SA :President Jacob Zuma Must Fast Track Approval for HIV/Aids Gel

President Zuma will this week launch a plan to combat HIV/Aids. Part of this plan must be to ensure that a world-renowned HIV preventative field trial gets approval from the Medicines Control Council (MCC).

For more than a year the Centre for the Aids Programme of Research in South Africa (CAPRISA) has been subjected to a bureaucratic ping-pong match as the MCC keeps inventing new reasons to delay approval for the CAPRISA 008 field trial.

This is a follow up to the CAPRISA 004 field trial which, last year, won international acclaim for its antiretroviral microbicide vaginal gel that proved successful in curbing the transmission of the HIV virus. Nearly 900 women from Vulindlela , KwaZulu-Natal participated in that trial.

CAPRISA 008 aims to identify some of the less common adverse effects of exactly the same vaginal gel before it is licensed for wider – and worldwide – use. The R30 million funding for this trial has been secured from UNAids and the Department of Science and Technology.

CAPRISA director Prof Salim Karim tells me that as soon as he believes they’ve satisfactorily addressed the MCC’s concerns, it comes up with a new and unknown requirement to fulfil before the trial can proceed.

During the past two months I approached both the Minister of Science and Technology Minister Naledi Pandor and the Minister of Health Dr Aaron Motsoaledi to help fast track the approval for the CAPRISA 008 trial.

Minister Pandor declined as the MCC does not fall under her department and, despite the fact that her department has allocated R15 million to the trial, she felt it was inappropriate to discuss the issue with the Minister of Health.

Minister Motsoaledi, in a response to my letter asking him to nudge the MCC, said that “any initiative aimed at prevention of the spread of HIV will always be treated as a priority”.

This has not been CAPRISA’s experience.

The Cabinet must take action to help stop this farcical process. We cannot let the ghost of previous Cabinets’ collective inertia on HIV and AIDS haunt us in perpetuity.

The MCC’s indifference to the life-threatening threats of HIV infection is an act of violence against millions of women who want to take control of their sexual health through the use of this gel.

Cabinet must redress the silence of its past and instruct the MCC to stop its delaying tactics in its approval of the CAPRISA 008 field trial.


Source:- Marian Shinn, Democratic Alliance (DA)   –  Press release – 27 Nov 2011