Transcript Global regulatory review

CAMS in South Africa
Dr Alan Tomlinson
Health Products Association
CAMS categories
1. Aromatherapeutic Essential Oils
2. Auyrvedic Medicine
3. Biochemical Medicines & Salts
4. Chinese Medicine
5. Energy Substances
6. Herbal Medicine
7. Homoeopathic Medicine
8. Nutraceuticals (incl. vitamins and minerals)
9. Sowa Rigpa Medicine
10. Unani-Tibb Medicine
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”]
World Health Organization Policy
 Framework for action for WHO and its partners, to enable
TM/CAM to play a far greater role. Four objectives:
1. Policy: integrate TM/CAM with national health care
systems.
2. Safety, efficacy and quality: expand knowledgebase on
TM/CAM; provide guidance on regulatory and quality
assurance standards.
3. Access: increase availability and affordability of TM/CAM,
with an emphasis on access for poor populations.
4. Rational use: promote therapeutically sound use of
appropriate TM/CAM by providers and consumers.
Source: WHO Traditional Medicine Strategy 2002–2005
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
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
$108 Billion U.S. Nutrition Industry
Consumer Sales in 2009
Source : Nutrition Business Journal estimates (consumer sales)
$108 Billion U.S. Nutrition Industry
Consumer Sales in 2009
Source : Nutrition Business Journal estimates (consumer sales)
$4.9 Billion U.S. Speciality Supplement Sales by
Product in 2009
Source : Nutrition Business Journal estimates (consumer sales)
All Segments
Research International: Market
quantification September 2010
Summary Category Market Size Analysis
(Level 1)
Category
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
Summary Category Market Size Analysis
(Level 1)
Energy Substances
Aromatherapeutic Essential Oils
Homoeopathy
Sports Nutrition
Health Foods & Beverages
Therapeutic Cosmetics
Weight Management
Ethical OTC Products
Herbals
Nutritional Food Substances and /or…
0.0
10.0
20.0
30.0
40.0
% Share of Products Surveyed
50.0
60.0
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.
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)
Regulation of Practitioners
DEPARTMENT OF
HEALTH
HEALTH PROFESSIONS
COUNCIL
ALLIED HEALTH
PROFESSIONS COUNCIL
DENTAL TECHNICIANS
COUNCIL
NURSING COUNCIL
PHARMACY
COUNCIL
TRADITIONAL HEALERS
COUNCIL
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 :
HOMEOPATHY
THERAPEUTIC
AROMATHERAPY
AYURVEDA
NATUROPATHY
THERAPEUTIC
MASSAGE THERAPY
UNANI TIBB
PHYTOTHERAPY
THERAPEUTIC
REFLEXOLOGY
CHINESE
MEDICINE AND
ACUPUNCTURE
CHIROPRACTIC
OSTEOPATHY
3,622 practitioners in May 2007
Research
 Increased emphasis on evidence based
medicine
 Websites for verification
•
•
•
•
Google Scholar
Medline
National Institute of Health (NIH)
Office of Dietary Supplements (ODS)
Reasons for high use of CAMS
1. Increased responsibility for personal health.
2. Perceived high cost of health services and
medicines.
3. Safety and low incidence of side effects.
4. Ease of access in front shop of pharmacy.
5. Increased education, knowledge and
awareness of the benefits of nutrition and
lifestyle.
Dietary Supplements
0,0001%
Honey Bee Stings
0,0008%
Insect Stings (All)
0,0020%
Sports injuries
0,0020%
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
0,19%
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
Cardiovascular Disease
22,11%
47%
Statistical comparison of
frequent causes of death in
USA (Law 2004)
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
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
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
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
The Health Products Association
(HPA)
Submission and comments on regulations
published
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, Unani Tibb etc.)
• Members of the public
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.
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.
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
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
Thank you.
For further information
www.hpasa.co.za
Or contact Deirdre Allen
011 789 4464