The over-hyped response to PhRMA's submission to the United States Trade Representative's Special 301 process has been exposed with the release of the 2025 National Trade Estimate (NTE).
The NTE is an annual report detailing the USTR's view on foreign trade barriers US exporters face and the agency's efforts to reduce those barriers.
In its submission to the Special 301 process, PhRMA restated its long-held views on Australia's intellectual property protection for pharmaceuticals and PBS policies, including implementing the Health Technology Assessment Review recommendations.
The remarkable political response included the claim that PhRMA was pushing the Trump Administration to 'dismantle' the PBS, despite many of its positions reflecting those of Australian stakeholders, including Health Minister Mark Butler.
In the NTE report, the USTR has not mentioned the PBS, focusing on Australia's failure to implement its commitment to establish a patent notification system under the bilateral trade agreement with the US.
"Under the FTA [Free Trade Agreement], Australia must notify a pharmaceutical product patent owner of a request for marketing approval by a third party for a product claimed by that patent owner. Australia must also provide measures in its marketing approval process to prevent persons other than the patent owner from marketing a patented product during the patent term. US and Australian pharmaceutical companies have expressed concerns about delays in this notification process," it says.
It is an objective statement of fact to say Australia has failed to implement the promised patent notification system. Instead, it implemented a reverse notification system under which third parties simply assert their application does not breach a patent. The assertion is not scrutinised or tested, meaning it provides no notification to patent holders.
The NTE report references "concerns about certain provisions in Australian law regarding potential civil damages in cases where a patent owner seeks a preliminary injunction. The United States will continue to monitor these issues."
The Trump Administration's grand US conspiracy against the PBS, pushed by PhRMA, is to restate its long-held position over Australia's failure to implement a commitment in the FTA and say it will "continue to monitor" civil damages cases regarding pharmaceutical patents.
