Since the AFSA-authored article ‘Rethinking the Three Rs: Growing Momentum Toward a New Gold Standard in Australian Research’ was published in August 2024, there has been a series of progressive events, funding announcements and developments in Australia. AFSA’s Science Outreach Consultant Dr Natalie Anderson shares them in our post-article publication update.
Progress
Australia made a significant step forward in 2023 with publication of the CSIRO non-animal model strategy for Australia (1) and progress accelerated in 2024 (2).
In August 2024, the non-animal technology network (NAT-NET) was established in NSW, a result of the 4.5 million AUD funding allocated by the NSW government after the NSW Parliamentary Inquiry into primate and other animals used in medical research in NSW (3).
Minister David Harris at NAT Net Funding Announcement
As part of the 2024 NSW government funding announcement, 2.5 million AUD was awarded via grants for equipment and services needed to rehome research animals ranging from $20,000 to $1 million (4).
In November 2024, the report from the WA government Inquiry into medical research funding and priorities was released outlining that a focus of WA health and medical research should include non-animal models (NAMs) and department of Health (DoH) and Department of Primary Industries and Regional Developments (DPIRD) establish an expert advisory panel to facilitate this (5).
In December 2024, consultation on the Australian Council for the Care of Animals in Research and Teaching (ANZCCART) commissioned options paper closed which outlines possible models for national reporting of statistics and was assisted by an advisory panel comprising of persons offering regulatory, institutional, animal protection and community perspectives (6). The summary of feedback is being prepared, and it is planned to be followed by the development of a proposed model which will be released in a further consultation, which we hope will result in long awaited reform on the collation of national animal use statistics.
With regard to regulatory progress, in August 2024, several international guidelines were adopted by the Australian Therapeutic Goods Administration (TGA) that will increase the uptake of NAMs) or include a 3Rs approach (Table 1). Consultation opened on November 21st 2024 for the adoption of several more international guidelines, some of which support NAMs, and closed on the 16th Jan 2025 (7).
In 2024, The Australian TGA also joined The International Medicines Regulators’ Working Group on 3Rs (IMRWG3R) and participated in several NAMs related events throughout Australia in 2024 which is a promising development given Australia’s limited international involvement in leading 3Rs initiatives. IMRWG3R released their terms of reference in October 2024 (8).
In October 2024 at the Australasian Biospecimen Network Association (ABNA) conference, a workshop was led by Phenomics Australia called “Identifying system-wide enhancements in Biobanking as National Research Infrastructure” which aimed to bring together the ABNA community to prepare an investment proposal for a ‘National Approach to collections’ and form a national working group to progress work towards development of a Biobanking National Research Infrastructure and Biobanking Strategy for Australia (9). Following that, a November 2024 Biobanking Panel Discussion event presented on the current landscape of Australian biobanking and related national research infrastructures and discussed what a fit-for-purpose Biobanking strategy for Australia might look like (10).
As part of the renewal of the Australian Animal Welfare Strategy, which includes animals in research and teaching as a Chapter, case studies were released to support the national statement, one of which included the CSIRO non-animal model strategy for Australia (11). The CSIRO case was presented as a case study of how Australia is leading the way in NAMs, which AFSA advocates is demonstrated by implementation of the recommendations.
There has been ongoing revision of animal welfare legislation including pending changes to Acts in South Australia and Victoria (12,13). More meaningful impact on animals in science would be seen in the regulations stage that follows after passing of the primary Acts.
Opportunities
In the background, AFSA has been active in enquiring to Australian medical research funding agencies as to the potential for developing specific funding programs for the development and validation of non-animal research methods. The response that such funding sits outside current strategic funding priorities or endowment policies has been disappointing. However, 2025 brings the opportunity to change this with the development of a National Health and Medical Research Strategy (14), which will guide funding at state and federal level. AFSA will be actively lobbying for the funding gap for human-relevant medical research to be addressed via this overlying strategy.
With a federal election in sight, we will continue to push for implementation of the recommendations identified in the CSIRO non-animal models report and be ready to brief new elected representatives as to the ethical, scientific and economic advantages offered by non-animal methods.
Table 1. Outline of international guidelines adopted by the TGA in August 2024
Guideline Name | Reason supportive of NAMs |
ICH harmonised guideline – Nonclinical safety testing in support of development of paediatric pharmaceuticals (ICH S11) | calls for efficiency in study design which is critical to reduce animal use as per the 3Rs and introduces a weight of evidence approach |
ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk and the ICH M7 Addenum | promotes the use of computer based approaches to make decisions on the mutagenic potential |
ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals | introduces possibility to leverage application of an integrative approach (with weight of evidence criteria) reducing the use of animals in accordance with the 3Rs |
ICH M9 guideline on biopharmaceutics classification system-based biowaivers | directly encourages the use of a Biopharmaceutics Classification System-based biowaiver approach intended to reduce the need for in vivo bioequivalence studies |
ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population | outlines how computer modelling and simulation can be used in paediatric drug development. |
Table 2. List of events and symposium throughout Australia in 2024 on NAMs.
