Presented by J F Luterek, Pr.Eng Hahn & Hahn Attorneys

 Pick ‘n Pay Retailers (Pty) Ltd are one of the largest food retailers in South Africa with a turnover of R45.4 Billion as at 29 Feb 2008  Pick ‘n Pay also operate a chain of pharmacies primarily in the Pick ‘n Pay Hypermarkets  Well known in the marketplace as discounter of foodstuffs, nutritional products, vitamin supplements, and now medicines both under their own brands and supplier brands

 Supplements and Vitamins  Foodstuffs  Schedule 0 Medicines  Unregistered Medicines  Complementary Medicines  Purpose of the Foodstuffs, Cosmetics and Disinfectants Act  Purpose of the Medicines and Related Substances Act

 Directorate of Food Control of the Department of Health is currently drafting Regulations in terms of the Foodstuffs, Cosmetics and Disinfectants Act to regulate Nutritional Supplements and Vitamins  Supplements and Vitamins are widely believed a crucial part in health support of Immune system compromised individuals  Inclusion into Medicines and Related Substances Act will severely limit access to supplements and vitamins by the poor, especially the rural poor

 Why is inclusion likely to reduce stocking thereof by Pick ‘n Pay? ◦ Effect of Section 18 of the principal Act (Sections 12 to 14 of the Bill)  Restrictions on marketing similar to medicines  No bonusing allowed i.e. rebates etc  No sampling of product allowed – free samples out! ◦ Effect of Section 22 of the prncipal Act is the restriction of where Pick ‘n Pay may purchase such products - (Section 26 of the Bill) ◦ Typical turnaround of supplements on shelves is MUCH slower than foodstuffs and over regulation makes it not viable to stock these products.

 Foodstuffs, Cosmetics and Disinfectants Act ◦ Administered by DoH, Directorate of Food Control ◦ Food labelling regulations  GNR2034/ Regulations Governing the Labelling and Advertising of Foodstuffs, Regulation 2(9)(c) prohibits “…the words ‘heal’ or ‘cure’ or ‘restorative’ or any other medicinal, therapeutic or prophylactic claim.”  Pending revised Labelling and Advertising Regulations published in GG on July 20 th 2007, Regulation 14(k) prohibits “…the word ‘cure’ or any other medicinal claim except those health claims permitted in terms of these regulations.”, and Regulation 52, 60 to 62 will regulate Health, Nutrition, and Disease reduction claims.

 Medicines and Related Substances Act ◦ Administered by Department of Health ◦ Main objective is to regulate medicines and related substances – littered with references to Doctors and Dentists e.g. Section 19 of the Bill ◦ Now: Introduction of foodstuffs if they make a medicinal claim. ◦ BUT: This is already regulated under GNR2034/1993 and even more strictly under the pending Food labelling regulations published on 20 July ◦ Lead to uncertainty and duplication of functions of various directorates within the Department of Health ◦ Application of medicines procedures to foodstuffs, supplements and the like detrimental to end user – cost!

 Schedule 0 medicines and complementary medicines are exempt from the provisions of sections 18A and 22G of the principal Act from 2004  Unregistered Medicines (those called up for registration in terms of the Bill), should also be subject to the exemption  Exemption should not be discretionary (later Regulations) but in the Bill or the Bill should include a review by the Portfolio Committee for all Regulations  The poor rely on these medicines and competition between retailers keeps prices down.

 Foodstuffs, Cosmetics, and Disinfectants Act and Regulations (FCD Act) ◦ Ensure food safety ◦ Require proper informative labelling of foodstuffs ◦ Prohibit false health, nutritional, and other similar claims on foodstuffs ◦ Interact with food manufacturers, retailers etc  Medicines & Related Substances Act (MRS Act) ◦ Market approval of medicines ◦ Regulate pricing and distribution channels of medicines ◦ Interact with pharmacy industry, doctors, dentists

 Exclude all foodstuffs from the Bill  If not, then: ◦ adopt a definition for “medicinal claims”. ◦ Amend Section 26 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

 New Definition required for “medicinal claims”  New Shorter Oxford Dictionary has the following meaning of “medicinal”: “ medicinal” - having healing or curative properties or attributes Thus, introduce a definition of “medicinal claims” – claims directed at the curing or healing of a recognized medical condition or illness of the human body by a foodstuff;

Section 26 (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.