EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 31 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AF
Summary
This instrument amends the principal legislative instrument, PB 16 of 2010, which determines the responsible persons for the brands of pharmaceutical items. Due to an administrative oversight, the “type of unit” for all forms of the listed drug dabigatran etexilate has been incorrectly described as “tablet” or “tablets” in instrument PB 16 of 2010 when the “type of unit” should be described as “capsule” or “capsules” wherever occurring.
Purpose and operation
Part VII of the National Health Act 1953 (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.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item. The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.
A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act. These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.
This amending instrument amends the principal legislative instrument before it commences by removing the reference to “tablet” or “tablets” and substituting with “capsule” or “capsules”. The correct forms for the listed drug dabigatran etexilate are capsules 75 mg (as mesilate), 60; capsules 110 mg (as mesilate), 60; capsule 75 mg (as mesilate) and capsule 110 mg (as mesilate). The amendment is set out in Schedule 1 to the instrument.
This instrument, expressed to commence on the day after registration on the Federal Register of Legislative Instruments, was made on 26 March 2010, and is intended to have effect before commencement of PB 16 of 2010, which commences on 1 April 2010.
Consultations
This amendment is required to be made as a result of an administrative oversight. The responsible person that supplies the listed drug dabigatran etexilate in the forms capsules 75 mg (as mesilate), 60; capsules 110 mg (as mesilate), 60; capsule 75 mg (as mesilate) and capsule 110 mg (as mesilate) has been advised of this correction. Medicare Australia has been advised of this correction for the purposes of administering payments for the supply of these pharmaceutical benefits.
Overview
The National Health Act 1953, amended by the F2010L00774 instrument, addresses an administrative oversight in the classification of the drug dabigatran etexilate. Enacted by the Australian Parliament, the Act underpins the Pharmaceutical Benefits Scheme (PBS), aiming to ensure that Australians have reliable, timely, and affordable access to a broad range of medicines. The 2010 amendment corrects an error in the principal legislative instrument (PB 16 of 2010) which had inaccurately described the form of dabigatran etexilate as tablets instead of capsules. This correction ensures that the forms of the drug listed for PBS benefits reflect the actual pharmaceutical presentations, thereby aligning the legislative requirements with the correct medical formulations. The amendment, which includes the substitution of references from "tablet" to "capsule," was intended to take effect before the commencement of PB 16 of 2010, ensuring continuity in the administration of the PBS.
Scope and Application
This instrument amends the National Health Act 1953 by correcting an administrative oversight in the description of the forms of the listed drug dabigatran etexilate. The Act applies to the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to affordable and reliable medicines. The Minister has the authority under the Act to declare drugs as listed drugs, determine their forms and administer the scheme. Part VII of the Act applies to listed drugs and certain extemporaneously-prepared medicinal preparations. The Minister can also determine the responsible persons for brands of pharmaceutical items, which entails various responsibilities such as entering into price agreements, complying with price disclosure requirements and supplying certain pharmaceutical items. The amendment corrects the description of the forms of dabigatran etexilate from “tablet” or “tablets” to “capsule” or “capsules” as appropriate, and this amendment applies nationally. The instrument does not specify exclusions, exemptions or thresholds, and the amendment is intended to take effect before the commencement of the principal instrument.
Key Provisions
The main sections of the legislation are sections 84, 85, and 84AF of the National Health Act 1953. Section 84 defines key terms such as “listed drug” and “brand of pharmaceutical item”. Section 85 provides for the declaration of pharmaceutical benefits by the Minister, including the form of a listed drug and the brand of the pharmaceutical item. Section 84AF empowers the Minister to determine the responsible person for a brand of pharmaceutical item. This amendment corrects an administrative oversight by specifying that the listed drug dabigatran etexilate is available in capsule form, rather than tablet form, as previously stated in instrument PB 16 of 2010. This correction is crucial to ensure that the correct pharmaceutical benefits are administered and that the responsible person for the drug brand is accurately identified.
The legislation imposes several obligations on the parties and entities it governs. Firstly, the Minister is required to declare pharmaceutical benefits by legislative instrument, including the form of a listed drug and the brand of the pharmaceutical item. This declaration is necessary to determine what constitutes the pharmaceutical benefit under Part VII of the Act. Secondly, the responsible person for a brand of pharmaceutical item has various responsibilities, including entering into price agreements, complying with price disclosure requirements, and supplying certain brands of pharmaceutical item for a specified period. The responsible person must ensure that the correct form of the listed drug is supplied and that any necessary declarations or determinations are made in accordance with the Act. Thirdly, the Minister must determine the responsible person for a brand of pharmaceutical item if the person has notified the Minister that they are or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. This determination is necessary to ensure that the correct person is held accountable for the supply of the pharmaceutical benefit.
There are no specific offences, penalties, or civil/criminal consequences mentioned in the legislation for breach of the requirements. However, failure to comply with the obligations and requirements imposed by the legislation may result in consequences such as non-compliance with price disclosure requirements, failure to supply certain brands of pharmaceutical item, or inaccurate declarations of pharmaceutical benefits. These consequences may have implications for the responsible person, the Minister, and the administration of the Pharmaceutical Benefits Scheme. It is important for all parties and entities governed by the legislation to ensure that they comply with their obligations and requirements to avoid any potential consequences.