THE SELF MEDICATION MANUFACTURERS ASSOCIATION OF SOUTH AFRICA (SMASA)

1. THE SELF MEDICATION MANUFACTURERS ASSOCIATION OF SOUTH AFRICA (SMASA) MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL, [BILL 6 OF 2014] Allison Vienings – Executive Director Dr Deepa Maharaj – Vice Chair – Technical Health Portfolio Committee Cape Town, 29 October 2014 SMASA - Medicines Bill 6

2. Who we are • SMASA was formed in 1999 and represents the interests of the manufactures of non-prescription medicines (OTC) • We serve to promote responsible self-medication to the public • SMASA welcomes and supports the introduction of SAHPRA and Bill 6 • SMASA is appreciative of the opportunity to present to Parliamentary Health Portfolio Committee SMASA - Medicines Bill 6

3. Full Members Adcock Ingram Healthcare Aspen Pharmacare Bayer Consumer Care Boehringer-Ingelheim SA FDC SA GlaxoSmithKline SA iNova Pharmaceuticals Johnson & Johnson Consumer Merck Consumer Healthcare Norgine Novartis SA Pfizer Consumer Healthcare Procter & Gamble Reckitt Benckiser Sandoz SA Smith & Nephew Takeda Vital Health Foods Winthrop Pharmaceuticals (Sanofi Consumer Healthcare) Associate Members Clicks Holdings Dischem Pharmacies Imperial Health Sciences MediRite Pharmacies SA (Shoprite Checkers) MRA Regulatory Consultants X-Procure Software SA SMASA members SMASA - Medicines Bill 6

4. Discussion points 1. Matters of Principle • Rationalisation required • Alignment and harmonization required • Main areas of concern • Specific Comment • Definitions : complementary products • Scheduled substances: where to remove • Scheduled substances are not products • Recommendation and Final Conclusion SMASA - Medicines Bill 6

5. Matters of Principle SMASA - Medicines Bill 6

6. Rationalization required • One size does not fit all • Create within SAHPRA structures that are appropriate for each product type e.g. medicines, cosmetics, medical devices, CAMs • Ensure adequate and fair representation of all products within SAHPRA board, committees and technical structures • Create registration flows and criteria appropriate to the type of product in question SMASA - Medicines Bill 6

7. Key: Rationalisation Law gives powers to NDoH / DG Law gives powers to MCC / SAHPRA Foodstuffs, Cosmetics & Disinfectants Act & draft regs Allopathic medicines Medicines Act + amendments + genlregs Foods CAMS – Complementary medicines Foodstuffs, Cosmetics & Disinfectants Act SAHPRA Medicines Act + amendments + genlregs Bill 6 & Act 72 Cosmetics Medical devices Disinfectants Act,National Regulator for Compulsory Specifications Act Act 72 + Bill 6 + draft device regs IVDs Disinfectants Hazardous Substances Act & regs Act 72 + Bill 6 + draft device regs SMASA - Medicines Bill 6 Electro-medical / radiation devices

8. Rationalisation Required • Learn from past experience: • What caused the backlog? • How can further backlogs be avoided as scope of control expands? Timelines? • SAHPRA as a PFMA entity? • Prevention by re-designing how we do things (instead of getting more “who’s”) • Incorporation of products without separate regulatory processes and appropriate staffing and structure (CAMs) SMASA - Medicines Bill 6

9. Alignment and harmonization • Reciprocal registration for OTC, medical devices and CAMs suggested where registered through reputable structures such as EU, TGA etc. • Suggest SAHPRA must enter into recognition agreements with reputable regulatory authorities for medical devices and IVDs, some of which are so-called borderline devices (denture, contact lens solutions) • This will be necessity given the regulatory scope and magnitude of numbers of products SMASA - Medicines Bill 6

10. Main Areas of Concern for SMASA • Structure and formation of SAHPRA – skills resources and capacity of SAHPRA to achieve the widest and most efficient form of regulation and control of medicines S.A. - one size (one regulatory model) will not fit all • Timelines associated with registrations and handling of backlog • SAHPRA as a PFMA entity – assurance of financial independence AND financial sustainability • “Regulatory oversight” of Foodstuffs and Cosmetics – Legislative control lies with the Foodstuffs, Cosmetics and Disinfectant Act 54 of 1972. Can mere amendments to the Medicines Act change this? SMASA - Medicines Bill 6

