The promise to the public: generic competition. Submission to the pharmaceutical patents review

Abstract

Governments have agreed time-limited monopolies to encourage domestic invention through the grant of patents. At the end of the agreed period, the patented invention should be reproducible by skilled persons without undue experimentation and the new knowledge embodied in the invention should be freely available and usable by all. This paper presents evidence on delays to the entry of generic pharmaceuticals in Australia, then considers (briefly) the arguments put by "big pharma" in support of a range of regulatory interventions that contribute to these delays. It then considers the key patent and health policy issues delaying competition. The regulatory environment is then assessed from the perspective of achieving a supportive policy environment for timely entry of competition at the expiry of the agreed patent monopoly period.