||Endorsed by CDNA
||Endorsed by AHPPC
||17 June 2015
||September 2015 out of session
This document details the process for nominating and assessing a disease for inclusion on the national notifiable diseases list (NNDL) in Australia, for removing a disease from the list and for making minor amendments to diseases on the list. It also provides an overview of the process of approvals and changing the NNDL once approval is given.
Australia has established a list of communicable diseases that are nationally notifiable (the NNDL). The NNDL is a legislative instrument under the National Health Security Act 2007. The Australian Government Minister for Health may vary the NNDL (add or delete a disease) following consultation with the Commonwealth Chief Medical Officer and each State and Territory Health Minister, or may make temporary additions without consulting state and territory health ministers. Temporary additions may not be subject to the usual assessment process.
For status as a nationally notifiable disease to have any practical effect, the disease must be notifiable in the states and territories, as this will provide the basis for laboratories and state and territories to collect the information under jurisdictional public health legislation.
In 2014, the Communicable Disease Network Australia (CDNA) endorsed a set of criteria (Appendix 1) to guide assessment of the need for inclusion of a disease on the NNDL, in order to advise the Minister for Health. The criteria are based on a system of scoring developed by the Public Health Agency of Canada (PHAC) which is designed to assist in determining surveillance priorities.1 CDNA had previously developed and endorsed a system in 2008 based on the Centers for Disease Control and Prevention surveillance goals2, but the system allowed too much variation in the way that diseases may be assessed, and the goals and criteria were vague and the criteria were never published.
Under CDNA criteria, diseases are ranked against 12 criteria that assess public health priority and feasibility of collection (Appendix 1). Public health priority criteria include: necessity for public health response, utility and significance of notification for prevention programs, vaccine preventability and, importance for Indigenous health. Feasibility criteria include: a case is definable, data completeness is likely to be acceptable and alternative surveillance mechanisms. The guide to how to assess and score the answers to each criterion will ensure consistency of scoring over time and between different assessors.
NNDL assessments and associated approval and legislative processes are co-ordinated within the Office of Health Protection (OHP) in the Australian Government Department of Health.
From time-to-time, it may be necessary to consider the removal of a disease from the NNDL, or to make a change to the name of a disease. The criteria for assessing the need to add a disease to the list may be used to assess the future need for national notification of a disease which is already on the list. A truncated consultation and approval process should be undertaken for changes to the list that are of a more minor nature, such as renaming, or separately listing a subset of notifications from one category into a new category.
Abbreviated assessment process for minor changes
Changes that are administrative in nature, or which do not represent a change of priority or resource allocation usually require only consultation with affected stakeholders (usually through CDNA subcommittees). There is usually no need for the formation of a Notifiable Status Assessment (NSA) panel, or for a full assessment to be undertaken.
Examples of minor changes include changes of name (such as arbovirus NEC to flavivirus unspecified to match the case definition), or the moving of a given serovar, or of infection of unspecified duration, for a disease that is already notifiable to be notified under a separate disease code.
Once an administrative change is endorsed by CDNA, the approval process is the same as for major changes (steps 7 to 10 outlined in the process diagram and sections below).
Process summary diagram
Figure: Summary of the process of modifying the National Notifiable Diseases List1
Detailed nomination and assessment process for major changes
Nomination of a disease for national notifiable status
A CDNA member, an expert disease committee (sub-committee of CDNA), an AHMAC Principal Committee, a state or territory Chief Health/Medical/Public Health Officer, the Australian Chief Medical Officer or any State or Territory Health Minister can nominate a disease for assessment for addition or deletion from the list. Nominations are passed to CDNA in writing. Nominators would need to outline their reasons for nominating a disease, and how these reasons are informed by the NNDL criteria (Appendix 1).
Note: Temporary additions to the NNDL may not be subject to this assessment process and may not be nominated to CDNA.
CDNA agreement to undertake an assessment and formation of Panel
If required, CDNA will discuss whether a sufficient case has been made for assessment and provide feedback to the nominator. Nominations are normally automatically assessed, unless there are compelling reasons not to undertake an assessment, such as if findings of a recent assessment recommending against national notification are thought to still apply.
If CDNA agrees to undertake an assessment, it will nominate an NSA panel. An NSA panel must include:
- a CDNA JEG member (chair);
- a laboratory expert from the Public Health Laboratory Network (PHLN) or nominated by PHLN;
- a public health unit representative (including people involved in frontline roles in jurisdictions such as Victoria with a centralised public health agency); and,
- a technical writer.
It may also include other experts and stakeholders drawn from CDNA or elsewhere and should ideally include at least one trainee who can gain experience through undertaking the assessment.
Operation of the NSA Panel
Background material is developed by the technical writer for the panel. The working group meets by teleconference to undertake an assessment against the CDNA criteria and prepare a report for CDNA on the outcomes of the assessment. Meetings are organised and documented by the technical writer, including the rationale for each criterion assessment, as per the reporting template (Appendix 2). The technical writer also drafts the report, which must be agreed by all members of the panel.
