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Legal barriers for the use of alternatives to animal testing: do current EU regulations and guidelines for regulatory acceptance of medicinal products pose legal barriers?

Wettelijke beperkingen voor het gebruik van alternatieven voor dierproeven bij de beoordeling van geneesmiddelen

Synopsis

Animal tests are used to evaluate the safety, quality and efficacy of medicines. The Dutch government wishes to minimize the number of animals used for this purpose. The Dutch National Institute for Public Health and the Environment (RIVM) has investigated whether European and Dutch legislation offers sufficient scope for using alternatives to animal testing for the evaluation of (new) medicines. The investigation showed that existing pharmaceutical legislation does not impose any legal constraints on the use of alternatives to animal testing, but neither does it actively encourage the use of these alternatives. Alternative methods are permitted, but it must be demonstrated that these have the same predictive value as animal testing. In practice, the required validation procedure is often complicated, costly and time-consuming.

There are mainly other factors that discourage the use of alternatives to animal testing. For instance, medicines must be evaluated in accordance with strict scientific guidelines. These guidelines are not legally binding, but they do determine whether marketing authorization is eventually granted. Although the guidelines devote extensive attention to reducing animal testing, they make frequent references to such tests and contain requirements that any alternatives to animal testing must meet.

Other obstacles include the lack of alternative methods that can fully replace animal testing. In addition, new alternative methods are not always accepted by the registration authorities in all countries. Medicines are usually intended to be marketed in multiple countries, and animal testing is still regarded as the 'gold standard' in some countries. Therefore, manufacturers sometimes opt for animal testing to concede to the demands of the various authorities.

To encourage the development of alternative methods, regulatory authorities, researchers and pharmaceutical companies must engage in ongoing consultation at the international level concerning the criteria applicable to such alternatives. RIVM recommends the continued promotion of research into suitable alternative methods and their implementation in guidelines.

 

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