Date | Event title | Host |
Friday 10th May | Advancing Translational and Clinical Tools for Improved Predictive Risk Assessment and Precision Medicine | Australia Research Council Centre for Personalised Therapeutic Technologies |
Oct 2024 | NAMs Discussion Panel | AusBioTech/CSIRO |
Sunday, December 1st | Advances in Microphysiological Systems (MPS): Technologies and Approaches Enabling FDA Modernization Act Impacts on Non-Animal Methods | Australian Society for Clinical and Experimental Pharmacology and Toxicology (ASCEPT), Asia-Pacific Federation of Pharmacologists (APFP) and the Australasian Pharmaceutical Sciences Association (APSA) (Joint Conference)
|
November 2024 | The Organoid Program Symposium | Monash |
July 2024 | Organoids R Us conference | Inaugural host: Doherty Institute/The University of Melbourne/The Royal Melbourne Hospital |
Sat Nov 30th 2024 | NAMs session | ASCEPT/Belberry |
References
- Non-animal models: A strategy for maturing Australia’s medical product development capabilities. Canberra: CSIRO, 2023, https://www.csiro.au/en/nonanimalmodels?utm_source=nationaltribune&utm_medium=nationaltribune&utm_campaign=news (accessed 21 Jan 2025).
- Anderson N, Smith R. Rethinking the Three Rs: Growing Momentum Toward a New Gold Standard in Australian Research. Alternatives to Laboratory Animals. 2024;52(4):224-231. doi:10.1177/02611929241259117
- NSW Health and Medical Research. Communities and Resources. Non-Animal Technologies Network (NAT-Net). Retrieved from: https://www.medicalresearch.nsw.gov.au/nat-net/ Last Accessed 21 Jan 2025
- NSW Government. Ministerial Releases. $2.5 million to support rehoming for research animals. Retrieved from: https://www.nsw.gov.au/media-releases/25-million-to-support-rehoming-for-research-animals. Last accessed 21 Jan 2025
- Parliament of Western Australia. Inquiry into support for health and medical research funding and priorities. Report: In the tube – finding WAs formular for health and medical research success. Retrieved from: https://parliament.wa.gov.au/Parliament/commit.nsf/(EvidenceOnly)/68F8C6A79918F9C348258B1E0025AD4B#Report Last accessed 21 Jan 2025
- ANZCCART Adelaide. National Statistics. Retrieved from: https://anzccart.adelaide.edu.au/national-statistics. Last accessed 21 Jan 2025.
- Australian Department of Health and Aged Care. Consultations. Adoption of International Scientific Guidelines in Australia R01-2024. Retrieved from: https://www.tga.gov.au/resources/consultation/consultation-adoption-international-scientific-guidelines-australia-r01-2024
- International Medicines Regulators’ Working Group on 3Rs. Terms of Reference. Accessed from: https://www.ema.europa.eu/en/documents/other/terms-reference-tor-international-medicines-regulators-working-group-3rs_en.pdf
- Phenomics Australia Workshop: Shaping the Future of Biobanking National Research Infrastructure: Accessed from: https://phenomicsaustralia.org.au/shaping-the-future-of-biobanking-national-research-infrastructure/ Last accessed 23 Jan 2025.
- Victorian Cancer Biobank. News and Resources. Events. Biobanking Panel Discussion. Accessed from: https://viccancerbiobank.org.au/news-resources/events/biobanking-panel-discussion.html Last accessed 23 Jan 2025.
- Australian Government Department of Agriculture Fisheries and Forestry. News and Media. Non-animal models. Case study. Accessed from: https://www.agriculture.gov.au/about/news/non-animal-models Last accessed 23 Jan 2025.
- South Australian Animal Welfare Bill. Accessed from: https://yoursay.sa.gov.au/animal-welfare-draft-bill. Last accessed 23 Jan 2025
- Reforming Victoria’s animal care and protection laws. Accessed from: https://engage.vic.gov.au/new-animal-welfare-act-victoria. Last accessed 23 Jan 2025.
- National Health and Medical Research Strategy. Accessed from: https://www.health.gov.au/our-work/national-health-and-medical-research-strategy. Last accessed 23 Jan 2025.