EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2017 (No. 3)
PB 27 of 2017
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: reflecting for plain English reasons the price changes and decreases to multiple brand premiums which took legal effect on 1 April 2017 due to price disclosure.
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 May 2017.
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 2017 (No. 3)
(PB 27 of 2017)
Section 1 Name of Determination
This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2017 (No. 3) and may also be cited as PB 27 of 2017.
Section 2 Commencement
This section provides that the Determination commences on 1 May 2017.
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 May 2017
Schedule 1 sets out the amendments to the Principal Determination which commence on 1 May 2017.
SUMMARY OF CHANGES
SCHEDULE 1
Brands with a price change and decreased brand premiums
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol | Fosamax Plus |
| Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Dronalen Plus Fosamax Plus 70 mg/140 mcg |
Alendronic acid with colecalciferol and calcium | Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) | Dronalen Plus D-Cal Fosamax Plus D-Cal |
Amlodipine | Tablet 5 mg (as besylate) | Norvasc |
| Tablet 10 mg (as besylate) | Norvasc |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Bicor |
| Tablet containing bisoprolol fumarate 5 mg | Bicor |
| Tablet containing bisoprolol fumarate 10 mg | Bicor |
Candesartan | Tablet containing candesartan cilexetil 4 mg | Atacand |
| Tablet containing candesartan cilexetil 8 mg | 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 12.5 mg | Atacand Plus 16/12.5 |
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg | Atacand Plus 32/12.5 |
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg | Atacand Plus 32/25 |
Ciprofloxacin | Tablet 250 mg (as hydrochloride) | Ciproxin 250 |
| Tablet 500 mg (as hydrochloride) | Ciproxin 500 |
Clindamycin | Capsule 150 mg (as hydrochloride) | Dalacin C |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Voltaren 50 |
Escitalopram | Tablet 10 mg (as oxalate) | Lexapro |
| Tablet 20 mg (as oxalate) | Lexapro |
Exemestane | Tablet 25 mg | Aromasin |
Felodipine | Tablet 2.5 mg (extended release) | Plendil ER |
| Tablet 5 mg (extended release) | Plendil ER |
| Tablet 10 mg (extended release) | Plendil ER |
Fluoxetine | Capsule 20 mg (as hydrochloride) | Prozac 20 |
| Tablet, dispersible, 20 mg (as hydrochloride) | Prozac Tab |
Ipratropium | Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 | Atrovent |
| Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 | Atrovent Adult |
Isosorbide Mononitrate | Tablet 120 mg (sustained release) | Imdur 120 mg |
Lamotrigine | Tablet 25 mg | Lamictal |
| Tablet 50 mg | Lamictal |
| Tablet 100 mg | Lamictal |
| Tablet 200 mg | Lamictal |
Lisinopril | Tablet 5 mg | Zestril |
| Tablet 10 mg | Zestril |
| Tablet 20 mg | Zestril |
Meloxicam | Capsule 7.5 mg | Mobic |
| Capsule 15 mg | Mobic |
| Tablet 7.5 mg | Mobic |
| Tablet 15 mg | Mobic |
Mirtazapine | Tablet 15 mg (orally disintegrating) | Avanza SolTab |
|
| Remeron SolTab |
| Tablet 30 mg | Avanza |
| Tablet 30 mg (orally disintegrating) | Avanza SolTab Remeron SolTab |
| Tablet 45 mg | Avanza |
| Tablet 45 mg (orally disintegrating) | Avanza SolTab Remeron SolTab |
Mometasone | Cream containing mometasone furoate 1 mg per g, 15 g | Elocon Alcohol Free |
| Lotion containing mometasone furoate 1 mg per g, 30 mL | Elocon |
| Ointment containing mometasone furoate 1 mg per g, 15 g | Elocon |
Montelukast | Tablet, chewable, 4 mg (as sodium) | Singulair |
Nifedipine | Tablet 20 mg | Adalat 20 |
| Tablet 30 mg (controlled release) | Adalat Oros 30 |
| Tablet 60 mg (controlled release) | Adalat Oros 60 |
Omeprazole | Tablet 20 mg (as magnesium) | Losec Tablets |
Perindopril with amlodipine | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) | Coveram 5/5 |
| Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) | Coveram 5/10 |
| Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) | Coveram 10/5 |
| Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) | Coveram 10/10 |
Pravastatin | Tablet containing pravastatin sodium 10 mg | Pravachol |
| Tablet containing pravastatin sodium 20 mg | Pravachol |
| Tablet containing pravastatin sodium 40 mg | Pravachol |
| Tablet containing pravastatin sodium 80 mg | Pravachol |
Quinapril | Tablet 10 mg (as hydrochloride) | Accupril |
| Tablet 20 mg (as hydrochloride) | Accupril |
Ranitidine | Tablet 150 mg (as hydrochloride) | Zantac |
| Tablet 300 mg (as hydrochloride) | Zantac |
| Tablet, effervescent, 150 mg (as hydrochloride) | Zantac |
Sertraline | Tablet 50 mg (as hydrochloride) | Zoloft |
| Tablet 100 mg (as hydrochloride) | Zoloft |
Sotalol | Tablet containing sotalol hydrochloride 80 mg | Sotacor |
| Tablet containing sotalol hydrochloride 160 mg | Sotacor |
Telmisartan with amlodipine | Tablet 40 mg-5 mg (as besylate) | Twynsta |
| Tablet 40 mg-10 mg (as besylate) | Twynsta |
| Tablet 80 mg-5 mg (as besylate) | Twynsta |
| Tablet 80 mg-10 mg (as besylate) | Twynsta |
Telmisartan with hydrochlorothiazide | Tablet 40 mg-12.5 mg | Micardis Plus 40/12.5 mg |
| Tablet 80 mg-12.5 mg | Micardis Plus 80/12.5 mg |
| Tablet 80 mg-25 mg | Micardis Plus 80/25 mg |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | Tramal SR 100 |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Tramal SR 150 |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Tramal SR 200 |
Trimethoprim with Sulfamethoxazole | Tablet 160 mg-800 mg | Septrin Forte |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Pricing Quantity 10) | Valtrex |
| Tablet 500 mg (as hydrochloride) (Pack Quantity 30) | Valtrex |
| Tablet 500 mg (as hydrochloride) (Pack Quantity 42) | Valtrex |
| Tablet 500 mg (as hydrochloride) (Pack Quantity 100) | Valtrex |
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 2017 (No. 3)
(PB 27 of 2017)
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: reflecting for plain English reasons the price changes and decreases to multiple brand premiums which took legal effect on 1 April 2017 due to price disclosure.
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.
Louise Clarke
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health