Updates

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UMCG studies cannabis oil for liver cancer patients with no further treatment options

The University Medical Centre Groningen (UMCG) is to study the effect of cannabis oil on liver cancer patients who have exhausted all other treatment options. The aim of the study is to see whether cannabis oil acts as an anti-cancer agent that will shrink the liver tumours.

This article is based on the press release sent by the UMCG.

The study was started after two separate reports that patients with advanced liver cancer had seen  their tumours shrink after using cannabis oil. Now, two and five years  after their diagnoses, the tumours have completely dissapeared and the patients are cured. Although laboratory research shows that cannabis can curb the growth of liver cancer cells, a possible anti-cancer effect of cannabis oil  in patients cannot be explained as no scientific research has been carried out.

CBD-Öl or medizinisches Cannabisöl
Cannabisöl, wie es von der Transvaal-Apotheke hergestellt wird

Cannabis oil

The cannabis oil being used is produced by the Transvaal Apotheek, a specialist pharmacy with the certificates needed to produce drugs for research purposes. The oil is produced according to a fixed recipe with precise amounts of THC and CBD, two of the important substances contained in cannabis.

The pharmacy only uses medicinal cannabis produced by Bedrocan. The Ministry of Health, Welfare and Sport has commissioned Bedrocan to standardize and grow the plant pharmaceutically in order to guarantee a consistent composition of the cannabis oil.

Research design

The first step in this study is to determine the correct dose for each patient. Patients will be given the maximum dose of cannabis oil that can be given without causing side-effects. Blood tests will be carried out and images made of the livers of those taking part after three, six and nine months to see whether the liver tumours are responding. The blood will be tested for the presence of tumour markers and to check the liver function of the participants.

Patients with liver cancer who have exhausted all treatment options

This study is being carried out with the help of patients with advanced liver cancer, for whom best supportive care is the only remaining option. As cannabis oil is broken down by the liver, all participants must have a good liver function. Patients with severe liver cirrhosis (liver damage caused by the formation of scar tissue) will not be considered for the study unless the cirrhosis is not affecting their liver function. Patients willing to join the study can be referred to the UMCG by their specialist. A total of 20 patients can take part. The study will last approximately three years.

Study: Medicinal cannabis can ease seizures in childhood epilepsy

The outcome of a retrospective study suggests a combination of CBD and THC-based products are effective in reducing seizure frequency in a range of epileptic conditions.

The study Ending the pain of children with severe epilepsy? An audit of the impact of medical cannabis on 10 patients shows that cannabis-based medicinal products (CBMPs) can offer patients significant relief from intractable epilepsy. According to the researchers, all ten patients used combined CBD and THC-based products (Bedrolite and Bedica), and the result was ‘statistically significant’. Of the ten patients enrolled in the study, 97% experienced a reduction in monthly seizure frequency after treatment with CBMPs.

The paper came out just before the British newspapers headlined about the struggle of English epileptic patients to get cannabis oil from the Netherlands after Brexit.

Despite the positive outcome of this study, authors Rayyan Zafar, Anne Katrin Schlag and professor David Nutt do not ignore the high costs and difficulties of accessing the treatments in the UK. “We highlight the inefficacy of the healthcare system in supporting these patients who bare great personal and financial burdens. We encourage specialist physicians and relevant bodies to permit easier access to these medications by those patients to whom efficacy has been shown.”

Maltese MEP Alex Agius Saliba launches Medicinal Cannabis Alliance within European Parliament

Europe should treat medicinal cannabis in the same way as opiates. That is MEP Alex Agius Saliba’s opinion, who, together with three other parliament members, founded the European partnership Medicinal Cannabis Alliance. The alliance will soon meet for the first time and, together with 35 affiliated members of the European parliament, will determine the European course in the field of medical cannabis. The Maltese MEP is already taking a position.

The fact that members work together is not unique. However, it is the first time that a partnership focuses exclusively on medicinal cannabis. Agius Saliba on this: “We keep our distance from recreational use. We want to stand up for patients’ rights and argue for European legislation that is the same in every Member State.” The 35 MEPs, mainly socialists and democrats from countries such as Portugal, Germany and Slovenia, responded to an email from Agius Saliba himself and his three supporters Robert Biedroń (Poland), Brando Benifei (Italy) and Maria Arena (Belgium). Agius Saliba is satisfied with the response: “It is a good number and a good start. This is a strong signal that there is a willingness to discuss medicinal cannabis.”

