Data Exclusivity
The current term of data exclusivity in Australia is 5 years, beginning from the date of a new active ingredient’s first inclusion on the Australian Register of Therapeutic Goods. This makes Australia’s data exclusivity system among the weakest in OECD and other developed countries. Achieving an extension of the term of data exclusivity is a priority for Medicines Australia, and over the last 12 months we have been working to build as strong a case as possible.
In December 2010, Medicines Australia sent a survey to our member companies, requesting specific examples of medicines which have not been marketed in Australia, or medicines which are not likely to be marketed in Australia, primarily or predominantly due a shorter than “average” term of data exclusivity. This was done to help establish a specific link between data exclusivity and access to new medicines, and, therefore, between data exclusivity and better health outcomes for Australian patients. 8 companies identified 13 medicines which they chose not to sell in Australia (or whose sale was delayed or otherwise affected in Australia) over the last 10 years due to what they perceived as an insufficient period of data exclusivity. The 13 medicines covered several therapeutic areas, including those on the Australian Government’s Health Priority List such as mental health, neurology, oncology and infectious diseases.
Medicines Australia’s Data Exclusivity Taskforce used this and other information (including the results of extensive in-house modelling) to finalise a position paper on why the term of data exclusivity in Australia should be extended to 10 years. In summary, the paper argues that extending data exclusivity in Australia will:
- bring the Australian intellectual property system in line with leading OECD nations;
- improve Australia’s attractiveness as a destination for foreign investment by global biopharmaceutical companies;
- support the local biotechnology sector, which has only recently begun entering the international market with its products such as Gardasil, Relenza and Axiron, and a suite of groundbreaking products based on stem-cell technology being developed by Victorian company Mesoblast;
- encourage companies to bring new medicines to Australia, and in doing so ensure that Australian patients continue to have access to as many treatment options as possible; and
- reduce reliance on patent protection, which involves expensive litigation and which, in any event, will become increasingly unreliable in preventing the premature market entry of generic biological medicines.
Page updated: August 2011