The technical writer should forward the results of the assessment to the OHP officer who coordinates NNDL assessments (via the CDNA secretariat for technical writers who are not OHP staff) for collation into a spreadsheet to facilitate the two year review (see section – Review of Criteria).
Guide to conducting the assessment
Diseases are ranked against 12 criteria that assess public health priority and feasibility of collection (Appendix 1). Public health priority criteria include: necessity for public health response, utility and significance of notification for prevention programs, vaccine preventability and, importance for Indigenous health. Feasibility criteria include: a case is definable, data completeness is likely to be acceptable and, alternative surveillance mechanisms. The guide to how to assess and score the answers to each criterion which are listed with the criteria ensure consistency of scoring over time and between different assessors.
The maximum score possible is 48. Following scoring, thresholds for action could be applied, and these have been set as:
- < 15 national notification not recommended
- 15 to 25 national notification to be considered further
- 26+ national notification recommended
Forming a recommendation
The panel utilises the thresholds for action, further discussion and their professional judgment in forming a recommendation regarding inclusion/non-inclusion on the NNDL. It is important to note that the score obtained for a disease may not direct the final recommendation of the panel. The expertise and judgement of the panel is required in making the overall assessment. There may be critical issues that should prevent/compel national notification, but which aren’t reflected in the score obtained.
For diseases falling within the threshold requiring further consideration, the NSA panel could consult with the full CDNA committee if required, seek other expert opinion or input and could consider a range of factors specific to a particular condition and achieve consensus about whether or not to recommend notification. Any further considerations should be documented and justified. Disease specific considerations could include but not be limited to the following:
- AIDS – national notification would not be required because all cases are already notified for public health action under HIV.
- Flavivirus unspecified–low levels of public concern about these particular infections (although not for mosquito-borne diseases generally) along with low rates of infection and mild symptoms may lead to a low score, but monitoring the emergence of new flaviviruses is very important.
- Campylobacteriosis–a very high burden disease but with little to no follow-up currently feasible, however, monitoring notifications allows an understanding of the efficacy of controls at the primary production level, and future technologies such as whole-genome sequencing may enable outbreak detection.
- Emerging trends overseas could indicate a need for close monitoring of a disease which currently is of marginal interest to public health
Endorsement, approval and legislative process
Recommendation to CDNA and CDNA outcome
The findings of the NSA panel should be presented to CDNA at a meeting, with a recommendation about whether the disease should be included on the NNDL. The outcomes of CDNA discussion and next steps may be one of the following options, and the process may be iterative:
- CDNA endorses a recommendation that a disease should be made notifiable and consultation and approval continues; OR
- CDNA does not endorse the finding of an NSA panel and the NSA panel should be asked to reconsider the nomination in the light of CDNA’s comments; OR
- CDNA decides that a nomination should not proceed (whether on the advice of the panel or against it) and the nominator will be provided with the outcomes of the assessment and any additional comments from CDNA, in the form of a letter from the Chair. PHLN and relevant CDNA subcommittees should be advised at this point, including provision of the assessment report.
CDNA endorsed recommendation presented to AHPPC
The Office of Health Protection will process the report and recommendation of CDNA through the relevant committee secretariats. The recommendation of CDNA, including the report of the NSA panel will be presented to AHPPC, where the scientific and technical aspects as well as the policy implications will be considered. For some diseases, it may be relevant to present a recommendation to other AHMAC Principal Committees for consideration.
Approval of the Commonwealth and State and Territory Health Ministers
Paragraph 38(e) of the National Health Security Agreement 2008 provides for AHPPC to advise the Commonwealth on additions or deletions to the NNDL. If AHPPC (and other Principal Committees if relevant) endorses the CDNA recommendation, the Office of Health Protection will initiate consultations first with the senior health officials in all jurisdictions through a submission to the Australian Health Ministers’ Advisory Council (AHMAC); and then with all jurisdictional Health Ministers through the COAG Health Council (CHC).
In consultation with the Office of Parliamentary Counsel, the Office of Health Protection prepares legislation for tabling in parliament.
Communication of change
Advising relevant stakeholders and publication
Communication about the progress of making a change to the NNDL should be made at various steps during the process. Where a disease is to be added, it may be necessary to develop new laboratory and surveillance case definitions and prepare the national notifiable diseases surveillance system for transmission of notifications for the disease. At a minimum the following groups should be advised during the process:
- National Surveillance Committee
- Case Definitions Working Group
- Other relevant CDNA sub-committees (e.g. National Arbovirus and Malaria Advisory Committee)
- All state and territory health departments (via updating CDNA and AHPPC on the process of making a change).
A brief summary report about the change should be published in Communicable Diseases Intelligence as a short report. This should be undertaken by the technical writer and the other panel members.
Review of the criteria
CDNA has recommended a review of the criteria be conducted two years after CDNA endorsement (July 2016). The review will be co-ordinated by the Office of Health Protection.
- Doherty, J.A., Final report and recommendations from the National Notifiable Diseases Working Group Canada Communicable Disease Report 2006;32.
- Guidelines Working Group., Updated Guidelines for Evaluating Public Health Surveillance Systems. MMWR 2001;50(RR13):1-35.