Urgent Action Alert:: Changes in Data exclusivity

Help protect the affordable generic medicines for the people
globally. Your letter, email, fax has helped in the past; it is
another opportunity to make a difference.

Stop HIV/AIDS in India Initiative
(www.shaii.org)

Association for India's Development - CP
(www.aidindia.org)

Health Global Access Project - Health GAP
(www.healthgap.org)

Students Global AIDS Campaign
(www.fightglobalaids.org)

American Medical Students Association
(www.amsa.org)

People's Health Movement - U.S.A
(www.phm-usa.org)

Global AIDS Alliance
(www.globalaidsalliance.org)

ACTION ALERT!

Are you concerned about people dying for lack of medicines in order
to increase profits of multinational pharmaceutical companies?

Are you disturbed by the fact that rich will have instant access to
newer medicines while the poor will have to wait for an extra 20
years?

Do you want to make a difference in the lives of millions of people
living with HIV/AIDS globally?

Please take the time to mail, fax, or email a letter to Indian
policymakers to let them know that the world is watching.

You may sign the petition online at
http://petitions.aidindia.org/data-exclusivity/

Join us NOW to protect the access to affordable medicines around the
world. Your fax, letter, phone call or email can make a great
difference!

Dear Friends and Colleagues,

Many of you have helped Indian advocacy groups in early 2005 to
oppose amendments to the Indian Patents Act that threatened access to
affordable generic medicines for millions of people living with
HIV/AIDS in the global south. Together, we helped secure significant
positive changes in the proposed amendments. Our letters, emails,
communications strengthened the Indian grassroots groups in their
efforts to protect the ability of Indian generic producers to
challenge weak patent applications, to continue producing generic
drugs already being produced, and to utilize all flexibilities
allowed by the WTO TRIPS Agreement.

We appreciate the Indian Health Ministry's response to the people's
voices. It no longer supports the data exclusivity changes in the
Indian Drugs and Cosmetics Act (information about data exclusivity
can be found at the end of the email).

Urgent need:

Various ministries in India are meeting this week to discuss data
exclusivity rules which would either preclude government reliance on
registration data to grant marketing approval to therapeutically
equivalent generic products or require costly payments to data
originators thereby increasing the costs of generic medicines. There
is urgent need to stop these ministries from bringing a proposal that
goes far beyond the requirements of international law to the Indian
parliament to amend the existing law.

Let us persuade the Indian prime-minister's office to choose people
over the business profits of major international pharmaceutical
companies.

Dr. RA Mashelkar, Director General, Council of Scientific &
Industrial Research is advocating for data exclusivity or
alternatively for data compensation and has submitted a study to
Indian officials to prove the alleged benefits of the data
exclusivity. However, this study is funded by MNC pharmaceutical
companies and serves their bottom line interest in delaying or
preventing generic competition.

Specifically, we are asking the Indian government to stand up to the
pressure of multinational pharmaceutical companies and refuse to
include data exclusivity or data compensation provisions in an
amendment to the Indian Drugs and Cosmetics Act. India is one of the
biggest suppliers of low-cost medicines globally, including Africa.

These data exclusivity amendments and the changes it will bring will
negatively affect poor people worldwide. In some instances, they
could even prevent effective utilization in India of patent
flexibilities granted by the WTO TRIPS Agreement, including the right
to produce and sell medicines pursuant to a compulsory license.

Please write to Dr. Mashelkar that people are watching him - people
who prefer people's lives over profits of a handful of rich
companies.

You can use the letter below. or write one of your own!

Contact information of the officials:

Available emails of all of the following for your convenience -
dgcsir@..., dg@...

pmosb@..., cim@..., psmin.cpc@..., hfm@...,
asdg@..., hiv-aids@...

Dr. RA Mashelkar

Director General
Council of Scientific & Industrial Research
Anusandhan Bhawan, 2 Rafi Ahmed Kidwai Marg
New Delhi 110001
Phone: 23710472, 23717053, 23731832
Fax: 23710618


CC:

Dr. Manmohan Singh
Prime Minister of India
Room No. 152, South Block, New Delhi
Tel: 91-11-23018939, Fax: 91-11-23019545, Email: pmosb@...

Sri Kamal Nath
Minster of Commerce & Industry
Room No. 45, Udyog Bhavan, New Delhi
Tel: 91-11-23063664, Fax: 91-11-23061796, Email: cim@...

Sri Ramvilas Paswan
Minister of Chemicals and Fertilizers
Shastri Bhawan, Dr. Rajendra Prasad Road, New Delhi
Tel: 91-11-23386519, Fax: 91-11-23384020, Email: psmin.cpc@...

Dr Anbumani Ramadoss
Minster of Health and Family Welfare
Nirman Bhavan, Maulana Azad Road, New Delhi
Tel: 91-11-23061751, Fax: 91-11-23792341, Email: hfm@...

Mrs. Sonia Gandhi
President, Indian National Congress Party
10, Janpath, New Delhi
Tel: 91-11-23014161, Fax: 91-11-23017047, Email: not available

Ms. Sujatha Rao
Director General, National AIDS Control Organization (NACO)
Chandralok Building, 9th floor, 36 Janpath, New Delhi
Fax: 91-11-23731746, Email: asdg@...

