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‘Extreme concern’ over EFF threats against SAHPRA

Threats by the Economic Freedom Fighters (EFF) against the SA Health Products Regulatory Authority (SAHPRA) unless it immediately approved the use of the Russia’s Sputnik V COVID vaccine and China’s Sinovak have been met with outrage from the medical fraternity, reports MedicalBrief.

A coalition of health organisations responded to EFF threats of “militant mass action” against SAHPRA with a call on the government and law enforcement authorities to act. “Safeguarding the integrity of a statutory body is a constitutional obligation of the government, and any physical threats against its personnel or governing board members is a law enforcement matter that should be be taken up immediately by the relevant agencies.

Political parties, across the spectrum, expressed outrage at the EFF’s intimidatory tactics, which have included sending threatening WhatsApp messages to female staff at SAHPRA.

On Friday (25 June) the EFF held a March To Save Lives  to SAHPRA’s office where they delivered a memorandum to SAHPRA CEO Dr Boitumelo Semete-Makokotlela in which they demanded that the organisation approves the use of the Sputnik V and Sinovac vaccines by the end of the week and that SAHPRA Chairperson Professor Helen Rees resign from her position, saying that Rees’ husband was involved with pharmaceutical company Aspen which is a partner in the manufacturing of the Johnson & Johnson vaccine.

In a statement the EFF said it “condemns SAHPRA for its refusal to allow the administration and usage of the Sinovak and Sputnik V vaccines in South Africa. Despite its commitments that the processes of vaccine approval is guided by science, it is evident that SAHPRA’s approval of vaccines was guided and informed by politics and the transactional interests of politicians in South Africa.

“Despite these realities, SAHPRA is still refusing to and actively frustrating the usage of Sputnik-V and Sinovac in South Africa, while allowing the usage of dangerous and poisonous vaccines from the West. It is evident that SAPHRA is being used by politicians and major capitalist interests to totally prevent the usage of vaccines from Russia and from China…”

The party threatened "mass militant action" if its demands were not met within seven days.

"If SAHPRA fails to approve the usage of vaccines that have been scientifically approved and authorised in many parts of the world, we will be left with no option but to engage in militant mass action against this captured regulatory authority. We will also approach our lawyers to explore the possibility of approaching the Constitutional Court on an urgent basis to force SAHPRA and the government to allow the usage of scientifically tested and proven vaccines, including Sputnik-V and Sinovak in South Africa.”

Health organisations expresses “extreme concern” at threats

On Monday, a coalition of health organisations came out in support of SAHPRA and issued a statement rejecting the EFF's accusations: “We note with extreme concern the unwarranted accusations … relating to SAHPRA’s ongoing evaluation of several vaccine candidates for approval in South Africa.

“This reckless rhetoric echoes similar attacks on the institution by parties such as AfriForum and special advocacy groups and lobbies unhappy with SAHPRA’s evidence-based stance on Ivermectin, alleging that the institution was ‘irresponsible’, ‘biased’ and abetting the ‘destruction of lives’.

“On 18 June, the EFF demanded that SAHPRA finalises the approval of both these vaccines within seven days, failing which it threatens 'militant' mass action against the regulator. The party has also reportedly levelled physical threats against SAHPRA personnel and members of its governing board, in a crude attempt to intimidate and bully an independent authority.

“We condemn such behaviour and fully support the vital regulatory role that SAHPRA plays in ensuring that all medications and vaccines undergo rigorous examination to assess the safety, efficacy and quality of products prior to them being registered or authorised for use in the country.

“It is in the interests of the public that SAHPRA is allowed to exercise its constitutional responsibility to ensure that only medicines where data addressing benefit against harm has been carefully weighed before being approved for use by the public.

“It is essential that SAHPRA, as a statutory body, is insulated from untoward political interference and protected from the threats that have recently been levelled against the organisation and its members. Safeguarding the integrity of a statutory body is a constitutional obligation of the government, and any physical threats against its personnel or governing board members is a law enforcement matter that should be taken up immediately by the relevant agencies.

