National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 7) (PB 92 of 2018)

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 7) (PB 92 of 2018) amends the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as outlined in the National Health Act 1953. Enacted by the Australian Parliament, this amendment responds to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which took effect on the same day. The amendment adjusts the Principal Determination (PB 119 of 2008) to include modifications to drugs and forms across Schedules 1 to 5. The objective of these amendments is to ensure the Pharmaceutical Benefits Scheme (PBS) remains effective and aligned with contemporary health needs. The Department of Health consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) in making these changes, ensuring that the recommendations are evidence-based and cater to the health requirements of Australians.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 7) is a legislative instrument that amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953, which sets out the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which includes additions, deletions, and changes to drugs and forms in Schedules 1 to 5 of the Principal Determination. The changes made by this Instrument are based on recommendations from the Pharmaceutical Benefits Advisory Committee, which consulted with interested pharmaceutical companies and recommended changes to the Minister. The Instrument applies to approved pharmacists and approved medical practitioners who supply pharmaceutical benefits, and the changes it makes affect the conditions under which payments will be made for those benefits. The scope of the Amendment is national, as it applies to the Pharmaceutical Benefits Scheme, which is a Commonwealth scheme. There are no stated exclusions, exemptions, or thresholds in the Amendment, and it does not extend or restrict application through subordinate instruments. This Amendment is compatible with human rights as it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The Pharmaceutical Benefits Scheme is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee ensures that decisions about subsidised access to medicines on the PBS are evidence-based. This Legislative Instrument is compatible with human rights because it advances the protection of human rights.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 7) (PB 92 of 2018) amends the existing conditions set out in the Principal Determination (PB 119 of 2008) under the National Health Act 1953. This Determination updates the Pharmaceutical Benefits Scheme (PBS) by making modifications to the drugs and forms listed in Schedules 1 to 5. Specifically, it includes additions, deletions, and changes to these schedules, as detailed in Schedule 1 of the Amendment. For example, hydromorphone oral liquid has been added to Schedule 3, subject to a dangerous drug fee, while betaxolol eye drops have been removed from Schedule 4, which requires the complete pack to be supplied. Conversely, dexamethasone intravitreal injection has been added to Schedule 4. Under the National Health Act, the Minister has the authority to determine the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners (section 98C(1)(b)). The Principal Determination (PB 119 of 2008) provides the framework for these payments. The Amendment 2018 (No. 7) modifies these conditions by altering the listings in the schedules, affecting which drugs and forms are covered under the PBS and how they are supplied. This ensures that the scheme remains current with medical and pharmaceutical developments, maintaining the accessibility and affordability of essential medications for Australians. The Amendment imposes specific obligations on approved pharmacists and approved medical practitioners by updating the list of pharmaceutical benefits covered under the PBS. These professionals must adhere to the new conditions outlined in the amended schedules, which dictate how certain drugs and forms are to be supplied. For instance, they must now account for the addition of hydromorphone oral liquid to Schedule 3, requiring the application of a dangerous drug fee, and the removal of betaxolol eye drops from Schedule 4, meaning they no longer need to supply the complete pack. Such changes necessitate updates to their record-keeping and compliance processes to ensure adherence to the new requirements. Failure to comply with the conditions set out in the amended Principal Determination could result in legal repercussions. While the specific penalties for non-compliance are not detailed in the Amendment itself, violations of the National Health Act 1953 can generally lead to civil or criminal penalties, depending on the nature and severity of the breach. For example, knowingly providing pharmaceuticals in a manner contrary to the Act could result in fines or other penalties as prescribed by the relevant legislation. The exact penalties would be determined in accordance with the provisions of the National Health Act and any other applicable laws. In summary, the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 7) modifies the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits by introducing changes to the drugs and forms listed in Schedules 1 to 5. These changes are designed to keep the PBS aligned with current medical practices and ensure continued access to essential medications. Approved pharmacists and approved medical practitioners must comply with these updated conditions, and failure to do so may result in legal consequences under the National Health Act 1953.