Jul. 16, 2008
Peru has imposed ten years of data protection for crop protection products. The government passed Decree 1074/2008 in late June. It affords ten years’ protection to efficacy and safety data for a new pesticide active ingredient from the date of its first approval in the country. The move fulfils part of a free-trade agreement with the US, the Decree adds.
The Decree also protects against the unauthorised use of the same data areas of an ai taken from the approval processes of other countries. Registrants of products in other countries must apply for approval of the product in Peru within five years of the registration to gain the protection. The protection would also be for ten years.
CropLife Latin America has welcomed the regulation. “The protection is an acknowledgement of the efforts and financial risks implicit in finding improved crop protection products, which typically amount to $200 million per molecule,” it says.
The Decree ratifies Decision 486 (the Intellectual Property Regime) of the four-member South American customs union, the Andean Community (CAN). Its agrochemical rules contain provisions for protecting undisclosed registration data against "unfair commercial use", but do not specify an exact exclusivity period. The CAN member states, Bolivia, Colombia, Ecuador, Peru and at that time, Venezuela, did not agree on the length of exclusivity periods, but Decision 486 stipulated a minimum period of five years. It was passed in 2000 and “clarified” in 2006 through Decision 632, allowing the setting of unconditional data exclusivity periods.