The Department of Health is attempting to amend the National Health Act 1953 to remove the right of companies to claim confidentiality over their PBAC submissions.
In what can only be described as a sneaky move, the federal government has tabled the National Health Amendment (Pharmaceutical Benefits Transparency and Cost Recovery Bill 2021) that moves to legislate away the current protection sponsors have under the National Health Act 1953.
It is transparently directed at addressing the fact PBAC Public Summary Documents and many other PBS publications have no standing in law - it is an explict acknowledgement of this fact.
Yet it goes well beyond Public Summary Documents.
It seeks to totally remove the rights of companies to confidentiality.
The change would give the federal government total control over the information contained in company submissions.
The explanatory memorandum says the Bill gives the federal government the power to publish any information it likes. It will effectively remove any protection to confidentiality for a PBAC submission.
The PBAC can probably look forward to much shorter meetings.
It also says this change is a result of the federal government's 2017 agreement with Medicines Australia. The industry did not agree to this. Has this Bill been discussed in the current agreement negotiation?
It seems the idea is that every other stakeholder in the health sector should have the protection of confidentiality, except the pharmaceutical industry.
Using the US-Australia Free Trade Agreement (FTA) as an excuse is odd - that agreement was signed 17 years ago and makes no mention of Public Summary Documents. Its transparency provisions are explicitly listed and do not include anything close to a Public Summary Document. Any claim they are an obligation under the FTA is a misrepresentation, at best, but more likely a deliberate falsehood.
The Department of Health is also attempting to make this change with no consideration or consultation on the potential impact on patient access to new medicines. In fact, the Bill's explanatory memorandum bizarrely claims it will enhance patient access to medicines.
Health minister Greg Hunt has put his name to the Bill. Did he read it or even seek to understand the implications for his commitment to access?
