High Court Overturns National Tender for Circumcision Device

The Gauteng High Court in Pretoria has declared the award of a tender for a circumcision device used in 40 provincial health districts and the military to be unlawful. Consequently, the device is not permitted for use in circumcising boys aged ten to 14.

The 36-month tender was granted to CircumQ by the National Treasury in April 2023, with implementation commencing on 1 September of that year.

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Concerns quickly emerged regarding the device’s safety and lack of testing, especially for the ten to 14 age demographic – a crucial group for South Africa’s voluntary medical male circumcision programme (VMMC) aimed at reducing HIV infection risk.

Unicirc, a competing entity, brought the matter to court, stating it was acting in the public interest.

On Thursday, Judge Elmarie van der Schyff concluded that the tender’s award had allowed the “mandatory use of an untested surgical device on children”. She reviewed and annulled the Treasury’s decision.

The judge remarked: “There are process and verification irregularities; however, there are no findings proving that the [CircumQ] device is clinically harmful or has caused systematic injury. Annulment of the tender would mean reverting all circumcision procedures within the programme to the dorsal slit method.”

She deemed it necessary to immediately suspend its use for boys aged 10 to 14.

The judge noted the impending expiration of the contract, stating it would be permitted to “run its course” rather than being terminated at considerable cost and disruption, despite the inherent unlawfulness affecting the entire award.

She mandated that Treasury and provincial health departments cannot instruct health providers to use the CircumQ device on boys under 14 years old.

Health authorities must ensure that healthcare professionals are “free to utilize any clinically appropriate method” deemed in the best interest of their patients.

The tender’s special conditions stipulated that the surgical aid must be non-invasive and either have obtained or be in the process of obtaining World Health Organization (WHO) approval.

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The tender also mandated that the device be suitable for boys aged ten to 14 and classified as a Class A device, which carries the lowest risk.

Although both Treasury and the Department of Health opposed the application, Judge van der Schyff found it “strange” that CircumQ did not contest or participate in the review proceedings.

Gauteng High Court, CircumQ, National Treasury, HIV infection, Unicirc, World Health Organisation, Department of Health

“All parties involved recognize the public health benefits of medical male circumcision and the advantages it provides in lowering a man’s HIV acquisition risk. They also acknowledge that circumcising boys between the ages of ten and 14 offers several significant benefits.

“Due to warnings regarding adverse effects associated with traditional and current dorsal slit methods, Treasury and the department advocated for a bid to help health professionals move away from that procedure.”

Concerning the WHO pre-qualification standards, she indicated that while CircumQ’s application had not been “outright rejected,” it had not secured approval to proceed. To date, it remains unapproved, and there are no public records indicating that the necessary additional studies have been completed or the deficiencies highlighted by WHO have been addressed.

“This tender was not a standard procurement activity. Its express purpose was to select a service provider to deliver high-quality, high-volume VMMC services to males ten years and older across 40 health districts as part of South Africa’s HIV prevention strategy. Consequently, the safety of patients, many of whom are children, is not a secondary concern but rather the foundational rationale of the tender,” the judge stated.

“The WHO pre-qualification requirement should be viewed not as a mere bureaucratic formality but as a direct indication of the objective to ensure patient safety.”

Bid Evaluation Committee Criticized

Judge van der Schyff criticized the Bid Evaluation Committee (BEC) for recommending the tender “without evidence of safety standards.”

She pointed out that the committee had “passively accepted” CircumQ’s self-declaration that its device was classified as “Class A.”

“No reasonable BEC could dismiss the question of whether a device being widely deployed is accurately classified when that classification directly affects its risk profile.

“A BEC that merely accepts the manufacturer’s claims and continues to recommend an award has failed in its duty to critically evaluate all relevant information and fully engage in the matter at hand,” the judge asserted.

The “safety issue” should have been prioritized significantly.

Furthermore, she observed that while the Gauteng Department of Health claimed the device was being used effectively, their data did not provide a breakdown for the crucial age group.

In January, GroundUp reported that approximately 96,000 circumcision devices purchased under this controversial tender were set to be distributed to clinics in KwaZulu-Natal.

Prior to the April hearing, Unicirc attempted to submit an affidavit from a nurse aware of a ten-year-old who allegedly experienced serious complications after using the CircumQ device. However, the court ruled this as hearsay and did not permit the evidence.

The judge ordered that the Treasury bear the costs associated with the review application.

© 2026 GroundUp. This article was first published here.