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 An Indian committee is reviewing up to a dozen
patented drugs to see if so-called compulsory licenses, which in
effect break exclusivity rights, can be issued for some of them, two
senior government officials said last month.
"I understand that India has issued one compulsory license, but
there's a lot of concern about what additional licenses are being
considered," U.S. Assistant Secretary of State Nisha Biswal told
reporters in the Indian capital.
"There's concern about ... whether next-generation drugs would be
protected, and how do you ensure that investments that are being
made to develop ever-more effective drugs can then be continued."
In 2012, India issued its first-ever compulsory license to domestic
drugmaker Natco Pharma Ltd on a kidney and liver cancer drug,
Nexavar, patented by Germany's Bayer AG.
That and a series of recent decisions on patented drugs in India, as
part of New Delhi's push to increase access to life-saving
treatments, is at the centre of trade friction between Asia's
third-largest economy and the United States.
Like other emerging markets, such as South Africa and China, India
is battling to bring down healthcare costs and boost access to drugs
to treat diseases such as cancer, HIV/AIDS and hepatitis.
Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding
AG and Sanofi SA, covet a bigger share of the fast-growing drugs
market in India.
But they have been frustrated by a series of decisions on patents
and pricing, as part of New Delhi's push to increase access to
treatments in a country where only 15 percent of the 1.2 billion
people have health insurance.
"The constant threat of compulsory licenses hangs like a Damocles
sword over patent-holders," Ranjit Shahani, vice chairman and
managing director of Novartis' India unit, told Reuters in an
interview on Tuesday.
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"Over the past two years, the government of India has issued
several intellectual property decisions that disproportionately
impact innovative biopharmaceutical companies," he said. "Not only
is this a concern for business in the Indian market, but also in
other emerging markets that may see India as a model to be
emulated."
India is on the U.S. government's Priority Watch List — countries
whose practices on protecting intellectual property Washington
believes should be monitored closely.
U.S. industry trade group Pharmaceutical Research and Manufacturers
of America (PhRMA) believes Washington should take a tougher line by
downgrading it to a Priority Foreign Country, a classification for
the worst offenders, which could trigger possible actions, sources
said last month.
If India is relegated by the U.S. to Priority Foreign Country level,
it would join Ukraine as the second country in that segment.
Countries in the Priority Watch List include China, Indonesia,
Pakistan, Russia, Thailand and Argentina.
(Writing by Sumeet Chatterjee; editing
by Ron Popeski)
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