E-DRUIG: U.S. pressure on India for taking legal steps to increase access to affordable medicines
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New Delhi/New York, 25 September 2013
On the eve of a meeting between U.S.
President Barack Obama and Indian Prime Minister Manmohan Singh, the
international medical humanitarian organization Doctors Without
Borders/Medecins Sans Frontieres (MSF) warned that India is facing an
onslaught of political pressure from the U.S. government and pharmaceutical
industry in retaliation for the country's entirely legal actions to limit
abusive patenting practices and increase access to affordable generic
medicines. This pressure is likely to increase through negotiations of a
potential bilateral investment treaty between the US and India, which is on
the agenda for the meeting.
'Every country has the right to take steps to increase access to medicines
and implement a patent system in line with its public health needs' said
Leena Menghaney, Manager of MSF's Access Campaign in India. 'Even though
India is acting completely within its rights, the country must now deal
with unrelenting, unwarranted and purposely misleading attacks from the
multinational pharmaceutical industry and U.S. government officials.'
To read the timeline of the US scaling up pressure on India:
http://www.msfaccess.org/about-us/media-room/press-releases/us-puts-unwarranted-pressure-india-taking-legal-steps-increase
India is a critical producer of affordable medicines. Competition among
generic producers in India has brought the price of medicines to treat
diseases such as HIV, TB and cancer down by more than 90 percent. The
majority of the antiretroviral medicines purchased by the U.S. government's
global AIDS program come from India, and more than 80% of the HIV medicines
MSF uses to treat more than 280,000 people with HIV in 21 countries are
generics from India. But the policies that make India the 'pharmacy of the
developing world' are under threat as routine decisions by India's patent
offices and courts are subject to international scrutiny and India faces
increased political pressure from the US.
Several recent legal decisions in India have set the stage for the
heightened tensions. Earlier this year, Novartis lost a seven-year-battle
to claim a patent on the salt form of the cancer drug imatinib, marketed as
Gleevec. The Indian Supreme Court ruled that this new formulation did not
meet the patentability requirement in Indian patent law that limits the
common pharmaceutical industry practice of 'evergreening' - extending drug
patents on existing drugs to lengthen monopolies.
In March of this year, the appellate court in India upheld the 'compulsory
license' for a kidney cancer drug, which at nearly $6,000 per month for
Bayer's patented version, the Patent Controller deemed unaffordable in the
country. As a result, a generic version was made available for 97% less.
This year, India's health ministry set up an independent expert committee
to identify exorbitantly-priced drugs for which further compulsory licenses
may be issued.
These decisions by the Indian judiciary are compliant with all existing
World Trade Organization rules on trade including those outlined in the
Agreement on Trade Related Aspects of Intellectual Property (TRIPS) and the
Doha Declaration on TRIPS and Public Health, both of which defend access to
existing medicines by allowing countries to use flexibilities such as
patent oppositions and compulsory licenses to overcome intellectual
property barriers.
Nevertheless, some U.S. pharmaceutical companies, led by Pfizer, are crying
foul, and are wrongly alleging that India's patent system is not consistent
with TRIPS. As a result, the pharmaceutical lobby is now engaged in a
concerted effort to pressure India to change its intellectual property
laws.
In June, 170 members of U.S. Congress wrote a letter to President
Obama urging him to send a 'strong signal' to India's high-level officials
about its intellectual property policies, which was preceded by
Congressional hearings designed in part to criticize India's robust defense
of public health. Several interest groups have been created to lobby the US
government about India's policies and, most recently, U.S. Congressional
trade leaders have requested that the US International Trade Commission
initiate an official investigation on India's intellectual property laws.
'Indian policymakers and courts have taken steps that are entirely legal
under international trade rules to keep medicines affordable, and should
not be facing any retaliatory tactics whatsoever,' said Judit Rius,
manager of MSF's Access Campaign in the US. 'We rely on affordable
medicines produced in India to do our medical work across the world, so we
are very concerned about the pressure India is facing. Intense US pressure
is clearly aimed at discouraging India and other developing countries from
using important legal flexibilities in the interest of public health in the
future.'
This pressure will only increase as talks on a new trade deal get underway.
Any new agreement would almost certainly contain provisions allowing
pharmaceutical companies to sue India outside of domestic courts.
Several such disputes have already been filed by US corporations against
governments. Tobacco company Philip Morris, using a provision in an
investment agreement, is suing Australia for hundreds of millions of
dollars over a government law that mandates plain packaging on cigarette
packs. This month, US pharmaceutical company Eli Lilly used the very same
tactics to start proceedings against Canada in a foreign tribunal, claiming
$500 million as compensation on the grounds that a Canadian court's
decisions to invalidate patents on some of the company's best-selling
medicines deprived it of future profits and interfere with the enjoyment of
its investments.
The US Government has a policy of negotiating and exerting pressure on
governments to give foreign investors the right to sue governments 'known as
Investor-State Dispute Settlement' for high amounts of damages if a law or
policy harms their investment. India will face the same pressure to include
such provisions as it pushes to negotiate a trade deal with the U.S.
'In a world where medicines are increasingly being patented, which blocks
the production of more affordable generic versions, we're going to see more
and more people become sick or die because the medicines they need to stay
alive are simply too expensive,' Leena Menghaney said.
To read the timeline of the US scaling up pressure on India:
http://www.msfaccess.org/about-us/media-room/press-releases/us-puts-unwarranted-pressure-india-taking-legal-steps-increase
Joanna Keenan
Press Officer
Medecins Sans Frontieres - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org