EU Directive 2010/63/EU adopted in September 2010 and which enters into force from 1st January 2013, requires member states to nominate a centre that will promote alternatives at a national level. These national centres of 3Rs expertise will undertake validation studies, and provide a hub for 3Rs research. In this way every member state can play their part.
Validation and regulatory acceptance
Before alternative methods can be used in the mainstream to replace animal testing, they have to undergo validation and international regulatory acceptance, which can take up to 9 years. Estimates put the cost of validating each new alternative typically at $300,0005 (€193,610). In Europe, this is undertaken by ECVAM (European Centre for the Validation of Alternative Methods).
Given that each country has their own specific regulations regarding safety testing, securing international regulatory acceptance for a new testing method is a time-consuming, tedious process. Speeding up the process of regulatory acceptance, ensuring regulatory bodies adopt replacements as soon as they become available has to be a priority.
Institutional change
The report Toxicology in the 21st Century” (National Research Council, 2007), sets out a blueprint for a new approach to toxicity testing – one which doesn’t use animals. Nurturing the right conditions in which researchers feel able to make the necessary shifts in perception and orientation is vital.
Co-operation and research dissemination are key components in ensuring the worldwide research community progress towards non-animal research methods. Centres of excellence, trade organisations, scientific institutes to name a few each play a part in this, informing membership, forging links and moving forward together.
Interdisciplinary approach
Many recent breakthroughs in alternatives have come about through different disciplines working together, for instance innovations in nanotechnology have been used in the field of tissue-engineering to construct 3D tissue models. This highlights the importance of an inter-disciplinary approach.