Primate testing in Europe
Political and Public Support for Replacement of Primate Tests
European Directive 86/609 governing the use of animals in research in the European Union is now over twenty years old. The new European Commission proposal for a new directive is the first major overhaul since 1986. ADI, NAVS and the LDF have jointly published a series of proposals (‘Vision for Europe’) to improve and update the legislation. This includes the introduction of periodic reviews and a timetable to phase out the use of primates in research.
Working towards an end to the use of primates in research would follow through on the commitment originally expressed in Directive 86/609, over twenty years ago. ADI, NAVS and LDF believe that it is time for this commitment to be fulfilled.
20 years on
The law has not kept pace with developments in science and technology. During the 22 years since Directive 86/609/EEC came into effect, the world has seen many changes:
- The digital age and the World Wide Web; communication and research tools changed our ability to share knowledge
- Sophisticated imaging technology – including brain and full body imaging
- Creation of the first virtual organs
- Introduction of microsurgical techniques and keyhole surgery
- Advances in biotechology
- DNA chips
- Transgenic animals and cloning
- Intelligent databases and modelling systems
- New mobile communication technology, allowing transfers of sound, text, pictures and moving images
- Videotape replaced film, then DVD replaced video tape, now we download, and next....
Thus, scientific and technological developments capable of replacing the use of primates in both regulatory (safety) testing and academic research continue to advance at a pace which has left legislation behind. These developments have the advantage of providing data directly applicable to humans, and they represent the cutting edge of science. Adoption of these high-level technologies would position Europe as the world leader in science.
Any new Directive on the use of animals for scientific purposes must therefore include thematic, periodic reviews involving all stakeholders to focus on implementation of advanced techniques and advances in knowledge to help to keep the legislation up-to-date.
Making a special case for non-human primates
Members of the European Parliament and European citizens have identified that there is a strong ethical, scientific and conservation case for phasing out the use of non-human primates in regulatory testing (required for products to be put on the market) and in academic/fundamental research.
All primate species show high levels of intelligence, are dextrous, good at problem solving, behave co-operatively and have extensive social structures with components of culture. Rhesus macaque monkeys have proved themselves capable of learning rudimentary arithmetic, to think using symbols and have demonstrated ‘theory of mind’ – how to reason about what others think – a cognitive ability previously considered paramount to human beings. Both chimpanzees and orangutans have shown an awareness of self. Humans share more than 90% of our DNA with the majority of non-human primates.
Various non-human primate species have expressed emotions such as affection, caring, empathy, humour, anger, sadness, jealousy, and courtship behaviour similar to humans. Some gestures and behaviours are similar to humans, too, such as the way that they greet and play with each other. They enjoy close family bonds, and forge life-long friendships. Chimpanzees in particular display a range of postures and gestures similar to humans, such as greeting one another with kisses and embraces, holding hands, and tickling and reassuring each other. Chimpanzees and gorillas have been taught to communicate with humans using American Sign Language, and they have passed this skill on to the next generation. Various species of primates have been shown to learn by observing each other’s behaviour, including tool use, fishing, and other activities.
All these attributes are significant because they explain why primates can be harmed not just physically, but through mental and emotional distress. This harm can be caused by capture, transport, isolation or barren environments.
We are primates. We know that they can suffer as we would.
The similarities between ourselves and the non-human primates has caused some to argue that this justifies their use in scientific research. However this argument fails on scientific, ethical and conservation grounds. In nature, we can see the richness of diversity that just a small percentage of difference in DNA has made. There are fundamental differences at the cellular, genetic and immune system level which we ignore at our peril, as they make the results from primate tests unreliable for humans.
These differences were illustrated when in the UK, test drug TGN1412 caused terrible, almost fatal, and permanent side effects in human volunteers. Yet the drug had been given to laboratory monkeys in doses 500 times that given to the volunteers, without side effects. Now many agree that this disaster could have been avoided by using advanced technology – microdosing (see later).
Researchers in Denmark and the USA compared genes found in humans to their equivalent genes in chimpanzees. They found that the genes which differ the most between humans and chimpanzees are those related to immune defence and cancer development. They also identified that the genes which are most similar between humans and chimpanzees are those which are expressed in the brain. This work has drawn attention to the misleading nature of primate testing, as results obtain from tests on primates for drugs, toxicity, disease and cancer would be inaccurate when applied to humans.1
Furthermore the assumption that animal, especially primate research is somehow vital for human health has never been properly put to the test through systematic and retrospective scientific reviews. A growing number of reports suggest that, far from reliable, animal models are untrustworthy and should be replaced by scientifically advanced alternative techniques.
