Transcript FOOD SECURITY IN PLWA BY KKCAF

STATUS OF TRADITIONAL
MEDICINE IN SOUTH
AFRICA
16-17 NOV 2006
ORDER OF WORK
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BACKGROUND
ACTIVITIES IN TRADITIONAL MEDICINE
CHALLENGES
WAYFORWARD
BACKGROUND
Health needs and utilization of Traditional Medicine
• 70 percent of South African citizen utilize the disciplines Traditional
Medicine (African and Complementary) for their healthcare needs.
Economic importance of African Traditional Medicine
• In Gauteng, there were approximately 244 herb-traders in 1994.
70% of whom were located in Johannesburg, 20% in East Rand and
10% in the West Rand (Williams et. Al).
• In Kwa Zulu-Natal, South Africa, over 4 000 tones of plant material is
traded a year, with a value of US$13 million [R600 million], some
one third of the value of the annual maize harvest in the province.
At national level, 20 000 tones may be traded a year, with a value of
approximately US$60 million [R270 million] (Myles Mander at. Al)
BACKGROUND
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1.
2.
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1.
African Traditional Medicines are any substances or mixture of
substances obtained from plants, animals, insects, microorganism and salts that are:
used or administered to human beings or animals to treat disease,
prevent or reverse a disease state and to maintain a good health
or good look, and
used for sanitation purposes (insecticides)
2.
Types of traditional medicinal plants
Raw plant as a medicine (e.g African Ginger, Ukhathazo –
Alepidea amatymbica)
Extemporaneous plant preparations
3.
Processed & marketed plant preparations
ACTIVITIES IN TRADITIONAL
MEDICINE
Research and Development
• 60 ATMs Monographs - plant origin (University of Western Cape
monographs project)
• Production of processed, labelled and marketed ATMs – Scelitium,
Sutherlandia, etc)
Documentation
• South African Primary Health Care Handbook- combining western
and Traditional Practices (Taryl Haber et. Al) – ATMs formulae
• Cultivation of medicinal plants (Myles Mander et. Al)
• Medicinal Plants and their utilisation (Nigel Gerick et al; Watt J.M &
Breyer-Brandwijk )
Conservation:
• National Botanical Gardens, National Parks
ACTIVITIES IN TRADITIONAL
MEDICINE (2)
Education and Training
• Western Cape Herbal College, Institute of Ethno-medicine
Research into ATMs
• Medical Research Council – medicinal plants (MP) used for malaria,
diabetes, TB, HIV and AIDS
• Council of Industrial and Scientific – mass screening and extraction
of MP
• Agricultural Research Council – MP seed breeding & cultivation
• Universities and other Institutions - natural product chemistry
Archiving of Traditional Medicines
• Libraries at National Botanical Gardens, South African
Pharmaceutical Society
CHALLENGES
• Regulating ATMs within the context of different definitions as
contained in Act 101 of 1965 and Act No 35 of 2004
• Clinical trials protocol that is appropriate for ATMs
• Quality assurance (GMP, GAP,GHP, etc.) of ATMs
• ATMs registration framework with a regulatory framework that was
designed for allopathic medicine
• Regulation of ATMs that are traded in the market
• Sustainable cultivation of medicinal plants
• Protection of Traditional Medicine Knowledge (TMK)
• Production of ATMs
GOVERNMENT INTERVENTIONS
• Medicines and Related Substances Control Act
101 of 1965 is utilized to regulate all medicines,
including ATMs and Complementary medicines
• Expert Committees of African Traditional and
Complementary Medicine exist. They are sub-
committees of the Medicines Control Council
(MCC).
• A sub- committee MCC on ATMs –has been established
in the Medicine Regulatory Authority.
TASKS OF THE MCC SUB-COMMITTE ON ATMs
• The Committee is in the process of developing:
a) a broad framework for quality assurance of
ATMs – monographs, medicinal plants
cultivation
b) Safety assessment protocol – phytochemical
analysis, toxicity studies, animals studies
c) Guidelines for determining efficacy of ATMsobservational studies, clinical studies
d) Criteria for exempting ATMs from being
subjected to clinical trials
GOVERNMENT INTERVENTIONS (2)
• Regulation of Traditional Health Practitioners and
practice –Traditional Health Practitioners Act of 2004
• Regulation of disciplines of Traditional Medicine
(Ayurveda, Unani-Tibb, TCM, etc) that do not originate in
Africa is done within the provisions of Chiropractors,
Homeopaths and Allied Health Service Professions
Amendment Act No 40)
• SA National Drug of 1996 mentions traditional medicines
regulation – facilitated the establishment of the National
Reference Centre of African Traditional Medicines
GOVERNMENT INTERVENTIONS (3)
Traditional Medicine Directorate:
• Focal point on African Traditional Medicine
• Coordinates the development of ATM and
follows up on recommendations made at
international fora
• Formulate a national policy on Traditional
Medicine (TM)
• Facilitation of establishment of institution
on ATM
GOVERNMENT INTERVENTIONS (4)
• Review or develop a new legislation for
protection of Indigenous Knowledge in African
Traditional Medicine
• Facilitates the establishment of a continuing
education program for Traditional Health
Practitioners (THPs)
• Encourage and / or support legal representation
on issues related to intellectual property rights
and patenting of innovations of THPs
GOVERNMENT INTERVENTIONS (5)
• Facilitate access to media and advocate for a
more positive attitude towards ATM
• Establish a national ethical committee for
research from the existing committees
• Adopt and adapt WHO guidelines on policy and
regulatory issues, registration of TMs, continuing
education & research for evaluating traditional
medicines used for the management of HIV &
AIDS, malaria, diabetes and hypertension
SPECIAL TASK TEAMS
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Ministerial Task Team – tasked inter alia to (1) review
the framework
for registration and regulation of
medicines, including African Traditional Medicines, and
(2) to make recommendations with regard to an
efficient regulatory body for medicines and health
technology, medical technology and medical devices
for consideration by the Minister.
Presidential Task Team on African Traditional Medicine
TERMS OF REFERENCE OF
PRESIDENTIAL TASK TEAM
• To
make recommendation with regard to a
national policy and an appropriate regulatory legal
framework for the institutionalization of African
Traditional Medicine (ATM) in South Africa
•To investigate policies and practices devised and
implemented by various government departments
and agencies to promote ATM
TERMS OF REFERENCE OF
PRESIDENTIAL TASK TEAM (2)
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To make recommendations on any steps that can be
taken by the South African government and other
stakeholders to create an enabling environment for the
institutionalization of ATM in South Africa, including
a)
Establishment of institutions on health care based on
the theory and practice of ATM in South Africa;
b)
Training and development of practitioners and
researchers;
c)
Creating practical linkages between ATM in SA and
other paradigms of theory and practice of medicine;
and
d)
The production and processing of ATM in SA
TERMS OF REFERENCE OF
PRESIDENTIAL TASK TEAM (3)
• To investigate and review current research
methodology with regard to ATM in SA at
research institutions in SA and to make
recommendations in regard thereto
• To compile ATM knowledge in SA in order
to preserve, codify and protect such
knowledge including developing a
pharmacopoeia on ATM in SA
TERMS OF REFERENCE OF
PRESIDENTIAL TASK TEAM (4)
• To undertake a survey of comparative
international practice with regard to
institutionalization and utilization of ATM in
the respective healthcare systems
• To make any recommendations and
undertake any such activity that in the
opinion of the Task Team will assist to
achieve the objective setout in these TOR
THANK YOU