“We affirm the vital importance of SAHPRA’s important regulatory task and call on all members of society who value the role of SAHPRA to refrain from all actions that serve to undermine this function.”

The statement was issued by the Wits University Faculty of Health Sciences; SA Medical Research Council (SAMRC); Southern African HIV Clinicians’ Society (SAHCS); Progressive Health Forum (PHF); South African Medical Association (SAMA); Infectious Diseases Society of South Africa (IDSSA); South African Antibiotic Stewardship Programme (SAASP); South African Academy of Family Physicians; Gauteng General Practitioner Collaboration (GGPC); Public Health Association of South Africa (PHASA); Health Justice Initiative (HJI); and the People’s Health Movement – South Africa (PHM-SA).

A second statement was issued by CEO of SAHPRA Dr Boitumelo Semete, describing the EFF allegations against the Board Chair, Prof Helen Rees, as “totally unfounded and false”.

“SAHPRA is an independent, science-based entity that follows strict guidelines and processes when approving health products. SAHPRA concerns itself, like other regulators across the world, with safety, quality and efficacy of health products. These essential requirements are consistently applied to all COVID-19 vaccines and therapeutics that SAHPRA has considered for use in the country.

“SAHPRA cannot allow political pressure to cloud a clear science-based approach to approving health products where the safety of the public could be compromised. It will be a sad day in the country when the regulator is undermined or influenced by any party.

“SAHPRA would like to emphasise the following: SAHPRA does not favour any applicant as alleged by the Economic Freedom Fighters (EFF); allegations against the SAHPRA Board Chair, Prof Helen Rees are totally unfounded and false.

“SAHPRA, as part of its mandate, focuses on the safety and well-being of the public and no vaccine can be made available until it meets these regulatory requirements. Furthermore, SAHPRA must take into account the local epidemiology, and specifically which SARS-CoV-2 variants of concern are circulating in the country. In essence, the EFF wants SAHPRA to approve vaccines without adherence to the critical components of safety, quality and efficacy. This could compromise public safety.”

Political parties speak out against EFF intimidation

Responding to threats by party leader Julius Malema of a “sleep-in” at the home of SAHPRA CEO Dr Boitumelo Semete-Makokotlela, Dakota Legoete, ANC National Executive Committee member, said: “A family home is a private space, and we do not encourage that (the sit-in) as the ANC to be done to anybody or for anybody to be attacked because you would traumatise the kids, house mates. Whoever lives in that house would be traumatised.”

Siviwe Gwarube, DA spokesperson and member of parliament’s portfolio committee on health, said that they found the EFF’s threat “incredibly worrying”. “It cannot be that political parties put pressure on the regulator for certain vaccines from certain manufacturers to be approved.

“Ultimately, SAHPRA’s job is, through its clinical trials and all the expert knowledge and resources that they have available to them, for them to approve vaccines that are not only safe for the people of South Africa also effective against the variants in South Africa but also the ones that we can use with ease,” Gwarube said.

She added that the country could not allow political parties meddling in the work that a regulator is meant to do because once a regulator is no longer apolitical, not entirely independent, then the country would have problems.

The IFP’s Chief Whip in parliament Narend Singh said that the threat was completely irresponsible, as were the thousands of marchers who took to the streets in the EFF’s  march.

Police lay charges against EFF over march

The police laid charges of contravention of the Disaster Management Act against the conveners of the EFF march.The protest contravened lockdown regulations that limit outside gatherings to 100 people. Media estimates of the march ranged from “hundreds” to 2,000 people. Police spokesperson, Brenda Muridili, told the media that a case had been opened at the Sunnyside Police Station.

“There is also a possibility of more charges that might be introduced. For now, there is an investigation on the part of the investigators to ensure they present to court a water-tight case,” said Muridili.

 

See also from the MedicalBrief archives:

 

Argentina's president tests positive despite taking Sputnik V vaccine<

 

Despite safety fears, China inoculates with experimental vaccines

 

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