1. Protection, Promotion, Development and Management of Indigenous Knowledge Systems Bill [Bill 6—2016]
Prof M. Roy Jobson
Parliamentary Portfolio Committee on Science and Technology: 24 January, 2017

2. Correction
Written submission dated 15 December, 2016: “1. The Bill does NOT explicitly exclude traditional health practitioners using indigenous knowledge in their healing practices; . . .”

3. Protection Hoodia gordonii Pelargonium sidoides Cannabis sativa???
Sceletium tortuosum
(Artemisinin afra)
Cannabis sativa???

4. “Ngoma Umuthi Wenyongo”

5. Patents?
No natural substances but “new” combinations e.g. “Omega-Caro-E”

6. Traditional Health Practitioners Act, 2007 (Act No. 22 of 2007)
[Traditional Health Practitioners Act, 2004 (No. 35 of 2004)?] Definitions: "traditional health practice" means the performance of a function, activity, process or service based on a traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as its object— (a) the maintenance or restoration of physical or mental health or function; or (b) the diagnosis, treatment or prevention of a physical or mental illness; or (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community; or (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and death, but excludes the professional activities of a person practising any of the professions contemplated in the Pharmacy Act, 1974 (Act No. 53 of 1974), the Health Professions Act, 1974 (Act No. 56 of 1974), the Nursing Act, 1974 (Act No. 50 of 1974), the Allied Health Professions Act, 1982 (Act No. 63 of 1982), or the Dental Technicians Act, 1979 (Act No. 19 of 1979), and any other activity not based on traditional philosophy;

7. Traditional Health Practitioners Act, 2007 (Act No. 22 of 2007)
"traditional health practitioner" means a person registered under this Act in one or more of the categories of traditional health practitioners; "traditional medicine" means an object or substance used in traditional health practice for— (a) the diagnosis, treatment or prevention of a physical or mental illness; or (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or well-being in human beings, but does not include a dependence-producing or dangerous substance or drug; "traditional philosophy" means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and customs and uses of traditional medicines communicated from ancestors to descendants or from generations to generations, with or without written documentation, whether supported by science or not, and which are generally used in traditional health practice; (emphasis added)

8. Indigenous Knowledge Systems Bill [Bill 6—2016]
‘‘indigenous knowledge’’ means knowledge which has been developed within an indigenous community and has been assimilated into the cultural make-up or essential character of that community, and includes— (a) knowledge of a scientific or technical nature; (b) knowledge of natural resources; and (c) indigenous cultural expressions; ‘‘indigenous knowledge practitioner’’ means a person who is accredited and certified as an indigenous knowledge practitioner to render a service utilising indigenous knowledge;

9. Indigenous Knowledge Systems Bill [Bill 6—2016]
‘‘discipline of practice’’ means a group of people who share the same understanding and methodology of a given practice, craft or profession, which evolves spontaneously or is created based on people’s engagement in a process of collective learning in a shared domain of human endeavour; CHAPTER 4 PROTECTION OF INDIGENOUS KNOWLEDGE Subject matter of protection 9. (1) This Act protects indigenous knowledge, whether it is cultural or functional in nature, or both, including medical, agricultural and scientific practices, in the manner and to the extent provided for in section 11. (2) Such indigenous knowledge shall constitute property within the meaning of this term as used in section 25 of the Constitution.

10. THP 2007 (Definitions) "traditional philosophy" means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and customs and uses of traditional medicines communicated from ancestors to descendants or from generations to generations, with or without written documentation, whether supported by science or not, and which are generally used in traditional health practice; (emphasis added)
Eligibility criteria for protection 11. The protection of indigenous knowledge contemplated in section 9 applies to indigenous knowledge which— (a) has been passed on from generation to generation within an indigenous community; (b) has been developed within an indigenous community; and (c) is associated with the cultural make-up and social identity of that indigenous community.

11. TRADITIONAL HEALTH PRACTITIONERS ACT 2007 (ACT NO
TRADITIONAL HEALTH PRACTITIONERS ACT 2007 (ACT NO. 22 OF 2007) TRADITIONAL HEALTH PRACTITIONERS REGULATIONS 2015
3. CATEGORIES OF TRADITIONAL HEALTH PRACTICE THAT MUST UNDERGO EDUCATION OR TRAINING The following categories of traditional health practice must undergo education or training at any accredited training institution or educational authority or with any traditional tutor: (a) Divination; (b) Herbalism; (c) Traditional birth attendant's practice; and (d) Traditional surgeon (circumcision) practice.

12. Indigenous Knowledge Systems Bill [Bill 6—2016]
Transnational arrangements 29. (1) Indigenous knowledge originating in a foreign jurisdiction must be given the same protection given to indigenous knowledge originating in the Republic: Provided that the laws of that foreign jurisdiction provide reciprocal protection to indigenous knowledge originating in the Republic.

13. ALLIED HEALTH PROFESSIONS ACT 63 OF 1982
Ayurveda
Chinese medicine and acupuncture
Unani-tibb

14. Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
Definition of a medicine: 'medicine' means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in- (a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in (hu)man(s); or (b) restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine.

15. Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
Regulation 1 [Notice R.870, 15 November 2013, Gazette 37032]
Definition of complementary medicine
"complementary medicine" means any substance or mixture of substances that
(a) originates from plants, minerals or animals;
(b) is used or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical or mental state; and
is used in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982);".
NB: There is no definition of African Traditional Medicines, but there is an African Traditional Medicines Committee in the MCC.

16. Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
Dispensing licence? (Pharmacy Act + Allied Health Practitioners Act)
What would the legal constraints be on accredited indigenous knowledge practitioners in terms of “formulating, compounding, dispensing” remedies / medicines?

17. Quasi-traditional practitioners / practices?
Ethno-medicine? (ethno-psychology?)
Integrative medicine?
(Traditional Healers Organisation – registration of practitioners? E.g. Dr Boxall? And Dr Boxall’s remedies?)

18. Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
3. In determining whether or not the registration or availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of (hu)man(s) or any animal, as the case may be. How will the safety, quality and therapeutic efficacy of African Traditional Medicines be determined, in the public interest? How will the safety, quality and therapeutic efficacy of Indigenous Knowledge Systems ‘medicines / remedies’ be determined, in the public interest?

19. Accreditation?
Could a conventional (“western”) medical practitioner also be accredited as an indigenous knowledge practitioner? Could an indigenous knowledge practitioner obtain a “practice number” from the Board of Health Funders? (Medical Aid? Council for Medical Schemes?)

20. Thank you