National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11) (PB 104 of 2017)

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 11) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This legislative instrument was created under the authority granted by subsection 100(1) of the National Health Act 1953, which empowers the Minister to establish special arrangements for the supply of pharmaceutical benefits. The primary policy objective of this amendment is to update the Special Arrangement to reflect recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Highly Specialised Drugs (HSD) program remains current and effective in meeting the health needs of Australians. The changes introduced by this Instrument include modifications to the prescribing circumstances for listed drugs, enhancing the alignment between the Special Arrangement and the current pharmaceutical listings. These amendments are in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that the decision-making process for the PBS remains evidence-based and inclusive of expert advice. This legislative instrument is compatible with the human rights and freedoms recognised in international human rights instruments, particularly engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by facilitating the progressive realisation of the right to the highest attainable standard of physical and mental health. The amendments support the advancement of this right by providing for continued subsidised access to medicines through the PBS, overseen by the PBAC's recommendatory role.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 to make changes to the Special Arrangement concerning the Highly Specialised Drugs (HSD) program. This legislative instrument applies to entities and persons involved in the supply of pharmaceutical benefits under the Special Arrangement, particularly those engaged in the provision of highly specialised drugs for the treatment of chronic conditions that require specialised treatment. The Instrument has a national reach as it is made under the National Health Act 1953, which is a Commonwealth Act. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and involve modifications to the circumstances for prescribing for listed drugs. The Instrument does not specify any exclusions or exemptions but extends or restricts application through subordinate instruments, ensuring alignment with the current listings in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment is designed to ensure that the Highly Specialised Drugs program continues to meet the evolving healthcare needs of Australians. The Instrument is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. By amending the Special Arrangement, the Instrument ensures that the Pharmaceutical Benefits Scheme provides evidence-based, subsidised access to highly specialised drugs, thereby advancing health outcomes for all Australians. The changes were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee, an independent expert body that advises the Minister on the listing of pharmaceutical benefits. This consultative process ensures that the amendments are based on sound clinical and economic evidence, contributing to the overall goal of improving health outcomes for patients requiring highly specialised treatments.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 11) (PB 104 of 2017) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to update the conditions for prescribing highly specialised drugs under the National Health Act 1953 (the Act). The changes are made to align with the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). These amendments specifically address the circumstances under which listed drugs can be prescribed, as detailed in Schedule 1 of the Instrument (sections 1 to 10). The Instrument also includes minor adjustments to ensure the Special Arrangement is consistent with the current listings on the Pharmaceutical Benefits Scheme (PBS). Under the amended Special Arrangement, certain obligations are placed on healthcare providers and pharmaceutical companies. Healthcare providers must adhere to the updated prescribing conditions for highly specialised drugs, ensuring that the treatments are administered in accordance with the specific criteria outlined in the Instrument. Pharmaceutical companies are required to supply these drugs in line with the conditions set out in the amended Special Arrangement, ensuring they are available to patients who meet the eligibility criteria. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending changes to the listings on the PBS, ensuring that decisions about subsidised access to medicines are evidence-based. Failure to comply with the provisions of the amended Special Arrangement may result in civil or criminal consequences. While the Instrument does not explicitly state penalties for non-compliance, breaches of the National Health Act 1953 can attract significant penalties. Under section 100 of the Act, the Minister can impose financial penalties for breaches of the Special Arrangement, which may include fines up to $22,200 for individuals and $111,000 for bodies corporate, depending on the nature and severity of the breach. Additionally, serious breaches may result in criminal charges, leading to further penalties including imprisonment, particularly if the breach causes harm to patients or results in significant financial loss. The amendments made by this Instrument reflect the recommendations of the PBAC, an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits. The PBAC's recommendations are based on the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. This ensures that the changes to the Special Arrangement are grounded in clinical evidence and are aimed at advancing the highest attainable standard of health for all Australians.