PHA-Exchange> Alert: major source of supply of generics to disappear after Jan 1 2005

[Claudio]

From: "Prasadini" <prasadini at haiap.org>

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 at healthgap.org, and read the note below for ideas for action on December
(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=abroad&countryID=39

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 at yahoo.co.in

Thank you.

---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
Organization¹s 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 ³Doha Declaration²), India promised to implement the TRIPS
Agreement ³in a manner supportive of WTO Members¹ right to protect public
health and, in particular, to promote access to medicines for all.²[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 India¹s 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 ³August
30th Decision²). 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>


cc:     The Honorable Minister Kamal Nath, Ministry of Commerce and Industry
        The Honorable Minister Ram Vilas Paswan, Ministry of Chemicals and
Fertilizers
        The Honorable Union Minister Dr. Anbumani Ramadoss, Ministry of
Health and Family Welfare
        The Honorable Ronen Sen, Ambassador of India to the United States of
America

[1] ³Declaration on the TRIPS agreement and public health,²
WT/MIN(01)/DEC/2, 20 November 2001