EXPLANATORY STATEMENT
Select Legislative Instrument 2012 No. 55
National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 1)
Section 140 of the National Health Act 1953 (the Act) provides that the
Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The purpose of the regulation is to amend regulation 37HA of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) to change a prescribed person to whom responsible persons are to provide the price disclosure information required under the Act and the Principal Regulations.
Paragraph 99ADC(1)(a) of the Act requires responsible persons to provide price disclosure information to a prescribed person or entity.
Subregulation 37HA(1) of the Principal Regulations currently prescribes Australian Healthcare Associates Pty Ltd as the entity to whom responsible persons are to provide price disclosure information. Subregulation 37HA(2) of the Principal Regulations provides that if written notice is received by a responsible person from the Department, the price disclosure information is instead to be provided to the Assistant Secretary, Pharmaceutical Evaluation Branch, Pharmaceutical Benefits Division, Department of Health and Ageing. The regulation updates this reference to the First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing.
The Act specifies no conditions that need to be met before the power to make the regulation may be exercised.
The regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The regulation commences the day after registration on the Federal Register of Legislative Instruments.
Consultation:
This instrument affects pharmaceutical companies with medicines listed on the PBS and that are subject to price disclosure. Pharmaceutical companies are required to provide price disclosure information to Australian Healthcare Associates Pty Ltd. However, on written request from the Department, pharmaceutical companies must provide this information to the First Assistant Secretary, Pharmaceutical Benefits Division.
During the amendment of Regulation 37HA, the Department did not consult with any stakeholders with an interest in price disclosure as this change is a minor administrative amendment that will have little or no impact on stakeholders.
Authority: Section 140 of the
National Health Act 1953
Overview
The National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 1) was enacted to amend regulation 37HA of the National Health (Pharmaceutical Benefits) Regulations 1960 under the National Health Act 1953. This regulation was introduced to address a minor administrative change regarding the entity to which pharmaceutical companies must provide price disclosure information. The amendment updates the reference in the Principal Regulations from Australian Healthcare Associates Pty Ltd to the First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing. The regulation was enacted by the Governor-General under section 140 of the National Health Act 1953, which allows for the creation of regulations necessary or convenient to carry out or give effect to the Act. The regulation aims to streamline the administrative process with minimal impact on stakeholders, and it commenced the day after its registration on the Federal Register of Legislative Instruments. The Department of Health and Ageing did not consult with stakeholders during this amendment as it was deemed a minor administrative change.
Scope and Application
The National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 1) applies to entities and individuals involved in the provision of price disclosure information for medicines listed on the Pharmaceutical Benefits Scheme (PBS). This includes pharmaceutical companies that must comply with the price disclosure requirements under Section 99ADC of the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 1960. The regulation affects these entities by changing the prescribed person to whom the price disclosure information must be provided, replacing Australian Healthcare Associates Pty Ltd with the First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing. The regulation has a national reach, applying across Australia in accordance with the jurisdiction of the Commonwealth under the National Health Act 1953. There are no specific exclusions or thresholds stated in the regulation itself, though it operates under the broader framework of the Act and Principal Regulations. The regulation extends the application of the Act by amending the Principal Regulations to reflect the current administrative structure within the Department of Health and Ageing.
Key Provisions
The National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 1) amends regulation 37HA of the National Health (Pharmaceutical Benefits) Regulations 1960, modifying the entity responsible for receiving price disclosure information from pharmaceutical companies. Under the existing regulation, responsible persons were required to provide such information to Australian Healthcare Associates Pty Ltd. However, if the Department issued a written notice, the information was to be provided to the Assistant Secretary, Pharmaceutical Evaluation Branch, Pharmaceutical Benefits Division, Department of Health and Ageing. The amendment updates this reference to the First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing (section 37HA(2)).
The obligations imposed by this regulation primarily pertain to pharmaceutical companies that have medicines listed on the Pharmaceutical Benefits Scheme (PBS) and are subject to price disclosure requirements. These companies must ensure that the price disclosure information is accurately and timely provided to the specified entity. If the Department issues a written notice, pharmaceutical companies must redirect their disclosures to the First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing. This administrative change aims to streamline the process by updating the relevant contact within the Department.
The regulation does not explicitly outline offences, penalties, or consequences for non-compliance. However, given that the Act and the Principal Regulations mandate the provision of price disclosure information, failure to comply with the amended regulation could potentially lead to enforcement actions under the National Health Act 1953 or the Principal Regulations. While specific penalties are not detailed in the regulation, they would likely align with the general enforcement provisions of the Act, which might include fines or other administrative sanctions. The precise nature and severity of penalties would depend on the specific circumstances of non-compliance and the interpretation by relevant authorities.