As the government’s national roll-out of anti-retrovirals (ARVs) intensifies, there is growing concern that the available sources of supply — including the only South African company manufacturing generic ARVs, Aspen Pharmacare — could be pressurised by the demand.
”The risk at the moment is that we can’t predict how much we need, both from Aspen and outside the country,” said Andy Gray, senior lecturer in the department of pharmacology at the Nelson R Mandela School of Medicine.
Gray said shortages have already been noted, with stocks of branded products not being available at times.
”Manufacturers and suppliers need to plan production and possibly import more raw materials in future, but are hampered by a lack of information about potential demand,” he said.
Gray said two factors holding up generic ARV supplies are the need for licences to be granted by patent holders — such as Boehringer Ingelheim, GlaxoSmithKline and Merck — to produce generics, and delays in the registration of generic medicines by the Medicines Control Council (MCC).
”Government is in a difficult position … with some generics sitting with the MCC for more than a year waiting for registration, meaning that in essence they [the government] must buy from brand-name sources.”
Gray said if South Africa had a range of suppliers selling products at the same or similar prices, it would help guard against shortages.
He said besides Aspen Pharmacare, which is physically manufacturing ARVs in South Africa, two other South African-registered companies have the potential to be ”large-scale” suppliers of ARVs in the country.
They are the Indian-based Cipla and Ranbaxy, both of whom manufacture ARVs abroad at competitive prices.
Ranbaxy has formed a joint venture with Adcock Ingram to market ARVs locally, trading as Thembalami.
These companies, and Aspen, are expected to tender as suppliers of the government’s ARVs, Gray said.
According to Médécins sans Frontières, an advantage of having a local manufacturer and distributor of generic ARVs is the creation of wealth.
”But even more important, having local manufacturing offers government the possibility to set up price-control policies on the ARVs to ensure affordability and sustainable supplies for the public sector,” said Dr Marta Darder, head of the Access for Drugs campaign.
Darder said a potential problem with companies such as Aspen is that it is ”100%” in private hands and will follow the rules of the market.
She said local manufacture in itself is not the only solution for a reliable supply of affordable drugs, citing the examples of Brazil and Thailand, where state-owned pharmaceutical companies were established to produce drugs, and where ”demand and price are set up over a long time”.
”In South Africa the pharmaceutical market is completely in private hands … two options that government could embark on … [is to] increase government control, probably through public-private partnerships, or ensure competition in the market to keep prices low.”
Aspen Pharmacare, which runs two factories in the Eastern Cape — one of which produces the continent’s first generic ARV, Aspen Stavudine — said it has been working with the government to assist in the national ARV roll-out.
”We have been working consistently with government for nearly three years to assist with the rollout of an ARV programme,” said Stephen Saad, group chief executive of Aspen.
Aspen was the first pharmaceutical manufacturer globally to be granted generic ARV licences from GlaxoSmithKline and Boehringer Ingelheim.
According to Saad, Aspen will be able to provide a cocktail therapy to treat Aids patients at ”competitive” international generic prices, once the MCC grants registration for the remaining ARVs, such as lamivudine and nevirapine.
Saad said Aspen will be increasing its Port Elizabeth-based manufacturing capability with the construction of a multimillion-rand oral solid dosage facility, which is expected to open in June.
”Having pioneered generic medicines in Africa, we are suitably prepared for the future demands for generic medicines and ARVs,” Saad said.
Approximately five million out of a population of about 45-million South Africans were infected with HIV by the end of 2002, while the government’s national ARV roll-out plan estimates less than 400 000 will require ARVs during the 12-month period between 2003 and 2004.
This means that about one in 10 people infected with HIV will obtain ARV treatment. — Sapa