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Public Health

The need for non-human primates in biomedical research, production and testing of products and devices (update 2017)

Non-human primates are used in medical research because of their similarities to human beings. Results from research on non-human primates can often be applied to humans, and scientists have learned much about diseases, disorders, prevention and treatments for both humans and animals. Using animals that are so similar to humans, however, raises serious ethical concerns, which is why the use of non-human primates is monitored and strictly regulated. Animal testing for cosmetics was entirely banned in the European Union in March of 2013, and much also has been done to specifically safeguard non-human primates: non-human primates used for research, for example, can no longer be obtained from the wild unless the objectives of the study specifically requires the use of wild-caught; and the use of great apes has been prohibited. As long as non-human primates continue to be used for medical research, the European Commission strongly advocates the "3Rs principle", now a legal obligation embedded in the EU legislation to: Replace non-human primates with viable alternatives whenever feasible, Reduce the use of non-human primates and Refine scientific procedures and the care and treatment of the animals. This Opinion is an update of the 2009 Opinion and addresses issues specifically related to implementing the "3Rs principle".

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8. Research areas to explore to further the 3R principle

8.1. Which research areas should be explored to help replace, reduce and refine the use of non-human primates?

Conducting systematic reviews and meta-analysis of all areas of non-human primate use would potentially significantly reduce the number of non-human primates used by identifying where they are unsuitable models or where their use has contributed very little to current knowledge. Work needs to continue to develop improved means of assessing pain, suffering and distress in non-human primates, including the psychological impact of their use in research.

Examples of efforts to be made in specific research areas are:

  • To progress towards complete replacement of non-human primates in drug safety testing, it will be necessary to gain further insight into molecular biology, including a better understanding of signalling pathways, modelling and bioinformatics and further research into integrated testing strategies. Further work is also needed on new models for investigating abuse potential, the assessment of reproductive toxicity and the characterisation of the safety of biopharmaceuticals.
  • Further research is necessary into 1) the relevance and limitations of the use of non-human primates models for infectious diseases and therapies, 2) the optimisation of novel non-non-human primates animal models, such as humanised mice, 3) development of new techniques such as organoïds and –omics technology.
  • In neuroscience, further progress is required in refinement of awake, behaving electrophysiology studies. There needs to be a focus on significantly improving the spatial and temporal resolution of non-invasive imaging technologies.

8.2. Further work needed for advancement

There is an urgent need to conduct systematic reviews and meta-analysis of all areas of non-human primates use and to build up public databases so that no duplication is allowed. This could potentially significantly reduce the number of non-human primates used and the resources required by identifying where they are unsuitable models or where they have contributed very little to current knowledge.

It is recommended that consideration be given to focusing non-human primate research in centres of excellence and improving existing networks for information sharing. Moreover, researchers and animal care staff must ensure that they keep abreast of the latest techniques that enable reduction in animal numbers and suffering, and put this evidence base into practice. Consideration should be given to development of an accredited training course for those working with non-human primates, harmonised across Member States, and improved access to training in experimental design. Work needs to continue to develop improved means of assessing pain, suffering and distress in non-human primates, including the psychological impact of their use in research. Scientific knowledge about the welfare impact of husbandry and procedures, even after refinement measures have been applied, needs to be assessed and factored into harm-benefit assessments.

For the development and safety testing of pharmaceuticals and medical devices it will be necessary to gain further insight into molecular biology, including a better understanding of signalling pathways, modelling and bioinformatics and further research into integrated testing strategies. Further work is also needed on new models for investigating abuse potential, the assessment of reproductive toxicity and the characterisation of the safety of biopharmaceuticals.

For the treatment and prevention of infectious diseases, further research is necessary into 1) the relevance and limitations of the use of non-human primate models for infectious diseases and therapies, 2) the improvement of techniques and non-human primate characterisation to further refine models and reduce the number of non-human primates required, 3) the optimisation of novel non-non-human primates animal models, such as humanised mice, 4) development of new techniques such as organoids and –omics technology to further reduce the current need to use non-human primates to study important infections.

In neuroscience, there has been progress with refinement of awake, behaving electrophysiology studies, but further progress is required, given the high impact on animal welfare. There also needs to be a focus on significantly improving the spatial and temporal resolution of non-invasive imaging technologies in order to refine and ultimately replace this use of non-human primates.

And in ophthalmology new technology is necessary for whole organ eye-culturing, in vitro and in silico models and simulations for advanced replacement techniques in vision research and to learn more about the structure and function of the visual cortex.