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India swallows bitter
bill
By Ranjit Devraj
NEW DELHI - The lower house of the Indian
parliament has passed a legislation that will
prevent Indian drug manufacturers from producing
cheap generic formulations without meeting the
obligation of paying royalty to the patent
holders. The bill now heads to the upper house,
where it's likely to be passed as well.
The bill to amend the Patents Act of 1970
gives medical drugs process and product patent
protection. Indian pharmaceutical companies have
so far been allowed to make generic versions of
patented drugs without paying royalties as long as
they follow a process different from what goes
into the making of the original drug. The Patents
(Amendment) Bill, 2005, introduces product patents
in pharmaceuticals, food and agrochemicals - the
three sectors where the process could be patented
but not the product. Under the trade-related
intellectual property rights (TRIPS) agreement of
the World Trade Organization (WTO), India was
obliged to provide product patents in these
sectors from January 1, 2005. The government met
the deadline by issuing an ordinance in December;
the bill is now aimed at replacing the Patents
Ordinance.
The bill was passed after 13
amendments, many of them suggested by the leftist
parties, which the government agreed to in a bid
to bring the powerful political bloc on board. The
left kept its part of the deal by not pressing for
some of the amendments it had earlier threatened
to move. The National Democratic Alliance
maintained its opposition but couldn't muster
enough numbers to stall the bill.
Angry
watchdog groups and experts have said the bill
would hurt poor patients - especially those
suffering from AIDS - not only in this country but
also globally. Millions of Indians will not be
able to afford the 99% increase in the cost of the
medicines. Some 5.1 million Indians, 38% of them
women, are living with the human immunodeficiency
virus (HIV), which can cause AIDS, totaling up to
approximately 12% of the HIV-positive people in
the world.
The argument for a stronger
patent regime for pharmaceutical companies - in
accordance with WTO requirements - is made on the
basis of the heavy capital investment costs for
research and development that goes into the
creation of a new drug. But the Washington-based
Global Campaign Against Indian Patents Amendment
(GCAIPA) argues otherwise. "It is critical for
people suffering from HIV/AIDS that India does not
lose its continuing supply of anti-retroviral
drugs and generic medicines. If India moves in
this direction, it will prove to be a serious
setback at a time when health activists and
medical professionals are trying to deal with
rising incidents of malaria and tuberculosis in
India," the GCAIPA had said in a petition to the
Indian government. "Not only Indians, but also a
majority of the African nations (notably Ghana and
South Africa) that are importing inexpensive
generic drugs from India stand to lose the battle
against HIV," added the international lobby group.
India's pharmaceutical industry is the
fourth-largest in the world in terms of volume,
with exports reaching an estimated 200 countries
globally. But this has been achieved largely
because India has been reluctant to allow the
patenting of pharmaceutical products. The Patents
Ordinance, passed on December 26, escaped public
attention largely because that was the day the
Asian tsunami struck, killing more than 220,000
people and wreaking havoc on the coasts of a dozen
countries around the Bay of Bengal.
But
the Indian parliament was under obligation to
ratify the ordinance within six months in order
for it to become law. What troubles watchdog
groups and those protesting against the move most,
according to B K Keyala - one of India's foremost
experts on patent law - is the haste with which
the ordinance was rushed in by circumventing
parliament and excluding flexibilities allowed
under TRIPS. "On the other hand, several sections
that were beyond TRIPS requirements were
included," Keyala said.
At the Doha
Ministerial Conference in November 2001, WTO
member states agreed that the TRIPS agreement
should not prevent members from taking measures to
protect public health. They underscored the
ability of countries to use the flexibilities that
are built into the TRIPS agreement, including
compulsory licensing and parallel importing. They
also agreed to extend exemptions on pharmaceutical
patent protection for the least-developed
countries until 2016.
The TRIPS agreement
says products made under compulsory licensing must
predominantly serve the domestic market. This
applies to countries like India that can
manufacture drugs. It limits the amount they can
export when the drug is made under compulsory
license. This has an impact on countries unable to
make medicines and therefore wanting to import
generics. They would find it difficult to find
countries that can supply them with drugs made
under compulsory licensing.
On August 30,
2003, WTO members agreed, in the so-called TRIPS
Plus plan, on legal changes to make it easier for
countries to import cheaper generics made under
compulsory licensing if they are unable to
manufacture the medicines themselves. The decision
waives obligations for exporting countries. Keyala
and other experts have little doubt that the
effect of the new law will put the price of
ordinary drugs way beyond the reach of ordinary
people not only in India but also in countries
that import generic drugs from India.
Said
Mira Shiva, a well-known physician attached to the
Voluntary Health Association of India: "As far as
India itself is concerned, the bottom line is that
even today a large majority of people cannot
afford to buy medicines, and this includes
medicines for HIV/AIDS." Against such arguments,
Indian Commerce Minister Kamal Nath has gone on
record stating that Indian pharmaceutical
companies will continue to manufacture and export
drugs invented before 1995, including 12 of the
most commonly used anti-retrovirals. "We are going
in for higher patent protection to allow India to
become a hub of global medical research, taking
advantage of cost savings and the vast pool of
scientific and technical manpower available in
this country," Nath has said.
Shiva said
Nath's grand statements, eagerly lapped up by the
pliant media, on how the law would improve
research and development, increase (rather than
decrease) the export of generic drugs, and put
Indian pharmaceutical companies in the big league
of global players were completely misleading.
"What is important to note in all this din is the
deafening silence of the Union Health Ministry,
which should be the one most concerned," said the
medical activist.
William Haddad, noted
campaigner for the import of cheap generic drugs
into the United States, said during his recent
meetings with Indian experts that the Patents
Ordinance was "extremely unfortunate" and that
TRIPS itself was not in the best interest of
public health. Haddad, often called the "father of
generics" in the US, said the generics business in
his country would be crippled if bulk drugs and
raw material from India ceased to be available as
a result of the new legislation.
Haddad
said he did not buy the argument that drug prices
in the US were high because of the high cost of
research but saw it as an alibi used by
transnational corporations to maintain high
prices. Many Indians were alerted to the dangers
of the Patents Ordinance after an editorial in the
New York Times on January 18 observed that it had
"little to do with free trade and more to do with
the lobbying power of US and European
pharmaceutical industries". The Times editorial
said that as a consequence of the new rules,
India's copycat industry for newer drugs would in
effect end - therefore doubly hitting the world's
poor by "cutting off the supply of affordable
medicines and removing the generic competition
that drives down the cost of brand-name drugs".
According to Amit Sen Gupta, a physician
with voluntary agency Delhi Science Forum, the
government's arguments have been a mix of
half-truths. "For example, the oft-repeated
argument that 97% of drugs are off-patent and will
not be affected is at best a half-truth because
there is no basis for that figure," he said. What
is of real concern is the rate at which drugs turn
obsolete and this, said Gupta, is especially true
of drugs used to treat infectious killer diseases
such as tuberculosis, malaria, pneumonia and now
AIDS. "The issue is not just drugs that are
off-patent - the more important concern is that
new drugs required to replace old ineffective
drugs will be patented and thus become
unaffordable," he said.
(Inter Press
Service) |
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