EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2018 (No. 6)
PB 73 of 2018
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 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 new brand premiums to 11 brands of pharmaceutical items and also increases brand premiums to other brands of pharmaceutical items in addition to removing one brand of a pharmaceutical item that no longer has a premium. In addition, it also changes multiple drug forms due to the International Harmonisation of Ingredient Names reform.
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 August 2018.
This Determination is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2018 (No. 6)
(PB 73 of 2018)
Section 1 Name of Determination
This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2018 (No. 6) and may also be cited as PB 73 of 2018.
Section 2 Commencement
This section provides that the Determination commences on 1 August 2018.
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 August 2018
Schedule 1 set out the amendments to the Principal Determination which commence on 1 August 2018.
SUMMARY OF CHANGES
SCHEDULE 1
Brands with increased brand premiums | ||
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Ciproxin 500 |
Dexamethasone with Framycetin and Gramicidin | Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL | Sofradex |
Doxepin | Capsule 10 mg (as hydrochloride) | Sinequan |
| Capsule 25 mg (as hydrochloride) | Sinequan |
Duloxetine | Capsule 30 mg (as hydrochloride) | Cymbalta |
| Capsule 60 mg (as hydrochloride) | Cymbalta |
Furosemide | Tablet 20 mg | Lasix-M |
| Tablet 40 mg | Lasix |
Irbesartan | Tablet 75 mg | Avapro |
|
| Karvea |
| Tablet 150 mg | Avapro |
|
| Karvea |
| Tablet 300 mg | Avapro |
|
| Karvea |
Irbesartan with hydrochlorothiazide | Tablet 150 mg-12.5 mg | Avapro HCT 150/12.5 |
|
| Karvezide 150/12.5 |
| Tablet 300 mg-12.5 mg | Avapro HCT 300/12.5 |
|
| Karvezide 300/12.5 |
| Tablet 300 mg-25 mg | Avapro HCT 300/25 |
|
| Karvezide 300/25 |
Lansoprazole | Tablet 15 mg (orally disintegrating) | Zoton FasTabs |
| Tablet 30 mg (orally disintegrating) | Zoton FasTabs |
Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Olmetec |
| Tablet containing olmesartan medoxomil 40 mg | Olmetec |
Roxithromycin | Tablet 150 mg | Rulide |
| Tablet 300 mg | Rulide |
Brands with new brand premiums | ||
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) | Nexium |
| Tablet (enteric coated) 40 mg (as magnesium trihydrate) | Nexium |
Esomeprazole and clarithromycin and amoxicillin | 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) | Nexium Hp7 |
Ibuprofen | Tablet 400 mg | Brufen |
Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg | Olmetec Plus |
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg | Olmetec Plus |
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | Olmetec Plus |
Rosuvastatin | Tablet 5 mg (as calcium) | Crestor |
| Tablet 10 mg (as calcium) | Crestor |
| Tablet 20 mg (as calcium) | Crestor |
| Tablet 40 mg (as calcium) | Crestor |
Brand that no longer has a brand premium | ||
Clindamycin | Capsule 150 mg (as hydrochloride) | Dalacin C |
International Harmonisation of Ingredient Names – form changes | ||
Listed drug | From | To |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg |
Diphenoxylate with Atropine | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate monohydrate 25 micrograms
|
Doxycycline | Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) | Capsule 100 mg (as hyclate) (containing enteric coated pellets) |
| Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Capsule 50 mg (as hyclate) (containing enteric coated pellets) |
Ipratropium | Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 | Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30 |
| Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 | Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30 |
Levodopa with Carbidopa | Tablet 100 mg-25 mg (anhydrous) | Tablet 100 mg-25 mg (as monohydrate) |
Methyldopa | Tablet 250 mg | Tablet 250 mg (as sesquihydrate) |
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg | Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)
|
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 2018 (No. 6) (PB 73 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
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 new brand premiums to 11 brands of pharmaceutical items and also increases brand premiums to other brands of pharmaceutical items in addition to removing one brand of a pharmaceutical item that no longer has a premium. In addition, it also changes multiple drug forms due to the International Harmonisation of Ingredient Names reform.
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