EXPLANATORY STATEMENT
National Health (Export Restriction – Chief Executive Medicare) Guidelines 2020
National Health Act 1953
- 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.