[Ip-health] Business Standard: Data exclusivity still key hurdle to India-EU FTA
katy.athersuch at googlemail.com
Thu Jan 27 05:25:19 PST 2011
Data exclusivity still key hurdle to India-EU FTA
Nayanima Basu & Joe C Mathew
New Delhi January 27, 2011, 0:31 IST, Business Standard
Despite all official assurances, the path towards a free trade agreement
(FTA) between India and the European Union (EU) this year remains ambiguous,
as both sides are unwilling to relax their stand on the biggest stumbling
block — the issue of “data exclusivity”.
While the commerce ministry, the government arm responsible for scripting
policy framework for intellectual property rules in the country, says there
is no let-down in this matter, its EU counterpart insist that insistence on
data exclusivity is integral to the trade deal.
The rigid stand taken up by the negotiating sides and simultaneous
assurances of a timely agreement are sending conflicting signals to various
stakeholders, including the domestic pharmaceuticals industry and public
health groups that oppose the inclusion of any clauses that go beyond
India’s World Trade Organization (WTO) commitments under the FTA.
Data exclusivity provides protection to the technical data generated by
innovator companies to prove the merit of usefulness of their products. In
the case of pharmaceuticals, it means the data generated by drug companies
through expensive global clinical trials to prove the efficacy and safety of
their new medicine. By gaining exclusive rights over this data, innovator
companies can prevent their competitors from obtaining marketing licence for
low-cost versions during the tenure of this exclusivity.
Indian drug firms that make generic versions of innovator medicines get
their approvals after proving that their product is bio-equivalent to the
original drug. In other words, they do not repeat the same clinical trials
conducted by the innovator company to generate data needed to prove its
safety under current laws.
“The most serious impact is likely to be on drugs that are not under patent.
In such cases, data exclusivity will create a “patent-like” barrier that
will prevent generic entry of new formulations during the entire period of
exclusivity. For instance, traditional medicine ‘colchinine’, which cannot
be patented as it has been used as a therapeutic agent in the treatment of
gout for thousands of years, was awarded data exclusivity in the United
States. Once the US drug regulator accepted the one-week trial of the drug,
the company was able to enforce data exclusivity to block affordable
generics. It enforced its exclusive rights, raised the price from $0.09 per
pill to $4.85, and sued to remove other competitors off the market,” Indian
Drug Manufacturers’ Association Secretary General Daara B Patel said.
Commerce ministry officials say they are aware of the seriousness of the
issue. “There is no question of data exclusivity. We are under no pressure
from anyone (to include this provision under FTA). EU and their negotiators
are well aware of India’s sensitivities and we have made our position very
clear to them,” a senior commerce department official involved in the
negotiations told Business Standard.
However, earlier in the week, Daniele Smadja, head of the delegation of EU
to India, said the India-EU FTA had to include data exclusivity. “This is a
very important issue and it has to feature prominently in the trade deal,”
Global pharmaceutical giants say data exclusivity is essential for their
future investments and research on developing country needs.
“Data exclusivity is very good as it will encourage innovation. It will also
make companies do clinical trials before they launch their products thereby
ensuring patient safety,” said Ranga Iyer, consultant to Pharmaceutical
Research and Manufacturers of America.______________________________________
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