Dr Lennox Mtshagi the President of Bfasa (Black Farmers Association of South Africa) has alleged that South African authorities, specifically, SAPHRA, The South African Health Products Regulatory Authority is skewing the granting of grow and production licenses for medical cannabis in favour of white applicants over black applicants.
Dr Mtshagi also alleges that apartheid era legislation still on the books aids the government in doing so.
The 1965 act is an apartheid act, remember in South Africa ?? 1965 No Blacks were allowed to participate in any business.
Dr Lennox Mtshagi
In early November 2020 the Bfasa organised a march and demonstration in Capetown to deliver a petition to highlight their belief that SAPHRA is using a “1965 act that exludes black people from entering a pharmaceutical field”
VIDEO: BFASA MARCHES AGAINST INEQUALITIES “rolled out by SAHPRA” IN THE CANNABIS INDUSTRY.
At the march in Capetown petitions were delivered to representatives of the Office of the President, the Prime Minister and the Presiding Judge of the High Court.
BFASA Chairman Dr Lennox Xolile Mtshagi said one of the demands made to the Chairman was to revoke all cannabis licenses issued to white-owned pharmaceutical companies by the South African Healthcare Products Regulatory Authority (Sahpra).
“The cannabis plant is a native plant that belongs to the indigenous people of this country. It is unfair that Sahpra grants these licenses to white companies. We also demand that all companies that sell cannabis oil products, like Clicks, Dis-Chem and Canna Africa, remove all their products from the shelves, as they are operating illegally under the 1965 law ” .
The group has called for firm action against Sahpra and the withdrawal of its current president, Helen Rees, and to investigate
“the blatant racism in the granting of permits and licenses against the principles of the Constitution”.
The Saphra Board (2020) Source: https://www.sahpra.org.za/the-sahpra-board/
Prof Helen Rees
Profile WITS RHI
THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965) AS AMENDED
The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), which was amended by Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015) and enacted in May 2017, enabled, amongst others, the establishment of SAHPRA, the licensing of manufacturers and importers of active pharmaceutical ingredients, and the regulation of medical devices.
In terms of the Medicines Act, the objectives of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, medical devices, radiation control, clinical trials and related matters in the public interest. It also provides for registration and control of veterinary medicines in such a way as to ensure that they are produced, distributed and used without compromising human and animal health. Antimicrobials intended for use in animals and registered under the Medicines Act may only be administered or prescribed by a veterinarian.
As per section 2B (1) of the Medicines Act, the Authority must, in order to achieve its objects:
Ensure the efficient, effective and ethical evaluation or assessment and regulation of medicines, medical devices, radiation emitting devices and radioactive nuclides that meet the defined standards of quality, safety, efficacy and performance, where applicable;
Ensure that the process of evaluating or assessing and registering of medicines, medical devices, radiation emitting devices and radioactive nuclides is transparent, fair, objective and concluded timeously;
Ensure the periodic re-evaluation or re-assessment and ongoing monitoring of medicines, medical devices, radiation emitting devices and radioactive nuclides;
Act Full Text
Capetown Marchers 2020
Also present at the 2020 demonstration was The African Cannabis Industry Association (ACIA) spokesperson, Raadia Khan who said….
“Our focus here is to facilitate BFASA’s negotiations with SAHPRA focusing on forging an amicable engagement. We are here to bring about legislative change in favour of growth”
Mtshagi adds in an email to Cannabis Law Report February 2020
In short the act doesn’t apply to the constitution of South Africa, in our country black economic empowerment is compulsory, and the custodians are excluded. The white companies that received the licenses are the very same that were against cannabis. . Bfasa and it’s affiliates are going to embark on another demonstration on March 24th and shutdown SAHPRA and demand all the licenses be revoked and the proceeds be channeled to the poor rural communities in South Africa
Cannabis Law Report has contacted SAHPRA’s media department for an official response but as yet has received no reply.
Dr Mtshagi supplied CLR with SAHPRA’s official response to Bfasa’a initial allegations and petition of October 2020.
SAHPRA RESPONSE IN FULL
SAHPRA REFUTES CLAIMS BY THE BLACK FARMERS ASSOCIATION
SAHPRA refutes claims made by the Black Farmers Association of South Africa (BFASA) that SAHPRA is a corrupt entity with an inclination towards White bias, in the issuing of licenses, generally and particularly with respect to cannabis products. SAHPRA is subject to inter alia the Public Finance Management Act (“PFMA”), and therefore conducts itself with the utmost integrity and prides itself in the ethos of transparency.
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).
It is specifically SAHPRA’s mandate to ensure that healthcare products as described above are safe and effective to ensure the health and well-being of potential consumers. Therefore, when considering licensing applications, the focus therefore is primarily on the safety and efficacy of the product, and less on the manufacturer or distributor.
With respect to the cultivation of medicinal cannabis and the manufacture of related products, all applicants have to abide by strict protocols.
(https://www.sahpra.org.za/requlatory- compliance/).This is because SAHPRA has the interests of the safety of the public as a central feature in all its dealings. Any person who can demonstrate that it meets the criteria applicable for the licence sought will be granted a licence. However, it must be stressed that because these products are utilised for treatment of health issues, SAHPRA must ensure that the products are safe for human consumption.
SAHPRA is legislatively obliged to ensure that the potential consumers remain protected. This has resulted in falsehoods and defamatory statements being made by members of these organisations, inter alia, against the SAHPRA Board Chairperson, Prof Helen Rees, who is accused of issuing and selling licences to affluent White people. The SAHPRA Board is not operational in the process of issuing licences and accordingly does not get involved in any operational functions of the Authority. There is a strict process and strict protocols involved in the issuing of licences and the relevant personnel and committees are tasked with this procedure. The allegations made against Prof Rees are rejected with contempt.
SAHPRA Executive Management has had numerous engagements with BFASA to address their concerns and to clarity the very narrow role of SAHPRA in the cannabis value chain. Furthermore, as SAHPRA takes the national policy issues raised by BFASA seriously, the SAHPRA Board and the Presidency have been pulled into these discussions. SAHPRA has taken a developmental approach and is currently reviewing a mechanism that will enable small farmers to enter this sector. Once finalised, this approach will be communicated to the relevant stakeholders.
Under the current legislation, SAHPRA does not issue licences for the cultivation of cannabis for non-medicinal commercial purposes. SAHPRA’s role is limited only to medical cannabis. The process to obtain a licence from SAHPRA to cultivate cannabis for medicinal purposes is a rigorous one, which must comply with the legislative framework. There needs to be standardisation of the medicinal cannabis cultivars and assurance that crops can be grown under conditions of strict security and good quality. 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, there is a national policy dialogue wherein SAHPRA and other institutions are involved. The oversight of current and possible future uses of cannabis involves many stakeholders, including SAHPRA, the Department of Health, Department of Agriculture Land Reform and Rural Development, Trade and Industry and Competition, the South African Police Service, and Parliament. SAHPRA is by no means the only entity 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 the BFASA because they confuse the public in what is a complex legal and national policy matter. Accurate reporting is essential to allow the public to participate constructively and meaningfully in this debate, and we accordingly urge the public to verify the facts for themselves in order to ensure that they make informed decisions.
SAHPRA is obliged to remain focused on its mandate, which is to ensure that potential healthcare products are safe and effective for human use prior to them being offered to potential consumers.