Here's timeline of the Medicines Control Council (MMC).
The Medicines and Related Substances Control Act is passed, establishing the Medicines Control Council.
1960s and 1970s
Every category of medicine for treating major diseases is called up for registration.
Johan Schlebusch joins the MCC, starting as an inspector (medicine controller).
Professor Peter Folb is appointed chairperson of the MCC. He is a leading international expert on drug safety and an outstanding scientist.
Schlebusch is appointed registrar of the MCC.
The MCC tries for the first time to regulate medical devices and complementary medicines.
The US Congress passes the Dietary Supplement Health and Education Act that deregulates the supplements industry, making it easier to sell diet remedies and other dubious products alleged to improve health.
Then director-general of health Dr Olive Shisana chairs a meeting of alternative practitioners to discuss their concerns. The concern is that such a meeting falls under the MCC and not the health department. The health department is thought to have undermined the MCC’s authority by hosting the meeting and rumours fly that change is in the offing. The sellers of complementary medicine seize on this time of uncertainty and illegal medicines start pouring on to the market. Drug policy is published for the first time in South Africa.
The MCC convinces Shisana to change her mind and Schlebusch moots a plan that would have brought the market under control. The plan never sees the light of day. Wide-ranging changes to the Medicines Act are introduced which the pharmaceutical industry opposes, resulting in years of litigation. The MCC stands firm against Mbeki on the false Aids medicine Virodene. The MCC suspends a clinical trial of Virodene which had proceeded without the approval of an ethics committee or the MCC. Precious Matsoso joins the MCC.
Folb is not reappointed when his term of office expires. Schlebusch and his deputy Christel Bruckner, who had both been with the MCC for over 20 years, are dismissed. Professor Helen Rees replaces Folb and Matsoso replaces Schlebusch. Deterioration of services is observed.
A CCMA award reinstates Schlebusch and Bruckner and the Labour Court makes it an order of
the court. The department reaches a monetary settlement with Schlebusch, but continues to refuse to reinstate Bruckner in an appropriate position. She brings a contempt of court application against the department, minister and director general.
The MCC publishes a notice in the Government Gazette superseding all previous calls for registration of medicines in the same class – the previous call-up notices for herbal drugs (1973), special foods for which a claim was made (1974), products using the terms ‘medicated’, ‘medicinal’, ‘medical use’ etc (1978) and vitamins and minerals (1985) are superseded. This allows quacks to claim their concoctions are ‘registered’ with the MCC just because they had lodged an application.
The court sentences Dr Manto Tshabalala-Msimang and Dr Ayanda Ntsaluba to 15 days in prison for contempt (re the Bruckner matter), but the sentence is suspended. Bruckner is reinstated and is still there today, but is not assigned any substantive work. Professor Peter Eagles is appointed chairperson of the MCC.
Matsoso leaves the MCC and joins the World Health Organisation. The Code of Practice for the Marketing of Medicines is published for the first time in terms of the drug policy. This has never been finalised and leaves the door open for some of the marketing practices seen today with complementary medicines.
After repeated calls, MCC registrar Dr Humphrey Zokufa claims they are investigating the operations of German vitamin seller Matthias Rath. These claims are exposed as untrue when the Treatment Action Campaign goes to court. It turns out that there was no investigation into Rath’s actions, nor into his unethical clinical trials. Zokufa leaves the MCC in November and becomes CEO of the Board of Healthcare Funders.
It emerges that the health department director general, Thami Mseleku, has been appointed interim registrar as a stop-gap measure to avoid any further delays in the registration of medicines. The acting head of pharmaceutical planning in the health department, Mandisa Hela, is later appointed registrar, a position she still holds.
The department of health proposes the introduction of regulations dealing with the registration of complementary and alternative medicines differently from scientific medicines. The Medicines Act is revamped, but has not yet been implemented. It provides, inter alia, for the MCC to be replaced by a new authority called the Medicines Regulation Authority which must be more independent of the health department. Barbara Hogan is appointed health minister. She sets up several task teams, one of which has the task of examining the legislation and problems linked to drug regulation. It is headed by Matsoso and includes several well respected experts in the field, including Folb.
(Some of this information has been sourced from Debunking Denialism by Nathan Geffen (Jacana 2010))
(This is an edited extract of an article first published in What’s New DOC, 10th issue, May 2010. What’s New Doc is a publication for medical doctors, produced in association with Health24.)