[Ip-health] Stat News (Pharmalot): India denies plans to restrict compulsory licenses for drugs

Thiru Balasubramaniam thiru at keionline.org
Wed Mar 23 04:51:32 PDT 2016


By ED SILVERMAN @Pharmalot

MARCH 22, 2016

After two weeks of confusion, the Indian government today denied it plans
to restrict compulsory licenses.

In a brief statement, the government press office said reports that the
government had “privately assured” business groups that licenses would no
longer be issued were “factually incorrect.”

The clarification was made after two prominent business groups earlier this
year had filed documents with the US Trade Representative’s Office
suggesting the Indian government had agreed to restrict compulsory
licenses. These licenses allow generic drug makers to make low-cost
versions of brand-name medicines without the consent of the brand-name
company holding a patent.

The documents, disclosed earlier this month, appeared to be a potentially
significant victory for global drug makers, which complain that successive
Indian governments favor India’s domestic pharmaceutical industry at their
expense. The companies regularly accuse India of upholding laws and issuing
court rulings that make it easier for their generic rivals to sell
lower-cost, copycat versions of their medicines.

The documents were filed by the US Chamber of Commerce and the US-India
Business Council, which hope to convince the US Trade Rep to keep India on
its annual Priority Watch list of countries that are singled out for
failing to protect and enforce patent rights. As we noted previously, India
is a perennial name in what is called the Special 301 report, which is
released each April.

Under pressure from the global pharmaceutical industry and the US
government, the Indian government has been reviewing its intellectual
property policy. In October 2014, a high-level working group was formed
with US officials, shortly after Indian Prime Minister Narendra Modi took
office and, at the time, vowed that India would be open for business.

However, the impression that the Indian government had given such
assurances was condemned by consumer and patient groups. Many generic drug
makers based in India are among the world’s largest suppliers of copycat
medicines, and these groups worried that any move to restrict licenses
would hurt patients who are unable to, otherwise, afford medicines.

These groups argue the pharmaceutical industry unfairly pressures India to
tighten its policies over competitive fears and has convinced Washington to
argue its case. They also note that the right for a government to issue
compulsory licenses was memorialized in a World Trade Organization
agreement known as Trade-Related Aspects of Intellectual Property Rights,

The Indian government, in fact, cited this agreement as its rationale for
maintaining its current policy toward compulsory licenses. “Even as (the)
government of India is conscious of the need to spur innovation and protect
individual rights, it retains the sovereign right to utilize the
flexibilities provided in the international intellectual property regime,”
the statement said.

One expert on the Indian market was not surprised that the government
issued a clarification. Vince Suneja, chief executive of TwoFour Insight
Group, a consulting firm that works with Indian drug makers, had told us
earlier this month that there are two scenarios under which the government
may issue a compulsory license, and it was not clear if any shift in policy
was planned.

Under one scenario, the central government can issue a license for a
national emergency, but this would not have any commercial application. In
the other scenario, a license may be issued by the Indian Patent Office in
response to affordability and patient access. Suneja today explained that
any government reassurances referred to the first scenario, which would not
constitute a change.

Not surprisingly, one consumer activist was relieved.

“The drug companies have embarrassed the Modi regime in their Special 301
filings,” said Jamie Love of Knowledge Ecology International, an advocacy
group that focuses on access issues. “Now the Modi administration will have
to demonstrate that a compulsory license is still possible, and that’s good

We asked the business groups for any comment and will update you

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