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".
- 1. Introduction
- 2. Background
- 3. Current use of non-human primates
- 4. Alternatives to the use of non-human primates
- 5. Reducing and refining the use of non-human primates
- 6. Determining a timeline for phasing out the use of non-human primates
- 7. Implications of an EU-ban on the use of non-human primates
- 8. Research areas to explore to further the 3R principle
- 9. Conclusion and Recommendations
5. REDUCING AND REFINING THE USE OF NON-HUMAN PRIMATES
5.1. When non-human primates cannot be replaced, how could their use be reduced and refined?
In order to reduce duplication of tests and therefore the number of animals used, researchers are encouraged to increase the yield of data per animal and experimental sessions and to share data and tissues with other researchers and to publish negative/null results. Greater efforts are needed to assess the quality of animal care and the levels of distress that the non-human primates experience so that refinements in husbandry and procedures can be implemented effectively. Caregivers and researchers need to have sufficient training to provide optimal husbandry for the animals in their care. For studies examining the effects of lesions or other interventions within or between groups of animals, factors such as effect size should be considered to reduce sample sizes.
5.2. Reduction and refinement of non-human primate use in areas where no replacement can be foreseen yet, in accordance with the 3R principle
Researchers are encouraged to yield more information per animal and per experiment and to share that information with others, to reduce the number of animals needed. To refine the use of non-human primates, more work needs to be done to assess the level of pain and distress experienced by non-human primates so that improvements in testing and care can be made. Researchers and animal care staff must keep abreast of the latest techniques and use them to reduce the number of animals required and to reduce their suffering. An accredited training course might be developed for those working with non-human primates, which Member States might chose to offer. Access to training in experimental design might also be improved.
Examples of currently available possibilities for reduction and refinement are:
- Safety assessment of chemicals and drugs is being enriched by increasing knowledge and substantial experience of non-animal techniques, which potentially greatly reduces the number of non-human primates used. Additionally, there are experimental clinical pain protocols developed for providing early clinical proof of concept within the boundaries of a phase I clinical trial design (analgesic drugs).
- Increasing costs of drug development of investigational medicinal products favour limited human exposure in exploratory clinical trials, including microdosing.
- Patient-derived induced pluripotent stem cells (iPSCs) have the potential to reduce the number of animal-based preclinical tests and even replace some of them.
- Application of novel sophisticated imaging techniques to study the development of infectious diseases may result in more information from fewer animals.
- Technological developments in neuroscience have enabled refinement of surgical and other procedures e.g., refining and de-sizing the devices used in invasive experiments, improving the anaesthetics and analgesics with faster recovery used in imaging experiments and surgery, non-invasive imaging methods help reduce and refine invasive techniques such as surgery, refinement of food and fluid control protocols and wireless technology have a positive impact on non-human primates welfare.