Africa/Global: India should ensure global access through patent law

Press Release

As the Indian Parliament prepares to tackle the country's implementation of the World Trade Organization's (WTO) agreement regulating patents on medicines, Doctors Without Borders/Medecins Sans Frontieres (MSF) is urging Indian decision makers to ensure that patients in developing countries will continue to have access to affordable medicines. "MSF has examined the proposed amendments to India's Patents Act of 1970. We believe they will drastically restrict, perhaps even prevent, the production and supply of vital therapies by Indian pharmaceutical companies to other developing countries," said Ellen 't Hoen, director of policy advocacy and research with MSF's Campaign for Access to Essential Medicines. Also included here is a two-page letter sent by the UN Special Envoy for HIV/AIDS in Asia and the Pacific, Dr. Nafis Sadik, and the UN Special Envoy for HIV/AIDS in Africa, Stephen Lewis, to the Prime Minister and the President of India.

India Should Ensure Global Access to Medicines When Amending Its
Patent Law

MSF Press Release
Doctors Without Borders/Medecins Sans Frontieres (MSF)

For Immediate Release
Contact: Kris Torgeson, +1-212-655-3764

Geneva, 15 March 2005 - As the Indian Parliament prepares to
tackle the country's implementation of the World Trade Organiza-
tion's (WTO) agreement regulating patents on medicines, Doctors
Without Borders/Medecins Sans Frontieres (MSF) is urging Indian
decision makers to ensure that patients in developing countries
will continue to have access to affordable medicines.

"MSF has examined the proposed amendments to India's Patents Act
of 1970. We believe they will drastically restrict, perhaps even
prevent, the production and supply of vital therapies by Indian
pharmaceutical companies to other developing countries," said
Ellen 't Hoen, director of policy advocacy and research with
MSF's Campaign for Access to Essential Medicines.

In the past few years, India has played a pivotal role in sup-
plying affordable generic versions of medicines used throughout
the developing world. It has also been a leader in the debates
on patent barriers to access to medicines at the WTO, fighting
for measures in international patent rules that protect public
health. But the country's obligation under WTO law to grant 20-
year patents on pharmaceutical products may be putting this
reputation at risk unless Indian politicians use their power
wisely. The lives of millions of people worldwide using afford-
able Indian medicines depend on India's future policies with re-
gard to medicines patents.

Nowhere is this more visible than in the case of HIV/AIDS treat-
ment. Of the 700,000 people currently receiving antiretroviral
treatment in developing countries, an estimated 50% rely on In-
dian generic production. MSF now treats 25,000 people with an-
tiretrovirals in 27 countries around the world, and roughly 70%
of the patients in those programs use medicines that originate
in India. Before generic drugs became widely available in 2001,
similar treatments cost over US$ 10,000 per patient per year -
40 times more than the average price of ARV treatment in MSF
programs today (US$ 250). The availability of affordable fixed-
dose combination therapy, or three-in-one pills, manufactured in
India has revolutionized AIDS treatment in developing countries.

But providing this user-friendly form of treatment has only been
possible because there are no patent constraints in India on
combining these medicines in one tablet. After India and other
developing countries with manufacturing capacity start granting
patents, generic drug manufacturers can no longer produce ge-
neric versions of patented drugs. Most new drugs are likely to
be patented, so sources of new low-cost medicines will dry up
globally.

It is crucial that India allows production and export of generic
versions of new medicines in the future. MSF urges Indian policy
makers to ensure that the proposed amendments to the 1970 Patent
Act incorporate the full flexibilities and safeguards of the
TRIPS Agreement and reflect the hard-fought outcome of the Doha
Declaration on TRIPS and Public Health, which affirmed that "the
TRIPS Agreement can and should be interpreted and implemented in
a manner supportive of WTO Members' rights to protect public
health and, in particular, to promote access to medicines for
all."

