A Decade after Cannabis Legalization in Uruguay: Perspectives of a Cannabis Entrepreneur and Patient.

Ten years have passed since Uruguay made history by becoming the first country to fully legalize cannabis. The bold decision to regulate the production, distribution, and consumption of this once-illegal substance has led to some success in reducing drug-related crime, however patients and companies have not had very positive outcomes.???

I came to Uruguay together with my wife almost 6 years ago with the objective of starting a cannabis company together and gaining access to cannabis medicine as a patient. In this article I reflect on some of the challenges I faced.?

One of the primary hurdles for companies has been navigating the complex regulatory framework and dealing with government bureaucracy. Striking a balance between meeting legal requirements, ensuring product safety, and maintaining profitability has been an ongoing challenge.

Uruguay’s cannabis industry consists of 3 sub industries: 1) medical, 2) recreational and 3) industrial. Our company, YVY Life attempted to operate within each of those industries and faced various challenges in each.?

We first obtained a license from the ministry of agriculture to produce and export non psychoactive cannabis flower (<1% THC). Our initial goal was to build a niche brand based on a network of small farms producing small batch and high quality cannabis. The law in Uruguay only allows for the sale of psychoactive cannabis in the recreational market, so CBD flower is not permitted to be sold within Uruguay. All product has to be exported in bulk with limited options to where they could export. The regulation of hemp derived products such as cosmetics, food, drinks has not been implemented leaving most companies stuck with tons of unsold hemp flower and biomass.?

We then decided to produce medical THC Flowers. The license took almost a year to receive and the export permit took almost two years to receive from the Ministry of Health, who also don’t recognize cannabis flower as a medical product so we were not allowed to sell this product locally. All product had to be exported to markets such as Israel, Germany and Australia, the biggest medical markets in the world where ironically, most popular medical product is dried THC flower. Selling medical flower on the international market is super complex, requiring various certifications, vigorous testing and irradiation, as well as international agreements recognizing each other's manufacturing standards, which Uruguay lacks. The cost of infrastructure to comply with all the requirements plus operational costs are extremely high in Uruguay.?

Our final attempt was to create a wellness centre in our property in Garzon. We decided to change licenses from medical to recreational, and create a club which would be able to sell to tourists. Unfortunately the Uruguayan government still has not legalized the sale of recreational cannabis to tourists, only Uruguayan citizens and residents. The recreational market is also confined to dried flowers.?

Despite legalization, access to cannabis for medical purposes has remained a challenge for most patients. There are only a handful of products available in the pharmacies, all exactly the same (5-10%) CBD and are replicas of Epidiolex, the only FDA approved CBD pharmaceutical medicine. There are no THC based products and there are no other categories of products, only pharmaceutical grade. Recently the government finally regulated formulas magistrales (compounded formulas) as another option but this was more than 2 years after the government passed a law to improve access to medical cannabis. Being more familiar with timing here in Uruguay, I don’t expect the formulas magistrales to be implemented within the next year. We are also still waiting for the government to implement the remainder of the items listed in the medical law that was passed over 2 years ago.?

For patients relying on medical cannabis, affordability remains an issue. The cost of cannabis products and doctor consultations, combined with no insurance coverage, can place a significant financial burden on patients, making it challenging for most to access the treatment they need.?

As a patient who was recommended to have at least 100mg of CBD / day for my autoimmune condition, I would need 5 or 6 of the pharmaceutical CBD tinctures per month which would be way too expensive. So, together with most other patients in Uruguay, I am left with making our medicine at home or buying from the black market, a side effect from poor cannabis policies and regulations.?

While I recognize that Uruguay is not the only country in the world suffering from “growing pains” and regulating a new industry following decades of prohibition, you would think that after 10 years of legalization, the government would be more proactive and open minded, listening to the needs of doctors, patients and industry and continuing to adapt and evolve regulations in this dynamic and ever changing industry. From an industry perspective, we have already seen many companies shut down while legalization is advancing fast in Uruguay’s neighbors, Argentina and Brazil who could very quickly overtake Uruguay’s first mover advantage especially as they can produce more economically and at scale.?

From a patient perspective, we really have no choice but to continue to make our own home made medicine or buy off the gray market.??

Many may argue that Uruguay has already lost a huge opportunity to be an international leader in the cannabis industry which is still very much in its infancy. I personally believe that there is still hope, however as Uruguay moves forward, it is crucial to address the above mentioned challenges and most importantly a complete reform of the original law that was passed 10 years ago which is in my opinion, obsolete.?