SIU Investigation into SAHPRA

In a Proclamation published in the Government Gazette 442773 on 18 October 2019, the President has referred matters relating to maladministration at SAHPRA to the Special Investigating Unit in terms of Section 2 of the Special Investigating Units and Special Tribunals Act 74 of 1996.

The Special Investigating Unit (SIU) is mandated to investigate serious malpractices or maladministration relating to state institutions, state assets and public money; to investigate any contact which may seriously harm the interests of the country and to establish a Special Tribunal to hear civil matters.

Section 2 of the Act provides for the President to establish Special Investigating Units or Special Tribunals as he/she deems necessary on grounds of any alleged:

• Serious maladministration;
• Improper or unlawful conduct by employees;
• unlawful, irregular or unapproved recuisitive act, transgression, measure or practise having a bearing upon State property;
• Intentional or negligent loss of public money or damage to public property;
• Offences in relation to the Prevention and Combating of Corrupt Activities Act, 2004; or
• Unlawful or improper conduct by any person which has caused or may cause serious harm to the interests of the public.

It is unclear what has lead to this Proclamation or the source or veracity of any underlying prima facia grounds for its referral. It is however, safe to say that if there is wrongdoing that it needs to be properly investigated and appropriate remedial actions implemented to correct and prevent even the appearance of any malfeasance at this important state institution.

SAHPRA have an enormous challenge ahead of it:

• The establishment of SAHPRA itself and the recruitment of staff;
• A massive backlog in medicines registration and amendment applications going back years;
• Licencing of Cannabis manufacturers;
• Licencing and imminent commencement of Medical Devices; and
• to mention just a few.

Therefore, one hopes that this is not a distraction from the important work it has in safeguarding everyday South African’s from substandard medical products which are unsafe, don’t do what they intend or are of poor quality.

Mark Banfield is an independent Health Technology Consultant specializing in Quality Assurance, Regulatory Compliance, Market Research and Development.