•  johannesburg
• Thursday, February 03, 2011
• Inter Press Service

Delays in drug registration by the country's Medicines Control Council (MCC), contribute to depriving South African HIV patients of important fixed dose combination antiretroviral (ARV) drugs. But there are indications that the effects of the delays are being felt even farther afield.

In December 2010, South Africa announced a new, two-year tender for ARVs which halved drug costs for the national HIV treatment programme; The tender however failed to include many fixed dose ARV combinations, which although approved by bodies like the World Health Organization are not yet registered by the MCC for use in South Africa.

By combining multiple drugs into one, fixed dose combinations reduce the number of pills HIV patients take daily and have been shown to improve treatment adherence — with added benefits for clinics, according to Dr Thembi Xulu, of the South African HIV non-profit, Right to Care. 'The more drugs you have, the more space clinics need to store them and our clinics just don’t have that kind of space,' said Xulu, adding that fixed dose combinations would also make managing and ensuring drug supply easier for clinics.

While the body has made recent progress in registering ARVs - which allowed for greater competition among suppliers and lower drug prices in the 2010 tender — there are fears that staffing changes could rob the MCC of its momentum.

According to Andy Gray, a senior lecturer at the department of therapeutics and medicines management at South Africa’s University of KwaZulu-Natal, the recent upsurge in registrations was due, partly, to pressure from South African Health Minister Dr Aaron Motsoaledi, which led to changes in the historically understaffed MCC.

'They brought in an additional set of part time staff to work through the [drug registration] backlog on fixed term contracts, which made some dent, and priority was given to ARV applications' Gray says. 'But the MCC remains quite opaque and it’s difficult to know what’s going on inside… whether the backlog was entirely eliminated and whether it is growing again now that those workers’ contracts are finished.' While the MCC has approved many dual fixed dose combinations, there remains a shortage of registered fixed dose combinations including the first-line ARV tenofovir (TDF), according to South African human rights organisation, SECTION27.

For example, the body has approved only two generic alternatives to brand name two-in-one pill, TRUVADA, which combines TDF with the ARV emtricitabine. Without more generics approved and greater competition among suppliers, prices for this combination drug remain high in South Africa and the two-in-one pill was included only in only limited amounts in the 2010 tender.

'The idea is to reduce patients’ pill counts but it has to be affordable to do it, and for this to happen we need generic competition to bring those prices down,' he says. 'I don’t think we can point any fingers at those who did the procurement [for the tender] given what was registered in the country at the time, but we’ve raised the issue [of fixed dose combinations] to keep it on the agenda.'

© Inter Press Service (2011) — All Rights Reserved. Original source: Inter Press Service

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