Will New Cannabis Regulation in Colombia Smoke the Competition?

Cannabis Regulation Colombia - GCI Content Hub - Global Cannabis Intelligence

As the cannabis sector picks up speed across the globe, industry experts discuss the latest cannabis regulation in Colombia, at the GCI Summit. Leonardo Arregocés, Director of Medicines and Health Technologies for the Colombian Ministry of Health, and Julián Wilches, Chief Regulatory Officer at Clever Leaves, discuss what makes winning regulation and why Colombia is well-positioned to be a global leader in cannabis.

How important is cannabis regulation?

Although rarely considered a riveting topic, fit-for-purpose regulation is the bedrock of any successful industry. Wilches believes that the regulatory framework established for medical cannabis in Colombia is “very competitive.” Thoughtful, effective and efficient regulation is foundational to ensure that safe, high-quality products are available to consumers; it is of paramount importance for cannabis businesses to thrive and for patients to have their needs met. Arregocés agrees that the Ministry of Health’s efforts have been focussed on facilitating the safe and effective deployment of top-quality pharmaceuticals, without becoming “a barrier for the commerce of these products.”

Arregocés, whose department played a crucial part in developing the latest iteration of Colombian cannabis regulation, likens the role of regulation to that of a referee: “we want to be like the referee within a football match,” he says. “The best referee is the one that makes the matches work, but you don’t see him.” Regulation is what happens behind the scenes to ensure that patients are benefitting from safe and effective products, without adding unnecessary burdens to the companies developing, producing and marketing these treatments.

“Regulation has to be done hand-in-hand with industry. We have patients and people in the centre, but we also want to understand from the industry, what’s important for them, and how best we can allow them to do their work. Because the better they do their work, the more beneficial products are available to patients.” – Leonardo Arregocés

The first piece of Colombian cannabis regulation – Law 1787 – legalised the use of cannabis “exclusively for medicinal and scientific purposes,” states Arregocés. This followed an amendment to the Constitution in 2009, which allowed the medicinal use of controlled substances. Enacted in July 2016, Law 1787 facilitates the exploration of the plant’s therapeutic potential, while allowing trade and granting patients regulated access. This was followed by a decree and 5 resolutions of the law in 2017.

Most recently, the Ministry of Health has built on previous regulations to ensure that they reflect the international industry, which has undergone massive changes worldwide in recent years, as states and countries legalize medical cannabis in droves.

What makes winning cannabis regulation?

According to Wilches, the latest iteration of Colombian cannabis regulation is mature and comprehensive, paving the way for Colombia to become a global leader in cannabis. He delineates the key purposes of cannabis regulation: “we have to open new markets, guarantee traceability and quality, and provide good products for the patients.”

Traceability, quality & patient access

Firstly, good traceability is needed, as cannabis remains a controlled substance. “Cannabis is controlled by seven or eight entities in different parts of the supply chain,” explains Wilches, “so this decree integrates a lot, reduces the paperwork, but guarantees good traceability.” Making regulatory requirements, such as obtaining a license, as efficient as possible ensures that safety standards are met without compromising the development and distribution of cannabis-based products. Secondly, Colombia’s regulation addresses quality, which must be assessed for both internal and external purposes. Because “most cannabis produced in Colombia is for exporting,” it must comply with the requirements of its destination market, as well as the internal health ministry’s standard for patients in Colombia.

“We have really good talent, a really good climate and really good geography – we also have very competitive regulation right now.” – Julián Wilches

Last, but not least, is the need for adequate patient access. Cannabis in Colombia is currently available throughout the health system as part of holistic treatment programmes, based on evidence showing that “in some specific cases, [cannabis] is useful,” Arregocés explains.

Centring patients throughout the facilitation of industry development goes to the heart of effective cannabis regulation. Wilches agrees that “this new degree improves the capacity of patients to access these medicines because it increases the possibility of distributing them.” Prior to the latest decree, cannabis was only distributed by specific pharmacies, whereas now cannabis can be accessed by patients from many drugstores across the country.

Open dialogue and communication

Perhaps the binding glue to Colombia’s air-tight regulations is the open dialogue between patients, industry and regulators. This is evident from the free-flowing and conducive nature of the conversation between Arregocés, a regulator, and Wilches, an industry leader. When regulators engage in patient-focussed dialogue with industry they are able to address and resolve issues medical cannabis users and businesses are facing on the ground.

“We’re in good traction with the government,” beams Wilches. “We have a very good dialogue between the private sector experts, the stakeholders, and the government. That’s what made these new regulations possible.” Arregocés concurs, explaining that “regulation has to be done hand-in-hand with industry. We have patients and people in the centre, but we also want to understand from the industry, what’s important for them, and how best we can allow them to do their work. Because the better they do their work, the more beneficial products are available to patients.”

Where next for cannabis in Colombia?

Consequently, industry operators are focussed on obtaining European Union GMP (General Manufacturing Practise) cannabis certifications, which will allow Colombia to supply medical cannabis markets worldwide. Additionally, Colombia’s cannabis regulation has introspective ambitions. Future regulatory plans include establishing a market framework for non-psychoactive components of cannabis, such as CBD supplements. Arregocés also stresses the importance of assessing the effectiveness of enacted regulation, to evaluate “how it is working and whether we are achieving what we set out to.”

The latest iteration of Colombia’s cannabis regulation has a forward-facing outlook which recognises international frameworks, considering the individual regulation and quality requirements of each market. Further, by nature of the country’s sunny, equatorial climate and farming expertise, Colombia is “one of the biggest [cannabis] flower exporters in the world,” Wilches beams. “We have really good talent, a really good climate and really good geography.” This means Colombia’s cannabis industry doesn’t require the expensive lighting infrastructures which some other cannabis producing nations rely on. Advantageous geography, alongside a mature, organized industry and progressive regulation, promise a bright future in cannabis is on Colombia’s horizon.

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