[Ip-health] Economic Times: Monopoly on pesticide test data set to be extended to 5 years

Thiru Balasubramaniam thiru at keionline.org
Wed Feb 23 21:56:50 PST 2011


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

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