Further information which the Democratic Alliance (DA) has been given shows that the Medicines Control Council (MCC) continues to be responsible for the delay or cancellation of clinical trials for potentially life-saving medications because of its antagonistic, obstructionist approach, aimed at limiting rather than expanding access to medicines in South Africa.

We have therefore written to the chair of the Portfolio Committee on Health to request that he summon the registrar of the MCC, Ms Mandisa Hela, before the committee to explain the reports we have received; we have also again written to the Minister of Health to ask her to attend to this crisis. South Africans should be able to rely on a safe, effective medicines supply, and it is unacceptable that the MCC should misuse the public funds that it receives so badly.

Earlier this year a clinical trial for selenium supplementation for patients with HIV (a promising new therapy) was scrapped after the funding lapsed, following a two year delay in the MCC's processing of the application.

We have been given further information showing countless similar examples. These records show that documents are frequently lost, or simply left unattended for months on end. There is case after case of mismanagement and neglect. For example: 

• An application for an oncology trial was rejected, apparently because the declaration page was not signed, even though the applicants have proof that it was signed.
• An application for a urology trial was rejected because of one hand-written CV.
• An application for a psychotic drug trial was rejected because it was claimed that it was poorly compiled, but it had been compiled in exactly the same way as a previously accepted application.

The MCC seems particularly bad at approving applications for new investigators for currently running trials, with many applications made a year or more ago still not even acknowledged. An enormously unpredictable approval rate means that anyone wanting to conduct a trial faces great uncertainty and therefore great costs. Laws in Europe and the United States stipulate that approval for clinical trials must be within two months. But in South Africa some applicants wait for more than two years.

Statement issued by Mike Waters MP, Democratic Alliance spokesperson on health, February 18 2009