EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
PHARMACEUTICALS BENEFITS
AMENDMENT DETERMINATION UNDER SUBSECTION 84C (7) No. 3
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. 3 (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 adjustment to the additional fee in the case of extemporaneously-prepared pharmaceutical benefit. The Principal Determination has been previously amended on 24 July 2007 (with effect from 1 August 2007) and 15 July 2008 (with effect from 1 August 2008). 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 for an extemporaneously-prepared pharmaceutical benefit will be amended to $1.39 to correct an error which occurred on the Pharmaceutical Benefits Scheme on 1 August 2008.
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 September 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.3.
Clause 2 – Commencement
Clause 2 provides that the Determination commences on 1 September 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 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 $1.39.
Overview
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No. 3 (Determination) was introduced to correct an error in the additional fee for extemporaneously-prepared pharmaceutical benefits within the Pharmaceutical Benefits Scheme. This amendment aims to rectify an oversight that occurred on 1 August 2008, ensuring that the additional fee does not cause the price to exceed the patient co-payment. The Determination, enacted by the Australian Government, amends the Principal Determination made on 14 June 2006, with the consultation and agreement of the Pharmacy Guild of Australia, and will take effect from 1 September 2008. The policy objective is to maintain the integrity of the Safety Net scheme, which provides financial protection for patients requiring a large number of medicines under the Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme.
Scope and Application
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No. 3 pertains specifically to the adjustment of the additional fee for extemporaneously-prepared pharmaceutical benefits within the Safety Net scheme, which is part of the broader Pharmaceutical Benefits Scheme (PBS) designed to provide financial protection for patients requiring a large number of PBS medicines. This legislative instrument applies to entities involved in the PBS, including patients, pharmacists, and potentially the Pharmacy Guild of Australia, as they are the ones who must adhere to and comply with the adjustments to the additional fee. The amendment is intended to correct an error in the Commonwealth price of certain pharmaceutical benefits and ensures that the price does not exceed the patient co-payment, thereby providing clarity and financial protection to those who rely on these benefits. The amendment is effective from 1 September 2008 and follows consultation and agreement with the Pharmacy Guild of Australia, ensuring that the changes are both lawful and considerate of the stakeholders involved. This Determination does not extend to other types of pharmaceutical benefits or different schemes within the National Health Act 1953, focusing narrowly on correcting the specified fee for extemporaneously-prepared medicines.
Key Provisions
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under subsection 84C (7) No. 3 (the Determination) amends the National Health Act 1953 Pharmaceutical Benefits Determination under subsection 84C (7) made on 14 June 2006 (the Principal Determination) to adjust the additional fee for extemporaneously-prepared pharmaceutical benefits (section 1). The purpose of this adjustment is to correct an error that occurred in the Pharmaceutical Benefits Scheme on 1 August 2008. The amended additional fee is set at $1.39 (Schedule, Item 1). This change is intended to ensure that pharmacists are appropriately compensated for recording the supply of pharmaceutical benefits where the Commonwealth price is less than the patient co-payment, while also ensuring that the price for a pharmaceutical benefit or repatriation pharmaceutical benefit does not exceed the patient co-payment.
The Determination imposes specific obligations on the parties involved. The Minister is required to consult with the Pharmacy Guild of Australia before determining the additional fee, and any changes must be agreed upon in writing by the Guild (subsection 84C (9)). The Pharmacy Guild of Australia has provided the necessary agreement for this Determination. Additionally, the Determination ensures that the price for a pharmaceutical benefit or repatriation pharmaceutical benefit will not exceed the patient co-payment, thereby protecting patients from excessive charges (section 1).
Breach of the obligations imposed by the Determination could lead to various legal consequences. While the Determination itself does not explicitly outline specific penalties for non-compliance, failure to adhere to the agreed additional fee or miscalculating the pharmaceutical benefits could result in legal actions being taken against the parties involved. The overarching objective is to maintain the integrity of the Safety Net scheme, which provides financial protection for patients who require a large number of pharmaceutical benefits. Any actions that undermine this objective could be subject to scrutiny and legal consequences under related provisions of the National Health Act 1953 and other relevant legislation. The specific penalties would depend on the nature and extent of the breach, as well as any applicable laws and regulations.