June 22, 2006

New India law feared to hit access to vital drugs

By Jonathan Allen

NEW DELHI (Reuters) - Plans to change India's drug approval
system would price life-saving drugs out of reach of millions
of poor people by preventing generic competition, campaigners
warned on Thursday.

New Delhi, under pressure from the United States and global
drug giants, is considering a law that could effectively grant
a monopoly to the developer of a new drug for several years
even without a patent.

"This will seriously affect accessibility to essential
drugs for people in developing countries," said Leena Menghaney
of Swiss-based Medecins Sans Frontieres, which has been
campaigning for better access to healthcare.

The law would particularly affect people with HIV who had
developed immunity to first-line anti-retroviral drugs and were
waiting for second-line drugs to become affordable, she added.

Making generic copies of a new, unpatented drug is a hugely
lucrative business in India.

Once a new drug is approved for sale, other drug companies
only need to point to the clinical safety data already filed
with India's drug controller by the drug's original developer,
and prove that their generic drug is identical to the original.

But innovating drug companies -- who invest millions of
dollars collecting the necessary data they need for marketing
approval through clinical trials -- say this is unfair.

This system allows them to recover little of their
investment and reduces the incentive to research and develop
new drugs, they say.

India, as a member of the World Trade Organization, should
give them exclusive rights to reap the benefit of their data
for several years under the Trade-related aspects of
Intellectual Property Rights (TRIPS) treaty.

Washington, in its bilateral talks with New Delhi, is also
urging India to adopt the change.

But others, including the World Health Organization, say
data exclusivity goes beyond what TRIPS requires, and should
not be introduced at the expense of public health.

They say generic drug companies are unlikely to invest in
conducting their own trials and would have to wait for the data
exclusivity period to end before making their cheaper versions.

Indian officials said the government was considering a
safeguard in the new law that would allow it to override data
exclusivity in the interest of Indian public health.

The possibility of generic drug-makers paying royalties to
use other companies' data was also being looked at.

"We are still trying to evolve some kind of consensus,"
Gurdyal Sandhu, a top official in the Ministry of Chemicals and
Fertilisers, told Reuters.