The new law, approved by Joe Biden at the end of December 2022, will allow the United States Food and Drug Administration (FDA) to approve new medications without the need for data resulting from animal testing. Formerly, pharmaceutical companies were required by law to test the safety and efficacy of their drug-candidates in several tests on animals by using as least two species, before being allowed to put them to the test in clinical trials on humans and patients.
Animal testing is therefore no longer the only option to approve medications in the United States
Thanks to a new law, modern and relevant techniques for our species, such as mini human organs (‘organoids’), organs-on-a-chip, and computerised methods, can now also be used for regulation purposes in the United States in place of animal testing. Numerous ethical processes have already proven to be more precise and more reliable than tests on animals. A recent study has also shown the toxicity of several compounds on the liver with the help of human liver chips, while former experiments on animals had erroneously classified these same compounds as being harmless.
An openness to ethics but not a paradigm shift
Animal testing, however, is not banned by the new law and remains allowed as a possible testing method. Nevertheless, the fact that pharmaceutical businesses are no longer bound by law to carry out tests on animals and are free to use these precise procedures, suitable for humankind and without using animals, represents huge progress.
While the United States is introducing this modern legislation and turning to the future, certain tests on animals in the EU, and therefore also in France, are still required by law for the approval of medications. In Germany, the percentage of regulation animal tests is around 17%. This percentage has reached 31% in France.
Will the European Union make up for their tardiness?
One Voice, like its German partner, asked the European Commission to establish and immediately implement a progressive elimination strategy for animal testing, a defective system if ever there was one, as requested by more than one million people who have signed the Save Cruelty Free Cosmetics European Citizens’ Initiative (ECI).
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Translated from the French by Joely Justice
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