India - amendments will adversely effect availability of AIDS medicines

[Guest guest]

The Hindu, Business, 25/06/2006

PM urged not to introduce data exclusivity

Special Correspondent - Repealing clinical trials will force drug companies

to perform unethical studies

NEW DELHI: The Washington-based non-profit agency, Global AIDS Alliance, has

urged Prime Minister Manmohan Singh to ensure that amendments are not made

to the Indian Drugs and Cosmetics Act to introduce data exclusivity

provisions as this will seriously affect India's ability to provide generic

drugs to millions of people in developing countries.

In a letter sent to Dr. Singh, the Alliance has expressed concern that such

amendments will have adverse effects on the global availability of

affordable essential medicines meant to treat HIV/AIDS, hypertension,

diabetes, asthma and many other diseases. " Without Indian generic drugs,

millions of people in developing countries will die as a result of lack of

access to affordable medicines,'' it says.

The broad based alliance, which has Bishop Desmond Tutu on its board of

directors, argues that 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. It maintains that

generic companies will be forced to repeat time-consuming and expensive

studies to receive regulatory approval.

Essential medications will be prohibitively expensive without the

competition from generic companies and generic drugs will take years to

bring to market under data exclusivity laws, it has stressed.

The Alliance has stated in the letter that repeating clinical trials will

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 will be denied access to the newest treatments available to

those who can afford brand name drugs,'' it has said.

In addition, it has pointed out that 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.''

It notes that World Health Organization's Commission on Intellectual

Property Rights, Innovation, and Public Health recently reinforced the view

that TRIPS does not require data exclusivity.

Underlining the need to avoid amending the Drugs and Cosmetics Act, the

alliance says the Commerce 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,'' it says.

© Copyright 2000 - 2006 The Hindu

http://www.thehindu.com/2006/06/25/stories/2006062502211300.htm

________________

Leena Menghaney

Project Manager-India

Campaign for Access to Essential Medicines

Medecins Sans Frontieres - Holland (in India)

Tel: +91 11 24337225, + 91 1151552413

msfh-india-medco-assist " <msfh-india-medco-assist@...>