18 December 2009

Table of Contents

• Foreword
• How data is protected
  • What is protected
    • 1. What data can be considered for protection?
    • 2. What data receives exclusive use protection status and what does it mean?
    • 3. What data receives compensable use protection status?
    • 4. What is the relationship between patents and pesticide data protection?
    • 5. Can an applicant rely on data without compensating once all protection has expired?
  • Re-evaluation
    • 6. What information used for purposes of a re-evaluation or special review is given compensable protection?
    • 7. What registrants are required to produce data if more is required for a re-evaluation or special review?
  • Minor uses
    • 8. What uses can be considered as "minor uses"?
    • 9. What is a federal or provincial agricultural authority?
    • 10. What is considered "a use the demand for which originates with a grower or a group of growers"?
    • 11. What are the requirements to extend the exclusivity period based on minor uses?
• How to obtain registrations relying on compensable data
  • General
    • 12. How are applications to register generic products processed?
    • 13. Can one apply to register a generic product before the exclusive protection expires?
    • 14. What are the equivalency criteria?
  • Required Data
    • 15. Will a list of all the studies and their protection status be available on Health Canada's website?
    • 16. Can applicants rely, fully or in part, on their own studies instead of on other registrants' data?
    • 17. When applying to register a generic product with fewer uses than the registrant's current database supports, what is compensable?
    • 18. What is the process to establish the list of compensable data?
  • Negotiation / Arbitration
    • 19. What is the Ministerial Agreement?
    • 20. Can one skip negotiations and go straight to arbitration?
    • 21. If there are multiple data owners, who does the applicant enter into an Agreement with?
  • Registration
    • 22. Are there circumstances when an early registration can be granted before the compensation payable has been determined?
    • 23. What if a letter of access is not provided?
    • 24. What if the generic registrant does not respect the set payment schedule?
    • 25. Is a letter of access needed if I have a letter of confirmation of source from the registrant of the product I am copying?

Foreword

These questions and answers are to provide further clarity on the Health Canada Pest Management Regulatory Agency (PMRA)'s intent for the implementation of the proposed data protection regulations (Regulations Amending the Pest Control Products Regulations) that were pre-published in the  Canada Gazette, Part I, on November 14, 2009.

Please forward written comments on the proposed Agreement to Regulatory Affairs by January 29, 2010.

How data is protected

What is protected

1. What data can be considered for protection?

Only test data, as defined in the Pest Control Products Act (PCPA) and hereafter referred as "data", can be considered for protection. Data must have been used by the Minister to support a registration or an amendment, or be provided in response to a notice delivered under sections 12, and subsections 16(3), 18(1), or 19(1) of the PCPA to be considered for protection. Waivers, scientific rationales, public data, and data generated by government are not eligible for protection.

Foreign data the Minister considers in the course of a re-evaluation or special review, including those used by the United States Environmental Protection Agency in a Re-evaluation Decision (RED), can be protected providing it is relevant to Canada and that the registrant is able to provide the data on request by PMRA.

The data that supports a registration made under section 2(b) of the Pest Control Product Regulations (PCPR) of a pesticide compound or substance that is not an active ingredient (e.g., safeners) can also be protected.

2. What data receives exclusive use protection status and what does it mean?

To receive the 10 year exclusive use protection period, the data must support the registration of a new active ingredient and associated pest control products in Canada and must have been used for the first time. This data includes information provided in response to a notice issued under section 12 of the Act for that first registration of the pest control product. A new active ingredient is one that has never been registered as a pest control product in Canada before, even if it has been registered in another country. Applicants cannot rely on exclusively protected data unless the registrant willingly provides a letter of access. However, the registrant is not in anyway obliged to provide a letter of access under these proposed regulations. The proposed regulation will allow the exclusive protection period to be extended up to 15 years through the addition of minor uses.

Data submitted and reviewed, supporting "new" forms (salts, esters or resolved isomers) of a registered or historical active ingredient could get exclusive protection if PMRA determines, on a case-by-case basis, that the form is actually a new active ingredient and not just a slight change.

Data submitted under previous data protection policies will also be protected according to these proposed regulations when an application is submitted and this data is being relied on by another applicant.

3. What data receives compensable use protection status?

Data submitted to PMRA subsequent to the first registration of a new technical grade active ingredient, and its accompanying end-use product or manufacturing concentrate, are assigned a compensable protection status, for example, the data that formed the basis for an additional/amended registration or maintenance of a registration. The compensation period begins when the application which the information supports is received by the Minister, and continues for 12 years.

