Biosecurity (Listed Human Diseases) Determination 2026

EXPLANATORY STATEMENT

Biosecurity Act 2015

Biosecurity (Listed Human Diseases) Determination 2026

Authority

The Biosecurity Act 2015 (the Act) provides the primary legislative means and a regulatory framework for the Australian Government to manage the risk of pests and diseases from entering Australian territory and causing harm to animal, plant and human health, the environment and the economy. The Act manages biosecurity risks – including the risk of listed human diseases – entering Australian territory, or emerging, establishing themselves or spreading in Australian territory or a part of Australian territory.

Subsection 42(1) of the Act provides that the Director-General of the Australian Centre for Disease Control (CDC) may, in writing, determine a human disease is a listed human disease under the Biosecurity (Listed Human Diseases) Determination 2026 (the LHD determination), if the Director-General considers that the disease may be communicable and may cause significant harm to human health.

The Biosecurity (Listed Human Diseases) Determination 2016 is due to sunset (automatically repeal) on 1 October 2026.

Purpose

The purpose is to remake the Biosecurity (Listed Human Diseases) Determination 2016 with the current listed human diseases and to add Andes virus infection. The nine diseases are required to be listed in the LHD determination to allow human biosecurity measures under Chapter 2 of the Act to be imposed, thereby enabling Australia to manage and respond to biosecurity risks to human health caused by those diseases.

Background

The nine diseases determined to be listed human diseases satisfy the legislative threshold in subsection 42(1) for listed human diseases as they may be communicable and may cause significant harm to human health.

It is time-critical to add Andes virus infection to the listed human diseases under the LHD determination following the suspected human-to-human transmission of Andes virus on a cruise ship, reported to the World Health Organization on 2 May 2026. Although the risk to the public is currently assessed as low, Andes virus infection meets the communicability threshold under paragraph 42(1)(a) of the Act with documented human-to-human transmission and has the potential to cause significant harm to human health under paragraph 42(1)(b) of the Act. Andes virus infection causes hantavirus pulmonary syndrome, a severe acute disease characterised by significant morbidity and mortality.

Most powers under Chapter 2 of the Act require that the disease be a listed human disease for the power to apply. These powers include the ability to screen incoming passengers for signs and symptoms of a listed human disease, the ability to impose Human Biosecurity Control Orders and implementing further risk mitigation measures.

To implement appropriate measures under the Act that are adapted to managing the risk, it is necessary for Andes virus infection to be determined as a listed human disease. The inclusion of Andes virus infection enables application of appropriate measures to manage these infections and their potential for human-to-human transmission as required.

Consultation

Subsection 42(2) of the Act requires that, before exercising the power to make the LHD determination, the Director-General must consult with the chief health officer (however described) for each state and territory, the Director of Biosecurity and Director of Human Biosecurity.

The Director-General consulted in writing with the chief health officers in each state and territory, the Director of Biosecurity and the Director of Human Biosecurity, both on the remaking the instrument ahead of its scheduled sunsetting on 1 October 2026, and on the addition of Andes virus infection as a listed human disease. Chief health officers in each state and territory, the Director of Biosecurity and the Director of Human Biosecurity all supported the remaking of the instrument and the addition of Andes virus infection as a listed human disease.

This instrument commences on the day after it is registered.

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

A provision-by-provision description of the Instrument is contained in Attachment A.

Authority: Section 42 of the Biosecurity Act 2015

ATTACHMENT A

Provision by provision description of the Biosecurity (Listed Human Diseases) Determination 2026

1.       Name

Section 1 states that the name of the instrument is Biosecurity (Listed Human Diseases) Determination 2026.

1.       Commencement

Section 2 provides that this legislative instrument commences on the day after it is registered.

1.       Authority

Section 3 specifies that this instrument is made under the Biosecurity Act 2015.

1.       Listed human diseases

Section 4 lists human diseases that are classified as listed human diseases. These diseases may require certain biosecurity measures be implemented to manage risks to human health. These diseases are:

(a) Andes virus infection;

(b) human coronavirus with pandemic potential;

(c) human influenza with pandemic potential;

(d) Middle East respiratory syndrome;

(e) plague;

(f) severe acute respiratory syndrome (SARS);

(g) smallpox;

(h) viral haemorrhagic fevers;

 (i) yellow fever