PRESENTATION BY CONSUMER GOODS COUNCIL OF SOUTH AFRICA ON: Proposed Medicines and Related Substances Amendment Bill 2008 Presented by: Nick Tselentis Nigel Sunley CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs POINTS TO BE RAISED Introduction Impact of the Bill Matters of concern to CGCSA members Need for control over health claims in food Potential interface between FC&D / Medicines & Related Substances Act Some implications Global considerations Summary CGCSA Legal & Regulatory Affairs

CONSUMER GOODS COUNCIL OF SOUTH AFRICA (CGCSA) Is the representative body in South Africa for both manufacturers and retailers of fast moving consumer goods such as food, cleaning materials and toiletries Represents its members on non-competitive issues, particularly in regard to legal and regulatory matters Works to improve supply chain efficiencies and acts as a communication body between manufacturers and retailers CGCSA Legal & Regulatory Affairs

FUNDAMENTALS OF THE BILL The CGCSA welcomes the principles behind the Bill and in particular any aspects of it that improve delivery of effective health services to the public We in principle support the establishment of the South African Health Products Regulatory Authority, provided it results in more effectively managed regulatory processes We do however have considerable concerns regarding the wide ranging nature of the product categories that will potentially be regulated under the Bill and in particular the potential impact on food products CGCSA Legal & Regulatory Affairs

HISTORICAL CONSIDERATIONS The food industry is concerned that the provisions of the proposed Bill in regard to foodstuffs are virtually identical to proposals put forward in 2004 under Act 101 At the time, the food industry and certain scientific bodies (ADSA / NSSA / SAAFoST) put forward comprehensive motivation to the MCC in regard to the exclusion of foodstuffs from Act 101 It appears that these representations have been entirely ignored and no consultation on them has been undertaken by the Department of Health during the interim period We therefore intend to reiterate many of the concerns raised in 2004 as these remain unchanged CGCSA Legal & Regulatory Affairs

IMPACT OF THE BILL ON FOODS CGCSA’s concerns are primarily focussed on the requirement that foodstuffs “making medicinal claims” will fall under the provisions of the Bill We are concerned that no definition is given for “medicinal claim” and that this potentially enables the authorities to arbitrarily place any claim relating to the health and nutrition benefits of a food into this category Such foodstuffs would then be subject to the extremely complex and costly regulations applicable to medicines CGCSA Legal & Regulatory Affairs

THE NEED FOR CONTROL OVER HEALTH CLAIMS The CGCSA fully recognises the need to protect the consumer from inaccurate and misleading statements in regard to the potential health and nutritional benefits of food Such controls are however in place under the Labelling and Advertising Regulations of the Foodstuffs Cosmetics and Disinfectants (FC&D) Act Regulation R642 gazetted for comment in July 2007 specifically incorporates provisions in this area There is no cross-referencing between the Medicines & Related Substances Act and the FC&D Act This has resulted in duplication of regulatory proposals and considerable frustration for the food industry CGCSA Legal & Regulatory Affairs

WE PROPOSE A CLEAR DIFFERENTIATION BETWEEN FOOD AND MEDICINE A food should be regarded as a product that is primarily consumed for the purposes of satisfying hunger and providing essential nutrients Products that provide a preventative health or nutritional benefit as a secondary attribute in addition to meeting the above criteria should also be regarded as foods These products should be regulated solely under the Foodstuffs Cosmetics and Disinfectants Act and adequate substantiation of any claims should be required. CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs MEDICINES Medicines should continue to be defined as per the Medicines Act i.e. “Any substance or mixture of substances in the use or proportion to be suitable for use or manufacture or sale for use in (a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or (b) restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine”. Foods should not fall into this category! CGCSA Legal & Regulatory Affairs

HOW TO MANAGE HEALTH AND NUTRITION CLAIMS FOR FOODS? The FC&D Act (both current and proposed amendments) incorporates comprehensive provisions for regulation of claims FC&D Act specifically prohibits the words “heal” and “cure” or “…any other medicinal therapeutic or prophylactic claim.” Proposed amendments gazetted in 2007 make provision for preventative health and nutrition claims: Nutrient content claims Enhanced nutrient function claims Reduction of disease risk claims Other specific claims e.g. probiotics, glycaemic index, slimming foods Proposed amendments also set out detailed labelling requirements for any food making claims CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs SOME LIMITED INTERFACE BETWEEN REGULATORY PROCESSES FOR FOODS AND MEDICINES MAY BE DESIRABLE Amendments to FC&D Act propose that the verification process for any new health claims will require a formal protocol Desirable that some measure of standardisation of documentation and process be achieved between foods and medicines - a single body could administer these However specific procedures will be required for foods and the assessing body should comprise food scientists and nutritionists as well as medical practitioners CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs WHAT WOULD THE IMPLICATIONS BE FOR FOODS IF THE BILL WAS PASSED IN ITS PRESENT FORM? Large numbers of existing foods for which established and well substantiated claims are being made would have to register under the Medicines & Related Substances Act and comply with its provisions in the areas of: manufacturing procedures documentation distribution & warehousing selling practices, promotional activities Cost of this would be huge and would probably result in many of them being discontinued The SA consumer would lose the benefits gained from these products or have to pay much more for the products concerned SAHPRA will need further specialist resources for foods – 482 is not enough! CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs POTENTIAL SCENARIOS Products such as maize meal, yogurt, margarine, certain breakfast cereals and fortified beverages would be treated as medicines as they all contain nutrients and other substances that help to maintain health and make claims for them Manufacturers of these products would have to upgrade their factories to pharmaceutical standards and maintain pharmaceutical-type records Promotion and sampling of these products would be prohibited Rebates and incentives for these products would be prohibited Supermarkets would have to register as pharmacies! WE BELIEVE THESE ARE UNINTENDED CONSEQUENCES OF THE BILL AND REQUEST THAT IT BE RE-CONSIDERED CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs THE GLOBAL POSITION No country in the world has implemented or is proposing to implement laws that classify foods as medicines Codex Alimentarius (the global food regulatory body) has clear provisions for foods that make health claims and treats them differently from medicines Imported foods will be unable to comply with the Bill, which could then be challenged as a potential Technical Barrier to Trade CGCSA Legal & Regulatory Affairs

CGCSA Legal & Regulatory Affairs IN SUMMARY The Bill has caused huge uncertainty in the food, beverage and retail industries due to lack of clarity and adequate definitions No guidelines in regard to foods were provided, whereas the FC&D Act makes comprehensive provision for regulating claims for foods and provides more than adequate protection to consumers The CGCSA therefore requests that all references to “foodstuffs” in the proposed Bill be removed and that any health and nutrition claims for foods continue to be managed under the Foodstuffs Cosmetics and Disinfectants Act by the Directorate of Food Control Some standardisation of the administrative procedures for approval of new claims for medicines and foodstuffs is however possible and we would encourage our members to support this CGCSA Legal & Regulatory Affairs

Questions are welcomed THANK YOU Questions are welcomed CGCSA Legal & Regulatory Affairs