Medicinal cannabis: Why more clinical trials and better access is needed

Medicinal cannabis

Michael Sassano, CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area.

The use of medicinal cannabis across much of the world is still in its infancy. Despite claims of a whole host of benefits, the clinical studies reality is that there are currently only a few proven indications.

However, the potential use of cannabis in a pharmaceutical setting is vast. It is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estimated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 20271.

But for this market to become a reality, we need much more research into cannabis products and potential indications. Only with more evidence-backed indications will the medicinal market boom.

Many companies are currently in a quandary however, about where to focus their research.

Some are looking towards the US and Canada, analysing if people are buying cannabis over the counter (OTC) and using it in an attempt it to alleviate specific ailments. The hope is that this can help signpost where clinical studies should be focused. But the data shows that people are using cannabis for almost every reason that can be imagined.

This tremendous amount of informal and self-administered data cannot be ignored, as it does have the potential to help pharmaceutical decisions at early stages when scoping studies. But more robust studies are needed across the board to help with the discovery and development of cannabis-based pharmaceuticals.

Big pharma is helping to shape the focus

The good news is that clinical trials are on the increase and market education is upping pace.

There are more than 1300 clinical trials on cannabis underway and companies focused on the cultivation and manufacturing of cannabis are also educating doctors and patients about its potential pharmaceutical use.

Large pharmaceutical companies are cautiously picking their spots as well. The GW Pharmaceuticals purchase by Jazz for $6.7 billion highlighted that epilepsy, multiple sclerosis and pain were areas that big pharma felt the market size and positive results were best suited to cannabis. Meanwhile, the Pfizer purchase of Arena Pharmaceuticals, highlights cannabinoid-based bowel disease treatments as a promising area. There are also many more encouraging therapeutics that pharmaceutical companies are pushing forward on, from cancer-related treatments for appetite and sleep disorders to stress, anxiety and PTSD. 

Chronic pain meanwhile, is currently one of the main reasons people turn to cannabis2. The fact that cannabis can be smoked or ingested safely daily, is non-addictive and is virtually impossible to overdose on makes cannabis the safer alternative to most drugs currently on the market for chronic pain. This ticks the box for many pharmaceutical companies looking for substantial revenue lines from mitigating an indication, especially one as prevalent as chronic pain. There are many studies underway on how to ween people off opioid addictions by using cannabis3. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues. 

Further work must also be done to identify the best delivery methods for cannabis-based medicine. But there is lots of data out there that is helping pharmaceutical companies scope out clinical trials – market intelligence firm BDSA for example, provides real-time data on consumer sales and preference in the US and in Canada, people can supply information about their usage via the StrainPrint app. This data is proving useful in testing hypotheses before starting any clinical trials.

These takeovers are helping focus the market and scope of research, and the consumer data is offering valuable insight, while the ongoing clinical trials offer hope that new indications will be discovered soon.

Better infrastructure needed across Europe

More clinical trials and further research alone will not increase the chances of more cannabis-based medicines entering the European market, however. Legislation, infrastructure, and access to cannabis varies drastically across the continent.

For example, there are only approximately 35 cannabis facilities in Europe, of which less than half are good manufacturing practice (GMP) approved – the minimum standard that a medicines manufacturer must meet in their production processes. As Europe develops, it will need more infrastructure to handle the continent’s cannabis demand – with it expected to become the second largest cannabis market within the next five years. 

If we take a look at the splintered landscape across Europe, it becomes clear the difficulties faced in completing the journey from drug discovery, to crop growth and drug production, to patient access. Growing the cannabis and manufacturing the products, for example, often must be conducted in completely different countries due to the varying levels of legislation in each European country.

Germany only has three licenses, and the current facilities are a small fraction of total sales. The Netherlands, meanwhile, is home to Bedrocan which has two decades of growing experience for the pharmaceutical markets. But the largest infrastructure in Europe for growing and manufacturing cannabis is Portugal. Portugal is home to Tilray and 19 other licensed pharmaceutical cannabis facilities. So far, for the first six months of 2022, Portugal has exported 3,177Kg of cannabis flower and is expected to easily beat last year’s exports of 4,907kg. Portugal will remain as the leader for cannabis production for the foreseeable future, but we are witnessing improving infrastructure in countries like Denmark – although production is very costly in this country. Greece, on the other hand, has the potential to match Portugal as a friendly low-cost producer, but regulation delays have hampered any roll-out for five years. Meanwhile, Spain has the makings of a potentially strong supplier once regulations become clearer.

As to clinical trials, Europe is home to 271 clinical trials4, with the majority being undertaken in Germany, Netherlands and the UK. As more companies push to develop drugs, the European framework for EU-GMP standards will provide access to proper clinical trial materials and increase Europe’s strength for EU-made cannabis. 

Having the proper manufacturing capabilities and properly registered APIs through EU-GMP standards is a cornerstone for not only researching the products but also making them. There’s a possibility that Europe will be the leader in the next few years for cannabis APIs, if it is not already.

Patient access must be improved

Patient access is also a barrier that needs to be overcome in many European countries.

Germany is the largest pharmaceutical cannabis economy now with approximately 200,000 patients estimated for 2022. Early referendums in 2017 which allowed doctors the freedom to prescribe cannabis was the main driver to growth. In opposition to that, countries like the UK require a patient to try three different therapies before a doctor can prescribe cannabis. Ireland, meanwhile, has limited prescription to serious ailments like multiple sclerosis, epilepsy and stage III cancer. France too is only undertaking a small pilot programme. 

But there are more countries going the German way, like Switzerland who last month changed the rules so that doctors no longer need to seek federal approval before prescribing cannabis. 

Notably, EU and UN law has accepted cannabis medically, but many regions are pushing forward with Over the Counter (OTC) adult use cannabis which are prohibited by EU and UN law currently. Germany, Netherlands, Malta, Luxembourg and Switzerland are all looking towards building a regulatory framework. With the right rules, regulations and frameworks in place, there is a place for pharmaceutical, medical herbal and OTC all to co-exist.

While the current pharmaceutical cannabis landscape is currently cloudy, its outlook looks positive. Pharmaceutical companies are watching the increasing demand and shifting appetite by increasing clinical trials. If obstacles are overcome, the European market is a perfect fit for medicinal cannabis and creative pharmaceutical applications.

DDW Volume 24 – Issue 1, Winter 2022/2023




Mike SassanoAbout the author:

Michael Sassano was an early investor in the United States cannabis industry and now heads SOMAÍ Pharmaceuticals, a next-generation biotech company centred on the cultivation, manufacturing, and distribution of GMP-certified cannabinoid-containing pharmaceutical products throughout the European Union. SOMAÍ opened Europe’s largest cannabis manufacturing facility earlier this year in Lisbon, Portugal.

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