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

2. CAMS categories Aromatherapeutic Essential Oils Auyrvedic Medicine
Biochemical Medicines & Salts
Chinese Medicine
Energy Substances
Herbal Medicine
Homoeopathic Medicine
Nutraceuticals (incl. vitamins and minerals)
Sowa Rigpa Medicine
Unani-Tibb Medicine

3. Terminology of TM/CAM
“Traditional medicine” (TM) is used to refer to systems such as traditional Chinese medicine, Indian Ayurveda and Arabic Unani Tibb 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)

10. $4.9 Billion U.S. Speciality Supplement Sales by Product in 2009
Source : Nutrition Business Journal estimates (consumer sales)

11. All Segments
Research International: Market quantification September 2010

12. Summary Category Market Size Analysis (Level 1)
Percentage
Nutritional Food Substances and /or Nutraceuticals
56.0
Herbals
16.2
Ethical OTC Products
14.9
Weight Management
4.4
Therapeutic Cosmetics
4.0
Health Foods & Beverages
2.2
Sports Nutrition
1.8
Homoeopathy
1.0
Aromatherapeutic Essential Oils
0.3
Energy Substances
0.1

13. Summary Category Market Size Analysis (Level 1)

14. 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.

15. 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)

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

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

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

19. 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.

20. Statistical comparison of frequent causes of death in USA (Law 2004)
Dietary Supplements
  0,0001%
Honey Bee Stings
  0,0008%
Insect Stings (All)
  0,0020%
Sports injuries
Lightning
  0,0041%
Animal Bites (dogs,etc)
  0,0048%
Horse/animal riding
  0,0052%
Penicillin Allergy
  0,0144%
Slips/Falls Whilst Walking
  0,019%
Electrical Accidents
  0,038%
Freezing
  0,048%
Firearms Accidents
  0,079%
Poisonings
  0,17%
Asthma
  0,19%
Home Fires
Drowning
   0,21%
Food
   0,24%
Pedestrians-vehicle
   0,37%
Radon Gas
   0,62%
Murder
   0,94%
Suicide
   1,41%
Motor Vehicle Accidents
   2,20%
Preventable Medical Misadventure
   2,40%
Alcohol
   4,49%
Properly Prescribed & Used Drugs
   5,18%
Smoking
   7,19%
Cancer
   22,11%
Cardiovascular Disease
   47%
Statistical comparison of frequent causes of death in USA (Law 2004)

21. 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

22. 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

23. 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

24. 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

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

26. 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 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, Unani Tibb etc.)
Members of the public

27. 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.

28. 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.  

29. 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

30. 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

31. Thank you. For further information www.hpasa.co.za
Or contact Deirdre Allen