European legislation

According to the Maltese MEP, the lack of European legislation is a thorn in the side that makes trade between European member states hardly possible. He cites his home country Malta as an example. Medical cannabis has been allowed there since 2018, but patients were left without their medicine last year. “Purely because distribution in Europe is not well organised. Patients are the victims of this. They are not only without but also pay a high price for their medication. Good access and an affordable price for medicinal cannabis is a basic right for every European patient.”

Lancering van het Medicinal Cannabis Alliance binnen Europees parlement

Alex Agius Saliba

Usually, the Maltese MEP Alex Agius Saliba deals with digital affairs and employment. He sits on the Internal Market and Consumer Protection Committee and handles petitions. At 33, this lawyer by profession is relatively young but enthusiastic.

He became involved in the topic of medicinal cannabis through a 25-year-old Maltese woman who spent 400 euros a month on medicinal cannabis. “This condition prevents her from getting out of bed, and she has a difficult life.” He wants to push for lower prices and better availability.

Agius Saliba calls the lack of uniform rules the biggest obstacle: “I’m not pointing the finger at the industry but at ourselves. It is important to go for the highest quality, but the European bureaucracy creates high prices and makes access to patients impossible. I, therefore, advocate treating medicinal cannabis in the same way as opiates.”

European Medicines Agency

The trade-in commodities such as morphine and other opiates are regulated at the European level. To gain a foothold in Europe, drug developers must adhere to the strict safety and quality standards set by the European Medicines Agency. And that also applies to the pharmaceutical raw materials (APIs) with which these medicines are made. “I don’t see the difference on medicinal cannabis. If there is a medical reason why stricter requirements apply to cannabis, please let me know. But I don’t think there are any.”

The Medicinal Cannabis Alliance will soon meet to work on the positions further.

Why doesn’t Bedrocan export cannabis oils to the UK?

Bedrocan would like to give patients abroad better access to medical cannabis. However, it is not always easy to develop activities outside the Netherlands or export cannabis oils to the UK. Our Business Development team is exploring international opportunities but experiences all sorts of regulatory obstacles. We asked Business Development Manager Varun Arora why we are not active in the United Kingdom yet and how he looks at the current situation, in which, due to the Brexit, UK patients could no longer access medicinal cannabis oils from the Netherlands.

Wasn’t it frustrating to see that UK patients, including very sick epilepsy patients, could no longer obtain their cannabis oil like Bedrolite?

“The situation that emerged in the UK post-Brexit was unfortunate, but just last month we heard that the joint efforts of the Dutch and UK governments, supported by Bedrocan and the Dutch Transvaal Pharmacy, have paid off. Supplies of medicinal cannabis oils will continue at least until a permanent solution is in place.“

Why doesn’t Bedrocan export cannabis oils to the UK?

Why can’t Bedrocan export these cannabis oils to the UK?

“While Bedrocan’s name came up in some media reports, it is important to understand that Bedrocan actually has a limited role in the supply chain under the current regulatory framework in The Netherlands. Manufacturing of cannabis extracts and oils is not allowed here. It is only permitted in a research or a pharmacy setting. In the Netherlands, besides Transvaal Pharmacy in The Hague, there are a couple of other pharmacies that manufacture oils. However, they are only allowed to do this on a named patient basis. That means that pharmacies can only produce these oils for a patient that carries a prescription. While patients from countries like Ireland and Belgium, besides the UK, have been able to access cannabis oil products from The Netherlands, they have to travel to collect these products in person.“

So, Bedrocan is not allowed to produce cannabis oils, and for UK patients to obtain their medicine, they have to travel to the Netherlands?

“Yes, before 31st December 2020, patients from the UK could come to the Netherlands and get their prescriptions filled in. As the UK is no longer part of the European Union, prescriptions issued in the UK are no longer recognised in any EU country. The immediate issue of access has been solved for now, and a permanent solution is also being put in place whereby UK patients can access the oils in their own country.”

