Position statements

Nevirapine

We, the Executive Committee of the South African Paediatric Association (SAPA), note with grave concern the decision of the Medicines Control Council of South Africa (MCC) to "reject HIVNET 012 as a pivotal study for the approved indication of the use of nevirapine in the reduction of risk of intrapartum transmission of HIV-1 infection from mother to child"(MCC Press Release - 29/07/2003)

The Executive Committee of SAPA believes the efficacy and safety of Nevirapine usage, as part of a strategy for the prevention of transmission of HIV from mother to child, has been adequately established beyond reasonable doubt.

The rollout of the prevention of mother-to-child transmission programmes (PMTCT) in South Africa (including the provision of Nevirapine) has already resulted in the saving of many hundreds or perhaps thousands of infant lives and any disruption of these programmes at this time would have tragic effects. We believe that failure to continue to administer Nevirapine at this time would constitute a dereliction of the Ethical duties of individual Health Care Professionals as well as an unconstitutional abdication of responsibilities of our Health Authorities.

We appeal to the MCC to immediately repeal their decision that is out-of-step with the extensive reviews and statements of authoritative bodies such as the National Institutes of Health (USA), the Federal Drug Administration (USA) and the World Health Association.

We urge our members in the field to follow their conscience by utilising the accepted practice of providing Nevirapine as part of the PMTCT programme. In doing so they will dramatically and significantly lower the risk of transmission of HIV from mother to child and thus prevent most cases of childhood AIDS.



31st July, 2003