Urgent Action Alert:: Changes in Data exclusivity

[Guest guest]

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. 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

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