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
2.1. Background on the update of the 2009 Opinion
This 2017 Opinion by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is an update of the 2009 Opinion by the Scientific Committee on Health and Environmental Risks (SCHER) on ‘The need for non-human primates in biomedical research, production and testing of products and devices’. In the 2009 Opinion, the SCHER stated that they considered non-human primates essential for scientific progress in important areas of disease, biology, research and safety testing. Non-human primates, however, should only be used in medical research when there are no other viable alternatives and when the research data have the potential to significantly add to medical knowledge.
There has been a decrease in the use of non-human primates since 2008. According to the latest available European Union statistics from 2011, around 11 million animals were used in scientific procedures in the European Union. Of these, approximately 6000 were non-human primates, compared to almost 10 000 in 2008.
The 2009 Opinion was reflected in the subsequent Directive 2010/63/EU on the protection of animals used for scientific purposes which required the implementation of the 3Rs principle (Replacement, Reduction and Refinement) during the design and conduct of animal studies. The Directive requires an update to be made of the situation regarding alternatives to the use of non-human primates. Therefore, the European Commission requested the Scientific Committee on Health, Environmental and Emerging Risks to issue an update of the 2009 Opinion.
2.2. What is the recent history concerning the use of non-human primates in research?
Back in 2002, the Scientific Steering Committee published a report highlighting the continuing need to use non-human primates in biomedical research. This was followed by the European Parliament Declaration adopted in 2007 urging the Commission to stop the use of great apes and wild-caught monkeys in scientific experiments and to establish a timetable for replacing all non-human primates in scientific procedures with alternatives. The Commission responded to the European Parliament that with the current scientific knowledge at the time, establishing a timetable with a fixed deadline to phase out all use of non-human primates in the area of biomedical research was not possible. However, the Commission also recognised that science was evolving rapidly in this field and novel technologies, such as genomics and computer modelling, were gradually emerging which could facilitate an increased use of alternatives.
As a result of these events, the Commission's department for Environment (DG ENV) requested the Scientific Committee on Health and Environmental Risks (SCHER) to issue an Opinion on the status of alternatives for the use of non-human primates. This SCHER Opinion was adopted in January 2009 and concurred with the Commission's view seeing no scientific reasons to support a discontinuation of the use of non-human primates in basic and applied research, or in the development and testing of new drugs. The 2009 Opinion assessed the different areas in which non-human primates were being used, examined areas for which partial or full replacement could be foreseen, and discussed the opportunities for the reduction and refinement of the use of non-human primates in areas where no replacement could be expected in medium or long term.
The 2009 Opinion helped shape Directive 2010/63/EU on the protection of animals used for scientific purposes, which replaced an earlier Directive adopted in 1986. The Directive on animal protection provides for controls of the use of live animals for scientific purposes including a systematic project evaluation and authorisation, sets binding standards for housing and care as well as for the education, training and competence of personnel both caring for the animals and supervising and conducting the procedures. Many of the points addressed in the Directive on animal protection also appear in the 2017 Opinion as recommendations and were listed again to stress their importance.