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Information Note – Questions and Answers Related to Data Requirements and Data Protection during Re-evaluation and Special Review

Pest Management Regulatory Agency
30 June 2021

Table of Contents

Foreword

Health Canada's Pest Management Regulatory Agency (PMRA) is continuing to work on proposed regulatory amendments that would clarify the data protection regulatory requirements for the re-evaluation and special review. PMRA is aiming to publish the proposed amendments in Canada Gazette Part I for consultation in fall 2021 and details can be found on the Forward Regulatory Plan: 2021-2023 page on Canada.ca.

While the work to amend the Regulations is on-going, PMRA has prepared the questions and answers in this document to provide further clarity on the data requirements and data protection during re-evaluation and special review under the current Pest Control Products Act and Pest Control Products Regulations. This document may be updated if necessary when the amended regulations are finalized.

For details on the relevant legislative requirements related to data requirements and data protection during re-evaluation and special review, please consult the Pest Control Products Act and Pest Control Products Regulations.

A. Data requirements during re-evaluation and special review

1. What data/information is considered by Health Canada for a re-evaluation or special review?

During a re-evaluation or special review, PMRA considers relevant test data and other information from pesticide manufacturers, published and unpublished scientific reports, and other regulatory agencies. As per section 2(1) of the Pest Control Products Act, "test data" means "scientific or technical information respecting the health or environmental risks or the value of a pest control product".

2. How does Health Canada determine the data requirements during a re-evaluation or special review?

A re-evaluation of a pest control product is conducted pursuant to section 16 of the Pest Control Products Act. The re-evaluation process is a step-by-step process as outlined in the Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy.

At the time of re-evaluation initiation under subsection 16(3) of the Pest Control Products Act, PMRA asks registrants to submit a data list and executive summaries of available studies for the active ingredient under review (i.e., studies that are available and studies that are underway or planned). PMRA may also issue a data call-in (DCI) pursuant to subsection 16(3). Following the initiation, PMRA considers previously conducted assessments to determine if they continue to meet the standards of current science/policy. In addition, PMRA considers other available information including public literature, incident reports, status of active ingredients in other jurisdictions, data lists provided by the registrants, new data requirements identified since last regulatory review, and conditions of product use. From these sources of information, PMRA identifies the primary focus of the re-evaluation based on potential risk of concerns and any additional data required to conduct the re-evaluation review. At the end of this scoping process, PMRA may issue a DCI pursuant to paragraph 19(1)(a) of the Pest Control Products Act to all registrants for additional information and/or studies that are considered necessary to conduct the review.

In general, studies included in the DCIs are selected from the lists of available studies submitted by the registrants of the technical grade active ingredient that is under re-evaluation as well as underlying studies from relevant published foreign reviews. In certain cases, new studies may need to be generated for a re-evaluation and be submitted within specified timeline.

All DCI notices are available in the public registry.

A special review is another type of post-market review under the Pest Control Products Act. However, as per the requirements of section 17 of the Pest Control Products Act, the review scope is narrower than a re-evaluation and it only evaluates the aspect(s) of concern that triggered the special review. PMRA's Guidance Document, Approach to Special Reviews of Pesticides outlines the special review process.

A special review is initiated pursuant to subsection 18(1) of the Pest Control Products Act. PMRA may also issue a DCI at the time of initiation. Following the initiation of a special review of an active ingredient, additional data/information that is necessary for the review may be required by issuing a DCI notice in accordance with paragraph 19(1)(a) of the Pest Control Products Act to the relevant registrants.

3. My generic technical product was registered in Canada a few years ago and the registration is supported with a very small data package, such as chemistry data. Why did I receive a data call-in notice from Health Canada so soon for a re-evaluation or special review?

In accordance with section 16 of the Pest Control Products Act, PMRA periodically re-evaluates pesticides that are in the market to assess whether they continue to meet the current health and environmental standards, including whether their health and environmental risks and value remain acceptable. In addition, a special review may be required as per the requirements of section 17 of the Pest Control Products Act to evaluate the aspect(s) of concern that triggered the special review.

Once a re-evaluation or special review is initiated for a registered active ingredient, all registrants for that active ingredient are required to meet the data requirements in support of the re-evaluation or special review (DIR 2016-04; also Approach to Special Reviews of Pesticides). Available options to meet the data requirements are outlined under Section B.2. As part of the re-evaluation or special review, all registered uses and pest control products containing the relevant active ingredient fall under that review. This includes uses and products containing the relevant active ingredient that are registered prior to or following the initiation of the re-evaluation or special review of that particular active ingredient. Therefore, a company that is granted registration of a pest control product containing an active ingredient that is under re-evaluation or special review becomes subject (along with other affected registrants) to any notice requiring data/information that is delivered in accordance with sections 16, 18, and 19 of the Pest Control Products Act. In addition, registrants of new generic products that are registered during an on-going re-evaluation or special review are informed of the on-going reviews in their registration letters.

