This EURL ECVAM report provides information on the progress being made in the development, validation and regulatory application of non-animal methods, as well as on their use and promotion for research purposes, and in education and training programmes.

INTRODUCTION

EU policies and legislation call for innovative and more efficient ways of safety testing and chemical risk assessment that do not depend on animal testing. Advanced technologies such as computational models, in vitro methods and organ-on-chip devices are being developed, evaluated and integrated to translate mechanistic understanding of toxicity into safety testing strategies. The ultimate goal is to achieve better protection of human health and the environment while supporting EU innovation and industrial competitiveness, without the use of animals. The development and use of non-animal models and methods are also essential for advancing basic, applied and translational research.

Education also plays an essential role in enabling a shift to non-animal methods through the introduction of the Three Rs (Replacement, Reduction and Refinement of animal use in science) into secondary school curricula and programmes of higher education.

The annual EURL ECVAM status report describes research, development and validation activities, as well as initiatives that promote the regulatory use and international adoption of non-animal methods and approaches and their dissemination in the regulatory and research arenas.

DEVELOPMENT

Considerable scientific and technical progress is being made on the development of non-animal methods via a range of EU-funded projects and collaborative partnerships. EURL ECVAM plays a supporting role in such activities by contributing its expertise, providing advice on method characterisation and standardisation, and by sharing the results of relevant in-house research activities. The overall aim is to identify promising methods and facilitate their translation into safety assessment practice, which remains a considerable barrier to acceptance and application.

VALIDATION

At the core of EURL ECVAM activities is the validation of test methods and approaches. Validation is at the interface between test method development/optimisation and regulatory acceptance/international recognition and ensures a science-based and rigorous evaluation of test methods and approaches by establishing their performance and fitness for a given purpose, i.e., their scientific validity.

The EURL ECVAM validation process encompasses four key steps, including the assessment of test method submissions, the planning and conduct of validation studies, the coordination of independent scientific peer reviews and the development of EURL ECVAM

Recommendations on the validity status of test methods. These steps involve close interaction with key stakeholders and international partners. The status of each test method can be monitored using the EURL ECVAM Tracking System for Alternative methods towards Regulatory acceptance (TSAR).

REGULATORY APPLICATIONS

One of EURL ECVAM’s main aims is to support the uptake of new approach methodologies for safety assessment into actual regulatory use through its engagement with the activities of numerous EU and international bodies, such as the OECD, WHO, UN and ICH.

Uptake is achieved through the transformation of methods into regulatory test guidelines, or inclusion in guidance documents as well as through the advancement of hazard assessment methodologies, in general.

Focus at OECD level is currently on integrated approaches to testing and assessment (IATA) which accommodate the combination of information from many different sources provided by a variety o available tools.

ALTERNATIVES IN BASIC AND APPLIED RESEARCH

Approximately 70% of animals used for scientific purposes are for basic, translational and applied research. Thus expediting the uptake and use of non-animal models, especially in areas where animal testing is high (nervous and mental disorder, oncology), is essential to reduce numbers and advance science.

In 2020, EURL ECVAM led several activities in order to identify the availability of alternatives in basic, translational and applied research, completing the review of available and emerging non-animal models in seven disease areas.

Furthermore, EURL ECVAM started a study to assess the impact of EU-funded research projects in the biomedical domain (based on animal models or not) to see how their work contributed to scientific innovation and benefited society.

With the aim to stimulate and support more knowledge sharing on new alternatives within and between biomedical research communities, EURL ECVAM also launched an exploratory project to model the pathogenesis of COVID19 using Adverse Outcome Pathways.

EDUCATION AND TRAINING

Education and training are fundamental to boosting the uptake of alternative methods and the application of the Three Rs in science. In 2016, EURL ECVAM conducted a study to gain an overview of existing Three Rs knowledge, identifying the sources and how they are used and shared (Holley et al., 2016). A main conclusion was that, although Three Rs courses and resources are abundant, there is a need to further complement and amplify current education and training opportunities, especially at secondary school level but also at the level of higher education.

Therefore, EURL ECVAM has been engaged in several education and training activities aiming at increasing the awareness of the Three Rs and alternative methods and approaches at the levels of secondary school, university and early professional training.

EURL ECVAM continues to build and expand on the experiences so far and to strengthen efforts to support Three Rs teaching. This is achieved by adding to its catalogue of resources and stepping up outreach towards educators, education experts and decision makers who play a key role in incorporating the Three Rs into education programmes and curricula. Furthermore, EURL ECVAM collaborates with university networks to develop a strategy for implementing enhanced teaching of the Three Rs and alternatives.

Finally, the third edition of the popular JRC Summer School, aimed at post-graduate students and early career scientists, will take place on 17 to 21 May 2021.

CONCLUSIONS

In 2020, EURL ECVAM continued to advance the field of non-animal methods and approaches through their development, validation and international promotion for regulatory uses and through the evaluation, dissemination and promotion of human-relevant non-animal models for use in basic, applied and translational research.

Source: 

Zuang, V., Dura, A., et al., Non-animal Methods in Science and Regulation – EURL ECVAM Status
Report 2020, EUR 30553 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978-92-76-28395-9, doi:10.2760/719755, JRC123531.