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CAMS in South Africa

CAMS in South Africa. Dr Alan Tomlinson Health Products Association. CAMS categories. Aromatherapeutic Essential Oils Auyrvedic Medicine Biochemical Medicines & Salts Chinese Medicine Energy Substances Herbal Medicine Homoeopathic Medicine

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CAMS in South Africa

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  1. CAMS in South Africa Dr Alan Tomlinson Health Products Association

  2. CAMS categories • AromatherapeuticEssential Oils • AuyrvedicMedicine • Biochemical Medicines & Salts • Chinese Medicine • Energy Substances • Herbal Medicine • Homoeopathic Medicine • Nutraceuticals (incl. vitamins and minerals) • Sowa Rigpa Medicine • Unani-TibbMedicine

  3. Terminology of TM/CAM • “Traditional medicine” (TM) is used to refer to systems such as traditional Chinese medicine, Indian Ayurveda and Arabic UnaniTibb medicine, and to various forms of indigenous medicine in Africa, Latin America, South-East Asia and the Western Pacific. • In countries where the dominant health care system is based on allopathic medicine, or where TM has not been incorporated into the national system, it is termed “complementary and alternative” (CAM). For example in Europe, North America and Australia. • When referring in a general sense to all of the regions, the comprehensive TM/CAM is used. • Allopathic medicine refers to the broad category of medical practice that is sometimes called Western medicine, biomedicine, scientific medicine, or modern medicine. [also “urban medicine”]

  4. World Health Organization Policy • Framework for action for WHO and its partners, to enable TM/CAM to play a far greater role. Four objectives: • Policy: integrate TM/CAM with national health care systems. • Safety, efficacy and quality: expand knowledgebase on TM/CAM; provide guidance on regulatory and quality assurance standards. • Access: increase availability and affordability of TM/CAM, with an emphasis on access for poor populations. • Rational use: promote therapeutically sound use of appropriate TM/CAM by providers and consumers. Source: WHO Traditional Medicine Strategy 2002–2005

  5. Beijing Declaration 8 November 2008 • Governments have a responsibility for the health of their people and should formulate national policies, regulations and standards, as part of comprehensive national health systems to ensure appropriate, safe and effective use of traditional medicine. • Recognizing the progress of many governments to date in integrating traditional medicine into their national health systems, we call on those who have not yet done so to take action. Source: WHO Beijing Declaration, 8 November 2008

  6. Market size • World market for herbals and vitamins – approx. US$50 Billion • SA Market size approx 7.8 Billion Rand - representing approx. 0.7% of world market (HPA Survey 2010) • South African market exceptionally buoyant over last few years with exports from SA growing

  7. $108 Billion U.S. Nutrition Industry Consumer Sales in 2009 Source : Nutrition Business Journal estimates (consumer sales)

  8. $108 Billion U.S. Nutrition Industry Consumer Sales in 2009 Source : Nutrition Business Journal estimates (consumer sales)

  9. $4.9 Billion U.S. Speciality Supplement Sales by Product in 2009 Source : Nutrition Business Journal estimates (consumer sales)

  10. All Segments Research International: Market quantification September 2010

  11. Summary Category Market Size Analysis (Level 1)

  12. Summary Category Market Size Analysis (Level 1)

  13. ANC Health Plan of 1994 “People have the right of access to traditional practitioners as part of their cultural heritage and belief system.” Source: ANC Health Plan 1994; South African Health Review 2007, Chapter 12.

