[Ip-health] Action Alert on Indian Patent Amendments

[Mike Palmedo]

ACTION ALERT!!

Global AIDS Alliance ++ Association for India's Development ++ Health GAP

March 6, 2005

India Could Cut-off Africa's Access to Affordable AIDS Drugs; Indian
Parliament May Begin Considering the Issue March 9

Fax and Email Indian Government & Urge It Preserve Access to Generic AIDS
Medicines

ISSUE:  Under pressure from the US government and brand-name drug makers
(such as Pfizer and Novartis), the Indian government is about to adopt new
patent rules that will make it impossible for Indian manufacturers to
produce many of the newer generic AIDS drugs.

This is a matter of life and death, as noted in the March 5 New York Times
editorial (see below).
http://www.nytimes.com/2005/03/05/opinion/05sat3.html

Indian production of these drugs is critical to Africa's survival (plus that
of other regions).  Many Indian organizations are urging the Government to
reject the change to the patent rules.

African organizations have been outspoken as well. Rolake Nwagwu of Positive
Action for Treatment (PATA), Nigeria has said: "India should be proud to be
producing and exporting cheap, generic AIDS drugs for people in need. The
changes to the patent law will increase the price of new drugs, as well as
some AIDS medicines that are already produced and exported in generic form.
Rising treatment costs will spell disaster for people with HIV in India and
around the world."

Doctors Without Borders has spoken out too: "MSF has examined the proposed
amendments to the Patents Act of 1970. We believe they will drastically
restrict, perhaps even prevent, the production and supply of this vital
therapy by Indian pharmaceutical companies to other developing countries."

WHAT YOU CAN DO:  Fax and email Indian government officials to urge they
modify or reject the new Patent Ordinance.  Appeal to India as a
forward-thinking, independent country that has for many years produced
life-saving, affordable medication. This is extremely urgent, so please take
action before March 9 and continue until March 14, since it's unclear when
exactly this issue will be taken up.

SAMPLE LETTER TO FAX:

"I am deeply concerned about the recent amendment that modified the Patent
Act of 1970 and its impact on access to AIDS and other medications. Indian
generic medications are a life-line for Africa and other regions fighting
the AIDS epidemic. The amendment goes far beyond what the WTO requires. As a
person/organization working to increase access to life sustaining HIV
treatment, I am urging you to not pass this amendment. Please ensure generic
production of medications patented after 1995. The world is counting on
India to continue an independent approach that protects public health and
promotes access to affordable generic medicines for all. I/We are closely
monitoring the decisions of the Government of India, as millions of lives
may hang in the balance. Please respond to this urgent request.
Respectfully, XYZ."

More info:  www.gcaipa.org and www.healthgap.org

SEND APPEALS TO:

Sonia Gandhi
10, Janpath,
New Delhi - 110011
Phone. +91-11-23014161, 23014481
Email: soniagandhi@sansad.nic.in

Dr. Manmohan Singh
Prime Minister of India
South Block, New Delhi
India-110 011
Phone: +91-11-23012312, 23013149,
Fax : +91-11-23016857
Email: pmosb@pmo.nic.in

Shri Kamal Nath
Minister for Commerce & Industry
Udyog Bhawan
New Delhi - 110011
Phone: +91-11-23010008, 23011492
Fax: +91-11-23019947
Email: csoffice@ub.nic.in

L K Advani
Leader of Opposition
30, Prithviraj Road,
New Delhi - 110003, India
Phone: +91-11-23794125, 23794124
Fax: +91-11-23017419
advanilk@sansad.nic.in

INDIAN NATIONAL CONGRESS (ruling Party office)
24, Akbar Road,
New Delhi -110011, India
Phone: +91-11-23019080
Fax: +91-11-23017047
aicc@congress.org.in

After you have faxed to these officials, send appeals to the Indian embassy
in your country as well.  You will find a list of embassies at this link.

http://indiaimage.nic.in/embassies.htm

Okay, now that you have taken action, read on for more details:

BACKGROUND:

India is a major source of supply of the world's generic medicines; it
exports two-thirds of its products to developing countries. These exports
are critical to the fight against AIDS in sub-Saharan Africa, South America,
and Southern and Southeast Asia. Generic competition fueled by Indian
production has been largely responsible for reducing the prices of
antiretrovirals by as much as 98%.

But, India passed an ordinance December 26, 2004 that eliminated 35 years of
national exemption of medicines from product patent protection. The changed
rules will affect the production of the drugs that patients need after the
initial course of treatment becomes ineffective (the so-called 'second-line'
drugs patented after 1995).

Many patients need this second line of medications to survive. At least 20%
of patients need these drugs after three years of taking the initial course,
and if they do not get the medication they will die. The costly, brand-name
versions are out of reach of most people living with AIDS. Brand-name
versions of these drugs can cost 26 times as much as the generic versions
that India could make under appropriate and flexible patent standards.

The global goal for the end of this year is to deliver AIDS medication to 3
million of the people that need them. 20% of these people can be expected to
need these second line drugs in three years time, and that adds up to
600,000 people!  These 600,000 people could die without continued access to
affordable medication.

The currently proposed new rules could also adversely affect generic
production of widely used combination tablets such as GlaxoSmithKline's
Combivir.

The decree will also prevent the production of newer medicines for many
other public health needs. This decree may come before the Indian Parliament
as early as March 9, 2005 when the body reconvenes.

The changes to the Patent Act include:

. A weakening of the procedure that allows a challenge to a patent
application; . A change that makes it easier to patent a drug, even if it's
not significantly different from an existing drug . A slow moving,
bureaucratic process that will prevent the export of compulsorily licensed
medicines to poor, importing countries

These changes are not necessary to stimulate investment into research and
development, and the new rules go beyond what the World Trade Organization
(WTO) requires. But, the Union Minister of Commerce and Industry, Kamal
Nath, has been influenced by the US government and US brand-name
manufacturers, and he seems determined to secure rapid approval of the
ordinance by the Parliament.

If the new rules are formalized, 20-year patent monopolies will drive up the
price of treatment in India and in hundreds of importing countries.  The
world's source of generic HIV medicines will essentially disappear.

The Parliament could, however, refuse to approve the change, in which case
the change will expire in May, 2005.  Or, the issue could be passed to a
Committee in Parliament that would give the matter more thorough
consideration.

Indian Nobel laureate economist Amartya Sen says: The government of India
must subject the issue of patent rights to "greater scrutiny" in the
interest of the people.  "I want more scrutiny in areas like patent rights.
This is a serious issue where the Government of India must make itself heard
in the world community. I hope the government will do this with humanity."

To maintain and support India's important leadership on issues of HIV/AIDS,
the Parliament should reject these changes. The Indian government should
amend the Patents Act in a manner that does not undermine protections for
public health and access to medicines. India should also do much more to
ensure its people have access to AIDS testing, counseling, prevention
services and treatment on a nationwide basis.