Improved Data Protection

Fact Sheet No. 5

The current data protection provisions are overly complex and do not provide meaningful access to data protection for information provided to a chemical review. The Better Regulation of Agricultural and Veterinary Chemicals reforms would improve consistency in data protection provisions and add incentives for industry to provide data in support of ongoing registration of agricultural and veterinary chemicals¹. 

What is Data Protection?

Where data protection applies, the APVMA is prevented from relying on the data generated or owned by one person or company when considering the use of chemical products from another person or company. This restriction on the use of the data is for a specific period of time and protects the data owner’s investment from competitors gaining unfair commercial advantage in the generation of those data.

Data protection is a common feature of agricultural and veterinary chemical regulation in countries that have comparable regulatory systems to Australia. Australia also has international obligations to provide data protection in certain circumstances. Investment in regulatory data can require significant resources and the protection of these data encourages innovation in new and existing agricultural and veterinary chemicals, and support for the ongoing registration of existing chemical products.

Reforms

The proposed reforms will significantly improve the protection for information submitted in relation to a chemical review. As is the case now, the data protection period will commence when data are submitted to the APVMA. However, the reforms will also extend the protection period to eight years after the date that the data are relied on to make a regulatory decision. This is an increase of the current protection period, which is a maximum of seven years from when the data are submitted for consideration during a chemical review. These reforms align the data protection for chemical reviews and registration, and provide an additional incentive to submitting data as part of chemical reviews.

The reforms also improve arrangements that support the negotiation of access to data to support a chemical review by enabling any party to trigger the existing mediation and arbitration provisions should parties not agree on compensation.  

In addition, the reforms extend data protection eligibility to efficacy data and data relating to the use of products on non-food-producing animals (for example, companion animals).

The reforms will maintain data protection eligibility where data are provided as part of an application and that application is withdrawn or refused. This will reduce applicants’ concerns about losing data protection for these applications and reduce the incentive to maintain deficient applications in the regulatory system. The regulatory system will be more efficient if it contains less poor quality applications. Under the reforms, data provided as part of a permit application will also be eligible for data protection if these data are provided in relation to a future application.

¹ _{See Schedule 5 of the DRAFT Agricultural and Veterinary Chemicals Legislation Amendment Bill 2011.}