More than seven years have passed since the first regulation on medical cannabis was issued in Colombia (Decree 2467 of 2015); unfortunately, the current industry development in Colombia is weak. Until 2022, 2,462 licences for cannabis cultivation and the handling of its seeds had been granted by the Ministry of Justice and Law, and 680 licences to manufacture derivates of cannabis had been granted by the Ministry of Health and Social Protection and the National Institute of Surveillance of Medicines and Foods (Invima).

The increase in the number of licences granted may be linked to the “green gold” boom in 2018 and 2019. During this time, investors expected to make quick and significant profits in the short-term, ignoring the intricacies of the pharmaceutical sector.

Notwithstanding, regarding cultivation, according to official statistics up to March 2023 a total of 34,934 hectares of psychoactive cannabis was authorised, with only 20.45 hectares being cultivated; while from the 67,384 hectares of non-psychoactive cannabis, 73.2 hectares had been cultivated. On calculation, less than 1% of the authorised land is currently in use. In other words, potentially 15% or less of cultivation companies are working.

Regarding the manufacture of cannabis derivatives, between 2017 and 2022 the extraction of 471.4 tonnes of psychoactive cannabis had been authorised for research (27.8 tonnes), national use (20.5 tonnes) and exportation (423 tonnes), but only 87.9 tonnes had been processed into derivates, of which 3.7 tonnes were for research, 5.5 for national use, and 78.7 for exportation. Ultimately, just 1 tonne was released – ie, the amount authorised to be exported, used as raw material in the manufacture of the final product, or given to a third party – again, less than 1% of the authorised amount to be processed. This phenomenon may be associated with inadequate company planning and market changes. Additionally, 106 kg of non-psychoactive derivates have been exported.

3.8 tonnes of dried flower have been exported; when the new Decree 811 of 2021 came into force, companies thought that exports of dried flower as a final product or raw material could provide a way out of their problems. Nevertheless, the quality requirements for this product, such as the Good Manufacturing Practices of the European Union and the Good Agricultural and Collection Practices, curbed such expectations, and not many companies meet these standards.

Furthermore, as reported by the Colombian Cannabis Industry Association (Asocolcanna), in 2023 at least 400 companies closed their operations, including Khiron – one of the largest vertically integrated companies – which closed its cultivation facility in Piedras (Tolima).

Nevertheless, the most crucial element of the regulation – the patient – has suffered from the failure of the industry. In the local market, it is only possible to find magistral formulas and one standard medicine made in Colombia for Dravet and Lenox-Gastaut syndromes under medical prescription. Although the Institute for Health Technology Assessment conducted a study of the efficacy of cannabinoids in the treatment of different pathologies last December, the Invima has not approved new medicines or expanded the pathologies of use for existing ones.

Among the multiple bureaucratic obstacles, one significant issue is the efficacy and safety criteria of the cannabis plant, necessary elements for a preparation (with a specific formulation) under the Medicinal Plant Schedule. In contrast with other medicinal plants, the cannabis plant has not undergone sufficient clinical studies due to its having illegal status in Colombia for many years; valid studies started after the recent regulations. In consequence, robust evidence of efficacy and safety is still being accumulated.

It is also worth noting that the beverages and foods industry (as relates to cannabinoids) has not really started yet in Colombia; two years since Decree 811 of 2021 ordered the regulation of the percentage of cannabidiol (CBD) in these kinds of products, the Ministry of Health and Social Protection has still not complied with the order. Currently, manufacturers can only obtain such a product and export it to countries with a framework that allows beverages and foods with cannabinoids, especially CBD.

Overall, the Colombian cannabis industry is in intensive care, and the national government could support it in different aspects, such as by:

The points discussed above could provide an optimal path for Colombia; otherwise, patients will not have access to cannabis medicines in the near future, as opposed to magistral formulas that are costly for both patients and manufacturers.

Moreover, the Ministry of Health and Social Protection should adhere to the directives outlined in Decree 811 of 2021 and regulate the amount of CBD and other cannabinoids in foods and beverages, considering the compared experiences of countries such as Ecuador (emergency regulation), Switzerland, or those following the guidelines of the European Industrial Hemp Association.

Strong political will is needed in order to bring about the desired change. The new government led by President Gustavo Petro is implementing a new drug policy that moves away from the “War on Drugs” and towards “Care of Life”. This is a significant step forward for Colombia. However, there are still challenges to face, and starting with minor issues is key.