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France set to launch landmark medical cannabis trial

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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’s managing director for France, Hélène Moore

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. The company is partnering with French-born pharmaceuticals company, Laboratoires Ethypharm.

READ MORE  Most Americans view cannabis as less harmful than alcohol

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.”

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; 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.

Photo: Aurora Europe

“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 are no big roadblocks, the understanding is that they will generalise the offering of medical cannabis to a larger scope of patients.”

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Although participating companies are not offered any guarantee as to whether they will remain 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”.

Photo: Aurora Europe

“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.

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.

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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.”

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Study: States with full legal access show fewer registered medical cannabis patients

“If true, this could have implications for public health and policy,” say researchers.

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Study shows U.S states where cannabis is legal for recreational purposes have experienced a decrease in patients registering for medical cannabis programmes.

The study on different US states, published in the International Drug Journal, revealed that numbers of registered and active medical cannabis consumers increased while it was not legal for recreational use.

Researchers in Arizona took data from the medical cannabis registry from two dozen states between 2013 and 2020.  These are mandatory registries that record the number of medical cannabis patients. They analysed the data to see if there were any changes around the times that recreational legalisation was introduced.

There are currently 19 states in the US that have legalised recreational cannabis including New Jersey, Vermont, Arizona and New York. However, more states have medical cannabis programs although some are still not operational. Some states such as Colorado have had recreational access since 2012, the year before the study was started.

Medical cannabis patients

The results confirmed that medical cannabis cardholders increased during times when recreational use was not legal. It then subsequently decreased when it became legal.

It also revealed an increase of 380 patients per 100,000 people per year when just medical cannabis was legal. This corresponded to a decrease of 100 patients per 100,000 after recreational cannabis was allowed. The researchers noted that active registered active male patients decreased faster than women. In states where only medical cannabis was legal, the older age groups (35 or older), increased faster.

They also found that in three states with medical-only use, the results showed significant increases in enrollment from 2016 to 2020 across white, African-American and Hispanic patients.

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The researchers wrote: “There is speculation that enrollment in U.S. state medical cannabis programs differs depending on whether adult recreational cannabis use is legal. If true, this could have implications for public health and policy.”

“Findings suggest that recreational cannabis legalisation is associated with decreasing enrollment in medical cannabis programs, particularly for males.”

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Latin American cannabis clinic Zerenia arrives in UK – promising patients more ‘affordable’ access

The clinic has recently joined Project Twenty21 with the promise of making medical cannabis more accessible.

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Zerenia clinic: doctor holding medical cannabis
The clinic will initially prescribe for chronic pain and mental health conditions.

Latin American medical cannabis clinic, Zerenia, has launched in the UK, with a bid to improve patient access as it joins Project Twenty21.

Zerenia Clinics, which launched in the UK in recent weeks, has joined a growing number of clinics on Project Twenty21 (T21), as it aims to make medical cannabis more affordable for patients. 

The clinic also offers competitive costs, with consultation fees at £80. 

The clinic’s three doctors will initially prescribe for chronic pain and mental health, with the majority of patients so far seeking treatment for indications such as anxiety, ADHD, PTSD and insomnia.

Zerenia, which already has 14 clinics across Latin America, has treated around 14,000 patients with medical cannabis, and according to Zerenia’s UK clinical operations director, Freeda Solliman, mental health is the predominant indication prescribed for. 

Many of these patients now get their prescriptions funded via private insurers, a model which the clinic now hopes to replicate in the UK. 

“In Latin America we’ve built a body of evidence there to support private insurers to fund medical cannabis treatment,” Solliman told Cannabis Health.

“We’ve seen about 14,000 patients who have been treated with medical cannabis and a large number of those actually get their prescriptions funded by private insurers. That’s the kind of model that you want to bring here.”

Zerenia has partnered with T21, which subsidises the cost of prescriptions, to help build the growing body of evidence for the safety and efficacy of medical cannabis. 

