The Democratic Alliance (DA) has called on the Minister of Health to demand an improvement plan from the Medicines Control Council (MCC)Chairperson, Prof. Peter Eagles, and Registrar of Medicines, Ms Mandisa Hela, and to remove them should they fail to produce one.
"Many South Africans' lives depend on being able to access safe and effective medicines, but the MCC, which must approve these drugs, is in a state of collapse," the DA said in a statement.
"The poor state of the Medicines Control Council 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," the DA said.
In the eighteen 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 emails have never been answered, the statement said.
Compares badly to 1997
According to the DA, the eighteen 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, the DA charges that there are many other areas in which the MCC is not performing to acceptable standards:
- Approvals for new medicines took one year in 1997, and now take more than two years
- Applications for pharmaceutical variations took less than six weeks in 1997, and now take more than a year
"These problems have dire consequences for our health. South Africans are denied access to new treatments for diseases available in the rest of the world; we are denied access to generic medicines; and the development of knowledge about how to treat some of our greatest scourges is slowed or stopped," the statement said.
In terms of an act passed recently, the MCC is about to be restructured and given an enormous funding boost. 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 concluded.
Source: Press release from the Democratic Alliance
Medicines bill approved
IFP, DA welcomes medicines decision