EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2014 (No. 14)
PB 109 of 2014
Purpose
The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A and 88 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to ensure that pharmaceutical benefits with the drug Paracetamol, in the form ‘Tablet 665 mg (modified release)’, and with the Responsible Person ‘Apotex Pty Ltd’ are not listed on the Pharmaceutical Benefits Scheme (PBS) on 1 January 2015.
PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).
Authority
This Instrument exercises various powers in Part VII of the Act, as set out below:
Brands of pharmaceutical items listed on the PBS
The Minister may determine a brand of a pharmaceutical item (subsection 85(6)). The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)). Under the provisions of section 84AK the Minister may determine the pack quantity for a brand of a pharmaceutical item.
Prescribing pharmaceutical benefits
Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit. Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.
Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion. Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated. The maximum quantities and repeats may be determined for all purposes or for particular purposes.
Variation and revocation
Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon for this Instrument.
Changes to PB 71 of 2012 made by this instrument
Schedule 1 to this instrument ensures that brands of pharmaceutical benefits with the drug Paracetamol, in the form ‘Tablet 665 mg (modified release)’, and with the Responsible Person ‘Apotex Pty Ltd’ namely: APO-Osteo Paracetamol 665 mg; Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg; Chem mart Pharmacy Osteo Relief Paracetamol 665 mg; and Terry White Chemists Osteo Relief Paracetamol
665 mg, are not listed on the PBS on 1 January 2015. These brands are included in the the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13) (PB 101 of 2014), with the effective date of 1 January 2015.
Consultation
Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.
General
This Instrument commences on 1 January 2015.
This Instrument 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 (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 14)
(PB 109 of 2014)
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 National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 14) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
This legislative lnstrument ensures that brands of pharmaceutical benefits with the drug Paracetamol, in the form ‘Tablet 665 mg (modified release)’, and with the Responsible Person ‘Apotex Pty Ltd’ namely: APO-Osteo Paracetamol 665 mg; Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg; Chem mart Pharmacy Osteo Relief Paracetamol 665 mg; and Terry White Chemists Osteo Relief Paracetamol
665 mg, are not listed on the PBS on 1 January 2015.
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.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health