[Ip-health] Reuters: U.S. industry body says India agreed to not issue 'compulsory' drug licences

Andrew S. Goldman andrew.goldman at keionline.org
Tue Mar 8 06:14:06 PST 2016


U.S. industry body says India agreed to not issue 'compulsory' drug licences


India has given private assurances that it will not grant licences allowing
local firms to override patents and make cheap copies of drugs by big
Western drugmakers, a U.S. business advocacy group said.

The comments were revealed in a submission last month by the U.S.-India
Business Council (USIBC) to the U.S. Trade Representative (USTR), which is
reviewing global intellectual property laws for an annual report
identifying trade barriers to U.S. companies.

The USTR has placed India on its "priority watch" list for two years in a
row saying the country's patent laws unfairly favour local drug makers. A
bone of contention has been a legal provision that allows the overriding of
patents on original drugs and granting of 'compulsory licences' to local
firms to make cheaper copycat medicines.

India can grant such licences under certain conditions, such as public
health emergencies, to ensure access to affordable medicines for its mostly
poor people. It granted the first such licence in 2012, allowing local firm
Natco Ltd to sell a copy of German drugmaker Bayer's cancer medicine
Nexavar at a tenth of the price.

Since that ruling, big Western pharmaceutical companies have criticised
India's patent law and lobbied for it to be changed.

In its submission to the USTR, a copy of which was seen by Reuters, the
USIBC said the government "privately reassured" the group that it would not
grant such licences to firms for commercial purposes.

The government has made no such statements publicly. Officials have said
they are committed to protecting the interests of patients.

Commerce Minister Nirmala Sitharaman, her joint secretary in charge of
pharmaceuticals, and the USIBC did not respond to requests for comment.

Washington-based non-profit Knowledge Ecology International (KEI) expressed
concern over the USIBC submission.

"If such an agreement in fact exists, this is extremely troubling news ...
this sort of pressure is basically a declaration of war on poor cancer
patients," KEI said in its own submission to the USTR last week. It called
for details of the agreement to be made public.

Under Prime Minister Narendra Modi, India has been undertaking a review of
its intellectual property (IP) policy. A revised policy is due to be
released imminently.

Several health activists and charities like Medecins Sans Frontieres have
criticised the review, saying India is buckling under U.S. pressure and
compromising the interests of patients.

The U.S. Chamber of Commerce and the Pharmaceutical Research and
Manufacturers of America, the biggest U.S. industry lobby group, have both
recommended keeping India on the U.S. "priority watch" list in separate
submissions to the USTR.

The Indian Pharmaceutical Alliance, which represents 20 big drug makers,
argued in its own submission that India's patent laws were fully
WTO-compliant. Its head chided the USIBC for breaching confidence in its

"If the government of India had said something privately, USIBC should not
have embarrassed it by making it public," said Secretary General D.G. Shah.

(Reporting by Zeba Siddiqui)

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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