Under the Pest Control Products Act (PCPA), which
regulates pesticide products, a generic pesticide manufacturer
may be able to rely on the data of any registrant provided that
the manufacturer can establish that its product uses an active
ingredient equivalent to that of the registered pesticide.
The PCPA requires that pesticide products be approved before
they can be imported into, manufactured, sold or used in
Canada. As part of the registration process, applicants must
submit data to establish the acceptability of the health and
environmental risks and the value of the pesticide product.
Health Canada's Pest Management Regulatory Agency
(PMRA) is drafting regulations for classifying the protection
status of data submitted by innovators. No date has been set
for completing these regulations. The PMRA currently implements
the relevant policies through regulatory directives and has
released a directive aiming to implement data protection
practices that are closely aligned with the current practices
of the U.S. Environmental Protection Agency.1 Any
data protected under the old Product-Specific Registration
policy currently remain unaffected by this newer data
Classification of the Protection Status of Data
Data submitted to the PMRA can be granted either protected
or non-protected status. Protected data may include any data
submitted by a registrant regarding a new active ingredient and
any associated end-use or manufacturing concentrate as well as
data regarding additional or amended registrations used for new
formulations or for expanding or updating existing data. In
addition, any data requested by the PMRA under the PCPA as a
condition of registration or for incident reporting may be
Data that have been granted protected status can be assigned
either exclusive protection or compensable protection.
The innovator of data granted exclusive protection may
voluntarily, but is not obliged to, enter into negotiations
with a generic pesticide manufacturer to provide access to and
receive compensation for the generic's reliance on the
Currently, exclusive protection is given only to data that
formed the basis for the registration of a new active
ingredient and its associated end-use product or manufacturing
concentrate, and lasts for 10 years from the date of
registration, with a possible additional extension of 5 years
in certain cases.
Compensable protection – currently given to all
protected data not exclusively protected – lasts for
a specific period, during which a generic pesticide
manufacturer can rely on the data by compensating the
innovator. The manufacturer and innovator would negotiate a
commercial agreement regarding access and compensation. This
includes any data that formed the basis for an additional or
amended registration, including new formulations and data
submitted for a re-evaluation of a registered pesticide.
Compensable protection status lasts for 12 years from (i) the
date of the application for expanded use or a change in
formulation; (ii) the date of submission if it is submitted in
response to a PMRA request under the PCPA; or (iii) the date
that the data are cited in a re-evaluation. The length of the
compensable protection period cannot be extended.
Compensation for Access to Protected Data
An innovator cannot refuse access to data with compensable
protection, unlike the case of exclusively protected data. The
negotiation of access to data with compensable protection
status is mandatory; if negotiations fail, the parties are
required to go to binding arbitration to determine the amount
of compensation the innovator will receive from the generic
pesticide manufacturer for access to the data. Under this
process, the Minister of Health will determine the terms and
conditions of the agreement once the compensation value has
been determined. In January 2008, the PMRA released a
regulatory directive outlining the procedure for the
negotiation/arbitration process.2 As of the time of
writing, no negotiations or arbitrations have occurred.
1. DIR2007-03 titled "Protection of Proprietary
Interests in Pesticide Data in Canada" on August 1,
2. DIR2008-01 titled "Registering a New Source of
Technical Grade Active Ingredient Under the Protection of
Proprietary Interests in Pesticide Data Policy" on January
The content of this article is intended to provide a
general guide to the subject matter. Specialist advice should
be sought about your specific circumstances.
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