Draft Guidance and a Draft Section 66 Agreement Regarding Data Compensation in the Context of Re-Evaluations and Special Reviews

Written By Julia Schatz

On September 10, 2024, Health Canada's Pest Management Regulatory Authority (PMRA) published two documents for consultation: Regulatory Proposal PRO2024-04, Consultation on guidance for registrants and data holders for use or reliance on test data considered in support of re-evaluation and special review decisions (here) and Consultation on the Proposed agreement for data compensation under section 66 of the Pest Control Products Act for re-evaluation and special review decisions (here). These will apply to the process for data compensation in respect of re-evaluation and special review decisions that were published prior to the coming into force of the regulatory amendments to the Pest Control Products Act Regulations (PCPR) on December 3, 2023. The consultation period is open for 60 days and will close on November 9, 2024.

Background to the Consultations

The data compensation provisions in the PCPR promulgated under the Pest Control Products Act (PCPA) came into force on June 3, 2010. These provisions established a regulatory framework under which an applicant, to support its application to register a pest control product in Canada, was able to use or rely on test data that had been submitted to the PMRA by a registrant in support of its product registration. Guidance to implement the data compensation provisions in the context of an application to register or amend a registration of a pest control product were published in October 2010 (here) and December 2014 (here). While the data compensation provisions were to apply, with necessary modifications, to a registrant who wanted to use or rely on test data of another registrant for the purposes of a re-evaluation or special review of a pest control product, no guidance had been published to address these scenarios.

Amendments to the data compensation provisions in the PCPR were published on June 7, 2023, and came into force on December 4, 2023 (Regulations Amending the Pest Control Products Regulations (exclusive rights and compensable data)). These amendments were aimed at clarifying the data compensation process in the context of re-evaluations and special reviews, specifically for those decisions that were published after December 4, 2023. Our blog of June 21, 2023 (here) provides further details regarding the substance of these amendments. 

To support the implementation of these amendments, the PMRA published a guidance document (here), as well as an agreement under section 66 of the PCPA (here). The PMRA also published a section 66 agreement for pest control product applications to support these amendments where reliance was on foreign test data and for non-equivalent active ingredients subject to exclusive rights. 

The Proposed Guidance and Section 66 Agreement

For those re-evaluation and special reviews decisions that were made public before December 3, 2023, the former PCPR provisions apply. The process for decisions made public after December 3, 2023, was made clear through the Amendments, however there remained uncertainty as to how the process was to work for decisions subject to the prior PCPR provisions. As such, this proposed guidance, supporting the interpretation of those former provisions, is a welcome development.

Some of the key proposals in the guidance document include:

• Creation of the Lists: The Minister of Health will make available the list of test data considered by the Minister in support of the final re-evaluation or special review decision for which compensation may be payable. The test data for which compensation may be payable will be in respect of re-evaluations and special reviews that were initiated since June 28, 2006 (when the current PCPA came into force) and for which a data call in was issued after June 3, 2010 (when the data compensation provisions in the PCPR first came into force). The decisions for which lists will be prepared are found in Appendix V to the consultation document, which includes 32 active ingredients. The data holders' and other registrants will be sent an initial proposed list and will have 30 days to provide comments to the PMRA. Criteria of what is eligible for compensation are listed in Appendix I of the guidance document. The details of the process for the creation of the list are set out in Appendix III of the guidance document. The information to be included in the list is identified in Appendix IV.
• Use of On-Hand Data: While the PMRA considers relevant test data from many sources as part of the re-evaluation or special review, it will only be test data that is called in (not data that is "on-hand") in respect of the equivalent active ingredient and considered by the PMRA for the first time in support of the final decision that may be eligible for compensation. Test data that is "on-hand" relevant to a non-equivalent active ingredient that was considered in a final re-evaluation or special review decision published after September 21, 2017, may be eligible for compensation.
• Called-In Data: Data submitted pursuant to notices under subsections 16(3), 18(1) or 19(1) of the PCPA are eligible for compensation if they are considered by the Minister in support of the re-evaluation or special review decisions.
• Who does this apply to: All technical grade active ingredient registrants who maintained the registrations of their active ingredient products since the date of the publication of the re-evaluation or special review decision are subject to the data compensation requirements under the PCPR as amended in 2010.  
• In case of product cancellation after decision rendered or decisions resulting in full cancellation of product: No compensation is payable if an active ingredient registration has been cancelled since the date of the publication of the associated re-evaluation or special review decision or if the registrations were cancelled as a result of the re-evaluation or special review.
• Foreign studies: If foreign studies were called-in by the PMRA, compensation may be payable for them. If they were considered as part of a review of regulatory decisions of other regulatory bodies in other jurisdictions, they will not be compensable.
• Process after the list is finalized: Once the final list has been delivered to the registrants, either party may initiate the data compensation process under the PCPR.  
• Registrant may discontinue the product registration: If, after receiving the final list, the registrant may wish to discontinue its product registration. When a section 66 agreement has been entered into, that agreement continues to apply. Registrants not wanting to be subject to such an agreement are encouraged by the PMRA to have their registrations canceled before the final list of test data for which compensation may be payable is delivered.  

The Proposed Section 66 Agreement

Under section 66 of the PCPA and section 17.9 of the PCPR, a registrant and data holder must enter into an agreement in the context of a re-evaluation or special review if the parties wish to follow the process specified in the PCPR to determine compensation payable for the registrant's use of or reliance on the data holder's test data. The PMRA has proposed a draft section 66 agreement for use in the context of re-evaluations and special review decisions that were published prior to December 3, 2023. The key difference between this and the previous section 66 agreements is that the arbitral award, if the parties proceed to arbitration, will be enforceable.

Stakeholder Webinar

PMRA has announced that it will be holding a stakeholder webinar to review these proposed documents on September 26, 2024, at 10 am to 12 pm ET. Prior registration is required (registration details here).

The Bennett Jones Food and Agribusiness group has extensive knowledge and experience in the pesticide regulatory space and would be happy to discuss any questions you may have regarding these developments with you.

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