[Ip-health] Guardian: African AIDS Drugs Trapped in the Laboratory

[mpalmedo@cptech.org]

http://www.guardian.co.uk/international/story/0,3604,960106,00.html

Africa's Aids drugs trapped in the laboratory

Kenya has the pills. Now the fight is on to get them to the people

Rory Carroll in Nairobi
Wednesday May 21, 2003
The Guardian

There is no lock on the door, no phalanx of guards, no visible impediment
to the drugs leaving the glass chamber that the laboratory technicians
call a "stability room". The pills come in little white boxes with labels
such as lamivudine, zidovudine and efavirenz, technical names disguising
the fact that these tablets are the stuff of life.
Take them together and if you have HIV you can stave off death for years.
Millions in Africa have the virus but not the pills. A stone's throw from
the laboratory Aids is wiping out communities, yet these pills cannot
leave the stability room.

This is Nairobi, the factory is Kenyan, and a web of influence spun by the
world's pharmaceutical giants encloses its labs, ensuring the Aids drugs
stay inside. For Africa, getting them out would be a milestone in
controlling the pandemic.

Two things are happening which could untangle the web. Activists are
preparing a legal challenge to allow Kenya to make and import generic Aids
drugs. And Nairobi's factories are boosting their capacity to make their
own cheap drugs in expectation of that court victory.

For decades, African companies have produced generic copies of antibiotics
and other drugs, paying royalties to those western companies which
developed and patented the formulas. Prices tumbled, making them
affordable to the poor.

But that has not happened with Aids. The western companies, fearing for
profits and market share, have refused permission for generic copies of
drugs known as anti-retrovirals (ARVs).

But in the labs of Nairobi manufacturers such as Cosmos they sense change
coming. Following World Health Organisation guidelines, they have
successfully copied branded Aids drugs, registered them with health
authorities, printed labels for the boxes and stored them in the stability
room. Under international patent law, there they must stay unless the
makers obtain a licence.

"There is nothing preventing me mass producing. We have the expertise, the
access to raw materials, the registration," said Prakash Patel, Cosmos's
chairman and managing director. "By the end of the year we will be
producing. I think we will be the first to produce ARVs in Africa."

Dr Patel's boast reflects swelling confidence that the multinationals will
not block African generics. Another Nairobi firm, Laboratory & Allied,
also said it could switch to ARVs within weeks.

That optimism stems from a series of victories in recent years which
asserted the right of countries facing public health emergencies in the
developing world to override intellectual property rights by issuing what
is called a compulsory licence to make or import generic drugs.

Countries such as Britain issue compulsory licences occasionally, giving
the NHS cheaper drugs, but African states have hesitated: the drug giants
have friends in Washington and other capitals who can withdraw investment
and trade concessions from uppity African states.

But such a threat has now receded. The World Trade Organisation's Doha
declaration said that developing-world countries could make or import
generics. Even President Bush wants cheaper drugs for Africa.

Yet the drugs industry is fighting back, by cutting prices of branded
drugs, warning health ministers that national treatment programmes would
bankrupt their budgets, and depicting generics as unsafe.

John Musunga, commercial director of GlaxoSmithKline's Nairobi office,
said the firm had no plan to stop generics, yet pinned on his wall was a
strategy apparently advocating the "promotion of doubt" of generics. Mr
Musunga also rejected claims that the industry exerted improper influence
over the Kenyan government.

Two years ago, an amendment protecting patents was slipped into Kenyan
legislation. After an outcry it was removed. The Guardian has obtained a
letter from Kaplan & Stratton, a Nairobi legal firm, to the Kenya
industrial property office, requesting an amendment for an unnamed client.

But the momentum towards African generics is growing. The Consumer Project
on Technology (CPTech), a not-for-profit group started by the radical
American campaigner Ralph Nader, is coaching groups in South Africa,
Ghana, Uganda and Kenya to mount legal bids for compulsory licences.

The plan is to reassure African governments that the international climate
has changed. The prize is not just lower prices, but more sustainable
supplies suited to Africa, such as all-in-one pills. Kenya seems to be
moving fastest, with some government officials enthusiastically backing
the initiative.

"The first case you get in Africa is going to have a huge effect on other
African countries. If it's a positive decision they'll look to that, it'll
have a domino effect," said James Love, of CPTech. "We should succeed in
Kenya. It would be a crime against patients if we don't succeed."

In Nairobi's biggest slum, Kibera, they are waiting. M=E9decins Sans
Fronti=E8res has identified candidates for ARVs, people such as Kevin
Wanjala, 11, who was born with HIV and has been chronically sick.

Shy and small for his age, he was at the top of his class in his favourite
subject, English, before dropping out due to illness. "When I grow up I'd
like to be a car mechanic," he says. Kevin is nearing full-blown Aids,
said Florence Olanya, an MSF nurse. Without drugs he is unlikely to last
two years.