The aim is that oils like Bedrolite will become available in the UK. What should the UK government do to make this possible?

“While Brexit led to the present situation, I must also add that the UK has been slow in rolling out its cannabis program. Although the UK legalised access to cannabis in late 2018, it is only prescribed as a last-line treatment when all other treatment options have failed. Moreover, wholesalers are not allowed bulk imports and can only order on a named patient basis. This means wholesalers cannot keep inventory, and patients always face the risk of not getting their medicines in time. Last year, authorities in the UK allowed import of products with advance prescriptions. While this does ensure that patients never run out of supplies, it is again not a permanent solution. “

Why doesn’t Bedrocan export cannabis oils to the UK?

The allowance for bulk imports is important. What else needs to change to be able to start a business in the UK?

“The simple answer is that a lot has to happen on the regulatory front in the UK first before a commercial case can be built. Bedrocan has been in discussions with a potential partner, but without clear guidelines on how these products will be put in the NHS system, a robust business case cannot be built. Considering that the events post-Brexit have created a sense of urgency among British policymakers, hopefully, we would have a framework in place in due course that would enable us to build a robust supply chain for high-quality products with our potential partner for the UK market.“

What else makes it difficult to start a company outside the Netherlands?

“The fact is that there has been too much hype created when it comes to the size of the global medicinal cannabis market. Reality is that outside of The Netherlands, Germany and Italy, no market in Europe or for that matter anywhere with the exception of the United States and Canada, is big enough to justify the investments required to start a production facility. Moreover, in the markets that matter like Germany and Italy, Bedrocan already exports substantial quantities. As for the US, it is a no go because federally it is still illegal to produce cannabis. Finally, although a big market, Canada has a significant supply glut and a very different model from what is practised here in Europe. While Canada is a longer-term possibility, in the short-to-medium-term, we are mainly focusing on the core markets.”

What would make the UK or any other market attractive for Bedrocan to invest in?

“For Bedrocan to consider investing in any country outside the Netherlands, there should be a large enough domestic market. Besides the countries mentioned before, there aren’t any medicinal cannabis market that justifies the investments in setting up domestic supply chains. Perhaps the UK in the long term but as I explained, a lot has to happen on the regulatory front there before we can think about building a commercial case.”

Comprehensive clinical handbook on medical cannabis

It is often said that doctors have too little knowledge about medicinal cannabis. Two prominent American doctors, a clinical psychiatrist and an addiction specialist, agreed with this. For that reason, they decided to write a comprehensive book, with all their knowledge about medicinal cannabis, specially bundled for their colleagues: Medical Marijuana – A Clinical Handbook. The book came out in September last year, and Bedrocan spoke with one of the authors.

Dr Samoon Ahmad, professor of Psychiatry of New York University Grossman School of Medicine and a psychiatrist at Bellevue Hospital, the oldest American hospital in the heart of New York, initiated the writing. That this book had to be published came as no surprise to Dr Ahmad. He sees it as his responsibility to inform and educate others: “In Latin, the word doctor does not mean ‘teaching’ for nothing. Our role as doctors is not just about asking the right questions or making the right diagnosis. It is also about providing objective information so that individual patients can choose their own treatment.”

As far as Dr Ahmad is concerned, medicinal cannabis can no longer be ignored as a treatment. But he did not always share that opinion. He too, as he puts it himself, was biased: “During my training as a psychiatrist, cannabis was mainly regarded as a drug of abuse. In addition, in my work as a psychiatrist, I encountered a large group of patients with serious mental problems. Seventy to eighty per cent of those patients suffer from some sort of comorbid substance use. Among them, cannabis was at the top of the list.”

Private practice

In his private practice as a psychiatrist, however, he saw a completely different group of patients. Primarily well-to-do professionals with a depression or anxiety disorder, they also used cannabis, but without the addiction problems that he knew so well from his patients from the hospital in New York.

Comprehensive clinical handbook on medical cannabis

Dr Ahmad: “Their use of cannabis was comparable to drinking a good glass of wine during the weekend. I saw two different worlds, and I did not understand why cannabis had a negative effect on one population and not the other. And that caught me by surprise.”

