Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (Under Co-payment Data Collection) Instrument 2012 (No. R21/2012)

Administered by Department of Veterans' Affairs

Legislation au F2012L00745 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (Under Co-payment Data Collection) Instrument 2012

 

EMPOWERING PROVISION

 

Subsection 18(5) of the Australian Participants in British Nuclear Tests (Treatment) Act 2006, (the Act).

 

PURPOSE

 

The attached instrument (R21/2012) amends the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (the Scheme). 

 

The Scheme is a legislative instrument made under subsection 18(5) of the Act and sets out the circumstances in which the Repatriation Commission (the Commission) may accept financial liability for the provision of pharmaceutical benefits to eligible persons for the treatment of malignant neoplasia. 

 

Eligible persons are Australian participants in British nuclear tests as described in the Act.

 

The purpose of the attached instrument is to provide a legislative basis for Community Pharmacists to give “under co-payment information” to the Secretary, Department of Health and Ageing (DoHA), for the purposes of the “Under Co-payment” initiative being undertaken by DoHA.

 

Information known as under co-payment information consists of details of prescription pharmaceuticals that are available under existing pharmaceutical benefits schemes that may be dispensed at a cost less than the relevant pharmaceutical copayment.

 

Because the price of the pharmaceutical is dispensed at less than the value of the relevant copayment there is no charge against the Commonwealth by the dispensing pharmacy.  Instead the cost is borne by the patient who pays the whole charge for the dispensed medicine.

 

The Commonwealth obtains data from pharmacists for items dispensed as a consequence of the pharmacy making a claim for payment through the Department of Human Services.  This requirement is imposed by the National Health Act 1953.  But previously pharmacists have not been required to give information about un-subsidised supplies of pharmaceuticals where there is no charge against the Commonwealth, that is, the cost is less than or equal to the co-payment otherwise payable (under co-payment supplies).

 

Under the Fifth Community Pharmacy Agreement between the Commonwealth and the Pharmacy Guild, it was agreed that pharmacies would provide undercoapyment data to DoHA. 

 

The parties considered the information will enhance the Pharmaceutical Benefits Schedule data set and will provide a valuable tool for health policy planning, monitoring and risk management protocols, pharmacovigilance and monitoring the quality use of medicines in the community.

 

The National Health Act 1953 has been amended to require pharmacists to give information to DoHA in relation to under co-payment supplies.  The amendments commence on 1 April 2012. 

 

However because some of the supplies could be made under the Department of Veterans’ Affairs (DVA) pharmaceutical schemes, the protection for pharmacists from privacy violations, provided by the National Health Act 1953, would not apply. 

 

Accordingly DVA’s pharmaceutical schemes have been amended to similarly provide a legislative basis for pharmacists to give information about under co-payment supplies under DVA’s pharmaceutical schemes to DoHA.

 

CONSULTATION

 

Yes.

 

Collection of under copayment prescription data was agreed between the Commonwealth (DoHA) and the Pharmacy Guild of Australia as part of the Fifth Community Pharmacy Agreement.  The nature of the consultation leading to the agreement was e-mail correspondence, telephone conversations and meetings.

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

The attached legislative Instrument does engage an applicable right or freedom.  It relates to the right to privacy. 

The prohibition on interference with privacy and attacks on reputation is contained in article 17 of the International Covenant on Civil and Political Rights .

The UN Human Rights Committee has not defined 'privacy'.  According to the Commonwealth Attorney-General’s Department privacy should be understood to comprise freedom from unwarranted and unreasonable intrusions into activities that society recognises as falling within the sphere of individual autonomy.

The attached instrument is intended to have a positive outcome for the Australian public in relation to the purchase and use of pharmaceuticals.  By enabling pharmacists to lawfully supply to Government certain information about pharmaceutical sales to eligible persons, the overall regulation of pharmaceuticals could be enhanced.

 

The extent to which the attached legislative instrument intrudes on the privacy of an individual (details of pharmaceutical sale) is not considered unreasonable in the context in that the measure is intended to ultimately benefit individuals who purchase and use pharmaceuticals.

 

Conclusion

 

The attached legislative instrument is considered to be compatible with the human right of privacy because the extent to which it interacts with that right is considered reasonable in the circumstances.

 

Warren Snowdon

Minister for Veterans’ Affairs

Rule-Maker

 

FURTHER EXPLANATION

 

Attachment A.


Attachment A

 

Items    Explanation

 

[1] sets out the name of the instrument.

 

[2] provides that the instrument commences on 1 April 2012.

 

Schedule

 

1. is a definition section.

 

2. inserts a new part in the Scheme – Part 5A

 

Part 5A provides legislative authority for a Community Pharmacist to disclose certain personal information about an eligible person to the DoHA.

 

The information will consist of certain details in relation to the supply of a pharmaceutical by the pharmacist to the eligible person.  The pharmaceuticals in question are those that are not subsidised by the Commonwealth and are sold at a price less than or equal to the co-payment that would otherwise be payable for the pharmaceutical if it had been sold at a subsidised price.

