After many years' wait, the revised draft regulations for Complementary and Alternative medicines were gazetted on 22 August 2008, and have been welcomed by the HPASA as a move in the right direction.
The closing date for comment on the revised regulations is 22 November 2008, and the HPASA is hopeful that with, some adjustments, a new and appropriate structure, together with guidelines, will be in place next year to serve CAMS consumers as well as health practitioners, manufacturers and distributors.
The HPA has been negotiating with the Department of Health for the past 12 years to try and establish regulations that were appropriate for complementary medicine. The HPA always held that each stream of medicine should be regulated in accordance with the model within which it operates. In other words, allopathic (orthodox)) medicine should have its own set of regulations; so should veterinary medicine; and complementary medicine too requires a different set of parameters on which to base regulations.
There was much excitement when, on 16 July 2004, long-awaited draft regulations to control complementary medicine were announced by the government. However when they were issued, delight turned to distress: they did not represent what the HPA had been discussing and negotiating. The purpose of the draft document was to subsume complementary medicine under orthodoxy - the exact opposite of what the HPA had been lobbying for.
HPA chairman Dr Alan Tomlinson recalls that the HPA had been very impressed with the publication of the SAMDRA Act that made separate provision for medical devices, orthodox medicine, veterinary medicine and complementary medicine. "We thought that the DoH had bought into that principle and that the draft regulations would reflect this. So it came as a shock to find that they did not do so."
In response to this development, a Complementary Medicine Stakeholders' Committee (CMSC) was set up in order that complementary medicine be represented as fully as possible. Stakeholders included not only the HPA but medical professionals, retailers, academics, the Medicines Control Council and industry representatives, and this very inclusive committee did a thorough job of responding to the draft published regulations.
A 600-page report from the CMSC was submitted to the DoH, outlining why the regulations were considered unsuitable and offering a full blueprint for what the CMSC believed was appropriate.
The DoH spent more than three years processing all the submissions made in response to the draft regulations (and there were no doubt others besides that of the CMSC). The DoH had two options: to come up with a revised draft of the 2004 regulations or abandon the original altogether and devise a new one.
This evaluation task has been in the hands of the Complementary Medicines Committee - a standing committee representing all the CAMS modalities and under the control of the Medicines Control Council - and the pace at which they have worked has been frustrating for all players within the field of complementary medicine.
"There seemed to be a tardiness, a lack of urgency about getting the task done," Dr Tomlinson reflects, "although in 2007 we saw a change in momentum and there was increased activity within the CMC. They met many times during the year and were doing a thorough job of looking at all the proposals - including the one that we submitted."
It's possible that the process was stimulated by objections raised during the year by the Democratic Alliance about the length of time it's taken for the revision of the regulations. They also referred the matter to the Parliamentary Select Committee on Health with the request that pressure be put on the DoH to have the regulations put in place.
There was evidence, early in 2008, of strong pressure by the Minster of Health to have the regulations issued as soon as possible.
Added Dr Tomlinson: "We were also encouraged by the fact that Peter Kreft (a member of the CMSC) was co-opted to be part of the working group in the CMC and DoH. And that Debbie Drake Hoffman (Registrar of the Allied Health Professions Council and also a member of the CMSC) was also been consulted about the regulations."
There was no guarantee what direction the draft regulations would take, but if they are in generally accord with the spirit of what has been submitted as appropriate for complementary medicine, the HPA will work with the draft regulations and make supportive suggestions. If, however, they are again in conflict with that the HPA has stood for, the Association is prepared to object as vociferously as before.
"We will use all the powers at our disposal to say ‘Start again'," says Dr Tomlinson, "but we're not anticipating the worst; we're hoping for something approaching the best."
Concurrent with the work being done on the draft regulations, representatives from the health industry and complementary medicine have devoted thousands of hours of voluntary time to developing "positive lists of substances" that will form part of the regulations. Specialist technical committees were put together and have been at work within each complementary modality to evaluate pertinent substances for safety and additional comment such as warnings (where necessary) and levels.
Lists were submitted to the Medicines Control Council and approved. But as new substances materialise, work on the lists has to continue - and the latest additions are subject to further scrutiny by the MCC. Additions are only made very cautiously however. Anyone wishing to add to the list must supply a complete bibliography for that substance and with pharmacopeial evidence of its safety.
Lists have been drawn up in the fields of:
Anthroposophy
Aromatherapy
Ayurveda
Chinese Traditional Medicine
Energy substances
Homeopathy
Nutrition (including supplements, weight loss, sport & performance substances)
Sowa Rigpa (Tibetan medicine)
Western herbals
Unani Tibb.
An extensive menu of claims for complementary medicine has also been suggested to the authorities.
In a report from the CMSC to their stakeholders in November 2006, they pointed out that other countries (such as Canada, India and Switzerland) have successfully implemented a regulatory framework that was inclusive of all paradigms of medicine. They concluded by stating that South Africa was a progressive country when it came to freedom of speech, regulation and rights of its people.
"Is it not also our responsibility to acknowledge and protect the traditions and practices of all medical paradigms and, in so doing, support all groups equally with respect to their preferred health practice and right to freedom of choice as set out in the Constitution?"
See information about the Self Monitoring Technical Committee.