National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021 [2021] AUSStaCSBSD 240 (24 November 2021)

• National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021
• Broad discretionary power
• Instruments not subject to parliamentary disallowance45

---

National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021

Purpose	This bill seeks to amend Part VII of the National Health Act 1953 to implement a range of measures, including changes to the operation of Statutory Price Reductions, changed price disclosure arrangements and a new stockholding requirement for certain medicines that are more susceptible to global medicines shortages.
Portfolio	Health
Introduced	House of Representatives on 28 October 2021

Broad discretionary power
Instruments not subject to parliamentary disallowance^[45]

1.95 The bill seeks to make amendments to Part VII of the National Health Act 1953 (the Act), which regulates the Pharmaceutical Benefits Scheme (PBS). These amendments include a number of alterations to the size, timing and application of statutory price reductions currently contained in the Act as well as changed price disclosure arrangements and a new stockholding requirement for certain medicines. The bill contains a number of provisions that would give the minister the power to determine not to apply, or to reduce, a statutory price reduction to brands of pharmaceuticals in certain circumstances. The bill would also allow the minister to determine how statutory price reductions would apply to particular brands categorised under the PBS in certain circumstances or to provide that price increases do not apply. The bill would also allow the minister to determine minimum stockholding amounts for certain medicines.

1.96 In granting these powers to the minister the bill provides that the minister may make the determinations by 'written instrument' or by 'notifiable instrument'. The committee notes that neither written instruments nor notifiable instruments will be subject to the tabling, disallowance or sunsetting requirements that typically apply to legislative instruments. As such there is no parliamentary scrutiny of these instruments. In addition, the committee's scrutiny concerns are heightened given the high level of discretion afforded to the minister to determine matters in relation to statutory price reductions and minimum stockholding obligations under the Act.

1.97 Given the impact on parliamentary scrutiny, the committee expects the explanatory materials to include a justification for why these determinations are not legislative in character and why it is proposed to allow such ministerial discretion to be exercised by way of written or notifiable instruments, which are not subject to parliamentary scrutiny and disallowance. In this instance, the explanatory memorandum does not provide a justification for providing a broad discretionary power to make ministerial determinations by written or notifiable instrument.

1.98 The committee therefore requests the minister's advice as to why the bill proposes to provide the minister with a broad discretionary power to apply statutory price reductions and amend minimum stockholding obligations and to do so by way of written or notifiable instrument (noting that such instruments are not subject to disallowance).

---

[45] Schedule 1, item 28, proposed subsection 99ACB(6A); item 33, proposed subsection 99ACC(5C); item 51, proposed subsection 99ACD(7A); item 76, proposed subsection 99ACR(6); item 80, proposed subsection 99ADHB(6); item 82, proposed subsection 99ADHC(2); item 85, proposed subsection 104B(2). The committee draws senators’ attention to these provisions pursuant to Senate Standing Order 24(1)(a)(iv).