COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85 (2AA)
No. PB 1 of 2001
I, ALAN WILLIAM STEVENS, Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Aged Care and Delegate of the Minister for Health and Aged Care, having in accordance with subsection 85 (2AB) of the National Health Act 1953 obtained the advice of the Pharmaceutical Benefits Advisory Committee, pursuant to subsection 85 (2AA) of the National Health Act 1953, hereby make the following Declaration:
- This Declaration commences on 1 February 2001.
2. The drugs and medicinal preparations specified in the Schedule to this Declaration shall cease to be drugs and medicinal preparations to which Part VII of the National Health Act 1953 applies.
THE SCHEDULE
Desipramine Hydrochloride
Ferrous Sulfate – Dried
Medrysone
Prednisolone Acetate
Dated this 4th day of January 2001.
ALAN WILLIAM STEVENS
Acting Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Aged Care
Delegate of the Minister for Health and Aged Care
Overview
The National Health Act 1953 was enacted to provide a framework for the administration of health services in Australia, with a focus on public health and the provision of pharmaceutical benefits. The Pharmaceutical Benefits Declaration, made under subsection 85(2AA) of the Act, serves to update the list of drugs and medicinal preparations that are eligible for subsidies under the Pharmaceutical Benefits Scheme (PBS). This particular declaration, made by the Acting Assistant Secretary of the Pharmaceutical Benefits Branch and a delegate of the Minister for Health and Aged Care, removes certain drugs from the PBS list, effective from 1 February 2001. The policy objective behind these changes is to ensure the efficient and effective use of public funds by periodically reviewing and adjusting the list of subsidised medications based on the advice of the Pharmaceutical Benefits Advisory Committee. This process helps to maintain the sustainability of the PBS while ensuring that Australians have access to necessary medications.
Scope and Application
The Pharmaceutical Benefits Declaration under subsection 85 (2AA) of the National Health Act 1953 applies specifically to the cessation of certain drugs and medicinal preparations from the list of those covered by Part VII of the Act. This legislation is a Commonwealth instrument, thereby extending its reach across the entire nation and impacting the availability of pharmaceutical benefits under the Act. The specified drugs and medicinal preparations, namely Desipramine Hydrochloride, Ferrous Sulfate – Dried, Medrysone, and Prednisolone Acetate, are removed from the list of those eligible for subsidies and benefits under the Pharmaceutical Benefits Scheme. The Declaration, made by Alan William Stevens as the Acting Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Health and Aged Care and Delegate of the Minister for Health and Aged Care, came into effect on 1 February 2001, following the advice of the Pharmaceutical Benefits Advisory Committee. The Declaration itself does not specify exclusions or exemptions other than those drugs and preparations listed in the Schedule, thereby directly modifying the scope of pharmaceutical benefits available under the National Health Act 1953.
Key Provisions
The main operative sections of this legislative instrument (sections 2 and the Schedule) declare that certain drugs and medicinal preparations will cease to be covered under Part VII of the National Health Act 1953, which pertains to the Pharmaceutical Benefits Scheme (PBS). This means that from the commencement date, 1 February 2001, the listed drugs and medicinal preparations will no longer be eligible for subsidies or benefits under the PBS (section 2). The specific drugs affected are Desipramine Hydrochloride, Ferrous Sulfate – Dried, Medrysone, and Prednisolone Acetate, as detailed in the Schedule.
The Act imposes obligations on the parties or entities it governs by delisting the specified drugs and medicinal preparations from the PBS. This delisting means that these drugs will no longer be subsidised by the Australian government for the public, effectively removing them from the list of medicines that can be provided at a reduced cost to the general population. Healthcare providers, patients, and pharmaceutical companies will need to adjust to these changes by considering alternative treatments or payment methods for these medications.
There are no explicit offences, penalties, or civil or criminal consequences outlined in this legislative instrument for breach of the provisions. The removal of these drugs from the PBS is a regulatory change that affects the availability and cost of these medications. However, entities or individuals who continue to claim PBS benefits for these delisted drugs after the effective date may face scrutiny and potential repercussions under the broader provisions of the National Health Act 1953, including financial penalties for incorrect claims or misrepresentation. The specific penalties for such actions are detailed in other sections of the Act, not in this particular legislative instrument.