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Latest news
June 2011
Government report on inappropriate use of intellectual property rights in medicines
Today the Government tabled its report to Parliament on barriers to medicines entering the market through the inappropriate use of intellectual property rights over product information.
The report centres on recent amendments to the Copyright Act (Cth) 1968 that allow the Therapeutic Goods Administration to approve the product information of a follow-on generic medicine in a form that is similar to that of the initial patented brand of the medicine.
The supply of the information provided by sponsors of follow-on generic medicines in substantially the same form as the initial medicine had been challenged via the claim of alleged copyright infringement by the sponsor of a patented medicine.
This important amendment to the Copyright Act (Cth) 1968 enacted on 27 May 2011 confirms the legitimacy of the current and future use and reproduction by sponsors of essential information provided to patients with their medicines.
The Government should be praised for the passing of the amendment. The Government’s report states that the amendments,
“restore the balance between ensuring timely access to generic medicines for all Australians and providing incentives for the research and development of new drugs by providing appropriate protection of intellectual property”.
Some sponsors of patented medicines in Australia are increasingly adopting commercial practices to extend the life of pharmaceutical patents of profitable medicines. This results in unjustified and preventable expense to the Government, taxpayers, and consumers.
Efficient and timely market entry of generic medicines brings the public and Government important benefits of more affordable medicines and contributes significantly to the sustainability of the Pharmaceutical Benefits Scheme (PBS) and the funding of new medicines. In the last four years the presence of a generic medicines sector has saved the PBS in excess of $1.4 billion.
There is still more work for Government to do in addressing cases of inappropriate use of intellectual property rights in medicines. The Government must ensure that it is not possible for the sponsor of the patented medicine to engage in practices that inappropriately renders the market inaccessible or commercially unviable to the sponsors of the follow-on generic medicines. Barriers to medicines entering the market through the inappropriate use of any intellectual property right impose a significant and avoidable cost to the community.
The Generic Medicines Industry Association (GMiA) is the national association representing companies that manufacture, supply and export generic medicines. The generic medicines sector is a high value-add sector delivering significant benefits to the Australian public by way of affordable medicines and high skilled jobs.