Key figures in the industry have welcomed a verdict by Europe’s highest court that CBD is not a narcotic and has no harmful effects on human health.
The European Court of Justice (CJEU) has confirmed that CBD is not a narcotic drug, in a significant milestone for the industry.
In a verdict delivered on Thursday 20 November, bringing the six-year KanaVape case to a close, the CJEU ruled that CBD is not a drug within the UN’s Single Convention.
It went on to say that the cannabinoid does not appear to have any ‘psychotropic’ or ‘harmful effect on human health’.
The decision marks a turning point for the European market, which has been shrouded in uncertainty following a preliminary conclusion issued by the European Commission (EC) earlier this year suggesting CBD should be classified as a narcotic drug rather than a Novel Food.
It comes following a six-year dispute between French authorities and the founders of the first CBD vaporizer, KanaVape, over whether restricting the sale of CBD products legally produced in other EU countries breaches single market rules.
In 2014 French authorities took legal action against co-founders Antonin Cohen and Sébastien Béguerie, for importing hemp flowers from the Czech Republic into the country, where the extraction of flowers from the cannabis plant is not permitted.
The CJEU ruling has been welcomed by key players in the industry, who now expect the EC to proceed with Novel Food applications.
In their analysis of the ruling, London-based cannabis consultancy firm, The Canna Consultants concluded that the Judgement ‘increases the pressure’ on the EC to ‘remove the present ban on the advancement of the Novel Food assessments’ of CBD products.
Co-founder Stephen Oliver commented: “We have always indicated that we believe that a literal and strict interpretation of the definitions within the 1961 Convention was against the spirit of that agreement, and undermined by the progress which has been made in cannabinoid understanding and technology in the almost 60 years since.
“We are pleased that Europe is now free of this restrictive and unjustified limitation on the advancement of the cannabinoid industry. In conjunction with our clients, we will now advance their Novel Food applications which have been on hold for a number of months.”
Stephen Murphy of cannabis market intelligence firm Prohibition Partners, congratulated those involved in the success of the case and described it as a ‘massive boost’ for European consumers.
He said: “The ruling is a blow to conservative parties who sought to discredit the benefits of a naturally derived compound and a massive boost to patients and consumers in Europe who are using CBD products daily to improve their quality of life. The ruling has significant implications for future classification by the UN on the subject later this year and gives much needed confidence to a sector looking to provide greater access.”
Meanwhile Peter Reynolds, of CannaPro, the trade association for the UK’s cannabis, CBD and hemp businesses, said the news brought into question the guidance issued by the Food Standards Agency (FSA), which requires British companies to apply for novel food status by March 31, 2021.
“The fact that the highest court in Europe has determined on the basis of the evidence that CBD poses no risk to human health, just highlights how the FSA is not operating on the basis of truth, but on the basis of the big business lobbyists, that have been pressing it to make the regulation of CBD so onerous that small companies can’t deal in it anymore,” he said.
“I don’t think the ruling in itself will have any direct impact on the FSA guidance in the UK, but it shines a light of truth on what is really going on.”
France set to launch landmark medical cannabis trial
A first-of-its-kind medical cannabis pilot is expected to launch by the end of March 2021. Cannabis Health speaks to one of the companies recently selected as an official supplier.
This week, the French Agency for the Safety of Medicines and Health Products (ANSM) revealed the companies that will supply cannabis products for a landmark medical cannabis trial.
Four main suppliers from Australia, Canada, Israel and the UK will partner with French pharmaceutical distributers to provide a total of nine cannabis-based medical products for up to 3,000 patients. With no funding from patients or the French government, the participating companies will have to cover the production and distribution costs themselves.
Taking place over a two-year period, patients with one of five medical conditions, including chronic pain, epilepsy, oncology and spasticity will be eligible for the pilot.
Physicians, nurses and pharmacists will be selected for the programme and will undergo special training for issuing and dispensing medical cannabis prescriptions to patients.
The concept of the trial was first suggested in 2018 when the ANSM brought together a committee to consider the feasibility of making medicinal cannabis available to French patients.
Over the past two years, the French government has been accused of dragging its feet in putting the pilot in motion, however after finally opening applications in October 2020, the long-awaited trial is set to commence by the end of March 2021.
Aurora Europe, a subsidiary of Canadian company, Aurora Cannabis Inc., has been selected to provide the entire supply of cannabis flower for the trial, which includes three types: high-THC, balanced THC to CBD and high-CBD flowers.
Aurora’s Managing Director for France, Hélène Moore, told Cannabis Health: “This is what we wanted, we decided to offer the product for which we are already a leader in Europe. We went for what we do well, and we won all the [flower] lots; we were very proud of that.
“It really shows how we have mastered the art of growing pharmaceutical-grade medical cannabis.”
Cannabis flower is a difficult product to develop when it comes to medicinal cannabis. Ensuring that the plant contains the same concentration of cannabinoids from batch to batch can be challenging and relies on precisely controlling the growing environment.
“All of our cannabis is grown indoors where every single variable that you can think of for growing a plant is controlled to the [letter] and it takes a long time to get it right.
