The South African Health Products Regulatory Authority (SAHPRA) says it is over-reliant on fee income and needs more money from Treasury to do its job properly.

CEO Boitumelo Semete presented the organization’s 2023/4 report to Parliament’s Health Portfolio Committee on 15 October 2024. She said government funding had dropped from R146m in 2021/22 to R137m in 2023/24, while its fee income rose from R169m to R228m over the period.

Business Day’s Tamar Kahn reports that Dr Semete told MP’s of her concerns about SAHPRA’s dependence on fee income from large pharmaceutical companies.

She said that ‘over-reliance’ on fee income put the authority in a “high-risk situation” because consolidation in the pharmaceutical industry had the potential to reduce revenue from companies seeking authorisation for their products. . 

“If you are fully reliant on industry it puts you in a risky position.”

“If we see a significant reduction in fees it will affect our operations. There are projects that you want to invest in, such as capacity building, infrastructure and IT systems, that you want to be able to pay for from the National Treasury allocation,”

Dr Semete told Parliament that SAHPRA staff complement stood at just 313, well short of the 500 personnel she said she required.

“We are understaffed; it is one of our biggest challenges,” she said. Sahpra was short of technical staff, hampering its ability to timeously process applications for medicines and clinical trials and forcing personnel to work overtime to meet the entity’s performance targets, she said.

Semete has previously made the case for Treasury to allocate a bigger budget to SAHPRA, telling parliament in 2021 that the regulator didn’t have enough money to hire the staff it needed to do its job properly. At the time, she said the regulator needed 500 staff but had just 290.

SAHPRA received a clean audit from the auditor-general for its 2023/24 annual report, improving on the previous year’s unqualified audit with findings.

SAHPRA was established in 2018 as a section 3a public entity, which allows it to retain revenue along similar lines to the SA Revenue Service.

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