Minister Motsoaledi must urgently recall the SD Bioline HIV test kit nationally and account to Parliament for how a R22.5 million tender was awarded by the Health Department for HIV tests banned and found to have critical nonconformities by the World Health Organisation (WHO).
In January the kit supplied by Pantech, was banned by the WHO because of findings that it could give incorrect outcomes. They recommended that Government should not procure these kits. The kits were recalled in South Africa at the time.
In March, the Department of Health, however, awarded a new tender worth R22.5 million for the supply of 4.5 million more of these faulty test kits to public hospitals.
Following a re-inspection, the WHO issued a notice of concern in June 2012, finding a 'significant number of major and critical nonconformities', including a lack of adequate quality control in the processing and release of kits.
Minister of Health, Aaron Motsoaledi, has begun to take tentative steps to address the problem. Until yesterday, however, the Minister was reportedly not aware that this tender had been awarded.
This is unacceptable.
I will be writing to the Minister to request that he urgently recalls the faulty HIV kit nationally.
In addition, I will also write to the Chairperson of the Portfolio Committee on Health, Dr Monwabisi Bevan Goqwana, to request that he calls the Minister to the Committee to brief the Committee on the steps taken to protect South Africans from the use of the faulty kits and to provide clarity on the procurement process in the Department of Health which has allowed for a massive tender to be awarded for tests not cleared by the WHO.
South Africa has an estimated overall HIV prevalence rate of approximately 10.6%, with the total number of people living with HIV estimated at approximately 5.38 million. One of the key strategies for combatting HIV is the drive to know your status. This facilitates timeous treatments and decisions on safe sex.
The Minister must be held accountable for placing South Africans at risk, even though his ignorance.
Patricia Kopane, Shadow Minister of Health