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

amit sen amit37064 at yahoo.com
Wed Mar 23 05:15:23 PDT 2016

The Indian Government's denial is almost in the nature of another assurance that India is not going to issue a CL anytime soon.
See below my response to the Government's clarification:
Amit SenguptaPeople's Health Movement------------------------------------------------------The response by the Government of India, through a Press Information Bureau (PIB) release, to reports of private assurances offered by the Government to industry that CLs will not be issued, is confounding to say the least. The standard disclaimer in the PIB release "It is hereby clarified that such reports are factually incorrect" is to be expected as one wouldn't expect the Government to acknowledge a private conversation which goes contrary to public policy. The subsequent (non) explanation in the release: "India has a well-established TRIPS compliant legislative, administrative and judicial framework to safeguard IPRs. Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted" does not in any way address the issues raised about 'private assurances' offered to industry regarding non-issuance of CLs. In fact, to the contrary, concerns that are being raised argue that India appears willing to sacrifice the rights of individual countries that were affirmed by the Doha Declaration.
The Government's assertion that it is "conscious of the need to spur innovation and protect individual rights" betrays the thinking of the current government which links protection of individual rights to promotion of innovation. It sounds more like a justification of why the Government is reluctant to issue CLs, seeing them in the same light as big pharma and votaries of strong IP protection i.e. as an infringement of 'private rights'. Global evidence, in fact, does not support a link between innovation and strong IP protection and rather indicates that countries attempting to 'catch up' in the arena of technological progress with historically more well endowed nations, benefit from low standards of IP protection, support to public innovation systems and the privileging of public good over private rights.
Particularly intriguing is the reference in the PIB release to the fact that "only one" CL has been issued in India and that it was issued "after a well-thought out and laid down process, which was subsequently upheld right up to the highest Court of the land". Such a 'clarification' further confirms that the Government views the issuance of a CL as a rare and extreme step. It strengthens apprehensions that even this "clarification" is really tailored to once again assure Big Pharma and the US Government that  India will not issue a CL any time soon.

      From: Thiru Balasubramaniam <thiru at keionline.org>
 To: "ip-health at lists.keionline.org" <Ip-health at lists.keionline.org> 
 Sent: Wednesday, March 23, 2016 5:21 PM
 Subject: [Ip-health] Stat News (Pharmalot): India denies plans to restrict compulsory licenses for drugs

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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