National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 5) (PB 53 of 2016)

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 5) (PB 53 of 2016) is a legislative instrument that amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act). The Act was enacted to provide for the administration of the Pharmaceutical Benefits Scheme (PBS) and ensure that all Australians have access to affordable and reliable medicines. The Amendment Determination was introduced to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 6) which commenced on 1 July 2016. The Amendment Determination removes a pharmaceutical item from Schedule 4 of the Principal Determination. The Minister of Health made this determination following consultations with the Pharmaceutical Benefits Advisory Committee. The policy objective of this Amendment Determination is to ensure that the PBS remains an effective and efficient system that provides Australians with access to necessary medicines while also maintaining fiscal sustainability. The Pharmaceutical Benefits Advisory Committee, which includes members from various interests and professions, provided recommendations to the Minister on which medicines should be subsidised through the PBS. The Minister then determined the changes to the conditions under paragraph 98C(1)(b) of the Act, which are reflected in this Amendment Determination. This legislative instrument 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 of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 5) amends the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as outlined in the National Health Act 1953. This amendment applies to the Pharmaceutical Benefits Scheme (PBS), which is administered under Part VII of the Act, and specifically affects the supply of pharmaceutical benefits by approved entities. The determination targets approved pharmacists and approved medical practitioners, who are required to comply with the specified conditions to receive payments from the Commonwealth. This Amendment Determination has a national jurisdictional reach, impacting all entities and individuals involved in the PBS across Australia. The amendment removes the glucose indicator—blood from Schedule 4 of the Principal Determination, reflecting changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 6). The amendment excludes any other pharmaceutical items not specifically mentioned in this Determination. The application of the Act may be further extended or restricted through subordinate instruments, though this particular Amendment Determination focuses on the specified changes to the conditions for payment.

Key Provisions

The main sections of this legislation are contained in the Amendment Determination, which amends the existing National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953. The Amendment Determination (F2016L01058) alters the conditions subject to which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, Schedule 4 to the Principal Determination is amended by the deletion of the item 'glucose indicator—blood'. This means that from the commencement date of this Amendment, payments for the supply of glucose indicator—blood will no longer be made under the Pharmaceutical Benefits Scheme (PBS). This Amendment Determination imposes obligations on approved pharmacists and approved medical practitioners, requiring them to adhere to the updated conditions outlined in the Determination. These conditions are integral to ensuring that pharmaceutical benefits are provided in accordance with the PBS and that any payments made by the Commonwealth are compliant with the statutory requirements. Approved pharmacists and medical practitioners must ensure that their practices align with these updated conditions to continue receiving payments for the provision of pharmaceutical benefits. Any breach of the conditions set out in the Amendment Determination may result in civil or criminal consequences. While the specific penalties are not detailed in the explanatory statement, breaches of the National Health Act 1953 or any regulations made under it can result in substantial penalties. Under Australian law, offences under the National Health Act can lead to fines and, in some cases, imprisonment. For example, providing false or misleading information to obtain payments could result in penalties that reflect the severity of the offence, including potential fines and imprisonment terms as stipulated in the Act and related regulations. The Amendment Determination is supported by consultations with the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that decisions about the PBS are evidence-based. The PBAC, comprising members from various relevant fields such as consumers, health economists, and medical specialists, plays a crucial role in recommending changes to the Minister. This ensures that the amendments are well-considered and reflect the needs and standards of the healthcare industry and the public. The legislative instrument is also compatible with human rights as it advances the right to the highest attainable standard of physical and mental health by ensuring continued access to subsidised medicines through the PBS.