The trade minister, Andrew Robb, has said Australia and the United States are within striking distance of a deal on the monopoly period for biologics medicines which could seal the Trans Pacific Partnership (TPP).
Robb was speaking in Atlanta at the current round of negotiations for the TPP, which if signed would create a preferential trade zone between 12 countries covering 40% of the world’s economy.
When asked whether the US and Australia were within striking distance of a compromise on biologics, Robb told US website Inside Trade “Yes, we are.”
At issue is the monopoly period secured by pharmaceutical companies in the Australian market for “next generation” drugs known as biologics, before cheaper generic drugs can be produced.
Biologic treatments are the vanguard of new medicines derived from biological sources and are used to treat diseases such as cancer and arthritis.
Under the current arrangements in Australia, US pharmaceutical companies have a five-year monopoly period to protect intellectual property for clinical data.
For the TPP, the US has proposed an eight-year monopoly period which includes five years of data exclusivity plus an additional three years of “pharmacovigilance” which would in effect keep cheaper versions off the market for eight years. Australia, New Zealand and Chile have consistently opposed the move.
Robb has consistently maintained the five-year cap on data exclusivity, telling US negotiators that the period was effectively closer to six or seven years due to the approval processes required.
“The US has got a different system to us, so to try and accommodate both our needs is very difficult,” Robb told reporters in Atlanta on Saturday night.
As of the last round of talks, it is unclear whether Australia’s position has changed.
The chief executive officer of the Public Health Association Australia, Michael Moore, wrote to Malcolm Turnbull over the weekend urging the prime minister to stand firm against the US push to lengthen biologics monopolies.
“We are still hoping there is no last-minute trade off that kowtows to the US pharmaceutical companies that are actually driving the agenda,” Moore said.
In his letter to Turnbull, Moore wrote: “We understand that monopolies for biologic products may become the final sticking point in the TPP negotiations and that Minister Robb is under intense pressure to compromise on his commitment not to agree to anything longer than Australia’s current five-year data exclusivity period.
“There is strong opposition amongst Australian health organisations to lengthening market exclusivity for biologics. On 1 September, 150 senior health experts wrote to Minister Robb to congratulate him on his resolve not to extend monopolies on these products, would delay affordable access to life-saving treatments for conditions like cancer and rheumatoid arthritis.”
The Australian Medical Association president, Brian Owler, has previously voiced concerns that any changes could push up the price of medications while a study by health academic Dr Deborah Gleeson showed keeping 10 biologics listed on the Pharmaceutical Benefits Scheme under monopoly protection cost taxpayers over $205m in 2013-14.
In his letter, Moore said it was also important that Australia retained the right to determine the definition of biologic products to give the government room to limit the scope of any TPP obligations and to respond to new advances in next generation drugs.
“It is vitally important that any biologic provision includes a specific public health exception for biologics that allows market exclusivity requirements to be waived in circumstances where it is necessary to protect public health, national security, non-commercial public use, national emergency or other urgent circumstances.”
Negotiations between the 12 member countries – including the US, Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – have been shrouded in secrecy. However there have been a number of documents leaked over the 10 years of negotiations.
Robb has consistently said the government would not “support outcomes that would increase the prices of medicines for Australians or adversely affect our health system more generally; end of story”.
“Nor would we accept outcomes that undermine our ability to regulate or legislate in the public interest in areas such as health,” Robb said, describing any criticism as “scaremongering”.
Robb also offered parliamentarians the chance to see the TPP draft if they agreed to a four-year non-disclosure agreement.
In response, a cross-party parliamentary working group has formed, including the Greens senator Peter Whish-Wilson, Labor MP Melissa Parke and independent senator Nick Xenophon.
Pharmaceuticals remains one of a number of contentious issues, which also includes the investor-state dispute settlement clause, wider intellectual property disputes, dairy trade, environmental protections and privacy obligations.