  14. Legislation impacting on CAMS in South Africa • Act 101 : Medicine and Related Substances Control Act (1965) • Act 54 : Foods, Cosmetics and Disinfectants Act (1972) • Act 63 : Allied Health Professions Act (1982) • Act 53 : Pharmacy Act (1974) • Act 68 : Consumer Protection Act (2008) • Act 36: Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (1947)

  15. Regulation of Practitioners Department of Health Health Professions Council Allied Health Professions Council Dental Technicians Council Traditional Healers Council Nursing Council Pharmacy Council

  16. The Professional Boards of the Allied Health Professions Council ALLIED HEALTH PROFESSIONS COUNCIL Professional Board 1 for: Professional Board 2 for : Professional Board 3 for : Professional Board 4 for : Ayurveda Therapeutic Aromatherapy Homeopathy Chiropractic UnaniTibb Naturopathy Therapeutic Massage Therapy Osteopathy Phytotherapy Chinese Medicine and Acupuncture Therapeutic Reflexology 3,622 practitioners in May 2007

  17. Research • Increased emphasis on evidence based medicine • Websites for verification • Google Scholar • Medline • National Institute of Health (NIH) • Office of Dietary Supplements (ODS)

  18. Reasons for high use of CAMS • Increased responsibility for personal health. • Perceived high cost of health services and medicines. • Safety and low incidence of side effects. • Ease of access in front shop of pharmacy. • Increased education, knowledge and awareness of the benefits of nutrition and lifestyle.

  19. Statistical comparison of frequent causes of death in USA (Law 2004)

  20. Extrinsic safety risks associated with CAMS • Not related to the product itself but to handling & Good Manufacturing Procedures (GMP) • Misidentification – mostly organoleptic tests done • Standardisation – min. level of actives • Contamination – particularly of herbals • Substitution • Adulteration – with a medicinal active e.g. sildenafil • Labelling – misleading, untruthful claims

  21. Conclusions on safety The critical factors to consider when looking at the safety of Dietary supplements Risks Related to the product (side effects & interactions) GMP Education Natural & safe Reporting use of and adverse effects related to CAMS by consumer Assess available full body of evidence

  22. HPA Objectives • Ensure high profile visibility of the health products industry as a dynamic, organized and responsible force • Maintain high ethical standards of production, quality control, marketing and advertising within the industry

  23. International Network • Affiliated to IADSA (International Alliance of Dietary Food Supplements Associations) • Founded in 1998 – represents 57 dietary supplement associations worldwide • IADSA Objectives • Establish, maintain, protect and promote international standards • Harmonisation of regulatory standards

  24. The Health Products Association (HPA)Submission and comments on regulations published

  25. WHO ARE WE ? • The HPA is the trade association representing the Complementary and Alternative and Traditional Medicines (CAMS) industry. • The CMSC is the CAMS stakeholder committee formed in 2004 which had support from the following : • Complementary and Traditional professions including Practitioners, Therapists and African Traditional Healers and their Associations • Retailers and their Associations • The Food Industry and its Associations • Complementary and Traditional Medicine Industry and its Associations • All Classes of CAMS (e.g. Aromatherapy, Western Herbal, Ayurvedic, African Traditional, Chinese Traditional, Homeopathy, Energy Medicines, UnaniTibb etc.) • Members of the public

  26. WHAT DO WE SUPPORT? • We support appropriate and equitable changes to the regulations and guidelines pertaining to the Quality, Safety and Efficacy of the paradigm of Complementary, Alternative and Traditional Medicines (CAMS). • We also support responsible advertising and trading.

  27. PARADIGMS OF MEDICINE • Different “disciplines” of medicine including Orthodox Medicine are based on belief systems that can be called paradigms. • Differs with respect to how it: • Views wellness and well-being • The human being • Orthodox paradigm is dominant in the Western world, other paradigms are equally relevant, growing rapidly and operate within different contexts. • We believe that no dominant paradigm should subsume another.

  28. MAIN CONCERNS • As these regulations were written primarily for Allopathic medicines, all CAMS will now be controlled as if they were Allopathic Medicines (unless exempted from or changes are made to certain of the regulations). • As such we have reviewed and commented on each regulation, all definitions and exemptions as they have a direct impact on CAMS

  29. MAIN CONCERNS • CAMS being subsumed within Orthodox paradigm • Lack of provision to separate foods, nutritional food substances and cosmetics from these regulations • Definitions • Section 25 – Classes and Classification • Omissions • Exemptions • Free market economy

  30. Thank you. For further information www.hpasa.co.za Or contact Deirdre Allen 011 789 4464

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