Posted 04 August 2014
MEDIA RELEASE: AHPCSA RESPONSE ON PROPOSED REGULATION/SCHEDULING OF COMPLEMENTARY MEDICINES
The Allied Health Professions Council of South Africa (AHPCSA) is a statutory health body established in terms of the Allied Health Professions Act, 63 of 1982 (the Act) in order to control all allied health professions, which includes Ayurveda, Chinese Medicine and Acupuncture, Chiropractic, Homeopathy, Naturopathy, Osteopathy, Phytotherapy, Therapeutic Aromatherapy, Therapeutic Massage Therapy, Therapeutic Reflexology and Unani-Tibb. You will find copies of all relevant legislation on our website www.ahpcsa.co.za .
The AHPCSA broadly welcomes the change in Regulations to the Medicines Act [Act 101 of 1965, as amended], as well as the accompanying explanatory Guidelines: Complementary Medicines – Quality, Safety and Efficacy (QSE), as a modus for assuring the control, safety, quality and efficacy of Complementary Medicines. The AHPCSA responded to the call for public comment on this matter to the Minister of Health and the MCC most recently in November 2011 and also interacted with both these parties in December 2013, after promulgation of Regulation 25A.
Where appropriate, Regulations should allow the MCC to restrict access to certain Complementary Medicines through appropriate complementary medicine-specific scheduling, primarily in order to protect the public, by limiting the use of certain Complementary Medicines to appropriately trained and registered practitioners who, in addition to appropriate education, training and registration, also possess an Act 101 Section 22C dispensing or compounding and dispensing licence.
This is particularly relevant when viewed against persons dispensing and/or prescribing complementary medicines in South Africa, with little or no education and training, which we consider injurious to the health of the public and therefore in opposition to the AHPCSA’s mandate which is to protect the health of the public. However, when considering appropriate complementary medicine-specific scheduling, it is the view of the AHPCSA that a large proportion of Complementary Medicines should remain Schedule 0 (for general sale, including potentially in health shops) or Schedule 1 (Pharmacy-only), which would not hinder access by the public to most registered Complementary Medicines. Certain Complementary Medicines should remain solely under the purview of correctly trained AHPCSA-registered practitioners, where such access control is required.
Complementary Medicines, in the view of the AHPCSA, while generally safer than conventional medicine, can and do have potential for harm and adverse effects and therefore the AHPCSA has welcomed the regulation of Complementary Medicines. The AHPCSA rejects the concept that a medicine is safe simply because it is ‘natural’. It should be noted that those AHPCSA professions that administer, dispense, or compound and dispense complementary medicines also complete a course in pharmacology so as to be in a position to understand conventional medicines, in particular the question of possible drug-interactions between Complementary Medicines and conventional medicines, both of which may exert physiological effects.
It is believed that the regulation of Complementary Medicines is a positive measure; registration and scheduling will have the effect of improving standards of quality, safety and efficacy of Complementary Medicines according to a discipline-sensitive method, as outlined in the MCC’s QSE Guidelines for such medicines, and that the public should welcome this move to ensure higher quality, safer and more reliable complementary medicines.
Much misinformation about the purpose and effects of the new regulations is currently in circulation and it is apparent that many people have not considered the Regulations or the accompanying explanatory QSE Guidelines (available from the MCC website www.mccza.com). The AHPCSA does not comment on legal opinions, unless pertinent to any legal action involving the AHPCSA itself (and then responds appropriately to the party concerned in the appropriate forum), nor to general statements that certain legal opinions hold that the Regulations have been ‘improperly promulgated’. The AHPCSA respects the right of any party to raise any matter via judicial processes and in this particular matter all queries surrounding ‘improper promulgation’ should be addressed to the Minister of Health.
Further, any questions surrounding the Regulations that the AHPCSA may have are currently being raised with the MCC. The AHPCSA does not engage with any party through the media and will only consider commenting once engagement with the MCC has seen its conclusion, if appropriate to do so. The AHPCSA would like to suggest that since the Regulations in question are Regulations to Act 101 that any interested party directs further enquiries to the Medicines Control Council, the Department of Health or the Minister of Health.
ISSUED BY: THE REGISTRAR: ALLIED HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA