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
7. Implications of an EU-ban on the use of non-human primates
7.1 What potential implications would there be for biomedical research if the use of non-human primates were to be banned?
As long as sufficiently validated alternatives are not available, a total ban would make further progress in some research areas and some safety studies impossible, at least in Europe. If, however, a total ban would be imposed, non-human primate research would be forced outside of Europe to countries where animal welfare standards for laboratory non-human primates are in general lower than in the European Union. There would likely be a net decrease in animal welfare and this could also have an impact on the quality of the research, on public health, on the accessibility of treatments developed under different standards and on the local economy.
7.2 Appropriate use of non-human primates remains essential in some areas of research
As long as sufficiently validated alternatives are not available, a total ban is not yet possible. There is consensus within certain sections of the scientific community that, where alternatives do not exist, appropriate use of non-human primates remains essential in some areas of biomedical and biological research and for the safety assessment of pharmaceuticals. For example: non-human primates can play a key role in drug development due to their similarity to humans with regard to sensory organs, hormonal systems, reproduction, immune system etc., to evaluate efficacy and safety, especially for biopharmaceutical compounds. There has been progress in a move toward a non-animal predictive mechanism-based approach, e.g. for testing of drugs for reproductive toxicity, but there are still obstacles to overcome in terms of regulatory acceptance and scientific validity.
Since animal welfare standards for laboratory non-human primates are on average higher in many European countries than in other parts of the world, it follows that if non-human primates research is forced outside of Europe due to a ban on the use of non-human primates, then there would likely be a net decrease in animal welfare, though some companies have developed global animal welfare policies. There are concerns that European scientists are transferring their research programmes outside the European Union to countries where welfare/scientific standards would not be judged ethically acceptable in Europe. This could have an impact on the quality of the research, on public health and accessibility of treatments developed under different standards and on local economy.
As long as a total ban is not feasible, when communicating about non-human primate use with the public, the scientific community should provide an accurate description of the benefits, harms to animals and limitations of such research, and be realistic about the potential outputs and impacts.