India to extend the monopoly period to 5 years

Date:02-28-2011

The Indian 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 three.