22 October 2019
The South African Health Products Regulatory Authority (SAHPRA) has been referred to the Special Investigating Unit.
The presidency confirmed the referral in Proclamation 54 in Government Gazette 42773.
SAHPRA is responsible for monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials, medical devices and related matters in the public interest.
It replaced the Medicines Control Council.
The terms of reference for the investigation include investigating any alleged serious maladministration in connection with the affairs of the SAHPRA; improper or unlawful conduct by employees of the SAHPRA; offence referred to in Parts 1 to 4, or section 17, 20 or 21 (in so far as it relates to the aforementioned offences) of Chapter 2 of the Prevention and Combating of Corrupt Activities Act, 2004 (Act No. 12 of 2004), and which offences were committed in connection with the affairs of the SAHPRA; or unlawful or improper conduct by any person, which has caused or may cause serious harm to the interests of the public or any category thereof that took place between 1 January 2015 and the date of publication of the Proclamation or which took place prior to 1 January 2015 or after the date of publication of the Proclamation.
Matters to be investigated include maladministration in relation to the authorisation of the sale of unregistered medicines or medical devices, including in vitro diagnostic medical devices, and licensing and any unlawful or improper conduct by SAHPRA employees or any other person or entity.