s76A of the Patents Act was introduced alongside the extension of term (EoT) scheme for pharmaceuticals in order to collect data with each application for an extension. This was intended to assist in evaluating whether EoTs were achieving their stated objective, namely encouraging pharmaceutical R&D in Australia. Patent holders are required to lodge a return with the Department of Health setting out R&D spending on the pharmaceutical which is the subject of the extension.
The Productivity Commission in its 2016 report considered that s76A was not performing its intended function due to a lack of clarity and compliance, and recommended that the provisions be substantially expanded. The Government however considered that the case had not been made and that other sources of data were available, and did not accept the recommendation, instead proposing that s76A could be repealed.
Consultation 23-Oct-2017 to 4-Dec-2017
Policy development 5-Dec-2017
In Parliament 28-Mar-2018
This item is included in the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 and introduced to the Australian Parliament on 28 March 2018.