1. THE ALLIED HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA (AHPCSA) MEDICINES AND RELATED SUBSTANCES ACT (101/1965) AMENDMENT BILL (B6-2014) PRESENTATION BY THE AHPCSA TO THE PARLIAMENTARY PORTFOLIO COMMITTEE ON HEALTH 31 OCTOBER 2014

2. LEGISLATION The AHPCSA is a statutory health body established in terms of the Allied Health Professions Act, 63 of 1982 in order to control all allied health professions: Ayurveda, Chinese Medicine and Acupuncture, Chiropractic, Homeopathy, Naturopathy, Osteopathy, Phytotherapy, Therapeutic Aromatherapy, Therapeutic Massage Therapy, Therapeutic Reflexology and Unani-Tibb

3. REGISTERED PRACTITIONERS / THERAPISTS ACUPUNCTURE65 AYURVEDA16 CHINESE MEDICINE AND ACUPUNCTURE158 CHIROPRACTIC701 HOMEOPATHY565 NATUROPATHY92 OSTEOPATHY43 PHYTOTHERAPY41 THERAPEUTIC AROMATHERAPY196 THERAPEUTIC MASSAGE THERAPY126 THERAPEUTIC REFLEXOLOGY594 UNANI-TIBB70 TOTAL2667

4. REGULATION OF COMPLEMENTARY MEDICINES The AHPCSA has broadly welcomed the intention to regulate complementary medicines and legislation, both promulgated and proposed

5. AHPCSA CONCERNS: SAHPRA No representation on the proposed composition of the SAHPRA board for a complementary medicine expert Currently the requirement for the medicines control council (MCC) (Regulation 35), even though this position on the MCC is currently vacant to the best of our knowledge The decisions of the SAHPRA board will affect both the practices of practitioners registered with the AHPCSA and the complementary medicines product industry

6. AHPCSA CONCERNS: SAHPRA Fundamental understanding of complementary medicines required in any aspect of regulation due to: The nature of the complexity of complementary medicines within the eight diagnostic professions regulated by the AHPCSA), and also The size and complexity of the complementary medicine product industry

7. AHPCSA CONCERNS: SAHPRA Imperative that a person or persons with expert knowledge of complementary medicine be appointed to the SAHPRA Board Will ensure that any matters considered by the SAHPRA Board in the complementary medicine paradigms are considered appropriately against an expert contribution at SAHPRA Board level The AHPCSA does not believe that delegation of this to committee level allows for sufficiently high level input

8. AHPCSA CONCERNS: SAHPRA The AHPCSA is also of the opinion that the person so appointed should, as a minimum quality parameter, hold a professional registration with the AHPCSA AHPCSA therefore recommends that B6- 2014 be amended accordingly and that two persons be appointed as experts to the SAHPRA Board for complementary medicine

9. AHPCSA CONCERNS: LICENSING The AHPCSA notes that the principal act already provides for ‘practitioner’ and the proposed amendment is therefore unnecessary. It remains AHPCSA policy as communicated to the National Department of Health (NDoH) that it is imperative that AHPCSA-registered diagnostic practitioners who either dispense, or compound and dispense, complementary medicines be required to hold such a licence.

10. DEFINITION OF COMPLEMENTARY MEDICINE The AHPCSA considers the definition in B6-2014 as wholly inadequate since it would exclude large numbers of complementary medicines / products from being registered, since: (a) It would exclude certain complementary medicines from registration due to source [section (a)] (b) It would cause problems with veterinary complementary medicines by being linked to AHPCSA disciplines (c) It makes no mention of the treatment of disease and

11. DEFINITION OF COMPLEMENTARY MEDICINE (d) It does not allow for products related to disciplines other than those regulated by the AHPCSA (e)It does not allow for registration of health products or complementary medicines that are not linked to disciplines

12. AHPCSA RECOMMENDATION The AHPCSA requests that the definition of complementary medicines as provided for in Government Notice R.176: General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965): Amendment, be substituted for the definition provided for complementary medicine in B6-2014

13. NEW DEFINITION: COMPLEMENTARY MEDICINE “complementary medicine” means any substance or mixture of substances that – (a) Originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by Council, and (b) Is used or purporting to be suitable for use or manufactured or sold for use – (i) in maintaining, complementing, or assisting the innate healing power or physical or mental state, or (ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state, of a human being or animal, and (c) is used – (i) as a health supplement, or (ii) in accordance with those disciplines as determined by Council, or (d) is declared by the Minister, on recommendation by the Council, by notice in the gazette to be a complementary medicine;

14. OTHER: LICENSING Section 22C(2) of the Medicines and Related Substances Act, Act 101/1965: (2) A licence referred to in subsection (1) (a) shall not be issued unless the applicant has successfully completed a supplementary course prescribed under the Pharmacy Act, 1974 (Act 53 of 1974), by the Interim Pharmacy Council of South Africa.

15. OTHER: LICENSING The AHPCSA understands that the addition of the word ‘supplementary’ was intended to provide regulation for those persons for whom education and training in dispensing, or compounding and dispensing, did not exist in primary medical qualifications AHPCSA practitioners undergo education and training in dispensing, or compounding and dispensing, in the course of completion of primary medical qualifications at tertiary institutions and a supplementary course is therefore not required

16. OTHER: LICENSING The AHPCSA requests that the word 'supplementary' be removed from 22C (2), or clarification added, for 'practitioners' as defined (allied health professions) Would allow the South African Pharmacy Council to exercise the necessary oversight over the providers of education and training to accredit dispensing, or compounding and dispensing, education and training courses within their programmes that could subsequently lead to an application for a dispensing, or compounding and dispensing, licence by allied health practitioners without the need for a ‘supplementary’ course

17. Thank you FOR MORE INFORMATION http://www.ahpcsa.co.za/