physicians are also weary of inhaling. Not all patients can or want to use a vaporizer. Chewing gum is easy to take with you, just like a pill.”

The goal is to have the gum officially registered as medication. This way a physician can prescribe it and determine the dose. But clinical trials must first show that the product works.

Changoer: ”Preliminary studies paint a positive picture of the implementation of CBD and THC. Research will provide us with more insight into dosage. The approach is that the patient will calmly chew on one piece of gum for about twenty minutes. The absorption of the active chemicals will then take place via the mucous membranes in the cheek.” Changoer expects it will take at least another three years before the chewing gum will be available on the market.

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