EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2015 (No. 9)
PB 108 of 2015
Authority
This legislative instrument, made under section 85B of the National Health Act 1953 (the Act) amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010) (the Principal Determination).
Subsections 85B(2), (3) and (4) of the National Health Act 1953 (the Act) provide for the Minister to determine, respectively, determined prices, claimed prices and the circumstances in which the Commonwealth will pay a special patient contribution. The National Health (Price and Special Patient Contribution) Determination 2010 (the Principal Determination) contains determinations of these matters.
Variation and revocation
Unless there is an express power to revoke or vary PB 109 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 109 of 2010.
Purpose
The Act provides for the Minister and the responsible person to agree a price that is taken to be the appropriate maximum price of a brand of a pharmaceutical item for the purposes of Part VII of the Act (section 85AD). Section 85B of the Act applies if the Minister and the responsible person have been unable to reach an agreement on a price for the pricing quantity. Whether or not an agreement is made for the pricing quantity, section 85B also applies if the responsible person is dissatisfied with the proportional ex-manufacturer prices that will apply to other pack quantities.
Subsection 85B(2) provides that the Minister may determine, by reference to the pricing quantity of a brand of a pharmaceutical item, an amount that is taken to be the appropriate maximum price of the brand for the purposes of Part VII of the Act. This is termed the ‘Determined Price’ in this Determination.
Subsection 85B(3) provides that the Minister may determine, by reference to a pack quantity of a brand of the pharmaceutical item, an amount that is taken to be the price claimed by the responsible person for the pack quantity of the brand, for the purposes of Part VII of the Act. This is termed the ‘Claimed Price’ in this Determination.
The Determined Price is the approved ex-manufacturer price and is used as the basis for working out the Commonwealth price for the brand of the pharmaceutical item (section 98B of the Act); for pack quantities other than the pricing quantity, the proportional ex-manufacturer price is used as the basis. Approved pharmacists are entitled to payment from the Commonwealth equal to the Commonwealth price less the applicable patient co-payment (section 99 of the Act).
The difference between the responsible person’s Commonwealth price for a pack quantity (ie, the price that would be the Commonwealth price if the responsible person’s claimed price had become the approved ex-manufacturer price or the proportional ex-manufacturer price for that pack quantity) and the Commonwealth price for the pack quantity is defined in subsection 85B(5) of the Act as the special patient contribution. An approved pharmacist may charge a patient an amount equal to the special patient contribution, in addition to any other amount that may be charged (subsection 87(2A) of the Act).
Subsection 85B(4) of the Act provides that the Minister may determine the circumstances in which the Commonwealth is to pay the special patient contribution for a brand. In such cases, the Commonwealth payment to the pharmacist is increased by the amount of the special patient contribution (subsection 99(2AA) of the Act) and the pharmacist may not charge the patient this amount (subsection 87(2A) of the Act).
The purpose of making subsection 85B(4) determinations is to enable patients for whom the base-priced brands (the ones without a special patient contribution) are not suitable, to obtain the higher priced brand (the one with the special patient contribution) without the need to pay the higher price. In such cases the Commonwealth pays the special patient contribution.
This instrument (the Amending Determination) amends the Principal Determination by: adding a new brand premium to three brands of two pharmaceutical items and increases, decreases or maintains brand or therapeutic group premiums to other brands of pharmaceutical items. It also removes one brand of a pharmaceutical item that no longer has a premium and another brand of a pharmaceutical item that is no longer PBS listed.
Consultation
This determination affects certain responsible persons with medicines listed on the PBS. Before a pharmaceutical benefit is listed on the PBS, and from time to time thereafter, price negotiations occur between the responsible person and the Minister for the purpose of reaching a price agreement for section 85AD of the Act. Consultation was considered unnecessary (or inappropriate) because this instrument essentially involves a price negotiation between the Minister (or delegate) and the responsible persons.
A provision by provision description of the Amending Determination is contained in the Attachment.
This Determination commences on 1 December 2015.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2015 (No. 9)
(PB 108 of 2015)
Section 1 Name of Determination
This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2015 (No. 9) and may also be cited as PB 108 of 2015.
Section 2 Commencement
This section provides that the Determination commences on 1 December 2015.
Section 3 Amendment of the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).
This section provides that Schedule 1 amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).
Schedule 1 Amendments commencing 1 December 2015
Schedule 1 sets out the amendments to the Principal Determination which commence on 1 December 2015.
