Tuesday, April 25, 2017

The European Union considers the way forward for non-animal approaches to research.

A scientific conference was held in Brussels, Belgium in December 2016 titled “Non-Animal Approaches – The Way Forward.” The conference was organised “to engage the scientific community and relevant stakeholders in a debate on how to exploit cutting edge advances in biomedical and other research in the development of scientifically valid non-animal approaches (alternatives to animal testing).” It was in response to the European Citizens’ Initiative “Stop Vivisection” signed by 1.17 million citizens and submitted to the European Commission on 3 March 2015. The initiative  asked the Commission to “abrogate Directive 2010/63/EU on the protection of animals used for scientific purposes and put forward a new proposal aimed at phasing out the practice of animal experimentation, making compulsory the use – in biomedical and toxicological research – of data directly relevant for the human species.”

At the conference, delegates from 23 countries and from a wide range of scientific disciplines explored the current benefits and limitations of different (alternative) models. While they touched on each of the 3 R’s (Replacement, Reduction, Refinement) their main focus was to identify the value of animal and non-animal methods and how science can move forward with Replacement.

Not all participants agreed that we are currently in a position to completely replace animals in science, and there was much concern about the obligation to protect human safety, but some very promising conclusions and recommendations came out of the conference. They included the following:

Session 1: Animal testing today

  • There is considerable motivation to change the scientific environment to speed up progress towards an animal-free research culture. There are considerable benefits in reaching this goal ethically, scientifically and in terms of business.
  • Inspiration, funding and better education are key elements to animal-free science.
  • There is a need for ongoing investment in public and private funding in non-animal alternatives.
  • The need to publish negative results systematically – starting with all publicly funded studies using animals.

Session 2: Biomedical research – Strengths and limitations of non-animal alternatives
  • There is a need and desire for better sharing of data, making information and knowledge available publically.
  • Effort is required to speed up and possibly simplify the process of validation leading to acceptance of alternatives and therefore greater uptake.
  • Greater resources should be made available for data sharing, including greater access to confidential data – or knowledge being made available from it.

Session 3: Regulatory testing - Strengths and limitations of non-animal alternatives
  • The tipping point for the use of non-animal approaches has been passed and there is now a need to change the regulatory environment to allow the introduction of a new generation of alternative approaches.
  • International collaboration is crucial.
  • New approaches for the validation of complex alternatives need to be developed.

Session 4: Reporting on European Commission Actions
  • The European Citizens’ Initiative was seen as a welcome challenge. It placed alternatives to animal testing at the centre of attention.
  • Over the past ten years there has been significant EU funding through FP6, FP7 and H2020 which has provided alternative methods which will have regulatory impact.
  • Support should be provided for dissemination events, such as conferences and workshops, to increase outreach especially for non-scientists.

Session 5: Responsible Research
  • The EU actively promotes the use of alternatives to animal testing, for ethical and scientific reasons, on a number of levels including fundamental, as well as applied, research and testing through science-based policy making that is responsive to the demands of the citizens.
  • Systematic review of animal experimentation is a key tool to improve this area of science.
  • There is wastage in scientific research, resulting in unnecessary animal use, due to poor statistical design of experiments ad resulting in poor reproducability.
  • Open science, and all means to provide access to data, should be encouraged to ensure transparency and reuse of data.
  • The rewards and incentives for research, such as publication in high impact journals and continued grant funding, may stimulate the reporting of overly optimistic research findings in order to demonstrate their significance.
  • The European Commission should continue (and increase) funding of research in alternatives in specific areas of fundamental, as well as applied, research and testing that will stimulate their uptake and implementation.
  • 2020 should be designated the “Year of Systematic Review”.

Session 6: The future – the way forward.
  • It is possible to create iPS for all organs. These, in combination with organ-on-a-chip technologies and in silico models, will provide for better and more ethical characterisation of diseases and their treatments and may be a solution to the lack of investment in rare diseases.
  • Imaging techniques can be linked to in silico models and provide better, real-time data for animals and humans. They provide insight into mechanisms of action and good prediction of effects.
  • Human tissue should be made more readily available and this should be addressed at EU level.
Also of interest was the road blocks identified for implementation of new technologies. They included:
  • Animal models being seen as the reference standard (especially for repeat dose toxicity);
  • “Institutional resistance” in that regulatory scientists are not necessarily receptive to change;
  • And the need for global harmonisation to accept and apply the new technologies.
HRA knows that it will never be an easy feat to convince the scientific community to completely replace animals in their research, but this conference was an essential step toward that end goal. It is encouraging that the European Union is opening up this very important discussion. 

I do hope that Australia will be inspired by this initiative and not lag behind the rest of the world. Our reputation on high animal usage in science should be reason to address this important issue here and contribute the “global harmonisation” rather than resisting this ethical and scientific progress.


The full report can be accessed at:
http://ec.europa.eu/environment/chemicals/lab_animals/3r/pdf/scientific_conference/non_animal_approaches_conference_report.pdf

For further information about animal experiments: Please visit www.HumaneResearch.org.au
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