The South African Health Products Regulatory Authority (SAHPRA) says it has made significant strides toward strengthening its capacity and fulfilling its mandate over the past year. In 2022, it received its first unqualified audit, cleared the backlog of regulatory applications inherited from the Medicines Control Council (MCC), and received strong validation of its effectiveness in regulating vaccines from the World Health Organization (WHO).

Spotlight reports that the country’s regulator says a process is underway to review the Medicines and Related Substances Act to “assess whether legislative reform is needed to address ambiguities and align the Act with the current context and needs”.

It has highlighted plans to further strengthen the organisation’s capacity over the next year by focusing on digitisation and recruiting more staff.

SAHPRA has seen its allocation from Treasury decline in recent years. SAHPRA’s funding from Treasury fell from R183-million in the 2019/20 financial year to R146-million in 2021/22.

It has been able to offset some of these losses by generating more fee income. Fee-generated income rose from R54-million in the 2019/20 financial year to R181-million in 2021/22.

The regulator has repeatedly highlighted funding shortages as a key challenge to fulfilling its mandate.

CEO Boitumelo Semete-Makokotlela told members of Parliament in October 2022 that “while we were able to achieve what we have, it’s been a very challenging period for us from a financial perspective… we are in a country with a very tight fiscus, and, whilst that is the case, I think it is important that the regulator is adequately capacitated”.

In October, SAHPRA CFO, Regardt Gouws, told parliamentarians that the 2021/22 financial year marked the first year that SAHPRA income raised through fees exceeded government grants. This year, SAHPRA also received its first unqualified audit – reflecting the regulator’s strengthened financial management and reporting systems.

While the increase in fee revenue is a step in the right direction to ensuring that the regulator is properly financed, adequate government financing remains critical to ensuring that the regulator can carry out its mandate without undue influence from fee-paying companies.

Funding shortfalls at the regulator have contributed to staffing shortages. SAHPRA told MPs in Parliament in October that more staff are needed for digitisation, quality management, regulatory inspections and pharmacovigilance.

“At the MHRA [Medical and Healthcare Products Regulatory Agency] in the UK, the size of the team they have in the area of pharmacovigilance, is about 60 individuals. At SAHPRA, we only have five individuals in this area, and we know that the reports that we receive in terms of numbers are quite comparable. So, we are severely understaffed in this area,” said Semete-Makokotlela.

According to SAHPRA’s 2021/22 annual report, only 265 out of 375 positions at SAHPRA are filled. Gouws explained to Parliament that 95 positions at SAHPRA remain unfunded and that filling these positions would require an additional R67-million in annual funding.

In response to questions from Spotlight, SAHPRA indicated that progress has been made since the October presentation to Parliament and that only 25 positions now remain unfunded.

SAHPRA indicated that funding has been secured to fill previously unfunded positions through fee-generated income, from the Global Fund (via the Department of Health), and through securing approval from National Treasury to run on a budget deficit based on prior accumulated revenue surpluses.

SAHPRA also told Spotlight that funding has been secured from Germany’s development agency (GiZ GmBH) and the UK Department of International Trade to support its planned digitisation efforts, and that additional funding proposals for these efforts were going out.

Another important development at SAHPRA, announced earlier this month, was the clearance of the regulatory backlog inherited from the MCC. When SAHPRA, took over from the MCC, it inherited around 16,000 regulatory applications dating back to 1992.

SAHPRA, developed a plan and raised funding for a dedicated budget and staff to clear the inherited backlog. The backlog clearance project was launched in August 2019 and, on 2 December 2022, SAHPRA announced that the backlog had been fully cleared.

Dr Nicholas Crisp, Deputy Director-General for National Health Insurance at the Department of Health, called clearance of the backlog “a milestone for SAHPRA”, while Stavros Nicolaou, chairperson of the Pharmaceutical Task Group (PTG), said the PTG “welcomes this development and congratulates the SAHPRA board and management in achieving the significant clearing of the registration backlog that has historically hampered the MCC”.

The most exciting development at SAHPRA in 2022 was the achievement of a maturity level 3 ranking for vaccines regulation from the World Health Organization (WHO).

The WHO uses a ranking system ranging from one (the lowest) to four (the highest) to rank the maturity and effectiveness of health products regulatory organisations in meeting their mandates to ensure that health products are safe and effective.

Following an initial 2021 and subsequent 2022 assessment of SAHPRA by the WHO, the regulator announced in October 2022 that it had received WHO maturity level 3 (ML3) ranking for vaccine regulation and maturity level 4 (ML4) status for vaccine lot release.

Only five health product regulatory authorities on the African continent have received a maturity level 3 designation from the WHO. South Africa and Egypt have received this designation for vaccine regulation, while Ghana, Tanzania and Nigeria have achieved this status for medicine regulation.

Only South Africa has received a maturity level 4 ranking for lot release, which involves evaluating batches of vaccines before they are released for use in the country. All batches of vaccines used in South Africa must be evaluated at the national control laboratory in Bloemfontein prior to their use.

SAHPRA has also become more transparent and improved its communications in recent years, most notably with a searchable database of registered products, but here too, there remains some way to go, especially on the reasoning and evidence behind regulatory decisions.

Much also remains to be done by the regulator to address areas for which regulatory systems must still be developed and strengthened, including complementary products and medical devices and addressing its organisational weaknesses (i.e. lacking digital systems and skills).

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