CAMS in South AfricaCAMS in South Africa

Dr Alan TomlinsonDr Alan TomlinsonHealth Products AssociationHealth Products Association

CAMS categoriesCAMS categories1.1. Aromatherapeutic Essential OilsAromatherapeutic Essential Oils2.2. Auyrvedic MedicineAuyrvedic Medicine3.3. Biochemical Medicines & SaltsBiochemical Medicines & Salts4.4. Chinese MedicineChinese Medicine5.5. Energy SubstancesEnergy Substances6.6. Herbal MedicineHerbal Medicine7.7. Homoeopathic Medicine Homoeopathic Medicine 8.8. Nutraceuticals (incl. vitamins and minerals)Nutraceuticals (incl. vitamins and minerals)9.9. Sowa Rigpa MedicineSowa Rigpa Medicine10.10. Unani-Tibb MedicineUnani-Tibb Medicine

Terminology of TM/CAMTerminology of TM/CAM ““Traditional medicineTraditional medicine” ” (TM) (TM) is used to refer to systems such as traditional is used to refer to systems such as traditional

Chinese medicine, Indian Ayurveda and Arabic Unani Tibb medicine, and to Chinese medicine, Indian Ayurveda and Arabic Unani Tibb medicine, and to various forms of indigenous medicine in Africa, Latin America, South-East various forms of indigenous medicine in Africa, Latin America, South-East Asia and the Western Pacific. Asia and the Western Pacific.

In countries where the dominant health care system is based on allopathic In countries where the dominant health care system is based on allopathic medicine, or where TM has not been incorporated into the national system, medicine, or where TM has not been incorporated into the national system, it is termed “it is termed “complementarycomplementary and al and alternativeternative” ” (CAM). (CAM). For example in For example in Europe, North America and Australia. Europe, North America and Australia.

When referring in a general sense to all of the regions, the comprehensive When referring in a general sense to all of the regions, the comprehensive TM/CAMTM/CAM is used. is used.

Allopathic medicine Allopathic medicine refers to the broad category of medical practice that is refers to the broad category of medical practice that is sometimes called Western medicine, biomedicine, scientific medicine, or sometimes called Western medicine, biomedicine, scientific medicine, or modern medicine. [also “urban medicine”]modern medicine. [also “urban medicine”]

World Health Organization PolicyWorld Health Organization Policy Framework for action for WHO and its partners, to enable Framework for action for WHO and its partners, to enable

TM/CAM to play a far greater role. Four objectives:TM/CAM to play a far greater role. Four objectives:1.1. Policy: Policy: integrate TM/CAM with national health care integrate TM/CAM with national health care

systemssystems..2.2. Safety, efficacy and quality:Safety, efficacy and quality: expand knowledgebase on expand knowledgebase on

TM/CAM; provide guidance on regulatory and quality TM/CAM; provide guidance on regulatory and quality assurance standards. assurance standards.

3.3. Access: Access: increase availability and affordability of TM/CAM, increase availability and affordability of TM/CAM, with an emphasis on access for poor populations. with an emphasis on access for poor populations.

4.4. Rational use: Rational use: promote therapeutically sound use of promote therapeutically sound use of appropriate TM/CAM by providers and consumers.appropriate TM/CAM by providers and consumers.

Source: WHO Traditional Medicine Strategy 2002–2005

Beijing Declaration Beijing Declaration 8 November 2008 8 November 2008

Governments have a responsibility for the health of their Governments have a responsibility for the health of their people and should formulate national policies, people and should formulate national policies, regulations and standards, as part of comprehensive regulations and standards, as part of comprehensive national health systems to ensure appropriate, safe and national health systems to ensure appropriate, safe and effective use of traditional medicine. effective use of traditional medicine.

Recognizing the progress of many governments to date Recognizing the progress of many governments to date in integrating traditional medicine into their national in integrating traditional medicine into their national health systemshealth systems, we call on those who have not yet done , we call on those who have not yet done so to take action. so to take action.

