National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 8) (No. PB 39 of 2013)

Overview

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 8) is a legislative instrument made under the National Health Act 1953. It was enacted to address a specific issue where two companies could not fulfil their obligations to supply certain pharmaceutical brands under the Pharmaceutical Benefits Scheme (PBS). As a result, the instrument delisted eight brands of rosuvastatin from the PBS due to the companies' inability to meet their supply guarantees, as stipulated under section 99AEB of the Act. This amendment ensures that the PBS continues to provide patients with access to essential medications by maintaining the availability of alternative brands, while holding companies accountable for their supply commitments. The instrument was enacted by the Australian Parliament and aims to uphold the integrity of the PBS by ensuring that only companies able to supply their products are listed. The policy objective is to maintain a reliable and accessible pharmaceutical benefits system, which is crucial for the public health infrastructure in Australia. By revoking the listings of the non-compliant brands and allowing the companies to reapply with assurances of supply, the instrument balances the need for accountability with the continuous availability of necessary medications.

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 8) operates under the National Health Act 1953 and specifically targets the Pharmaceutical Benefits Scheme (PBS) by delisting eight brands of the drug rosuvastatin from the PBS due to non-compliance with supply obligations by the responsible entities. This instrument applies to the entities responsible for these pharmaceutical brands, essentially affecting the companies that failed to meet their obligations under section 99AEB of the Act. The geographic reach of this amendment is nationwide, as it pertains to the PBS, a national scheme. The instrument revokes specific determinations related to these brands under sections 84AF, 84AK, 85, 85A, and 88 of the Act, ensuring that the consequential revocations align with the legislative framework. This legislative instrument does not specify any exclusions, exemptions, or thresholds but relies on the Acts Interpretation Act 1901 for consequential revocations. It is a legislative instrument under the Legislative Instruments Act 2003 and is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health through the PBS.

Key Provisions

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 8) (PB 39 of 2013) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 by removing the listing of eight brands of pharmaceutical items that contain the drug rosuvastatin from the Pharmaceutical Benefits Scheme (PBS). This decision is based on the inability of the companies responsible for the brands to meet their obligations to supply their brands, as outlined in section 99AEB of the National Health Act 1953 (the Act) (section 2). The delisted brands include Cavstat and Rosuvastatin GH, available in tablet forms of 5 mg, 10 mg, 20 mg, and 40 mg, which were first listed on 1 June 2013 (section 2). This amendment ensures that the availability of rosuvastatin in these strengths remains unaffected for patients, as other substitutable brands are still available on the PBS. The responsible companies have the option to reapply for the relisting of these brands on the PBS, provided they can assure continuity of supply (section 2). The Act imposes specific obligations on the parties and entities it governs. Primarily, responsible persons, such as drug companies, must comply with their guarantee of supply obligations under section 99AEB of the Act (section 2). When a responsible person fails to meet these obligations, the Minister, or their delegate, has the authority to revoke the listing of the pharmaceutical brand under section 99AEH(2)(a) of the Act. The Minister's decision must be made after considering the matters specified in subsection 99AEH(3) of the Act (section 2). Additionally, the Act includes provisions for consequential revocations of determinations related to the delisted brands, under sections 84AF (responsible person), 84AK (pack quantity), 85 (prescription circumstances), 85A (maximum quantity and number of repeats for particular purposes), and 88 (PBS prescriber), as outlined in subsection 33(3) of the Acts Interpretation Act 1901 (section 2). There are no specific offences, penalties, or civil/criminal consequences mentioned for breaches of the provisions in this legislative instrument. However, the Act provides that the Minister can take action to delist pharmaceutical brands from the PBS if a responsible person fails to meet their supply obligations. This action is intended to ensure the availability and reliability of medications on the PBS, maintaining public health standards and patient access to necessary treatments (section 2). The consequences of such a delisting include the removal of the brands from the PBS list and the revocation of related determinations, which can be appealed or rectified by the responsible companies upon demonstrating compliance with the required obligations (section 2).