HIV Pill Court Ruling Leaves Patients Watching and Waiting

HIV Pill Court Ruling Leaves Patients Watching and Waiting

Court orders health department to redo key antiretroviral awards within 120 days

For millions of South Africans living with HIV, a single daily pill containing tenofovir, lamivudine and dolutegravir is the difference between stable treatment and a potentially life-threatening interruption. That pill is now at the centre of a court battle that has upended one of the country’s largest health procurement decisions. The people who depend on it will be watching closely over the next four months.

This week, Acting Judge Graham Girdwood of the Pretoria High Court set aside the awards for the one-month and three-month packs of the fixed-dose combination, finding them unlawful and unconstitutional. The awards form the bulk of a R15.5-billion antiretroviral tender that came into effect in December 2025, with R12.6-billion of it tied up in the combination packs. The judge ordered the National Department of Health to redo the split and award of the two items within 120 days.

For patients, the immediate fear of a shortage has been addressed. Current suppliers will keep delivering in the meantime, and the setting-aside of the awards will only take effect 90 days after the department finalises the new awards, so that supplies continue until the companies chosen in the redone process are ready to step in. These three medicines constitute the first-choice standard regimen for adults in South African treatment guidelines. Any stockout could have been dangerous for many people.

The case was brought by Cipla Medpro Manufacturing, a local manufacturer with a strong track record of supplying drugs to the market, which received no award for the one-month or three-month packs and scored only three smaller awards worth R215-million. Together with another unsuccessful bidder, Hetero Drugs South Africa, which wanted its own bid reconsidered, Cipla turned to the court.

In a lengthy ruling, the judge worked through each of Cipla’s challenges. They raised issues of non-responsive bidders, poor past performance, wrongful granting of local manufacturing status, failure to substantiate claims of historically disadvantaged individual ownership, and possible collusion.

At the heart of the judgment was a simple finding about two of the winning bidders, Innovata Pharmaceuticals and Viatris Healthcare. It was common cause, the judge said, that neither had a valid licence for their Isando-based manufacturing site when bidding closed. “A licence that has expired is not, and was not on bid closure date, a valid licence,” he said. On that basis, the two companies should never have progressed beyond the first stage of adjudication, and he specifically ordered that their bids be excluded from reconsideration.

Cipla had also argued that Innovata’s past performance should have counted against it. The company had been unable to perform under a previous contract, which it had itself asked the department to cancel. The Bid Evaluation Committee treated that history as materially relevant, but the Bid Adjudication Committee, which makes the final recommendation, found no evidence that Innovata had been prohibited or restricted from doing business with the state, and directed that it be considered anyway, with reduced volumes. It received an 11.38% allocation. Judge Girdwood rejected that reasoning. “Formal debarment is reserved for the most serious cases of established wrongdoing and is not a precondition for, nor a proxy for, an assessment of ordinary supply-performance risk,” he said, finding this was a ground to review the tender.

Meanwhile, the judge found that bidders had not been judged on the same standards when it came to local manufacturing status. The department accepted claims of historically disadvantaged individual status from Innovata and Barrs Pharmaceuticals without investigation, which pushed up their scores and rankings. He ordered that the scores of Innovata and Barrs be adjusted because they had been given HDI points without proving the ownership they claimed. He further directed that the final bid prices of Barrs and Aurobindo Pharma be restored to their pre-negotiation prices, insofar as they did not qualify for local manufacturing preference.

The concerns around Innovata and Barrs run deeper still. Both are subsidiaries of Avacare and went into business rescue in December 2025. Days later, Barrs was out of stock of both items it was supposed to supply. The companies exited business rescue this year. The judge ordered the department to conduct an investigation into whether the two had colluded in their bids, saying it should have investigated further before awarding substantial volumes to both.

By contrast, Hetero’s application was dismissed. The judge said the department had a reasonable, rational suspicion of collusive bidding involving other companies, but that the review was not the occasion to determine conclusively whether Hetero in fact colluded. Noting that the company had not participated in the hearing, he ordered it to pay the respondents’ costs on a punitive scale for having to meet a case that was never argued. The minister and director-general were ordered to pay Cipla’s costs.

For the patients who swallow that one-pill regimen every day, the judgment offers reassurance that supplies will continue while the department redoes the awards. But it also lays bare how procurement failures at the top can ripple down to the pharmacy counters where treatment is actually collected. Whether the redone tender, due within 120 days, delivers a more reliable supply chain is the question now hanging over everyone who depends on that daily pill.

Q&A

What did the Pretoria High Court decide about the antiretroviral tender?

Acting Judge Graham Girdwood set aside the awards for the one-month and three-month packs of the fixed-dose combination, finding them unlawful and unconstitutional. These packs represent R12.6-billion of the R15.5-billion tender, and the National Department of Health must redo the split and award within 120 days.

Will patients experience a shortage of their HIV medication?

No immediate shortage is expected. Current suppliers will keep delivering, and the setting-aside of the awards takes effect only 90 days after the department finalises the new awards, so supplies continue until the newly chosen companies are ready to step in.

Why were Innovata Pharmaceuticals and Viatris Healthcare disqualified?

It was common cause that neither had a valid licence for their Isando-based manufacturing site when bidding closed. The judge said a licence that has expired is not a valid licence, ordered their bids excluded from reconsideration, and also ordered score adjustments for Innovata and Barrs over unproven historically disadvantaged individual ownership claims.

What happened to the two companies that brought the court case?

Cipla Medpro Manufacturing's challenge succeeded, and the minister and director-general were ordered to pay its costs. Hetero Drugs South Africa's application was dismissed; the judge found a reasonable suspicion of collusive bidding involving other companies but did not conclusively determine Hetero's role, and ordered it to pay the respondents' costs on a punitive scale for not participating in the hearing.