On the basis of the evidence, there does not appear to be substance to the corruption claims made by the Black Farmers Association of South Africa (BFASA) against the South African Health Products Regulatory Authority (SAHPRA). Leaders of the two organisations squared off against each on Newsroom Afrika on 20 October 2021 in a debate hosted by Thami Ngubeni. In the doctor vs doctor debate, it was clearly a calm and rational SAHPRA CEO Dr Boitumelo Semete-Makokotlela who came out with the upper hand against BAFASA’s Dr Lennox Mtshagi who was unable to offer any evidence of SAHPRA corruption in the issuing of cannabis licenses and had his allegations refuted..
“Check the facts, Dr Lennox, you allegations are unfounded” said Dr Semete-Makokotlela, who said that SAHPRA had a whistle-blowing facility on its website and would investigate any allegations of corruption. During the debate Dr Mtshagi made the following accusations against the SAHPRA CEO, and the response is in her own words.
Dr Mtshagi’s Allegation # 1:
SAHPRA favours “white monopoly colonialists” in the issue of cannabis licenses and has effectively cut black people, “including traditional monarchs and traditional healers, Rastas, rural farmers and marginalised communities” out of the legal marijuana market. Dr Mtshagi said SAHPRA’s board and chairman were acting on instruction of former Health Minister Dr Zweli Mkhize in awarding cannabis licenses only to white businesses.
Dr Semete-Makokotlela: “SAHPRA is a regulator that only has oversight of THC and CBD used for medicinal purposes; outside of that SAHPRA is not the entity to come to – that’s the Departments of Justice and Agricuture who are involved in cannabis policy. We are only concerned where there are medical claims being made about cannabis products. We ask the licence applicant what they want to use the product for; we look at their manufacturing facility and they have to comply with good management practice, because the safety of the public, when they consume a product for medicinal purposes, is paramount. Hence we only issue licenses to those companies that are compliant and there are many black-owned companies in the pharmaceutical sector that have been licensed by SAHPRA.”
Dr Mtshagi’s Allegation # 2:
SAHPRA does not follow BEE principles in the awarding of cannabis licenses and is operating under the Medicines Act which was drawn up in the Apartheid era.
Dr Semete-Makokotlela: “We have engaged with the BEE commissioner and have received our own legal opinion. We are governed by the Medicines Act (drawn up in 1965 and amended in 2017) to look at product quality, safety and efficacy and thereafter the issuing of licenses. If we do anything on BEE we go against the Medicines Act because it silent on that. That’s why we got legal opinion; there’s a process to follow; we are aware of the BEE matter, we are addressing it, we know where the gaps are, what the gaps need and how we must address those gaps, but it’s an ongoing process.
Dr Mtshagi’s Allegation # 3:
SAHPRA awarded a license to store and manufacture anti-Covid vaccines to a company, Liseko Investments in which SAHPRA chairperson Helen Rees’s husband, Dr Faizel Randera, was involved. Liseko had a relationship with Aspen and there was a conflict of interest in that it showed SAHPRA was biased towards “Big Pharma”.
Dr Semete-Makokotlela: “Until we get evidence around these claims it’s not a matter we’re going to entertain; the matter has been dealt with around vaccines and I don’t know why it’s surfaced now around cannabis.
We have checked our records; none of the companies that have been licensed to manufacture cannabis are connected to Dr Randera. Liseko issued a statement at the time denying the allegations and no evidence to the contrary has come forth. We have a whistle-blowing facility at SAHPRA, the number’s on our web site and we will investigate any act of corruption; we have no tolerance for corruption.”
Dr Mtshagi’s Allegation # 4:
SAHPRA did not inform the new Minister of Health, Dr Joe Phaala, that the BFASA wanted him to be present for the handover of a memorandum of demands. Because the Minister was not present at the conclusion of the SAHPRA march, BFASA did not want to hand over the memo to Advocate Mobela because it would be like “leaking evidence” to someone who may not be trusted.
Dr Semete-Makokotlela: “I personally spoke to the Minister yesterday (18 October 2021) and he asked Advocate Mobela from the Department of Health to collect it as he had prior commitments. But the marchers didn’t want to deliver the memorandum even though the Minister had the courtesy of sending someone from the Department. And Adv Mobela told the marchers he was representing the Minister of Health who was not available. There’s nothing I can do if the Minister is unavailable and the protestors don’t want to give the memorandum to his representative.”
Dr Mtshagi’s Allegation # 5:
SAHPRA has back-tracked on the issuing of “bankable pre-licenses” to licence applicants who did not have the funding to build GMP facilities, which could well be over R5 m; these “pre-licenses” could be used by the previously disadvantaged to try and fund facilities ahead of SAHPRA inspections (in South Africa cannabis license applicants are required to first build a GMP facility before they are awarded a license after meeting SAHPRA’s compliance conditions). “Dr Helen Rees made it clear that we would get pre-licenses” said Dr Mshagi, “SAHPRA went as far as inspecting our sites and we are still waiting for them to finalise”.
Dr Semete-Makokotlela: “Inspection reports were given on the sites we visited and what had to be done to make them compliant. We are only regulators. When it comes to funding there are other mechanisms to talk about access: the Department of Science and Innovation, the Department of Small Business; we’ve tried to put them in touch with the DTI because you cannot expect the regulator to be involved in how you set up structures. We are merely regulators. There are other players in government they should be talking to. We’ve said this to them many times, and their feedback is: ‘oh, those people are not responding, you’re the only ones responding, so we will come to you’. You must understand we cannot operate outside of our mandate.