Data Protection Submission Review Process

Table of Contents

• Purpose
• Background
• Changes to the Data Protection Submission Review Process
• Implementation
• Effective Date
• Questions
• Appendix 1 - Data Protection Submission Review Process
• Appendix 2 - Eligibility Criteria for Compensable Protection Status
• Appendix 3 - Eligibility Criteria for Compensable Protection Status for Foreign Test Data

Purpose

The purpose of this communication is to outline changes to the data protection submission review process.

Background

The data protection provisions (section 17) of the Pest Control Products Regulations (PCPR) came into force on June 3, 2010. The objectives of these regulations are to encourage the registration of new innovative pesticides; facilitate timely entry of competitively priced generic pesticides; and, ultimately benefit pesticide users.

The data protection process is reflective of the regulations and involves the following phases:

1. Equivalency Assessment + Data Compensation Assessment
2. Negotiation (between applicant and registrant)
3. Regulatory Decision

Challenges have been encountered with the current application process. These include the complexity of the data compensation assessments and in the tracking and reporting of data protection applications. These challenges have necessitated the need to make revisions to the current process.

An overview of the amended data protection submission review process is found in Appendix 1.

Changes to the Data Protection Submission Review Process

Changes are being made in the following areas:

• Application management
• Generation of the initial data compensation list
• Applicant review of data compensation list
• Format of final data compensation list

The objectives of the changes to the submission review process are to:

• Make the submission review process more transparent and predictable
• Streamline the data compensation assessment
• Resolve some of the operational challenges identified, to date, in processing these applications
• Allow more accurate tracking and reporting on performance

1. Management of the Applications

The first change will be to close the application after the equivalency and data compensation assessments are finalized by the PMRA (i.e, Phase 1). Once access to the compensable data has been obtained by the applicant, a separate application will be required to be submitted for the regulatory decision.

This change is being made to allow for accurate tracking of data protection applications and workload; to clearly distinguish between Pest Management Regulatory Agency (PMRA) and Applicant/Registrant activities; and, to add transparency in the process regarding regulatory decisions. The PMRA will be withdrawing the applications which are currently at a stage where negotiations can be initiated by the applicant. In other words, the equivalency and data compensation assessments have been finalized and a letter outlining this decision has been sent to the applicant.

2. Generation of the Initial Data Compensation List

Upon notification from PMRA, the registrant will be required to provide the PMRA with a listing of data eligible for compensation for a cited precedent(s). The registrant will have 45 days to submit this list to the PMRA. An explanation as to why the data should be considered as compensable should be provided with the response. A listing of the eligibility criteria for compensable protection is outlined in Appendix 2. If a response is not received in this timeframe, the PMRA will proceed as if the data base is generic.

2.1 Generation of the Initial Data Compensation List - Foreign Test Data

The registrant will need to identify all relevant foreign test data in their initial data compensation list. When compensability is being claimed for foreign test data, the registrant must submit the data with the response. If a registrant is unable to provide a study, it will not be eligible for compensable protection and will not be included in the final data compensation list. The eligibility criteria for compensable protection for foreign test data can be found in Appendix 3. The foreign test data is being requested at this stage to ensure that the compensability of this data is determined prior to the completion of the data compensation assessment.

3. Applicant Review of Data Compensation List

Applicants will be provided with a 45 day period to review the data identified as being compensable in the assessment. The applicant can provide written comments on the list. The scope of the comments will be limited to the following:

• Confirmation that the data was used in the review
• Clarification on the uses which the data support

This change is being implemented to add transparency to the data compensation assessment process. Specifically, to increase the understanding of decisions related to compensable protection. As well as providing information to assist in subsequent business decisions.

4. Format of Final Data Compensation List

The final data compensation list will be amended to include the report number, report date and purpose of the study. In providing additional details regarding the compensable data, the PMRA hopes to address some of the issues identified in recent consultations held between the PMRA and stakeholders.

