Review of Pharmaceutical Patents in Australia
Terms of Reference
The review will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.
Central to this will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).
The review will also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review will consider how patents for new formulations are granted, consider the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market.
Should such evidence be found, the review should provide an assessment of the subsequent impact on competition, innovation and investment.
In conducting the review and making recommendations the panel is to have regard to:
- The availability of competitively priced pharmaceuticals in the Australian market
- The role of Australia's patent system in fostering innovation and hence to bringing new pharmaceuticals and medical technologies to the market
- The role of the patent system in providing employment and investment in research and industry
- The range of international approaches to extensions of term and arrangements for pharmaceutical inventions
- Australia's obligations under international agreements (including free trade agreements and the World Trade Organisation agreements)
- Australia's position as a net importer of patents and medicines
Conduct of the Review
A public consultation process is now underway as part of the review.
The Review Panel members are:
- Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair;
- Professor Dianne Nicol, Associate Dean, Research, Law Faculty at the University of Tasmania; and
- Dr Nicholas Gruen, CEO of Lateral Economics.
The Panel released its Draft Report on 2 April 2013. It is available from the Review's website. Written responses to the Draft Report closed at 5pm on 30 April 2013.
A Background and Suggested Issues Paper was released by the Panel on 21 November 2012 and submissions closed on Monday 21 January 2013. Public hearings were held in Canberra, Sydney and Melbourne on 11, 12 and 15 February 2013 respectively.
The Panel will provide a final report to Government in May 2013.
Last Updated: 01/5/2013