The Pest Management Regulatory Agency (PMRA) invites stakeholders to submit written comments on the proposed Agreement for Data Protection under Section 66 of the Pest Control Products Act (currently called the Ministerial Agreement for Data Protection under the Pest Control Products Act) and the proposed Eligibility Criteria for Compensable Protection Status for Foreign Test Data.
The data protection provisions of the Pest Control Products Regulations intend to strike a balance between encouraging the registration of new innovative products and generic pesticides by outlining the conditions that an applicant needs to follow to rely on an existing registrant's data to support their application. Data generated by pesticide registrants to support registrations in Canada receive exclusive or compensable protection status for a period of time to encourage innovation. Registrants of products under exclusive protection status can voluntarily allow applicants (generic registrants) to rely on their data. After the exclusive period, the data can be relied upon by others (generic registrants) to support the registration of competing "generic" products, thereby potentially lowering the price for pesticide users. During the compensable protection status period data can be relied upon providing compensation is paid.
PMRA requested advice from a neutral third party consultant on whether its pesticide data protection system was achieving the right balance, thereby optimizing its impact on the competitiveness of the Canadian agricultural sector. On November 20, 2014, the final report from the Intersol Group Ltd. (titled Recommendations: Administering the Data Protection Program for Pesticides in Canada ) was received and sent to stakeholders. The report indicated that most stakeholder representatives from among grower groups, innovative companies and generics companies supported the overall approach and design of the data protection program, and saw no need for a fundamental re-design. At the same time, many stakeholders noted that the current design and delivery of a number of key process elements were limiting the timeliness and predictability of the data protection program, and inhibiting the rate at which companies were seeking to register generic products.
Many of the consultant's recommendations regarding the application process, including timeliness, were addressed through the revised process set out in the Memorandum to Applicants and Registrants: Data Protection Submission Review Process. These proposed documents for consultation are intended to address the consultant's recommendations for changes to the arbitration process and to clarify foreign test data eligibility criteria.
Interested parties are encouraged to provide comments by 28 February 2017.
The following consultations are open for comment from 30 December 2016 to 28 February 2017 (60 calendar days). Open the links below to access the documents.
If you would like to comment, please forward your comments to the PMRA Publications Section. Questions or comments can also be directed to the Pest Management Information Service. Please be sure to include the title of the consultation document on which you are commenting.
Health Canada will make the results of these consultations available on the Pesticides and Pest Management portion of Health Canada's website.
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