EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2018 (No. 6)
PB 52 of 2018
Purpose
The purpose of this legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953 (the Act) is to amend the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015) (the Principal Instrument).
PB 120 of 2015 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply.
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.
Authority
Subsection 84AAA(1) of the Act provides that a supply of a pharmaceutical benefit (whether or not the supply is of a kind described in paragraph 84C(4A)(a) of the Act) to a person is an early supply of a specified pharmaceutical benefit if:
(a) The supply is made within 20 days after the day of a previous supply to the person of:
(i) the same pharmaceutical benefit; or
(ii) another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or
(iii) another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit;
whether or not the previous supply is a supply of a kind described in paragraph 84C(4A)(a) of the Act; and
(b) The pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2); and
(c) The supply does not result from a prescription originating from a hospital.
Subsection 84AAA(2) of the Act provides that the Minister may specify, by legislative instrument, pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act.
Subsection 84AAA(3) provides that the instrument may specify a pharmaceutical item by reference to the circumstances in which a pharmaceutical benefit that has the pharmaceutical item is supplied or any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item.
Paragraph 84C(4A) of the Act refers to repatriation pharmaceutical benefits supplied under the schemes established under section 91 of the Veterans’ Entitlements Act 1986 or section 18 of the Australian Participants in British Nuclear Tests (Treatment) Act 2006 or supplied in accordance with a determination made under paragraph 256(1)(c) of the Military Rehabilitation and Compensation Act 2004.
Subsection 101(3AA) of the Act requires the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2).
Changes to PB 120 of 2015 made by this instrument
Schedule 1 to the Principal Instrument is amended by the addition, deletion and alteration of listed pharmaceutical items and associated periods and circumstances. These changes are summarised, by subject matter, in the Attachment.
The ‘listed drug’, ‘form’, ‘manner of administration’, ‘maximum quantity or number of units’ and ‘maximum number of repeats’ for a pharmaceutical item are the same as declared and determined under the Act for pharmaceutical benefits that have a pharmaceutical item. These declarations and determinations are made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Therefore, a supply of a pharmaceutical benefit that has this pharmaceutical item will be an early supply of a specified pharmaceutical benefit providing the requirements of subsection 84AAA(1) are met.
Variation and revocation
Unless there is an express power to revoke or vary PB 120 of 2015 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 120 of 2015.
Consultation
The involvement of PBAC constitutes a formal and ongoing process of consultation. The PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. The Committee also includes a pharmaceutical industry nominee. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the Committee. The PBAC has provided advice regarding what should be specified in this Instrument.
This amendment is minor and machinery in nature.
General
This Instrument commences on 1 July 2018.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2018 (No. 6)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2018 (No. 6) and may also be cited as PB 52 of 2018.
Section 2 Commencement
This section provides that the Instrument commences on 1 July 2018.
Section 3 Amendment of National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015)
This section provides that Schedule 1 amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015).
Schedule 1 Amendments
The amendments in Schedule 1 involve additions, deletions and changes to pharmaceutical items listed in Schedule 1 of the Principle Instrument and the associated periods (days) and circumstances. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Ribociclib | Tablet 200 mg |
Forms Deleted
Clopidogrel | Tablet 75 mg |
Maximum Quantity Deleted
Balsalazide | Capsule containing balsalazide sodium 750 mg [Maximum Quantity: 180; Number of Repeats: 5] |
International Harmonisation of Ingredient Names – listed drug changes
The following listed drug names have been updated to align with the International Harmonisation of Ingredient Names (IHIN) reform being administered by Therapeutic Goods Administration (TGA).
From | To |
Aclidinium with eformoterol | Aclidinium with formoterol |
Benzhexol | Trihexyphenidyl |
Esomeprazole and Clarithromycin and Amoxycillin | Esomeprazole and Clarithromycin and Amoxicillin |
Oestradiol | Estradiol |
Oestradiol and Oestradiol with Dydrogesterone | Estradiol and Estradiol with Dydrogesterone |
Oestradiol and Oestradiol with Norethisterone | Estradiol and Estradiol with Norethisterone |
Oestradiol with dydrogesterone | Estradiol with dydrogesterone |
Oestradiol with Norethisterone | Estradiol with Norethisterone |
Frusemide | Furosemide |
Levonorgestrel with Ethinyloestradiol | Levonorgestrel with Ethinylestradiol |
Norethisterone with Ethinyloestradiol | Norethisterone with Ethinylestradiol |
Phenobarbitone | Phenobarbital |
Salcatonin | Calcitonin salmon |
Thyroxine | Levothyroxine |
International Harmonisation of Ingredient Names – form changes
The following forms of listed drugs have been updated to align with the International Harmonisation of Ingredient Names (IHIN) reform being administered by Therapeutic Goods Administration (TGA).
