Medical Cannabis and CBD report: International models

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Medical Cannabis and CBD: international models

Published 1 October 2020

Several countries have loosened restrictions on medical cannabis, offering the UK lessons in terms of its approach to research, manufacturing and access.

At the end of 2019, Thai Prime Minister Prayut Chan-o-cha launched the government’s medical cannabis education website at an event alongside its official mascot Dr Ganja – in white lab coat and a green marijuana leaf head.

Thailand already has a string of government medical cannabis clinics and is one of many countries making medical cannabis products available. It is also creating significant production and manufacturing bases. But the rate of change and the level of ambition varies from place to place.

The Canadian, Israeli and Maltese governments face similar critiques
to the UK that access to medical cannabis is limited by cost and bureaucracy which helps the black market flourish.

All three nations have individual approaches, and are at different stages in their relationships with medical cannabis, but experts say all three offer the UK lessons in terms of its approach to research, manufacturing and access.

Canada

In 2001 Canada became the first G7 country to create an exemption in criminal law to allow approved patients to possess and grow their own cannabis following the lengthy legal battle of Terry Parker, a man with epilepsy who was arrested for cannabis possession, cultivation and trafficking.

In 2013, the Canadian Federal Government implemented regulations which created a commercially licensed industry for the production and distribution of medicinal cannabis. Some 37,800 people are authorised to possess marijuana under the programme, up from fewer than 100 in 2001.

Patients with the authorisation of their doctor can access cannabis by either registering with a licensed producer, registering with Health Canada to produce a limited amount for their own medical purposes, or designate someone else to produce it for them.

However, Canada’s black market is still flourishing as medical grade cannabis is expensive to produce and there are a limited number of suppliers.

Karine Cousineau is the Director, Government Relations and Sustainability at The Green Organic Dutchman which grows, manufactures and sells a range of cannabis products including prescription items. She says this is a problem the Canadian Government is trying to address.

Given public demand, Cousineau says that while it could be tempting for policy makers in Canada and across the world to demand RCTs before providing access to patients, it would be a mistake. “There is enough data, anecdotal evidence and advocacy out there to do a reasonable assessment of the minimal risk associated with cannabis use as medicine. The development of the industry and research needs to be done in tandem in order to be successful. Waiting for clinical trials would delay everything by about 10 years, while patients resort to potentially more harmful substances and drugs – such as opioids,” she says.

She feels the UK, with its reputable institutions, could take the lead in an industry that is still in its infancy. “Considering some of the public health challenges like opioid usage, the health costs of an ageing population, and the fact that general stigma associated with cannabis is diminishing, it would be less of a political risk for a government to invest in cannabis research.”

Malta

Medical cannabis has a growing role in the Maltese economy – it has already created more than 900 jobs and it is expected to increase trade in exported goods by 30%.

In April 2018 Malta introduced medical cannabis legislation covering production, manufacture, distribution and, significantly, research – one of the freedoms UK doctors are hoping for.

Marion Zammit is the head of medical cannabis activity at Malta Enterprise, Malta’s economic development corporation, and the first point of entry for anyone wanting to invest in the medical cannabis industry.

Zammit says local producers can export, as well as sell, locally to licensed
pharma distributors who then sell onto pharmacists. Any doctor can prescribe medical cannabis; however patients need to apply for a permit from the country’s Superintendent of Health.

The country aims to become an influential producer and exporter of CBMPs. More than 50 companies including businesses based in the UK, Israel, Canada and Australia have applied to work in Malta. To date, Zammit says 27 have been approved with more to come.

She says that greater competition will help drive CBMP prices down. “When evaluating projects for approval, three main criteria are used, namely, due diligence on the shareholders of the company, financial viability of the project, as well as sectorial/relevant experience of the shareholders.”

As the science is in a fledging state, the legislation does not put any restrictions on the amounts or combinations of THC and CBD used in medical cannabis. “Nonetheless, products manufactured in Malta needs to be produced adhering to the highest pharmaceutical standards. Drugs produced in Malta are renowned for their quality all around the world, and the same standards will be applied to medical cannabis products.”

Some Maltese doctors are reluctant to prescribe, given the lack of RCTs. “When it comes to the medical profession, cannabis represents a paradigm shift,” Zammit concedes. “Patients come to doctors saying would you prescribe. Not all doctors are taking it up, as for many it represents a challenge in their prescribing habits, especially since there is a lack of medical information. But some are seeing patient benefits from the drug, and the more happy-ending stories and empirical evidence they see, the more likely they will prescribe.”

Israel

Israel has been at the centre of cannabis research for decades, with the Ministry of Health playing an active role in finance and support. THC, the psychoactive molecule in marijuana that causes a high, was first isolated in 1964 by Professor Raphael Mechoulam, a scientist at Hebrew University.

Marijuana for medical use has been permitted since the early 1990s
for cancer patients and those with pain-related illnesses such as Parkinson’s, MS and Crohn’s disease, but recreational use remains illegal.

In April 2017 it was made possible for medical cannabis companies to export their products, with analysts estimating that the measure could generate Israel some $267m per year.

According to iCan, an Israeli company which invests in the local cannabis market, more than 50 US companies have relocated or invested in cannabis research in Israel to evade onerous research regulations in the UK and US.

There are eight government-sanctioned cannabis growing operations in
Israel, which distribute to patients who have a licence from the Ministry of Health and a prescription from an authorised doctor.

Dr Inbar Maymon-Pomeranchik is the founder of BioDiligence Partners, which advises investors and biotech companies on medical cannabis. While some 50-60,000 Israelis use prescribed medical cannabis, Maymon-Pomeranchik says the regulatory system is still too bureaucratic, which means people turn to the black market.

“Until a year ago patients could choose the farm that supplied their products. Now the farm must sell to a GMP [good manufacturing practice] registered pharmaceutical company, then it goes to a pharmacy where the patient can buy their supply on prescription.

“There is a lot of bureaucracy around the process and patients are complaining because they knew their strain and they knew the farms they got it from. The intention, which was to ensure labs safety, was very good, but the bureaucracy is very tough and complying with GMP adds to the expense,” she says.

Around 100 Israeli physicians can prescribe medical cannabis but Maymon-Pomeranchik says doctors are required to present extensive evidence that other treatments have failed.

That said, she feels more doctors are willing to prescribe cannabis simply because of the empirical evidence that it seems to be effective. To help doctors understand how medical cannabis can be used she says there has been a big growth in physician education programmes, but there will always be those who want to see hard evidence in the form of RCTs.

In terms of lessons for the UK, she feels that more emphasis must be placed on physician and patient education programmes, as well as ways of reducing the bureaucracy and cost in terms of access, particularly around import licences.

 

Click here to download ‘Medical Cannabis and CBD: Challenges and opportunities’ in full.

Authors

Jonathan Deverill

Jonathan Deverill

London - Walbrook

+44 (0)20 7894 6045

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