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Published on Wednesday, March 23, 2005 by OneWorld.net

by Abid Aslam

=A0
WASHINGTON -- Indian lawmakers adopted a new patent law Tuesday that would =
ban 
domestic firms from making low-cost generic versions of patented drugs. Hea=
lth 
campaigners warned that as a consequence, millions of people around the wor=
ld would be 
denied access to cheap life-saving medicines.

The Lok Sabha, parliament's lower house, approved the legislation after the=
 government 
agreed to demands from leftist allies and made several last-minute amendmen=
ts to 
placate concerns that the new law would help multinational companies gain d=
ominance 
and push up prices in the Indian market.

International aid groups, however, said the law would restrict the ability =
of Indian 
companies to supply generic drugs to Africa and other poor regions. With re=
spect to AIDS 
alone, the effect would be to threaten the survival of hundreds of thousand=
s of current 
patients and millions more who had hoped the medicines would become more wi=
dely 
available, not less.

''The patent law will cut the lifeline to other countries,'' said Ellen 't =
Hoen, policy advocacy 
and research director at Doctors Without Borders' campaign for access to es=
sential 
medicines.

The measure was expected to become law later this week after being cleared =
by the upper 
house. It stemmed from India's membership of the World Trade Organization (=
WTO), which 
enhances the South Asian powerhouse's participation in global commerce but =
requires the 
country to tighten patent rules for its $5 billion pharmaceutical industry.=


It would replace a long standing policy of allowing local firms to make gen=
eric versions of 
Western drugs so long as these involved modified production processes. This=
 approach 
helped to foster a strong drug manufacturing industry in India for more tha=
n three 
decades and turned the country into a leading supplier of inexpensive pharm=
aceuticals to 
the rest of the world.

India exports two-thirds of its pharmaceutical output to developing countri=
es, according 
to the World Health Organization. Generic competition fueled by Indian drug=
s has been 
largely responsible for reducing the prices of antiretroviral drugs used to=
 treat AIDS, in 
some cases by as much as 98 percent.

''We are deeply disturbed and concerned that you are failing to listen to t=
he voices of your 
people who have entrusted you with their welfare, not to mention the poor i=
n the 
developing world who rely on affordable medicine from India,'' Hoen of Pari=
s-based 
Doctors Without Borders and representatives from other aid groups said in a=
 letter to 
Sonia Gandhi, leader of the governing Congress Party.

The new measure empowers the government to override a patent on a medicine =
if such a 
large number of people need it and cannot afford it that this constitutes a=
 national 
emergency.

Despite having some 5.1 million people infected with the AIDS-causing HIV v=
irus--the 
second largest number after South Africa--the disease is not seen as a nati=
onal 
emergency and Indian companies will therefore no longer be allowed to copy =
new 
inventions in AIDS treatment, said Doctors Without Borders, also known by i=
ts French 
initials MSF.

In the case of AIDS, Indian modifications have revolutionized treatment. We=
stern cocktails 
of up to three separate drugs have been combined into one pill, for example=
, reducing 
costs and making it easier for poor people to keep up with treatment under =
difficult 
circumstances.

Of the 700,000 people receiving antiretroviral treatment in developing coun=
tries, half rely 
on Indian generics. MSF said it treats 25,000 people in 27 countries and ro=
ughly 70 
percent of these patients use Indian-made drugs.

Before generic drugs became widely available in 2001, similar treatments co=
st more than 
$10,000 per patient per year--40 times more than the $250 average price of =
such 
treatment in MSF programs today.

Groups voicing concern about the supply of cheap drugs have run the gamut f=
rom 
international aid agencies like ActionAid and Oxfam and health campaigners =
like Health 
GAP (Global Access Project) to regional organizations like Washington-based=
 Africa Action, 
a group more accustomed to working on U.S. policy toward the continent.

Brazil, Canada, China, Singapore, and South Africa are among other countrie=
s producing 
generic drugs. India is the biggest producer, however, and its companies ma=
ke not only 
the finished tablet forms of drugs. They also make generic versions of the =
raw ingredients 
and chemicals used in the drugs' manufacture. Many of these they actually e=
xport to 
global pharmaceutical companies to produce their brand-name versions.

India's new law is supposed to bring it in line with a WTO agreement called=
 TRIPS, for 
''trade related aspects of intellectual property rights.''

Since 2003, TRIPS has contained a waiver that allows ''compulsory licenses'=
' to be issued to 
override specific patent restrictions. With these, countries that suffer a =
serious health crisis 
but are unable to produce drugs at home can import generics from other nati=
ons. Some 
governments have been reluctant to enforce the licenses, however, for fear =
of jeopardizing 
the supply of aid and investment from wealthy nations.

Major pharmaceutical companies can decide to issue voluntary licenses, bypa=
ssing the 
TRIPS system and making it easier for their drugs to be produced genericall=
y.

In 2001, 39 major drug companies tried to prosecute the South African gover=
nment for 
passing a law which they said violated TRIPS regulations by easing rules fo=
r producing and 
importing generics.

Following immense pressure from the South African government, the European =
Parliament, 
and an international petition, the global firms backed down. At least one o=
f them, 
GlaxoSmithKline, subsequently granted a voluntary license to a major South =
African 
generics producer.

Copyright =A9 2005 OneWorld.net

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