Sample letter:
September 5, 2006

Dr. RA Mashelkar
Director General
Council of Scientific & Industrial Research
Anusandhan Bhawan, 2 Rafi Ahmed Kidwai Marg
New Delhi 110001


Dear Dr. Mashelkar,

The global HIV/AIDS Community is thankful to India for the health and
hope that the Indian generic pharmaceutical industry gives to people
living with HIV/AIDS around the world. We would like to express our
concern that certain laws and policy changes in India may adversely
affect both the domestic and thereby the global availability and
affordability of essential HIV/AIDS medicines of assured quality and
of other new inventions such as women-controlled prevention methods
(microbicides).

Through this letter, we would like to communicate our concern
particularly about contemplated data-related amendments in the Indian
Drugs and Cosmetic Act. The implementation of data exclusivity or
data compensation provisions as an amendment to the Drug and Cosmetic
Act would primarily affect India's ability to provide drugs to
millions of its own people living with diseases
such as HIV/AIDS, hypertension, diabetes, asthma, among others.
However, the deterrent to local production and marketing of generic
medicines would have a knock-on effect on the willingness of Indian
generic producers to enter the global market as well.

There are actions that can be taken that will allow for maximum
availability of generic drugs while being TRIPS compliant. Without
Indian generic drugs, millions of people in developing countries will
die as a result of lack of access to affordable medicines.

Data exclusivity provisions, if added to the Drugs and Cosmetic Act,
will prevent generic companies from using registration data on
existing drugs to gain regulatory approval for therapeutically
equivalent generic versions.

Under data exclusivity, generic companies will be forced to repeat
time-consuming, expensive, and unethical studies to receive
regulatory approval during the period of exclusivity. Under
alternative proposals for data compensation, there will be procedural
delay and litigation bottlenecks that will also delay access and/or
increase costs of essential generic products. Under either option,
generic drugs could take years to come into the market and medicines
would be more expensive in the interim. The people of India and the
developing world would be denied access to the new treatments
available to their richer counterparts who can afford brand name
drugs.

The WTO TRIPS Agreement does not require data exclusivity, and thus
India is not obligated to adopt TRIPS-plus data exclusivity laws.

TRIPS Article 39.3 simply merely requires that members
protect "undisclosed test or other data..against unfair commercial
use." The World Health Organization's Commission on Intellectual
Property Rights, Innovation, and Public Health recently reinforced
the view that TRIPS does not require data exclusivity:

"Article 39.3, unlike the case of patents, does not require the
provision of specific forms of rights. It does not create property
rights, nor a right to prevent others from relying on the data for
marketing approval of the same product by a third party or from using
the data except when unfair (dishonest) commercial practices are
involved."

India has a human-rights obligation to protect its own residents and
the citizens of the world from the ravishes of the HIV/AIDS pandemic
rather than change its law to assist a handful of multinational
pharmaceutical companies in making more profits while people are
dying for lack of medicines.

You are head of the Council of Scientific & Industrial Research
(CSIR), an industrial research and development organization whose
mission is to provide economic, environmental and societal benefits
to the people of India. Data exclusivity or data compensation changes
will not only severely limit the access to affordable medicines in
India but have enormous adverse impact worldwide. Millions of people
around the world are currently taking generic
drugs made in India.

Please do not undermine India's leadership. We urge you to keep these
life-saving medicines available and affordable to all those in need
for the future by not supporting the new amendment that includes data
exclusivity provisions in the Drugs and Cosmetic Act.

Sincerely,

Your name

This petition supports the efforts of various global and Indian
organizations working to protect production of affordable medicines.
The organizations include

Global AIDS Alliance, Health Gap, Students Global AIDS
Campaign, Association for India's Development - CP, American Medical
Students Association, People's Health Movement, Lawyers Collective,
Indian Network of Positive People, Doctors without Borders, Drug
Action Forum -Karnataka, Center for Trade and Development, India's
Centre for Human Rights and Law, All India Drugs Action Network,
International Peoples Health Council, Diverse women for Diversity,
Society for Conflict Analyses and resolution, Alliance for
Development, Centre for Research and Advocacy.

Please take the time to mail, fax, or email a letter to let Indian
policymakers know that the world is watching.

Data exclusivity protection means:

1. Data exclusivity provisions will prevent generic companies from
using registration data on existing drugs to gain regulatory approval
for therapeutically equivalent generic versions. Generic companies
would be forced to repeat time-consuming and expensive studies to
receive regulatory approval. Essential medications would remain
prohibitively expensive during the period of exclusivity without the
competition from generic companies.

2. Data compensation provisions will require generic companies to
reach "reasonable royalty" agreements with data originators or resort
to expensive and time consuming litigation to seek government
mandated regulatory access to the data. Access to generic medicines
would typically be delayed and the costs of generic medicines would
increase because of royalty payments.

3. The research-based pharmaceutical industry is also seeking to
link the rights of registration to the original drug's patent status.
The linkage would require a drug registration authority to postpone
registration of a generic competitor until expiration of the entire
20-year patent term. As a practical matter, five-year data
exclusivity and patent-term market exclusivity will fully bar access
to the newest medicines, relegating consumers in developing countries
to the charitable whims of proprietary manufacturers. The people of
India and the developing world would be denied access to the newest
treatments available to those who can afford brand name drugs.

For more information visit websites of the organizations mentioned in
the header, or write to us at info@...

In solidarity,

Vineeta
(For the action alert team)

Dr. Vineeta Gupta
M.B.B.S (MD), LL.B (JD), LL.M
Director, Stop HIV/AIDS in India Initiative
Email: vineeta@...
Phone: 202-789-0432 Ext 207
www.shaii.org