Question NW1458 to the Minister of Health
02 June 2023 - NW1458
Ceza, Mr K to ask the Minister of Health
Considering that in November 2022 the SA Health Products Regulatory Authority gave notice of their investigation into Tembisa Hospital on the procurement of hospital consumables and medical devices, what was the outcome of the specified investigation?
Reply:
According to the South African Health Products Regulatory Authority (SAHPRA), the Regulatory Compliance inspectors conducted investigations of which terms of reference were based on the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as amended, read with Medical Devices Regulations relating to Medical Device establishment licensing and the distribution (that include sales) of medical devices including In Vitro Diagnostics (IVD’s).
The investigations included amongst others, meeting with Tembisa Hospital Executive management, visiting the addresses of referenced businesses, meeting with Directorate for Priority Crime Investigation (DPCI) and the Special Investigating Unit (SIU).
All the stock at hand supplied by the unlicensed companies found at Tembisa Hospital was seized by SAHPRA inspectors during the investigations. The Regulatory Compliance inspectors finally deposed multiple affidavits as evidence for contravention of the Act and the Regulations referred to above. The matter is currently handled/managed by the DPCI and the National Prosecuting Authority (NPA).
The latest update received is that based on the SAHPRA inspectors’ evidence in the form of the affidavits, the DPCI conducted raids of the alleged suppliers of medical devices and that more raids and arrests are imminent.
END.