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TRIPS Protocol

In March 2011, the Australian Government announced its intention to implement measures consistent with the principles (and terms – “Paragraph 6″) of the Doha Declaration on the TRIPS Agreement and Public Health (“TRIPS Protocol”). Under the proposed system, the Australian Government (through the Federal Court of Australia) will be able to issue compulsory licenses for the manufacture and export of generic copies of patented medicines to the world’s least developed countries that are facing specific and prolonged health emergencies. This internationally accepted system is being progressively implemented around the world; it has, for example, already been implemented in Canada and the European Union.

Medicines Australia supports the implementation in Australia of the TRIPS Protocol. In a submission to IP Australia in July 2010, we said that we would welcome the introduction of laws that would make it easier for Australian companies to play a major role in addressing sudden and prolonged health crises in the world’s least developed countries. Medicines Australia’s principal recommendation to IP Australia was that the authority to issue and amend compulsory licenses under the new system should be vested in the Federal Court of Australia rather than the Commissioner of Patents as originally proposed. We also recommended strict safeguards such as distinctive packaging and labelling requirements to prevent re direction of exported medicines to other markets. Both these recommendations were reflected in the Government’s announcement in March as well as in the “drafting instructions” given to IP Australia.

To date, specific legislation to implement the TRIPS Protocol has not been introduced in Parliament. But we understand that the Government will seek to implement these measures by the end of 2011.

Page updated: August 2011

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