US won't give aid for generic HIV drugs

Published May 9, 2004

Share

As South Africa starts rolling out the world's biggest HIV and Aids treatment programme, an unexpected stumbling block is hindering attempts to provide medication to the estimated four million sufferers in sub-Saharan Africa.

An attempt by the Bush administration to make its $15-billion (about R105-billion) Aids treatment grants conditional to brand-name medicines has aid workers and activists, as well as South Africa's pharmaceutical industry, up in arms.

Some are planning protests.

The matter has caused tensions that could erupt at the World Health assembly this month, to be attended by Manto Tshabalala-Msimang, the health minister.

George Bush's President's Emergency Plan for Aids Relief (Pepfar) is headed by Randall Tobias, a former chief executive of drug giant Eli Lilly. Tobias visited South Africa recently as part of a tour of Africa.

Activists are concerned about so-called guidelines and comments by Tobias that suggest that the generic drugs judged most suitable for Africa are not acceptable to the United States and that its taxpayers should not be made to pay for "substandard" medicines.

Aids workers believe this could thwart plans to provide millions more Africans with anti-retrovirals (ARVs) by December next year.

Tobias's statements indicate that grants from Pepfar would be given only on condition that brand-name products from the big multinational companies are used.

Medicines sans Frontieres (MSF), the aid organisation that set up the first pilot site for ARVs in South Africa in 2002, started administering a generic drug at the Lusikisiki site this year and was hoping to expand its use.

The drug is a three-in-one pill that combines drugs from three brand names, called a fixed-dose combination, and is made by Indian generic companies.

MSF's Khayelitsha pharmacist, Marta Darder, said the two-a-day pill had immense clinical advantages as it simplified treatment, therefore boosting adherence, and reduced the development of resistance - the exact opposite of Tobias's claims.

It is also much cheaper than both the brand-name drugs and their generic equivalents, despite the fact that prices have dropped dramatically over the past two years.

The drugs will soon cost as little as $140 a year per patient, compared with the cheapest alternative at $562, which makes it affordable for developing countries in the long run.

Fixed-dose combinations have been recommended by the World Health Organisation since 2002 and the results of a three-year clinical study were released this week judging it the "ideal cocktail" for the developing world. It is available only as a generic.

"The battle for us is now not about prices, but to keep the generic market open for the big contracts to ensure that treatment in the developing world is affordable in the long run," said Darder. She feared the US was trying to close down the burgeoning generic market.

"The problem is not one of quality, it is political. The battle is far from over."

The Bush administration has so far paid only for medicines that are still under patent and that cost four times more.

Tobias questioned the safety and efficacy of fixed-dose combinations as they had not been tested in the US.

"Maybe they are safe and effective. Maybe they aren't. Nobody really knows. With the money that we are putting into this process, it is a whole new ball game," he said.

Darder said that this made it clear that the money would be conditional to certain medicines. "But it is still vague, because there is no policy."

A representative of South Africa's fledgling ARV industry, who did not want to be named, said: "There are strings attached to the donor funding, they want the money to be given back to US companies.

"We say this is not in spirit of Nepad and building capacity on the continent. They are trying to obfuscate the issue."

Nathan Geffen, a spokesperson for the Treatment Action Campaign, said: "They are doing this to protect the pharmaceutical industry in the US, which has been a big contributor to the Bush campaign."

Democrat Henry Waxman accused the Bush administration of trying to set standards for Indian generics higher than those applied to US products.

Related Topics: