The Western Cape’s investment promotion agency Wesgro says it is optimistic about the potential offered by local production of medicinal cannabis, despite the slow pace of SA’s medicines regulator.
Growing cannabis for medical purposes — be it for research or pharmaceutical production — requires a licence from the SA Health Products Regulatory Authority (Sahpra), but it has yet to issue any. Similarly, any medicinal cannabis products manufactured or sold in SA require approval of the regulator.
Wesgro CEO Tim Harris said there have been several expressions of interest from domestic and foreign medicinal cannabis investors since the health department introduced a legal framework in late 2017.
“There is now an opportunity for SA to become the leader on the continent, and for provinces such as the Western and Eastern Cape to lead the country in the creation of jobs in this emerging sector. It is not often that an entire new global industry emerges from nothing to become a $50bn-plus sector, as cannabis is predicted to in the next decade,” he said.
“There is significant economic benefit a timely, responsible and innovative regulatory regime can bring to SA.”
The licensing system for cultivating medicinal cannabis has been in place since November 2017. Since then, Sahpra has received 21 applications, of which it has scrutinised only 16. To date, not a single one of the applicants has met the regulator’s stringent requirements. Sahpra’s head of law enforcement Griffith Molewa said officials had found “a multitude” of problems when they inspected the premises of licence applicants.
Applicants included individuals, farming co-operatives, researchers and established commercial entities, but none had adequate security measures to safeguard their medicinal cannabis crops and ensure they were not diverted for other uses, he said.
Applicants also needed to have measures in place to ensure the integrity of their crop to protect it from accidental pollination with other cannabis strains. The regulatory framework for medicinal cannabis has drawn on the approach taken in several other countries, including Canada and Australia, he said.
A licence application costs R21,800 and a licence is valid for five years, he said.
No local product is yet legal
Earlier this week Sahpra warned consumers that none of the cannabis-containing medicines currently on sale in SA are legal, as none has been approved by the regulator. Only a handful of patients who obtained permission to import cannabis-containing medicines under a Section 21 exemption to the Medicines and Related Substances Amendment Act were taking legal products, it said.
A Section 21 application, which can be submitted electronically, currently costs R300 per patient and the turnaround time is 24 hours, according to Sahpra’s acting registrar Portia Nkambule.
There is limited local research currently under way into medicinal cannabis, but the department of science and technology has funded a study exploring the potential of local cannabis strains for treating medical conditions.
The department has invested R500,000 in seed funding into the University of the Free State’s indigenous knowledge systems health research unit, according to the department’s director for indigenous knowledge Aunkh Chabalala. “The next step is to explore innovations based on existing formulation by SA healers, and later clinical studies for commercial products.”