Sign-on Letter to Prime Minister of India

Sign-on letter to the Prime Minister of India on the January TRIPS Deadline, India's Patent Legislation, and Access to Healthcare

Text of the Sign-on Letter

Dear Friends,
This World AIDS Day, please take action to fight for preservation of the world's major source of supply of affordable generic medicines.
India is in the process of becoming compliant with WTO rules on Trade Related Aspects of Intellectual Property Rights (TRIPS), but India does not appear to be taking the public health needs of people dying without access to medicines into consideration.
Civil society organizations in India are calling for international solidarity to pressure the India to prioritize public health and access to medicines in revising its patent amendment. The decisions of the Indian government will impact people who need access to affordable medicines in India, a country with more than 5 million HIV positive people, and around the world.
Please endorse the attached sign on letter, send your endorsement to asia@healthgap.org, and read the note below for ideas for action on December7. (Note: we are not accepting individual endorsements at this time.)
Background:
India, and several other countries, are working to become compliant with World Trade Organization intellectual property rules, set out in TRIPS, by January 1, 2005. By that date, India plans to change its patent rules and begin to protect and enforce patents on pharmaceutical products. The draft amendments to revise the national Patents Act will be debated in Indian Parliament after December 1 2004, when Parliament comes back into session.
This dramatic change will have a profound impact on access to affordable versions of newer medicines, patented after 1995, such as second-line antiretroviral treatment and other newer, more expensive medicines where generic competition is desperately needed to reduce cost and increase access.
Generic production in India is the engine that is driving the cost of AIDS drugs down. It is the cornerstone of treatment access scale up in poor countries. In order to preserve routine generic production in India, the government must take the following actions:

Delay compliance with this stage of TRIPS implementation until the impact of implementation can be fully assessed, and until full transparent consultation with all sectors of civil society can be accomplished. WTO Member Countries have been unable to meet artificial TRIPS deadlines in the past--why should India be any different, particularly since the consequences of implementation are potentially very grave?
Revise India's compulsory licensing guidelines to streamline, expedite, and normalize that procedure.
Remove all provisions in the draft amendment that exceed India's obligations to protect and enforce intellectual property rights on medicines under TRIPS.

Take Action:
The Affordable Medicines and Treatment Campaign (India); Focus on the Global South, Mumbai; Peoples Health Movement-Mumbai Chapter; Lawyers Collective HIV/AIDS Unit; National Alliance of Peoples Movements (NAPM), Mumbai; and Mumbai Grahak Panchayat (MGP) are calling for international pressure on the Government of India. On December 7 they will march to Parliament to call on the Government of India to meet their demands.
These civil society organizations are requesting organizations to support their efforts by taking action Tuesday December 7 at Indian Embassies around the world. Go to: http://www.goabroad.com/embassy/embassy.cfm?embassy=3Dabroad&countryID=3D39 For a list of Indian embassies.
Suggestions for actions concerned organizations can take include:

Public events at Indian Embassies to pressure the Indian Prime Minister. These could include: protests, vigils, and press conferences.
Meetings at with representatives of the Indian government at Indian Embassies.
Educating journalists about the problems with the Indian government's draft amendment.
If you have additional ideas please contact Indian activists and cc Health GAP: write to the Affordable Medicines and Treatment Campaign: amtc_india@yahoo.co.in
Thank you.
Asia Russell

-- BEGIN SIGN-ON LETTER --

The Honorable Dr. Manmohan Singh
Prime Minister of India
South Block, Raisina Hill
New Delhi, India 110 011

Sent by Facsimile: +91.11.23019545

Dear Mr. Prime Minister,

We, the undersigned organizations, are gravely concerned that India will trade away its rights to protect the public health of people who need access to low-cost, quality generic medicines - people living with HIV/AIDS and other public health problems in India and around the world. As you know, poor people around the world depend on India as the major source of supply for affordable generic medicines. We are asking you to prioritize the needs of those people while you consider changes to the Patents Act.

By January 1, 2005, India is expected to become compliant with World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and begin to protect and enforce product patents on pharmaceuticals. Product patents will prevent the routine generic production that has been responsible for major reductions in the cost of antiretroviral medicines, as well as other medicines that treat public health problems. As a result, drug prices will increase and lack of access to medicines will worsen-in India and around the world. This will be particularly true for newer, more expensive medicines such as second-line antiretrovirals, which are currently priced out of reach of those who most need them, because of a lack of generic competition.

As a signatory to the Doha Declaration on the TRIPS Agreement and Public Health (the "Doha Declaration"), India promised to implement the TRIPS Agreement "in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all."[1] We strongly urge you to keep your promise and make full use of your rights under the TRIPS Agreement, as reaffirmed by the Doha Declaration, in order to prioritize public health and access to medicines for all over excessive monopoly rights for pharmaceutical companies. Draft amendments to the Patents Act currently under consideration by your government could undermine medicines access for people in need--in India and around the world. We call on you to take the following steps in amending the Patents Act:

India should delay implementation of the TRIPS Agreement until sufficient pro-public health safeguards are included in the Patents Act. Many WTO Member Countries--developed and developing countries alike--have in the past been unable to meet artificial deadlines when such deadlines would have pre-empted sound decision making regarding critical public health matters such as access to medicines. India should complete an assessment of the impact of protection and enforcement of product patents on public health before revising the Patents Act. Transparent, public consultation with all sectors of civil society prior to revision and implementation is another necessary prerequisite to amendment of the Patents Act.
Simplify and streamline India=B9s compulsory licensing procedure. Routine issuance of compulsory licenses after January 1, 2005 in India is critical if the rapid entry of generic versions of important pharmaceuticals is to continue. But compulsory licensing in India is cumbersome and time consuming. The process must be changed to facilitate routine and expedited compulsory licensing of important medicines. A strictly enforced deadline of one to three months should be established for the grant of a compulsory license, and rights of appeal should not include permission for injunctive relief that would impede the use of the license.
Retain the pre-grant opposition procedure. This procedure permits opposition to potentially frivolous patent applications, protecting consumers against high prices on non-innovative pharmaceutical products under consideration for patent protection.
Remove draft provisions for new-use or second-use patents, currently described in Section 3(d) of the Patents Act. TRIPS does not require the granting of additional patents for new uses or new dosage forms for known medicines. New use or second use patents do not reward or encourage true innovation; they will however increase the cost of important medicines, compromise patient access, and extend monopolies over a longer period of time.
Fully implement the decision of the WTO General Council on the implementation of paragraph 6 of the Doha Declaration for countries that lack sufficient domestic pharmaceutical manufacturing capacity (the "August 30th Decision"). The draft amendment to the Patents Act would not permit export of compulsorily licensed medicines from India without a compulsory license granted in the importing country. If the importing countries does not have a patent for the compulsorily licensed medicine in force, it would not be allowed to import compulsorily licensed medicines exported by India, even though the August 30th Decision clearly permits this. Despite its flaws, the August 30th Decision should be implemented in as complete a manner as possible.

We look forward to your response to this urgent request.

Sincerely,

[list in formation]

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FOOTNOTE:

[1] "Declaration on the TRIPS agreement and public health," WT/MIN(01)/DEC/2, 20 November 2001

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