Australia’s trade minister, Andrew Robb, has said that they are very close to striking a deal on monopoly period for biologics medicines with the United States which could seal the TPP. The issue is the monopoly period secured by pharmaceutical companies in the Australian market for “next generation drugs” known as biologics before cheaper drugs can be produced.
Currently in Australia, US pharmaceutical companies have a 5-year monopoly period to protect intellectual property for clinical data. For the TPP, the U.S. has proposed 8-year period which includes five years of data exclusivity plus addition three years of “pharmacovigilance” which would keep cheaper versions off the market for 8 years. However, Australia, New Zealand and Chile have opposed it.
Michael Moore, CEO of Public Health Association Australia wrote to prime minister urging him to stand firm against the US push to lengthen biologics monopolies. Around 150 senior health experts wrote to Minister Robb for resolving the issue of not extending the monopoly period which would delay affordable access to life-saving treatments.
Minister Robb has consistently said that they would not support outcomes that would increase prices of medicines for the Australians or adversely affect their health system. Pharmaceuticals remain one of the contentious issues in the TPP including the investor-state dispute settlement cause, wider intellectual property rights, dairy trade, and environmental issues. Will Australia stand firm on 5-year monopoly period? Or will the U.S. be able to convince them?