Michael Sassano, founder, CEO and chairman of the board, Somai Pharmaceuticals, discusses the European medical cannabis sector, and its impact on pharmaceuticals, alongside the challenges that Somai aims to address.
Key insights:
- Europe has been paving the way for cannabis adoption in pharma since 2016 - however is still behind the US and Canadian product markets.
- Europe adopted GMP-pharmaceutical standards and treated cannabis like other narcotic medicines allowing for the highest standards of production and cross-border cannabis market.
- Portugal created a regulatory framework that attracted the largest EU cannabis companies and is host to 21 registered cannabis companies in operation - supporting the pharma industry.
Europe has been paving the way for cannabis adoption with a proper global and quality perspective since approximately 2016. The timing corresponds to the US and Canada’s early-stage high growth phase which took off around 2015 with legalisation spreading across states and an over-the-counter (recreational) surge. Europe adopted true GMP pharmaceutical standards and treated cannabis like any other narcotic medicine paving the way for the highest standards of production and cross-border cannabis market.
Current scope of Europe
The German patient market - the largest to date in Europe - boasts roughly 200,000 patients and helped them gain greater access to cannabis medicine by allowing doctors to treat their patients at their discretion. Today, the largest category of usage is for pain relief. Countries like Portugal - the largest producing country in Europe - created beneficial business environments to bring back the pharmaceutical industry by creating rules and a regulatory framework that attracted the largest EU cannabis companies and is now host to 21 registered cannabis companies operating.
The market extends into Europe to Denmark, as the second largest producing country, Italy as the second largest patient base, and many others like Czechia, Poland, Malta, Luxembourg, and Austria, to name a few. But also, Europe serves as an import hub for countries like Canada (the current number 1 exporter to Europe), South Africa, Lesotho, Uruguay, and Columbia. More and more countries are adopting access for their population: Spain is expected to announce regulation within the next few months, France is preparing to expand their current trials, and every other country in Europe is considering the path they want to create better access.
Europe sits in a pivotal moment where there are enough producers for the current market to service the industry for cannabis flower, but this amount must increase as access opens through the many countries. Additionally, as of 2020, Europe started seeing the first extracted products and is just getting to the 2.0 versions which still are far behind the US and Canadian products that consumers prefer.
Supporting global access
Somai sits in a unique position as one of the largest cannabis extract manufacturing facilities, and prides itself on delivering the 3.0 versions of cannabinoid herbal medicines to Europe and globally - by bringing the US know-how to the pharmaceutical industry of Europe. Somai is an EU herbal medicine pharmaceutical company with a focus to get market authorisation for medicines under the EU-pharmacopeia rules, and take those gold standards for quality to sell its products globally from their Lisbon manufacturing headquarters.
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From Portugal, Somai can reach all corners of the globe as access opens and patients can finally receive treatment for symptoms, such as pain, with a safer and more effective medicine than those currently on the market. In order to accomplish this, Somai believes that not only spending capital in market authorised finished products, as opposed to just magisterial prep APIs (1.0, 2.0), having 42 different formulations plus delivery methods will help doctors to better identify and prescribe the right products to treat patients.
As access increases for patients in Europe, the EU standards treating cannabis as a pharmaceutical GMP product will increase adoption, as well as confidence to solidify cannabis herbal medicines' place within the pharmaceutical world.
Already, big pharma has made inroads, like the $6.7 billion purchase of GW Pharma by Jazz, and a similar $6.7 billion purchase by Pfizer of Arena Pharmaceuticals, but also Teva Pharmaceuticals entering distribution and Dr. Reddy Pharmaceuticals buy Nimbus a German distributor. There are also roughly 1300 clinical trials on cannabinoids going on around the world, of which approximately 35% are in Europe which will provide some winners that big pharma will eventually buy. But cannabis also fits into the $150 billion herbal medicine market as well as the OTC markets which are commonly referred to as adult use or recreational. The cannabis already covers the main pillars of the pharmaceutical industry by catering for the traditional AIM pharma, herbal medicines, and OTC to increase adoption after being banned for so many decades. And doctors and patients of all demographics are changing their position throughout Europe.
The challenges
Cannabis markets and entrepreneurs are not without problems. The main issue is education and regulations. Education has spread quickly through the United States and Canada but is still shrouded in stigma for most of Europe. Additionally, although there are more studies now, illegality prevented wider investment in clinical trials. Politics and regulations have also been a hindrance to the industry. The US is still Federally illegal and only just recently allowed pharmaceutical-level facilities to operate and study cannabis. Canada still has the government sitting in between the sales and producers creating an unprofitable environment for producers that cannot own dispensaries directly.
Some European countries like Germany have classified cannabis as only magisterial prep and not allowed producers to get market authorisation for their products, causing high-priced compounding products on patients. Some countries like the UK have made it difficult for doctors to prescribe cannabis by limiting their discretion for their patients. And the UN has created problems by not rescheduling cannabis under the 1971 Convention greatly stifling the global market. To some extent, Europe is one of the best global models for a global market because they adopted the highest standard of production while others like USA basically operate under restaurant quality rules.
Conclusion
Regardless of difficulties, there is now a minority that doesn’t accept that people should have access to cannabis to treat various ailments from epilepsy, MS, cancer-related issues, pain, sleep, stress, anxiety and many more self- or doctor-administered efforts. The big pharmaceuticals are already watching the movements on all three pillars of distribution. And patients are happy because they are getting safer relief. There is much to cheer about for EU cannabis and more work to go as entrepreneurial companies enter to produce high quality products for the global community. And companies like Somai will be innovating the way.