Exclusive Protection Of Pesticide Data At Risk In Canada

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