In the case of information requested by the Minister for re-evaluation or special review purposes the compensation period begins when the information is submitted to the Minister, and continues for 12 years. In the case of data identified in a RED or other foreign reviews and not previously submitted to PMRA, the protection starts on the date PMRA initiates the re-evaluation. Here the foreign data must have been considered by the Minister and be relevant to Canada, and the registrant must be able to provide the data to the Minister on request.

It should be noted that the protection starts from the first time the data is used by the Minister. The protection timelines do not reset when the data is used for a second time.

4. What is the relationship between patents and pesticide data protection?

Data protection and patent protection in relation to pesticides are separate and independent legal regimes. It is possible that an applicant could rely on compensable data and receive a registration under the PCPA while a patent exists, but the patent law protection for that product would continue to apply.

5. Can an applicant rely on data without compensating once all protection has expired?

Once all protection has lapsed, the data would be considered 'open' or 'generic' and could be relied on without having to pay compensation or obtaining a letter of access. Here, PMRA will ensure that the database is generic and contact the company.

Re-evaluation

6. What information used for purposes of a re-evaluation or special review is given compensable protection?

All information used in a re-evaluation or special review that qualifies for protection in accordance with the answer to question 3 above, or that is provided for purposes of the re-evaluation or special review, is given compensable protection in relation to an application to register a product or to amend a registration.

All information that is provided by registrants in response to a call-in of data for purposes of a re-evaluation or special review is given compensable protection in relation to other registrants who did not respond to the call-in. However, when a product is re-evaluated, a registrant does not have to compensate for data that the minister has on hand. The registrant only has to compensate if he later wants to rely on it to register a new product or amend a registration.

7. What registrants are required to produce data if more is required for a re-evaluation or special review?

If the Minister calls in data for purposes of a re-evaluation or special review, all registrants would be required to submit their own data or compensate the registrant providing the data. Registrants may wish to collaborate on generating the data. If a registrant does not either submit the requested data or a letter of access from the registrant submitting the data, their registration will not be renewed.

Minor uses

8. What uses can be considered as "minor uses"?

A "minor use" generally means a necessary use of a pest control product for which the anticipated volume of sales is not sufficient to persuade a manufacturer to register and sell the product in Canada. These include agricultural food and feed crops, ornamental and forestry uses. Minor uses are typically identified by Agriculture and Agri-Food Canada's (AAFC) Pest Management Centre on its list of national priorities, or by provincial minor use coordinators.

9. What is a federal or provincial agricultural authority?

For the purpose of the proposed regulations, a "federal or provincial agricultural authority" means AAFC or provincial/ territorial government agricultural representatives.

10. What is considered "a use the demand for which originates with a grower or a group of growers"?

"A use the demand for which originates with a grower or a group of growers" means a use that a grower or a grower group has identified as essential through consultation with AAFC or Provincial Minor Use Coordinator (PMUC).

11. What are the requirements to extend the exclusivity period based on minor uses?

Applicants will have to demonstrate how the use is a minor use (i.e., it meets a grower demand and is supported by a federal or provincial agricultural authority), identify the supporting data (including the relevant specific residue or exposure data), and provide PMRA with the submission number under which the application to add the minor use was made.

How to obtain registrations relying on compensable data

General

12. How are applications to register generic products processed?

Upon receipt of an application relying upon data supplied by another registrant, PMRA determines whether the proposed product is equivalent to the pest control product cited by the applicant. During this time, PMRA will determine the protection status of the data related to the precedent product. If there are compensable data, PMRA will provide a listing of this data to both the registrant and applicant.

If the applicant wishes to continue the registration process once the list of compensable data is received, the applicant would then obtain the Ministerial Agreement from the Health Canada website and request(s) the registrant to enter into the agreement in accordance with the regulations. The parties must reach a negotiated settlement or arbitral award in accordance with the regulations at the end of which a letter of access should be available. The applicant re-applies to PMRA with the letter of access referencing the initial application number, and PMRA proceeds towards registration.

13. Can one apply to register a generic product before the exclusive protection expires?

Yes, an applicant can apply to determine equivalency to register a generic product before the exclusive protection expires and resolve the compensation payable, but a registration will only be granted after the exclusive use period has expired. As the exclusive use period could be extended if minor uses are added any requested extension would have to be resolved before a generic product application could be considered. The PMRA intends to only accept such generic product applications in the 18 months prior to the end of the exclusive use period.

