Enhanced Protection of Confidential Information for Product Formulations on Horizon
Agricultural Compounds and Veterinary Medicines Bill 2015 given its first reading...
A Bill that seeks to amend the Agricultural Compounds and Veterinary Medicines Act 1997 has recently been given its first reading. The Bill provides for an extended term of protection for confidential information relating to innovative product formulations and would create protection for confidential information relating to non-innovative product formulations.
New Zealand became bound by the TRIPs Agreement in 1995. Article 39.3 of the TRIPs Agreement requires Members to protect data submitted to governments or governmental agencies as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities.
One of the Acts that implemented New Zealand’s commitments to the TRIPs Agreement is the Agricultural Compounds and Veterinary Medicines Act 1997. Part 6 of that Act provides for the protection of certain confidential information about innovative agricultural compounds. The current Bill would replace Part 6 and make similar consequential amendments to the Medicines Act 1981. In particular, protection for confidential information given in support of an application for the registration of an innovative agricultural compound changes from a maximum of 5-years after the date of that registration or refusal to a maximum of 8-years after the date of registration. In the case of refusal of the application the term remains the same, but, where registered (granted), the term can increase in 1-year increments up to the 8-year maximum for each new use authorised as a result of successful variation applications. For non-innovative agricultural compounds the Bill would provide protection of confidential information up to a period to 3-years after the date of registration or refusal. However, in the case of a of successful variation application relating thereto, this can be extended to 3-years from the date of registration of the variation.