Naive

“I was a naive doctor,” he admits promptly, but a curious one who went in search of literature on the subject. “Nobody taught me about the endocannabinoid system. Like any other doctor, I had to investigate myself. I was ignorant in that regard.”

In his search, Ahmad soon discovered that unbiased information and independent scientific research could not be found in one place or in one book. And so the idea for his own book was born.

Misinformation

Dr Ahmad worked on the book for two years together with Dr Kevin Hill, an addiction physician and Director of the addiction psychiatry department at Beth Israel Deaconess Medical Center in Boston. Finding the right information was not always easy. “You can hardly imagine how much misinformation is out there. It is worrisome to think that hundreds of thousands of doctors see the same thing when they have to look for good information about medicinal cannabis and don’t know enough to tell fact from fiction.”

In addition to the book, there is also a website called Cannabis Textbook that is updated weekly.

About the book

Medical Marijuana – A Clinical Handbook provides an objective view of the pharmacology of cannabis. The authors wrote the book, as they put it themselves, completely free of any bias, politics or preconceived beliefs. The reader will gain insights into the pharmacodynamics and pharmacokinetics of cannabinoids THC and CBD, including the molecular action of the cannabis-based drugs dronabinol, nabilone and Epidiolex (cannabidiol). The authors provide extensive data, including dosages, routes of administration and side effects.

Unique are the twelve chapters organised by organ system – from endocrinology to dermatology – which provide an up-to-date overview of the conditions that cannabis can help treat. Note that the clinical handbook was written by American doctors, which gives it an American touch. For example, the chapter on US cannabis regulations may be less interesting to non-US readers.

Medical Marijuana – A Clinical Handbook

Temporary solution found for UK epilepsy patients

Brexit had meant that some ´life saving´ cannabis oils, which are solely produced and dispensed by the Dutch Transvaal Pharmacy, were no longer able to be legally handed over on the basis of a UK prescription. This unfortunate outcome of Brexit, which made headlines in early January because many patients in the UK were left out in the cold, is being discussed by the Dutch and English governments. Now at least there seems to be a temporary solution for UK based epilepsy patients.

Medicinal cannabis oil
The pharmacist prepares medicinal cannabis oil at the Transvaal Pharmacy, the Netherlands

Six month reprieve

It was revealed on Thursday that the Dutch health ministry had granted a six month reprieve which allows the Dutch pharmacy to still prescribe the oils to UK residents on a receipt from a UK based physician. According to the Dutch ministry of Health, Welfare and sport, this provides sufficient time to arrange a more structural solution. The Transvaal Pharmacy confirmed that they were given permission to continue to supply prescriptions to UK residents until the 1st of July.

According to the UK press, the cannabis oils Bedica® and Bedrolite®, ´have revolutionized the treatment of drug resistant epilepsy and has led to children who formerly suffered hundreds of seizures daily to go long periods of time seizure free’.

Read also:

Netherlands to supply medical cannabis until july despite Brexit ban

Mother fears son could die as Brexit stops medical cannabis supply

See also:

Availability
Bedrocan currently produces medicinal cannabis for patients (under the care of a physician), pharmaceutical companies and researchers from around the world. Availability of Bedrocan products per country is listed here

“Mother fears son could die as Brexit stops medical cannabis supply”

Hannah Deacon, mother of nine-year-old epilepsy patient Alfie Dingley, sounded the alarm in the British press on 6 January. She says Alfie’s life is at risk after being told that Brexit stops medicinal cannabis supply for English patients.

Alfie suffers from a severe form of epilepsy, with 150 seizures a day being no exception. The condition is considered “life threatening” and Alfie does not respond to available regular medication. A few years ago it appeared that cannabis oil, according to pharmaceutical quality requirements and on the basis of standardized medicinal cannabis produced by the Transvaal Pharmacy in The Hague, was the solution.

Brexit threatens Alfie
Alfie Dingley

Permission

After petitioning, in which Deacon received support from more than 40 families with children who have the same condition, British doctors were given permission in 2017 to prescribe the Dutch oil and the children had access to their “life-saving” medicine. Initially by travelling to the Netherlands and picking up the medicines themselves, later with the help of a courier service.

