Calls for wider data exclusivity reforms should not be supported in Australia, says GMiA

Most of the world’s population live with no more than six years or no data exclusivity at all, with regard to pharmaceutical patents. Many countries have no data exclusivity including major markets such as India and Brazil. Many countries such as Australia, New Zealand, China, Singapore, South Korea, Israel, Chile, Taiwan, Turkey, Jordan and Saudi Arabia have five or six years data exclusivity.

Only Japan, the USA and Europe (bound under the single European Union law) currently have data exclusivity periods that are for 10 or more years. Consequently, Australia’s current five years is a sensible middle ground, claims the country’s Generic Medicines Industry Association (GMiA.

The international convention, the Trade Related Aspects of Intellectual Property Rights (TRIPs), does not require data exclusivity. Instead, it protects from unfair commercial use of confidential data. Countries can readily comply with TRIPS simply by protecting against disclosure and misappropriation of data, the GMiA argues.