Has anyone noticed that the claimed US plan to 'dismantle' the PBS is rarely accompanied by any evidence or even specifics?
The language is generally vague but accusatory. It's based on the emotive language of moral outrage.
Oddly, nobody appeared to mind multinational pharmaceutical companies actively supporting and, in some cases, financing the campaign to amend Australia's Constitution. Yet advocating for a change in comparator selection conspires to 'dismantle' the PBS. Spare me.
When you break it down, it amounts to the allegation of PhRMA animus toward Australia's use of economic modelling to determine PBS listing arrangements.
This listing arrangement is underpinned by a statutory framework with the sole objective of prioritising the Commonwealth's economic interest.
Is the PBS a system of universal subsidy for prescription medicines? Or is it an academic exercise in economic modelling? For many, the system lives or dies based on the latter.
It's utterly ridiculous ideological nonsense.
In the words of George Orwell, “But if thought corrupts language, language can also corrupt thought.”
Be under no illusion that the confected outrage on PhRMA's two-month-old submission, virtually unchanged in a decade, risks poisoning the well and corrupting any thoughtful dialogue on PBS reform.
There's nothing like some industry hate to generate social media likes and ill-considered opinions.
A PhRMA-led conspiracy to undermine the foundational elements of PBS. It's a lazy ideological dog whistle that taps into anti-industry prejudice and some negative sentiments towards US President Donald Trump.
What's the source used to support this claimed conspiracy? PhRMA's Special 301 Submission. The document was published in late January, almost two months ago, and is such a standard annual feature of US trade policy that it's' hardly worth reading, let alone reporting.
The annual Special 301 process has existed since the 1970s. It's a yearly congressionally mandated review of the global state of intellectual property rights protection and market access barriers, focused on priority countries or those with trade agreements with the US.
The report includes chapters on 20 countries. Australia is not even included in the list of priority markets.
As the claim goes, if PhRMA is angry about the PBS, it must be apoplectic about New Zealand. Not so much. New Zealand is not included in PhRMA's submission. Given the egregious nature of its pricing and procurement policies, Pharmac's exclusion appears odd. Of course, New Zealand is a small market with no formal trade agreement with the US.
What does PhRMA's 2025 Special 301 say about Australia? What's the grand conspiracy?
"Australia has yet to implement critical patent enforcement provisions of the US-Australia Free Trade Agreement," it says, which is an objective statement of fact. Australia has not implemented a patent notification system reflecting its commitment in the FTA. It implemented a reverse notification system that only requires companies to declare to the TGA that their product does not breach any patent.
What about the PBS?
The grand conspiracy, with PhRMA listing Australia on its lower priority watch list, starts on page 195 of the 243-page document. The Australia chapter is included between Turkey and Egypt.
It says, "PhRMA member companies continue to face challenges and uncertainty in securing positive recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) to list new medicines on the Pharmaceutical Benefits Scheme (PBS) (or Medical Benefits Schedule (MBS)). Unnecessary supplemental data requests, infrequent PBAC meetings and other administration motions cause significant delays between regulatory approval and reimbursement listing."
Would anyone dispute that?
It continues, "Policies such as lowest cost comparator selection, legislated price reductions for innovative therapies and restrictive subsidy caps that can result in prices far below the cost-effectiveness standard do not support investment in innovation and ultimately result in delayed access to innovative medicines for Australian patients."
The most recent example of frustration over comparator selection was Health Minister Mark Butler intervening to ensure the reimbursement of a 20-year-old oral contraceptive.
The logical extension of some analysis is the Minister Butler has dismantled a key aspect of the PBS.
"The HTA Review final report was released by the Health Minister in September 2024. We encourage the Australian Government to implement the report’s recommendations aimed at reducing delays to access of new medicines for Australian patients and maintaining the attractiveness of Australia as a first-wave launch country," says PhRMA.
Medicines Australia was making the same point late last week and over the weekend.
PhRMA also criticises the Australian Government's pursuit of market-size damages in patent cases, a 2019 law that enables compulsory licensing, inadequate clinical data protection, PBS post-market reviews, biosimilar policy, and the publication of confidential data in PBAC Public Summary Documents.
That's it. The grand conspiracy was laid out in a published document, with the section on Australia remaining virtually unchanged over the past decade.
