National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 5) (No. PB 56 of 2013)

Overview

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No. 5) was enacted to amend the existing special arrangement for the supply of highly specialised drugs to hospitals under the National Health Act 1953. This amendment was introduced to incorporate changes resulting from the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument was made under the authority provided by subsections 100(1) and 100(2) of the Act, enabling the Minister to make and modify special arrangements for the supply of pharmaceutical benefits. The objective of these amendments was to align the Special Arrangement with the latest updates to the Pharmaceutical Benefits Scheme, specifically adding two new brands of the drug Filgrastim and two new forms of the drug Raltegravir to the list of drugs available under the highly specialised drugs program for hospitals. The amendments were made in consultation with the Pharmaceutical Benefits Advisory Committee and relevant pharmaceutical companies, ensuring that the changes reflect recommendations and agreements based on clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No.5) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, affecting the supply of certain pharmaceutical benefits under the National Health Act 1953. This amendment applies to the highly specialised drugs program for hospitals, which provides medications for the treatment of chronic conditions to patients in public or private hospitals with access to appropriate specialised facilities. The amendment, effective from 1 September 2013, introduces two new brands of the drug Filgrastim and two new forms of the drug Raltegravir into the program, reflecting updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. 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 drugs on the Pharmaceutical Benefits Scheme. The amendment ensures that the Special Arrangement remains aligned with the most recent updates to the Pharmaceutical Benefits list.

Key Provisions

The main sections of the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No.5) (section 1) identify the instrument as the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No.5) and also provide the citation PB 56 of 2013. Section 2 specifies the commencement date of the instrument as 1 September 2013. Section 3 and Schedule 1 detail the amendments to the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, which include the addition of two new brands of Filgrastim and two new forms of Raltegravir, along with relevant restrictions for the new forms of Raltegravir. The obligations and requirements imposed by this Act primarily involve the Minister's authority to make special arrangements for the supply of pharmaceutical benefits under the National Health Act 1953. The Act enables the Minister to create, vary, or revoke special arrangements related to the supply of highly specialised drugs to hospitals. This includes the requirement to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) and other stakeholders, such as pharmaceutical companies, to ensure the recommendations align with the objectives of the Act. Furthermore, the Act mandates the inclusion of new drugs and their forms based on PBAC's recommendations, which consider factors such as clinical effectiveness, safety, and cost-effectiveness. Any breaches of the provisions set out in this Act may result in civil or criminal consequences, though specific offences and penalties are not detailed in the explanatory statement. Generally, under Australian law, breaches of legislative instruments can lead to penalties, including fines and imprisonment, depending on the severity of the offence and the specific provisions of the Act. The Pharmaceutical Benefits Scheme (PBS) and associated legislation outline various penalties for non-compliance, which could apply to violations of the special arrangement amendments. The amendments to the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010 by this Instrument reflect the changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This includes the introduction of two new brands of the drug Filgrastim and two new forms of the drug Raltegravir, as well as new restrictions for the forms of Raltegravir. These changes are intended to ensure that the highly specialised drugs program for hospitals is up-to-date and aligned with the latest recommendations from the PBAC and other relevant stakeholders. The amendments are effective from 1 September 2013, aligning with the commencement date of the Instrument.