Registrants can refer to PMRA's published annual update to the multi-year work plan, which provides an update of the on-going re-evaluations and special reviews, as well as the initiation schedules for upcoming re-evaluations. The multi-year work plan is available among the Re-evaluation Notes on the Decisions and updates page in the Pesticides section of the Canada.ca website.

4. Why is PMRA asking for multiple studies for the same data code? What is the scientific basis for this duplication?

PMRA strives to make sure that the best available relevant information is used in making regulatory decisions. Following the initial registration of a pest control product, it is possible that many new studies could have been generated relating to that product (for example, by registrants to meet the requirements of other international regulatory organizations; or by the scientific community). In some cases, studies may be conducted with different animal or plant species or different soil types. All relevant available information will be considered during a re-evaluation or special review. This means, if multiple studies for one data code (DACO) are available, PMRA may consider them and take a "weight-of-evidence" approach. In other words, in each review area PMRA will evaluate the totality of available and relevant scientific evidence to determine if the science supports a particular conclusion.

The details on the DACO are available on the Use Site Category page in the Pesticides section of Canada.ca.

For more information on the weight-of evidence approach, please consult PMRA's Guidance Document A Framework for Risk Assessment and Risk Management of Pest Control Products.

5. Would PMRA issue additional data call-in notices during the course of re-evaluation or special review?

During the course of a re-evaluation or special review, additional DCI notices may be issued pursuant to paragraph 19(1)(a) of the Pest Control Products Act to registrants if further information is needed to complete the risk assessments. As per paragraph 19(1)(b) of the Pest Control Products Act, the burden of persuasion is placed on the registrants to demonstrate that the health and environmental risks and value of the product remain acceptable.

6. How do I know what studies are actually considered in a re-evaluation or special review?

All studies/information considered by the Minister in support of the re-evaluation or special review will be included as part of the references in the published documents (i.e., consultation and final decision documents).

7. How does PMRA consider foreign reviews for re-evaluations or special review?

PMRA considers available relevant foreign reviews during a re-evaluation or special review. In some cases, PMRA may need to review certain underlying studies to confirm the interpretation or conclusion on certain aspects addressed in a foreign review. In this latter case, the specific studies will be identified and may be included in the DCI notice.

While each regulatory body considers all the available scientific information, each country conducts their own risk assessments, taking into consideration country-specific legislation and policies, and conditions of use. That is why regulatory decisions are independent and may differ from country to country.

B. Data protection and data submission

1. For re-evaluations and special reviews, what kind of data is protected (compensable) under the current Pest Control Products Regulations?

2. I do not have all the required studies outlined in the data call-in notice. What are my options to address the data requirements?

All registrants are required to meet the data requirements and must respond within the established timelines.

The following options are available for registrants during a re-evaluation or special review to address the data requirements. Registrants must choose one of the three options for the studies listed for each of the data requirements in the DCI:

Registrants may wish to collaborate on generating the data as per paragraphs 16(5)(a) and 18(3)(a) of the Pest Control Products Act. To the extent possible, the data protection program encourages data reliance over duplication of studies; unnecessary, duplicative animal testing should be avoided. In some cases where new products are registered during the re-evaluation or special review, option 2 may be the only possibility if registrants choose to keep their products registered. The re-evaluation cannot be delayed to accommodate late data submission from the new registrant.

3. For option 2, is PMRA asking for a commitment from registrants to agree to compensate data holders for studies used in a re-evaluation or special review decision or to agree to enter into negotiations regarding data compensation with the data holders?

If option 2 is selected, PMRA is seeking a registrant's commitment to compensate other registrants (data holders) whose eligible data is relied on once the re-evaluation or special review is complete, in accordance with the requirements of the Pest Control Products Regulations. Registrants relying on data that supports the re-evaluation or special review would enter into negotiations and, if necessary, arbitration, with the data holder to determine the amount payable to the data holder for reliance on the latter's data. Although the Minister establishes the terms and conditions for the agreement that parties must enter into (i.e., the Agreement for Data Protection under Section 66 of the Pest Control Products Act), PMRA is not involved in the negotiations or arbitrations between registrants regarding compensation.

4. We are not ready to choose any of the three options. Are we required to respond to the data call-in? Is PMRA going to cancel our registrations if we do not select any of the three options?

Registrants are required to respond to the DCI and meet the requirements of the DCI notice within the timeframe indicated in the letter. Failure to meet the requirements of the DCI notice may result in cancellation or amendment of the registration as per paragraph 20(1)(a) of the Pest Control Products Act.

5. Does PMRA allow registrants to generate their own studies when another registrant already has the study required in the data call-in notice? If not, why? And, if yes, what additional time frame is allowed to generate their own data?

Yes, PMRA may allow registrants to generate their own studies to respond to a DCI notice in certain circumstances. However, these studies have to be relevant, of acceptable quality and provided within the time period specified. If the registrant is not able to generate a new study and submit it within the specified time period, the re-evaluation will proceed based on all available relevant information at that time.