Source: WHO Beijing Declaration, 8 November 2008

Market size Market size World market for herbals and vitamins – World market for herbals and vitamins –

approx. US$50 Billionapprox. US$50 Billion

SA Market size approx 7.8 Billion Rand - SA Market size approx 7.8 Billion Rand - representing approx. representing approx. 0.7%0.7% of world market of world market (HPA Survey 2010)(HPA Survey 2010)

South African market exceptionally buoyant South African market exceptionally buoyant over last few years with exports from SA over last few years with exports from SA growinggrowing

$108 Billion U.S. Nutrition Industry $108 Billion U.S. Nutrition Industry Consumer Sales in 2009Consumer Sales in 2009

Source : Nutrition Business Journal estimates (consumer sales)

$108 Billion U.S. Nutrition Industry $108 Billion U.S. Nutrition Industry Consumer Sales in 2009Consumer Sales in 2009

Source : Nutrition Business Journal estimates (consumer sales)

$4.9 Billion U.S. Speciality Supplement Sales by $4.9 Billion U.S. Speciality Supplement Sales by Product in 2009Product in 2009

Source : Nutrition Business Journal estimates (consumer sales)

All Segments All Segments Research International: Market quantification September 2010

Summary Category Market Size Analysis Summary Category Market Size Analysis (Level 1) (Level 1)

Category Category PercentagePercentage

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 Summary Category Market Size Analysis (Level 1) (Level 1)

ANC Health Plan of 1994ANC Health Plan of 1994

Source: ANC Health Plan 1994; South African Health Review 2007, Chapter 12.

““People have the right of access to traditional People have the right of access to traditional practitioners as part of their cultural heritage practitioners as part of their cultural heritage

and belief system.” and belief system.”

Legislation impacting on CAMS in Legislation impacting on CAMS in South AfricaSouth Africa

Act 101 : Medicine and Related Substances Act 101 : Medicine and Related Substances Control Act (1965)Control Act (1965)

Act 54Act 54 : Foods, Cosmetics and Disinfectants : Foods, Cosmetics and Disinfectants Act (1972)Act (1972)

Act 63Act 63 : Allied Health Professions Act (1982): Allied Health Professions Act (1982) Act 53Act 53 : Pharmacy Act (1974): Pharmacy Act (1974) Act 68Act 68 : Consumer Protection Act (2008): Consumer Protection Act (2008) Act 36: Fertilizers, Farm Feeds, Agricultural Act 36: Fertilizers, Farm Feeds, Agricultural

Remedies and Stock Remedies Act (1947)Remedies and Stock Remedies Act (1947)

Regulation of Regulation of PractitionersPractitioners

DEPARTMENT OF DEPARTMENT OF HEALTHHEALTH

DEPARTMENT OF DEPARTMENT OF HEALTHHEALTH

HEALTH PROFESSIONSHEALTH PROFESSIONS COUNCILCOUNCIL

HEALTH PROFESSIONSHEALTH PROFESSIONS COUNCILCOUNCIL ALLIED HEALTH ALLIED HEALTH

PROFESSIONS COUNCIL PROFESSIONS COUNCIL ALLIED HEALTH ALLIED HEALTH

PROFESSIONS COUNCIL PROFESSIONS COUNCIL DENTAL TECHNICIANS DENTAL TECHNICIANS

COUNCIL COUNCIL

DENTAL TECHNICIANS DENTAL TECHNICIANS

COUNCIL COUNCIL TRADITIONAL HEALERSTRADITIONAL HEALERS

COUNCILCOUNCIL

TRADITIONAL HEALERSTRADITIONAL HEALERS

COUNCILCOUNCILNURSING COUNCILNURSING COUNCILNURSING COUNCILNURSING COUNCIL

PHARMACYPHARMACY

COUNCIL COUNCIL

PHARMACYPHARMACY

COUNCIL COUNCIL

PROFESSIONALPROFESSIONALBOARD BOARD 22 FOR : FOR :

PROFESSIONALPROFESSIONALBOARDBOARD 3 3 FOR : FOR :