Advances in science and technology provide non-animal techniques that are faster, more accurate and of direct relevance to people. Animal research on the other hand is outdated and suffers from the flaw that all species respond differently to substances. Studies have shown differences between humans and laboratory monkeys, on average, a third of the time.
Threats to the existence of non-human primates
The case for conservation of non-human primates is weakened by the trade for European laboratories. New studies have found that a third of primate species are in danger of being wiped off the face of the earth because of human exploitation. As governments in primate home ranges make desperate efforts to prevent the poor and hungry eating some species to oblivion, the western research community demands the right to take these species for unnecessary and unreliable experiments, when alternatives are available.
Furthermore European authorities can do little to influence the standard of welfare or the breeding programmes at foreign suppliers, which means that captive breeding facilities abroad can make up their stocks from wild populations.
The DVD accompanying this report highlights the ecological damage and suffering to primates caused by the capture of owl monkeys in South America for malaria research. Research which has received strong scientific criticism.
It is vital that Europe becomes the standard-bearer and leads the world on this issue, in order to influence foreign governments.
The unethical and short-sighted nature of snatching animals from the wild, as well as the suffering it causes, was acknowledged in EU Directive 86/609/EEC on animal experiments, over twenty years ago. Nevertheless, an estimated 10% of primates in EU labs still come from the wild. Good intent has not been enough.
A clear end to this trade is needed.
Political and Public Opinion
In 2002 the European Parliament adopted this policy, “the need for the continued use of non-human primates in research and testing should be critically evaluated in the light of scientific knowledge, with the intention of reducing and eventually ending their use”.
In 2005, at the World Congress on Alternatives, animal welfare, conservation and protection groups made a declaration on primate experiments. This was later expanded into the Berlin Declaration, which has now been signed by over 70 international animal protection groups (with combined supporters approaching 2 million people), together with many prominent individuals as well as members of the scientific community. The Declaration reads,
“Animal protection organisations and scientists have united to call for an end to the use of non-human primates in biomedical research and testing. We urge governments, regulators, industry, scientists and research funders worldwide to accept the need to end primate use as a legitimate and essential goal; to make achieving this goal a high priority; and work together to facilitate this. In particular, we believe there must be an immediate, internationally co-ordinated effort to bring all non-human primate experiments to an end”.
The European Federation of Pharmaceutical Industries and Association “supports current restrictions for the use of Great Apes” and encourage “European initiatives aiming at eliminating the need for NHP [non-human primates]”.
On the subject of toxicology, which represents 70% of primate use in the EU, the UK’s National Centre for the 3Rs (NC3Rs) and the Association of the British Pharmaceutical Industry (ABPI) have concluded, “there are no regulatory guidelines that specifically require the use of primates and there is scope to review the scientific rationale for their use”.
An end to the use of primates in research would receive wide public support:
80% of respondents to the European Commission’s public consultation on the revision of Directive 86/609/EEC responded that the use of primates in laboratories is ‘not acceptable’. The awareness of primate suffering in laboratories is very high among the public in Europe and is a source of widespread concern.
In 2007, 433 Members of the European Parliament – the majority – signed Written Declaration 40, calling for the Commission, the Council of Ministers and the Parliament to use the revision process of Directive 86/609/EEC to:
(a) make ending the use of apes and wild-caught monkeys in scientific experiments an urgent priority
(b) establish a timetable for replacing the use of all primates in scientific experiments with alternatives
Written Declaration 40/2007 had received unprecedented cross-party support, with every Member State represented. It included prominent Europeans including former government ministers.
- Political and Public Support for Replacement of Primate Tests
- Drug development and safety testing using animals
- Advanced Techniques to Replace use of Primates
- The Investigation
- Suppliers and Travel
- The Primate Environment and Animal Welfare at Huntingdon Life Sciences (HLS)
- (HLS) Husbandry-related welfare issues
- (HLS) Health and sickness
- (HLS) Procedures, handling and restraint
- (HLS) Welfare and suffering related to specific studies
- (HLS) Critique of studies observed at HLS
- Replacing primates