New European Union statistics on laboratory animal use – what really counts!

Abstract

These days, with a world in lockdown because of the COVID-19 crisis, show us impressively the importance of statistics for policy and public health decisions. Less acute, but a topic that is driving discussions in our part of the life sciences, after seven years AbstractSeven years after the last release, the European Commission has again collated and released data on laboratory animal use. The new report is the first to correspond to the requirements of the new Directive 2010/63/EU. Beside minor problems in reporting, the new reporting format is a major step forward, with additional new categories like severity allowing insight into animal use related questions that goes far beyond the previous reports. An in-depth analysis confirms a slight decrease in animal use from 2015 to 2017, but also compared to the 2005, 2008 and 2011 reports, though the new reporting scheme makes this comparison difficult. Notable success is evident for replacing rabbit pyrogen testing but, in general, the implementation of accepted alternative methods lags behind expectations. Beside the roughly 10 million animals per year covered in the report, about 8 million animals were identified that fall under the Directive but are not included in this number. Their omission downplays the impact of REACH on animal use. The report, second to none in its detail internationally, represents an important instrument for benchmarking and strategically focusing activities in the 3Rs. This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited.

Harnessing the power of novel animal-free test methods for the development of COVID-19 drugs and vaccines

“…There have been large successes in some toxicological areas, but also gaps to be filled (Basketter et al 2012;Leist et al 2014). These approaches have contributed to limit animal use in toxicology, but much less in biomedical research (Daneshian et al 2015;Busquet et al 2020). The use of NAM is not just an animal welfare issue.…”

“…For influenza, for example, that amounted to about 6000 batches in Europe between 2006 and 2016 (Kretzschmar et al 2018). This type of batch control testing is among the most animalconsuming in regulatory testing, and especially where actual challenge tests infecting the animals is required, constitutes the most severe suffering inflicted on laboratory animals (Busquet et al 2020). Major progress for many vaccines has been made converting to serological tests, i.e., where animals' antibody titers or the protective value of the antibodies induced is measured and no infection of the animals (to show protection) is carried out.…”

“…In parallel to these highly visible government activities, industry moved from largely animal-based efficacy testing in the 1980s to predominantly (90%) animal-free efficacy research methods today. The same is true for academia and especially for industry-driven research on target discovery (Busquet et al 2020). Here, cell culture-based methods combined with modern molecular biology and stem cell technology play a major role, but the use of computational research (in silico models) has recently increased as well (Pinero et al 2018;Vamathevan et al 2019), in parallel with an increasing awareness of shortcomings of animal models (Olson et al 2000;Hartung and Leist 2008;Leist and Hartung 2013).…”

The state of the scientific revolution in toxicology

“…In the case of toxicology, in 2008, we already listed the following anomalies: − The effort of REACH − The change in drug industry to biologicals and the rise of nanomaterials − The drying out of the pharmaceutical pipeline − Market forces − Legislation forestalling scientific developments (e.g., EU cosmetics legislation) − Globalization In fact, finally attempting to tackle the backlog of testing chemicals already on the market, first by REACH and in the meantime by other legislations world-wide, challenges the limits of our test capacities (Hartung and Rovida, 2009a;Rovida and Hartung, 2009;Hartung, 2010a). While these analyses were disputed by some stakeholders, especially the European Chemicals Agency and the Environmental Defense Fund (Hartung and Rovida, 2009b), the numbers were actually almost spot on: With the EU animal use statistics published in 2020 (Busquet et al, 2020a), the extent of animal use due to REACH becomes evident, though disguised by the fact that these statistics do not report embryos in reproductive toxicity tests despite the fact that they fall under the EU Directive on the use of animals for scientific purposes 2010/63/EU (Hartung, 2010b). We had predicted that reproductive toxicity testing would dominate animal use for REACH (Hartung and Rovida, 2009a) with about 90% of animals used.…”

“…Applying this to 140,513 animals for reproductive toxicity testing or 97,671 animals for developmental toxicity in 2017, several million animals would need to be added." (Busquet et al, 2020a). Thus, in 2017 alone, applying average factors for non-counted pups, 7.8 million animals were used for REACH reproductive toxicity testing.…”