[Ip-health] The Independent: Licensing deal threatens cheap pharmaceuticals

Thiru Balasubramaniam thiru at keionline.org
Wed Dec 1 02:00:57 PST 2010

Licensing deal threatens cheap pharmaceuticals
Stella is four, and lives on HIV drugs. Next week, the EU may cut her

By Daniel Howden in Bwindi, Uganda
Wednesday, 1 December 2010


Stella's life is in the balance. She was born, four years ago,

HIV-positive. Her mother, Rebecca Mbabazi, 23, only discovered – like so
many mothers in Uganda – that she had the virus when she was already

Mother and daughter live in the verdant hills on the edge of Bwindi
Impenetrable Forest in the remote west of the country. It is famed for
mountain gorillas but during the 1990s became infamous for lethally high
rates of HIV/Aids infections.

Like most little girls, Stella doesn't much like pills – she pulls a  
face when they are mentioned – but she takes them anyway, twice a day.  
save her life. But for how long? If the European Union has its way, the
supply of cheap drugs on which Stella depends could be cut off.

A collection of plastic bottles on the sideboard in the gloomy back  
room of
her grandmother's house contains her life-savers. They are  
drugs (ARVs) that suppress the HIV virus and boost her immune system,
slowing the onset of full-blown Aids. The brand on the pill bottles is  
a household name. "Aurobindo" is one of the unheralded, generic drug
producers in Hyderabad – an Indian city at the centre of a  
revolution that has saved millions of lives in places such as Bwindi and
across Africa. In the past decade, companies such as this, mass- 
generic copies of Western drugs, have turned India into the "pharmacy of
the developing world" and helped to bring affordable, high-quality
medicines to many of the areas of greatest need.

More than 80 per cent of ARVs bought by donors for use in Africa come  
India. Since 2003, the average cost of treating an HIV patient has  
from nearly $500 a year to $70, says the International Aids Society.  
2001, Indian generics have provided antiretroviral treatment for 4  
HIV-positive people in the developing world. They are the reason  
Stella is
alive, and that she still has a mother and brother. But this remarkable
progress is under threat.

Half a world away, the EU is preparing for trade talks with India in
Brussels next week. Among the reams of small print are several clauses  
seek to protect the intellectual property rights and commercial  
of European pharmaceuticals giants. If the deal is agreed, it would  
a new patent-like barrier which threatens the flow of cheap, life-saving
medicines to children like Stella.

The clause causing most concern is "data exclusivity", which would
effectively block Indian producers from registering copies of foreign
drugs, including those not protected by the existing patents system.  
would mean delays of up to 10 years in delivery of generic versions of  
improved medicines and up to 15 years in the case of paediatric  
versions of
the same drugs.

Médecins Sans Frontières (MSF), which treats hundreds of thousands of
patients in the developing world, is campaigning against the changes and
demanding talks with the EU. "It is a case where profits are coming  
lives," said Dr Unni Karunakara, the MSF president. "We are talking  
real lives. They may be hidden away in remote areas but they are real.
There are millions of lives depending on these cheap drugs, so we're  
hands off our medicines."

He warns that "data exclusivity", and clauses that could see safe  
seized and destroyed as counterfeits at EU ports, will "criminalise"  
medicines and drive up costs for Indian manufacturers. Those costs would
then drastically hit the ability of doctors in poor countries to offer  

EU officials insist the changes will not affect India's ability to  
affordable drugs. "My position, and that of the EU, is very clear,"  
De Gucht, EU Trade Commissioner, said. "We are negotiating a free trade
agreement between the EU and India. Any agreement will have no impact on
the right or the capacity of India to produce generic medicines." But  
is sceptical about those promises.

The implications of these talks will travel the thousands of miles to
Uganda's capital, Kampala, and the 12-hour drive over rutted roads to  
Stella and her family live. It was in places like Bwindi that rumours  
of a
terrifying new disease, known locally as "slim", started to be heard  
in the
late 1980s. Its victims wasted away, often dying behind closed doors,
imprisoned by stigma. At its height, a quarter of Ugandans were  
Dr Richard Kazibwe, who runs the Aids programme at Bwindi Hospital,  
grew up
in what he calls the "HIV generation". "When I was a kid I lost close
relatives to HIV," he says. "People were dying like nobody's business  
dying in a horrible way – slim to the bone."

The doctor, 28, says free ARVs made possible by cheaper drugs, and a  
surge in donor funding, brought about a "transformation". "People's
attitude to HIV is changing. They know that if you come and get tested  
can get treated, but this is recent. When you had HIV in the  
would just forget about you."

Across Uganda, the roll-out of life-saving drugs has helped to bring
infection rates down to below 7 per cent. Serious challenges remain and,
after five years of historically high spending by the US and other  
HIV funding has flatlined this year. The global financial crisis is  
budgets and that already means intermittent supplies of ARVs at Bwindi.
Yet there is another big problem. Even if existing drugs keep coming  
at the
same price, Dr Kazibwe explains, they will not solve the crisis. Growing
numbers of patients on long-term courses of ARVs are developing  
to the drugs. In the West, the failure of "first line" regimens is  
by switching to second or third line alternatives. A stream of new
treatments helps HIV victims in the rich world to stay ahead of the
mutating virus.

Dr Kazibwe points to a battered chart on the wall showing the dozen or  
drugs that make up his dwindling arsenal. He draws a line through  
about a
half dozen to show those which are no longer available or no longer  
"New mutations of the HIV virus are coming and if generic producers are
blocked the whole battle against Aids will be lost," he warns.

Hope Tukahirwa, a voluntary Aids worker, is living proof of the ARV
miracle. She is 47 and HIV positive. It is 11 years since her husband  
of Aids and seven since the disease killed her son, Brian. It was only
after her little boy died that she got tested. "Before, I was afraid to
take the test as I thought that would mean I would die faster," she  
"I thought that if people knew they would ignore me or hate my kids."
Her three surviving children were nearly orphaned. She became  
seriously ill
four years ago, just as treatment was becoming more widely available.  
changed from bad to good," she says. "I don't get sick very often any  
The only stress I have is finding money for school fees."

With income from a small farm, Hope managed to put her twin daughters,  
20, through school and into university. She admits "it is not easy" but
says her children are her hope. She worries that the ARV drugs will stop
coming. "In the old days, people were dying like rats. The drugs were  
expensive and if it happened again we would be back in the old days."
Muhumuza Gervis, a teacher, was a skeleton on the edge of death when he
began taking ARVs. He and his wife, who is also HIV positive, support  
children. He remembers first hearing about miracle drugs that were  
rich Ugandans alive in Kampala. But there was no way even at a "fair  
that a teacher could afford them.

"If the ARVs are not free there will be no way of surviving," he says.
After four years, Muhumuza's drugs are no longer working. He is one of a
growing number of drug-resistant patients at Bwindi. Any delays in the  
of cheap new drugs will be a death sentence for him and many thousands  

*****TAKE ACTION TODAY, Help protect millions of ppl in the developing
world’s access to AIDS meds. Join MSF today, & tell Europe "Hands Off  
Medicine" https://action.msf.org ****************


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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