According to a joint submission by the Aids Law Project (ALP) and the Treatment Action Campaign (TAC), proposed new laws (draft medicines and related substances amendment bill, 2008) may grant the Minister of Health, Manto Tshabalala-Msimang, undue power with regard to registration of new medicines. An article on Health24.com stated that the new laws 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 untested “treatments” and “cures”.”

In light of the minister’s attitude that garlic, beetroot, lemon etc is the answer to AIDS, and the controvercial AIDS-drug Virodene’s development and testing, this is indeed concerning. Then there is also the fact that the Minister has always said that traditional medicine should not be judged by Western standard. Which, as I understand it, means that it should not have to be scientifically proven.

Up untill now the job of regulating medicine has been that of the Medicine Control Council. According to the MCC, “It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.” However Jonathan Berger, of the ALP, says that “the MCC, as it stands, is only semi-independent.” and “Much of its independence has been undermined already. It must be independent (reporting to parliament in terms of empowering legislation, not floating freely without any lines of accountability) to protect it from political and commercial pressure. Its mandate on quality, safety and efficacy cannot and should not be compromised to satisfy political or commercial considerations” Should this new laws be passed, the MCC will lose all independence.

It has also been said that the MCC does not take the regulation of Alternative medicine very seriously. The Democratic Alliance alleges that, “in relation to alternative medicines, the MCC has almost completely ignored its responsibilities. …there are several avenues available to it to respond to misleading or false claims. The Medicines Act, for example, specifically prohibits the sale of any product as a medicine unless clear specifications are met, including meeting safety and efficacy standards. Yet contraventions of this law happen every day, with apparently little action.” As a result of this, the Health Products Association of South Africa (HPA) launched a self-regulatory programme with the stated aim of excluding manufacturers who are destroying the industry by means of unethical behaviour in June 2006, which is run by the people it intends to regulate… which could most definitelly pose a problem.
So once this Bill is passed, the MCC and HPA’s self-regulatory programme would be of little use. What South Africa needs is something simmilar to the American Food And Drug Administration, that is responsible for the regulation of “most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics”, and that is totally independent from government, and scientifically based.