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Animal testing has been the gold standard in drug research for decades. In the US, the ventilator is now being opened – and methods that do not require animal life are also allowed.

No medicines without (dead) animals – animal testing is a legal requirement for the development and approval of medicines. At least in most parts of the world.

So also in Switzerland. In 2021, more than 570,000 animals were used in Germany for experimental purposes, mainly for research into human diseases. It is not known how many of the animals were killed – and how many survive, for example with an amputated limb.

The question keeps popping up: Can research work without suffering? There is no consensus among scientists on this subject. Not only the ethical aspect is controversial, but also the efficiency, because biological structures and processes of animals and humans cannot always be compared. In other words, if a drug is successful in an animal model, it doesn’t mean it will have the same effect in humans.

“A mouse or rat doesn’t always handle or process drugs and chemicals the way humans do.”

Alternative methods can help here. In the US they now want to slowly approach more modern development opportunities. US President Joe Biden approved the animal testing requirement for drug development, which has existed since 1938: Animal testing is still allowed, but no longer required by law.

The Association of Doctors Against Animal Experiments celebrates the amendment as a “unique success”. But how can you research medicines? And what are the chances of change?

How drugs can be tested now

In addition to the usual animal testing, more modern methods may be used in drug research in the US in the future. The alternatives would be “rigorously tested, fully validated and based on the best scientific evidence,” said Namandjé Bumpus, a senior scientist with the US Food and Drug Administration (FDA). Possible technologies include:

Stem cells from the laboratory

Human-induced pluripotent stem cells (hiPsCs) are created in the laboratory. Tissue cells of the skin serve as starting material. The induced pluripotent stem cells (iPS cells) can transform into any cell found in the body.

Multi-organ chips

So-called “multi-organ chips” can also be used in research: small in vitro systems that can imitate human tissue, organs or even a body using a 3D printer.

computer models (AI)

Another option is computer models that can replace animal testing in the development of drug research, among other things. The models can make predictions about the effectiveness of a medicine based on data already collected.

The scientists at the FDA assume that research with these alternatives will become cheaper and that medicines can therefore be brought to the market faster and more efficiently.

Is this a turning point?

The change in law does not represent a tsunami that will reshape the drug approval process, estimates Jim Newman, communications director at Americans for Medical Progress.

According to Newman, animal-free methods are still in their infancy and are unlikely to replace animal testing for years to come.

Why Europe is not (yet) following suit

In Europe, the competent medicines authority EMA does not yet see time for such a step. The EMA told the German press agency in Amsterdam that animal testing cannot be completely abolished just yet.

New alternative methods that can be used instead should be tested to ensure they are reliable. Last year, the EMA set up a working group to speed up this process.

3R principle: replace, reduce, refine
In Switzerland, animal testing may only be carried out according to the 3R principle (Replace, Reduce, Refine). In this way, animal suffering should be reduced for experimental purposes and other methods should be used if possible. However, this does not apply to the development of a drug.

Every animal experiment and keeping of laboratory animals in Switzerland must be approved by the veterinary office of the canton. The researchers must demonstrate that the social benefits of their research outweigh the harm (weighing of interests).

What animal welfare law is the US in its infancy

The European Union is a role model for the US with another law: animal testing for cosmetics.

The EU Cosmetics Directive prohibits the trade in all cosmetic products that have been tested on animals. The ban also applies to individual ingredients in a product.

Animal testing for the development of cosmetic products is not expressly prohibited in Switzerland, but may not be carried out in this country. Because cosmetics are considered superfluous. As a result, cosmetic articles do not meet the legal requirements for the admission of animal testing.

The US, on the other hand, has not yet completely banned animal testing for cosmetic products from the country. Only individual states such as California, Hawaii, Illinois or New York have passed a law banning animal testing for cosmetics.

However, it should be mentioned that even in the EU and Switzerland it cannot be ruled out that a product has been manufactured without animal testing. Because: Some ingredients belong to medicinal preparations. They therefore do not fall under the cosmetics regulations.

Author: Chantal Staubli

Soource :Watson

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