SA’s medicines regulator has again appealed to National Treasury for more funding, saying its increasing reliance on fee income puts it in a precarious position, and that with a shortage of technical staff, it is struggling to do its job.
It was established in 2018 as a section 3a public entity, allowing it to retain revenue along similar lines to the SA Revenue Service, but the government grant for the SA Health Products Regulatory Authority (SAHPRA) has been shrinking for several years, dropping from R146m in 2021/22 to R137m in 2023/24, while its fee income rose from R169m to R228m over the period.
Over-reliance on fee income puts it in a “high-risk situation” because consolidation in the pharmaceutical industry had the potential to reduce revenue from companies seeking authorisation for their products, said CEO Boitumelo Semete.
“A significant reduction in fees affects our operations. There are projects we want to invest in, such as capacity building, infrastructure and IT systems, that we want to be able to pay for from the National Treasury allocation,” she said shortly after presenting SAHPRA’s 2023/24 annual report to Parliament. “But being fully reliant on industry puts you in a risky position.”
Semete has previously asked Treasury for a bigger budget, telling Parliament in 2021 that the regulator didn’t have enough money to hire the staff it needed to do its job properly. Business Day reports that she had said the organisation needed 500 staff but had just 290.
Last Tuesday, she told the Portfolio Committee on Health that SAPHRA’s staff complement had barely grown since then, and stood at just 313.
“We are understaffed; it is one of our biggest challenges,” she said. A shortage of technical staff, she added, was hampering its ability to timeously process applications for medicines and clinical trials and forcing personnel to work overtime to meet performance targets.
The regulator received a clean audit from the Auditor-General for its 2023/24 annual report, improving on the previous year’s unqualified audit with findings.
Semete told MPs the regulator expected to make a decision about Bavarian Nordic’s mpox vaccine, Jynneous, within the next week. The shot has been pre-qualified by the World Health Organisation (WHO), enabling faster assessment by medicine regulators like SAHPRA.
“We are relying on the WHO decision (and) are not doing a full review. This will ensure the country gets the stock it needs,” she said. Bavarian Nordic submitted a dossier on Jynneos to SAHPRA three weeks ago.
The Health Department has been trying to secure mpox vaccines for months. In June, then health minister Joe Phaahla said officials were working with the WHO and hoped to receive the first doses within days.
Business Day PressReader article – Medicines regulator calls for step-up in funding (Open access)
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