National Antivisection Society
Ending primate experiments in Europe
15 February 2008
The European Parliament has created a remarkable opportunity to end considerable suffering and advance European science. Will the regulators and legislators seize the moment?
In September 2007, the European Parliament adopted Written Declaration 40/2007 on primates in scientific experiments, which urges the Commission, the Council of Ministers and the European Parliament to use the revision process of Directive 86/609/EC as an opportunity 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.
The Declaration was signed by 433 MEPs, which represents 55% of the Parliament, including every member state, and all political persuasions. The European Commission has now been asked to produce a plan for implementation. Animal Defenders International, who drafted the Declaration, recently met with EU Commissioner Stavros Dimas (see p3) concerning implementation under the revision of EU Directive 86/609.
A phased end to primate testing is an appropriate objective for the revision of 86/609. During the revision process, the European Commission stated: “While the principal reason for the Directive 86/609/EEC is to prevent distortions of competition or barriers to trade, it is also clearly to harmonise the implementation of the Three Rs of Replacement, Reduction and Refinement.”
80% of respondents to the European Commission’s public consultation on the revision of Directive 86/609/EEC on animal experiments deemed the use of primates in laboratories as ‘not acceptable’. According to Eurobarometer 225 of June 2005 on ‘Social values, Science and Technology’, over four out of five EU citizens say that we have a duty to protect animals, whatever the cost.
Ending the use of apes in scientific experiments
In 1999, six Great apes were used in experiments in the EU. By 2002, this had dropped to zero and in 2004, the Netherlands, the last EU country conducting invasive research on chimps, called a halt.
In October 2006 the last Japanese pharmaceutical company still conducting invasive research on chimps stopped. In 1995 the National Center for Research Resources (NCRR), a wing of the US National Institutes of Health, instituted a moratorium on chimp breeding for research. In May 2007 the NCRR announced a permanent end to the breeding of chimps for research.
Ape experiments are prohibited in the Netherlands, Austria, the UK and Sweden (except where research is in the interests of the species – rather unlikely). Spain has been pressing for a law to extend some rights to apes.
During the Commission’s consultation process a centralised EU chimp facility was mooted, but appears to have been dropped. Such a facility would represent a huge and unnecessary expense; it could never be more than an academic curiosity, working as it would in isolation due to the closure of other such facilities around the world. Such a facility would have been out of step with the rest of the scientific community from the outset.
Ape experiments should be ended in the EU immediately.
Ending the use of wild caught primates in scientific experiments
Whilst wild-caught primates account for less than 10% of primates used in EU laboratories, Europe remains influential in this cruel and damaging trade. Primate supply facilities continue to capture wild animals to supplement their breeding stock and there is relatively uncontrolled capture of wild animals from the wild for laboratories in South America and Asia. The trade is difficult to monitor and has previously devastated wild populations – for example Rhesus macaques in India
Use of primates in research involve recognised welfare impacts that affect the data obtained:
- Stress and fear; suffering during capture, transport, confinement and the environment in the laboratory are acknowledged to cause biochemical changes.
- Inadequate background; history of the animal’s health, diet, environment, age.
- Risk of disease and unidentified viruses.
The UK, one of the largest users of laboratory primates in Europe, has an informal ‘ban’ on the use of wild-caught primates in force already.
The principle is already established – an aim of ending the use of wild caught primates was implicit in the original 1986 EC Directive 86/609. The prohibition of the use of wild caught primates would:
- Prevent considerable suffering
- Prevent expansion of primate use in favour of advanced scientific methods
- Protect wild populations
- Send a consistent conservation message – 26% of primate species are endangered
- Remove a major variable in research data, leading to improvements in public safety and human health
Establishing a timetable for replacing the use of all primates in scientific experiments
Approximately 10,500 primates are used per year in European laboratories – around a third of the number being used in cosmetics tests at the time the Commission outlined a timetable to end such tests.
At the time of the cosmetic test ban, and throughout the course of its implementation, there were those arguing it would not be possible, yet obstacles have been overcome and progress has steadily been made. Whilst there might be debate over timescales, it would appear irrational to argue that a timetable is not possible – to do so is to deny the spur to scientific advancement that has been made in recent decades, as a result of public demand.
Primates represent 0.1% of EU animal experiments. A serious intent to replace animal experiments can start here.
In terms of replacement, it is important to accept that the animal model can only, at best, provide an approximation of the human condition. The differences between humans and other animals at the cellular level, combined with biochemical changes due to stress, make extrapolation of results from animal tests to humans unreliable.
Some simple examples of species differences include:
- Gout is a disease caused by excess uric acid which is produced in monkeys, apes and humans; but only humans get gout.
- Monkeys can carry Herpes B virus without suffering the disease; in humans, the disease is rare but almost always fatal.
- UK volunteers taking test drug TGN1412 almost died after multiple organ failure caused by an uncontrollable immune reaction. Side effects included: Soaring body temperatures; dilated blood vessels; falling blood pressure; swollen neck and head; limbs turning purple; permanent damage to immune system; fingers and toes requiring amputation; early signs of cancer; early stage lupus. Yet laboratory monkeys given doses of the drug 500 times that given to the human volunteers, did not show such side effects.
EU primate use falls into two key blocks: Up to 90% are applied studies – toxicity testing, studies of pharmacokinetics of novel drugs, etc., the remainder is fundamental research – predominantly neuroscience.
In fact primates are a comparatively small part of the overall testing strategy – so replacement can, potentially, be faster than with cosmetics where a ‘start to finish’ testing strategy needed to be addressed.
Furthermore, in the role of ‘second mammalian species’ in the testing strategy, primate use is not legally required.
From a third to two thirds of drug candidates fail in Phase I clinical trials. This failure rate highlights the predictive failure of animal tests and the need for more sophisticated and economic techniques.
Europe can replace animal testing in the second mammalian species (often dogs or primates) part of the strategy by moving straight to human-based strategies, such as micro-dosing and toxicogenomics (p4 & 5).
Microdosing involves giving ultra-low, safe, doses of new compounds to human volunteers and responses can then be analysed by Accelerator Mass Spectrometry (AMS). Many agree that the TGN1412 drug disaster would have been avoided by this approach.
The European Union Microdose AMS Partnership Programme (EUMAPP) is underway. This could put replacement of animals on the timetable as early as 2009 or 2010.
Europe wide implementation of microdosing would accelerate drug development, improve safety data – providing human based data before human clinical trials – make considerable cost savings and prevent the suffering of primates and dogs currently used at this ‘second mammalian species’ stage of the testing strategy.
Advanced non-animal techniques, ready to replace primate use in various fields, include:
- Computer database and analytical programmes
- Scanning and analytical techniques as mentioned earlier
- Computer modelling, QSARs (chemical structure-activity relationships)
- Cell, tissue and organ cultures
- Patients studies and epidemiology.
In the field of fundamental research and study in neuroscience, where we are looking for answer for the diseases of ageing populations such as Parkinson’s and Alzheimer’s, there can be little argument that the modern scanning techniques such as fMRI, MEG (see p10-12), combined with others are superior to animal studies. With EU support, research previously conducted on primates could be distributed to research hotels across Europe, making high field MR and MEG more widely available.
Already primate neuroscience research is concentrated in the UK, Germany and France. Germany is probably best placed with high field MR and MEG, closely followed by the UK, then France. Thus the facilities are already where they are needed.
The technology and methods to enable the EU to start implementing a timetable for the replacement of primates in experiments are in place. The European Commission and the Council of Ministers now need to make the commitment to implement a new policy.
Please help us end the abuse of animals, please make a donation today…
action alerts