EXPLANATORY STATEMENT
National Health Act 1953
National Health (Price and Special Patient Contribution)
Amendment Determination 2012 (No. 4)
PB 45 of 2012
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).
The Principal Determination provides for price determinations in relation to brands of pharmaceutical items 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.
Purpose
The Act provides for the Minister and the responsible person to agree a price that is taken to be the appropriate maximum price for sales of a brand of a pharmaceutical item to approved pharmacists (section 85AD). Section 85B of the Act applies if the Minister and the responsible person have been unable to reach an agreement.
Subsection 85B(2) provides that the Minister may determine an amount that is taken to be the appropriate maximum price for sales of a brand of a pharmaceutical item to approved pharmacists. This is termed the ‘Determined Price’.
Subsection 85B(3) provides that the Minister may determine an amount that is taken to be the price claimed by the responsible person as the appropriate maximum price for sales of the brand of the pharmaceutical item to approved pharmacists. This is termed the ‘Claimed Price’.
The Determined Price is the approved price to pharmacists (subsection 98B(3) of the Act) and is used as the basis for working out the Commonwealth price for the brand of the pharmaceutical item (subsection 98B(2) of the Act). 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 (ie, the price that would be the Commonwealth price if the responsible person’s claimed price had become the approved price to pharmacists) and the Commonwealth price for the brand is defined in subsection 85B(4) 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 applicable patient co-payment (subsection 87(2A) of the Act).
Subsection 85B(5) of the Act provides that the Minister may determine the circumstances in which the Commonwealth, rather than the patient, is to pay the special patient contribution for a brand of a pharmaceutical item.
This instrument (the Amending Determination) amends the Principal Determination by: adding one new brand premium, removing three brands that no longer have a brand premium and provides the increases and decreases of brand premiums to other brands of pharmaceutical items.
Consultation
The Amending 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. If the Minister and the responsible person cannot agree on a price, further consultation occurs with the responsible person, and thereafter the Minister determines the price that will be the approved price to pharmacists for the brand. The Minister also determines the corresponding price claimed by the responsible person which is used to calculate the special patient contribution that will apply to the brand.
A provision by provision description of the Amending Determination is contained in the Attachment.
The Amending Determination commences on 1 August 2012.
This instrument 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 2012 (No. 4)
Section 1 Name of Instrument
This section provides that this Amending Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2012 (No. 4) and may also be cited as PB 45 of 2012.
Section 2 Commencement
This section provides that the Amendment Determination commences on 1 August 2012.
Section 3 Amendment of PB 109 of 2010
This section provides that Schedule 1 of the Amending Determination amends the determination under section 85B of the Act, the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).
Schedule 1 Amendments commencing 1 August 2012
Schedule 1 sets out the amendments to the Principal Determination which commence on 1 August 2012. These changes are summarised below.
SUMMARY OF CHANGES
SCHEDULE 1
Brands with an increased brand premium
Alendronic Acid | Tablet 70 mg (as alendronate sodium) | Fosamax Once Weekly |
Alprazolam | Tablet 250 micrograms | Xanax |
| Tablet 500 micrograms | Xanax |
| Tablet 1 mg | Xanax |
| Tablet 2 mg | Xanax Tri-Score |
Amlodipine | Tablet 5 mg (as besylate) | Norvasc |
| Tablet 10 mg (as besylate) | Norvasc |
Captopril | Tablet 25 mg | Capoten |
| Tablet 50 mg | Capoten |
Cefaclor | Tablet (sustained release) 375 mg | Ceclor CD |
| Powder for oral suspension 125 mg | Ceclor |
| Powder for oral suspension 250 mg | Ceclor |
Cephalexin | Capsule 250 mg (anhydrous) | Keflex |
| Capsule 500 mg (anhydrous) | Keflex |
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Keflex |
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Keflex |
Citalopram | Tablet 20 mg (as hydrobromide) | Cipramil |
