ACTION ALERT: Help protect the affordable generic medicines for the people globally

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.
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@csir.res.in, dg@csir.res.in

pmosb@pmo.nic.in, cim@nic.in, psmin.cpc@sb.nic.in, hfm@alpha.nic.in,
asdg@nacoindia.org, hiv-aids@who.int

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@pmo.nic.in

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

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@sb.nic.in

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@alpha.nic.in

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@nacoindia.org

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@shaii.org

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@shaii.org
Phone: 202-789-0432 Ext 207
www.shaii.org
______________

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)