The Special Investigating Unit will probe allegations of maladministration at the South African Health Products Regulatory Authority.
President Cyril Ramaphosa's proclamation, signed on October 4, 2019, was gazetted on Friday.
The health products regulator oversees the regulation of medicines, medical devices, in-vitro diagnostic tests and devices, radiation emitting products and devices used in the health care and industry, according to the SAHPRA website. It replaced the former Medicines Control Council and the Directorate of Radiation Control.
The matters for investigation date back to January 2015.
The terms of reference of the investigation include having the SIU look into any alleged "serious maladministration in connection with the affairs of the SAHPRA," the proclamation read. The SIU must also investigate allegations of "improper or unlawful" conduct by employees of the regulator.
The investigation will also cover whether certain sections of the Prevention and Combating of Corrupt Activities Act. This includes section 17 – which has to do with employees of a public body unlawfully scoring a private interest in a contract or investment connected to the public body; section 20 – which has to do with an individual unlawfully benefiting through corrupt or unlawful activities and section 21- which has to do with conspiring or attempting to involve another person in an offence.
Finally, the SIU will investigate allegations of "unlawful or improper" conduct by any person which caused or may cause "serious harm" to the "interests of the public".
The maladministration relates to the authorisation of the sale of unregistered medicines or medical devices, including in vitro diagnostic medical devices and licensing. The SIU will also look into the causes of the maladministration, the proclamation read.
SAHPRA in turn issued a statement on Saturday, throwing its weight behind Ramaphosa's proclamation.
According to SAHPRA, in February 2019 it had received reports of alleged fraudulent activity implicating "a small sector of the authority and an external stakeholder," the statement read. SAHPRA’s acting CEO, the board and the Health Minister had reported the allegations to the SIU.
SAHPRA did not name the those involved or give details on the fraudulent activities.
"Core to SAHPRA's success is ethical conduct and good governance. All allegations of misconduct involving either internal or external stakeholders will be thoroughly investigated and responded to," said Professor Helen Rees, board chairperson.
Acting CEO Portia Nkambule said the organisation is in the process of rebuilding its regulatory systems to "improve efficiency, transparency and accountability." This includes developing appropriate communication channels for complaints such as unethical and criminal behaviour.
Sahpra spokesperson Yuven Gounden told Fin24 via email that the investigation will be launched "shortly". "SAHPRA awaits feedback from the SIU. The length of the investigation will depend on the nature of the allegations and the extent of the alleged allegations," Gounden said.
The investigation is not expected to impact on the daily operations of the regulator, he added.
*This article was updated at 15:50 on Monday October 21, 2019 to include comment from SAHPRA spokesperson Yuven Gounden.