Medicines regulator calls for step-up in funding

SA’s medicines regulator has once again appealed to the National Treasury for more funding, saying its increasing reliance on fee income is putting it in a risky position.

The SA Health Products Regulatory Authority (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. Its government grant has been declining for several years and dropped 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 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, said Sahpra CEO Boitumelo Semete.

“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,” she said shortly after presenting Sahpra’s 2023/24 annual report to parliament. “If you are fully reliant on industry it puts you in a risky position.”

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 Sahpra needed 500 staff but had just 290.

On Tuesday she told parliament’s portfolio committee on health that Sahpra’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. 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.

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.

Semete told MPs the regulator expected to make a decision about Bavarian Nordic’s Mpox vaccine, known as Jynneous, within the next week. The shot has been pre-qualified by the World Health Organisation (WHO), enabling faster assessment by medicine regulators such as 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.

SA reported five unlinked Mpox cases in 2022. There were no confirmed cases in 2023, though this year 25 laboratoryconfirmed cases and three deaths were recorded between May and early September, according to the WHO.