PROFESSIONAL PROFESSIONAL BOARD BOARD 44 FOR : FOR :

ALLIED HEALTH PROFESSIONS COUNCILALLIED HEALTH PROFESSIONS COUNCIL

The Professional Boards of the Allied Health The Professional Boards of the Allied Health Professions CouncilProfessions Council

PROFESSIONALPROFESSIONALBOARD BOARD 11 FOR: FOR:

3,622 practitioners in May 2007

PHYTOTHERAPYPHYTOTHERAPY

NATUROPATHYNATUROPATHY

HOMEOPATHYHOMEOPATHYTHERAPEUTICTHERAPEUTICAROMATHERAPYAROMATHERAPY

THERAPEUTICTHERAPEUTICMASSAGE THERAPYMASSAGE THERAPY

THERAPEUTICTHERAPEUTICREFLEXOLOGYREFLEXOLOGY

CHINESE CHINESE MEDICINE MEDICINE AND AND ACUPUNCTUACUPUNCTURERE

AYURVEDA

UNANI TIBBUNANI TIBBOSTEOPATHYOSTEOPATHY

CHIROPRACTICCHIROPRACTIC

ResearchResearch

Increased emphasis on evidence based Increased emphasis on evidence based medicinemedicine

Websites for verificationWebsites for verification• Google ScholarGoogle Scholar• MedlineMedline• National Institute of Health (NIH)National Institute of Health (NIH)• Office of Dietary Supplements (ODS)Office of Dietary Supplements (ODS)

Reasons for high use of CAMSReasons for high use of CAMS1.1. Increased responsibility for personal health.Increased responsibility for personal health.2.2. Perceived high cost of health services and Perceived high cost of health services and

medicines.medicines.3.3. Safety and low incidence of side effects.Safety and low incidence of side effects.4.4. Ease of access in front shop of pharmacy.Ease of access in front shop of pharmacy.5.5. Increased education, knowledge and Increased education, knowledge and

awareness of the benefits of nutrition and awareness of the benefits of nutrition and lifestyle.lifestyle.

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

Extrinsic safety risks associated with Extrinsic safety risks associated with CAMSCAMSNot related to the product itself but to handling & Not related to the product itself but to handling & Good Manufacturing Procedures Good Manufacturing Procedures ((GMPGMP))

Misidentification – Misidentification – mostly organoleptic tests donemostly organoleptic tests doneStandardisation – Standardisation – min. level of activesmin. level of activesContamination – Contamination – particularly of herbalsparticularly of herbalsSubstitutionSubstitutionAdulteration – Adulteration – with a medicinal active e.g. sildenafilwith a medicinal active e.g. sildenafilLabelling – Labelling – misleading, untruthful claimsmisleading, untruthful claims

The critical factors to consider when looking at the safety The critical factors to consider when looking at the safety of Dietary supplementsof Dietary supplementsRisks Risks

• Related to the product (side effects & interactions)Related to the product (side effects & interactions)• GMPGMP

EducationEducation• Natural & safeNatural & safe• Reporting use of and adverse effects related to Reporting use of and adverse effects related to

CAMS by consumerCAMS by consumer• Assess available full body of evidenceAssess available full body of evidence

Conclusions on safetyConclusions on safety

HPA ObjectivesHPA Objectives Ensure high profile visibility of the health Ensure high profile visibility of the health

products industry as a dynamic, organized and products industry as a dynamic, organized and responsible forceresponsible force

Maintain high ethical standards of production, Maintain high ethical standards of production, quality control, marketing and advertising quality control, marketing and advertising

within within the industrythe industry

International NetworkInternational Network Affiliated to Affiliated to IADSA (International Alliance of IADSA (International Alliance of

Dietary Dietary Food Supplements Associations)Food Supplements Associations)

Founded in 1998 – represents 57 dietary Founded in 1998 – represents 57 dietary supplement associations worldwidesupplement associations worldwide

IADSA ObjectivesIADSA Objectives

• Establish, maintain, protect and promote Establish, maintain, protect and promote international standardsinternational standards

• Harmonisation of regulatory standards Harmonisation of regulatory standards

The Health Products Association The Health Products Association (HPA)(HPA)

Submission and comments on regulations Submission and comments on regulations published published

WHO ARE WE ?WHO ARE WE ? The HPA is the trade association representing the The HPA is the trade association representing the

Complementary and Alternative and Traditional Medicines Complementary and Alternative and Traditional Medicines (CAMS) industry.(CAMS) industry.

