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 HI 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.
Last November 18 CAPRISA lodged its application with the MCC for permission to proceed with CAPRISA 008. Inexplicable delays in communication from the MCC to CAPRISA - one of them as long as five months - have been interspersed with detailed explanations by the CAPRISA researchers on the reasons for, and details of, the application.
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.
The most recent, which according to CAPRISA's legal advisors is technically illegal, wants the trial's informed consent forms approved by the National Health Research Ethics Committee (NHREC). The law under which NHREC operates does not give this committee jurisdiction to review individual studies or consent forms. This ‘requirement' has not been raised by the MCC at any time during the past year's bureaucratic ping-pong match.
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.
Statement issued by Marian Shinn MP, DA Shadow Minister of Science and Technology, November 28 2011
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