EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 27 OF 2019
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2019 (No. 1)
Purpose
The purpose of this legislative instrument, made under section 84AH of the National Health Act 1953 (the Act), is to amend the legislative instrument titled National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84 AH) Determination (as amended) (PB 81 of 2017) to make changes to the pharmaceutical items that are determined to be exempt items.
Background
Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines for all Australians.
Drugs and medicinal preparations to which Part VII applies are declared as such by the Minister, by legislative instrument under subsection 85(2) of the Act. These are listed drugs (as defined in subsection 84(1)). The Minister may also determine by legislative instrument the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)) and the manner of administration of the form of the listed drug so determined (subsection 85(5)). If a drug has a declaration under subsection 85(2) in force in respect of it and determinations under subsections 85(3) and 85(5) in force in respect of it, then that declared drug in that determined form with that determined manner of administration is a pharmaceutical item. The Minister may also determine, by legislative instrument, brands of pharmaceutical items (subsection 85(6)).
Section 84AH empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an ‘exempt item’ if the pharmaceutical item satisfies the criteria in section 84AH. The criteria in section 84AH are as follows:
(a) that there is only one listed brand of the relevant pharmaceutical item; and
(b) there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the one listed brand of the relevant pharmaceutical item; and
(c) there is at least one other pharmaceutical item that has the same listed drug as the relevant pharmaceutical item; and
(d) the Minister is satisfied (having regard to advice, if any, from the Pharmaceutical Benefits Advisory Committee (PBAC)) that:
- the listed drug in the relevant pharmaceutical item represents suitable therapy for a particular patient population; and
- the relevant pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration; and
- no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item.
The effect of a pharmaceutical item being determined to be an exempt item is that the listed brand of that pharmaceutical item is excluded from statutory price reductions and price disclosure requirements under Divisions 3A and 3B of Part VII of the Act. The intention is to encourage the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (eg. children or geriatric patients) for whom other formulations of the drug are not suitable.
Changes to PB 81 of 2017 made by this instrument
This instrument makes the following changes to PB 81 of 2017:
One pharmaceutical item (listed drug = Levodopa with carbidopa, form = Tablet (modified release) 200 mg-50 mg (as monohydrate), manner of administration = oral) is no longer determined to be an exempt item because it no longer meets the criteria under subsection 84AH(b). This is due to the temporary listing of another pharmaceutical item and brand that is bioequivalent or biosimilar to the listed brand of the relevant item.
Variation and revocation
Unless there is an express power to revoke or vary PB 81 of 2017 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 81 of 2017.
Consultation
Consultation on the Amending Determination was deemed unnecessary for the removal of exempt status on levodopa with carbidopa as it is expected that the exempt status will be reinstated once the alternative temporarily listed brand delists from the PBS.
General
The instrument commences on 1 April 2019.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
Overview
The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2019 (No. 1) was enacted under section 84AH of the National Health Act 1953. This legislative instrument was introduced to address the need for amendments to the determination of pharmaceutical items that are exempt from statutory price reductions and price disclosure requirements under Divisions 3A and 3B of Part VII of the Act. This amendment was necessary to maintain the integrity of the Pharmaceutical Benefits Scheme by ensuring that only pharmaceutical items meeting specific criteria are classified as exempt. The determination was made by the Minister for Health under the authority of the National Health Act 1953, with the policy objective of encouraging the availability of certain pharmaceutical items with particular formulations of drugs that are suitable for specific demographic subgroups. The instrument came into effect on 1 April 2019.
Scope and Application
The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2019 (No. 1) amends the existing Pharmaceutical Benefits Scheme-Exempt items determination under the National Health Act 1953. This Act applies to the Pharmaceutical Benefits Scheme (PBS), which is overseen by the Commonwealth Government to ensure Australians have reliable, timely and affordable access to a wide range of medicines. The Minister for Health is responsible for determining which pharmaceutical items are exempt from statutory price reductions and price disclosure requirements, which is crucial for ensuring that suitable medications are available to specific patient populations. The exemption applies to pharmaceutical items that meet certain criteria, such as having only one listed brand, no bioequivalent or biosimilar brands, and being suitable for a particular subgroup of patients due to the form and manner of administration. The amendment made by this instrument removes the exempt status of a particular pharmaceutical item, Levodopa with carbidopa, due to the listing of another brand that is bioequivalent or biosimilar, which no longer meets the criteria for exemption. The changes outlined in the instrument are effective from 1 April 2019, and no consultation was required for the removal of the exempt status as it is expected that the status will be reinstated once the alternative brand is removed from the PBS.
Key Provisions
The National Health (Pharmaceutical Benefits Scheme-Exempt Items – Section 84AH) Amendment Determination 2019 (No. 1) amends the existing Pharmaceutical Benefits Scheme (PBS) regulations under the National Health Act 1953. The main operative sections (84AH and 85) outline the criteria for determining pharmaceutical items as 'exempt items' and the process for listing these items. Section 84AH specifies that a pharmaceutical item may be determined as an exempt item if it meets certain criteria, such as having a unique listed brand and being suitable for a specific patient population. This determination excludes the listed brand of the pharmaceutical item from statutory price reductions and price disclosure requirements.
The obligations and requirements imposed by the Act on the parties involved are primarily centered around the Minister's responsibility to make determinations under section 84AH. The Minister must ensure that pharmaceutical items meet the specified criteria before they can be designated as exempt items. This involves considering advice from the Pharmaceutical Benefits Advisory Committee (PBAC) and making informed decisions based on therapeutic suitability and the needs of specific patient populations. The Minister must also review and update the determinations as necessary to reflect changes in the pharmaceutical market, such as the listing or removal of bioequivalent or biosimilar items.
Offences, penalties, or civil/criminal consequences for breach of the provisions under the National Health Act 1953 are not explicitly stated in the Explanatory Statement. However, it is reasonable to infer that non-compliance with the Act's requirements could lead to legal repercussions, as is common with statutory frameworks. For instance, failure to adhere to the determinations or misrepresentation of pharmaceutical items could result in penalties. While specific maximum penalties are not provided in the explanatory statement, breaches of similar legislative instruments can typically lead to fines or other legal consequences, depending on the severity and intent of the breach. It is essential for entities and individuals involved in the pharmaceutical industry to ensure compliance with the Act to avoid potential legal issues.