3 February 2017

Developing countries may now receive improved access to generic versions of patented medicines due to a global policy update.

The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was amended on 23 January 2017; marking the first intellectual property (IP) policy change since its establishment in 1995.

“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 update was introduced specifically to adapt the rules of the global trading system to the public health needs of people in third-world countries, recognising the need to deal with illnesses such as HIV/AIDS, tuberculosis or malaria, and other epidemics.

The change makes permanent a mechanism known as the TRIPS Protocol. Under the TRIPS Protocol, medicine producers can make generic versions of patented pharmaceuticals to send to countries experiencing a health crisis. The generic medicines are made available under a compulsory licence from the patent holder.

The TRIPS 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.