[Ip-health] Business Standard: Drug-trial data issue invites pharma fire

[Thiru Balasubramaniam]

http://www.business-standard.com/india/news/drug-trial-data-issue-invites-p=
harma-fire/378650/

Drug-trial data issue invites pharma fire

Joe C Mathew / New Delhi December 5, 2009, 0:51 IST

The controversial issue of exclusivity of drug-trial data =97 which saw
overseas multinational companies and Indian pharma companies taking
opposite positions =97 is back on the table.

A Delhi-based law agency, Anand and Anand, has circulated a series of
questionnaires on the subject, which it claims are a part of a World
Health Organisation (WHO)/health ministry survey.

This has irked the Indian Pharmaceutical Alliance (IPA) =97 a grouping
of the 12 leading domestic pharmaceutical companies =97 as Anand and
Anand has many MNC pharma companies as its clients. The IPA is also
upset at the limited time of one week, till December 8, given for
responses to the questionnaire.

Data exclusivity essentially delays the introduction of generic
versions of a drug, according to domestic companies and public health
groups who are against its grant.

In a letter to the department of pharmaceuticals, IPA said it was
"stunned" to =93receive an email from Anand and Anand, a firm
representing foreign intellectual property (IP) owners=94, seeking
response to the =93WHO commissioned survey=94 over the impact of the data
exclusivity.

=93We are stunned for three reasons =96 one, the obvious and gross bias in
the questionnaire, two, the selection of a firm representing mainly IP
owners which has in the past refused to take up patent litigations in
favour of Indian generic companies on the ground of conflict of
interest with their foreign clients and third, as Pravin Anand, the
key person behind Anand and Anand was a member of the Satwant Reddy
committee (that had originally prepared the 'data exclusivity=92 report
for the government)=94, D G Shah, secretary-general of IPA, told
Business Standard.

Satwant Reddy, former secretary to the government, chaired the 15-
member committee which went into the question of data exclusivity. The
panel, which finalised its report in 2007, favoured the introduction
of data exclusivity, though only after further studies of its impact.

Pravin Anand was part of the committee. When asked, Anand declined
comment.

The IPA has also requested the department of pharmaceuticals to
confirm the role of the WHO in a national policy debate, "as it is
contrary to its practice.=94

The health ministry official in charge of WHO affairs said he was not
aware of the development.

Data exclusivity has been a subject of heated debates since 2005, soon
after India implemented a product patent regime in pharmaceuticals.
The initial debate was whether data exclusivity was a Trips (Trade
Related Aspects of Intellectual Property Rights) requirement under
World Trade Organisation (WTO) rules. Foreign multinational
pharmaceutical companies, which own intellectual property rights for
almost all medicines, and developed countries like the US, have been
pressurising the central government to introduce data exclusivity
based on their interpretation of the Trips agreement.

Domestic drug companies had been opposing this, as they felt India was
not obliged to give data exclusivity under Trips. Instead, it was a
Trips-plus clause meant only to delay the entry of low-cost generic
medicines, they argued. Public interest groups had also maintained
that data exclusivity could prevent the registration of low-cost
quality generic versions of medicines even when there is no patent on
a medicine.


http://www.business-standard.com/india/news/drug-trial-data-issue-invites-p=
harma-fire/378650/

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997