No alternative

There was great shock when the parents received a letter from the British Ministry of Health on December 17, in which it became clear that – in line with Brexit – they will have to look for an alternative medicine as of January 1, 2021. But according to Deacon, there is currently no alternative and her son’s life – and that of the other children – is in danger. “I am facing the fact that my son might go into refractory epiletic seizures again which can kill people”, she told the British press. “If Alfie is forced to take another product, his life is in danger.”

Empty-handed

Hannah Deacon’s alarm bell has also been heard in the Netherlands. The AD, one of the largest daily newspapers, asked pharmacist Paul Lebbink of the Transvaal Pharmacy for an initial response. Lebbink and colleagues are not allowed to honor doctors’ prescriptions from the United Kingdom due to Brexit and are currently left empty-handed. “We have developed a relationship with these patients and now have to abandon them.”
Lebbink indicates that the Transvaal Pharmacy will do everything possible to make sure that English patients can obtain their medicine in the future. At the same time, the Dutch Ministry of Health, Welfare and Sport has announced that the Dutch government wants to prevent as many problems as possible as a result of Brexit, “certainly for vulnerable people” and also if it concerns residents of the United Kingdom. “The Netherlands has indicated which steps the United Kingdom can take to solve the problem in practical terms and is in discussion with the British government about this. For this group it is important that a solution is found as soon as possible”, the AD quotes.

Update January 12

On December 9, 2020, Sage Journals published Ending the pain of children with severe epilepsy? An audit of the impact of medical cannabis in 10 patients, in which RR Zafar, AK Schlag and DJ Nutt report a case of series of 10 individuals using CBMP’s in the UK to treat their conditions. This retrospective study suggests that a combination of CBD and THC based products are effective in reducing seizure frequency in a range of epileptic conditions.
See link below.

On january 6, the Dutch Member of Parliament Carla Dik-Faber (ChristenUnie) has sent questions to the Minister for Medical Care on the consequences of Brexit for the supply of Dutch medicines to the United Kingdom. These questions explicitly refer to the situation of the more than 40 British children who are dependent on cannabis oil from the Netherlands. She also questions the solution provided by the UK Department of Health, namely alternatives to cannabis-based medicines that are accessible to British patients, but which are not a solution for Alfie Dingley and the other children. Almost at the same time, the Dutch ministry answered press questions, in which it was again indicated that in close consultation with the English government, a solution is being sought for the supply of products based on medicinal cannabis in both the short and long term.

On Saturday, January 8, The Times also posts an interview with Hannah Deacon. She outlines the seriousness of the condition Alfie suffers from and elaborates on the proposal by the English authorities (DHSC) to use similar alternatives to Dutch cannabis oil available in England, with different cannabinoid profiles. According to Deacon, this is ‘evidence of the DHSC’s “gross misunderstanding of botanical products.”

“Each product is made with a different plant, with different cannabinoid profiles. So it’s not like swapping a generic paracetamol for another one. You can’t just switch and hope for the best.”

Farewell to 2020… And then suddenly everything was a bit different

This year the world has become a little different, both in general and for cannabis as a medicine in particular. I don’t need to say more about the first, as we know the Corona (Covid-19) implications all too well. But for cannabis as a medicine, there has been a small landslide in 2020. A majority in our world is now convinced that cannabis really has medicinal qualities. Or at least the way is open to investigating it further thanks to a positive decision by the UN Commission on Narcotic Drugs (CND) on the last December 2nd.

I have to disappoint anyone who thinks that cannabis has become freely accessible now. According to the UN, cannabis still remains a ‘dangerous’ substance with rather worse than good properties for healthy people. But it is clear that those good properties do exist for people with certain, sometimes really nasty conditions. It offers mankind a route to a whole new class of medicines with natural cannabinoids as active ingredient(s).

Farewell to 2020… And then suddenly everything was a bit different
Tjalling Erkelens

This means that an important barrier in research into the efficacy of cannabis has been removed and, in particular, in the training of doctors, pharmacists and other medical care providers.

