Medical cannabis: Growth by leaps and bounds

pharmafile | October 18, 2019 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Canada, Canopy Growth, medical cannabis, pharma 

This article follows parts one and two of our trio of in-depth pieces focusing on the growing medical cannabis phenomenon. In June 2019, Pharmafocus visited the headquarters of cannabis company Canopy Growth in the Canadian town of Smiths Falls. Louis Goss investigates how the industry is taking off in Canada and how this might inform the evolution of medicinal cannabis legislation in the UK.

Terry Parker developed epilepsy after being hit in the head by a swing, aged four. In trying to control his seizures, he had been subjected to two lobotomies and a daily regimen of anticonvulsant drugs. However, he began self-medicating with cannabis as a teenager. For Parker, cannabis worked. Yet what he was doing was against the law.

It was therefore unsurprising that in 2000 a defiant Parker found himself in court – and not for the first time. Luckily for him, public opinion had turned.  Now, with 90% of Canadians in favour of legalising medical marijuana, the judge ruled that the federal government’s laws prohibiting cannabis were unconstitutional, as they did not allow for medicinal use. Justice Marc Rosenberg gave the government a year to find a resolution.

In 2001, Rosenburg’s ruling saw Canada become the first country in the world to adopt a formal system through which patients could access cannabis for medicinal use. The Canadian system allowed people with terminal illnesses and severe health conditions to buy cannabis through the government and grow the plant themselves. Since then, the country has seen a gradual relaxation of the laws. After allowing for a private sector medical cannabis industry in 2011, the Canadian Government fully legalised the drug for both recreational and medicinal use in July 2018. Marijuana is now sold freely in high street stores.

Last year, on 1 November 2018, medicinal cannabis was legalised in the UK. However, as of May 2019, just three patients have received prescriptions for medicinal cannabis through the NHS. So far, very few British patients have been able to legally access cannabis at all. In June of last year, 82% of those responding to a SkyData poll said they thought the drug should be legal for medicinal purposes in the UK.

Making Smiths Falls great again

Smiths Falls is a typical Ontario town, and like many small towns, it has had quite a few dark days. The town’s Deputy Mayor Wendy Alford told Pharmafocus that the closure of the Hershey’s factory in 2008 “came on top of what seemed like a cascade of bad news,” leaving the community at a loose end.

This changed with the arrival of Canopy Growth, which took over Hershey’s old facilities as their headquarters in 2014. Founded in 2013, Canopy Growth trades on the Toronto Stock Exchange under the tag WEED. The firm owns a global network of cannabis subsidiaries, which together operate more than 520,000m2 of growing facilities across the globe, from Saskatchewan to Lesotho. Canopy is now Smiths Falls’ biggest employer with around 1,300 staff. In total, fewer than 9,000 people live in Smiths Falls.

The firm has put Smiths Falls back on the map. “Snoop Dogg has visited. Martha Stewart has been here… We’ve always believed that Smiths Falls is the centre of the world, so we’re getting a real kick out of it that everybody else thinks so too,” Alford said.

Canopy says the Smiths Falls model can be exported around the world. Bruce Linton, Canopy Growth’s co-founder and now former co-CEO (Linton was, in his own words, “fired” on 3 July), explained: “Every country on the planet has some part of their country which is underemployed and underutilised. This is a silver bullet piece of work because the best place for us to show up is where there are people who want to work, empty buildings that are less costly, and a whole bunch of infrastructure that’s underused. There’s a reason we’re in central Denmark; Odense had a bunch of bankrupt greenhouses… I’ve been around a lot of the UK and a lot of towns look like Smiths Falls too.”

For Linton, the path towards legalisation is relatively clear. In short, the battle starts on the ground, as individual ‘first patients’, like Terry Parker in Canada, force the government to fight with sick people in the media, causing public opinion to turn. In England, Alfie Dingley, a six-year-old British boy with a severe form of epilepsy, acted as the country’s ‘first patient’. The public outcry pushed the Home Office into legalising medicinal cannabis. “Your first patients are sick and they’re getting a really tough ride to get access to something they could buy illegally,” Linton said. “That little shuffle will maybe last months. Then you have more patients, who are very similar to them… over time, they might say: ‘We want to produce it here!’”

Either way, Linton was confident in the trend towards liberalisation around the world: “When I started this, Canada was such an outlier. There were a couple of other countries reluctantly dealing with it and Canada was opening it up for medical. It was the only place on the planet really regulating medical… Now there are 31 countries actively running medical programmes. Germany is our second biggest market. Germany is not exactly a low barrier regulator… Soon it’s going to be a list of who’s not regulating.”

“Other countries are already doing it and they’re getting economic outcomes and they’re getting patients who aren’t upset with them. After a while it’s like: ‘What’s wrong with you guys, why are you so far behind?’ That’s a very different conversation than it was five or six years ago,” Linton concluded.

Spectrum Therapeutics

Canopy’s medical subsidiary, Spectrum Therapeutics, is now modelling itself as a pharmaceutical company. At the beginning of June, the firm stated its intentions to focus on clinical research, as it announced the completion of two Phase 1 trials. Canopy has around 15 clinical trials on the go. Spectrum also launched a worldwide medicinal cannabis pharmacovigilance programme.

Soon after, in July of this year, the UK Government called for more research into medicinal cannabis. The call came just a few months after England’s Chief Medical Officer, Dame Sally Davies, said she had “concerns about safety.” She also warned that the legalisation of medicinal cannabis had opened a ‘Pandora’s box,’ with both patients and physicians confused as to what the law change actually means. Similar concerns have left doctors reluctant to prescribe the drug.

The confusion surrounding the legal situation is understandable. While GW Pharma’s Sativex (nabiximols) is the only cannabis-based medicine to be licensed in the UK, British doctors are now also able to prescribe unlicensed ‘cannabis-based medical products’ (CBPMs). In July, the company’s Epidyolex also secured recommendation from the EMA’s CHMP.

Still, few patients have been able to legally access the drug. While getting a prescription is difficult, out-of-pocket costs are high (as much as £25,000-£35,000 a year). Equally, doctors are wary of prescribing the drug – especially with the lack of safety and efficacy data from clinical trials. This has led to a situation in which, as said by Paul Steckler, Spectrum’s COO: “Patients want access to cannabis but clinicians have no experience.”

In addressing these concerns, clinical trials seem like the way to go. Clinical data will instil confidence in healthcare professionals, thus ensuring patients are able to access medicines that will benefit them most. Meanwhile, the UK Government has said it is ready to learn from the successes seen “in other EU member states such as the Netherlands.”

The march towards widespread access to medicinal cannabis in Britain is underway. In July, a group of British MPs, including Labour’s David Lammy and Liberal Democrats’ Sir Norman Lamb, travelled to Canada on a fact-finding mission in part sponsored by cannabis firm MPX, arguing on their return that they anticipated that the substance would be made legal in Britain within five years. The stance echoes Linton’s, who notes that “the similarities between the NHS and Health Canada,” mean the UK is a natural home.

However, unlike Canada, the UK is much more likely to see medicinal cannabis in a ‘pharmaceutical’ form. As explained by Linton: “[Canada] is very unusual. Because of the legal rulings, smokeable products were the main form. In most jurisdictions they’re not going to have that start. They’re going to start with formats that are non-combustible: vape pens, gel caps, hard pills. There’s all kinds of ways you can deliver it that are very symmetrical to pharmaceutical delivery.” According to Linton, Canopy’s job is to bring cannabis “under a regulatory format and make it reliable and safe…  We’re not introducing something that doesn’t exist.”

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