[Ip-health] Health GAP letter to Indian PM on TRIPS Dealdline

[Mike Palmedo]

 From the HealthGAP list...
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November 8, 2004

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,

I am writing on behalf of Health GAP (Global Access Project), a U.S.
advocacy organization fighting for access to affordable HIV treatment in
developing countries.

India, a major source of the world's generic medicines supply, is in the
process of becoming compliant with the World Trade Organization's
Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS). TRIPS requires that, by January 1, 2005, India protect and
enforce product patents on pharmaceuticals. Widespread generic
production in India has been possible because India currently only
recognizes patents on pharmaceutical processes. The dramatic change to
India's patent regime that will take place by January 1, 2005 will
effectively eliminate a major source of supply of generic versions of
new medicines for importing countries, while also jeopardizing access
for Indians in need of affordable treatment.

Health GAP is gravely concerned that the draft amendments to the Patents
Act currently under consideration by the Group of Ministers will not
remedy this situation. In fact, the amendments proposed would worsen the
future of medicines access for people in need--in India and around the
world.

India is a signatory to the Doha Declaration on the TRIPS Agreement and
Public Health (the "Doha Declaration"), which reaffirmed the right of
all WTO Members to implement the TRIPS Agreement "in a manner supportive
of WHO Members' right to protect public health and, in particular, to
promote access to medicines for all." [1] India has made repeated public
commitments to cooperate and collaborate with other developing countries
and use the flexibilities afforded by the TRIPS Agreement to increase
access to more affordable generic medicines. We strongly urge you to
uphold your commitment, and to 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.

Therefore, we call on you to take the following steps as you consider
amendments to the Patents Act:

* Retain the pre-grant opposition procedure. This procedure permits
opposition to patent applications the public feels are frivolous,
protecting consumers against high prices on non-innovative
pharmaceutical products under consideration for patent protection. The
pre-grant opposition procedure aids in protecting India from wasting
limited resources conferring monopoly rights on products that do not
warrant patent protection.

* 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. However, compulsory licensing in India
is unnecessarily cumbersome and time consuming. The Indian regime for
compulsory licensing must be reformed 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.

* 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.  Many of the pharmaceutical patent
applications filed in India's patent "mailbox" are patent requests for
second- or new-uses.

* 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. Countries that
need to import a low-cost generic medicine produced by compulsory
license in India, but do not have a patent for the compulsorily licensed
medicine in force, would not be allowed to import compulsorily licensed
medicines exported by India, even though the August 30th Decision
clearly permits this.

Finally, we call on you to support a transparent process for the
consideration of amendments to the Patents Act. We are extremely
troubled by rumors that the Patents Act will be amended by Ordinance,
which will eliminate the opportunity for the public to comment on and
influence the amendment process.

I look forward to your response to this urgent request.

Sincerely,

Asia Russell

Director, International Policy
Health GAP (Global Access Project)

cc: The Honorable Minister Ram Vilas Paswan, Ministry of Chemicals and
Fertilizers
The Honorable Minister Kamal Nath, Ministry of Commerce and Industry
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 Americ=
a
Dr. Peter Piot, Director, UNAIDS
Dr. Jong-Wok Lee, Director General, World Health Organization

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FOOTNOTE:

[1] "Declaration on the TRIPS agreement and public health,=B2
WT/MIN(01)/DEC/2, 20 November 2001