11. Main Areas of Concern for SMASA • To find a solution to the immediate crisis facing the health and wellness sector of industry • Address concerns of the potential damaging effects on the viability of the CAMs industry • Threat of little future availability of health and wellness products for which there is a demand SMASA - Medicines Bill 6

12. Main Areas of Concern for SMASA • Serious consideration must be given to the fact that a “ONE SIZE FITS ALL APPROACH” WILL NOT WORK SMASA - Medicines Bill 6

13. Main Areas of Concern for SMASA • Lack of legal certainty in many areas • The current overlap of regulations has resulted in erroneous categorization and registration of foods, disinfectants, cosmetics and medical devices as medicines • Clear Guidelines needed SMASA - Medicines Bill 6

14. Key: Complexity Law gives powers to NDoH / DG Law gives powers to MCC / SAHPRA Foodstuffs, Cosmetics & Disinfectants Act & draft regs Allopathic medicines Medicines Act + amendments + GenlRegs Foods CAMS – Complementary medicines Foodstuffs, Cosmetics & Disinfectants Act SAHPRA Medicines Act + amendments + GenlRregs Bill 6 & Act 72 Cosmetics Medical devices Disinfectants Act,National Regulator for Compulsory Specifications Act Act 72 + Bill 6 + draft device Regs IVDs Disinfectants Hazardous Substances Act & regs Act 72 + Bill 6 + draft device regs SMASA - Medicines Bill 6 Electro-medical / radiation devices

15. Specific Comments SMASA - Medicines Bill 6

16. Definition • Definition of a complementary medicine Section 1 (d) “Complementary Medicine” • Inflexible, ill-conceived and misplaced • Should be moved from Principal Act to Regulations • Existing definition of a medicine should stay unchanged • At most the following words should be added: - and includes any veterinary medicine; - biological medicine and - complementary medicine • Definitions for these in Regulation • Definition needed for ‘food supplement’ SMASA - Medicines Bill 6

17. Definitions • We propose the below definition to be adopted in the regulation “Complementary medicine” means any substance or mixture of substances that- (a)    originates from, but not limited to plants, fungi, algae, seaweed, lichens, minerals, animals and includes one or more substances included in the substance list as determined by the Council;or other substance as determined by Council (b)    is used or purporting to be suitable for use or manufactured or sold for use— (i) in maintaining, complementing, or assisting the innate healing power or physical or mental state, or (ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state of a human being or animal, and (iii) restoring or correcting organic functions in humans, or (c) is used- (i) as a health supplement (ii) in accordance with those disciplines as determined by Council, or • is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary medicine • In addition a substance list to be published Note: Disciplines are problematic… e.g. rooibos products relate to which discipline? SMASA - Medicines Bill 6

18. “Complementary Medicine” Vitamin and minerals Homeopathic products Plant extracts Pro and prebiotics Glucosamine SMASA - Medicines Bill 6

19. Definitions Examples of Borderline Medical Devices SMASA - Medicines Bill 6

20. Scheduled substances: where to remove SMASA - Medicines Bill 6

21. Scheduled substances are not products SMASA - Medicines Bill 6

22. Scheduled substances are not products Food supplement? SMASA - Medicines Bill 6

23. Transitional Measures • Remove products erroneously registered as medicines from the register • Pre-assessment of regulatory scope required to enable SAHPRA to plan adequately • A clause is needed for all medical devices, cosmetics and foodstuffs that are not registered but on the market to be grand-fathered to allow market access and business continuity. • Industry should be given 3 years to comply with regulatory requirements SMASA - Medicines Bill 6

24. Recommendations and final conclusions • SMASA welcomes and supports an enhanced regulatory framework and urges the NDoH to consider existing frameworks in mature authorities • For example, Health Canada’s approach to the regulation of Natural Health Products use of monographs • UK MHRA’s approach to the regulation of medical devices and borderline medical devices such as EU Manual on Borderline and Classification in the Community Regulatory framework for MD (July 2016) • SMASA is happy to partner with NDoH to ensure a legal framework that is appropriate, and an efficiently functioning SAHPRA SMASA - Medicines Bill 6

25. Contact details Allison Vienings E-mail: smasa.cc@gmail.com Tel: 012 803 6223 www.smasa.cc Thank you SMASA - Medicines Bill 6

26. SMASA - Medicines Bill 6