National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 20 of 2010)

Overview

The Amendment determination — Conditions (PB 20 of 2010) was enacted to amend the Pharmaceutical Benefits Scheme under the National Health Act 1953, aiming to address the problem of ensuring that the Pharmaceutical Benefits Scheme (PBS) provides access to necessary and cost-effective medicines for all Australians. This legislative instrument was prepared by the Office of Legislative Drafting and Publishing, Attorney-General’s Department, and it was introduced to provide clarity and updates to the list of approved medicines, their forms, and strengths available under the PBS. The policy objective of this amendment is to ensure that the PBS remains a viable and effective system by updating the list of pharmaceuticals to include new medications and removing outdated or no longer required forms of existing medications.

Scope and Application

The Amendment determination — Conditions (PB 20 of 2010) as amended, made under the National Health Act 1953, pertains to the regulation of specific pharmaceutical products by modifying the existing provisions of Pharmaceutical Benefits Scheme (PBS) determinations. This legislative instrument applies to individuals and entities involved in the prescription, supply, and administration of the listed medicines, primarily targeting healthcare providers, pharmaceutical companies, and relevant industry stakeholders. The geographic reach of this legislation is national, given its foundation under Commonwealth law. It does not specify exclusions or exemptions but operates within the broader framework of the PBS, which inherently includes thresholds for subsidy eligibility. This instrument extends its application through amendments to subordinate instruments, such as the Schedule 4 amendments to the PBS, which dictate the forms, strengths, and quantities of specified medications eligible for subsidy.

Key Provisions

The Amendment determination — Conditions (PB 20 of 2010) primarily concerns amendments to Schedule 4 of PB 119 of 2008, which pertains to the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Section 2 of the Amendment determination specifies the commencement date of the instrument, which is 1 April 2010. Schedule 1 of the Amendment determination lists specific changes to the PBS schedule, including the addition of Dabigatran etexilate in various dosage forms (section [1]), the removal of specific forms of Hydrocortisone cream (section [2]), the removal of specific forms of Pilocarpine eye drops (section [3]), and the replacement of entries for Rivaroxaban with new dosage forms (section [4]). The Amendment determination imposes obligations on the entities involved in the PBS, including the Australian Government Department of Health, pharmaceutical manufacturers, and suppliers. These obligations include updating the PBS schedule to reflect the specified amendments, ensuring that the new entries for Dabigatran etexilate are correctly listed, and removing or modifying the listed forms of Hydrocortisone, Pilocarpine, and Rivaroxaban as specified. The amendments require these entities to comply with the updated schedule to ensure the correct provision and reimbursement of these medications under the PBS. There are no explicit provisions detailing offences, penalties, or civil/criminal consequences for breach in the Amendment determination itself. However, non-compliance with the PBS regulations, including failure to adhere to the updated schedule, could potentially lead to administrative actions or penalties under the National Health Act 1953. Such penalties might include fines or other sanctions imposed by the relevant authorities for non-compliance with the legislative requirements governing the PBS.