Implementation

The PMRA will be withdrawing the applications which are currently at a stage where negotiations can be initiated by the applicant. In other words, the equivalency and data compensation assessments have been finalized and a letter outlining this decision has been sent to the applicant. A separate application must be submitted to obtain a regulatory decision.

Effective Date

These changes will come into effect on the date that this document is published.

Questions

Any questions on the new process should be directed to the PMRA Information Service.

Appendix 1 - Data Protection Submission Review Process

Phase 1 - Data Compensation Assessment

a. Performance Standard

The overall review time will be 365 days

b. Submission Review Process

The data compensation assessment will follow the steps outlined below.

Step 1 - Initial Data Compensation List

Upon receipt of a data protection application, the PMRA will contact the registrant(s) of the precedent product(s). The registrant is to provide the PMRA with a listing of data eligible for compensation for the cited precedent(s). The registrant will have 45 days to submit this list to the PMRA. An explanation as to why the data should be considered as compensable should be provided with the response. When compensability is being claimed for foreign test data, the registrant must submit the data with this response. If a response is not received in this timeframe, the PMRA will proceed as if the data base is generic.

Step 2 - Data Compensation Assessment

The PMRA will analyse the submitted Initial Data Compensation List following the eligibility criteria for compensable protection listed in Appendix 2 - Eligibility Criteria for Compensable Protection Status. The PMRA will identify the data eligible for compensable protection along with the data not meeting the eligibility criteria.

Step 3 - Appeal Process

Step 3a - Registrant

The registrant will be provided with a 45 day period to review the PMRA's data compensation assessment. The registrant can submit a written appeal of this assessment. The written appeals must provide proof explaining how the data identified meets the criteria for compensation protection. If a response is not received in this timeframe, the PMRA will proceed according to results of the data compensation assessment.

Step 3b - Applicant

The applicant will be provided with a 45 day period to review the data identified as being compensable in the assessment. The applicant can provide written comments on the list. However, the scope of the comments will be limited to the following:

• Confirmation that the data was used in the review
• Clarification on the uses which the data support

The purpose of the data compensation assessment is to determine if the data was used to support a regulatory decision. It is not an opportunity to question why certain data were used by the PMRA. Opportunities to comment on the science decisions are available during the consultation process for a number of PMRA regulatory decisions (e.g., re-evaluations, special reviews, major new uses).

Step 4 - Appeal Assessment

Step 4a - Appeal from Registrant

The PMRA will consider the written comments provided by the registrants and make a final decision.

Step 4b - Appeal from Applicant

The PMRA will consider the written comments provided by the applicant and make a final decision. In cases where the selective approach is requested by the applicant, the applicant will need to submit a revised label with its response and specify the uses which are being removed from the label. The amended use pattern will be taken into consideration in the finalization of the data compensation assessment.

Step 5 - Final Data Compensation List

After reviewing both the applicant's and registrant's responses, the data compensation assessment will be finalized by the PMRA. Once equivalency has been established, both the applicant and the registrant will receive the following:

• Letter providing the outcome of the data compensation decision
• Final data compensation list
• Applicant's proposed label

Step 6 - Closure of the Application

After the equivalency and data compensation assessments are finalized by the PMRA, the application will be closed. The application will be closed regardless of whether the data compensation assessment identifies compensable data or whether the data base is generic.

Phase 2 - Negotiation and Arbitration

a. Ministerial Agreement

The PMRA will send a letter to both the registrant and the applicant to indicate that equivalency has been established and to provide the list of protected data. In order to initiate the negotiation process under the PCPR, the applicant must send to the registrant(s) a signed copy of the Ministerial Agreement by a means that provides proof of delivery. The Ministerial Agreement can be found on Health Canada's website.

b. Negotiation

Applicant and registrant(s) will have 120 days to complete negotiations as per the PCPR unless the parties agree otherwise. The PMRA will not be a party to the negotiation process. The result could be a negotiated agreement and a Letter of Access (LOA), or a request to go to binding arbitration. The applicant may also decide to withdraw from the process.

