Huge success in the United States: it is no longer necessary to carry out tests on animals to develop medications
A new American law will allow medications to be approved without animal testing. A first. When will this happen in the EU?
For the first time in more than eighty years, a change in American law will allow testing of new medications without having to use animals, via modern methods based on humans. One Voice, with its German partner within the ECEAE, Doctors Against Animal Experiments, is delighted with this tremendous step and is calling on the EU, as well as Germany and France of course, to follow this example by developing and implementing a development strategy for medications suitable for humans without animal testing.
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.
«Various data clearly shows the failures of the obsolete animal testing system. On average, 92% of drug-candidates that pass all animal tests are then abandoned in human clinical trials, mainly because they do not work or they have secondary effects.»Dr Dilyana Filipova, Scientist at Doctors Against Animal Experiments
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.
«Such examples highlight the importance of this legislative change, not only to save countless animals from horrific tests and atrocious deaths, but also to ensure better safety for patients.»Dr Dilyana Filipova
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).
«Europe must use the United States as a model and no longer carry out tests on animals for medications. If we want to develop better treatments and keep up with the global drug market, we must rely on the most modern, effective, reliable methods based on humans, and not on animal testing which has proven to be ineffective.»Dr Filipova.
More information and sources:
- Wadman, M.: “FDA no longer needs to require animal tests before human drug trials”, Science, 2023; doi : 10.1126/science.adg6264.
- H.R.2617 – Consolidated Appropriations Act, 2023. Sec. 3209. Animal Testing Alternatives.
- Ewart, L. et al., “Qualifying a human Liver-Chip for predictive toxicology: Performance assessment and economic implications”, bioRxiv 2021 ; doi : 10.1101/2021.12.14.472674:2021.12.14.472674
- https://www.experimentation-animale.com/
Translated from the French by Joely Justice