Integrated Regional Information Networks - August 29, 2002

One could be forgiven for wondering why a tiny minority of HIV-positive Kenyans have access to anti-retroviral drugs (ARVs) to keep themselves alive, or to be precise, 6,000 of an estimated two million who need the same drugs.

The issue is not simply one of availability, but availability at the right price. The vast majority of Kenyans cannot afford the current market price of at least US $75 per month, while cheaper generics - available at half the price - are hardly available at all.

The question is why? Since the re-amendment of the Industrial Property Act 2001 earlier this month, there are no legal obstacles preventing imports of generic drugs.

"There is no legal barrier to stopping the government from importing cheaper ARVs that are of a good quality. It is time that we used our strong Industrial Property Act for this purpose," said Christa Cepuch, a pharmacist with Medecins Sans Frontieres.

REGISTRATION OF DRUGS

At the moment, only three generic ARVs have been registered in Kenya - Lamivudine/Zidovudine, Zidovudine, and Stavudine. By 19 August, 87 ARVs were awaiting registration by the Kenyan regulatory authority, the Pharmacy and Poisons' Board (PPB), Bibiana Njue, Head of Drug Registration, told IRIN. Of these, 82 had been discussed and the PPB required additional information from the manufacturers about them.

Chris Ouma, from the Kenya Coalition for Access to Essential Medecines, said the PPB was "very slow" to give permission for use of the drugs. He noted that some awaited registration from as far back as 1999. "For bureaucratic reasons, Kenyans are still waiting for those drugs. The registrations are not handled with the urgency that the situation requires."

Njue told IRIN that such delays were the manufacturers' fault, but noted that the average length of time required for registration was about three months.

"The companies do not respond to our queries on time. There is no way that we can register them without all of the information required."

She added that while the World Health Organisation (WHO) had produced a list of recommended and tested ARVs, it only specified the name of the drugs and not the manufacturer. "WHO gives us a model. You can take it or leave it - it is up to the regulatory body to check each one," she said.

A regularly updated list is available from WHO and states not only the name of the drug but also that of the manufacturer and of the manufacturing site. "Once a drug has been added to this list, there is no reason why drugs from that manufacturing site should not be registered in Kenya, because the WHO process of evaluation is much more stringent and thorough than Kenya's process," Cepuch said.

While campaigners for cheaper drugs agree that it is the responsibility of the manufacturers to provide the correct information, many feel that given the emergency at hand - an estimated 700 Kenyans dying each day - the PPB could take the initiative to assist the companies through more information-sharing.

"They should give us a helping hand," said one Kenyan manufacturer of ARVs, who asked not to be named. "Why doesn't the [health] ministry look at this aspect, and call a meeting of manufacturers to explain. It would show they have taken an interest." He added that under the Kenya National Drug Policy 1994, the health ministry had an obligation to support local drugs manufacturers.

He said no priority was given to ARVs by the registration board. "For a normal drug, it usually takes about a year to be registered, for ARVS maybe even one and a half years," he said.

"It is the Board's responsibility, as part of the Ministry of Health, to ensure that drugs necessary for Kenyans are on the market," Cepuch stressed.

NO PROFIT

One Nairobi pharmacist told IRIN that even though he was able to order ARVs, he did not stock them, because it was not worth his while. High costs and low demand did not warrant them, as the few who could afford them went to hospitals to obtain them. Moreover, while he knew that cheaper generics were importable, he said he would not go out of his way to make them available.

"People go to the big hospitals in Nairobi, where they buy in bulk so it's cheaper," said Janet Sang, another pharmacist. She said she did not know how people managed in rural areas, where the vast majority of Kenyans live.

Another pharmacist accused some distributors of not stocking ARVS at any price.

"Even distributors are hesitant to stock ARVs, because they are not making a profit out of them. It would be easier if there was a small mark-up on ARVs."

IGNORANCE KILLS

Even when ARVS are available free of charge, many Kenyans are reluctant to obtain them because of ignorance and fear.

British American Tobacco (BAT) began an offer of free ARVs to all its workers (about 2,200) in Kenya in 2001, Dr Tesfa Led, heading the programme, told IRIN.

The company had written a letter to all its employees stating they would not be discriminated against, or sacked, and advising those who were HIV-positive to go for counselling. Of the 330 who were expected to be HIV-positive - based on the national average of 15 percent - a mere eight had availed themselves of the treatment.

"It boils down to stigma," Led added. "Some employees are afraid they might be retrenched, that their superiors might find out, or their colleagues." The rest were probably unaware that they were HIV-positive, he said, and reluctant to go for a test.

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