‘Gold rush’: The cannabis business is flourishing around the world, including in Colorado in the United States (above). Zimbabwe already has opened up the industry and South Africa is now following suit. Photo: Gallo Images
South Africa is relaxing laws for farming cannabis and hemp as the world moves away from a fear-based approach to the plant and research into its health and industrial benefits gains momentum.
Cecil Mogatse, the department of agriculture, land reform and rural development senior official responsible for issuing hemp licences, and the South African Health Products Regulatory Authority (Sahpra) compliance manager, Daphney Fafudi, spoke about changes in the legal landscape governing the cultivation, production and sale of cannabis products at the Bio Africa Conference in Durban this week.
This comes after President Cyril Ramaphosa announced during his State of the Nation address in February that development of the hemp and cannabis sector is an economic priority that could create more than 130 000 jobs. The government has developed a national masterplan to develop the sector.
The country is following the lead of Zimbabwe, which has relaxed regulations, resulting in a “gold rush” in pursuit of licences to grow the plant, as scientific research into its benefits gain pace.
Mogatse said the department regulated Cannabis sativa (hemp) as an agricultural crop with a tetrahydrocannabinol (THC) content of below 0.2% but it was awaiting a decision by Sahpra to increase the allowable content to 1% because it was difficult for farmers to produce plants with such low levels of the chemical compound.
He outlined further relaxations to the Hemp Regulatory Framework in terms of the Plant Improvement Act of 2018, which will make it easier for growers to obtain licences after applicants complained about excessive red tape.
He said proposed new regulations would remove the limitation of cultivation to 50 hectares and the expensive requirement to install a security fence around the production area.
“Police clearance is no longer a requirement and we have increased the licence validity period from three years to five years on new applications,” Mogatse said.
The department anticipated that the amendments to the regulations would be passed before the end of the year.
He said 246 licences had been issued for hemp cultivation so far, with most of these in KwaZulu-Natal (61) followed by Gauteng (59), the Eastern Cape (38), the North West (25), Mpumalanga (23) and Limpopo (22).
Fafudi said there had initially been an outcry regarding how strict Sahpra had been regarding its medicinal cannabis regulation, after it was legalised for personal adult use in 2019. But, she said, the country was bound by the 1961 United Nations Single Convention on Narcotic Drugs to prioritise public health and safety and report accurate data on licensed activities such as the cultivation and production of cannabis.
She said in terms of the convention, the country was required to report accurate data on licensed cannabis activities to the UN regardless of the percentage of THC in products manufactured locally.
“Before we can even start cultivating, manufacturing and distribution, we need to inform them of the estimated annual consumption that we will require as a country and then we need to quarterly and annually report in terms of the medical cannabis cultivation licences [issued] in this regard,” she said.
Fafudi said Sahpra, which controls medicinal cannabis products, had so far issued 100 licences for cultivation of cannabis, of which 33 were issued in Gauteng, 22 in the Western Cape and 14 in KwaZulu-Natal.
Products containing cannabidiol are listed as schedule four drugs under the Medicines and Related Substances Act, except in complementary medicines containing no more than 600mg cannabidiol (CBD) per sales pack and in processed products made from raw plant material intended for ingestion containing 0.0075% CBD or less.
According to the Act, cannabis products containing THC are listed as schedule six drugs, except in raw plant material and processed products intended for industrial purposes and not human or animal ingestion, where the level of THC is 0.2% or less. Other exceptions are processed cannabis products that contain 0.001% or less THC and when the plant is cultivated, possessed and consumed by an adult in private.
Richard Rukwata, the director general of the Medicines Control Authority of Zimbabwe (one of the first countries to introduce cannabis production legislation), said the world was moving from a fear-based approach to embracing cannabis.
“We are dealing with exactly the same issue and problems [as South Africa] and when you look at the world over we are moving from a state of fear to embracing the inevitable … For a long time, research into cannabis was always hush-hush, so you wouldn’t find a lot of papers, but all of a sudden we have a situation where it is being rediscovered, and there is hemp research and medicinal research,” he said.
“Particularly when you look at cannabis and hemp the difference is largely legal depending on the level of THC and there is huge debate about where cannabis ends and hemp starts.”
The Medicines Control Authority of Zimbabwe published a circular in 2022 to allow cannabis in complementary medicines to take advantage of the fact many hemp growers could extend into the CBD business, Rukwata said.
“The most interesting development was this year when the government decided to review the allowable quantity of THC in hemp and now the law is a maximum of 1%. What happened in the preceding five years is that research showed that to get strains that would yield less than 0.3% of THC would be very difficult and raising that to 1% is to make it more accessible,” he said.
Zimbabwe has issued 59 grower licences at a cost of $50 000 each.
“At some point there was a kind of cannabis gold rush and many parties rushed to get these licences and they may have been speculating as only 10% to 15 % are currently engaged in cannabis cultivation and none of them have exported yet,” he said.
The country has done away with its policy that cannabis had to be grown on government-owned land, and redrafted laws that led to a new plan to focus on the development of a “field to bedside” framework that would develop local industries rather than exports. He said CBD traders had shown interest in registering products with the authority.
“The new laws will focus more on exploitation of cannabis and hemp for the development of local value-adding industries. Hemp is likely to be a game changer considering it has much higher utility than cannabis.”
Rukwata said governments needed to be willing to work closely with industry as partners.
“It is critical for countries to develop legislation that promotes best practices in cultivation. Government, cannabis stakeholders and regulators need to educate the public as there are a lot of misconceptions about cannabis and the deregulation of cannabis and a lot of work has to be done to change these perceptions,” he said.
“There is now an international arms race, so to speak, and the countries that are going to get the most out of cannabis are the ones that work at speed and embrace it.”
Johns Hopkins University’s Wilfred Ngwa, who addressed the conference virtually, said the US Food and Drug Administration (FDA) had recently approved a cannabis clinical trial for the treatment of pancreatic cancer involving 15 patients.
He said CBD had broad potential medicinal properties and research was now focusing on its “anti-cancer activity” driven by immunomodulation of the CBD compound.
“We’re also working on cancers, including brain cancer, glioblastoma, as well as acute myeloid leukaemia,” he said.
He said myeloid leukaemia was an immediate global problem with a need to develop new treatments because there was only an 8% survival rate.
Sandra Carrillo, of the faculty of medicine at the University of Panama, who is also the cofounder of the Colombian Medical Cannabis Association, said cannabis has been used in medicine since 2700BC.
She said medical research into cannabis was gaining momentum in randomised control trials including publications in journals with a focus on studies into uses for refractory epilepsy and other conditions.
“We have multiple studies talking about the use of cannabidiol in refractory epilepsy with very good results. We also have studies, randomised control trials [for the] use of cannabinoid therapies, and particularly preparations with CBD and THC imbalance ratios for the treatment of spasticity patients with multiple sclerosis. We also have evidence and publications in journals and randomised controlled trials for the treatment of patients with chronic pain, non-oncological pain and ontological pain,” Carrillo said.
She welcomed the latest FDA trial announcement saying there was a need to train doctors in the prescription of cannabis based medications for use in the future.