One step closer to less animal testing
In the future, a part of animal testing for new medicines will no longer be necessary. In most cases, testing on one species of animal instead of two will be sufficient to rule out harmful adverse effects of a medicine during pregnancy. This is one of the conclusions from studies done by the Medicines Evaluation Board (MEB) and the National Institute for Public Health and the Environment (RIVM) together with a number of research institutes and educational institutions.
The research results are a great step forward in reducing the use of animal testing during medical research. The results reflect the MEB and RIVM's ambition to create medicine development that is safe for patients without the use of animal testing.
Databases with information
Researchers collected information on hundreds of medicines and chemicals in two databases. One database was focused on harmful effects during pregnancy, the other on carcinogenic effects. Information collected on the effects during pregnancy show that in general, rats and rabbits show equal results when it comes to predicting effects. Animal-free testing using cultured cells may give a first impression on the possible impact of the medicines. Testing on only one species seems to be sufficient to map the harmful effects of medicines. This is the case for the majority of the medicines researched (70 to 80%). The MEB estimates that worldwide, this would spare 250,000 animals a year from being used for animal testing. When working to reduce animal testing, patient safety is always the top priority.
Adjusting the guidelines for animal testing
The research results, published in scientific journals, are cause to modify the current international guidelines on toxicity during pregnancy. Medicines authorities and pharmaceutical companies in Europe, America, and Japan are consulting on the new guideline during the first half of 2017. The MEB and RIVM hope that all countries reduce testing with multiple species as a step towards animal-free testing and research. If less or no animal testing was needed, a medicine could be introduced to the market much faster.
An international regulatory experiment is ongoing for the studies on carcinogenic effects. Companies predict the effect of 50 substances, after which researchers check if their predictions are accurate. If they are accurate, the guideline on carcinogenic effects can be changed. This means that in about half the cases, the standard 2 years of animal testing would not be necessary. The shorter test that lasts 6 months that is already being used, in combination with the pharmacological data, can be predictive. Based on this study, the MEB and RIVM advise decreasing the amount of animal testing.
Other projects to decrease animal testing
- Innovations by Dr. Geny Groothuis, a MEB member and professor of Drug Metabolism and Toxicology, have led to a decrease in the use of animal testing in medicinal and pharmacological research, as well as in schools. On 10 March 2017, Groothuis was named Knight of the Order of the Netherlands Lion for her achievement.
Participating in a European project (VAC2VAC) to develop animal testing-free safety and efficacy testing for vaccines for both humans and animals.
The development of a register, subsidised by the government, for animal models that prove effective for testing if medicines work and if the results will translate well to the effects they have on humans.
Research into the predictive value of safety studies for humans in medicine development.
RIVM is working on various projects aimed at reducing, replacing, and refining animal testing.