Health minister Greg Hunt says he does not have to formally exercise any power under the National Health Act 1953 to remove patient protections to PBS co-payments and the safety-net.
Late last week, and in response to questions about the Opiate Dependence Treatment Program (ODTP), a spokesperson for Minister Hunt said he had the power to make 'special arrangements' under Section 100 of the National Health Act 1953 (Act) without a legislative instrument.
Special arrangements do not remunerate community pharmacy for dispensing medicines through the ODTP with patients forced to pay uncapped and unregulated private dispensing fees that can exceed $200 per month.
The arrangements have never been enacted in law through a specific legislative instrument.
A document released in 2019 in response to a Freedom of Information request shows a Department of Health official exercising a power under Section 100 (1) of the Act to impose the ODTP arrangements. However, it was never lodged as a legislative instrument - meaning the power was never formally exercised and the arrangements have never come into force.
Under The Legislation Act 2003, which governs the exercise of ministerial power, a legislative instrument is required when the exercise of power "has the direct or indirect effect of affecting a privilege or interest, imposing an obligation, creating a right, or varying or removing an obligation or right.".
Yet according to Minister Hunt, removing the protection of co-payments and the safety-net does not constitute "varying or removing an obligation or right."
There are also serious doubts whether under Section 100 the minister can make the determination of a 'special arrangement' without a legislative instrument. The wording of Section 100 clearly presumes any action taken under its powers will be exercised through a legislative instrument.
BioPharmaDispatch asked Minister Hunt whether he stood by last week's statement and also to explain the policy rationale for denying patients access to these basic protections under the PBS
In the response provided late yesterday, a spokesperson said, "The Minister is deeply committed to addressing the burden of illicit and prescription opioids on Australians."
"The department has advised that the Program is established under section 100 (s100) of the National Health Act 1953 (the Act) and this section provides the legal basis for the program. The department has further advised that the ODTP is being administered within existing legal authority," said the spokesperson.
The response did not identify any specific legal authority.
The minister is effectively saying he has the power under "existing legal authority" to remove patient rights to the protection of PBS co-payments and the safety-net for any medicine listed under Section 100. According to Minister Hunt, in policy and without any exercise of power or reference to parliamentary scrutiny, he can deregulate patient fees for Section 100 medicines.
Minister Hunt's defence is set against the backdrop of stakeholders calling for an immediate moratorium on private dispensing fees for the ODTP.
BioPharmaDispatch understands the federal government will consider reforms to the ODTP, including the impact of private fees. However, this is little comfort for patients who currently are denied the protection of PBS co-payments and safety net under 'special arrangements' that have never been enacted in law and may not be enforceable.
