Replacing Animals

HRA concedes that animal research has generated scientific knowledge and advanced medical progress. However, HRA proposes that the benefits are overstated, and that superior methods based on human-biology are much needed to progress human health in the modern era. Whilst there are ongoing attempts to improve the reliability of  animal models, animals cannot accurately mimic human biology, an inherent obstacle which cannot be overcome. 

With the advancement of new approach methodologies (NAMS), defined as ‘non-animal, scientific approaches that focus on human biological processes to investigate disease and potential treatments, using cells from human tissues and organs, as well as existing data’, there are now better ways to do research. 

Around the globe, progress is being made toward eliminating animal testing. Yet Australia is falling behind when it comes to making a commitment to phasing it out.

The Netherlands is leading the way with The Dutch Government committing to a phase out of toxicology tests for chemicals, food ingredients, pesticides, veterinary medicines, and vaccines by 2025. Their Transition Program for Innovation without the use of Animals sets out the means to achieve this through collaboration between the science, health care, government and business community.

In the United States, the Senate passed the FDA Modernization Act in 2022. The Act amends the outmoded regulatory guidance by the FDA (Food and Drug Administration) to broaden the options for drug developers seeking regulatory approvals to include modern and human-relevant testing methods (such as organ on a chip) in lieu of less effective animal experimentation. This follows the Environmental Protection Agency in the US pledging to eliminate all mammal testing by 2035.

The Consolidated Appropriations Act, 2023 has provided funding to federal agencies for various initiatives aimed at increasing transparency, developing new approaches, encouraging rehoming and providing sanctuary for chimpanzees formally used in research. 

In 2021, the European Medicines Agency (EMA)—responsible for the safety and monitoring of medicines in the EU—put in place measures to encourage and accelerate the development and adoption of non-animal methods in the testing and approval of new human drugs

The European Parliament passed a recent resolution calling for an action plan to end the use of animal experimentation. Passed with a resounding vote of 667 to 4, the resolution calls for the European Commission to establish an EU-wide action plan with ambitious yet achievable targets and milestones to accelerate progress in phasing out the use of animal methods in scientific research and education. The plan should prioritise funding for the development of non-animal science and technologies. 
The UK also has a published roadmap, strategy, and vision for non-animal technologies in the UK, although admittedly seems to be failing in following this roadmap.

It is time for Australia to set a roadmap to eliminate animal testing, which requires resourcing of the non-animal research sector and collaboration between multiple sectors.

Approximately 90% of drugs found to be safe and effective in preclinical research, of which animal testing is currently mandatory, fail to make it to human clinical use (i) 

A sample of water is injected into the abdomen of a mouse. No anaesthetic is used. She displays disorientation, paralysis of hind limbs, breathing difficulties and a violent jumping reaction. She becomes unresponsive and cold to the touch.

Within 5 hours she has died from heart failure.
(Mouse Bioassay – used to determine the toxicity caused by algal blooms in water supplies.)

White Mouse in front of a white background

Internationally, and now, within Australian water authorities, the mouse bioassay has been replaced with a number of alternatives, including the Elisa test[ii] – a similar technology to those used in home pregnancy tests – and the Lawrence Method (HPLC)[iii]. These methods have proven to be far more accurate than the mouse bioassay which was often criticized for its inconsistency between laboratories.

As new technologies emerge, the range of non-animal methods continues to grow. Despite claims by some researchers that alternative methods are not yet sophisticated enough to replace animal tests, they are more dependable and produce more accurate results than tests on species who differ from humans in their metabolism of toxins, absorption of chemicals, mechanisms of DNA repair and lifespan – all factors that have a profound effect on the efficacy of drugs.

HRA advocates for the replacement of animals, not just because of the unethical and cruel treatment, but just as importantly for the ability of science to advance in delivery of vital drugs and other treatments to humans.

Here are a few examples of the inefficient and unethical use of animals, and what could be used to replace the animal to provide an accurate and effective result.

