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Medicines and Related Substances Amendment Bill

Medicines and Related Substances Amendment Bill. Joint comment by The Nutrition Society of South Africa Association for Dietetics in South Africa Presented by Prof Johann Jerling. NSSA & ADSA. Represent around 2000 dietitians and nutrition scientists in SA

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Medicines and Related Substances Amendment Bill

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  1. Medicines and Related Substances Amendment Bill Joint comment by The Nutrition Society of South Africa Association for Dietetics in South Africa Presented by Prof Johann Jerling

  2. NSSA & ADSA • Represent around 2000 dietitians and nutrition scientists in SA • Custodians of science and practice of nutrition at a therapeutic and public health level in SA • Food Legislation Advisory Group of the DOH (Directorate Food Control)

  3. Support • We support the creation of an agency that will effectively regulated Foods and Medicine in SA • We are in agreement that health claims on foods in SA should be regulated

  4. Concerns – key points • Duplication • Consultation • Definitions • Impact

  5. DOH - Directorate Food Control • Food Legislation Advisory Group (FLAG) • Published draft regulations deal extensively with health claims

  6. Pharmaceutical Industry Association of South Africa (PIASA) Innovative Medicines of South Africa (IMSA) National Association of Pharmaceutical Manufacturers (NAPM) South African Clinical Research Association (SARCA) Physicians of the Pharmaceutical Industry (PPI) (SARHA) National Association of Pharmaceutical Wholesalers (NAPW) Health Product Association (HPA) South African Medical Device Industry Association (SAMED) Pharmacy Council of South Africa (PCSA) Medicines Control Council (MCC) Medicines Regulatory Authority (MRA) Stakeholders consulted

  7. Nutrition & Health Stakeholders • NSSA – Nutrition Society of South Africa • ADSA – Association for Dietetics in South Africa • PHASA – Public Health Association of South Africa • SAAFOST – South African Association for Food Science & Technology • ILSI – Institute of Life Sciences • CGCSA – Consumer Goods Council of South Africa

  8. Definitions • Medicine and Related Substances Act (Act 101 of 1965)No definition of medicinal claim – average person may assume that it is derived from the word medicine • Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972)Health claim - means any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health, and include but are not limited to nutrient function claims, enhanced function claims, reduction of disease risk claims, prebiotic claims, probiotic claims and slimming claims

  9. Medicine and Related Substances Act (Act 101 of 1965) Definition of Medicine “any substance or mixture of substances used or purporting to be suitable for use or manufacture or sale for use in - the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine” Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972) Definition of Foodstuff “any article or substance (except a medicine as defined in the Medicine and Related Substances Act,1965 [Act no.101 of 1965]) ordinarily eaten or drunk by a person or purporting to be suitable, or manufactured or sold, for human consumption, and includes any part or ingredient of any such article or substance, or any substance used or intended or destined to be used as a part or ingredient of any such article or substance”. Definitions

  10. Impact…. Definition of Medicine “any substance or mixture of substances used or purporting to be suitable for use or manufacture or sale for use in - • the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or • restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine”

  11. Conclusions • Remove “foodstuffs” from the current Bill until inclusive consultation has taken place with food and nutrition stakeholders to: • Merge/unify/align parallel processes within DOH • Formulate clear definitions • Assess the impact of the proposed changes and definitions on food security, food prices, advertising, global trade and most importantly - public health

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