The CEO of the South African Health Products Regulatory Authority (SAHPRA) has expressed concern at the inaccuracies in the narrative that Black Farmers’ Association of South Africa (BFASA) is spreading as part of its campaign over the exclusion of black farmers from being granted medicinal cannabis licences.
This comes after BFASA staged a march to SAHPRA’s offices last week, claiming that SAHPRA’s management, under instruction from health minister Zweli Mkhize, has been granting licences to affluent white people and foreign-owned companies without considering indigenous people. This includes traditional healers, rural agriculture and Rastafarians..
SAHPRA CEO Dr Boitumelo Semete-Makokotlela says in a statement that BFASA’s narrative is full of inaccuracies that confuse the public in what is a complex legal and policy matter. “Accurate reporting is essential to allow the public to participate constructively and meaningfully in this debate,” she said.
At the march, BFASA president Dr Lennox Mtshagi maintained they are being discriminated against.
“We are going to protest outside SAHPRA until our call is heard by the minister because the minister is also implicated by SAHPRA. He is the one that is instructing (SAHPRA) to give licences to white people not to black people. So, we’ve got that on record. We want the minister to come and answer today,” Mtshagi demanded.
BFASA feels that the skewed allocation of these licences to white companies is a crime against the policy of Black Economic Empowerment (BEE) and the constitution of South Africa. They are making a call for all issued “illegitimate” licenses to be revoked.
SAHPRA refuted all claims made by the president of BFASA that they have an inclination towards white bias.
In a statement, SAHPRA said that they treat all applicants equally and with respect, and do not practise any prejudice in its dealings with any stakeholders. This includes applicants for licenses.
“SAHPRA is tasked with regulating, monitoring, evaluating, investigating, inspecting and registering all health products. This includes clinical trials, complementary medicines, medical devices and in-vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa.
“SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973). SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of all who reside in South Africa: safety, efficacy and quality of health products.”
The allegation that the SAHPRA Board Chairperson, Professor Helen Rees, and the CEO, Dr Boitumelo Semete-Makoktlela, are issuing medicinal cannabis licences to affluent white people on the directive of the minister of health is far from the truth, the organisation says.
“The minister is not involved in any way with SAHPRA operational processes such as the issuance of licenses and neither has he issued such a restrictive directive. SAHPRA denies this flawed allegation unequivocally,” it says.
SAHPRA also indicated that there is a strict process and protocols involved, and the relevant personnel and committees are tasked with this procedure. The body adds that the current legislation does not permit SAHPRA to issue licences for the cultivation of cannabis for non-medicinal commercial purposes, including food use.
Strict protocols to obtain medical cannabis license
The process to obtain a licence from SAHPRA to cultivate cannabis for medicinal purposes is a rigorous one. There needs to be standardisation of the cannabis cultivars and assurance that crops can be grown under conditions of strict security.
The cultivation of cannabis for medicinal purposes requires strict control as South Africa is a signatory to international treaties that prohibit the production and supply of narcotic and psychotropic drugs, including the Single Convention on Narcotic Drugs of 1961.
“SAHPRA recognises that there is an ongoing global dialogue around the use of cannabis for both medicinal and non-medicinal purposes. In South Africa, the regulation of current and possible future uses of cannabis involves many stakeholders, including SAHPRA and the departments of health; agriculture, land reform and rural development; trade, industry and competition; the South African Police Service, and the Legislatures to name a few. SAHPRA is by no means the only body that is involved with the regulation of cannabis,” says Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.
SAHPRA says it is concerned about the inaccuracies of such narratives by BFASA because they confuse the public in what is a complex legal and policy matter. Accurate reporting is essential to allow the public to participate constructively and meaningfully in this debate.
Furthermore, the department of agriculture, land reform and rural development together with other departments and entities, are in the process of developing the Cannabis Master Plan which will provide a roadmap for the cannabis industry.