The Animal Protection Index (API), produced by World Animal Protection, is a ranking of 50 countries worldwide according to their legislation and political commitment to animal protection.
In order to assess each country’s animal protection index, they were rated on various indicators covering the most important aspects of animal protection. One of these indicators concerns the protection of animals used in scientific research: Click here to access the map.
This index was first established in 2014, and its methodology revised in 2020.
Methodology : click here
It’s easy to compare the legislation of different countries, as each country has a sheet summarizing its position with regard to the various indicators.
United States
Click here to access the summary of the “Animal Protection Index” explanatory leaflet written in 2020.
Important legislative developments took place in 2022 and 2024 with the passage of two laws modernizing the FDA (Federal and Drug Administration), which is responsible in particular for bringing drugs to market. The first law (known as FDA 2.0), enacted in December 2022, updated the legal definition of non-clinical testing to include methods other than animal testing, such as in vitro testing or computer modeling (amending the 1938 law requiring potential drugs to be tested for safety and efficacy in animals). However, this is only a possibility, nothing is made compulsory, but the law introduces more flexibility and establishes a level of equivalence between animal testing and the new methods.
Under the second law (FDA 3.0), passed in December 2024 by the US Senate, the FDA must establish a qualification process for non-clinical testing methods designed to replace or reduce animal testing and either improve the predictivity of non-clinical tests for safety and efficacy, or reduce the development time of a drug (including any biological product). The law requires the FDA to evaluate new test methods within a maximum of 180 days.
With this opportunity comes the responsibility for manufacturers to provide convincing evidence of the predictivity, sensitivity and specificity of new methods to the highest scientific standards.
Already in April 2022, the FDA authorized the launch of a human clinical trial based on efficacy data from experiments conducted on organs-on-a-chip. This trial, promoted by Sanofi, focuses on a rare disease, autoimmune demyelinating neuropathy (CIDP: Chronic inflammatory demyelienating polyneuropathy) : more information here
10 April 2025: FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs
The FDA’s animal testing requirement could be replaced by a range of alternative approaches, including computational models of toxicity based on artificial intelligence, cell lines and toxicity testing on organoids in the laboratory. Implementation of this programme begins immediately for Investigational New Drug (IND) applications, where the inclusion of data from NAMs is encouraged, and is described in a roadmap that was also recently published. ‘This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate meaningful treatments and cures for Americans while reducing animal use,’ said FDA Commissioner Martin A. Makary.
10 April 2025: The FDA publishes its roadmap for reducing the use of animal testing in preclinical safety studies
This roadmap outlines a strategic, stepwise approach for FDA to reduce animal testing in preclinical safety studies with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays. By partnering with federal agencies like NIH and VA through ICCVAM, FDA can accelerate the validation and adoption of these human-relevant methods, improving predictive accuracy while reducing animal use. This transition will enhance public health by streamlining drug development and ensuring safer therapies reach patients faster, while positioning FDA as a global leader in modern regulatory science and innovation.
To access this roadmap: click here
The NIH issued a similar statement on 29 April: click here
These announcements were very well received by companies marketing organs-on-chips and organoids: click here
Canada
Click here to access the summary of the 2019 Animal Protection Index.
Canada finally amended the Food and Drugs Act in 2023 to ban animal testing in the cosmetics industry, as well as the sale of cosmetics whose safety is established by animal testing data, following legislation in other countries such as the European Union, Australia, the UK and South Korea. The ban came into force on December 22, 2023.
For more information, click here.
The Canadian Council of Animal Care (CCAC) provides a wealth of information on the use of animals for scientific purposes in Canada: statistical data, guidelines, training modules, establishment certification, animal welfare incidents and publications.
The CCAC, made up of member organizations from the scientific and animal welfare communities and federal granting agencies, promotes animal ethics by focusing on the following strategies:
- developing science-informed standards that incorporate expert opinion, the values of Canadians, and strategies to reduce the need for, and harm of, animals in science, while promoting their wellbeing;
- encouraging the implementation of the highest standards of ethics and care for animals in science in collaboration with the animal care community and scientists across Canada;
- providing assessment and certification programs that empower scientific institutions in achieving high standards of animal ethics and care; and
- providing education, training, and networking opportunities to support individuals, animal care committees, and institutions in implementing our guidelines and sharing best practices in the oversight of animal ethics and care in science.
Switzerland
Click here to access the summary of the “Animal Protection Index” leaflet.
Japan
Click here to access the summary of the “Animal Protection Index” leaflet.
India
Click here to access the summary of the “Animal Protection Index” leaflet.