Pest Control Products Regulations (SOR/2006-124)

Re-evaluations and Special Reviews

Marginal note:Additional information — affidavit and contents

• 17 (1) When, in the context of a re-evaluation or special review, the Minister considers additional information under paragraph 19(1)(c) of the Act that is not publicly available, the registrant must be given access to that information by the Minister for the purpose of making representations under that paragraph with respect to the information, if the registrant submits to the Minister an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits that

  • (a) identifies the information to which access is being requested;

  • (b) acknowledges that the access is given only for the purpose of enabling the registrant to make representations to the Minister with respect to the information;

  • (c) states that the registrant will not use the information or make it available to any person for any other purpose; and

  • (d) states that the information and any copies of it will be returned to the Minister when the stated purpose has been achieved.

• Marginal note:Copying or other use

  (2) The registrant to whom access to additional information is given under subsection (1) must not use the information or provide it to any person for any purpose other than to make representations under paragraph 19(1)(c) of the Act with respect to the information.

• Marginal note:Return of information

  (3) Additional information to which access is given under subsection (1) and any copies of it must be returned to the Minister by the registrant immediately after they have made their representations with respect to the information.

Protection of Test Data

Definitions

Marginal note:Definitions

17.01 The following definitions apply in this section and sections 17.02 to 17.17.

agreement

agreement means an agreement referred to in subsection 66(1) of the Act. (entente)

compensable data

compensable data means test data that the Minister considers for the first time in support of a registration, confirmation of the registration or amendment of the registration, but does not include

• (a) test data that is referred to in the definition exclusive rights;

• (b) test data that is included in a scientific study that has been published; or

• (c) test data that is generated by a scientific study that is fully funded by a government or one of its institutions. (données assujetties à des droits à payer)

crop group

crop group means a group of crops in which the residues at harvest are similar, based on similarities in appearance, harvestable commodity, edible portions and growth habits. (groupe de cultures)

data holder

data holder means a registrant to whom compensation may be payable in respect of test data. (détenteur de données)

exclusive rights

exclusive rights means the exclusive rights to use or rely on any of the following test data that the Minister considers for the first time in support of a registration:

• (a) test data that the applicant provides in support of an application to register a new active ingredient;

• (b) test data that the applicant provides in support of a concurrent application to register a new pest control product that contains the new active ingredient referred to in paragraph (a); or

• (c) test data that the applicant provides in support of an application to register a new compound or substance referred to in paragraph 2(b), if the compound or substance has never been an ingredient in a registered pest control product. (droits exclusifs)

minor use

minor use, in respect of a pest control product, means a use the demand for which originates with a grower or a group of growers and which product is intended to be used on a particular pest in connection with a particular host organism, in all of the following circumstances:

• (a) the use is for an agricultural purpose;

• (b) the use is supported by a federal or provincial agricultural authority;

• (c) the use is supported by crop residue data or dislodgeable foliar residue data. (usage limité)

representative crop

representative crop means a crop in a crop group from which extrapolations of residue levels and maximum residue limits may be made to one or more crops in the group. (culture répresentative)

test data

test data means test data that is provided to the Minister

• (a) in support of an application to register a pest control product or to amend a registration made under section 7 of the Act, or

• (b) in the context of a re-evaluation or special review, in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act. (données d’essai)

Application

Marginal note:Non-application — product copies

17.02 When an applicant wishes to use or rely on the test data of a registrant in order to register a pest control product that is equivalent to the registrant’s product by using an active ingredient provided by the registrant, sections 17.03 to 17.11 do not apply if

• (a) the registrant provides the Minister with a letter, signed by the registrant, that specifies the active ingredient that they agree to provide to the applicant; and

• (b) the only active ingredient used in the manufacture of the applicant’s pest control product is the one provided by the registrant.

Exclusive Rights

Marginal note:Period — general

• 17.03 (1) A registrant has exclusive rights for 10 years after the date of registration of the new active ingredient, of the new pest control product that contains the new active ingredient or of the new compound or substance.

• Marginal note:Extension — minor uses

  (2) The Minister must extend the period of exclusive rights if all of the following conditions are met:

  • (a) the registrant meets one of the following requirements:

    • (i) they proposed a minor use in the concurrent application to register a new pest control product referred to in paragraph (b) of the definition exclusive rights in section 17.01, or

    • (ii) they made one of the following applications within seven years after the date of registration of the product referred to in subparagraph (i):

      • (A) an application to amend its registration by adding a minor use, or

      • (B) an application to register another new pest control product that contains the same active ingredient as the product and in respect of which a minor use is proposed;

  • (b) the registrant requests an extension of the period of exclusive rights, within eight years after the date of registration of the new active ingredient referred to in paragraph (a) of the definition exclusive rights in section 17.01;

  • (c) the Minister determines that the proposed minor use is a minor use and approves its addition to the registration of the product referred to in subparagraph (a)(i) or the other new pest control product referred to in clause (a)(ii)(B).

• Marginal note:Calculation of extension

  (3) The Minister must apply the following rules when calculating an extension:

  • (a) the period of exclusive rights is extended by one year for every three minor uses that are added, whether one or more at a time, to the registration for a total period of exclusive rights of 15 years; and

  • (b) the maximum number of minor uses in respect of a crop group is the number of representative crops in the crop group.

