EXPLANATORY STATEMENT
National Health Act 1953
National Health (Subsection 84C(7)) Amendment Determination 2012 (No. 2)
PB 85 of 2012
Authority
Subsection 84C(7) of the National Health Act 1953 (the Act) provides that the Minister may determine the manner in which the price for all or any pharmaceutical benefits and repatriation pharmaceutical benefits is to be ascertained for the purpose of the Safety Net.
This price is determined in the National Health (Subsection 84C(7)) Determination 2010 (the Principal Determination) as being the sum of the Commonwealth price for a pharmaceutical benefit, calculated in accordance with the determination by the Pharmaceutical Benefits Remuneration Tribunal under paragraph 98B(1)(a) of the Act, and certain additional fees.
Purpose
The purpose of this Amendment Determination is to amend the Principal Determination to reflect amendments to the Act made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 (the Amending Act) which commence on 1 October 2012.
Background
Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Division 1A of Part VII the Act provides for the Safety Net arrangements for the PBS and Repatriation Pharmaceutical Benefits Scheme (RPBS). The Safety Net is designed to reduce the cost of medicines for individuals and families who require a large number of pharmaceutical benefits.
Section 84C of the Act provides that a person is eligible to receive a Safety Net concession card or entitlement card when expenditure on pharmaceutical benefits for the person and their family during an entitlement period reaches a certain amount (the Safety Net amount). A Safety Net concession card or entitlement card enables access to PBS or RPBS medicines at a reduced rate or free of charge for the remainder of the entitlement period. An entitlement period for the Safety Net is a calendar year from 1 January to 31 December.
Section 84C also sets out the amounts which can be taken into account for the purpose of the Safety Net. Where the Commonwealth price for a medicine is equal to or greater than the maximum amount the patient may be charged (the patient co-payment), the amount for Safety Net purposes is the amount charged as the patient co-payment. Where the Commonwealth price for a pharmaceutical benefit is less than the patient co-payment, subsection 84C(4)(e) of the Act provides that the amount to be taken into account for Safety Net purposes will not exceed the sum of the subsection 84C(7) price for the pharmaceutical benefit or repatriation pharmaceutical benefit and any charges (where applicable) for supplying the pharmaceutical benefit outside of normal trading hours and/or by delivery to premises other than the approved pharmacy.
Subsection 84C(7) of the Act provides that the Minister may determine the manner in which the price for all or any pharmaceutical benefits or repatriation pharmaceutical benefits (including those referred to in subsection 84C(4)(e)) is to be ascertained for the purpose of the Safety Net. Subsection 87C(8) provides that the manner determined under subsection (7) shall accord with the requirements set out in subsection (8).
Amendments
Prior to 1 October 2012, paragraph 84C(8)(a) of the Act provided that a manner determined under subsection 84C(7) in relation to a listed brand of a pharmaceutical item, shall take as its base the approved price to pharmacists of the brand. The Amending Act substitutes the “approved ex‑manufacturer price or a proportional ex-manufacturer price” for the “approved price to pharmacists” from 1 October 2012. This Amendment Determination makes the same substitution in the explanation of subsection 84C(8) of the Act in paragraph (a) of Note 1 to section 5 of the Principal Determination.
The subsection 84C(7) price is determined in the Principal Determination to be the sum of the Commonwealth price for a pharmaceutical benefit, calculated in accordance with a determination made under paragraph 98B(1)(a) of the Act, and certain additional amounts. Prior to 1 October 2012, that determination of the Commonwealth price took as its base the approved price to pharmacists of the benefit, but from 1 October 2012 the base is the approved ex-manufacturer price or a proportional ex-manufacturer price of the benefit, reflecting amendments to paragraph 98B(2)(a) of the Act made by the Amending Act. This Amendment Determination makes the same substitution in the explanation of the Commonwealth price in Note 1 to section 5 of the Principal Determination.
Consultation
Consultation was not necessary for this Determination as the amendments are consequential to amendments to the Act and for which consultation was undertaken. There are no changes to substantive provisions in the Principal Determination. The amendments are to explanations in Notes only and are minor and technical in nature.
This Determination commences on 1 October 2012.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Subsection 84C(7)) Amendment Determination 2012 (No. 2)
PB 85 of 2012
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the legislative instrument
The purpose of this legislative instrument, made under subsection 84C(7) of the National Health Act 1953 (the Act), is to amend the National Health (Subsection 84C(7)) Determination 2010 (the Principal Determination) to reflect amendments to the Act commencing on 1 October 2012.
The Principal Determination sets out the manner of determining the price of pharmaceutical benefits for the purposes of the Pharmaceutical Benefits Scheme Safety Net.
This instrument contains no amendments to substantive provisions of the Principal Determination; the amendments are to explanations in Notes only; they are minor and technical in nature, reflecting amendments to the Act.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Pharmaceutical Benefits Scheme is a benefit scheme which assists with advancement of this human right by providing for subsidised access for patients to medicines.
Conclusion
The legislative instrument is compatible with human rights because it advances the protection of human rights.
Tanya Plibersek
Minister for Health