“You need to have it validated, you have to demonstrate to the authorities that you can do the same batch after batch and we have done that.”
At the end of the pilot, the French government will decide on permitting the use and sale of medical cannabis products, however Moore stresses that the pilot’s purpose is not to test the efficacy of cannabis-based medicine.
“The intention is really to test the distribution system, to test prescribers; the whole machine. The pilot is not a clinical trial, and this has to be very clear.” Moore added.
“What’s going to be assessed is the feasibility of putting together a larger scale medical cannabis programme for patients in France.
“If this pilot is successful, and there’s not like big roadblocks, the understanding is that they will generalise the offering of medical cannabis to a larger scope of patients.”
Although participating companies are not offered any guarantee as to whether they will continue as official suppliers after the trial, Moore says Aurora’s intention is to continue working with French stakeholders and be “part of the equation in the long run”.
“Our partner is well established, they want to get into this market, and we will do this together,” Moore said. “Now we have a partner that knows how to do things in France, our goal is to extend the relationship from a post-pilot perspective.”
In addition to the four main suppliers, French authorities also selected a number of substitute suppliers to cover any gaps.
Another Canadian company, Tilray, will supply two sublingual oils as a main supplier and two types of flower as a substitute.
Meanwhile, Israel’s largest manufacturer of medical cannabis, Panaxia, will supply four products, two as a main supplier and two as a substitute. In partnership with Neuraxpharm, the company is providing two cannabis-based oils in various doses of THC/CBD and two types of sublingual tablets.
Deemed a “huge success” for the company, Panaxia’s CEO, Dr Dadi Segal believes the trial is the first step towards France becoming one of the world’s “most advanced medical cannabis markets”.
Dr. Malgorzata (Gosia) Meunier, VP Innovation at Panaxia, added: “Being personally linked to France, I’m especially proud that Panaxia will participate in this prestigious experiment and provide a response to the enormous need of patients in France […] this is an amazing regulatory achievement for us.”
The Australian company Little Green Pharma will be a main supplier for two CBD-dominant sublingual oils and a substitute for a balanced CBD-THC oil.
Other substitute suppliers include Australia-based, Athlea, and UK-based independent cannabis company, EMMAC Life Sciences Group, which will supply two types of orally administered cannabis medicines together with Paris-based distributor, Boiron.
CEO of EMMAC, Antonio Costanzo, hopes the company’s involvement with the trial will “advance the industry’s understanding of the benefits of medical cannabis”.
Due to the country’s strict regulations surrounding cannabis, none of the chosen suppliers are French companies, however partnering with a French distributor was mandatory for all participants. Moore believes that involving the existing pharmaceutical ecosystem could be a key factor in the success of France’s future cannabis sector.
“This is really unique. There are no other countries in Europe that have made that distinction. I think this is something that could provide a key success factor for France in the long run.”
‘Godfather of Canadian cannabis’ to advise European producer
Industry heavyweight, dubbed the ‘Godfather of Canadian cannabis’, Chuck Rifici has joined the board of one of Europe’s newest medical cannabis players.
Founding partner of UK-based Integro Medical Clinics, Eurox Pharma, plans to begin commercial production of cannabis based products in early 2021.
Canadian entrepreneur Rifici, who currently serves as executive chairman of Feather Company and co-founder of Canopy Growth Corporation and the Auxly Cannabis Group, will bring several years of expertise to the advisory role, as the firm sets out to become a major player in the medical cannabis market over the next five years.
Founded in 2019, it will produce a range of cannabis-based pharmaceuticals and products in Bensheim, Germany.
Its 10,000 sq meters manufacturing plant was certified as a fully GMP facility in October 2020, with the potential to manufacture 50 tonnes of product at full capacity.
Rifici, who previously served on the board of directors at Aurora Cannabis Inc, The Supreme Cannabis Company, Origin House and Meta Growth Corp, joins Amy Peckham, CEO of Etain Health, USA, and Michael Reckeweg, Chairman of Dr. Reckeweg & Co, on the advisory board.
The organisation is backed by cutting-edge research and together with its partners has a global distribution network.
In addition to its’ German operations Eurox is a founding partner in the cannabis medicines based Integro Medical Clinics Limited in the UK with leading British pharmaceutical company IPS.
Eurox was founded by ex-Deutsche Bank senior executive, Neil Smith, Bernhard Babel, ex- Partner at McKinsey & Co and David Reckeweg-Lecompte, CEO of Dr Reckeweg & Co, a 75 year old pharmaceutical company producing plant-based medicines in Germany.
“We are absolutely delighted to welcome Chuck, an industry legend to our organisation,” said co-CEO Smith.
“The experience and advice he will be able to offer us as a new player in the European cannabis pharmaceutical market will be invaluable. It is our goal to see Eurox as a major independent player in this market within the next three to five years.
“The market has massive growth potential which we intend to embrace and exploit.”
“I experienced peace I’d never felt before”: The African encounter which inspired a CBD empire
Suffering with a severe fever while in Kenya as a teenager, Paul Shrive was given a cannabis-based brew by a local. He not only recovered from the illness, but experienced mental clarity for the first time in his life, he tells Cannabis Health.