14. What are the equivalency criteria?

For a technical grade active ingredient, the criteria can be found in Regulatory Directive DIR2008-01, Registering a New Source of Technical Grade Active Ingredient under the Protection of Proprietary Interests in Pesticide Data Policy (PPIP).

For end use products and manufacturing concentrates, PMRA will assess equivalency to the pest control products cited by the applicants. Formulation differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity such as safety, residues or efficacy.

Required Data

15. Will a list of all the studies and their protection status be available on Health Canada's website?

A list of all the studies and their protection status is not yet available on Health Canada's website. The PMRA is working on developing such capacity.

16. Can applicants rely, fully or in part, on their own studies instead of on other registrants' data?

Yes, a generic applicant has the option to either compensate the registrant for reliance on existing data or submit their own supporting data. In these situations, the application will be processed as a Category B application. The application will be reviewed according to the standard Management of Submission Policy time lines with the applicable application fees.

17. When applying to register a generic product with fewer uses than the registrant's current database supports, what is compensable?

An applicant must compensate for the data that is required for the uses they are applying for, as determined by PMRA.

18. What is the process to establish the list of compensable data?

The current process to establish the list of compensable studies consists of the following steps.

1. PMRA generates a listing of all the information (e.g., data, waivers, information) that is linked to a particular registration number.
2. The data list is sent to the registrant(s) to ensure that PMRA records include a complete listing of the submitted information.
3. PMRA assesses the data list according to the eligibility criteria outlined in the proposed regulations (section 17.7)
4. After this assessment, a Data Compensation List is generated and sent to the registrant(s). The registrant(s) has (have) an opportunity to appeal PMRA assessment.
5. If an appeal is submitted, PMRA will subsequently review the information provided with the appeal and make a final decision.
6. The final Data Compensation List is sent to both the applicant and registrant(s).

Once a list has been established for an active, the above process will only be used to update the list.

Negotiation / Arbitration

19. What is the Ministerial Agreement?

The Ministerial Agreement is prescribed by the Minister of Health and sets out the process for determining the amount of compensation payable for the reliance on a registrant's data, including mandatory negotiations and binding arbitration. Registrants and applicants will be able to download the Agreement from the Health Canada website.

20. Can one skip negotiations and go straight to arbitration?

Negotiations are required unless both parties agree otherwise.

21. If there are multiple data owners, who does the applicant enter into an Agreement with?

An applicant may have to enter into an Agreement with, and obtain a letter of access from, more than one registrant to obtain the registration, depending on the uses applied for and the data needed to support them. The PMRA will identify what data is needed and the registrants that are to be compensated if the data is to be relied upon. The payment of compensation, as determined in accordance with the regulations, does not give a generic registrant a proprietary interest in the data unless a private arrangement has been made.

Registration

22. Are there circumstances when an early registration can be granted before the compensation payable has been determined?

An applicant cannot obtain an early registration simply by promising to pay the compensation when determined. However, an early registration can occur if, after commencement of the arbitration period, an escrow account is established by the applicant for the full amount of the last offer provided by the registrant at the end of the negotiation period. At the end of negotiations, if the registrant does not provide a last offer to the applicant in writing in accordance with the regulations, the applicant can obtain an early registration without having to establish an escrow account.

The last offers of the parties at the end of negotiations serve as the final offers for purposes of the arbitration.

In situations where negotiation or arbitration takes place in the final year of the exclusive protection, a generic registration cannot be granted prior to the end of the exclusivity period.

23. What if a letter of access is not provided?

If the registrant does not provide a letter of access in accordance with the settlement or award, and the applicant has complied, registration could be granted and the applicant could be relieved of having to pay any further outstanding compensation to the registrant.

24. What if the generic registrant does not respect the set payment schedule?

If the letter of access indicates there is a payment schedule for compensation, PMRA will adjust the expiry date accordingly (i.e., less than 5 years). In these situations PMRA will require that an updated letter of access be submitted with the renewal application. This will continue until the payment schedule has been completed. If PMRA does not receive confirmation that the applicant is meeting the payment schedule at renewal in the form of an updated letter of access, the product will not be renewed.

25. Is a letter of access needed if I have a letter of confirmation of source from the registrant of the product I am copying?

No, if a letter of confirmation is given by the registrant, access to the data attached to the end-use product is implied as long as the only pest control product used in the manufacture of the applicant's product is the one provided by the registrant being copied. However, if the registrant changes their end use product(s), access to this new data would not be permitted unless a new letter of confirmation of source is received or a letter of access to the data is received.