The New Zealand Government is proposing to increase the protection given to confidential data submitted to regulatory authorities to gain marketing approval for agricultural and veterinary compounds. This will effectively extend the period within which manufacturers of innovative compounds or formulations can exclude generic competitors from the market.
As with human medicines, agricultural and veterinary compounds can only be approved for use if they are shown to be safe and effective. The safety and efficacy data submitted to regulatory authorities is confidential and commercially valuable. As a quid pro quo for developing innovative compounds, the law protects the data companies submit from disclosure for a period of time (currently five years). Most significantly, during this protected period the regulatory authority can't refer to the data for the purposes of approving another product. This data exclusivity therefore gives an effective period of marketing exclusivity, separate from what may be given by a patent.
The Agricultural Compounds and Veterinary Medicines Bill, currently before Parliament, increases the data exclusivity period for innovative (ie, new) products from five years to a possible eight years. The Bill also introduces a three year data exclusivity period for non-innovative products, namely reformulations of or new uses for existing products.
With the Bill, the Government aims to balance the objectives of encouraging competition and incentivising innovation. While increased data exclusivity does mean competitors may have to wait longer in some cases before entering the market, introducing data exclusivity for non-innovative product encourages the development of innovative formulations and uses.
This change comes at an interesting time. Currently there is fierce debate in the TPP negotiations over the appropriate data exclusivity period for human pharmaceuticals, and in particular biotherapeutics. Many TPP members are resisting calls to increase the data exclusivity period to 12 years, with eight years touted as a possible middle ground.
The Bill has yet to have its first reading.