SUMMARY OF CHANGES
SCHEDULE 1
Brands with a increased brand premium
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Fosamax Plus |
Betamethasone | Cream 200 micrograms (as valerate) per g, 100 g | Celestone-M |
| Cream 500 micrograms (as dipropionate) per g, 15 g | Diprosone |
| Ointment 500 micrograms (as dipropionate) per g, 15 g | Diprosone |
Betaxolol | Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL | Betoptic |
Brinzolamide | Eye drops 10 mg per mL, 5 mL | Azopt |
Candesartan | Tablet containing candesartan cilexetil | Atacand |
| Tablet containing candesartan cilexetil | Atacand |
| Tablet containing candesartan cilexetil 16 mg | Atacand |
| Tablet containing candesartan cilexetil 32 mg | Atacand |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide | Atacand Plus 16/12.5 |
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide | Atacand Plus 32/12.5 |
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg | Atacand Plus 32/25 |
Carbamazepine | Tablet 100 mg | Tegretol 100 |
| Tablet 200 mg | Tegretol 200 |
Carbomer | Eye gel 2 mg per g, 10 g | Viscotears |
Ciprofloxacin | Eye drops 3 mg (as hydrochloride) per mL, 5 mL | Ciloxan |
| Tablet 250 mg (as hydrochloride) | Ciproxin 250 |
| Tablet 500 mg (as hydrochloride) | Ciproxin 500 |
Citalopram | Tablet 20 mg (as hydrobromide) | Cipramil |
Clarithromycin | Tablet 250 mg | Klacid |
Clomipramine | Tablet containing clomipramine hydrochloride 25 mg | Anafranil 25 |
Doxycycline | Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) (pricing quantity 7) | Doryx Mayne Pharma Doxycycline |
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) (pricing quantity 21) | Doryx Mayne Pharma Doxycycline |
| Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Doryx Mayne Pharma Doxycycline |
Escitalopram | Tablet 10 mg (as oxalate) | Lexapro |
| Tablet 20 mg (as oxalate) | Lexapro |
Hypromellose | Eye drops 3 mg per mL, 15 mL | Genteal |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3mg-2mg per g, 10 g | Genteal gel |
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, | Tears Naturale |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets | Microgynon 30 ED |
| Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets | Triquilar ED |
Metoprolol | Tablet containing metoprolol tartrate | Betaloc Lopresor 50 |
| Tablet containing metoprolol tartrate | Betaloc Lopresor 100 |
Nifedipine | Tablet 10 mg | Adalat 10 |
| Tablet 20 mg | Adalat 20 |
| Tablet 30 mg (controlled release) | Adalat Oros 30 |
| Tablet 60 mg (controlled release) | Adalat Oros 60 |
Propranolol | Tablet containing propranolol hydrochloride 10 mg | Inderal |
| Tablet containing propranolol hydrochloride 40 mg | Inderal |
Simvastatin | Tablet 10 mg | Lipex 10 Zocor |
| Tablet 20 mg | Lipex 20 Zocor |
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| Tablet 40 mg | Lipex 40 Zocor |
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| Tablet 80 mg | Lipex 80 Zocor |
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Verapamil | Tablet containing verapamil hydrochloride 80 mg | Isoptin |
| Tablet containing verapamil hydrochloride 180 mg (sustained release) | Isoptin 180 SR |
| Tablet containing verapamil hydrochloride 240 mg (sustained release) | Isoptin SR |
Zolmitriptan | Tablet 2.5 mg | Zomig |
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Brand with a price change and no change to brand premium
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Depo-Medrol |
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Brand with a price change and increased brand premium
Oxazepam | Tablet 15 mg | Serepax |
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Brands with new brand premiums
Imiquimod | Cream 50 mg per g, 2 g, 2 | Aldara Pump |
| Cream 50 mg per g, 250 mg single use sachets, 12 | Aldara |
Sumatriptan | Tablet 50 mg (as succinate) (pricing quantity 4) | Imigran |
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Brands with increased therapeutic group premiums
Eprosartan | Tablet 400 mg (as mesylate) | Teveten |
| Tablet 600 mg (as mesylate) | Teveten |
Brand that no longer has a brand premium
Potassium Chloride | Tablet 600 mg (sustained release) | Slow K |
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Brand that is no longer PBS listed
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Duratears
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Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Price and Special Patient Contribution) Amendment Determination 2015 (No. 9) (PB 108 of 2015)
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
This legislative instrument, made under section 85B of the National Health Act 1953 (the Act), amends the National Health (Price and Special Patient Contribution) Determination 2010 (the Principal Determination), which provides for price determinations in relation to brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) for which the Minister and the responsible person have not been able to make a price agreement. It also provides for the circumstances in which the Commonwealth will pay the special patient contribution resulting from these price determinations. This instrument (the Amending Determination) amends the Principal Determination by: adding a new brand premium to three brands of two pharmaceutical items and increases, decreases or maintains brand or therapeutic group premiums to other brands of pharmaceutical items. It also removes one brand of a pharmaceutical item that no longer has a premium and another brand of a pharmaceutical item that is no longer PBS listed.
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.
Penny Shakespeare
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health