EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 2)
PB 8 of 2018
Authority
Subsection 88(1) of the National Health Act 1953 (the Act), as amended by the National Health Amendment (Pharmaceutical Benefits – Budget and Other Measures) Act 2017 (the Amendment Act), provides that the Minister may determine, by legislative instrument, the pharmaceutical benefits for which a medical practitioner is authorised to write a prescription for supply as a pharmaceutical benefit.
Purpose
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 2) (the instrument) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (the principal instrument) to make changes required as a result of the commencement of Schedule 8 of the Amendment Act. Under subsection 88(1) of the Act as amended, it is necessary for the Minister to determine the pharmaceutical benefits for which a medical practitioner is authorised to write a prescription under the Pharmaceutical Benefits Scheme (PBS).
To meet this requirement, the instrument inserts new subsection 9(1A) into the principal instrument which provides that the Minister has determined that a medical practitioner is authorised to write a prescription for the supply of any pharmaceutical benefit. The instrument also repeals a note at the end of section 9 of the principal instrument which had reminded the reader that subsection 88(1) of the Act had provided previously that a medical practitioner could prescribe any pharmaceutical benefit. The insertion of the new subsection in section 9 means that this note is no longer required.
Background
Prior to the changes made by the Amendment Act, subsection 88(1) of the Act provided an overarching authority for a medical practitioner to write a prescription for the supply of any pharmaceutical benefit.
Subsection 88(1) as amended provides that a medical practitioner is authorised to write a prescription for the supply of any pharmaceutical benefit determined from time to time by the Minister by legislative instrument.
The amendment of the Act has brought the provisions for specifying the PBS medicines for prescribing by medical practitioners into line with those for other PBS prescribers. It means that pharmaceutical benefits for prescribing by medical practitioners are determined by the Minister; as are pharmaceutical benefits for prescribing by dentists, optometrists, nurse practitioners and midwives.
The change is necessary to enable an existing PBS listing for a medicine to be designated as being for ‘supply only’ when certain particulars of a listing change. For a supply only listing, existing prescriptions held by patients can be dispensed by approved suppliers, but no new prescriptions can be written by medical practitioners (or any other PBS prescriber). Prescriptions written with the old details remain valid for dispensing using the old listing, but all new prescriptions are written and supplied using the revised listing. To achieve this, a pharmaceutical benefit needs to be able to be listed without automatic authority for a medical practitioner to write a prescription for supply of that benefit (that is, it is necessary to be able to ‘turn off’ medical practitioner prescribing for supply only items).
The instrument determines that any pharmaceutical benefit listed on the PBS on the date of effect of the instrument can be prescribed by a medical practitioner. This in effect ‘grandfathers’ all PBS listings to the new arrangements.
The effect of the amendment to the principal instrument is that all pharmaceutical benefits currently listed on the PBS are determined for prescribing by medical practitioners under subsection 88(1) the Act. The amendment does not change the pharmaceutical benefits that can be prescribed by medical practitioners and does not result in any change to listings for pharmaceutical benefits. The instrument does not designate any listings as supply only.
Consultation
Consultation has occurred with the Department of Human Services. Public consultation was not considered necessary as the amendment maintains the pharmaceutical benefits that can be prescribed by medical practitioners.
General
A provision by provision description of the instrument is contained in the Attachment.
This instrument commences immediately after the commencement of Schedule 8 to the Amendment Act.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
This instrument has been made in anticipation of the commencement of subsection 88(1) of the Act as amended by the Amendment Act. As such, it relies on subsection 4(2) of the Acts Interpretation Act 1901.
ATTACHMENT
Provision by provision description of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 2)
Section 1 Name of Instrument
This section provides that the instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 2) and which may also be cited as PB 8 of 2018.
Section 2 Commencement
This section provides that the instrument commences immediately after the commencement of Schedule 8 to the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2017 (the Amendment Act).
Section 3 Authority
This section provides that the instrument is made under subsection 88(1) of the National Health Act 1953 (the Act).
Section 4 Schedule
This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the instrument has effect according to its terms. The Schedule to the instrument specifies the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
Item 1 Before subsection 9(1)
This item inserts new subsection 9(1A), which provides that for the purposes of subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of any pharmaceutical benefit.
This means that a medical practitioner may prescribe any drug listed for supply as a pharmaceutical benefit under the Pharmaceutical Benefits Scheme. It should be noted, however, that the writing of a prescription for supply as a pharmaceutical benefit can only be in accordance with any circumstances and purposes determined by the Minister under the Act.
Item 2 Section 9 (note)
This item repeals the note at the end of section 9, which is obsolete. The note reminded the reader that prior to the amendment of subsection 88(1) of the Act by the Amendment Act, a medical practitioner was authorised to prescribe any pharmaceutical benefit. Under subsection 88(1) as amended, the Minister determines the pharmaceutical benefits a medical practitioner is authorised to prescribe, and new subsection 9(1A) of the instrument serves this purpose by indicating the relevant pharmaceutical benefits.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 2)
(PB 8 of 2018)
This 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 Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 2) (the instrument) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the principal instrument) which determines the pharmaceutical benefits that are included on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms and brands. The principal instrument also provides for related matters, including prescribing circumstances, schedule equivalence, maximum quantities, numbers of repeats, determined quantities, pack quantities, and drugs which are section 100 only or prescriber bag only.
The instrument does not alter the drugs currently listed in the principal instrument. Rather, it makes changes in response to the amendment of subsection 88(1) of the National Health Act 1953 (the Act). The amendment of subsection 88(1) replaced an overarching provision which authorised medical practitioners to prescribe any pharmaceutical benefit under the PBS with a new power that provides for the Minister to determine the pharmaceutical benefits that may be prescribed by medical practitioners under the PBS. The change to the Act has brought the provisions for medical practitioners into line with the existing provisions for determining benefits for prescribing by other PBS prescriber groups.
The principal instrument now provides that a medical practitioner is authorised to write a prescription for the supply of any pharmaceutical benefit. The effect is that medical practitioners may prescribe all the same pharmaceutical benefits after commencement of the instrument as before.
Human rights implications
The instrument is compatible with human rights, being the rights and freedoms recognised or declared by the international instruments listed in subsection 3(1) of the Human Rights (Parliamentary Scrutiny) Act 2011 as they apply to Australia.
The principal instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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. It does this by supporting arrangements for access to affordable medicines for consumers via the PBS. The amendment to the principal instrument ensures that medical practitioners can continue to prescribe all pharmaceutical benefits listed on the PBS and does not affect the benefits listed on the PBS, or any other aspect of the operation of the principal instrument.
Taking into account the effect of the instrument and the nature of the applicable rights and freedoms, the outcome is that the instrument promotes the right to health and does not limit any rights or freedoms.
Conclusion
The instrument is compatible with human rights as it does not raise any human rights issues.
Greg Hunt
Minister for Health