/ 3 December 2008

Medicines body in poor state, says DA

A clinical trial which could benefit Aids patients is about to lose its funding because of the inefficiency of the Medicines Control Council (MCC), says the Democratic Alliance (DA).

According to the DA’s Mike Waters, the poor state of the MCC was demonstrated most recently by the fact that an important clinical trial for selenium supplementation for Aids patients – which observational studies suggest may postpone the onset of full-blown Aids – is about to lose its funding because the applicants cannot get a response from the council.

”In the 18 months since the application was made, and with a scientist from the University of Cape Town phoning at least once a day for the past year to try and follow up on the application, the phone has been answered only twice and faxes and e-mails have never been answered,” Waters
said on Wednesday.

”The 18-month wait [thus far] for approval compares dismally to the average 14-day approval time for clinical trials in 1997; this despite a trebling of the MCC’s budget and a doubling of staff numbers in 2001.

In addition to delays in approving clinical trials, there are many other areas in which the MCC is not performing to acceptable standard.”

He said that approvals for new medicines took one year in 1997, and now take more than two years; and applications for pharmaceutical variations took less than six weeks in 1997, and now take more than a year.

The DA has called on Health Minister Barbara Hogan to demand an improvement plan from MCC chairperson Peter Eagles and the registrar of medicines Mandisa Hela, and to remove them should they fail to produce one.

”In terms of an Act passed recently, the MCC is about to be restructured and given an enormous funding boost,” Waters pointed out.

”But until its employees are able to at least answer the phone and attend to basic procedures, this additional funding will do nothing to improve the council’s performance. The DA calls on the minister to act urgently.” – I-Net Bridge