National Health (Export Restriction - Chief Executive Medicare) Guidelines 2020

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00488 In force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020

National Health Act 1953

 

 

  1. This is the Explanatory Statement to the National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020.

 

Background

2.      Division 4D of Part VII of the National Health Act 1953 (‘the Act’) imposes restrictions on the export of drug like substances where a person cannot take Pharmaceutical Benefits Scheme (PBS) subsidised medicines overseas, unless it is for personal use or for someone who is accompanying the person.

 

3.      Division 4D of the Act also establishes processes and provides certain powers to Customs officers, and the Chief Executive Medicare to deal with restricted drug like substances carried overseas or consigned for export.

 

4.      As part of these processes, Section 99ZS of the Act enables the Chief Executive Medicare, by legislative instrument, to issue guidelines related to functions, duties and powers that can be exercised by the Chief Executive Medicare and Departmental employees (within the meaning of the Human Services (Medicare) Act 1973).

 

5.      The former guidelines have sunset. This instrument will in effect replace the previous guidelines.

 

Purpose and operation

 

6.      The guidelines set out the administrative processes to be followed by Departmental employees following notification by a Customs officer about detained drug like substances.  These include:

 

  • transfer of substances in question from the point of detention to the agency;
  • examination of substances in accordance with the Act; and
  • handling of detained substances including recording and storage, re-consignment and/or disposal.

 

7.      These guidelines largely replicate the principles of the former guidelines. The key differences are that the Instrument:

 

  • contains minor and machinery updates including name changes to organisations and offices;
  • is less prescriptive for the purpose of use as an overarching guide; and
  • has deleted provisions of the former guidelines that repeated provisions in the statute.

 

 

 

Consultation

 

8.      The Instrument has been developed in consultation with the Department of Home Affairs.  The agency also invited comments and sought input from the Department of Health and the Health Products Regulation Group (Therapeutic Goods Administration) on the content of the Instrument.

 

Regulation Impact Statement

 

9.      Following a preliminary assessment (OBPR reference ID 249344), the Office of Best Practice Regulation (OBPR) determined that no Regulation Impact Statement is required for the Instrument as it has no more than minor regulatory impact on business, community organisations or individuals.


ATTACHMENT A

Statement of Compatibility with Human Rights

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

 

National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020

 

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

Division 4D of Part VII of the National Health Act 1953 (‘the Act’) imposes restrictions on the export of drug like substances where a person cannot take Pharmaceutical Benefits Scheme (PBS) subsidised medicines overseas, unless it is for personal use or for someone who is accompanying the person.

 

Division 4D of the Act also establishes processes and provides certain powers to Customs officers, and the Chief Executive Medicare to deal with restricted drug like substances carried overseas or consigned for export.

 

As part of these processes, Section 99ZS of the Act enables the Chief Executive Medicare, by legislative instrument, to issue guidelines related to functions, duties and powers that can be exercised by the Chief Executive Medicare and Departmental employees.

 

These guidelines prescribe certain administrative matters in respect of the performance of those functions.

 

Human rights implications

This Legislative Instrument does not engage any of the applicable rights or freedoms.

 

Conclusion

This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

Overview

The National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020 were enacted to provide clear administrative processes for handling the export of restricted drug-like substances under Division 4D of Part VII of the National Health Act 1953. The primary aim of the Act, which was passed by the Australian Parliament, was to address the gap in existing legislation by imposing restrictions on the export of drug-like substances where a person cannot take Pharmaceutical Benefits Scheme (PBS) subsidised medicines overseas, unless it is for personal use or for someone who is accompanying the person. The guidelines were introduced to ensure that Customs officers and the Chief Executive Medicare have clear processes and powers to manage these substances effectively. The guidelines were developed in consultation with relevant departments and were deemed to have no more than minor regulatory impact on businesses, community organisations, or individuals, as confirmed by the Office of Best Practice Regulation.

Scope and Application

The National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020, issued under Section 99ZS of the National Health Act 1953, apply to individuals and entities involved in the export of drug-like substances, specifically those that cannot be taken overseas under the Pharmaceutical Benefits Scheme (PBS). These guidelines are designed to govern the administrative processes followed by Departmental employees when dealing with detained drug-like substances, including their transfer, examination, and handling. This instrument is intended to replace the previous guidelines, with minor updates and a reduced prescriptive nature to serve as an overarching guide, and it excludes provisions that are already detailed in the statute. The Act applies to all persons and entities involved in the export of such substances, and the guidelines have a national reach, aligning with the Commonwealth's jurisdiction. The guidelines do not specify any exclusions, exemptions, or thresholds, but they do extend the application of the Act through subordinate instruments by detailing the specific administrative processes to be followed.

Key Provisions

The National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020, issued under Section 99ZS of the National Health Act 1953, detail the procedures to be followed by Departmental employees when they are notified by Customs officers about detained drug-like substances (Section 6). These guidelines cover the transfer of substances from the point of detention to the relevant agency, the examination of these substances in accordance with the Act, and the handling of detained substances, including recording, storage, re-consignment, and disposal. The guidelines aim to provide a clear administrative framework for dealing with restricted drug-like substances that are intended for export. These guidelines impose specific obligations on the parties involved, primarily the Chief Executive Medicare and Departmental employees, to ensure that the processes for handling detained drug-like substances are followed accurately and efficiently (Section 6). The Chief Executive Medicare and Departmental employees must adhere to these guidelines to manage and process the detained substances appropriately, ensuring compliance with the National Health Act 1953. In terms of enforcement and consequences, the guidelines themselves do not explicitly outline penalties for non-compliance. However, breaches of the provisions in the National Health Act 1953 that these guidelines support could result in civil or criminal penalties. For instance, exporting restricted drug-like substances without adhering to the Act's requirements could lead to fines or imprisonment. The exact penalties would depend on the specific provisions of the Act that are breached and the circumstances of the offence, but they could include significant financial penalties and imprisonment terms as prescribed by the relevant sections of the Act.

Legal classification tags

Area of Law
Administrative Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Enforcement Powers
Compliance Obligations
Prohibited Conduct

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.