SIU probes medicines regulator on fraud allegations
SA’s medicines regulator has suspended two members of its inspectorate and is facing a probe from the Special Investigating Unit (SIU) for alleged fraud relating to an undisclosed “external stakeholder”.
The probe raises questions about the processes for seeking regulatory approval for medicines and manufacturing sites and whether they have been tampered with, as well as the integrity of the products on the market. But the SA Health Products Regulatory Agency (Sahpra) assured consumers on Monday that the investigation will not affect the health and safety of the public “in any way”.
Sahpra is the third health sector watchdog agency to find itself in the sights of the SIU in 2019. The development comes hard on the heels of probes into the Council for Medical Schemes, which regulates the medical schemes industry, and the Health Professions Council of SA, which oversees healthcare professionals.
The SIU’s current focus on health is a mark of the elevated status afforded to the sector under President Cyril Ramaphosa and his determination to fight corruption, which he has made one of his top priorities.
The SIU is also investigating several provincial health departments and the National Health Laboratory Service.
Sahpra, which is charged with ensuring that the medicines and medical devices sold in SA are safe and effective, issued a statement at the weekend, saying it had received reports of alleged fraudulent activity implicating a small part of the organisation and an external party, but did not elaborate.
Two independent sources told Business Day on Monday that two members of Sahpra’s inspectorate had been placed on precautionary suspension.
The inspectorate has oversight of manufacturing facilities, wholesalers and clinical trial sites where experimental medicines are tested.
The SIU investigation was authorised in a proclamation signed by Ramaphosa and published in the Government Gazette on Friday. It says the SIU is to investigate allegations of serious maladministration and improper or unlawful conduct by Sahpra employees, dating back to January 2015.
Sahpra spokesperson Yuven Gounden declined to comment on the specifics of the probe.
Revealing who the stakeholder was, or identifying the two employees placed on precautionary suspension might compromise the investigation, he said. “Once the process has been completed, we shall release these details,” he said.
Sahpra had received information about the alleged corruption from a whistle-blower,
and its acting CEO Portia Nkambule, the Sahpra board and the then health minister Aaron Motsoaledi reported the matter to the SIU in February, he said.
The Pharmaceutical Task Group, an industry association for medicine manufacturers, said it had recently established a forum with Sahpra to discuss areas of mutual interest.
Pharmaceutical Task Group chair Stavros Nicolaou welcomed the SIU investigation, saying that allegations of bribery, corruption and other criminal activity “had been doing the rounds” for some time.
Sahpra is also under pressure from parliament, after it received a qualified opinion from the auditor-general for the 2018/2019 financial year, with irregular expenditure running at about R1.2bn.
It presented its annual report to parliament’s portfolio committee on health last week, which has asked it to return early in 2020 to report back on how it is dealing with its governance issues.