Routine Use of Animal Models in Medical Research According to Expert Opinion
In recent years, significant strides have been made in the quest to reduce animal testing in research and industry. This transition has been primarily driven by the adoption of alternative testing methods, such as human cell models and mathematical/computational models, along with strong regulatory backing and ethical commitments by key agencies.
More than 30% of animal experiments are conducted for applied research, drug and chemical testing. However, it is worth noting that these tests are no longer considered the "gold standard." In fact, the European Pharmacopoeia Commission has removed rabbit fever tests from its list due to the development of tests that activate certain immune cells.
The European Union provides an ethical and scientific framework for many funding programs, including the 3R principle (Replacement, Reduction, and Refinement of animal experiments). This principle is also promoted by agencies like the European Medicines Agency (EMA), which is developing roadmaps to phase out animal testing, particularly in chemical safety.
Key successes and best strategies include regulatory roadmaps and commitment, ethical leadership and policy shifts, the adoption of human cell models, mathematical and computational models, and global harmonization efforts.
The FDA and NIH have jointly released a Roadmap to Reduce Animal Testing in Preclinical Safety Studies, outlining clear plans to transition from animal models to human-relevant, non-animal methodologies. This includes publishing real-world use cases of new approach methodologies (NAMs) to build confidence and creating transparent regulatory policies that support the adoption of alternative strategies.
FDA Commissioner Dr. Marty Makary has made a landmark ethical statement emphasizing respect for animals and a commitment to reducing their use in testing, signaling a cultural shift within federal agencies. The NIH has pledged to reduce and eventually end certain animal experiments, including beagle testing on campus.
The pharmaceutical industry is increasingly replacing animal testing with human-based cell models, which provide more accurate predictions of human biology for drug safety and efficacy. Advances in computational modeling and artificial intelligence tools are also critical to this transition, enabling better prediction of toxicology and safety profiles without animal subjects.
Greater international harmonization is expected as confidence grows in non-animal methods. Agencies like the EMA promote the “3Rs” principle (Replace, Reduce, Refine) and are developing roadmaps to phase out animal testing, particularly in chemical safety.
Beyond ethical considerations, non-animal methods offer economic benefits by reducing costs associated with animal care and increasing throughput. They improve scientific relevance by focusing research on human biology, leading to better health outcomes.
However, fully ending animal testing remains a gradual process, dependent on continued validation of alternatives and regulatory acceptance worldwide. Ongoing transparency through publishing case studies and open regulatory pathways is critical to accelerate this transition.
Notable figures in this field include Thomas Hartung, a professor of evidence-based toxicology at the Johns Hopkins School of Public Health. Under his leadership, 26 animal tests were replaced by alternatives at the European Centre for the Validation of Alternative Methods (ECVAM), officially recognized by the Organisation for Economic Co-operation and Development (OECD).
Hartung's vision is a project that systematically records the effect of chemicals on our bodies and assigns them to specific diseases, replacing animal testing with measurements taken where substances actually end up in the body. In vitro models, brain organoids, organ-on-a-chip procedures, artificial intelligence, machine learning, and mathematical models are among the key areas of research without animal testing.
Omics technologies are also used to investigate the entire interplay of cell components without animal testing. Hartung's work has been recognised with the prestigious Peter Singer Prize for his commitment to animal-free research.
In the EU, about a million animal tests have been replaced by alternative methods in recent years. Despite stricter animal experiment standards set at the European level 40 years ago, the number of animal experiments is still increasing. This underscores the need for continued efforts to reduce or end animal testing in the future.
Better enforcement strategies on the political and legal level, more incentives for science, and increased investment in animal-free testing methods are key strategies to achieve this goal. It is a gradual process, but with continued commitment and collaboration, a future without animal testing in research and industry is within reach.
- Science is increasingly focusing on the development of human-relevant, non-animal methodologies, such as human cell models and computational models, to replace medical-conditions tests, aiming for health-and-wellness with fewer animal subjects.
- The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have outlined plans to transition from traditional animal testing to therapies-and-treatments-oriented alternatives, leveraging strategies like regulatory roadmaps and the use of new approach methodologies (NAMs).
- CBD and other chemical testing are being replaced by advanced non-animal methods, like in vitro models and omics technologies, as part of the ongoing effort to adhere to the 3R (Replace, Reduce, Refine) principle in the pursuit of ethical health-and-wellness research.