Codeine with Paracetamol | Tablet containing codeine phosphate | Panadeine Forte |
Doxepin | Capsule 10 mg (as hydrochloride) | Sinequan |
| Capsule 25 mg (as hydrochloride) | Sinequan |
Doxycycline | Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) [Quantity or Number of Units 7] | Doryx |
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) [Quantity or Number of Units 21] | Doryx |
| Tablet 50 mg (as hydrochloride) | Vibra-Tabs |
| Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Doryx |
Enalapril | Tablet containing enalapril maleate | Renitec M |
| Tablet containing enalapril maleate | Renitec |
| Tablet containing enalapril maleate | Renitec 20 |
Erythromycin | Capsule 250 mg (containing enteric coated pellets) | Eryc |
Frusemide | Tablet 20 mg | Lasix-M |
| Tablet 40 mg | Lasix |
Gabapentin | Capsule 100 mg | Neurontin |
| Capsule 300 mg | Neurontin |
| Capsule 400 mg | Neurontin |
| Tablet 600 mg | Neurontin |
| Tablet 800 mg | Neurontin |
Glimepiride | Tablet 1 mg | Amaryl |
| Tablet 2 mg | Amaryl |
| Tablet 3 mg | Amaryl |
| Tablet 4 mg | Amaryl |
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL | Tears Naturale |
Lisinopril | Tablet 5 mg | Prinivil 5 |
| Tablet 10 mg | Prinivil 10 |
| Tablet 20 mg | Prinivil 20 |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 5 mg | Provera |
| Tablet containing medroxyprogesterone acetate 10 mg [Quantity or Number of Units 30] | Provera |
| Tablet containing medroxyprogesterone acetate 10 mg [Quantity or Number of Units 100] | Provera |
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Depo-Medrol |
Mirtazapine | Tablet 30 mg | Avanza |
| Tablet 45 mg | Avanza |
Norfloxacin | Tablet 400 mg | Noroxin |
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Duratears |
Piroxicam | Dispersible tablet 20 mg | Feldene-D |
Pravastatin | Tablet containing pravastatin sodium | Pravachol |
| Tablet containing pravastatin sodium | Pravachol |
| Tablet containing pravastatin sodium | Pravachol |
| Tablet containing pravastatin sodium | Pravachol |
Prednisolone | Oral solution 5 mg (as sodium phosphate) per mL, 30 mL | Redipred |
Quinapril | Tablet 5 mg (as hydrochloride) | Accupril |
| Tablet 10 mg (as hydrochloride) | Accupril |
| Tablet 20 mg (as hydrochloride) | Accupril |
Roxithromycin | Tablet 150 mg | Rulide |
| Tablet 300 mg | Rulide |
Sertraline | Tablet 50 mg (as hydrochloride) | Zoloft |
| Tablet 100 mg (as hydrochloride) | Zoloft |
Simvastatin | Tablet 5 mg | Zocor |
| Tablet 10 mg | Lipex 10 |
|
| Zocor |
| Tablet 20 mg | Lipex 20 |
|
| Zocor |
| Tablet 40 mg | Lipex 40 |
|
| Zocor |
| Tablet 80 mg | Lipex 80 |
|
| Zocor |
Sotalol | Tablet containing sotalol hydrochloride 80 mg | Sotacor |
| Tablet containing sotalol hydrochloride 160 mg | Sotacor |
Temazepam | Tablet 10 mg | Normison |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Tramal |
| 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 |
Trandolapril | Capsule 2 mg | Gopten |
| Capsule 4 mg | Gopten |
Verapamil | Tablet containing verapamil hydrochloride 180 mg (sustained release) | Isoptin 180 SR |
| Tablet containing verapamil hydrochloride 240 mg (sustained release) | Isoptin SR |
Brands with an increased therapeutic group premium
Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Olmetec |
| Tablet containing olmesartan medoxomil 40 mg | Olmetec |
Brand with a new brand premium
Lansoprazole | Tablet 30 mg, (orally disintegrating) | Zoton FasTabs |
Brand with a price change and an increased brand premium
Methyldopa | Tablet 250 mg | Aldomet |
Brands with a price change and a decreased brand premium
Aspirin | Tablet 100 mg | Astrix |
Cyproterone | Tablet containing cyproterone acetate | Androcur |
| Tablet containing cyproterone acetate | Androcur |
| Tablet containing cyproterone acetate 100 mg | Androcur-100 |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg | Natrilix |
Brands where a brand premium no longer exists
Cyclosporin | Capsule 50 mg | Neoral 50 |
| Capsule 100 mg | Neoral 100 |
Isotretinoin | Capsule 20 mg | Roaccutane |
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 2012 (No. 4)
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 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 one new brand premium, removing three brands that no longer have a brand premium and provides the increases and decreases of brand premiums to other brands of pharmaceutical items.
Human rights implications
This legislative instrument engages Article 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.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing