Discussion Document DIS2012-01, Reliance on Proprietary Data for the Purpose of Re-evaluation and Special Review

Pest Management Regulatory Agency
30 November 2012
ISSN: 1929-4840 (PDF version)
Catalogue number: H113-3//2012-1E-PDF (PDF version)

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Table of Contents

• 1.0 Introduction
• 2.0 Purpose
• 3.0 Identification of Data On-hand and Data Gaps during Re-evaluation or Special Review
• 4.0 Data Specific to the Active Ingredient under Re-evaluation or Special Review
• 5.0 Proposal for Data Applicable to More Than One Active Ingredient
• 6.0 Data Compensation where Registrations or Uses Are Cancelled
• 7.0 Proposed Protection of Data Supporting Foreign Reviews
• 8.0 New Registrants during a Re-evaluation or Special Review
• 9.0 Responsibilities Post Re-evaluation or Special Review Decision
• 10.0 Ministerial Agreement
• 11.0 Application

1.0 Introduction

The Minister's primary objective in the administration of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. In support of this objective the Pest Control Products Act provides authority to be used at the Minister's discretion to conduct a re-evaluation or special review of registered pesticides. The purpose of a re-evaluation or special review is to confirm the continued acceptability of an active ingredient (and the associated end use products) for a given use pattern in light of advances in regulatory science or new scientific information. Following a re-evaluation or special review decision, any changes to an approved pesticide label beyond those required by the Minister to address health or environmental concerns (for example, the expansion of a use pattern) require an application, supported by appropriate data, to amend the registration.

The data protection provisions of the Pest Control Products Regulations apply to test data submitted to support a registration or the amendment of a registration of a pest control product. The data protection provisions also apply to data submitted in response to a data call-in and which is subsequently used by the Minister to support a re-evaluation or special review regulatory decision. The data protection provisions do not automatically apply to data on-hand used to support a re-evaluation or special review decision.

Section 17.3 of the Pest Control Products Regulations allows for the regulations to be applied with modifications to accommodate re-evaluations and special reviews. This document proposes to clarify how the data protection provisions apply to re-evaluations and special reviews.

2.0 Purpose

This document is intended to provide stakeholders an opportunity to comment on the proposed application of the data protection provisions of the Pest Control Products Regulations for re-evaluations and special reviews.

3.0 Identification of Data On-hand and Data Gaps during Re-evaluation or Special Review

During a re-evaluation or special review the Minister identifies any data on-hand which may be relevant to determining the continued acceptability of the active ingredient in question. This includes proprietary test data in the Minister's possession that may be:

• under compensable or exclusive protection status,
• submitted to support an application actively under evaluation,
• submitted in response to a notice under subsection 16(3), 18(1), or 19(1) of the Pest Control Products Act,
• submitted with an incident report,
• submitted previously but not used to support a regulatory decision,
• owned by multiple registrants, or
• foreign test data.

Following the review of any data on-hand the Minister determines whether "data gaps" exist and whether a data call-in is necessary to address those gaps. The Minister initiates a re-evaluation or a special review by delivering a written notice to registrants in accordance with sections 16(3) or 18(1) of the Pest Control Products Act, obliging registrants to provide any required data (data call-in); foreign test data is only requested as required. All proprietary data that registrants provide in response to a call-in is compensable if used by the Minister. Compensation for the data provided in response to a call-in is determined after the re-evaluation or special review decision is completed, and is determined through negotiation or arbitration between the applicant and the data owner.

4.0 Data Specific to the Active Ingredient under Re-evaluation or Special Review

Data specific to the active ingredient under re-evaluation or special review, submitted in response to a notice under sections 16(3), 18(1), or 19(1) of the Pest Control Products Act, and which is used to support a regulatory decision receives twelve years of compensable protection status, starting the date that the Minister receives the data.

Any data on-hand previously submitted for the active ingredient that is the subject of the re-evaluation or special review, including foreign test data, may be used by the Minister without consideration for compensation.

5.0 Proposal for Data Applicable to More Than One Active Ingredient

Data gaps may be addressed by data which is applicable to more than one active ingredient (for example, exposure data). This data may:

• Have not been previously used to support a regulatory decision; or
• Have been previously used to support another active ingredient and still under protection status (for example, either exclusive or compensable).

The PMRA proposes that compensation be payable as per the Pest Control Products Regulations, where registrants without access choose to rely on data applicable to more than one active ingredient for the purposes of re-evaluation or special review. This proposal recognizes the significant investments made by data generators and the importance of this data to re-evaluation and special review decisions. The proposal is intended to encourage the continued submission of data applicable to more than one active ingredient.

The notice requesting information from registrants to fill data gaps would include information about any known sources of applicable data (including information which is applicable to more than one active ingredient, such as task force data) so that registrants involved in re-evaluations or special reviews may seek to demonstrate access to it in advance of a potential regulatory decision.

Registrants indicating that they wish to rely on data which is applicable to more than one active ingredient, and has been identified by the Minister in support of their re-evaluation or special review decision may be subject to any or all of these situations:

• If it is the first time that the data is used to support a regulatory decision,^{Footnote 1} the Minister would grant 12 years of compensable status starting on the date that at least one registrant involved in the re-evaluation or special review indicates that they wish to rely on that data.
• If the data is under exclusive protection status for an active ingredient in accordance with section 17.5 of the Pest Control Products Regulations, the data would also be granted compensable status in relation to other active ingredients for the remaining duration of the exclusive period (i.e. 10 to 15 years).
• If the data is under compensable protection status in relation to another active ingredient, it would be compensable for the remaining duration of that original compensable period.

6.0 Data Compensation where Registrations or Uses Are Cancelled

If registration is cancelled under section 21(1) (b) of the Pest Control Products Act following a re-evaluation or special review, then registrants that produced the required data may not be able to seek compensation. If only certain uses are cancelled, then registrants relying on data called in and submitted by another registrant may be required to compensate the data owner.

7.0 Proposed Protection of Data Supporting Foreign Reviews

In the course of a re-evaluation or special review, the Minister may consider foreign regulatory decisions and/or the test data used to support it. For the purpose of a re-evaluation or special review, foreign regulatory decisions would not be compensable for participating registrants. Following a decision, however, data which supports foreign reviews will be compensable only if the data was generated no more than 15 years prior to the initiation of the Canadian re-evaluation or special review. Lists of compensable studies will be generated in accordance with this principle. This policy is intended to limit compensation to data submitted in response to data call-ins which support foreign regulatory decisions.

8.0 New Registrants during a Re-evaluation or Special Review

A company which is granted registration of an active ingredient which is under re-evaluation or special review becomes subject (along with other affected registrants) to any notice requesting information under sections 16, 18, and 19 of the Pest Control Products Act.

9.0 Responsibilities Post Re-evaluation or Special Review Decision

The process to determine compensation payable for the called in or on-hand test data can only begin once a re-evaluation or special review decision by the Minister has been made. Therefore, after the final decision, the Pest Management Regulatory Agency will send a letter to all relevant registrants identifying the data that requires compensation, the registrant(s) who provided the data, and the registrants relying on it. The registrant(s) that provided the data may send the Ministerial Agreement to the other registrant(s) to formally begin the negotiations. The process to obtain a letter of access will be the same as described in Section 5.0 of Regulatory Directive DIR2010-04, Guidelines for Reliance on Proprietary Data under the Pest Control Products Regulations. Failure to produce a letter of access could result in the product not being renewed. The data owner may choose to apply section 17 of Pest Control Products Regulations for the negotiation and/or arbitration process.

The registrant that wishes to rely on another registrants' data to continue their registration(s) following the re-evaluation or special review decision, would be treated as the "applicant" under the data protection provisions of the Pest Control Products Regulations for the reliance on that compensable data.

An applicant seeking registration of an active ingredient and/or an end-use product following the completion of a re-evaluation or special review decision must satisfy all current scientific requirements and may seek to demonstrate access to data on the compensable data list, if applicable.

10.0 Ministerial Agreement

Following this consultation, the Ministerial Agreement may be revised to reflect re-evaluation or special review situations, depending on the outcomes of this consultation.

11.0 Application

This policy is proposed to come into effect for any re-evaluations or special reviews initiated after 1 April 2010. For applications to register products or amend registrations, this policy is proposed to come into to effect on the date that the finalized policy document is published.