New bill extends data protection for agricultural compounds and veterinary medicines
Thursday 13th August 2015
A new bill introduced by the New Zealand Government seeks to extend and broaden exclusivity periods for confidential data relating to agricultural and veterinary compounds.
The Agricultural Compounds and Veterinary Medicines Amendment Bill, introduced to the New Zealand Parliament on 11 August 2015, relates to data which must be provided to the government as part of an application to approve the introduction and use of a new agricultural or veterinary compound in New Zealand.
This data is currently protected for a period of 5 years, during which time competitors are prevented from relying on this information as part of their own applications for regulatory approval.
The new bill extends the period of protection from 5 years to a period of 8 years for applications relating to new active ingredients. The bill also broadens the applicability of protection periods to include applications for reformulations and new uses of known (non-innovative) active ingredients. The current Act only provides protection for confidential information relating to active ingredients which have not been the subject of an earlier application for approval.
In the official press release, Food Safety Minister, Jo Goodhew, says “This extension to data protection laws will help increase the availability of products needed by our primary industries, whilst still allowing for robust competition in the New Zealand marketplace.”*
As part of its progress through Parliament, the bill will be subjected to debate, Select Committee consideration, and the public will be able to make submissions.
Data exclusivity also currently features in international media reports as a topic of apparently serious contention in the negotiations of the Trans Pacific Partnership trade agreement, to which New Zealand and Australia are a part.