"MSF hopes that India will continue to demonstrate the kind of
international leadership it has shown with the WTO Doha Declara-
tion on TRIPS and Public Health thus far," 't Hoen said. "Any
amendments to the country's new patent law must safeguard not
only the citizens of India, but also the millions of children,
women and men in the developing world whose lives depend on ac-
cess to affordable generic medicines."

To download MSF briefing documents on this topic, click on the
links below

"Will the Lifeline for Affordable Medicines Be Cut? Consequences
of Medicines Patenting in India"
http://www.accessmed-msf.org/documents/India%20briefing%20note%20Feb%20…

"The Effects of the 2005 TRIPS Implementation Deadline on Access
to Medicines"
http://www.accessmed-msf.org/documents/technical%202005%20briefing%20Fe…

For additional information, go to:
http://www.accessmed-msf.org/index.asp

New York, 11 March 2005

The Honourable Dr. Manmohan Singh
Prime Minister of India
South Block, Raisina Hall
New Delhi, 110 001, India

Dr. Avul Pakir Jainulabdeen Abdul Kalam
President of India
Rashtrapati Bhawan
New Delhi 110 004, India

Excellencies,

We are writing to you, in our capacities as the United Nations'
Special Envoys for HIV/AIDS in Asia and the Pacific, and in Africa, on a
matter of urgent importance. We believe that enlightened decisions by the
Indian Parliament over the next several days can offer the protections
needed to prolong millions of lives, and maintain India's leading role as a
supplier of affordable medicines to the developing world.

As a reflection of our deep concern, we should note that this is the
first time that the two of us have ever collaborated on such an appeal.

India's role in addressing the global AIDS pandemic has been
crucial. Your Government's long history of ensuring the primacy of public
health over intellectual property set the stage for principled positions and
legislation promoting access to essential HIV medicines. As a result, the
lives of HIV-positive people throughout the developing world are now being
sustained by quality generic drugs.

Continued access to affordable antiretrovirals and other HIV-related
medicines promises to prolong millions more lives in the immediate future.
We are deeply concerned that, following the 1 January 2005 full
implementation deadline for the TRIPS Agreement, those lives are now in
jeopardy.

As you know, Excellencies, the Indian Parliament's current
discussion of the President's Patent Ordinance will determine the scope of
India's patent protection for the future. Approximately one-half of the
700,000 people currently receiving HIV treatment in developing countries
depend on India's pharmaceutical manufacturers. Because international
efforts are underway to multiply the number of people on treatment many
times over, the outcome of Parliament's discussions will also decide the
futures of millions of people worldwide.

We are truly at a turning point in our response to the pandemic of
HIV/AIDS. The goal of putting three million people into treatment by the
end of this year has prompted a reservoir of hope. But for that hope to be
fulfilled, generic drugs must be available. People Living With AIDS stand
poised between life and death. The Parliament of India can make it possible
for millions of people to embrace life.

Excellencies, we urge that every flexibility offered by the TRIPS
Agreement be incorporated in the President's Patent Ordinance and that no
"TRIPS-plus" provisions are included which would jeopardize the continued
supply of crucial, affordable AIDS therapies and other essential medicines
by India to the world. It is not possible to exaggerate the international
importance of the decisions facing India.

It is our fervent hope that amendments to the 1970 Patent Act will
be made in the praiseworthy spirit that characterized India's courageous
leadership during negotiations of the World Trade Organization's Uruguay
Round and the Doha Declaration on TRIPS and Public Health.

Accept, Excellencies, the assurances of our highest consideration.

Nafis Sadik, M.D. Stephen
Lewis,
Special Envoy of the UN Secretary-General Special Envoy of the
UN Secretary - HIV/AIDS in Asia and the Pacific General for
HIV/AIDS in Africa

cc: The Hon. Kamal Nath, Minister of Industry and Commerce
Ministry of External Affairs, South Block Raisina Hall, New Delhi 110
001, India

Mrs. Sonia Gandhi, Indian National Congress Party Chairman
10, Janpath, New Delhi 119 001, India