Phase-In to Phase-Out—Targeted, Inclusive Strategies Are Needed to Enable Full Replacement of Animal Use in the European Union

Abstract

In September 2021, the European Parliament voted overwhelmingly in favour of a resolution to phase out animal use for research, testing, and education, through the adoption of an action plan. Here we explore the opportunity that the action plan could offer in developing a more holistic outlook for fundamental and biomedical research, which accounts for around 70% of all animal use for scientific purposes in the EU. We specifically focus on biomedical research to consider how mapping scientific advances to patient needs, taking into account the ambitious health policies of the EU, would facilitate the development of non-animal strategies to deliver safe and effective medicines, for example. We consider what is needed to help accelerate the move away from animal use, taking account of all stakeholders and setting ambitious but realistic targets for the total replacement of animals. Importantly, we envisage this as a ‘phase-in’ approach, encouraging the use of human-relevant NAMs, enabling their development and application across research (with applications for toxicology testing). We make recommendations for three pillars of activity, inspired by similar efforts for making the shift to renewable energy and reducing carbon emissions, and point out where investment—both financial and personnel—may be needed.

Considerations in the Preclinical Assessment of the Safety of Antisense Oligonucleotides

“…In March 2021, dosing in this trial was stopped because the high-dose patient group performed worse on clinical rating scales and had higher frequencies of serious adverse events. Ongoing studies are aiming to better predict neurotoxicity with human-based cell models, in line with the European Union directives on animal use in science to advance the development of alternative model systems to replace animal studies [ 141 ].…”

Human‐based new approach methodologies to accelerate advances in nutrition research

“…Consequently, current drug development strategies based on animal modeling are increasingly called into question by the scientific community, recognizing the need to accelerate the growth of human‐focused and human‐relevant science and research both in toxicology/regulatory testing and in other fields (Archibald et al., 2018; Bailey, 2018; Bailey et al., 2015; Chandrasekera & Pippin, 2015; Greek et al., 2012; Hall, 2020; Herrmann et al., 2019; Horejs, 2021; Ingber, 2020; Marshall & Willett, 2018; Nuwer, 2022; Pistollato et al., 2015; Pound, 2020; Pound & Ritskes‐Hoitinga, 2018; Seifirad & Haghpanah, 2019; Van Norman, 2019). In addition to scientific issues, there are increasing public concerns about laboratory animal suffering (EuropeanUnion, 2012; Strauss, 2018) and a commitment to explore alternative methods to replace laboratory animals in developing new drugs and products (Marshall et al., 2022; Neuhaus et al., 2022; Nuwer, 2022). However, conducting experiments on human subjects to test hypotheses and treatments related to human disease or to evaluate the safety of food or food additives may be difficult or impossible due to obvious ethical or practical issues.…”

Animals in Respiratory Research

“…In September 2022, the European Parliament overwhelmingly voted in favor of a resolution to phase out the use of animals in research, testing, and training. Between 2015 and 2018, the average annual percentage decrease in animal use for basic, applied, and translational research in 28 Member States (excluding Norway) was 1.6% [ 4 ]. If the current annual decrease of 1.6% is maintained, the use of animals will not be halved even by 2050.…”