[e-drug] Kenya says yes to generic ARVs but fails to win Global Fund cash

[Beverley Snell <bev@burnet.edu.au>]

E-drug: Kenya says yes to generic ARVs but fails to win Global Fund cash
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[Copied as fair use. BS]

Kenya says yes to generic ARVs but fails to win Global Fund cash
Bulletin of the World Health Organization 2002, 80 (7)
http://www.who.int/bulletin/pdf/2002/bul-7-E-2002/80(7)606-609.pdf

James Njoroge, Nairobi, Kenya

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
short- age, 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 Me�decins Sans Frontie`res (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.
--

Beverley Snell
Centre for International Health
Macfarlane Burnet Institute for Medical Research & Public Health
Telephone 613 9282 2115 / 9282 2275
Fax 61 3 9282 2144  or  9282 2100
Time zone: 10 hours ahead of GMT.
email <bev@burnet.edu.au>

GPO Box 2284, Melbourne 3001 Australia
Site: Alfred Medical Research & Education Precinct (AMREP),
corner Punt & Commercial Roads, Prahran 3181

Time zone: 10 hours ahead of GMT.



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