Letter to the PM on Data Exclusivity

[Guest guest]

Global AIDS Alliance, stop HIV/AIDS in India Initiative

June 19, 2006

Dr. Manmohan Singh

Honorable Prime Minister of India

The Prime Minister’s Office

South Block, Raisina Hill,

New Delhi, India 110 011

Fax: 23019545 / 23016857

Dear Prime Minister,

The global HIV/AIDS Community is thankful to India for the health and hope that

the Indian generic pharmaceutical industry gives to those people living with

HIV/AIDS around the world. We would like to express our concern that some law

and policy changes in India may have adverse effects on the global availability

of affordable quality essential HIV/AIDS medicines and new inventions such as

women-controlled prevention methods (microbicides).

Through this letter, we would like to communicate our concern particularly about

the amendments in the Indian Drugs and Cosmetic Act. The implementation of data

exclusivity provisions as an amendment to the Drug and Cosmetic Act would

seriously affect India’s ability to provide drugs to millions of people around

the world living with diseases such as HIV/AIDS, hypertension, diabetes, asthma,

and many more.

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 data on existing drugs to gain regulatory approval

for generic versions. Generic companies would be forced to repeat

time-consuming and expensive studies to receive regulatory approval. Essential

medications would be prohibitively expensive without the competition from

generic companies and generic drugs would take years to bring to market under

data exclusivity laws. Repeating clinical trials would force drug companies to

perform unethical studies that withhold medicines known to be effective from the

control group. 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.

In addition, the TRIPS agreement does not require India to implement data

exclusivity provisions. Article 39.3 simply 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.”

All WTO members also agreed in the Doha Declaration of 2001 “that the TRIPS

Agreement does not and should not prevent members from taking measures to

protect public health…we affirm that the Agreement can and should be interpreted

and implemented in a manner supportive of WTO members' right to protect public

health and, in particular, to promote access to medicines for all.” As a member

of the WTO, India has an obligation to protect the rights of the citizens of the

world in the face of the HIV/AIDS pandemic.

The Ministry of Commerce has already publicly stated its opposition to the

implementation of data exclusivity provisions. We hope that the Ministry of

Health and Family Welfare and the Ministry of Chemicals and Fertilizers will

follow suit and oppose a data exclusivity amendment to the Drug and Cosmetic

Act.

On behalf of the millions of people around the world currently taking generic

drugs made in India, we sincerely thank you. And we urge you to keep these

life-saving medicines available and affordable to all those in need for the

future.

We would welcome an opportunity to meet with you in person to share our concerns

and suggestions.

Sincerely,

Dr. Vineeta Gupta

Director, Stop HIV/AIDS in India Initiative

Phone: 202-789-0432 Ext. 207

Email: vineeta@...

DeGennaro MPH

Consultant, Global AIDS Alliance

Phone: 202-789-0432

Email: vincedegennaro@...

Cc:

Sri Ramvilas Paswan

Honorable Minister of Chemicals and Fertilizers

Shastri Bhawan, Dr. Rajendra Prasad Road

New Delhi 110 001, India

Fax: 23384020

Dr. Anbumani Ramadoss

Minister of Health and Family Welfare

Nirman Bhavan, Maulana Azad Road

New Delhi 110011, India

Fax: 23062358

Sri Kamal Nath

Honorable Minister of Commerce and Industry

Room No. 45, Udyog Bhavan

New Delhi 110 011

Fax: 23012947

Shri Jairam Ramesh

Minister of State for Commerce

Udyog Bhavan, New Delhi 110 011

Fax: 23062807