 

For the disclosure of the information to be authorised by the Scheme a number of conditions must be met:

 

  • the pharmacist must not have claimed any part of the dispensing price of the pharmaceutical from the Commission or the Department of Veterans’ Affairs; and
  • the dispensing price of the pharmaceutical must be less than or equal to the co-payment the Eligible Person would have otherwise needed to pay for the pharmaceutical if it had been sold at the subsidised, instead of discounted, price.
  • the information is given in accordance with the requirements of section 98C of the National Health Act 1958, to the extent they can be applied, as if the information being given under the Scheme to the Secretary of the DoHA is being given to the Secretary under that provision.

 

Section 98C regulates the provision of information by pharmacists to the Secretary of the DoHA in relation to supplies of unsubsidised pharmaceuticals that are dispensed at a price less than or equal to the price that would be payable had the price of the pharmaceutical been subsidised.  It was included in the National Health Act 1958 for the purpose of the Under Co-payment initiative.

 

 

 

 

 

Overview

The Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (Under Co-payment Data Collection) Instrument 2012 was enacted to amend the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006, thereby providing a legislative basis for Community Pharmacists to supply "under co-payment information" to the Secretary, Department of Health and Ageing (DoHA). This initiative seeks to enhance the Pharmaceutical Benefits Schedule data set and provide a valuable tool for health policy planning, monitoring, and risk management protocols. The instrument was enacted under subsection 18(5) of the Australian Participants in British Nuclear Tests (Treatment) Act 2006 by the Parliament of Australia to address the need for comprehensive pharmaceutical data, particularly concerning unsubsidised supplies of pharmaceuticals. The policy objective is to facilitate better regulation and monitoring of pharmaceuticals, ultimately benefiting individuals who purchase and use these medicines.

Scope and Application

The Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (Under Co-payment Data Collection) Instrument 2012 amends the Repatriation Pharmaceutical Benefits Scheme to provide a legislative basis for Community Pharmacists to disclose “under co-payment information” to the Secretary, Department of Health and Ageing (DoHA). Eligible persons under the Act are Australian participants in British nuclear tests. The instrument seeks to facilitate the collection of data on unsubsidised pharmaceuticals that are dispensed at a price less than or equal to the co-payment that would otherwise be payable if the pharmaceutical had been sold at a subsidised price. This data collection aims to enhance the Pharmaceutical Benefits Schedule data set, improve health policy planning, and monitor the quality use of medicines in the community. The changes are in line with the Fifth Community Pharmacy Agreement between the Commonwealth and the Pharmacy Guild of Australia. The instrument applies to Community Pharmacists and eligible persons, focusing on the provision of under co-payment pharmaceuticals and related data disclosure. The legislative amendments are intended to align with the National Health Act 1953 and provide a legislative basis for the Department of Veterans’ Affairs (DVA) pharmaceutical schemes to similarly require pharmacists to give information about under co-payment supplies to DoHA. The instrument commenced on 1 April 2012.

Key Provisions

The primary sections of the Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006 (Under Co-payment Data Collection) Instrument 2012 (R21/2012) are focused on amending the existing Scheme to include the collection of under co-payment data from community pharmacists. Under Part 5A of the Scheme, which is newly introduced by this instrument, pharmacists are authorised to disclose specific details about the supply of unsubsidised pharmaceuticals to the Secretary of the Department of Health and Ageing (DoHA) (section 1(2)). This information pertains to pharmaceuticals sold at a price less than or equal to the co-payment that would otherwise be applicable if the pharmaceutical were sold at a subsidised rate. The obligations imposed on the parties governed by this Act primarily concern the collection and disclosure of under co-payment data by community pharmacists. Pharmacists must ensure that they are not claiming any part of the dispensing price from the Repatriation Commission or the Department of Veterans’ Affairs and that the dispensing price is less than or equal to the co-payment the eligible person would have otherwise needed to pay (section 1(3)). Additionally, the information must be provided in accordance with section 98C of the National Health Act 1958, as if it were being provided under that provision (section 1(4)). The legislative changes aim to integrate this data collection process into existing legal frameworks to facilitate better health policy planning and monitoring. In terms of compliance, failure to adhere to the requirements for disclosing under co-payment data may result in legal repercussions. Although specific penalties are not detailed in the explanatory statement, non-compliance with provisions under the National Health Act 1958 could lead to enforcement actions as stipulated in that Act. The overarching goal of these provisions is to ensure that the data collected contributes to enhancing the quality use of medicines and overall health policy effectiveness without unduly infringing on privacy rights. The legislation is designed to be compatible with human rights, particularly the right to privacy as outlined in Article 17 of the International Covenant on Civil and Political Rights. The explanatory statement asserts that the intrusion on privacy is reasonable given the context and the benefits it provides to the public in terms of improved pharmaceutical regulation and health policy. This balance is intended to respect individual privacy while achieving broader public health objectives.

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