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 |
Amlodipine | Tablet 5 mg (as besylate) | Tablet 5 mg (as besilate) |
| Tablet 10 mg (as besylate) | Tablet 10 mg (as besilate) |
Amlodipine with Atorvastatin | Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) |
| Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) |
| Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) |
| Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) |
| Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) |
| Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) |
| Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) |
| Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) |
Amlodipine with valsartan | Tablet 5 mg (as besylate)-80 mg | Tablet 5 mg (as besilate)-80 mg |
| Tablet 5 mg (as besylate)-160 mg | Tablet 5 mg (as besilate)-160 mg |
| Tablet 5 mg (as besylate)-320 mg | Tablet 5 mg (as besilate)-320 mg |
| Tablet 10 mg (as besylate)-160 mg | Tablet 10 mg (as besilate)-160 mg |
| Tablet 10 mg (as besylate)-320 mg | Tablet 10 mg (as besilate)-320 mg |
Amlodipine with valsartan and hydrochlorothiazide | Tablet 5 mg (as besylate)-160 mg-12.5 mg | Tablet 5 mg (as besilate)-160 mg-12.5 mg |
| Tablet 5 mg (as besylate)-160 mg-25 mg | Tablet 5 mg (as besilate)-160 mg-25 mg |
| Tablet 10 mg (as besylate)-160 mg-12.5 mg | Tablet 10 mg (as besilate)-160 mg-12.5 mg |
| Tablet 10 mg (as besylate)-160 mg-25 mg | Tablet 10 mg (as besilate)-160 mg-25 mg |
| Tablet 10 mg (as besylate)-320 mg-25 mg | Tablet 10 mg (as besilate)-320 mg-25 mg |
Eprosartan | Tablet 400 mg (as mesylate) | Tablet 400 mg (as mesilate) |
| Tablet 600 mg (as mesylate) | Tablet 600 mg (as mesilate) |
Eprosartan with Hydrochlorothiazide | Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide | Tablet 600 mg eprosartan (as mesilate) with 12.5 mg hydrochlorothiazide |
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* | Tablet containing oestradiol valerate 1 mg | Tablet containing estradiol valerate 1 mg |
| Tablet containing oestradiol valerate 2 mg | Tablet containing estradiol valerate 2 mg |
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 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 |
| 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 |
Estradiol with Norethisterone* | 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 |
| 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 |
Levothyroxine* | Tablet containing 50 micrograms anhydrous thyroxine sodium | Tablet containing 50 micrograms anhydrous levothyroxine sodium |
| Tablet containing 75 micrograms anhydrous thyroxine sodium | Tablet containing 75 micrograms anhydrous levothyroxine sodium |
| Tablet containing 100 micrograms anhydrous thyroxine sodium | Tablet containing 100 micrograms anhydrous levothyroxine sodium |
| Tablet containing 200 micrograms anhydrous thyroxine sodium | Tablet containing 200 micrograms anhydrous levothyroxine sodium |
Olmesartan with amlodipine | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) | Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) | Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) |
Perindopril with amlodipine | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besilate) |
| Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) | Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besilate) |
| Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) | Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besilate) |
| Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) | Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besilate) |
Sorafenib | Tablet 200 mg (as tosylate) | Tablet 200 mg (as tosilate) |
Telmisartan with amlodipine | Tablet 40 mg 5 mg (as besylate) | Tablet 40 mg 5 mg (as besilate) |
| Tablet 40 mg 10 mg (as besylate) | Tablet 40 mg 10 mg (as besilate) |
| Tablet 80 mg 5 mg (as besylate) | Tablet 80 mg 10 mg (as besilate) |
Trihexyphenidyl* | Tablet containing benzhexol hydrochloride 2 mg | Tablet containing trihexyphenidyl hydrochloride 2 mg |
| Tablet containing benzhexol hydrochloride 5 mg | Tablet containing trihexyphenidyl hydrochloride 5 mg |
* 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 (Pharmaceutical Benefits – early supply) Amendment Instrument 2018 (No. 6)
(PB 52 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 National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2018 (No. 6) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 which specifies the pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.
Schedule 1 to the Principal Instrument is amended by the addition, deletion and alteration of listed pharmaceutical items and associated periods and circumstances.
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