The pharmaceutical sector, in Australia and overseas, is anticipating the Turnbull government's response to the Productivity Commission's report into Australia's intellectual property arrangements.
The report contained controversial recommendations, suggesting a range radical changes to pharmaceutical patent law, including what amounts to the practical abolition of the five-year patent term extension.
Government requested the Commission conduct the inquiry following a recommendation in the Harper Competition Review.
The report acknowledged the increasing cost and complexity of drug development, including requirements imposed by regulators, but then essentially argued Australia should 'free-ride' on larger commercial markets.
"The Commission understands that, in most cases, where drugs are developed and approved for sale in larger overseas markets, the additional burden of obtaining regulatory approval in Australia (relying largely on data already submitted overseas) is not large and would not be material to the global returns available from a given drug," it said.
The report triggered a fierce response from the research-based sector, including Medicines Australia and AusBiotech, with both highlighting the report's implications for innovation policy and even the risk of reprisals from other countries.
BiotechDispatch understands the sector is anticipating the Turnbull government is close to releasing its response to the report.
Any move to adopt its more controversial recommendations, which were even the subject of discussions during pre-Budget PBS negotiations this year, would be sure to generate a savage global response from the research-based sector.
It is understood health minister Greg Hunt at one stage suggested government commit to maintaining the five-year patent term extension as part its strategic agreement with Medicines Australia. The association rejected the option, forthrightly, on the basis its inclusion would imply it is a matter for future negotiation.