[pp.int.general] Fwd: [A2k] Economic Times: Monopoly on pesticide test data set to be extended to 5 years

Amelia Andersdotter teirdes at gmail.com
Thu Feb 24 07:46:28 CET 2011

you wonder how they think these things up :-\

-------- Original Message --------
Subject: 	[A2k] Economic Times: Monopoly on pesticide test data set to 
be extended to 5 years
Date: 	Thu, 24 Feb 2011 06:56:50 +0100
From: 	Thiru Balasubramaniam <thiru at keionline.org>
To: 	ip-health at lists.keionline.org, a2k at lists.keionline.org


24 Feb, 2011, 03.27AM IST,ET Bureau

Monopoly on pesticide test data set to be extended to 5 years

NEW DELHI: The government has proposed an increase in the monopoly
period enjoyed by pesticide manufacturers over test data , used to
support claims for the efficacy of their products, to five years. The
proposals form part of amendments to the pesticides bill, which were
circulated to MPs last week. The amendment may prove controversial
given that similar provisions, with respect to pharmaceuticals have
been opposed by India in its negotiations with the European Union.

Such proprietary data is generated by manufacturers while testing new
pesticides and is submitted to regulators in support of claims for the
efficacy of the product. The data is relied on by the regulators to
give permission to the manufacturer to make and sell the product in
the Indian market. The pesticides bill, pending in Parliament since
2008, had proposed that such data submitted by a manufacturer, could
not also be used by others to gain approvals for similar products, for
a period of theee years. Each manufacturer would be required to
generate its own data to support claims for efficacy, a process which
can be time-consuming and expensive. Agriculture minister Sharad
Pawar, in the amendments circulated to MPs, has proposed to raise this
'data exclusivity' period to five years.

Ironically, similar proposals with respect to pharmaceuticals and
drugs have been strongly opposed by both civil society, and reportedly
by Indian officials in negotiations with the European Union over a
possible Free Trade Agreement. Critics such as the humanitarian and
medical aid agency Medicins Sans Frontieres (MSF) claim that such data
exclusivity provisions are used by manufacturers to ensure that other,
low-cost generic versions of the drug or chemical, cannot be approved
by regulators using the same data. Such provisions are seen as a way
of effectively extending the monopoly that a drug or pesticide has in
a certain market, even when it goes off-patent.

However, it's unclear to what extent such provisions will have a
similar effect in the case of pesticides in India, since the bill
restricts the term of exclusivity to within the term of the patent.
Also, the norms do not apply to certain types of data which are
required to be generated specifically in Indian conditions, but only
to data submitted at the time of the first marketing approval,
anywhere in the world. Finally, the government can relax such data
exclusivity provisions in 'public interest'.

The pesticides Bill, if passed, will put in place a new regulatory
regime for pesticides. The BJP had opposed the 'data exclusivity'
provisions in the bill, which had, however, been upheld by the
parliamentary standing committee on Agriculture in its report on the
Bill in February 2009. It was the committee moreover, which had
proposed increasing the data exclusivity period to five years, from


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

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

A2k mailing list
A2k at lists.keionline.org

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