Proposed amendments to the Pest Control Products Regulations have been published for comment. These proposed amendments relate to the protection of data submitted to the Pest Management Regulatory Agency (PMRA) for the registration of a pesticide product. Under these proposed amendments, a generic pesticide manufacturer may be able to rely on the data of an innovator-manufacturer provided that the generic manufacturer can establish that its product uses an active ingredient equivalent to that of the registered pesticide. These proposed amendments correspond to the data protection regime implemented by the PMRA under the regulatory directive titled Protection of Proprietary Interests in Pesticide Data in Canada (PPIP policy), on August 1, 2007 and have been modelled after the U.S. Environmental Protection Agency regime.
Exclusive-Use Protection for Data
Certain test data submitted to the PMRA will receive exclusive protection for a limited period. Any registrant of a new active ingredient will be granted 10 years of exclusive protection, from the date of registration, of any test data submitted if the test data are (i) provided in support of the initial application; (ii) provided in support of a concurrent application to register a pesticide product containing the same active ingredient; or (iii) provided at the request of the government as a requirement of registration.
The exclusive protection of the test data can be extended by one year for every three minor uses that are submitted with a new registration or submitted in an amendment to a registration within seven years of the date of registration, up to a maximum of an additional five years of protection (or 15 minor uses). The purpose of the minor-use incentive is to encourage pesticide companies to register the use of their pesticides in areas where the anticipated volume of sales is not normally high enough to justify the expense of conducting additional studies, such as for use with fruits and vegetables.
Compensable-Use Protection for Data
Compensable data are test data submitted to the PMRA that are not entitled to exclusive-use protection, provided that they are not in the public domain and were not generated by the government. An innovator-manufacturer will receive compensation from a generic pesticide manufacturer for the use and reliance on the compensable data for 12 years if the compensable data were submitted in support of (i) the registration of a new pesticide product whose active ingredient is already registered; (ii) an application to amend a registration (provided that the data are not entitled to exclusive-use protection); or (iii) a re-evaluation or special review requested by the government. This means that a generic pesticide manufacturer may use or rely on an innovator's test data, provided that the generic pesticide manufacturer compensates the innovator-manufacturer.
Negotiation and Arbitration for Access to Data
Once a generic manufacturer establishes that its generic pesticide product is equivalent to a registered pesticide product of an innovator-manufacturer, the PMRA will provide the generic manufacturer with a list of all compensable data available. The generic manufacturer is entitled to use or rely on some or all of this compensable data to support the registration of its generic pesticide product.
An agreement regarding the compensation payable for the right to use and rely on compensable data is delivered to the innovator-manufacturer. The government determines the terms and conditions of the agreement; however, the amount of compensation payable to the innovator-manufacturer is determined through negotiation and/or binding arbitration with the generic manufacturer. On receiving the agreement, the innovator manufacturer must begin the negotiation process with the generic manufacturer to determine the amount of compensation payable.
If the innovator-manufacturer and generic manufacturer fail to reach an agreement on the compensation payable within 120 days, the generic manufacturer may initiate binding arbitration procedures to determine the amount of compensation payable. Concurrently, the generic manufacturer may request that the Minister of Health register its generic pesticide product in reliance on the compensable data of the innovator; in this case, the generic manufacturer would enter into an escrow agreement and deposit compensation equal to the last amount offered to the innovator manufacturer in negotiations. Once the compensation payable is determined by binding arbitration, the generic manufacturer will pay, or be refunded, the difference. No right of appeal to the binding arbitration is allowed, with some limited exceptions under the Commercial Arbitration Act (Canada).
Previous Data Protection Regime
The data protection regime implemented by the PPIP policy and by these proposed amendments represent a deviation from the previous "Product Specific Registration and Proprietary Rights to Data Policy."1
The comment period runs until January 28, 2010, and interested persons are invited to provide comments to the PMRA. A copy of the proposed amendments can be accessed here (www.gazette.gc.ca/rp-pr/p1/2009/2009-11-14/html/reg2-eng.html).
1. Under this policy, all data required for the registration of a new active ingredient were granted 10 years of exclusive protection, starting from the date of registration. To encourage continued submission of data by innovator pesticide manufacturers throughout the life of a pesticide product, this policy provided that every new study produced by an innovator would be granted 15 years of partial data protection, starting from the completion date of the study. This partial protection required that generic manufacturers provide some of their own data if they wanted to access and rely on the data of an innovator. A value-point system assigned points to partially protected data submitted by innovators, based on the type of study. Generics were required to produce their own studies, totalling 75% of the points of the innovator studies, in order to access and rely on innovator data (further details are available here dsp-psd.pwgsc.gc.ca/Collection/H113-3-5E.pdf).