Special Investigating Units And Special Tribunals Act, 1996 (Act No. 74 of 1996)

Proclamations

Referral of Matters to Existing Special Investigating Unit

South African Health Products Regulatory Authority SAHPRA

Proclamation No. R. 54 of 2019
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Proclamation No. R. 54

18 October 2019

GG 42773

PROCLAMATION NO. R.54 OF 2019

by the

PRESIDENT of the REPUBLIC of SOUTH AFRICA

 

WHEREAS allegations as contemplated in section 2(2) of the Special Investigating Units and Special Tribunals Act, 1996 (Act No. 74 of 1996) (hereinafter referred to as "the Act"), have been made in respect of the affairs of the South African Health Products Regulatory Authority established in terms of section 2 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) (hereinafter referred to as "the SAHPRA");

 

AND WHEREAS I deem it necessary that the said allegations should be investigated and civil proceedings emanating from such investigation should be adjudicated upon;

 

NOW, THEREFORE, I hereby, under section 2(1) of the Act, refer the matters mentioned in the Schedule, in respect of the SAHPRA, for investigation to the Special Investigating Unit established by Proclamation No. R. 118 of 31 July 2001 and determine that, for the purposes of the investigation of the matters, the terms of reference of the Special Investigating Unit are to investigate as contemplated in the Act, any alleged—

(a) serious maladministration in connection with the affairs of the SAHPRA;
(b) improper or unlawful conduct by employees of the SAHPRA;
(c) 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
(d) 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,

which took place between 1 January 2015 and the date of publication of this Proclamation or which took place prior to 1 January 2015 or after the date of publication of this Proclamation, but is relevant to, connected with, incidental or ancillary to the matters mentioned in the Schedule or involve the same persons, entities or contracts investigated under authority of this Proclamation, and to exercise or perform all the functions and powers assigned to or conferred upon the said Special Investigating Unit by the Act, in relation to the said matters in the Schedule.

 

Given under my Hand and the Seal of the Republic of South Africa at Pretoria this 4 day of October Two thousand and nineteen.

 

CM Ramaphosa

President

 

By Order of the President-in-Cabinet:

 

R Lamola

Minister of the Cabinet

 

SCHEDULE

 

1. Maladministration in connection with the affairs of the SAHPRA in relation to―
(a) the authorisation of the sale of unregistered medicines or medical devices, including in vitro diagnostic medical devices; and
(b) licensing,

in terms of the Medicines and Related Substance Act, 1965, including the causes of such maladministration.

 

2. Any unlawful or improper conduct by―
(a) employees of the SAHPRA; or
(b) any other person or entity,

in relation to the allegations set out in paragraph 1 of this Schedule.