20 February 2008

1. Members which initiated the declaration pursuant to Rule 116 of the European Parliament’s Rules of Procedure: Jens Holm, Rebecca Harms, John Bowis, Martine Roure and Mojca Dr?ar Murko
2. EP reference number: DCL-0040/2007 / P6_TA-PROV(2007)00407
3. Date of adoption of the Declaration: 25 September 2007
4. Subject: Written declaration on primates in scientific experiments
5. Background: Around 12 million animals are used on a yearly basis in experiments in the EU. Of these, around 10.000 are non-human primates.
Due to the genetic proximity to humans and to their highly developed social skills, the use of non-human primates in experiments raises specific ethical questions and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. The capture of non-human primates from the wild is stressful for the animals and increases the risk of injuries and suffering during capture and transport. Furthermore, the use of non-human primates in experiments is of the highest concern to the citizens.
Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes was adopted to improve the controls on the use of experimental animals and to harmonise practices in the area of animal experimentation in the EU. Article 7 of the Directive provides that "an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available." It is therefore in the spirit of the Directive to encourage methods, which will ultimately replace the use of animals in experiments.
Further on, Article 7 states that "When an experiment has to be performed, the choice of species shall be carefully considered and, where necessary, explained to the authority. In a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neuro-physiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected. Experiments on animals taken from the wild may not be carried out unless experiments on other animals would not suffice for the aims of the experiment."
The scientific grounds on which Directive 86/609/EEC was based date back over 20 years. A number of provisions are undeniably out of date and the Directive therefore does not incorporate latest advancements and new knowledge in the field of animal welfare, nor does it cater for modern techniques in the field of animal experimentation. Furthermore, the current Directive does not allow for a case-by-case scrutiny of the proposed use of animals as there is no requirement for a compulsory authorisation or ethical evaluation on these projects. The Directive is therefore currently under review.
6. Brief analysis / assessment of the Declaration and of requests made in it:
The Declaration calls for immediate restriction on the use of great apes and wild caught monkeys as well as phasing out of the use of all non-human primates with alternatives.
The European Parliament based its declaration on the following elements:
A. more than 80% of respondents to the 2006 Commission’s public consultation on animals in experiments considered the use of primates in experiments as not acceptable,
B. more than 10.000 primates are used in experiments every year in EU laboratories,
C. almost all primate species share more than 90% of their DNA with humans and it is acknowledged that the primate species have a capacity to suffer greatly in captivity,
D. 26% of primate species are in danger of extinction and wild-caught primates continue to be used in laboratories, in addition it may be difficult to protect primates from threats such as human consumption if it is perceived that these species are used freely by Western academic institutions,
E. advanced technology and techniques now provide alternative methods that are proving to be more efficient and reliable than primate experiments, such as functional magnetic resonance imaging (fMRI), microdosing, computer modelling or tissue and cell culture,
F. despite genetic similarities, there are important differences between humans and other primates, and primate experiments cannot match the precision of human-based study.
The Declaration 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 make ending the use of apes and wild-caught monkeys in scientific experiments an urgent priority, and to establish a timetable for replacing the use of all primates in scientific experiments with alternatives as part of the over all revision of Directive 86/609/EEC.
7. Reply to these requests and outlook regarding the action that the Commission has taken or intends to take:
The use of non-human primates has been one of the central points of focus throughout the preparatory work for the revision of Directive 86/609/EEC on the protection of animals used for experimental purposes.
Already at present, non-human primates are used only in exceptional circumstances where no alternative methods are available and no other species may suffice for the purposes of the research. The majority (67%) of the non-human primates used in experiments today are required by legislation for the testing of pharmaceutical products for their safety and efficacy. The rest are used for biological studies of a fundamental nature as well as for the research and development of products and devices for human medicine, dentistry and veterinary medicine.
The species of non-human primates most commonly used in experiments are not included in the list of endangered species under the Convention on International Trade of Endangered Species (CITES). The species of non-human primates used in experiments include Macaques, Marmosets, Vervets and Baboons.
In the European Union, a number of Member States have taken legislative measures to prohibit the use of Great Apes in experiments in their territory. The last use of Great Apes in the European Union was reported in 1999 (6 chimpanzees).
The Commission is examining the possibility to ban the use of Great Apes in experiments throughout the EU, with the exception of those aiming at the preservation of the species themselves. A similar approach is being considered for animals caught in the wild with specific exceptions on scientific grounds.
Given the current state of knowledge, the use of a limited number of other species of non-human primates remains, however, unavoidable for several vital research programs such as on immune based diseases (e.g. multiple sclerosis), neuro-degenerative disorders (Parkinson, Alzheimer, etc), infectious diseases (HIV, Malaria, TB, Hepatitis, SARS, etc.) and other serious diseases. 12 out of 17 diseases listed by the World Health Organisation (WHO) under the programme to fight epidemics and pandemics require the use non-human primates during the development, production or testing of the related vaccines and medicines. In this context, it is important to note that the European Parliament has just recently voted in favour of a Resolution on the International Health Regulation calling for inter alia more support to the WHO programme to fight epidemics and pandemics.
Some alternative techniques are available and have been successfully used to reduce our need to resort to non-human primates. However, it is recognized that, with the current scientific knowledge, not enough alternative methods are yet available to replace the use of non-human primates in all areas of biomedical research today, nor in the near future. The need for their continued use in biomedical research is also highlighted in the opinion of the Scientific Steering Committee in 2002.
In light of the above, a timetable with a fixed deadline to phase out all use of non-human primates is not possible at present as the scientific development has not yet reached the stage that would make such a programming realistic. However, the revision of the Directive can incorporate strong incentives combined with a specific review clause to provide the appropriate and effective mechanism to move towards the ultimate goal of phasing out the use of non-human primates in experiments.
The Commission is convinced that this goal can only be achieved with a vision, close co-operation and combined effort of all concerned.
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