EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2018 (No. 5)
PB 51 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: removing one brand of a pharmaceutical item that no longer has a premium in addition to changes to multiple drugs and forms due to the International Harmonisation of Ingredient Names reform.
The Instrument makes changes required to implement the International Harmonisation of Ingredient Names (IHIN). Under the IHIN, the names used for active ingredients and pharmaceutical formulations in Australia are being updated to conform with nomenclature used internationally. The changes in the Instrument are consistent with changes already made to the Australian Register of Therapeutic Goods. These changes are detailed in the attached Summary of Changes.
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 July 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. 5)
(PB 51 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. 5) and may also be cited as PB 51 of 2018.
Section 2 Commencement
This section provides that the Determination commences on 1 July 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 July 2018
The amendments in Schedule 1 provide for the deletion of a brand premium and changes to drug names and forms as described in Schedules 1 and 2 of the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010). These changes are summarised below.
SUMMARY OF CHANGES
Brand that no longer has a brand premium | ||
Glipizide | Tablet 5 mg | Minidiab |
|
|
|
International Harmonisation of Ingredient Names – Listed drug changes | ||
From | To |
|
Amoxycillin | Amoxicillin |
|
Amoxycillin with Clavulanic Acid | Amoxicillin with clavulanic acid |
|
Cephalexin | Cefalexin |
|
Frusemide | Furosemide |
|
Indomethacin | Indometacin |
|
Levonorgestrel with Ethinyloestradiol | Levonorgestrel with ethinylestradiol |
|
Norethisterone with Ethinyloestradiol | Norethisterone with ethinylestradiol |
|
Thyroxine | Levothyroxine |
|
|
|
|
International Harmonisation of Ingredient Names – form changes | ||
Listed drug | From | To |
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) |
Amoxicillin with clavulanic acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) |
| Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) |
| Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL |
| Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL |
Cefalexin | Capsule 250 mg (anhydrous) | Capsule 250 mg (as monohydrate) |
| Capsule 500 mg (anhydrous) | Capsule 500 mg (as monohydrate) |
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL |
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL |
Eprosartan | Tablet 400 mg (as mesylate) | Tablet 400 mg (as mesilate) |
| Tablet 600 mg (as mesylate) | Tablet 600 mg (as mesilate) |
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 |
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) |
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 5 mg (as besilate) |
| Tablet 80 mg 10 mg (as besylate) | Tablet 80 mg 10 mg (as besilate) |
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. 5) (PB 51 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: removing one brand of a pharmaceutical item that no longer has a premium in addition to changes to multiple drugs and 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