Responses to comments on proposals on data compensation for re-evaluation and special review decisions published before 4 December 2023

Health Canada – Pest Management Regulatory Agency
6 March 2025

Health Canada's Pest Management Regulatory Agency (PMRA) invited stakeholders to comment on the proposals "guidance for registrants and data holders for use or reliance on test data considered in support of re-evaluation and special review decisions published before 4 December 2023" (guidance document) and the "proposed agreement for test data compensation under section 66 of the Pest Control Products Act for re-evaluation and special review decisions published before 4 December 2023" (section 66 agreement). The guidance document sets out the process that the PMRA will follow to implement the data compensation requirements for re-evaluation and special review decisions published before 4 December 2023. The section 66 agreement has to be entered into when a registrant and data holder wish to follow the process specified in the Pest Control Products Regulations as published in the Canada Gazette, Part II publication SOR/2010-119 on 23 June 2010 (2010 Regulations) to rely on a data holder's test data in respect of which compensation may be payable to meet the re-evaluation or special review test data requirements. These documents were open for a 60-day comment period from 9 September to 9 November 2024. PMRA held a public webinar with 106 attendees on 26 September 2024 to inform interested stakeholders, partners, and the public about PMRA's consultations on data compensation for past re-evaluation and special review decisions. PMRA received seven written submissions by the end of the comment period.

One comment was received from CropLife Canada, a trade association representing developers, manufacturers, and distributors of plant science innovations for pest control products and products of modern plant breeding. Six comments were received from individual CropLife members, with five from innovator registrants and one from a representative of a generic product manufacturer. In addition, one comment was received from a member of the public. Only two comments resulted in changes to the guidance document, and none resulted in changes to the section 66 agreement. In addition, a variety of topics were raised in these comments concerning implementing data compensation for past re-evaluations and special review decisions. The comment summaries and PMRA responses are found below.

Stakeholder comments and PMRA responses

1. An innovator registrant requested that the time to review the initial list of test data for which compensation may be payable be extended to 45 days from the proposed 30 days. Similarly, a representative of a generic manufacturer proposed that PMRA provide a 60-day window to review the initial list noting that 30 days is too short of a period, from the perspective of the industry, to allow for internal discussions and approvals. The representative of a generic manufacturer also questioned whether data holders would have an opportunity to substantively challenge the lists of test data after re-evaluation, whether this new guidance changes the current process for how registrants and data holders enter into a section 66 agreement, and whether these test data lists will be incorporated into new applications.

   • PMRA response

     PMRA proposed a 30-day timeline for data holders and registrants to review the initial list of test data because this is the timeline used in the guidance document. PMRA provided for 30 days in that guidance document because there is a regulatory requirement to have the list of test data for which compensation may be payable made available at the time of publication of the final re-evaluation or special review decision. However, the 2010 Regulations do not specify a time limit related to the review of the initial list of test data.

     PMRA recognizes that in the case of new registrations involving compensable data, applicants are given 45 days to review the initial list of data identified as being compensable and that this has been the practice since 2010. PMRA also understands that internal discussions can take time. However, the 60-day timeline proposed by the generic representative, being twice as long as proposed, may impact the timeliness of finalizing these lists.

     Considering these requests, PMRA will provide data holders and registrants with 45 days to review the initial list of test data for which compensation may be payable, instead of 30 days as originally proposed.

     As indicated in Appendix III of the guidance document, there is an opportunity for data holders and other registrants to provide input on whether the initial list of test data for which compensation may be payable was established as per the eligibility criteria outlined in Appendix I of the guidance document.

2. CropLife Canada and an innovator registrant asked when PMRA plans to complete the assessments for lists of test data for which compensation may be payable for the list of past re-evaluation and special review decisions found in Appendix V of the proposed guidance document. Another innovator registrant suggested that PMRA also provide timelines for which PMRA will finalize the list of test data for which compensation may be payable and not only timelines for registrants and data holders.

   • PMRA response

     The guidance document outlines the process for establishing the final data compensation list for past decisions. The PMRA will start implementing the process upon publication of the finalized guidance. This includes providing the initial lists of test data for which compensation may be payable to data holders and registrants for the past decisions outlined in Appendix V of the guidance document. The PMRA intends to finalize the data compensation lists within 12-18 months after the publication of the guidance document.

3. A member of the public would like to see less test data for re-evaluations and special reviews that involve the use of vertebrate animals. The individual also requested that all vertebrate animal pesticides like rodenticides and predacides be banned due to humaneness concerns and non-target effects, and to restrict pesticides that affect invertebrates.

   • PMRA response

     One of the purposes of the data compensation program is to allow for reliance on the test data of a data holder by other registrants to avoid duplicative studies, including those involving vertebrate animals. Health Canada is a certified institute of the Canadian Centre on Animal Care that follows the three Rs - replacement, reduction, and refinement for the humane treatment of animals used in research.

     Pest control products are registered on an individual product basis and are subject to cyclical re-evaluations or special reviews in certain cases. Comments related to individual pest control products should be made during public consultations on proposed decisions for these products. Alternatively, written comments can be sent to the PMRA's Pest Management Information Service (or "InfoServ") at any time.

4. A respondent representing a generic manufacturer suggested that the guidance could be simplified by including equivalent test data for compensation and not including non-equivalent test data. Also, an innovator registrant asked why the list of active ingredients for which a list of test data may be established goes beyond September 2017, but the compensability of non-equivalent test data on hand only starts on September 2017.

   • PMRA response

     The Pest Control Products Regulations were amended on 21 September 2017 with the Canada Gazette, Part II, publication SOR/2017-169 (the 2017 Amendments) to permit reliance on test data relevant to an active ingredient that is not equivalent to the active ingredient contained in a pest control product that is the subject of a re-evaluation or special review. As a result, only test data relevant to a non-equivalent active ingredient that had a compensable period that had not expired at the time of the final re-evaluation or special review decision of a pest control product containing another active ingredient issued after 21 September 2017 is eligible for compensation. Prior to the 2017 Amendments, compensation could only be required for data supporting the equivalent active ingredient.

5. An innovator registrant proposed that the compensable period of 12 years start on the publication date of the final re-evaluation or special review decision instead of the date when the test data is received during the re-evaluation or special review. Similarly, another innovator registrant requested the compensable time period be extended to cover from the re-evaluation or special review publication date to the cancellation of the active ingredient for the registrant relying on that test data.

   • PMRA response

     The compensable period timelines are set out in section 17.7 of the 2010 Regulations, and cannot be changed through policy. The 2010 Regulations establish the rules that were in effect at the time of the re-evaluation and special review decisions published prior to 4 December 2023.

6. CropLife Canada and a representative of a generic product manufacturer asked in what scenarios would the data holder be or not be compensated, including where the test data's compensable period has expired but the test data was under compensable protection status at the time of the final re-evaluation or special review decision.

   • PMRA response

     The expiry of the compensable period for test data that was eligible for compensation at the time of the final re-evaluation or special review decision may be a relevant factor for consideration during negotiations and, if necessary, binding arbitration.

7. An innovator registrant requested that PMRA publish clear criteria for compensable test data and generate data call-ins for these test data. Similarly, another innovator registrant requested that PMRA provide data holders and other registrants the information on data ownership and their commitments before a re-evaluation or special review is finalized.

   • PMRA response

     Appendix I of the guidance document sets out the compensable criteria for both test data for an equivalent active ingredient and for on-hand test data from a non-equivalent active ingredient that may be eligible for compensation on or after the 2017 Amendments. Criteria for developing lists of test data for which compensation may be payable are described in Section 3.1 of the guidance document and include that the re-evaluation or special review was initiated after 28 June 2006, and eligible test data was received in response to a data call-in after 3 June 2010.

     The determination of whether test data considered by PMRA in a final re-evaluation or special review decision is eligible for compensation is made at the time of the final decision and communicated by publication. For test data to be eligible for compensation, a data holder must have responded to a data call-in notice, under section 16, 18, or 19 of the Pest Control Products Act.

8. An innovator registrant asked how can PMRA ensure that registrants who are relying on the test data of others and who cancel prior to the publication of the data list are not permitted to register their products subsequently.

   • PMRA response

     An applicant may apply to register a cancelled product. A data compensation assessment will be conducted on the precedent product(s) as part of their application review. The applicant will be subject to the registration requirements at that time, including compensating for any test data for which compensation may be payable.

9. An innovator registrant requested that PMRA provide data holders with the names of all parties receiving initial lists of test data for which compensation may be payable.

   • PMRA response

     As indicated under Section 3.6 of the guidance document, the PMRA will provide all relevant registrants and data holders for each past decision with the initial list of test data for which compensation may be payable. After considering all comments received on the initial list, the final list containing the eligible test data considered in support of the Minister's re-evaluation or special review decision will be made available to all relevant parties using the format set out in Appendix IV of the guidance document. PMRA's letter accompanying both the initial list and the final list of test data for which compensation may be payable will identify the data holders and other registrants.

10. A representative of a generic manufacturer asked PMRA to provide clarity regarding per capitas or divisors or how they are determined based on existing registrants in the market in order to determine payable shares.

    • PMRA response

      The compensation principles that the arbitrator may consider are found in Appendix E of the section 66 agreement and are consistent with the section 66 agreements for both the product applications and re-evaluations and special review decisions subject to the current Pest Control Products Regulations data protection provisions. A registrant can provide information or propose a divisor factor considering how many existing registrants are on the market and a payable share could be made during negotiations with the data holder as well as for consideration by the arbitrator if binding arbitration is pursued.

11. An innovator registrant requested that registrants who discontinue their registrations to avoid paying compensation should be required to compensate if they show sales to PMRA on or after the re-evaluation or special review final decision date.

    • PMRA response

      In these situations, when the registration has been cancelled, there is no registrant to enter into the section 66 agreement, so compensation cannot be compelled under the 2010 Regulations. If a registration has been cancelled after a discontinuation request and is authorized for a phase-out period to deplete existing stocks, the data compensation provisions would not apply.

12. An innovator registrant suggested data compensability be extended to test data used in support of foreign reviews or regulatory decisions.

    • PMRA response

      Foreign reviews are publicly available information for the re-evaluation or special review for which it is considered, and therefore compensation is not required. However, as per section 17.7 of the 2010 Regulations, the underlying test data supporting a foreign review is compensable when a product application is made and the data holder provided the test data to the PMRA.

13. An innovator registrant requested to have the burden placed upon the registrants who are relying on the test data of others by requiring those registrants to contact the data holder within 90 days of receiving the final list of test data for which compensation may be payable to initiate negotiations or their registration will be cancelled by the PMRA.

    • PMRA response

      Consistent with the process outlined in the guidance document in effect for re-evaluations and special reviews final decisions published after 4 December 2023, subject to the current Pest Control Products Regulations, either party can initiate negotiations by sending the section 66 agreement. This ensures there is timeliness in the process of determining compensation payable.

14. Two innovator registrants suggested that there should be a provision where data holders can request the PMRA to cancel a registration upon proof that the registrant has failed to respond to the data holder 120 days after delivery of the section 66 agreement. Failure to respond to the data holder's issuance of a section 66 agreement should trigger a cancelation of registration 180 days after delivery of the section 66 agreement.

    • PMRA response

      If the data holder initiates negotiations with the registrant by delivering the section 66 agreement, they can initiate binding arbitration at the end of the 120-day negotiation period. The arbitrator is to render an arbitral award based on the information provided and that includes whether or not the registrant participated. Once an Arbitral Award has been rendered it can be enforced in court.

15. A representative of a generic manufacturer asked PMRA to clarify the timing of the actual payment owed and whether this would be at the time of issuing a Letter of Access (LOA).

    • PMRA response

      The LOA must be provided on determination of the compensation payable in accordance with the settlement or award as per section 17.94 of the 2010 Regulations. The actual payment owed could be paid at the time of issuing the LOA or there could be scheduled payments depending on what was agreed to in the settlement or as determined by the arbitrator.

16. An innovator registrant indicated that renewals are typically for five years after a final re-evaluation or special review decision has been published at which point a registrant relying on the data holders' test data could request to discontinue their registration and avoid paying compensation.

    • PMRA response

      Renewals are not re-set with a final re-evaluation or special review decision publication and are independent of these decisions. However, as proposed, once a list of test data for which compensation may be payable is sent to both parties, the registrants relying on that test data will need either an LOA for that test data or evidence that the section 66 agreement has been entered into and they are either in negotiations or pursuing binding arbitration. If there is no LOA or evidence of negotiations or arbitration being underway at the time of renewal, their product will not be renewed.

17. An innovator registrant indicated that the final list of test data for which compensation may be payable should not be published before the final re-evaluation or special review decision is published.

    • PMRA response

      The guidance document is for past decisions where the final re-evaluation or special review decision has already been published on the Health Canada website. For a list of applicable decisions, see Appendix V of the guidance document. The list of test data for which compensation may be payable for these past decisions will be based on the criteria set out in Appendix I of the guidance document.

18. An innovator registrant suggested removing the recommendation for registrants relying on the test data of others to discontinue their products before the list of test data for which compensation may be payable is finalized because at that time the section 66 agreement can be sent by either party to initiate negotiations.

    • PMRA response

      The PMRA agrees and this statement has been removed from the guidance document.

19. A representative of a generic manufacturer requested that when a data holder sends a section 66 agreement to the registrant relying on their test data, the agreement should not be entered into until the registrant signs. This would allow the registrant to decide to discontinue their product's registration at any time without having to be bound by the terms and conditions of the section 66 agreement until they actually sign.

    • PMRA response

      A section 66 agreement is entered into on delivery of that agreement by either the data holder or registrant. Discontinuation requests can be made to the PMRA at any time.

20. Two innovator registrants suggested that Appendix I of the guidance document include test data submitted as required under the Incident Reporting Regulations. As well, they suggested that all test data relied upon by PMRA for the proposed decision and consulted on should be included in the eligibility criteria in Appendix I. Two other innovator registrants indicated that voluntarily submitted test data should be compensable if it is subsequently used by PMRA in a final re-evaluation or special review decision and stated that is outlined under section 17.12 of the amended regulations.

    • PMRA response

      As per the 2010 Regulations, test data must be submitted pursuant to sections 16, 18, or 19 of the Pest Control Products Act to be eligible for compensable protection at a re-evaluation or special review or be on-hand compensable test data from another non-equivalent active ingredient since the 2017 Amendments. Test data submitted under the additional information and mandatory reporting requirements under sections 12 and 13 of the Pest Control Products Act are not eligible for compensable protection.

      As per section "3.2 Test data requests communicated in writing" of the guidance document, the PMRA may have requested the submission of test data for re-evaluations and special reviews in writing in various ways, including via email correspondence or consultation documents. If such test data were used in support of final decisions, they may be eligible for compensation as set out in Section 3.1 of the guidance document. Test data not submitted in response to a written request is considered voluntarily submitted test data and is not eligible for compensation.

      Paragraph 17.12(1) (b) of the Pest Control Products Regulations applies to final re-evaluation and special review decisions published since 4 December 2023 and sets out the conditions for use or reliance test data that is not equivalent to the one under review.

21. A representative of a generic manufacturer indicated that the 4 December 2023 date is somewhat arbitrary and that PMRA may not respect that date for the active ingredients set in Appendix V of the guidance document.

    • PMRA response

      The 4 December 2023 date is the date the data compensation amendments to the Pest Control Products Regulations came into force. The guidance document addresses final re-evaluation and special review decisions published before that date, which are subject to the 2010 Regulations.