The Government has recently issued a notice indicating it has completed its review of New Zealand’s data protection regime for agricultural compounds (including veterinary medicines). The Government indicates it has agreed to some amendments to the relevant provisions in the Agricultural Compounds and Veterinary Medicines Act. In making its decision, Government took into account feedback from stakeholders on policy options in a discussion paper released at the end of 2011.
Implementation of the changes will require amendment of the Agricultural Compounds and Veterinary Medicines Act 1997 (and potentially the Hazardous Substances and New Organisms Act 1996).
Officials are working on the necessary amendments, with a view to the changes taking effect from late 2013.
The review analysed New Zealand’s data protection settings in three areas:
- innovative agricultural compounds;
- new uses and reformulations of non-innovative compounds; and
- reassessments of existing compounds.
The Government notice states it has agreed to the following:
Innovative agricultural compounds
This refers to compounds that are, or contain, an active chemical ingredient that has not been previously registered in New Zealand.
The review found that the current five year period of protection was appropriate, and as a result Ministers have agreed to retain the status quo of five years data protection for innovative agricultural compounds.
However, in order to encourage the registration of additional uses, it will now be possible to seek an extension of the five-year period of protection by one year for each additional use that is registered within three years of initial product registration, up to a maximum of three extra years. This would give a potential maximum of eight years of protection for the original data.
This change is being introduced because the review found that a number of important New Zealand horticultural crops and commercially farmed animals are considered “minor” commercial crops or species internationally, so products are not registered for use on them. The change is intended to encourage the registration of these additional “minor” uses in the New Zealand market.
It has also been agreed that the definition of “innovative agricultural compound application” will be amended so that:
- “innovative” means an active that has not previously been granted full registration in New Zealand at the time of the application; and
- where there has been a previous application for provisional registration, an application for full registration is not restricted to the original applicant.
The current definition potentially inhibits the development of uses for innovative compounds that may have been referred to in applications for provisional registration, but which, for various reasons, have not proceeded to full registration.
New uses and reformulations of non-innovative compounds
This refers to compounds that are, or contain, active chemical ingredients that have been previously registered in New Zealand.
Currently there is no data protection provided for new uses or reformulations. The review found that the lack of data protection in this area may be inhibiting the registration and development of uses and products for the New Zealand market. As a result, a three-year period of data protection will be introduced for new uses and reformulations. This is intended to provide an incentive to register additional uses and reformulations of existing products in the New Zealand market.
Reassessments of existing approved compounds
There is currently no protection provided for data supplied to the regulator for the purposes of a reassessment. The review found that the costs associated with the options for data protection in this area are likely to outweigh the benefits. Thus there will be no change from the status quo (no data protection).