In a joint submission on the draft Medicines and Related Substances Amendment Bill, 2008, the Aids Law Project (ALP) and the Treatment Action Campaign (TAC) warn that the proposed new laws could "sound the death knell" to the scientific governance of medicine in South Africa.
Essentially, the proposed changes will see the Minister of Health being given much greater powers in the regulation of medicines, and, says Jonathan Berger of ALP, "destroy" the independence of the MCC.
Earlier this year, addressing members of the presidential task team on African traditional medicine, Health Minister Manto Tshabalala-Msimang said, "We cannot use Western models or protocols for research and development. We should guard against being bogged down with clinical trials."Her statements unleashed a barrage of criticism, possibly best summarised by the American critic Steven Novella who said that the minister is "fighting to protect the traditional healers of South Africa from having their methods tested".
The minister has not explained why standard clinical trials are not valid when it comes to traditional medicines.
Clinical trials are not Western
Tshabalala-Msimang's tendency to refer to clinical trials as "Western" frames the debate as Africa vs "the West", rather than a matter of science.
Clinical trials are not Western, points out Berger. "They are – to date – the only ways we have developed to determine, in accordance with internationally accepted ethical standards, whether products are safe and effective."
There have been many examples of traditional medicines being subjected to clinical trials, and found to work.
A recent task team report recommended that the efficacy, safety and quality of traditional African medicines which claim cures for serious conditions, would have to be established to the same level as mainstream medicine: through clinical trials, manufacturing standards, and the like. But, the report continued, the challenge is to find "appropriate tools" for establishing evidence. "Clearly defined criteria to describe the amount and type of data required for evaluating products for safety, quality and efficacy are necessary. An expert group of the Medicines Control Council is currently investigating this issue."
The Health Department has not responded to inquiries regarding the composition of the expert group nor to questions on what may be "appropriate tools".
Most likely though, the "expert group" refers to the Presidential Task Team on Traditional Medicine – which is chared by the controversial Professor Herbert Vilakazi, who has himself been involved with the marketing of the fake Aids cure ubhejane.
A matter of culture?
The issue has to a large extent to do with the blurring of the lines between culture and science.
"As we all know," says Tshabalala-Msimang, "apart from its medicinal values, African traditional medicine also defines us as a people. It is this heritage amongst others that we are not simply going to give away purely because of the humiliation we get subjected to for the things we believe in."
Her critics argue that whether a treatment works or not is not a matter of culture, but something that could and should be tested in a transparent and logical manner – particularly where public policy is involved.
In the final chapter of her book Mortal Combat: AIDS Denialism and the Battle for Antiretrovirals, Professor Nicoli Nattrass, of the Aids and Society Research Unit at the University of Cape Town, relates the story of a grandmother who, distrusting "Western" medicines, treats her HIV-positive granddaughter with the supposed Aids cure, ubhejane.
"Not only was she denying the child access to appropriate treatment, but it was probably costing her almost half of her monthly pension to do so," Nattrass writes.
This sums up the essential dilemma: where people are encouraged to reject proven treatments in favour of those deemed more "culturally" acceptable – and for this, to pay dearly, in both health and financial terms – critics feel government has an obligation to act.
Dangerous new laws?
According to the ALP/TAC submission, the amendments would "allow the Minister of Health to block the registration of medicines of proven quality, safety and efficacy, as well as to allow the sale and provision of tested 'treatments' and 'cures'."
In a worst case scenario, says Berger, this could result in the minister giving the go-ahead for the sale and promotion of products like ubhejane. He goes as far as suggesting that sections of the Bill may have been designed with the express intent of allowing just this.
The minister's track record
Given the minister's track record of supporting fringe ideas, these fears may not be unfounded.
For example, reacting to concerns raised by the Democratic Alliance (DA) concerning ubhejane, Tshabalala-Msimang said in 2006: "It is disturbing to note that the DA continues to perpetuate racist stereotypes that African traditional medicines are inferior products manufactured by wizards."
The minister only distanced herself from the supposed cure after the Advertising Standards Authority (ASA) earlier this year ruled against claims made by Zeblon Gwala, the former truck driver who makes ubhejane.
Though many concerns relate to the current minister in particular, Berger argues that the extended powers over the regulation of medicines would be inappropriate irrespective of who happens to be the minister of health.
In this regard Berger argues that:
- A political appointee is unlikely to have the relevant expertise to make the kinds of decisions required of the minister in the draft Bill.
- Locating such powers in a minister weakens the regulatory authority's role in retaining independence from political or commercial lobbying.
- The sheer volume of work such discretionary powers will generate makes it inappropriate for these decisions to be handled at this level.
- Where discretionary powers are given, the draft bill does not provide sufficient guidance on the exercise of those powers, arguably in conflict with the constitution.
- Registration should be based solely on the basis of quality, safety and efficacy. Other considerations do not come into the picture at all. Where these might be relevant is in relation to the funding of new drugs, whether by government or medical schemes - not in relation to registration.
- Marcus Low, Health24, 30 May 2008
The medicine control amendment bill
The ministerial task team report on the regulation of medicines
The ALP/TAC submission on the bill