Confusion within the Department of Health has delayed a government plan to issue the anti-retroviral drug, nevirapine, free of charge to HIV positive pregnant women at 18 sites countrywide.

An estimated 1 800 HIV positive babies are born in South Africa every day, and nevirapine can reduce the mother-to-child HIV transmission rate by up to 50%.

KwaZulu-Natal, the Free State and Northern Cape were due to start issuing nevirapine to pregnant HIV positive women at selected hospitals and clinics last Monday (2 April).

But after racing against the clock to train staff to start the programme, the provinces were told two weeks ago by the national Department of Health to sit tight until the Medicines Control Council (MCC) had registered nevirapine.

The department also recently decided to seek Cabinet approval for the nevirapine programme – which may mean a further delay.

The Treatment Action Campaign’s Nathan Geffen said the delay “over technical issues surrounding the registration of nevirapine” was “disgraceful”.

“Children are dying of HIV/AIDS while the Department of Health, the MCC and Boehringer Ingleheim, the manufacturers of nevirapine, continue to display a lack of will to fulfill their ethical responsibilities,” said Geffen.

According to MCC chairperson Professor Helen Rees, the department only submitted its nevirapine research protocol for approval “a couple of weeks back”.

“There was a genuine misunderstanding about nevirapine, as the department thought it had been registered and did not realise that they had to get a proposal to us for approval,” said Professor Rees.

“Some of the things in government’s proposal are contrary to the package insert for nevirapine, which reflect the science of the drug. These have to be changed before we can approve the proposal.”

Blaming “misleading media reports” for government’s confusion, Professor Rees said that the MCC was “keen to get things going as soon as possible”, and would fast-track an amended government proposal through its executive committee.

However, she said it would probably take another month to sort out the confusion.

“Nevirapine is in the final stages of being registered”, according to Professor Rees. “The package insert was approved last Friday, and the only outstanding issue is whether Boehringer Ingleheim will agree to monitor drug resistance.”

The Western Cape started issuing nevirapine to HIV positive pregnant women in Gugulethu in January, but provincial sources said national government had threatened legal action against the province for using an unlicensed drug.

Secretary for Health in KwaZulu-Natal, Professor Ronald Green Thompson, said he wanted the nevirapine programme to go ahead in his province “as soon as possible, but we cannot do so until we receive formal approval from the MCC”. Over 36% of pregnant women in KwaZulu-Natal are HIV positive, according to the latest ante-natal survey.

Free State official Ms Lache Katzen said her staff “can’t wait to start”, and would go ahead as soon as nevirapine was registered and national government had sent them a supply of nevirapine.

The Northern Cape’s Ms Carvia Kula said urban sites in Kimberley and rural sites in De Aar were ready and waiting for nevirapine to arrive.

Gauteng’s Director of Public Health, Dr Mmipe Modise, said her province would phase in the use of nevirapine, starting with JG Strijdom and Natalspruit hospitals, followed by Kalafong and Pretoria West hospitals.

Voluntary HIV counselling and testing was already available at the sites where nevirapine was to be offered, but the province was still involved in staff training and was waiting for its supply of nevirapine.

Cabinet’s nod for the programme – which was approved by the minister and provincial health MECs by September last year – has yet to be granted.

National health department spokesperson Ms Jo-Anne Collinge confirmed that her department had to respond to “a number of questions from the MCC about the research proposal for the 18 sites” before the programme could begin.

She also confirmed that Cabinet approval had been sought and that the matter was due to go before Cabinet “very soon”.

Meanwhile, TAC has called on government to offer nevirapine free at all ante-natal clinics, as “the 18 sites only reach about 10% of women who attend public antenatal clinics”.