For 2021, I hope that we can continue on the right path: On the level of cannabis research, improving accessibility to cannabis medicine for patients in more countries and with regulatory harmonisation. But especially also with education. The next topic on the cannabis agenda should be structural education on cannabis as a medicine for our new generation of doctors and pharmacists.

In particular, concerning the cannabis receptor system (endocannabinoid system) in our human body and the clinical results (and successes) that have been achieved so far. The time is now right as we have finally formally stated that cannabis has medical value.

Despite everything, I wish you all happy holidays and a beautiful 2021.

Tjalling Erkelens

CEO/Founder

Genetic research: Production of THC and CBD really unique for cannabis plant

Scientists are increasingly learning more about the genetic composition of the cannabis plant. All genes have now been mapped so that researchers can study them in-depth.

Dutch plant expert Robin van Velzen has discovered that the genes responsible for making THC, CBD and CBC originated in the cannabis plant. They do not occur, as has been suggested, in the genetically related hop plant. “The question of whether plants that are closely related to the cannabis plant can also make cannabinoids, such as THC and CBD, is virtually ruled out,” said the researcher from Wageningen University, who also works as a scientist for Bedrocan.

Cannabinoid oxidocyclase gene family

Van Velzen, together with fellow researcher Eric Schranz, has analysed available gene sequences from cannabis plants from the Genbank, a worldwide gene database. This genetic research focused on the very last step of biosynthesis. That is the moment when enzymes are controlled to produce cannabinoids, the active substances in the cannabis plant.

Cannabis initially produces CBG (cannabigerol) and then converts it into either THC, CBD or CBC. Van Velzen: “We know which enzymes are responsible for this conversion and which genes are involved. But we didn’t know when these genes originated.” In the research, this gene family is called the cannabinoid oxidocyclase gene family.

Robin Van Velzen

In addition, Van Velzen makes a recommendation for the classification of this gene group: “Many genes within this family are still relatively unknown and did not yet have unambiguous names. I compared all gene sequences that are known so far, and then made an unambiguous classification. That improves communication between scientists.”

The results of the research have now been made public in a so-called preprint with the title Origin and evolution of the cannabinoid oxidocyclase gene family. Fellow researchers can now comment on the findings before the result is published in a scientific journal.

cannabinoid oxidocyclase gene family

Comprehensive phylogenetic classification of all currently known sequences, including three main clades and seven subclades (top right corner) that is intended to aid unequivocal referencing and identification of cannabinoid oxidocyclase genes.

Ireland announces permanent delivery service for medicinal cannabis

Patients in Ireland who are prescribed medical cannabis will no longer need to travel to the Netherlands to collect medication, according to Health Minister Stephen Donnelly. A new permanent delivery service – providing medicinal cannabis for Irish patients – will be established, after a temporary delivery service was created in April due to the travel difficulties created by the Covid-19 pandemic.

Delivery of medicinal cannabis to Irish patients to be made permanent

“Many patients and their families have shared stories with both me and officials in my Department about how this initiative has made a huge improvement to their lives”, Donnelly says.

Medicinal Cannabis for Irish patients

“They spoke about the stress of having to travel regularly and the associated health risks with that, as well as their concerns that they would run out of their medication”, says Donnelly. “I am so pleased that these problems will now be a thing of the past for them. There will no longer be a need for them to travel abroad in order to collect their prescribed cannabis products. Instead, they can focus on their health and wellbeing. The welfare of patients and their families comes first and I am happy to reassure them that they will no longer have to personally source their prescriptions.”

See also:

Availability
Bedrocan currently produces medicinal cannabis for patients (under the care of a physician), pharmaceutical companies and researchers from around the world. Availability per country is listed  here

Commission on Narcotic Drugs transfers cannabis to schedule 1

According to some, Wednesday, December 2 will go down in the history books as a historic day. At least, for those involved in medicinal cannabis. Why? Because the United Nations, more specifically the Commission on Narcotic Drugs (CND), has decided to transfer cannabis from ‘Schedule 4’ to ‘Schedule 1’ of the Single Convention. Bedrocan’s Director of Government Affairs Ole Heil responds to question what this change means for Bedrocan. Is this indeed a historical moment?

