The registration of traditional medicines
a new medicines bill
by Andy Gray
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The latest of the department of health’s transformatory
Bills before Parliament is the dauntingly named South
African Medicines and Medical Devices Regulatory
Authority Bill (SAMMDRA bill). This piece of legislation
will, if passed and implemented, bring a totally new
look to the regulation of medicines in this country.
In brief, the Bill establishes a new regulatory authority,
the South African Medicines and Medical Devices
Regulatory Authority (SAMMDRA), to replace the
Medicines Control Council (MCC) which was set up in
1965. This Council has had control over all forms of
medicine, be they of orthodox or complementary
nature. Crucially, however, the MCC held all medicines
(both orthodox and complementary) to the same set
of standards and procedures. These focussed on three
issues: safety, quality and efficacy. In the case of
efficacy, the standard test was the double-blind
randomised controlled trial. The SAMMDRA Bill, in
contrast, makes provision for different procedures to
be applied when registering orthodox (science-based,
allopathic) medicines and complementary (herbal,
traditional, or homeopathic) medicines. This will be
done by establishing separate expert committees for
the two major types of medicine (in addition to those
for veterinary medicines and medical devices). In the
case of traditional medicines, issues of safety and
quality will take precedence over demonstrations of
efficacy. The aim is to regulate and not to prevent
access to what many people use in preference to
Western, allopathic medicine.
From a traditional healer’s perspective, this testing of
medicines by an independent body may seem
unnecessary. Mr. S.J.Mhlongo, head of the Inyanga’s
Association, says that traditional healers have been
testing their own medicines for the past 4 000 years.
There are still questions about the bill though. Although
the Transformatory Task Team on Medicines
Regulation has suggested that complementary
medicines be divided into three categories (those
available in open shops, those restricted to pharmacies
only, and those available only through registered
practitioners), this is not clearly discernible in the Bill.
The Bill also makes mention only of the
complementary practitioners who are registered in
terms of the Chiropractors, Homeopaths and Allied
Health Professions Act, not of the traditional healers
of South Africa (although it later talks of informing the
Interim Co-ordinating Committee of Traditional Medical
Practitioners of South Africa of the results of
applications for registration of a traditional medicine).
Thus it would seem that the prescribing rights of
traditional healers, as opposed to mainly western
complementary practitioners, have not been settled.
Registration of all forms of medicine is also tailored to
the orthodox setting, and might be unenforceable in
the traditional medicine arena. Thus, while the National
Drug Policy (and National Veterinary Drug Policy) might
have been intended for application to all medicines,
including traditional medicines, this Bill leaves many
issues perhaps as muddy as before. It leaves us with
as many questions as answers.
Public hearings on the Bill have been scheduled for
Monday 26 October. Thereafter the National Assembly
Portfolio Committee will consider any possible
amendments, before the Bill is tabled for its second
hearing, and probable adoption. However, given the
number of unresolved issues in many areas (not just
related to traditional medicine), the possibility of a court
challenge after passage through Parliament cannot be
ruled out.
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