Not yet two years old, health body is already ailing

The portfolio committee on health this week “expressed concern” about the performance of the newly constituted South African Health Products Regulatory Authority (SAHPRA) and gave it four months to come up with a turnaround plan.

“It informed the committee [of] a qualified audit opinion, with irregular expenditure amounting to about R1.2 million,” committee chairperson Dr Sibongiseni Dhlomo said yesterday.

“The irregular expenditure relates to noncompliance with supply chain management (SCM) regulations, which emanates from a lack of capacity in its SCM unit,” said Dhlomo.

Irregular expenditure is not SAHPRA’s only problem, either.

According to the June South Africa Pharmaceutical Industry Report 2019, a changing industry, the advent of National Health Insurance and a changing regulatory environment were among other challenges.

“The pharmaceutical sector, which researches, develops, markets and distributes drugs, as part of the wider healthcare system, is valued at R50 billion at manufacturers’ exit price and R68 billion using retail sales,” the report said.

Other issues facing the industry include intellectual property regime overhaul, Competition Commission health inquiries and the introduction of a new regulator for medicines, medical devices and complementary medicines, such as SAHPRA.

Rising from the ashes of the Medicines Control Council, SAHPRA also inherited a Special Investigation Unit (SIU) probe initiated in 2015 and given legs by President Cyril Ramaphosa’s gazetting of Proclamation 54 of 2019 this month.

This will allow the SIU to investigate “any alleged” serious maladministration, improper or unlawful conduct and unlawful or improper conduct caused “or may cause serious harm to the interests of the public or any category thereof”.

In its year-end report, chairperson Professor Helen Rees noted the new organisation had inherited 16,000 applications.

“Of these applications 50% are over five years old and 90% are generic medicines,” Rees said. “Using the current strategies, it would take eight years to clear the backlog even if no new applications were received.”

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