Written By Julia Schatz

Following stakeholder consultations in the fall of 2024, on March 6, 2025, Health Canada's Pest Management Regulatory Authority (PMRA) released the final guidance document and the Section 66 Agreement under the Pest Control Products Act (PCPA) for registrants and data holders for use or reliance on test data considered in support of re-evaluation and special review decisions published. These will apply to 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.

Background to the Newly Published Guidance and Agreement

Amendments to the data compensation provisions in the Pest Control Products Regulations (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, A New International Treaty on Intellectual Property and Indigenous Knowledge and its Potential Impact on Canadian Agricultural Innovation, provides further details regarding the substance of these amendments.  The PMRA published guidance and Section 66 Agreement for data compensation for post-December 4, 2023, re-evaluation and special review decisions (second reference is to where reliance was on foreign test data and for non-equivalent active ingredients subject to exclusive rights). These did not apply to those decisions published prior to December 4, 2023.

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. While the process for decisions made public after December 3, 2023, was made clear through the Amendments, there remained uncertainty as to how the process was to work for decisions subject to the prior PCPR provisions. The PMRA undertook a consultation process in the fall of 2024 in respect of its proposed approach to data compensation for data supporting these previous decisions. Our blog of September 2024, Pest Management Regulatory Authority is Seeking Stakeholder Input, set out the proposals being considered by the PMRA at that time. The final guidance document and Section 66 Agreement have now been released.

Some of the key provisions are set out below:

• Creation of the Lists: The Minister of Health will establish the lists of test data considered by the Minister in support of the final re-evaluation or special review decisions 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 guidance document, which includes 32 active ingredients.
  
  The PMRA will establish these lists in the following order:
  
  1. Re-evaluation and special review decisions for active ingredients that have ongoing applications to register generic technical grade active ingredient products seeking to use or rely on data holders' test data.
  
  2. Re-evaluation and special review decisions for active ingredients that had recent data compensation assessments completed as a result of a product application.
  
  3. The remaining decisions in chronological order starting with the oldest first.
  
  While the original proposal by the PMRA was to give data holders and other registrants 30 days to provide comments on the initial proposed list, the final guidance now allows for such comments to be given within 45 days. The nature of the comments is limited. It is not an opportunity to question why certain test data was considered or not in support of a decision by the PMRA. The PMRA notes that other opportunities were available as part of the re-evaluation and special review processes where data holders and other registrants could comment on the studies considered in support of the decisions made.
  
  The criteria for what is eligible for compensation are listed in Appendix I of the guidance document. Test data may be eligible for compensation if the compensable protection period had not expired by the date of the publication of the final re-evaluation or special review decision under subsection 28(5) of the PCPA. The details of the process for the creation of the lists are set out in Appendix III of the guidance document. The information to be included in the lists is identified in Appendix IV. The final lists will then be made available by the PMRA to registrants.
• 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, and was within the compensable period when that re-evaluation or special review decision was made, 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 the decision rendered, decisions resulting in full cancellation of product or decisions resulting in cancellation of certain uses: 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. Registrants whose products are subject to the re-evaluation or special review decision are required to compensate for the use of or reliance on a data holder's test data that supports a re-evaluation or special review decision, including a decision resulting in the cancellation of certain uses.
• 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. 
• Letter of Access (LOA): At the next registration renewal as per subsection 16(2) of the PCPR following the conclusion of the negotiation or arbitration period, registrants using or relying on the data holder's test data will be required in their renewal applications to provide an LOA, or relevant documents indicating that parties are still in negotiation or arbitration, or that though a negotiated settlement has been reached or an arbitral award issued, the data holder has not provided the registrant with an LOA.
• Registrant may discontinue the product registration: After receiving the initial or final list, the registrant may wish to discontinue its product registration. The PMRA will cancel the registration of the products in accordance with subsection 22(3) of the PCPA. The PMRA may allow for a phase-out period, with timelines consistent with the Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review (here). 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 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 released the 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 Agreement is that the arbitral award, if the parties proceed to arbitration, will be enforceable.

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.