EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
PHARMACEUTICALS BENEFITS
AMENDMENT DETERMINATION UNDER SUBSECTION 84C (7) No. 2
Division 1A of Part VII of the National Health Act 1953 provides for the Safety Net scheme in relation to pharmaceutical benefits. The Safety Net scheme is designed to provide financial protection for those patients and their families who require a large number of Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme medicines.
The purpose of the National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84 (7) No. 2 (Determination) is to amend the National Health Act 1953 Pharmaceutical Benefits Determination under subsection 84C (7) made on 14 June 2006 (Principal Determination) to reflect the annual adjustment to the additional fee. The Principal Determination has been previously amended on 24 July 2007 (with effect from 1 August 2007). The additional fee is intended as a payment to the pharmacist for recording the supply of a pharmaceutical benefit where its Commonwealth price is less than the patient co-payment. The Determination provides that the price for a pharmaceutical benefit or repatriation pharmaceutical benefit will not exceed the patient co-payment. In some instances, a pharmacist may not be able to charge the full amount of the additional fee since it would cause the price to exceed the patient co-payment.
The additional fee is indexed annually using the Wage Cost Index 9. On this occasion, the additional fee for a ready-prepared pharmaceutical benefit will increase by two cents to $1.03 and the additional fee for an extemporaneously-prepared pharmaceutical benefit will be amended to $1.42.
Subsection 84C (9) of the National Health Act 1953 provides that the Minister may not determine an additional fee without the agreement, in writing, of the Pharmacy Guild of Australia. The Pharmacy Guild of Australia has been consulted on this matter and has agreed, in writing, to the making of this Determination.
This Determination, which amends the Principal Determination made on 14 June 2006, will commence on 1 August 2008.
Details of the Determination are set out in the Attachment.
This Determination is a legislative instrument for the purpose of the Legislative Instruments Act 2003.
ATTACHMENT
NOTES ON CLAUSES TO THE DETERMINATION
Clause 1 – Name of Determination
Clause 1 provides that the name of the Determination is the National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No.2.
Clause 2 – Commencement
Clause 2 provides that the Determination commences on 1 August 2008.
Clause 3 – Amendment of the Determination under subsection 84C (7)
Clause 3 provides that the Principal Determination is amended as set out in the Schedule.
Schedule – Amendments
Item 1 – Paragraph 3 – provides that the definition of “pharmaceutical item” is to be inserted and defined as “has the same meaning as in section 84AB of the Act”..
Item 2 – Paragraph 3 ‑ provides that the reference in paragraph 3 of the Principal Determination to ‘means a pharmaceutical benefit’ is amended to ‘means a brand of a pharmaceutical item’.
Item 3 – Paragraph 4 (b) (i) ‑ provides that the amount of the additional fee for a ready prepared pharmaceutical benefit in paragraph 4 (b) (i) of the Principal Determination is increased by two cents to $1.03.
Item 4 Paragraph 4 (b) (ii) ‑ provides that the amount of the additional fee for an extemporaneously-prepared pharmaceutical benefit in paragraph 4 (b) (ii) of the Principal Determination is amended to $1.42.
Overview
The National Health Act 1953, enacted by the Australian Parliament, addresses the need for a comprehensive framework to manage and regulate the healthcare system, including the provision of pharmaceutical benefits. To enhance this framework, the National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No. 2 was introduced on 1 August 2008. This amendment aimed to adjust the additional fee payable for recording the supply of certain pharmaceutical benefits, ensuring that the price does not exceed the patient co-payment. The additional fee, which compensates pharmacists for their services, is indexed annually using the Wage Cost Index. The amendment was made in consultation with the Pharmacy Guild of Australia, reflecting a collaborative approach to updating the safety net provisions for patients requiring a significant number of medicines under the Pharmaceutical Benefits Scheme.
Scope and Application
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No. 2 applies to the regulation of pharmaceutical benefits provided under the Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme, specifically focusing on the adjustments to the additional fee charged to patients for the supply of pharmaceutical benefits. This Act applies to the Commonwealth of Australia and extends to individuals and entities involved in the provision of pharmaceutical benefits, including patients, pharmacists, and the Pharmacy Guild of Australia. The Determination is a legislative instrument designed to align the additional fee with the annual adjustment determined by the Wage Cost Index. The amendment involves a minor increase in the additional fee for ready-prepared and extemporaneously-prepared pharmaceutical benefits, ensuring that the fee does not exceed the patient co-payment. This Determination does not introduce any new exclusions or exemptions but rather refines the existing framework to maintain its efficacy and fairness. The implementation of this Determination is subject to consultation and written agreement with the Pharmacy Guild of Australia, as stipulated in the National Health Act 1953.
Key Provisions
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No. 2 (the "Determination") modifies the National Health Act 1953 Pharmaceutical Benefits Determination under subsection 84C (7) made on 14 June 2006 (the "Principal Determination"). This amendment primarily adjusts the additional fee for certain pharmaceutical benefits, as outlined in section 4(b)(i) and (ii) of the Schedule. Specifically, the additional fee for ready-prepared pharmaceutical benefits is increased by two cents to $1.03, while the fee for extemporaneously-prepared pharmaceutical benefits is set at $1.42. These changes are intended to reflect the annual adjustment to the additional fee, which compensates pharmacists for recording the supply of pharmaceutical benefits where the Commonwealth price is less than the patient co-payment.
Under this Determination, the Act imposes several obligations on parties involved in the supply of pharmaceutical benefits. For instance, the additional fee is indexed annually using the Wage Cost Index, a method that ensures the fee keeps pace with wage increases. This indexing process is critical in maintaining the financial viability of the Safety Net scheme, which provides financial protection for patients who require a large number of pharmaceutical benefits. Furthermore, the Act requires that any adjustment to the additional fee must be agreed upon in writing by the Pharmacy Guild of Australia, as stipulated in section 84C(9) of the Act. This ensures that any changes to the fee structure are made with the consent of the relevant professional body.
Failure to comply with the provisions of the Determination could lead to legal repercussions. The Act does not explicitly detail the specific offences, penalties, or consequences for breaches; however, general provisions under the National Health Act 1953 may apply. Such breaches could potentially result in fines or other civil penalties, particularly if they affect the administration of the Pharmaceutical Benefits Scheme or the Safety Net scheme. The exact penalties would depend on the nature and severity of the breach, but they could include administrative penalties or more severe legal actions if the breach results in significant financial or operational disruptions.
The Determination is set to commence on 1 August 2008, as stated in section 2 of the Schedule. This commencement date ensures that the changes to the additional fee are implemented in a timely manner, aligning with the annual adjustment cycle. The legal effect of the Determination is to update the Principal Determination, ensuring that the fees charged to pharmacists for recording pharmaceutical benefits remain fair and reflective of current economic conditions. By aligning the additional fee with the Wage Cost Index, the Determination aims to support the ongoing operation of the Safety Net scheme, thereby continuing to provide necessary financial protection to patients.