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Kenya says yes to generic ARVs but fails to win Global Fund cash

Generic AIDS drugs are now allowed into Kenya under compulsory licensing provisions in the Industrial Property Act of July 2001, which came into force in May this year. These antiretrovirals (ARVs) could halve the price of current ARV therapies.

Badara Samb, who deals with drugs access issues at WHO, says the Kenyan route to cheapening ARVs is not the only one. "Countries should look at all legal avenues to widen access". They can engage in friendly negotiations with manufacturers to reduce prices, for instance. "And they can cancel taxes. Some countries like Burundi for example impose import taxes of 40%."

Compulsory licensing is the key step to introducing generics, although most countries contain the provision in their existing patents legislation. The declaration of a "health emergency" is not necessary, but it speeds up the use of the licences, as negotiations with patent holders can then be waived.

According to Kenyan government figures, only 2500 out of the 200 000 AIDS patients in Kenya are currently receiving antiretrovirals. The drugs are only available in high-cost private hospitals such as the Aga Khan, the Nairobi, the Pandya Memorial Hospital, the private wing of the public Kenyatta National Hospital, and a few church-run hospitals.

Nicholas Otieno, who has been living with HIV/AIDS since 1992, speaks of the irregular supplies of ARVs, which can lead to HIV- resistance to the treatments. "Since I started taking antiretroviral drugs last July, I have twice been unable to get my regular supply of Zerit," he said. "Once I could get Epivir as a substitute, but that costs 4000 Kenya shillings (US$ 50) per month instead of the usual KES 440 (US$ 5) I pay for Zerit. The other time I went without a substitute for two weeks."

Otieno is just one of the many AIDS patients in Kenya nominally on ARVs but still advancing towards full-blown AIDS, because of the shortage, inaccessibility and unaffordability of ARVs in Kenya's health institutions.

But with generics, the government plans for all patients to receive the drugs — if it can get the funding. Nairobi hopes that the generics will undercut the prices of branded ARVs, which despite manufacturers' reductions still cost US$ 850 a year for the cheapest triple therapy. That is less than a tenth of the price in the developed world, but still too much for the 10 million people in Kenya who live on less than US$ 1 a day.

Generic triple therapies including AZT, 3TC and nevirapine are now down to prices of around US$ 295 a year, Samb told the Bulletin — but that is still dear in the African context. Ellen 't Hoen, coordinator of the globalization section of the Médecins Sans Frontières (MSF) campaign for access to essential medicines, knows of other courses costing only US$ 209. It's still not low enough "but the prices could go down further," she says.

However, patients will still not get the drugs "unless there is loads and loads of funding available," said 't Hoen. The experience now being built up in Africa of how to administer ARVs in resource-poor settings must be collected, "and absolutely crucial is single tablet combinations, which will most likely come from the generic manufacturers," 't Hoen said.

Despite the legal steps towards generics in Kenya, the drugs will not be in patients' hands there any time soon. The country has failed in its first application for funding from the Global Fund to fight HIV/ AIDS, Tuberculosis and Malaria (the Global Fund). And Kenya's Pharmacy and Poisons Board — which must vet all imported drugs for efficacy and toxicity — was out of action from September last year when its tenure expired until this May when a new Board was appointed. As a result, the five Indian generics companies which already have applications pending, according to the MSF Office in Nairobi, are still waiting for approval.

According to Sophie-Marie Scouflaire, Regional Pharmacist for MSF, the Pharmacy and Poisons Board is run by "senior officers at the Ministry of Health who are always busy with office work — that's made it ineffective and compromised its independence". Scouflaire thinks the Board should be restructured along the lines of the Uganda National Drugs Authority, which, she says, is a technical body and quasi-independent of the government.

Kenya's Public Health Minister, Professor Sam Ongeri, however, says haste would be dangerous — the drugs have to be introduced with care. "ARVs are not chewing-gums to be given to Kenyans at a whim. They have to be thoroughly tested for toxicity and efficacy before they are allowed into the market."

Cash will also be a problem. Kenya had applied for US$ 293 million from the Global Fund against an estimated commitment of US$ 1.2 billion by the government, civil society, private sector and other donors. Some 70% of the Global Fund sums were earmarked for drugs and treatment of sexually transmitted infections (STIs), prevention of mother-to-child HIV transmission and prophylaxis. But the proposal was rejected.

The government aimed to be able to provide 300 000 people in Kenya with ARVs, in addition to enhancing uninterrupted availability of quality drugs for treatment of other STIs. Ongeri thought Kenya's proposal had not been properly evaluated. "We sent them 17 kg of documents but I am convinced they did not go through them. Kenya has the best country coordinating mechanism for AIDS, malaria and tuberculosis. I can't understand why we were not given the money," Ongeri said.

One theory is that the application did not adhere to the Global Fund Guidelines, which require countries coordinating proposals to link budgets to specified partners. The Ministry has already announced its intention to make a reapplication to the Global Fund when its board sits again in September.&nbsp

James Njoroge, Nairobi, Kenya

World Health Organization Genebra - Genebra - Switzerland
E-mail: bulletin@who.int