The Colombian Government issued Decree 811 of 2021, which replaces Decree 613 of 2017. This new decree is mainly aimed at ensuring safe and informed access to the medical and scientific use of cannabis and its derivatives, while complementing and strengthening the monitoring, follow-up and control measures of the licenses issued for these purposes. The new decree is the result of conversations held between the Colombian Government and trade unions, companies and other stakeholders, who have been repeatedly requesting modifications to the regulations on medical cannabis, especially in the sense of eliminating the prohibition on the exports of dried cannabis flower.
The new decree revamps the regulation on the use of cannabis for medicinal purposes and reaffirms the presence of this industry in the country as one of the most promising in the context of economic reactivation after the COVID-19 pandemic. Indeed, the decree lays solid foundations for the development of cannabis for three specific purposes: scientific, industrial and medical. Thus, it regulates and provides for the use of medical cannabis for study, use and medical analysis, but also for the production of food, cosmetics and non-psychoactive derivatives for human and veterinary use. This not only regulates the procedure to be followed for the use of medical cannabis, but also opens the door for Colombian producers to enter new markets.
Precisely, taking into account Colombia's difficult relationship with drug trafficking, the decree allowed the expansion and dynamization of the medical cannabis industry, but also struck a balance by strengthening the requirements for the granting of the necessary licenses for its use. In that sense, the decree contemplates the issuance of seven (7) types of licenses, depending on the specific activity to be performed, as well as the execution of an anti-corruption commitment by the applicant to obtain any license. Particularly, a license for the manufacture of non-psychoactive cannabis derivatives is created, which is granted by INVIMA and allows the traceability of the non-psychoactive cannabis raw material that will later be transformed into derivatives and medical or industrial products. Additionally, it establishes that the licenses granted must be operational, so that those licenses that are in force will be cancelled if they are not being used to develop the activities for which they were granted. To this effect, the decree also establishes a new quota system under which the Cannabis Control Information Mechanism (MICC) plays an essential role.
Another fundamental aspect brought by the new Decree 811 of 2021 is the possibility of exporting medical cannabis with added value, due to the authorization of the entry of the dried flower as raw material to the country's free trade zones. Although the entry of medical cannabis to free trade zones had already been regulated by Resolution 315 of 2020, Decree 811 allows the export of dried flower from the national customs territory to these zones to be cut, dried, transformed and packaged. With this, it grants the most awaited authorization by the industry, which will surely have an impact on the entry of new medical cannabis projects to the free trade zones, and with it an increase in investment and job creation as part of this industry.
Finally, the decree makes the Colombian medical cannabis industry more competitive by strengthening scientific research, encouraging the processing of derivatives by the pharmaceutical industry in free zones and establishing the activities permitted for the manufacture of food products. Additionally, this new regulation allows the procurement of magistral preparations from cannabis in pharmacies and drugstores, which will make them more accessible, while eliminating the prohibition to advertise cannabis products and the plant itself.
As a result, Decree 811 of 2021 pretends to promote Colombia as a key and competitive player in the industrial production of medical cannabis. This constitutes a step forward in the economic reactivation of the country and promises to be an important source of employment that creates 7.772 jobs by 2025, according to predictions from the Foundation for Higher Education and Development (Fedesarrollo).