c. Early registration

The PCPR allows for an early registration provided certain conditions are met. In order to consider registration, the applicant must demonstrate that these conditions have been met or that the circumstances described in section 17.92 of the PCPR exist.

d. Binding arbitration

In cases where an agreement could not be obtained during the 120-day mandatory negotiation process, the applicant can request binding arbitration as per the PCPR. The PMRA will not be a party to the arbitration process. The result could be a negotiated settlement or an arbitral award both of which leading to a LOA to the data being relied upon. The applicant may also decide to withdraw the application.

e. Letter of access to Data

Once a negotiated settlement has been reached or an arbitral award has been rendered, the registrant must provide to the applicant an LOA allowing the applicant to rely on the data identified in Appendix A of the ministerial agreement as listed by the Minister. Otherwise, section 17.94(2) of the PCPR may apply. The LOA should be prepared based on the template in Appendix II. An LOA must have no limitation other than a limitation on the period of validity where payments are still outstanding as per the settlement or award. The PMRA will not proceed with the registration until an acceptable letter is submitted. For example, limitations on the uses of data to which the applicant has gained access would not be acceptable. This does not prevent applicants and registrants to make other arrangements but the PMRA will not enforce a business agreement on behalf of the companies. It will be up to the parties to monitor and enforce compliance of these agreements.

Phase 3 - Regulatory Decision

a. Performance Standard

The overall review time will be 45 days

b. Application Requirements

An application to register or amend a generic product requires the following:

• Cover letter: contains both the purpose of the application and the submission number of the Phase 1 - Equivalency Assessment and Data Compensation Analysis application.
• Application form (6005)
• Fee Form (6011) and appropriate fees
• Statement of Product Specification Form (SPSF)
• Text label (English and French)
• e-index in XML format
• Copy of LOA(s)

c. Phase 3 - Review Process

Step 1 - Screening

The PMRA will screen the application to ensure all of the required elements have been submitted and are of acceptable quality

Step 2 - Review

The PMRA will review the submitted SPSF and label to ensure that they are the same as those approved in the Phase 1 application. The LOA will also be reviewed to ensure its acceptability.

Step 3 - Regulatory Decision

Once the PMRA has completed its review as outlined in Step 2-Review, a regulatory decision will be made for this application. The applicant will receive a decision letter, approved bilingual label and the certificate of registration.

Appendix 2 - Eligibility Criteria for Compensable Protection Status

Eligibility criteria for compensable protection status

Section 17 of the PCPR outlines the test data which is eligible for compensable protection:

• Test data used in support of a regulatory decision for a new or amended registration under a pest control product or to amend a registration under section 7 or 12 of the Act;
• In response to a notice delivered to the registrant under subsection 16(3), 18(1) or 19(1) of the Pest Control Products Act; or
• In support of a registration before June 28, 2006

The following data are not eligible for protection:

• data summaries
• waivers/scientific rationales
• data that are in the public domain (e.g. data published in the open literature)
• data that is fully funded by a government or one of its institutions
• data that the PMRA deemed to be invalid for regulatory purposes
• data not considered in the registration decision
• data in support of an application that were received by the PMRA outside the protection period assigned to test data

Appendix 3 - Eligibility Criteria for Compensable Protection Status for Foreign Test Data

Compensable protection will be granted to foreign test data if the following conditions are met:

• Foreign review supports a PMRA decision
• Data, underlying the foreign review, is considered relevant to the Canadian re-evaluation decision
• This data not previously been submitted and used by the PMRA to support a regulatory decision
• Foreign test data is submitted to the PMRA upon request

The above eligibility criteria for foreign test data are currently being reviewed under DIS2012-01: Reliance on Proprietary Data for the Purpose of Re-evaluation and Special Review. If changes are made to the eligibility criteria, they will be reflected in the data compensation assessments.