“Our goals are quite well aligned, we want to build the evidence and we want to make medical cannabis more affordable for patients,” continued Solliman.

“We want to work to encourage the NHS first and foremost, but also private insurers to fund at least part of the costs involved in being treated with medical cannabis.”

She added: “We did our research to understand some of the bottlenecks in the industry and how hard it is for some patients to go through the process, so we wanted to support patients through that and try to offer them more of a seamless experience.”

Zerenia is now taking on new patients who wish to join T21, or those who may want to try a different clinic. 

Initial consultations for new patients are priced at £80, for those transfering from a different clinic, £40. Find more information here

READ MORE  Most Americans view cannabis as less harmful than alcohol
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CiiTECH to launch medicinal cannabis range Provacan THC in Israel

Israeli patients will have access to the first Provacan THC oil in January 2022, followed by Brazilian and British patients.

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CiiTECH and Cannassure have announced a major deal to develop and market Provacan THC products for medical cannabis use in Israel.

It marks CiiTECH’s long-awaited move into medicinal cannabis.

In addition to offering established consumer CBD brands, CiiTECH’s flagship brand Provacan is considered one of the most respected in the UK.

Clifton Flack, CEO and founder of CiiTECH, intends to bring Provacan’s reputation for quality and consistency to the troubled Israeli medical cannabis market.

“CiiTECH is unique in its approach to the CBD wellness and medicinal cannabis markets. We built an international reputation as a market-leading CBD company by producing pharmacy trusted CBD oil tinctures and selling them as food supplements before making our move into THC. Our intention is to bring these International standards to the Israeli market,” says Flack.

“As a UK company with strong roots in Israel, CiiTECH is well-positioned to make its THC debut and there is no better place to do so than in Israel, the epicentre of global cannabis research.”

Cannassure is known for producing high-grade medical cannabis in Israel with an advanced indoor-aeroponic growing system and state-of-the-art extraction.”

CiiTECH collaboration

The collaboration with CiiTECH, a leading company in the field of cannabis research and marketing and owner of the leading brand Provacan, is an important step in the field of cannabis oils for us, an area that enjoys significant growth among patients who do not want to consume inflorescence cannabis. We are confident that this collaboration will bring value for us, for CiiTECH and for cannabis patients in Israel, and we believe that it will help us conquer a more significant share of the cannabis oil market in Israel,” said Ran Amir, Cannassure CEO.

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As part of its business strategy, CiiTECH seeks and collaborates with best-of-breed cannabis providers up and down the supply chain in multiple geographies. With this agreement, CiiTECH continues to demonstrate its effective business strategy, commitment to quality assurance, and speed of entry into the market that the industry has grown to expect from CiiTECH.

With the help of Cannassure, CiiTECH will help reform, standardise, educate and establish quality, consistency, and reliability in the Israeli medical cannabis market. In order to achieve this goal, CiiTECH is developing a hybrid solution in which a superior quality product is offered to patients and a unique professional enrichment program is offered to help doctors and pharmacists support patients on a deeper level.

CiiTECH education

Around 80 per cent of Israel’s 100,000 licensed medical cannabis users smoke, rather than using tinctures. The biggest complaint in those groups is the lack of quality and consistency. It is CiiTECH’s mission to show these users how much better tinctures are than smoking. Provacan ambassadors and users will benefit from comprehensive education courses provided by CiiTECH as part of this re-education so they will feel more confident and better supported while using CiiTECH products.

“As cannabis market experts and our involvement in the cannabis ecosystem in Israel, we understand the nature of the demand and the gaps in the Israeli market. Our new THC tincture will revolutionise the lives of many patients who are currently suffering from inconsistencies in the medical cannabis supply chain, and it will be made to the same strict UK and European guidelines as our current products,” concluded Flack.

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Israeli patients will have access to the first Provacan THC oil in January 2022, followed soon by Brazilian and British patients.

www.ciitech.co.il
www.provacan.co.uk

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