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SOUTH AFRICA: Delayed Drug Registration Could Affect Region

Laura Lopez Gonzalez

JOHANNESBURG, Feb 2 2011 (IPS) - 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.

Delays keep drugs off shelves

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.”

Ripples in the pond

Drug registration delays in South Africa may also far-reaching consequences for other African countries following the regional leader.

South Africa is currently the only African country that is a member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S), which strives to harmonise drug manufacturing standards and regulation among member countries. Gaining membership in July 2007, South Africa’s MCC and drug manufacturers first had to pass stringent reviews by international teams.

According to Gray, there have been discussions within the Southern African Development Community (SADC) to try to allow other countries to capitalise on this strong regulatory capacity, perhaps introducing formal arrangement in which MCC registrations would be recognised by other SADC countries.

While Gray says he believes there have been no formal agreements, there already exists a degree of informal recognition of MCC approvals in other countries, some of which have barely any regulatory capacity.

Currently, only Kenya and Uganda have anything close to the MCC and duplicating the body for countries that lack an equivalent would cost millions of dollars, according to Professor Peter Eagles, who spoke in his personal capacity. Eagles, who is also the chairperson of the MCC.

Trevor Schoerie is the managing director of PharmOut, a phameceutical consulting company based in South Africa and says it’s not uncommon for smaller regulatory authorities to take registrations done by larger counterparts into consideration, often through international mutual recognition agreements (MRAs). He cites Asian examples.

“It’s not uncommon for smaller authorities to accept larger authorties’ work,” he says. “This is done by [Singapore’s] Health Sciences Authority (HSA), so if you have registered [a product] with five recognised authorities, HSA accept the product for sale more easily.

“Association of Southeast Asian Nations [member] countries ‘look up’ to HSA, i.e. if HSA has approved it, then it passes through a MRA,” Schoerie adds. “The arrangements… are common and make drugs cheaper and safer, I think.”

Countries that may be ‘looking up’ to South Africa’s MCC may also be affected by delays in drug registrations, warns Brenda Waning, Coordinator of Market Dynamics for UNITAID, the United Nations drug-funding agency.

“Given the fact that some countries recognise what South Africa registers in their own countries, there could be a ripple effect as most of Africa is looking at South Africa to be the leader in drug registrations and that could cause delays [in other countries],” she says.