With the Criminal Law Reform enacted a year ago, the cannabis and industrial hemp industry has become an emerging industry in Ecuador. Our partner Felipe Samaniego writes about it for Pharma Boardroom.
Samaniego begins the article by writing about what’s new since the reforms now include decriminalizing the possession of drugs that contain cannabis or derivatives as an active ingredient for therapeutic, palliative, medicinal use, or alternative medicine.
The Law for Drug Use, Prevention, and Control is also modified with the change, which now excludes the control of non-psychoactive cannabis or hemp.
On October 19, 2020, the Ministry of Agriculture issued Ministerial Agreement No. 109-2020, which regulates the Import, Sowing, Cultivation, Harvest, Post-harvest, Storage, Transportation, Processing, Marketing, and Export of non-psychoactive cannabis or hemp and hemp for industrial use.
Samaniego adds that “this regulation establishes the requirements that must be met to obtain the seven types of licenses, which authorize the following activities only concerning cannabis or hemp with a THC concentration of less than 1%:
- License for Import and Marketing of Non-Psychoactive Cannabis or Hemp Seeds or Cuttings, or Hemp Seeds for Industrial Use.
- License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds, or Non-Psychoactive Cannabis or Hemp Cuttings or Hemp Seeds for Industrial Use.
- License for the cultivation of cannabis or non-psychoactive hemp.
- License to grow hemp for industrial use.
- License for the processing of non-psychoactive cannabis or hemp and production of non-psychoactive cannabis or hemp derivatives.
- License for Banks and Research of Plant Improvement and/or Germplasm.
- License for the Acquisition of Non-Psychoactive Cannabis or Hemp Derivatives and/or Biomass or Flowers, or Hemp Biomass for Industrial Use for Export.
As soon as this came into effect, the Ministry of Health and the Agency for Health Regulation, Control, and Surveillance had to develop regulations applicable to finished products. This happened because the Criminal Law “also opened the door to producing and importing finished products,” according to our partner.
Samaniego also adds that at the end of February of this year 2020, “the Health Regulation, Control, and Surveillance Agency issued a resolution with the ‘Sanitary Technical Regulations for the regulation and control of products for human use and consumption that contain cannabis non-psychoactive or hemp, or its derivatives.” This resolution makes it possible to legally produce, import, and commercialize the following finished products with the THC concentration specified in each category:
- Less than 1% THC: general, natural pharmaceutical products processed for medicinal use and homeopathic. Also cosmetic products and medical devices; hygienic products for industrial use; pesticides for domestic use, for public health or for industrial use; household hygiene products and absorbents for personal hygiene.
- Less than 0.3% THC: processed foods and food supplements.
On February 26, Ministerial Agreement No. 148-2021 was also issued after a meeting of experts developed regulations for the prescription, provision, and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids.
Samaniego concludes by pointing out that “the regulatory framework for cannabis / hemp has moved relatively quickly in Ecuador and has opened the eyes of many local and international investors. The authorities are aware of what this industry can generate for the country regarding research and investment. Ecuador is the only country in the region that has shown such openness; the players will be able to develop a myriad of producs as long as they abide by all the rules. As a result, this area is expected to become a research and development group for cannabis and hemp products to be sold worldwide.”
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