1. Presented by The Health Products Association (HPA) of South Africa Honourable Members – Thank you for this opportunity. Act 101 – Draft Amendment Bill The Parliamentary Portfolio Committee on Health Act 101 – Draft Amendment Bill The Parliamentary Portfolio Committee on Health Norman Fels Janet Welham Howard Snoyman 5 Nov. 2014 Norman Fels Janet Welham Howard Snoyman 5 Nov. 2014

2. Our Presentation Confined to: Who we are & a Brief History Our market place and diversity of players. The current situation. Why we have problems and projected consequences Act 101 – Medicines = Transport & “clubs” One size fits all? Key Issues The route to success

3. WHO IS THE HPA Established 1976 Represent 114 member companies from the Health Products Industry A R7 Billion turnover Industry Founding Member of IADSA (International Alliance of Dietary Supplements Association) which works closely with CODEX

5. HPA POSITION The HPA hopes to continue with the constructive and proactive approach adopted over the past 30 years. The HPA supports: – The control of Complementary and Traditional Medicines through Separate, Appropriate and Equitable Regulations that control appropriate Quality, Safety and Efficacy The HPA does not support: – Misleading and irresponsible advertising – Manufacturers and marketers of products that do not take safety, efficacy and quality seriously

6. The Current Situation Misguided perception that the HPA does not want to be regulated The Legislative and Regulatory framework for CAMS is unclear, confusing and problematic. Carts before horses! The November 2013 Regulations precipitated litigation which is unfortunate. This process legal will not solve anything – only constructive engagement and rational debate among all stakeholders can produce a successful outcome.

7. What happened? Act 101 of 1965 was written for allopathic medicine and the definition of a medicine has stood the test of time. In the 1980s it was acknowledged that CAMS were different and had to be regulated against some different criteria (e.g. Paradigms, belief & energy systems/traditional practice) Not so easy with one “rule book”. Good progress made but never promulgated (2004,2008,2011) Total change in direction in 2013 Regulations. No comment period. No impact assessment.

8. Potential Consequences Estimated 60% of products may be removed from shelves. (i.e. R4 Billion). Impact on S.A. economy about R20 billion. Tax revenue lost. Registration could take 5 years or longer. (CTD system) Few CAMS companies could survive the loss of revenue. Consumers could be deprived of their freedom of choice of products and health modality. Practitioners may not have access to product. Retailers (particularly small pharmacies) will suffer badly. The distribution chain, advertising, manufacturing and packaging industries will lose revenue. Job losses are difficult to quantify but will be significant. Import and export trade jeopardised.

9. What is a Medicine? Act 101 says EVERYTHING THAT ENTERS OUR BODIES – Brilliant! Can all medicines be regulated in the same way? Natural does not mean safe. Regulation does not guarantee safety. The Transport Analogy. Diversity= complexity. Trains and Boats Planes What is Appropriate? A = f{Risk} Clubs & money. SABS Easy, inexpensive and fast registration will promote conformance. Under-regulation and bad or inappropriate regulations breed “cowboys”

10. Key Issues. Definitions Licenses Responsible pharmacist/person CTD Registration & capacity concerns Schedules Concern: The link between Act 101 and the Pharmacy Act

11. The Roadmap to Success Amend the Bill to create a sustainable structure and management team for SAHPRA. Broadly define the various “Pillars” of Control (i.e. Allopathic, Devices, Vet, Cosmetics, CAMS) in the ACT. CAMS definition to excluded Allopathic medicines. Empower the Minister to create and define, in the Regulations, sub- categories/classes to accommodate the various modalities/classifications Apply appropriate criteria for each. E.g. Listing system. Uncouple Act 101 from the Pharmacy Act (vis-a-vis licences and Responsible Person/Pharmacists where appropriate).

12. Allopathic CAMSVET COS DEV ETC SAHPRA BOARD Cat A Cat D The ACT Regulations CAMS and Traditional Medicines AHP Indian TM Chinese TM African TM Non invasive Supplements Accommodate and regulate all classes/modalities of CAMS and Traditional Medicines in an appropriate and risk related way.

13. THE WAY FORWARD Clearly, there is a great sense of urgency in finding solutions. The Act can make this possible. Litigation should be avoided – it can’t solve the problems The process of constructive engagement must continue. Legislate and regulate in “bite-sizes pieces” – it’s much easier. THANK YOU