National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2018 (No. 1) (PB 27 of 2018)

Overview

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2018 (No. 1) was enacted by the Minister for Health under the National Health Act 1953 to amend the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010. This amendment was necessitated to address the issue of price disclosure and subsequent price reductions of certain listed drugs in the Pharmaceutical Benefits Scheme (PBS) as stipulated by section 99ADH, effective from 1 April 2018. The instrument specifically removes the listed drugs 'olmesartan and valsartan' from the Angiotensin II receptor antagonist group as part of the 2018 April Cycle of Price Disclosure. The enacting body is the Minister for Health, and the policy objective aligns with ensuring that the PBS remains effective and evidence-based, thereby supporting the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised by the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2018 (No. 1) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 to adjust the grouping of certain listed drugs under the Pharmaceutical Benefits Scheme (PBS) as required by the National Health Act 1953. This amendment pertains specifically to drugs within the Angiotensin II receptor antagonist group, removing olmesartan and valsartan from this group effective from 1 April 2018. This change is consequential to the 2018 April Cycle of Price Disclosure, which necessitates adjustments to therapeutic groups for drugs subject to new price disclosure requirements. The amendment applies to pharmaceutical companies with brands listed on the PBS that are subject to these price disclosure requirements. The instrument operates under the Commonwealth jurisdiction and is a legislative instrument as defined by the Legislative Instruments Act 2003. There are no exclusions or exemptions outlined in this determination, but it relies on the Acts Interpretation Act 1901 for its variation and revocation powers. This legislative instrument is compatible with human rights as it does not raise any human rights issues and aligns with the principles of the International Covenant on Economic, Social and Cultural Rights by facilitating access to affordable medicines under the PBS.

Key Provisions

The main operative sections of this legislative instrument include subsection 84AG(1) of the National Health Act 1953 (the Act) (1), which provides the authority for the Minister to determine a therapeutic group and that two or more listed drugs are in the same therapeutic group. The purpose of this amending instrument is to remove from its therapeutic group, each listed drug which has at least one listed brand to which section 99ADH will apply on 1 April 2018 (2). The Act requires this amending determination (3), which is effective 1 April 2018. This instrument amends Part 2 of Schedule 1 to the Principal Determination (4), which sets out the ATRA group (the Angiotensin II receptor antagonist group) (5). This instrument removes the listed drugs ‘olmesartan and valsartan’ from this group (6). The obligations and requirements imposed by this Act on the parties or entities it governs include the requirement for pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) to disclose information relevant to this determination to Australian Healthcare Associates Pty Ltd (AHA), known as the Price Disclosure Data Administrator (PDDA). AHA is prescribed by subsection 85(6) of the Regulations as the person to whom, in accordance with paragraph 99ADC(1)(a), a responsible person is to provide price disclosure information. Pharmaceutical companies are required to provide this information to the PDDA prior to the data being used to arrive at the weighted average disclosed price for listed brands. Any disputes that arise from this process are resolved through an industry agreed dispute resolution process prior to the reduction day. There are no specified offences, penalties, or civil/criminal consequences for breach in this legislative instrument. However, the Amending Instrument affects pharmaceutical companies with medicines listed on the PBS, and the Act requires this amending determination as a consequence of the 2018 April Cycle of Price Disclosure. Failure to comply with the requirements of the Act may result in the pharmaceutical company's brand being delisted from the PBS, which would result in a loss of government subsidy for that brand. This could have significant financial implications for the pharmaceutical company and may also impact on patient access to that medication. This legislative instrument is compatible with human rights as it does not raise any human rights issues. The PBS is a benefit scheme which assists with advancement of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, as recognised in Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based, which further supports the realisation of this human right.