21 Apr SAHPRA Refutes Claims Made by the Black Farmers Association of South Africa (BFASA)
21 April 2021
SAHPRA refutes claims made by the President of the Black Farmers Association of South Africa (BFASA) that SAHPRA has an inclination towards White bias.
SAHPRA treats All applicants equally and with respect and does not practise any prejudice in its dealings with all stakeholders, including ALL applicants.
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, Prof 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, Dr Zweli Mkhize, is far from the truth. 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.
There is a strict process and strict protocols involved and the relevant personnel and Committees are tasked with this procedure.
The current legislation does not permit SAHPRA to issue licences for the cultivation of Cannabis for non-medicinal commercial purposes including for use in food. 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.
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“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,” indicates Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.
SAHPRA 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.