A long-awaited change in global intellectual property law has been adopted after the necessary number of countries ratified a change to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Under the change, known as the TRIPS Protocol, medicine producers can make generic versions of patented medicines to send to developing countries experiencing a health crisis. The generic medicines are made available under a compulsory licence from the patent holder.
The Protocol has come into force after two-thirds of World Trade Organisation members ratified the amendment. It is the first change to TRIPS since it was established in 1995.
The practical impact of the change is unclear given many companies either voluntarily grant licences to ensure supply in developing countries or cooperate to directly supply their medicines in response to a public health crisis. The only real debate is what constitutes a public health crisis.
“It gives legal certainty that generic medicines can be exported at reasonable prices to satisfy the needs of countries with no pharmaceutical production capacity, or those with limited capacity,” said WTO Director-General Roberto Azevedo.
“It helps the most vulnerable access the drugs that meet their needs.”
The Protocol was first accepted by the Australian Government in 2007. The necessary implementing legislation was passed in the Intellectual Property Laws Amendment Act 2015. The Act allowed the Protocol to operate in Australia from August 2015 under an interim waiver. The recent WTO amendment has activated further amendments under the Act to make the Protocol permanently in force.