Education

Question by: 
Hon Brett Herron
Answered by: 
Hon Debbie Schäfer
Question Number: 
12
Question Body: 

With reference to the reply to question 3 published in the Question Paper for Written Reply dated 19 February 2021 received from the Minister of Finance and Economic Opportunities paragraph (g): “It is not a requirement for companies to be registered with SAHPRA” According to a presentation by SAPHRA dated 10 July 2020 titled “The role of SAHPRA and the licensing process for PPE medical device establishments” the following PPE is regarded as medical devices Masks, Gloves, Gowns and Surface sanitisers. According to the Provincial Procurement Reports, Masiqhame Trading 1057 supplied, inter alia, the following PPE: Plastic Aprons, Cloth Masks, Disposable Masks, Gloves and Sanitiser. The tender documents issued by the Western Cape Provincial Government tenders for PPE has a mandatory section, which requires suppliers to Register with SAPHRA. 

 

(a) Why was Masiqhame Trading 1057 exempted from being a SAPHRA licensed supplier, (b) what process was used to exempt Masiqhame Trading 1057 from being a licensed supplier, (c) what is the total procurement, in Rand value, of PPE medical devices as defined by SAPHRA from Masiqhame Trading 1057 and (d) what is the total procurement Rand value, by her Department, from March 2020 to date?

Answer Body: 

It is important to distinguish between medical-grade PPE (used in hospital and other healthcare settings) and protective materials used by the general public, such as cloth masks. During a pandemic, we must ensure that our healthcare facilities have an adequate supply of medical-grade PPE to prevent the spread of infection in that setting, while non-medical items, such as cloth masks, aprons and gloves, can be used in other settings.

Unfortunately, it has become common practice to collectively incorrectly term both medical and non-medical protective materials as “PPE”, which explains the member’s confusion regarding SAHPRA licencing. The items acquired from Masiqhame Trading are not medical grade PPE, and do not require SAHPRA approval.

  1. The WCED utilised its current contract with Masiqhame Trading for the supply and delivery of certain protective materials. This was in line with the requirements of the National Treasury Instruction 5 of 2020. The said Instruction made no reference to the requirements of SAHPRA licensing at the time.   
  2. As stated in (a) above, there was no requirement by the National Treasury that service providers had to comply with SAHPRA. 
  3. No medical products as defined by SAHPRA were purchased, as the WCED does not operate healthcare facilities.

 The member needs to clarify this – total procurement of what specifically?

Date: 
Friday, March 26, 2021
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