Paul Shrive, founder of Leafline CBD, had a challenging childhood. He would frequently get in trouble with his schoolteachers and was bullied by his classmates for being “different than everybody else”.
“It was a very, very difficult and traumatic time for me at school,” Paul recalls, speaking to Cannabis Health.
“Teachers used to look at me as a problem child, because when somebody was screaming at me, I just couldn’t take it; it was like I was being attacked.”
Although he has never been formally diagnosed, Paul has been told unofficially that he is on the autism spectrum, which has meant he experiences his senses differently to most people.
“Everything just goes a zillion miles per hour,” he explains.
“Something wasn’t right, but I spent my life thinking it was just me, that it was just who I was. But there was actually something out there that could make it better, I just didn’t realise it at the time.”
In 1986, when Paul was fourteen years old, his father was offered an opportunity to come out of retirement and travel to Africa to carry out work on a food manufacturing plant that he had helped set up a decade previously.
Paul was given the choice of either going to Africa or staying in school in the UK. Given the difficulties he was experiencing with his teachers and fellow pupils, Paul jumped at the opportunity and boarded the plane to Nairobi with his Dad.
Over the next nine months, Paul came to discover cannabis, which he says was part of everyday life in Kenya despite its illegality.
Paul remembered walking around the outskirts of Nairobi and seeing small children picking a mysterious plant.
“I started noticing these little kids in fields picking plants and filling up these clear bags,” Paul says.
“I wondered what they were doing.
“I got back into Nairobi centre and around the markets I saw the same boys, around eight or ten years old. My Dad told me they were shoeshine boys.
“I noticed that they had dozens of these bags around the waist – I know now that they were bags of cannabis; pure hemp growing everywhere in the fields.
“Businessmen would have their shoes polished and buy these bags and take them to their wives, because they use them for cooking, they use it as herbal remedies – it’s part of their everyday life.”
Not long after arriving in Africa, Paul became ill, catching a serious bug causing an intense fever that continued to rise despite being seen by a number of doctors. He was hooked up to a drip in his hotel room while doctors attempted to cure him through various treatments.
A British chef working at the hotel heard about Paul’s situation and approached his Dad. He believed, as the boy was suffering from an African illness, it would require African medicine to treat.
“I was delirious,” Paul says. “I was all over the place. I really wasn’t well.”
“They had a chat with one of the major tribes in the area and asked if they could help me.
“I don’t know exactly what happened, but I know that I was visited by a ‘witch doctor’ or ‘shaman’ of some kind.
“The next thing that I remember is my father waking me up. He had a clay vial in his hand containing a black and gloopy kind of liquid. It had had alcohol and pure hemp in there.
“I was out for the count completely for more than a day, but while I was knocked out, my temperature started to drop, and drop, and it allowed me to heal.”
Many people, including his father, believed his recovery was purely coincidental, but Paul says it didn’t matter whether it was or wasn’t. What struck him when he regained consciousness was how clear his head was.
“When I came around, for the first time ever, I experienced peace that I’d never felt before,” he says.
“I felt normal. There was nothing that agitated me, I could sit there without fidgeting, I could sit there without having to worry, or feel as though I had to put my hands over my ears.
“When you’ve had a whole life of what you feel is torture, it was a revelation to find that kind of peace and tranquillity.”
For the remainder of his time in Nairobi, Paul was provided with a less potent form of the concoction without the addition of alcohol. He consumed a small amount twice a day. As it contained THC, Paul remembers feeling a rush from the medicine, but it was manageable.
“I could think and I could hold a full conversation. I could look at people in the eye and totally hear what they were saying,” he adds.
On his return to the UK, Paul says he had a “short, sharp shock” when he discovered that the plant was illegal. As a young teenager, he was unaware that people were using cannabis for recreational purposes. With no access to the plant, Paul says he suffered for a number of years.
When CBD began to see an increase in popularity several years ago, Paul was quick to launch his own business, Leafline CBD with his wife Sonia, who has her own journey with the supplement. Having suffered with severe PMS for many years, her doctor prescribed her a low dose of anti-depressants.
Paul suggested to his wife that she try CBD to manage the symptoms instead, so she started taking an oil every morning and night and over time, her symptoms subsided.
“The last thing I wanted, was a pharmaceutical drug to treat it,” says Sonia.
“PMS isn’t a mental problem, it is a hormonal problem.”
Like the rest of the UK’s CBD sector, Leafline are preparing for the Food Standard Agency’s Novel Food Applications which close on the 31st March.
But as a firm believer in the power of whole-plant extract since his experiences in Nairobi, Paul is fearful that full-spectrum products will no longer be permitted following the deadline.
“Isolate-based [CBD] does have a purpose, it does have a mode of action, but the true goal is whole-plant and I’m really scared because I think it’s going to be taken away from us,” he says.
“Unfortunately, by doing that, it that will create a black market. I’ve had somebody that has been on whole-plant for a long time and then when we gave them an isolate tincture, it didn’t work.”
Paul adds: “You can’t mess with nature. Leave nature alone and nature will do its job.”
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