The PMRA Has Provided Clarity For Data Compensation In The Re-Evaluation And Special Review Contexts

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On June 7, 2023, Health Canada's Pest Management Regulatory Agency (PMRA) published the Regulations Amending the Pest Control Products Regulations (exclusive rights and compensable data)...
Canada Food, Drugs, Healthcare, Life Sciences
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On June 7, 2023, Health Canada's Pest Management Regulatory Agency (PMRA) published the Regulations Amending the Pest Control Products Regulations (exclusive rights and compensable data) in the Canada Gazette Part II. These amendments are aimed at providing clarity with respect to the process to be followed for reliance on data during post-market reviews of pest control products in Canada. They are to come into force 180 days after publication or December 4, 2023.

The Registration and Re-Evaluation/Special Review Processes

Pesticides are regulated in Canada by the PMRA under the Pest Control Products Act, SO 2002 (PCPA). Before a pest control product can be approved for use and marketed in Canada, it must be registered or otherwise authorized under the PCPA. The PMRA considers the data submitted by an applicant as part of its pre-market, science-based assessment to determine if the risks to human health and the environment are acceptable and the products have acceptable value.

Once a pest control product is registered for use in Canada, it becomes subject to several post-market risk management controls under the PCPA, which include re-evaluations and special reviews. Under the PCPA, registered pest control products are generally re-evaluated on a 15-year cycle to ensure that they continue to meet current health and environmental standards and continue to have value. Unlike re-evaluations, special reviews have narrower scopes, and they may be triggered when the Minister has reasonable grounds to believe that health or environmental risks of the pest control product, or its value, are unacceptable. In either a re-evaluation or special review, the Minister can decide to continue the registration as is, modify it (e.g., by establishing measures to mitigate risks), or cancel it. PMRA publishes its proposed decision document respecting a post-market review for consultation followed by a final decision document.

To verify the continued acceptability of the registration of a pest control product, the Minister may specify that additional data is required for the review that is being undertaken. During these pre-market or post-market processes, the applicant or registrant may submit data to support the registration or continued registration of the pest control product or may choose to pay compensation to use or rely on the data submitted by others.

The Amendments

The PCPA and the Pest Control Products Regulations, SOR/2006-124 (PCPR) set out how the amount of compensation payable for reliance on another registrant's data is to be determined. Although section 17.3 of the PCPR indicates that the pre-market data compensation process applies "with any necessary modifications, to a registrant who wishes to use or rely on test data of another registrant" in the context of re-evaluations or special reviews, the PMRA learned through stakeholder consultations that these provisions were neither comprehensive nor clear, prompting the PMRA to seek to provide clarity. The PMRA undertook consultations, beginning in 2018 and again following publication in the Canada Gazette Part I on June 11, 2022. It also published a proposed Agreement for Exclusive Rights and Compensable Data under section 66 of the PCPA for Re-evaluations and Special Reviews on July 26, 2022, and held a stakeholder session to discuss these changes. The PMRA acknowledged the input from stakeholders that the current data compensation provisions of the PCPR lack specificity regarding the reliance on data that are part of re-evaluations and special reviews.

Instead of adding sections to address these scenarios to the existing provisions of the PCPR, which came into force in June 2010, the PMRA decided to amend the entire section of the regulations relating to data compensation, permitting it to make minor technical amendments "to bring further clarity to the existing data compensation provisions"and to comprehensively address data compensation in re-evaluation and special review situations.

Key Provisions and Considerations

Once the new regulations are in force, either the registrant wishing to rely on the data holder's data that has been submitted as part of the re-evaluation or special review or the data holder themselves will need to deliver an Agreement for Exclusive Rights and Compensable Data under section 66 of the PCPA for Re-evaluations and Special Reviews to the other registrant no later than 60 days after the day on which the final decision document is made public by the PMRA. The PMRA will be publishing this Agreement on its website.

The Minister will create a list of the data in respect of which compensation may be payable arising out of the re-evaluation or special review at the time it makes the final decision public. This list, to be made available to data holders and other registrants, can include data that was called in by the Minister for the re-evaluation or special review under subsections 16(3), 18(1), or 19(1) of the PCPA and data that was already on hand and relevant to a non-equivalent active ingredient if the latter was considered in support of a previous pre- or post-market review. Several stakeholders identified the need to have an opportunity for input and review of the list of data for which compensation may be payable prior to it being made available for parties to commence negotiations. The PMRA has indicated that it is working on guidelines for the establishment of the list of data for which compensation may be payable, although no time frame has been set for these to be released.

Once the list of data has been finalized, the parties would then follow the same process as is in place for the application to register a pest control product, namely, a 120-day negotiation period and, if no settlement is reached, a 120-day final-offer arbitration process. Registrants of pest control products will want to be mindful of the timing of the publication of final re-evaluation or special review decision documents given that it is this date which triggers the 60-day window to deliver a section 66 Data Protection Agreement.

At the time a registrant renews its registration, it will be required to provide proof of its right to rely on the data holder's data, or evidence to support that the data compensation process is underway.

While some stakeholders sought to have the new regulations have retroactive effect to August 2007 when the data compensation process was first included in PMRA guidance, this suggestion was rejected. For special reviews or re-evaluations, the transition clauses provide that the current regulations will apply to test data received as part of one of those processes if the final decision document has been made public as at the date the new regulations come into force. If no final decision has been made public when the regulations come into force, the new regulations will apply.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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