EXPLANATORY STATEMENT
Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953
PB 75 OF 2012
Authority
Paragraph 98C(1)(b) of the National Health Act 1953 (the Act) provides that the Minister may determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. PB 119 of 2008 (Determination under paragraph 98C(1)(b) of the National Health Act 1953) (the Principal Determination) sets out the conditions subject to which these payments will be made.
Purpose
This Amendment Determination amends the Principal Determination to reflect amendments to the Act made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 which commence on 1 October 2012.
The principal amendments to the Act which are reflected in this Amendment Determination are:
- the removal of the concept of an approved price to pharmacists and its replacement with approved ex-manufacturer price as the base PBS price. The approved ex-manufacturer price of a brand of a pharmaceutical item is the price agreed or determined under the Act as the appropriate maximum price for the purposes of Part VII of the Act. The price for each brand of a pharmaceutical item must be agreed or determined by reference to the lowest pack quantity of any brand of the pharmaceutical item. The Act provides for proportional
ex-manufacturer prices for other pack quantities and - the removal of the approved price to pharmacists and its replacement with the approved ex-manufacturer price as the basis for calculating Commonwealth payments to pharmacists.
This Amendment Determination also amends the Principal Determination to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 commencing on the same day by:
- adding the listed drug Carbomer with Triglyceride Lipids in the form eye gel
2 mg-10 mg per g, 10 g to Schedule 4 of the Principal Determination; and - removing the listed drug Risedronic acid and calcium with colecalciferol in the form pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms from Schedule 4 of the Principal Determination.
A provision by provision description is contained in the Attachment.
Background
Part VII of the National Health Act 1953 (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.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
Consultations
The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme. The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.
The instrument commences on 1 October 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the Determination under paragraph 98C(1)(b) of the National Health Act 1953
Section 1 Name of Determination
This section provides that the title of the Determination is the Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 and that it may also be cited as PB 75 of 2012.
Section 2 Commencement
This section provides for the Determination to commence on 1 October 2012.
Section 3 Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008)
This section provides that Schedule 1 amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008).
SCHEDULE 1―AMENDMENTS
Item [1] – Section 3
This item omits the definition of approved price to pharmacists and inserts a definition of the term approved ex-manufacturer price. From 1 October 2012 this will be the base PBS price in the Act and legislative instruments. The Minister will agree an approved ex-manufacturer price for each brand of a pharmaceutical item with the responsible person for the brand, or will determine an approved ex-manufacturer price if no agreement can be reached. Commonwealth payments in relation to the supply of pharmaceutical benefits will be based on the approved ex-manufacturer price under the Principal Determination and other legislative instruments from 1 October 2012.
Item [2] – Section 3
This item inserts a definition of the new term pack quantity. Pack quantity has the same meaning as in the Act. This is a new term in the Act from 1 October 2012. The Minister will determine pack quantities for each listed brand of a pharmaceutical item. Responsible persons will request the Minister to determine pack quantities for each of their PBS pack sizes. The approved ex-manufacturer price for each brand of a pharmaceutical item will be agreed or determined by reference to the lowest pack quantity for any brand of that pharmaceutical item. All other pack quantities will have proportional ex-manufacturer prices calculated under the Act.
Item [3] – Section 3
This item inserts a definition of proportional ex-manufacturer price. The term has the same meaning as in the Act.
Item [4] – Section 5
This item replaces a reference to the approved price to pharmacists for the brand with a reference to the approved ex-manufacturer price or the proportional ex-manufacturer price for a pack quantity of the brand. The change reflects the change to the ex-manufacture price as the base PBS price from which Commonwealth payments are calculated.
Item [5] – Section 6
This item replaces a reference to the approved price to pharmacists with a reference to the approved ex-manufacturer price or the proportional ex-manufacturer price for a pack quantity. The change reflects the change to the ex-manufacture price as the base PBS price from which Commonwealth payments are calculated.
Items [6] and [7] – Section 9
These items amend references to paragraph numbers in another legislative instrument to section numbers in the instrument to reflect amendments to the numbering in that instrument. The legislative provision under which the instrument is made is also clarified.
Item [8] – Schedule 4, after entry for Carbomer
This item inserts the listed drug Carbomer with Triglyceride Lipids in the form eye gel
2 mg-10 mg per g, 10 g into Schedule 4 of the Principal Determination to make it a condition that all pharmaceutical benefits with the drug in that form must be supplied as a complete pack regardless of any lesser quantity prescribed.
Item [9] – Schedule 4, entry for Risedronic acid and calcium with colecalciferol
This item removes the listed drug Risedronic acid and calcium with colecalciferol in the form pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms from Schedule 4 of the Principal Determination reflecting that the pharmaceutical benefit with the drug in this form is being removed from the PBS.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Determination under paragraph 98C(1)(b) of the National Health Act 1953
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 determination under paragraph 98C(1)(b) of the National Health Act 1953 sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
This legislative instrument amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008). The amendments provide for changes to the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners and reflect amendments to the Act made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 which commence on 1 October 2012.
This instrument adds one drug and form and removes one form of a drug from Schedule 4 of the Determination.
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 PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Kim Bessell
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health and Ageing