Instead of drug testing on dogs:

  • Microdosing – involves giving research participants miniscule doses of an experimental drug then tracking the drug’s movement through the body by radio labelling. Its distribution and metabolism in bodily fluids is measured and enables researchers to quantify its concentrations in blood, urine, saliva and white blood cells.
  • Microfluidic chips – consist of a network of interconnected reservoirs mimicking the organ systems of a living being. Researchers can place lung, liver, fat, gastric or heart cells inside the reservoirs, add a particular drug and quickly evaluate how the chemical is distributed, metabolised and excreted.
Puppy

Instead of invasive brain research on marmosets:

  • Non-invasive imaging techniques – such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) allow us to visualize internal structures of the human brain.
  • Transcranial Magnetic Stimulation (TMS) – a non-invasive treatment using a magnetic field to stimulate nerve cells in areas of the brain. It has been shown to affect mood, motor and cognitive functioning. TMS has few side effects, and is also used as a treatment for mental illness.

Instead of eye irritancy and skin abrasion tests in rabbits:

  • Eytex(TM) –  uses a vegetable protein extracted from jack beans. Like the cornea of the eye, this clear protein gel becomes cloudy when in contact with an irritating substance. The degree of cloudiness (“damage”) is measured with a spectrophotometer, which is much more accurate than assessing the damage to a rabbit’s eyes.
  • Reconstructed human epidermis – involves a multi-layered human skin grown in the laboratory. Cells can be examined under the microscope, membrane damage can be assessed by leakage of enzymes, or inflammation can be determined by release of proteins and molecules called interleukins.
Bunny

Instead of antibody production in mice:

Phage Display – is the interaction between a virus and a bacterium to produce antibodies, which can be produced in a much shorter time than traditional animal methods.

These examples provide a simple snapshot of non-animal methods already available that not only eliminate animal suffering, but are also more predictive of human outcomes.

It’s imperative that we move away from archaic animal tests and instead embrace new technologies.

Other nations are already doing this, with government-funded centres in the UK, Europe and the United States dedicated to the development and validation of non-animal methods. Sadly, Australia has no such commitment.

You can access EU reports on alternatives to animals in breast cancer, neurodegenerative ,respiratory disease, autoimmune disorders and immuno-oncology.

See our 2008 presentation at University of Wollongong for an overview of other countries’ commitment to this issue. Australia needs to keep up!

Alternatives Symposium Wollongong 

For more in-depth information about replacements for animals, see our Business Case for Alternatives August 22 publication and visit the following sites:

Are you a student or researcher and cannot find the alternative you are looking for?

Contact us and our Scientific Consultant will respond with advice specific for your research area. See also our for researchers page for more recommended resources. 

To review the economic benefits of non-animal methods, read our Business Case

What you can do:

Please write to the Federal Minister for Health (details below) and ask that Australia invests in the development and validation of non-animal methods and/or take action by signing the Petition to the Hon Mark Butler to fund non-animal methods of research.    

The Hon. Mark Butler
Federal Minister for Health and Aged Care
House of Representatives
PO Box 6022
Parliament House
Canberra ACT 2600
Email:  minister.butler@health.gov.au

And write to the NHMRC asking that funding be redirected from animal-based research to human-specific research that will replace animal experiments.

Prof. Anne Kelso
CEO National Health & Medical Research Council
GPO Box 1421
Canberra ACT 2601
Email: nhmrc@nhmrc.gov.au

Animals should NOT suffer when there are more efficient methods.

We need your help!

Please support Humane Research Australia with your membership and/or donation so that we can continue the fight to end cruel and ineffective animal experiments and promote a better future – for both animals and for human medical progress.


[i] G.A. Van Norman (2019)  Phase II trials in drug development and adaptive trial design J Am Coll Cardiol Basic Trans Science, 4 pp. 428-437

[ii] Enzyme-linked immunosorbent assay

[iii] High performance liquid chromatograp

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