Massmart Presentation on Medicines and
Related Substances Amendment Bill, 2008
Presentation by Graham Rebello
Massmart Channel Executive
The Massmart Portfolio
MASSMART HOLDINGS
243 Stores
MASSDISCOUNTERS
GM discounters >LSM 5 - 10
92 stores
MASSWAREHOUSE
Warehouse Club > LSM 5 - 10
13 stores
MASSBUILD
DIY HI Outlets > LSM 6 - 10
67 stores
MASSCASH
Food cash & carry > LSM 2 - 5
72 stores + 574 members
“Foodstuff” & “Cosmetic”
• Foodstuffs, Cosmetics and Disinfectants Act
Regulations thereunder
and
– Directorate of Food Control
– Current food labelling regulations
• GNR2034/1993 - Labelling and Advertising of
Foodstuffs, Regulation 2(9)(c) prohibits use of words
such as ‘heal’, ‘cure’, ‘restorative’, or any other
medicinal, therapeutic or prophylactic claim.
– Proposed Food labelling regulations published 07/2007:
• Regulation 14(k) prohibits use of the word ‘cure’ or any
other medicinal claim except those health claims
permitted in terms of these regulations. See Reg 62
- Nutritional Supplements regulations currently being
prepared by Directorate of Food Control which will
regulate all aspects of supplements.
Foodstuffs & Cosmetics – “products”
• Medicines and Related Substances Act
– Regulates medicines and related substances
– Now: Bill introduces foodstuffs & cosmetics if “medicinal
claims are made” – no definition creates confusion?
•
•
•
•
Regulatory enforcement
Manufacturers and importer compliance
Wholesalers and Retailers compliance
Customer issues / awareness
– Lead to uncertainty and duplication of functions of
various directorates within the Department of Health
– “Food Control” should be in control of claims made in
respect of foods?
Wholesaler
• Massmart are “wholesalers” in the broad meaning of
th
the word and by definition within GN R510 of 10 April
2003 – “"wholesaler" means a dealer who purchases medicines from a
manufacturer and sells them to a retailer and includes a wholesale pharmacy;” :
– Jumbo sells foodstuffs, cosmetics, and OTC
medicines to both the public directly (consumers)
and to independent retailers (commercial).
– The wording of Section 22H of the Act, should be
redrafted to exclude Cash and Carry wholesalers
who sell general consumer goods to consumers on
demand from the definition of "wholesaler".
– Accordingly a definition of wholesaler should be
introduced and an amendment to Section 22H is
proposed (Section 27 of the Amendment Bill).
Schedule 0, Complementary and
Unregistered Medicines
• Schedule 0, Unregistered and Complementary
Medicines are like other fast moving consumer goods
– Highly competitive market because of extensive sales
channels through companies like Massmart
– Competition is healthy and the consumer effectively
dictates prices in a highly competitive market
– Advantageous for the poor who can’t afford to consult
doctors but need simple medication for ailments
– Sold widely to spaza shops and small retailers for
resale in small quantities to the public, especially in
rural areas.
• Exemption from Sections 18A and 22G of the Act (prior
to amendment) must be made explicit in the Bill
Unforeseen Consequences
• Many of Massmart’s outlets are located in rural areas
and serve rural communities
• Supply spaza shops and small retailers as well as the
public directly (bulk purchases)
• Massmart would have to discontinue entire ranges of
products so as not fall foul of the Bill either because of
the lack of definition of “wholesaler” and “medicinal
claim”
• fortified maize and wheat, margarines claiming to
reduce cholesterol etc could be considered medicines
• Spaza and small retailers would be unable to source
these products and the rural consumer would be
unable to obtain such products which would only be
stocked in pharmacies
Submissions
• Introduce a definition of “wholesaler” which clarifies the
position of companies such as Massmart
• Exclude all foodstuffs and cosmetics from the Bill
• Alternatively:
– adopt a definition for “medicinal claims”.
– Amend Section 27 of the Bill (Section 22H of the Act) to
remove unforeseen consequences around wholesalers
selling foodstuffs
– Amend Section 7 of the Bill (Section 15(7) of the Act) to
reduce the administrative burden on small companies
which manufacture foodstuffs considered to fall under
the Bill
Proposed Amendments
• Proposed New Definitions
– “medicinal claims” – claims directed at healing or
curative properties or attributes of the human body by a
foodstuff or cosmetic;
– “wholesaler” – entity which distributes or sells
medicines and/or medical devices solely to the retail,
but excluding general merchandise and food
wholesalers;
Proposed Amendment
Section 27 (22H of the Act)
• (1)(a) No wholesaler shall purchase [medicines] products
medicines or medical devices from any source other than
the original manufacturer or from the primary importer of
the finished product.
• (b) A wholesaler shall sell [medicines] products medicines
or medical devices only into the retail sector.
Section 7 of the Bill (15(7) of the Act)
• Any certification or registration under this section, shall be
valid for a period of five years in the case of medicines
and medical devices and indefinitely until revoked in
the case of cosmetics and foodstuffs and may be made
subject to such condition as may with regard to the
succeeding provisions of this section to be determined by
the Authority or the Minister respectively.