Phasing Out Animal Research In The European Union
Animal experimentation in biomedical research is commonly seen by regulators and the public as a necessity. However, in recent decades, great advancements have been made in non-animal models (NAMs). At the same time, many experts are recognizing the flaws in using conventional animal models to predict human biology. This research commentary focuses on how the European Union (E.U.) can achieve its stated goal of fully replacing animal testing with NAMs.
A little over a decade ago, the E.U. passed legislation called the European Directive 2010/63/EU on the Protection of Animals for Scientific Purposes. The Directive sets goals to replace, reduce, and refine animal testing. Despite its passage in 2010, total rates of research animal use in the E.U. has remained at around 10 million animals per year. Analyses of databases containing information on animal use across the E.U. found no significant signs of reduction in the number of animals used in fundamental and biomedical research from 2015-2018. Fundamental and biomedical research is conducted to generate new knowledge (e.g., researching the progression of a disease), as opposed to fulfilling regulatory requirements (e.g., testing new drugs before they can be sold). These forms of research are responsible for around 70% of all animals used in research in the European Union.
The authors emphasize the need for more actionable policy changes, as the current ones are proving to be inadequate. Such changes would be in line with the E.U.’s September 2021 resolution to adopt an action plan to phase out the use of animals in research and testing. However, a better approach would be to focus on “phasing in” NAMs by passing policies and approving funding to accelerate their development and application.
NAMs include research on human cells and research using computer simulations. They also include “organs on a chip,” which are small devices that mimic the conditions of human organs and can be used to test the effects of a variety of drugs, diseases, and environments. Organs on a chip are especially useful for studying rare genetic diseases, new uses for existing pharmaceutical drugs, and human-specific processes in complex organs such as the human brain. Because NAMs are based on human biology, can incorporate real patient data, and can be designed to model patient- or population-specific circumstances, they can contribute to the growing practice of personalized medicine.
The authors propose three pillars that can help the E.U. reach its goal of ending animal testing. The first pillar is to promote models based on human biology as the gold standard for biomedical research. This pillar encourages setting aside greater amounts of funding for NAMs, e.g., from the E.U.’s Horizon Europe funding program. Additionally, it encourages funding collaborative projects between existing NAM researchers and traditional animal researchers who want to learn how to use these innovations. Finally, it calls for converting animal research facilities into research centers dedicated to advancing NAMs.
The second pillar is to adapt regulations to increase confidence in NAMs in the science community. This would involve setting standards for regulatory tests and explicitly making NAMs the preferred method to satisfy regulatory requirements. The third and final proposed pillar is knowledge transfer, which involves education and training. This could be accomplished through structured collaborations between E.U. Member States, programs and courses at universities, and post-graduate continuing education for those already in the field. There would need to be a shift in academia to educate journal reviewers about the validity of NAMs so that NAM-based research is not rejected on the basis of excluding animal-based data.
The authors conclude that the E.U.’s commitment to progressing toward research without animals must include actionable steps, such as those outlined in the three pillars. If the status quo continues, total research animal use in the E.U. would still be above one million animals per year by 2095. However, if the E.U. commits around 10% of its research budget (with yearly increases) towards NAMs, this could lead to an annual reduction of around 200,000 animals per year and the elimination of live animal use in fundamental and biomedical research in just 30 years.
Animal advocates in the biomedical field can help by applying for grants to conduct research that advances NAMs while encouraging their peers to commit to the use of NAMs. Advocates outside the biomedical field can petition their universities or governments to direct more funding toward NAMs and to pass resolutions banning live animal testing. Additionally, advocates can donate to nonprofits that support NAM research and promote advancements in NAM technology through social media or traditional news sources.