Everyone is talking about sustainability and the will to replace animal testing with alternative methods, such as New Approach Methodologies (NAMs). But couldn’t both issues be realised at once by re-using test data? What if data trading between science and the major regulatory authorities could be harmonised? Would authorisation processes suddenly be simplified and much quicker? In this article, we have summarised how the European authorities EFSA, ECHA and EMA publicly present how they establish the use of NAMs and the topic of data sharing in their assessment processes.
New Approach Methodologies (NAMs)
Looking at the progress for alternative animal testing, one can see strong efforts at all levels. In the scientific community, a great deal of focus has recently been placed on so-called NAMs (New Approach Methodologies). NAMs are computer or lab-based research approaches intended to more accurately model animal or human biology to replace or sometimes at least complement traditional research models. Numerous research funds are offered as prizes (SET Foundation, BMEL Animal Welfare Research Prize, NIH Common Fund Complement-ARIE programme and many others) to promote research into replacement methods or to recognise successful efforts. In addition, databases are created that make it possible to find alternative methods (e.g. NAMs Network). On the NAMs Network homepage, e.g. 257 different NAMS for hazard characterisation can now be found. These are categorised into organ/systems, guidance, regulations and many more.
The authorities are also recognising more and more alternative methods for authorisation work. Whereas not so long ago, all toxicological tests were still carried out in-vivo, tests such as ‘the eye irritation test on reconstructed human cornea-like epithelium’ have become established as in-vitro tests for the safety assessment of feed additives, among other things. The EFSA (European Food Safety Authority) has a favourable attitude towards NAMS. The recognition of alternative methods is also laid down in Regulation (EC) 429/2008 Annex 2, Article 3: “In-vitro methods or procedures are recommended which refine or replace the usual studies on laboratory animals or reduce the number of animals used in these studies. Such methods shall have the same quality and validity as the methods they are intended to replace”. In addition, EFSA published an activity proposition of the Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment. The roadmap is as follows: EFSA will develop a “guidance on the integration of NAM data into feed and food risk assessment and incorporate the concepts of a weight of evidence approach (as used in traditional human risk assessment) into NAM approaches”. They mention that the alternatives to animal testing “have the potential to provide sound, cost-effective, timely and reliable information, but their regulatory acceptance has not yet been established”. This guidance might bring more information on that topic.
The ECHA (European Chemicals Agency) also runs workshops on the implementation of NAMs and has REGULATORY & MARKETPLACE established NAMs in various areas of the assessment of chemicals. But at the moment they only accept alternative methods as a direct replacement for animal testing for acute and short-term effects. Examples of this are eye irritation, skin sensitisation or bioaccumulation tests. The ECHA still “considers animal testing to be indispensable, especially for the assessment of long-term effects such as organ damage, weakening of the immune system, development of allergies or asthma or reproductive problems and birth defects”.
The EMA (European Medicines Agency) is also open to NAMS. They offer “scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals”. The EMA also publishes their opinion on various NAMs that have been shown to be successful in the context of science and drug development.
But what about the obvious, the direct re-use of data again. With everyone talking about sustainability, wouldn’t that be the non-plus-ultra? Not only does it save animals from experiments, but it also protects the environment, considering the material cost of a new experiment, whether in vivo or in vitro. Not forgetting the time aspect. Every experiment takes time to plan and time again to carry out. If the experiment fails, it has to be planned and carried out again. Let’s have a look at three different authorities (EFSA, ECHA and EMA) and how they handle the re-use of data.