The CMSC is the CAMS stakeholder committee formed in 2004 The CMSC is the CAMS stakeholder committee formed in 2004 which had support from the following :which had support from the following :

• Complementary and Traditional professions including Practitioners, Therapists and Complementary and Traditional professions including Practitioners, Therapists and African Traditional Healers and their Associations African Traditional Healers and their Associations

• Retailers and their Associations Retailers and their Associations • The Food Industry and its AssociationsThe Food Industry and its Associations• Complementary and Traditional Medicine Industry and its AssociationsComplementary and Traditional Medicine Industry and its Associations• All Classes of CAMS (e.g. Aromatherapy, Western Herbal, Ayurvedic, African All Classes of CAMS (e.g. Aromatherapy, Western Herbal, Ayurvedic, African

Traditional, Chinese Traditional, Homeopathy, Energy Medicines, Unani Tibb etc.)Traditional, Chinese Traditional, Homeopathy, Energy Medicines, Unani Tibb etc.)• Members of the public Members of the public

WHAT DO WE SUPPORT?WHAT DO WE SUPPORT?

We support appropriate and equitable We support appropriate and equitable changes changes to the regulations and guidelines to the regulations and guidelines pertaining to pertaining to the Quality, Safety and Efficacy the Quality, Safety and Efficacy of the paradigm of the paradigm of Complementary, of Complementary, Alternative and Traditional Alternative and Traditional Medicines Medicines (CAMS).(CAMS).

We also support responsible advertising and We also support responsible advertising and trading.trading.

PARADIGMS OF MEDICINEPARADIGMS OF MEDICINE Different “disciplines” of medicine including Orthodox Medicine Different “disciplines” of medicine including Orthodox Medicine

are based on belief systems that can be called paradigms. are based on belief systems that can be called paradigms.

Differs with respect to how it:Differs with respect to how it:

• Views wellness and well-beingViews wellness and well-being

• The human beingThe human being

OrthodoxOrthodox paradigm is dominant in the Western world paradigm is dominant in the Western world, other , other paradigms are equally relevant, growing rapidly and operate paradigms are equally relevant, growing rapidly and operate within different contexts. within different contexts.

We believe that no dominant paradigm should subsume We believe that no dominant paradigm should subsume another. another.

MAIN CONCERNSMAIN CONCERNS

As these regulations were written primarily for As these regulations were written primarily for Allopathic medicines, all CAMS will now be Allopathic medicines, all CAMS will now be controlled as if they were Allopathic Medicines controlled as if they were Allopathic Medicines (unless exempted from or changes are made to (unless exempted from or changes are made to certain of the regulations).certain of the regulations).

As such we have reviewed and commented on each As such we have reviewed and commented on each regulation, all definitions and exemptions as they regulation, all definitions and exemptions as they have a direct impact on CAMShave a direct impact on CAMS

MAIN CONCERNSMAIN CONCERNS CAMS being subsumed within Orthodox paradigmCAMS being subsumed within Orthodox paradigm

Lack of provision to separate foods, nutritional food Lack of provision to separate foods, nutritional food substances and cosmetics from these regulationssubstances and cosmetics from these regulations

DefinitionsDefinitions

Section 25 – Classes and ClassificationSection 25 – Classes and Classification

OmissionsOmissions

ExemptionsExemptions

Free market economyFree market economy

Thank you.Thank you.

For further information For further information www.hpasa.co.za

Or contact Deirdre AllenOr contact Deirdre Allen011 789 4464011 789 4464