[Ip-health] Firstpost: US pressure on India to grant more patents on pharma products 'appalling', say health advocates

Thiru Balasubramaniam thiru at keionline.org
Fri Jun 30 07:18:53 PDT 2017


US pressure on India to grant more patents on pharma products 'appalling',
say health advocates


Shreerupa Mitra

Jun, 30 2017 10:52:32 IST

Top health advocates have called the attempt by the US to pressure India to
grant additional patents on drugs and vaccines as “appalling” and are
writing a letter to a US lawmaker to register their protest. On 23 June,
four American lawmakers including Richard Neal (D-MA), Kevin Brady (R-TX),
Ron Wyden (D-OR) and Orrin Hatch wrote to US president Donald Trump to use
the then-impending Indian prime minister Narendra Modi’s Washington visit
to address New Delhi’s "inadequate" protection of patents, trademarks and
copyrights, and the "arbitrary" style of pricing medical products.

The letter points out that India accounts for less than two percent of
total US exports of goods and services — "(I)f tariff and investment
restrictions were fully eliminated (by India) and standards of IP
protection were made comparable to US and western European levels, US
exports to India would rise by two-thirds, and US investment in India would
roughly double," the letter reads referencing an American international
trade report.

"India’s weak standards and insufficient enforcement remain an area of
concern for US rightholders, including with respect to pharmaceutical
patents and in the area of copyright protection…," the letter adds.

It also criticises the government’s decision to cap prices for coronary

"Moreover, India has imposed additional barriers in 2017. One such example
is the expansion of India’s nontransparent and arbitrary system of pricing
on medical products, recently expanded to include coronary stents."

"According to some US producers, India’s arbitrary system has forced them
to sell certain products at a loss in order to retain access to the Indian
market," the senators and representatives complained.

To recall, leaked diplomatic cables last year by Knowledge Ecology
International (KEI), a non-profit working on drug patents, showed that
Colombian officials were worried after a conversation with a staffer from
Hatch’s office about the potentially negative impact of US funding for the
Colombian peace process should Colombia issue compulsory licences for
producing cheaper versions of a cancer drug manufactured by Novartis.

Colombia, nevertheless, went ahead and reduced the price of the drug
Imatinib by 44 percent.

On 26 June, Trump, in his joint statement in the White House with Modi,
sought "to create a trading relationship that is fair and reciprocal".

"It is important that barriers be removed to the export of US goods into
your markets, and that we reduce our trade deficit with your country,"
Trump said.

Their respective teams will look into "creative ways to improve bilateral
trade", the joint statement added.

"Modi has already bowed to pressure from (former US president Barack) Obama
on granting compulsory licenses on cancer drug patents. He leads a country
of more than a billion people, and he should not sacrifice their health and
their lives of people in India to gain the affection of an unpopular US
president who has the attention span of a six-year-old," Jamie Love,
director of KEI, told Firstpost in an email interview.

"The United States is paying too much, and so does everyone else, just not
to the degree that the US gets ripped off. What Trump and Modi should focus
on is a new trade framework that focuses on sharing the costs of funding
research and development as a public good," he added.

The US Trade Representative’s Special 301 report — a
Congressionally-mandated annual report that has been issued every year
beginning in 1989 — puts India under the 'Priority Watch List' for its
"serious intellectual property rights deficiencies".

In response to the American lawmakers’ appeal to Trump, a number of top
health advocates are sending a letter to Wyden, a Democrat from Oregon,
that they "are surprised and dismayed that you are pressuring India to
grant additional patents on drugs and vaccines".

In 2015, the income per capita of India was 35 times lower than the per
capita of the US.

"A country with as much poverty as India should not enforce patents on
drugs and vaccines the same way as high-income industrialised countries,"
the letter further states.

India is a "critically important source" of affordable generic products in
many developed and developing countries.

"The practical effect of the type of trade pressures you advocate is to
enhance the monopoly power and raise the prices of new drugs for cancer and
many other diseases. This is appalling," it adds.

The recently-released draft reform healthcare bill wants foreign countries
to pay more for medicines through directing American executive agencies to
review all multilateral and bilateral agreements for greater IP protection
and possible enforcement options in case of violations, and to review other
countries’ supply and procurement systems and price differentials.

"The implication of the proposed actions to force higher drug prices on
other countries is that Big Pharma would take it easy on US consumers and
payers. To date, there is no evidence of any such price moderation by Big
Pharma either on existing or new medicines despite much stronger IP
protections in multiple bilateral, regional, and multilateral trade
agreements since the 1990’s,” wrote Brook K Baker, professor at
Northeastern University School of Law, in his blog on 23 June.

Trump’s draft executive order on healthcare is an issue of fierce debate in
the US with a Congressional report estimating that 22 million Americans
would lose insurance by 2026 should this bill be passed.

"As the draft executive order shows, Trump wants to make foreign countries
pay more for medicine, even though that will do nothing to make medicines
more accessible in the United States, and exorbitant prices already cost
lives around the world," said Peter Maybarduk, director of Public Citizen’s
Access to Medicines Program on 27 June in a press statement.

Meanwhile, in a World Trade Organisation’s Council for TRIPS (Trade-Related
Aspects of Intellectual Property Rights) meeting on 13 June, India along
with Brazil, China, Fiji and South Africa tabled a first-of-its-kind
proposal that called on governments to examine the growing concern of
"imbalance between intellectual property and the public interest".

It asked member States to hold dialogue "on measures within the IP system
that they have adopted to promote the public interest, including but not
limited to compulsory licensing, patentability criteria, IP and
competition, and the Bolar exception".

The flexibilities within TRIPS allow governments to tailor their national
IP laws within the minimum standards set by the TRIPS agreement taking into
account their developmental needs, including public health interests.
However, a September 2016 report of the UN Secretary-General’s High-Level
Panel on Access to Medicines shows that many governments are reluctant to
use these flexibilities, including issuing compulsory licenses, for various
reasons that include undue political and economic pressure from powerful
governments and corporations.

India has used this flexibility only once in March 2012 when Indian generic
manufacturer NATCO Pharma was granted compulsory license to manufacture
Bayer’s drug Sorafenib Tosylate (Nexavar) used for the treatment of kidney
and liver cancer.

"Political and economic pressure placed on governments to forgo the use of
TRIPS flexibilities violates the integrity and legitimacy of the system of
legal duties and rights created by the TRIPS agreement and as reaffirmed by
the Doha Declaration," India had said in a statement to the TRIPS meeting
of 13 June.

"Patent rights cannot be allowed to impede protection of public health," it

It also invited Colombia to share its experience of covert threats from
"domestic and foreign parties" when it was to issue a compulsory license on

The Trump administration has made IP rights one of its topmost priorities
"and conflated it with the issue of big-ticket investments in India", a
Hindu report citing sources said.

Issues around patent protection and affordability of health products is one
of the trickiest sticking points in India-US bilateral relations.

Published Date: Jun 30, 2017 10:52 am | Updated Date: Jun 30, 2017 10:52 am

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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