EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2018 (No. 5)
PB 64 of 2018
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. The Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) (the Principal Determination) sets out the conditions subject to which these payments will be made.
Purpose
The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
The amendments made by this Instrument include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle Determination.
The Instrument also makes changes required to implement the International Harmonisation of Ingredient Names (IHIN). Under the IHIN, the names used for active ingredients and pharmaceutical formulations in Australia are being updated to conform with nomenclature used internationally. The changes in the Instrument are consistent with changes already made to the Australian Register of Therapeutic Goods. These changes are detailed in the attached Summary of Changes.
A provision by provision description of this Instrument is contained in the Attachment.
Variation and revocation
Unless there is an express power to revoke or vary PB 119 of 2008 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 119 of 2008.
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, medical specialists and a pharmaceutical industry nominee. 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.
This Instrument commences on 1 August 2018.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2018 (No. 5)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 5) and may also be cited as PB 64 of 2018.
Section 2 Commencement
This section provides that the Instrument commences on 1 August 2018.
Section 3 Amendment of 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
The amendments in Schedule 1 include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle Determination. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Clozapine | Oral liquid 50 mg per mL, 100 mL |
International Harmonisation of Ingredient Names – listed drug changes
From | To |
Aclidinium with eformoterol | Aclidinium with formoterol |
Amoxycillin | Amoxicillin |
Amoxycillin with Clavulanic Acid | Amoxicillin with clavulanic acid |
Beclomethasone | Beclometasone |
Budesonide with Eformoterol | Budesonide with formoterol |
Cephalexin | Cefalexin |
Dexamphetamine | Dexamfetamine |
Eformoterol | Formoterol |
Esomeprazole and Clarithromycin and Amoxycillin | Esomeprazole and clarithromycin and amoxicillin |
Fluticasone with eformoterol | Fluticasone with formoterol |
Frusemide | Furosemide |
Oestradiol | Estradiol |
Oestradiol and Oestradiol with Dydrogesterone | Estradiol and estradiol with dydrogesterone |
Oestradiol and Oestradiol with Norethisterone | Estradiol and estradiol with norethisterone |
Oestradiol with Norethisterone | Estradiol with norethisterone |
Oestriol | Estriol |
International Harmonisation of Ingredient Names – form changes
Listed drug | From | To |
Aclidinium with formoterol* | Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses |
Amoxicillin with clavulanic acid* | Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL |
Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | |
Atropine | Eye drops containing atropine sulfate 10 mg per mL, 15 mL | Eye drops containing atropine sulfate monohydrate 10 mg per mL, 15 mL |
Beclometasone* | Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) |
Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | |
Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) | |
Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | |
Budesonide with formoterol* | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses |
Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | |
Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 | Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 | |
Cefalexin* | Granules for oral suspension 125 mg per 5 mL, 100 mL | Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL |
Granules for oral suspension 250 mg per 5 mL, 100 mL | Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL | |
Codeine | Tablet containing codeine phosphate 30 mg | Tablet containing codeine phosphate hemihydrate 30 mg |
Dexamfetamine* | Tablet containing dexamphetamine sulfate 5 mg | Tablet containing dexamfetamine sulfate 5 mg |
Electrolyte Replacement, Oral | Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 |
Esomeprazole and clarithromycin and amoxicillin* | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) |
Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) | |
Estradiol and estradiol with dydrogesterone* | Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg | Pack containing 14 tablets estradiol 1 mg and 14 tablets estradiol 1 mg with dydrogesterone 10 mg |
Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg | Pack containing 14 tablets estradiol 2 mg and 14 tablets estradiol 2 mg with dydrogesterone 10 mg | |
Estradiol and estradiol with norethisterone* | Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate | Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate |
Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate | Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate | |
Estradiol with norethisterone* | Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 | Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 |
Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 | Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 | |
Ferrous sulfate | Oral liquid 30 mg per mL, 250 mL | Oral liquid containing 30 mg ferrous sulfate heptahydrate per mL, 250 mL |
Flucloxacillin | Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Powder for oral liquid 125 mg (as sodium monohydrate) per 5 mL, 100 mL |
Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL | |
Fluticasone with formoterol* | Pressurised inhalation containing fluticasone propionate 50 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses |
Pressurised inhalation containing fluticasone propionate 125 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses | |
Pressurised inhalation containing fluticasone propionate 250 micrograms with eformoterol fumarate dihydrate 10 micrograms per dose, 120 doses | Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses | |
Formoterol* | Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses | Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 6 micrograms per dose, 60 doses |
Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 12 micrograms per dose, 60 doses | |
Mercaptopurine | Oral suspension 20 mg per mL, 100 mL | Oral suspension containing mercaptopurine monohydrate 20 mg per mL, 100 mL |
Morphine | Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets) |
Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets) | |
Capsule containing morphine sulfate 30 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 30 mg (controlled release) | |
Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets) | |
Capsule containing morphine sulfate 60 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 60 mg (controlled release) | |
Capsule containing morphine sulfate 90 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 90 mg (controlled release) | |
Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets) | |
Capsule containing morphine sulfate 120 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 120 mg (controlled release) | |
Injection containing morphine hydrochloride 10 mg in 1 mL | Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL | |
Injection containing morphine hydrochloride 20 mg in 1 mL | Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL | |
Injection containing morphine hydrochloride 50 mg in 5 mL | Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL | |
Injection containing morphine hydrochloride 100 mg in 5 mL | Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL | |
Injection containing morphine sulfate 10 mg in 1 mL | Injection containing morphine sulfate pentahydrate 10 mg in 1 mL | |
Injection containing morphine sulfate 15 mg in 1 mL | Injection containing morphine sulfate pentahydrate 15 mg in 1 mL | |
Injection containing morphine sulfate 30 mg in 1 mL | Injection containing morphine sulfate pentahydrate 30 mg in 1 mL | |
Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 200 mL | |
Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL | |
Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL | |
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet | |
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet | |
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet | |
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet | |
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet | |
Tablet containing morphine sulfate 5 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 5 mg (controlled release) | |
Tablet containing morphine sulfate 10 mg | Tablet containing morphine sulfate pentahydrate 10 mg | |
Tablet containing morphine sulfate 10 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 10 mg (controlled release) | |
Tablet containing morphine sulfate 15 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 15 mg (controlled release) | |
Tablet containing morphine sulfate 20 mg | Tablet containing morphine sulfate pentahydrate 20 mg | |
Tablet containing morphine sulfate 30 mg | Tablet containing morphine sulfate pentahydrate 30 mg | |
Tablet containing morphine sulfate 30 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 30 mg (controlled release) | |
Tablet containing morphine sulfate 60 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 60 mg (controlled release) | |
Tablet containing morphine sulfate 100 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 100 mg (controlled release) | |
Tablet containing morphine sulfate 200 mg (controlled release) | Tablet containing morphine sulfate pentahydrate200 mg (controlled release) |
* New listed drug name (refer to table: International Harmonisation of Ingredient Names – listed drug changes)
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 5)
(PB 64 of 2018)
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 (PB 119 of 2008) (the Principal Determination) 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 Principal Determination to provide for changes to those conditions. Schedule 1 to this Legislative Instrument provides for additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle Determination. This includes changes required to implement the International Harmonisation of Ingredient Names.
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.
Lisa La Rance
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health