Progress on the 2006 Own-Use Import Task Force Report: 2006-2007 to 2008-2009

December 2009

Executive Summary

The following document is a progress update on the 2006 Own-Use Import (OUI) Task Force Report. It outlines the implemented initiatives, programs, activities and related decisions up to fiscal year 2008-2009, resulting from the discussions held by the OUI Task Force. The recommendations were focused on three key areas: the registration of generic pest control products, international regulatory cooperation activities and imports for own use (for agricultural purposes).

The current programs and initiatives will continue as outlined, with ongoing program development a priority, through feedback from industry and growers, particularly in the areas of Protection of Proprietary Interests in Pesticide Data in Canada (PPIP) and Grower Requested Own-Use (GROU).

The task force will conduct a summative or full evaluation following the 2011 growing season on whether the package of recommendations has proven effective.

Background

The OUI Task Force was assembled by Health Canada in November 2005 to review a number of issues identified with the OUI Program by a variety of stakeholders. The Task Force included a variety of these stakeholders including federal and provincial governments, industry and grower groups. The outcomes and recommendations were captured in the 2006 OUI Task Force Report and were supported by all participants.

The 2006 Report addressed the issues raised during the meetings of the OUI Task Force, with a focus on ensuring that growers had continued access to a price discipline mechanism. The initial objective of the OUI Task Force was to address a number of issues raised during the extensive use of the OUI program in 2005, but the Task Force did not limit its recommendations to addressing price differentials. The group felt it was critical that its recommendations address some of the broader agricultural issues identified as part of the OUI review, including registration of generic products, data protection policies and the impact of regulatory harmonization on pesticide product availability in general.

The following specific issues were identified and were to be addressed within the context of the three recommended activities-the registration of generic pest control products, international harmonization activities, and imports for own use (for agricultural purposes):

• Container disposal
• Post-registration controls - provincial regulations
• Equivalency
• Impact on new registrations/investments in Canada
• Data compensation/intellectual property rights
• Lower input costs for farmers
• Third-party facilitation

The recommendations (listed in Appendix I) outlined that an evaluation following the first year of implementation, originally planned for 2006, was to be completed. However, the GROU program commenced late in the 2007 growing season; therefore, the evaluation was rescheduled to follow the first and full year of implementation in 2008.

Objectives

This document will describe progress made on the 2006 OUI Task Force Report recommendations in the following areas:

• PPIP (generic product registration)
• International Regulatory Cooperation
• GROU Program
• Task Force Recommended Transition Steps

Conclusion

Initiatives resulting from the Task Force Report have been developed and implemented with co-operation between industry, growers and governments. Specifically, the GROU Nomination Committee and industry continue to provide feedback on the program to ensure smooth operation and support to increase the number of approved GROU products. Similar positive results can be seen with international harmonization activities through the North American Free Trade Agreement Technical Working Group on Pesticides and stakeholders. In addition, the first year of the new generic registration process saw twice the average number of submissions compared to the previous program.

The current programs and initiatives will continue as outlined with ongoing program development a priority through feedback from industry and growers, particularly in the areas of PPIP and GROU.

GROU policy decisions that are currently under development and to be finalized in 2009-2010, in line with the planned consultative process for the amended import regulations, are:

• patent protection issues in relation to GROU candidate products;
• enhanced price monitoring and analysis of market conditions by Agriculture and Agri-food Canada; and
• continued consultative process with grower groups and industry on the PPIP policy and GROU Program in 2009-2010 and on an on-going basis.