Changes Required to Allow Commercial Poppy Growth in Canada

Navigating the regulatory framework to bring this poppy project to fruition in Canada and around the world is a complex process. In Canada, the regulatory framework for research and commercialization is governed by the federal Controlled Drugs and Substances Act, and a number of related regulations, administered by Health Canada. Certain new regulations have been adopted and API Labs is currently examining their impact on our research and commercialization plans. We are working with policy-makers and regulators with a view to ensuring a science-based regulatory framework that rewards innovation.

Since API Labs intends to establish a commercial industry around the cultivation of opium poppies (a controlled substance) specific regulatory changes are required. There are two separate actions that would support this establishment of this industry. The first is an exemption to the existing regulation that according to Section 56 of the Controlled Drugs and Substances Act, may be granted by the Health Minister. The second, would be an actual change or amendment to the existing Canadian regulation that considers the opium poppy as a narcotic controlled substance which is illegal to produce or possess. This regulation change would put our laws in line with other producing nations that do not consider the opium poppy a controlled substance until the straw is processed (i.e. the alkaloids are extracted from the biomass).

Recently, API Labs has formally requested Health Canada issue an exemption for the licit cultivation of poppy crops for the sole purpose of seed production. When granted, this exemption will allow for commercial scale growth and subsequent sale of poppy seed to the world market. Since poppy seed is not a controlled or regulated substance, no further government approval is required to sell this commodity. Additional inquiries have been made regarding the process required to gain a regulation change that would permit the production of poppy crops for pharmaceutical purposes.