[Ip-health] The Hindu: PM urged not to introduce data exclusivity

[Sheila.SHETTLE@geneva.msf.org]

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

 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.