Report to Parliament on barriers to generic medicines

Report to Parliament on barriers to generic medicines entering the market through the inappropriate use of intellectual property rights over product information

Page last updated: 30 June 2011

This report comprehensively examines the barrier to generic market entry posed by the inappropriate use of copyright on product information. The report looks into legal action surrounding the issue, international approaches to the issue, and the recently passed amendments to the Copyright Act 1968 which will principally resolve the issue. The report also examines Product Information and the current regulatory practices of the TGA, including the policy rationale behind the Agency’s current practices.

Full Report: Report to Parliament on barriers to generic medicines entering the market through the inappropriate use of intellectual property rights over product information (PDF 76 KB)