23 October 2017
Companies seeking to register a new crop protection product for use in Australia must provide the results of extensive research to the independent regulator, the Australian Pesticides and Veterinary Medicines Authority (APVMA), demonstrating the product is safe for people and the environment when used according to label instructions, and that it doesn’t present any unacceptable risks to export markets.
The research required to generate data for the registration process is expensive, with overall costs to research, develop and register just one new product reaching up to $256 million. Companies recoup this research investment through sales of the product once it is registered, thereby providing the funds for the next product to be researched and developed.
Data protection is a means of protecting the research data submitted by companies during the registration process from unfair commercial use by competitors. It enables registrants of new technologies the opportunity to recoup their investment by preventing competitors from using submitted data for a defined period of time.
The World Trade Organisation (WTO) requires companies’ regulatory data be protected under its Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
Data protection is standard practice in countries that have comparable regulatory systems to Australia.
Australia’s current data protection system remains inadequate and, combined with an inefficient registration process, provides little incentive for companies to bring innovative new products to our nation’s farmers.
Improvements to Australia’s data protection were expected as part of the National Harmonisation project, but these have not yet been delivered.
Detailed information on CropLife’s proposed improvements to data protection is provided in our Submission on Data Protection.
Information on data protection provided in Australia is available from the APVMA’s Data Protection, Early Disclosure and Transparency Provisions page.