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The regulation, registration and control of medicines in South Africa is (still) chaotic. A What's New DOC (WND) investigation uncovered an MCC trying to pick up the pieces amid a fractured past which includes massive backlogs, political meddling, allegations of bribes and vested commercial interests, lack of control over complementary medicines and quack remedies flooding the country
By ANSO THOM, (award-winning journalist, Health-e News Service)
Below are some of the issues What’s New DOC attempted to discuss with MCC registrar Mandisa Hela. In April, she finally agreed to answer a list of questions by email and promised to follow it up with a telephonic interview. She never replied to the questions and also ignored all follow-up attempts to get hold of her. A senior source in the health department said these questions are ‘spot on’ and cut to the core of the challenges facing the MCC.
Allegations of questionable conduct
- Some members of the MCC have very close relationships with representatives of the pharmaceutical industry. How are these relationships monitored?
- Why don’t members of committees or the Council routinely recuse themselves from discussions or decision-making when possible conflicts of interest may arise, as prescribed by section 4 of the Medicines Act?
- Is there any record of MCC chairperson Professor Peter Eagles recusing himself from discussions or decision-making relating to products sold by Clicks while he was still a non-executive director of Clicks?
- Is it true that the wife of a Council member runs or owns the laboratory used by the MCC for testing?
- What was the outcome of the 2007 investigation into advocate Thomani Mulaudzi’s alleged bribery?
- Is it true that some medicines are registered even though the documentation may only have been given to Council members on the same day as the meeting?
Complementary medicine
- How can manufacturers and other members of the industry decide for themselves that a product is a complementary medicine and therefore only needs to comply with the abbreviated complementary medicines call-up process? Who double-checks the claim that a product is a complementary medicine and hasn’t already been called up for registration as a conventional medicine?
- Is it true that some generic medicines are registered while no bioequivalence studies have been done comparing them with the SA reference product?
- How strict is the MCC when it comes to registration of bioequivalent generic ingredients, as a high number of poor-quality generic ingredients is flooding African markets?
- Will new regulations or new primary legislation be needed for complementary medicines and how will the public be protected in the meantime?
- What is being done to stop charlatans offering unregistered medicines for a range of diseases, including Aids?
MCC operations
- How is the campaign to clear the backlog progressing? What steps are being taken?
- How do you respond to claims by pharmaceutical companies that the backlog is affecting their patent rights?
- Why must drugs already approved by the Food and Drug Administration and European Medicines Agency be reassessed?
- What is being done to improve the efficiency of the Medicines Control Council?
- Which expert committees are making headway and which ones are struggling?
- What has happened to the many millions of rand the MCC has been paid since 2003? Why isn’t this money being used to employ more staff or pay more academics to assist on the various committees?
- It is said a member of the Complementary Medicines Committee is using a SCIO machine on members of the public. SCIO is unproven and is a device that is not registered. How can the MCC have such a person as a member of one of its committees?
General
- Why have no regulations been published yet for registration of devices? The 2003 Medicines Act includes registration of these devices. How many have been registered in the past seven years?
(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.)
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