Australia could be responsible for bringing down the 12-country Trans Pacific Partnership Agreement, according to US-based sources.
In a series of exasperated conversations, sources close to the USTR told BiotechDispatch the intransigence of the Abbott Government on data exclusivity for biologics was putting the entire TPP at risk.
If signed, the TPP would cover 40 per cent of the world’s economy, covering major Australian export markets including the US and Japan.
The US is pushing for enhanced intellectual property and copyright protection across the 12 countries, including longer data exclusivity periods for biologic medicines. Under the US proposal, Australia’s current five-year data exclusivity period for all medicines would be extended to 12-years for biologics.
US sources expressed dismay over Australia refusing to give anything on intellectual property while demanding major concessions from the US on access to that country’s domestic agriculture markets.
“They are refusing to give anything while demanding everything in return,” said one source, who went on to say the Australian position is undermining efforts to secure enhanced intellectual property across the Asia Pacific region.
They negatively contrasted Australia’s refusal to concede anything on intellectual property with New Zealand’s willingness to accept change, including to pharmaceutical purchasing agency Pharmac.
According to one source, developing countries are now “hiding behind” Australia on intellectual property, which is causing “absolute dismay” in the US.
“Australia went to the last round of negotiations in Hawaii clearly with a view to test US resolve on this issue – they received a very clear message from President Obama himself, but they still show no signs of conceding, preferring to ‘fan’ opposition domestically.
“Frankly, the 12-country TPP can become 11 if Australia continues down this path,” they said.
They also mocked Australian claims that extending the data exclusivity period would increase the cost of PBS, pointing to the multi-billion dollar savings announced through the PBS Access and Sustainability Package, a fact not lost on the USTR, they said.
“This is also a matter of principle,” they said. “There is no example anywhere in the world of a biosimilar approved within 12 years of registration of the biologic – the average is 18-19 years.
“It is becoming increasingly possible that, if Australia doesn’t want to give anything, the US will say fine, leave them out of the agreement.”