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
6. DETERMINING A TIMELINE FOR PHASING OUT THE USE OF NON-HUMAN PRIMATES
6.1. What is the scientific viewpoint about establishing a phasing-out time-table, gradually reducing the use of non-human primates until they are no longer necessary in medical research?
A number of factors determine the timetable for complete replacement of non-human primates use:
- The availability of funding and resources for developing alternatives to non-human primates models and ensuring they are fit for purpose. Criteria for prioritisation of areas of further research could be used, e.g. the absolute number of the non-human primates used and the severity of procedures.
- The progress in the formal validation of alternative test methods within the regulatory arena and in reducing the timescale and bureaucracy associated with this process.
- Lack of regulatory harmonisation both within and across sectors and the condition that is often included that an alternative method must be formally validated and accepted by regulatory authorities before it can be used
- The progress to validate new non-animal models against existing animal models.
- The extent to which justification for the use of alternative models is laid down in internationally accepted guidelines.
- The risk aversive nature of society makes it difficult to move away from familiar methods to new alternative methods where there is less historical data to fall back on.
- Factors related to scientific practice and career progression where dynamics such as competition, the reputation and track record of researchers (in terms of grants and publications), and entrenchment discourage switching from non-human primates to alternative (animal and non-animal) models.
- New demands for non-human primate use in science, such as emergence and re-emergence of infectious diseases where non-human primates are the only relevant model, and biosimilars for which non-human primates have been advocated as better models because they have a higher tolerance for human proteins.
This wide spectrum of positive and negative incentives for non-human primate use makes it difficult to predict a timetable for complete replacement for each of the research areas.