While a registrant may wish to submit their own data, they may still be required to rely on, and pay compensation for, any other studies submitted by other registrants that PMRA determines are necessary to support the re-evaluation or special review decision.

All registrations must be supported by relevant health, environmental and value data. To the extent possible, PMRA encourages data reliance over duplication of studies; unnecessary, duplicative animal testing should be avoided. In addition, registrants are permitted to submit the required data jointly as per paragraphs 16(5)(a) and 18(3)(a) of the Pest Control Products Act.

6. Why does PMRA require in the data call-in notice that registrants make a commitment regarding compensation during the re-evaluation or special review when a compensable data list is not issued until a final re-evaluation or special review decision is published?

A DCI issued under subsection 16(3) or 18(1) or paragraph 19(1)(a) of the Pest Control Products Act applies to all registrants subject to the re-evaluation or special review. Paragraph 16(5)(b) or 18(3)(b) of the Pest Control Products Act allows registrants to rely on another registrant's data to fulfill the DCI requirements. When PMRA issues DCI notices during a re-evaluation or special review, PMRA provides all registrants (both data holders and data seekers) with three options to address the data requirements (see Q2 and Q3). It is necessary for all registrants to respond to the DCI by selecting one of the three options to help ensure that PMRA knows whether the data requirements will be satisfied in order for it to properly conduct the review. If a registrant fails to respond to address a DCI, the Minister may cancel or amend the product registration in accordance with paragraph 20(1)(a) of the Pest Control Products Act.

In addition, selecting one of the options in response to a DCI helps to establish a fair and transparent process by ensuring that all registrants are aware of their obligations regarding data requirements and data reliance for the re-evaluation or special review early on. This may also help to facilitate the timely conclusion of negotiation and, if necessary, arbitration once the final re-evaluation or special review decision is published and the list of compensable data is established.

Note that parties may also choose to negotiate access for data reliance independently and outside of the process in the Pest Control Products Regulations, including before a final re-evaluation or special review decision is made (for example, registrants could decide on a cost-sharing approach up-front). As noted above, registrants are also permitted to submit the required data jointly as per paragraphs 16(5)(a) and 18(3)(a) of the Pest Control Products Act.

7. If a registrant determines that the amount of compensation proposed by the data holder is too high, can the registrant choose to withdraw from the negotiation and discontinue their registration at that time, thus avoiding payment of any compensation?

If a product's registration is cancelled by the Minister (including following a request for discontinuation from a registrant) before the final re-evaluation or special review decision is published, then no compensation would be payable in relation to that registration for data used in the final re-evaluation or special review decision. If a data seeker chose to withdraw from negotiations and discontinue their registration (and the registration is cancelled by the Minister) before a final decision is published, then no payment would be required.

However, for products that remain registered at the time that the final re-evaluation or special review decision is published, compensation is payable for any data used in the final decision that supports a data seeker's product registration. This applies even if the data seeker sought to discontinue its product's registration after the date that the final decision is published. If a data seeker chose to withdraw from negotiations and discontinue their registration after a final decision is published, then compensation would still be payable for the duration of the compensable period that their products remain registered (unless the parties agree otherwise) as they are relying on the other registrant's data from the day the final decision is published.

Likewise, compensation is payable where a registrant requests discontinuation of their registration before the final re-evaluation or special review decision is published, if the effective date of the cancellation takes place after the publication of the final re-evaluation or special review decision (such as if there is a phase out periodFootnote 1 for the product). In this situation, compensation is payable for the duration of the compensable period until the completion of the product's cancellation or phase-out period.

However, the amount of compensation payable would be subject to negotiation, and possibly arbitration, by the registrants involved and may take into account any factors that the parties (or the arbitrator, if applicable) consider relevant. PMRA would have no role in those discussions.
PMRA encourages parties to work together at the outset of a re-evaluation or special review to either provide the data jointly or work out any data access and reliance arrangements at that time.

8. If an active ingredient is under both special review and cyclical re-evaluation, what is the data compensation policy for the same studies that are used for both reviews?

Except for certain limited data supporting active ingredients that are not equivalent to the active ingredient under re-evaluation or special review, data is eligible for compensable protection when it is called in and used by the Minister for the first time. For example, if the data is used in a final special review decision first, then the data is protected following that decision. For a subsequent re-evaluation, if the same data is used for the same active ingredient, it does not receive protection for that review as it is considered data on hand for that subsequent review.

9. Why do registrants need to compensate for the same data in multiple international jurisdictions?

Each country is subject to its own domestic data protection laws. The Pest Control Product Regulations on data protection requirements operate independently from other jurisdictions.

The Pest Control Products Regulations requires registrants to compensate for access to compensable data. The amount of compensation payable is subject to negotiation, and possibly arbitration, by the registrants involved and may take into account any factors that the parties (or arbitrator, if applicable) consider relevant.

Footnotes

Footnote 1

See Regulatory Directive, DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review for more information on phase-outs: https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines.html

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