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 three 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 three.
