Almost a decade of work by the research-based life sciences industry has come to nothing with the 11 countries remaining in the Trans Pacific Partnership Agreement (TPP) deciding to scrap key clauses on data protection and patent-term extensions.
Lead negotiators from each country met in Sydney last week to discuss how they would proceed following US withdrawal from the agreement.
Donald Trump officially withdrew the US from the TPP as one of his first acts as president.
According to media in Japan, the 11 remaining countries unanimously supported suspending clauses on data exclusivity and patent-term extensions.
Australia met the TPP patent-term extension requirement. New Zealand sought to so narrowly define patent term extensions virtually no pharmaceutical could ever qualify for one.
Data protection was a significant focus of the negotiation. The US pushed countries to adopt longer data protection periods for biologics and former Australian trade minister Andrew Robb described it as the most difficult aspect of the negotiation.
The US pushed hard for a 12-year data protection period for biologics. However, in the end, the agreement included a somewhat ambiguous outcome, giving countries the option of providing a legislated 8-year data protection period for biologics or a 'market protection' period that delivers a "comparable outcome" of 8 years comprised of a legislated 5-year period plus "other measures".
Australia and New Zealand currently maintain legislated five-year data protection periods for all pharmaceuticals.
Australia argued during the negotiation its regulatory and reimbursement system effectively provided an additional period of 'market protection'.
However, a former US Trade Representative said they expected countries to adopt the 8-year period while Australian government officials publicly said the TPP would not require any change to existing regulatory and reimbursement processes.