• Marginal note:When minor use removed

  (4) The Minister must cancel any extension of one year if

  • (a) the Minister, on his or her own initiative or in response to a request from the registrant, amends the registration and removes one or more minor uses; and

  • (b) the remaining number of minor uses is insufficient to uphold the extension.

Marginal note:Consent

17.04 Subject to paragraph 17.05(1)(b), during the period of exclusive rights an applicant may use or rely on a registrant’s test data in an application to register a pest control product or amend a registration if the registrant provides the applicant with written consent to use or rely on the test data.

Compensation Payable

Registration

Marginal note:Conditions — use of or reliance on test data

• 17.05 (1) Subject to subsection 17.1(2), an applicant who makes an application to register a pest control product or to amend a registration may, in accordance with the agreement concluded with the data holder under subsection 17.07(2), use or rely on the following test data if they pay compensation to the data holder in accordance with the negotiated settlement or arbitral award for the period provided for in subsection (2) and if the applicant provides the Minister with a copy of a letter of access:

  • (a) compensable data that the applicant wishes to use or rely on;

  • (b) test data for which the data holder has exclusive rights, if the test data is relevant to the pest control product of the data holder and the test data is relevant to an active ingredient that is not equivalent to the active ingredient contained in the applicant’s pest control product; and

  • (c) test data that was considered during an evaluation or review of a pest control product by a foreign regulatory authority and that the data holder has not previously provided to the Minister, if the following conditions are met:

    • (i) the Minister has considered for the first time the decision that results from the evaluation or review of the pest control product by the foreign regulatory authority in support of the re-evaluation or special review decision of the data holder’s pest control product,

    • (ii) the Minister requests that the data holder provide the Minister with the following in the form and manner directed by the Minister:

      • (A) documents demonstrating that the test data was provided to the foreign regulatory authority in support of the evaluation or review of the pest control product, or in response to a request from the foreign regulatory authority relating to the evaluation or review,

      • (B) documents demonstrating that the foreign regulatory authority considered the test data in support of its decision of the evaluation or review, and

      • (C) the test data, and

    • (iii) the data holder complies with the request.

• Marginal note:Compensable period

  (2) The period for which compensation is payable by the applicant to the data holder commences on one of the following days and must not exceed 12 years, except in the case of the test data referred to in paragraph (d) for which the period must not exceed the period set out in section 17.03:

  • (a) in the case of compensable data in support of an application to register a pest control product of the data holder, the day on which the Minister receives the application;

  • (b) in the case of compensable data in support of an application to amend the registration of a pest control product of the data holder, the day on which the Minister receives the application;

  • (c) in the case of compensable data that is considered by the Minister during a re-evaluation or special review of a pest control product of the data holder, if the test data was provided by the data holder in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act, the day on which the Minister receives the data;

  • (d) in the case of test data referred to in paragraph (1)(b), the day of registration referred to in subsection 17.03(1); or

  • (e) in the case of test data referred to in paragraph (1)(c), the day on which the Minister initiates the re-evaluation or special review.

Marginal note:Minister to identify test data

17.06 For the purpose of subsection 7(2) of the Act, the Minister must provide the applicant with a list of the test data referred to in subsection 17.05(1) for which compensation may be payable by the applicant and in respect of which an agreement is required to be entered into between the applicant and each data holder whose data the applicant wishes to use or rely on.

Marginal note:Proposed agreement on test data

• 17.07 (1) On receipt of the list of test data, an applicant may deliver to each data holder a proposed agreement that specifies the test data that the applicant wishes to use or rely on.

• Marginal note:Agreement entered into

  (2) On receipt of the proposed agreement, the data holder must enter into the agreement with the applicant.

Marginal note:Negotiation of compensation payable and settlement

• 17.08 (1) When the agreement is entered into, an applicant and a data holder must, in order to reach a settlement, begin to negotiate the compensation payable in respect of the test data that the applicant wishes to use or rely on.

• Marginal note:Period of negotiation and settlement of compensation payable

  (2) The applicant and the data holder must reach a negotiated settlement in respect of the compensation payable

  • (a) within 120 days after the day on which the data holder receives the proposed agreement; or

  • (b) by the end of any additional negotiation period, if the parties agree in writing to continue negotiating.

Marginal note:Arbitration

• 17.09 (1) Despite subsection 17.08(2), in the absence of a negotiated settlement at the end of the negotiation and in accordance with the agreement entered into by the parties, the applicant may, by delivering to the data holder a written notice, submit the determination of the compensation payable to binding arbitration.

• Marginal note:Notice

  (2) The notice must contain the last offers of the applicant and the data holder, if they were presented in writing at the end of the negotiation.

• Marginal note:Arbitral award

  (3) The arbitrator must make an arbitral award within 120 days after the day on which the notice is delivered, unless

  • (a) the parties agree to an extension before the end of that period and provide written notice to the arbitrator; or

  • (b) the arbitrator provides written notice of an extension to the parties before the end of that period.