Commission on Narcotic Drugs transfers cannabis to schedule 1 transfers cannabis to schedule 1
Ole Heil

What is Schedule 4 of the Single Convention about?

‘In 1961 the countries affiliated to the UN signed a treaty in which they make agreements on to deal with drugs. This is popularly called the Single Treaty. However, not all agreements apply to all drugs. There are four categories of drugs, and each category has its own rules. The substances on Schedule 4 have the strictest regime. They are considered to be dangerous and with no positive aspects. Countries are, therefore, prohibited from doing anything with these substances. In fact, it is an unfortunate numbering. Schedule 4 is the toughest category, but Schedule 1 is the second toughest category. The lightest criteria apply to Schedules 2 and 3.’

Has the Commission on Narcotic Drugs now removed cannabis from this strict list 4?

‘That’s right. The World Health Organization already recommended in 2018 to remove cannabis from that toughest list (Schedule 4). This is because the WHO says that there are indeed positive sides to cannabis. The CND voted on this recommendation, and the majority was in favour.’

Can cannabis now be traded freely?

‘No, definitely not. Cannabis is still on Schedule 1 of the convention, the second toughest category. So very strict rules still apply, and cannabis products cannot be traded freely. However, cannabis is no longer seen as “completely bad and absolutely prohibited.” The substances on Schedule 1 are still prohibited substances, but they are recognized as having medicinal value. Research and product development is therefore allowed if a country so wishes.’

So what changes for Bedrocan?

‘Not to spoil the fun, but nothing really changes. It is primarily a symbolic statement. All kinds of legislative changes are needed to have a real impact. Starting with the treaty itself, as it still states that countries must set up an agency which buys the entire harvest if they want to do something with cannabis. If we really want something to change, that article will also have to change.

The symbolism will definitely have much positive influence in the longer term. The Netherlands, for example, is now conducting research into the system surrounding medicinal cannabis and how we want to proceed with it. The outcome of that process will probably look different now with this decision than it would without this decision. For countries that do not yet make medicinal cannabis available to patients, this may be a boost to do something with it.

In short, this decision has no effect on day-to-day business. In the very long term, it can indeed have a positive impact on laws and regulations in the Netherlands and other countries. But as long as they have not yet been changed, nothing will happen in practice.’

If you want to know more, read the MJBizDaily article about this topic. Or read the articles Bedrocan has published about this matter: Will the UN point of view on cannabis be modified or not? and ‘WHO recommendations are likely to change international law’.

Bedrocan supports unique research into pain that is difficult to treat

The Danish Center for Clinical Research will conduct research into the treatment of chronic pain patients who have been prescribed the products Bedrocan® and Bediol®. Bedrocan supports the research financially, together with Nordic Cannabis Research, a research arm of CannGros – distributor of Bedrocan products in Denmark. The researchers will analyse retrospective data from 415 Danish patients treated at the Danish pain clinic Clinic Horsted.

Bedrocan support research into pain

Research into pain: real-patient data

According to Dr. Mikael Kowal, research coordinator at Bedrocan, this is a unique retrospective study: “It is not often that researchers have access to very solid real-patient data on difficult-to-treat chronic pain patients which are using Bedrocan products.”

The aim of the study is to assess the efficacy and tolerability of medicinal cannabis in patients with chronic pain who do not respond adequately to conventional medications.

Among other things, it is examined whether the current conventional pain medication, like opioids, and associated side-effects were reduced after the start of adjunctive medicinal cannabis.

Knowledge about the efficacy and tolerability of cannabinoids, the active substances in cannabis, for medicinal treatment is limited so far. The researchers hope to identify potential indicators of evidence that cannabis can be used as an adjunctive therapy with the aim of reducing pain significantly and, as a result, improving the patients’ quality of life.

The analysis of the retrospective data will focus on patients who were prescribed the medicinal cannabis products Bediol (THC 6.3% | CBD 8%) and Bedrocan (THC 22% | CBD <1.0%) during their outpatient treatment. This involves patients with refractory neuropathic pain, spasticity due to multiple sclerosis or spinal cord injury. Refractory pain means pain that does not respond adequately to conventional therapy.

The research results are expected in mid-2021.

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