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Export of Patented Pharmaceuticals to Countries Experiencing a Health Crisis – Details-stage Regulation Impact Statement – IP Australia

Intellectual Property Australia has released the Intellectual Property Laws Amendment Bill 2014 for consultation. The amendment will enable the Australian Federal Court in limited circumstances to grant a license to export patented medicines to countries experiencing a serious epidemic, in cases where negotiations with patent owners have failed. The legislation implements article 31 of the World Trade Organisation ‘Agreement on Trade-Related Aspects of Intellectual Property Rights’ to which Australia is a signatory. A Regulation Impact Statement (RIS) was previously prepared for this amendment and assessed as adequate under the June 2010 best practice regulation requirements and released on 15 August 2011. As the amendment is yet to be implemented, Intellectual Property Australia has updated the RIS and certified it as a details stage RIS under the July 2013 best practice regulation requirements. The details stage RIS has been approved by the OBPR.