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The European politics of transgenic animals
Not many countries record the number of transgenic animals used in experiments separately, but the data that is available suggests that the use of transgenic animals in Europe is increasing rapidly. Transgenic animals are one of the 'hot' issues in animal experimentation in Europe. They bring together two areas of public concern and active protest: animal experimentation and genetic engineering.
There are a number of factors which suggest that, over the next few years, this subject will become the focus of increasing public and political attention. The proposed directive on the patenting of biotechnological inventions, which was defeated by the European Parliament last year is being re-introduced by the European Commission. Although it has been significantly modified, it is unlikely to get a better reception from the animal rights and environmental groups who lobbied so hard against the first version. The first clinical use of transgenic xenografts, which is likely to happen in the next year, will attract considerable public attention. In addition, the British Union for the Abolition of Vivisection (BUAV), the dominant group in the European Coalition to End Animal Experiments, has stated that animal genetic engineering is going to be its main campaigning issue from now onwards.
Just how the European Union (EU) and Council of Europe will react to public and political pressure on this issue remains to be seen. However, several projects have already been initiated with a view to producing reports which may set the scene for political initiatives.
Directorate-General XII (Science and Technology) of the European Commission has a research programme on Socio-Economic Impact Studies of Biotechnology. This programme includes a study into the welfare aspects of transgenic animals being conducted by Miriam van der Meer and Professor Bert van Zutphen of the Department of Laboratory Animal Science at the University of Utrecht.
The first part of the project funded by Directorate-General XII of the European Commission, concentrated on analysing the numbers of transgenic animals used in EU Member States; by a combination of literature searches, national government data and surveying. This was continued, with funding from Solvey Duphar, to develop a reasonably sophisticated protocol to assess the welfare impact of both the transgene itself and the derivation of the transgenic line. This will be used in a survey to assess the overall animal welfare impact of the creation and use of transgenic animals. The results of the first part of the project, which are expected to be published in the near future, will provide a useful analysis of the numbers of transgenic animals used in research in the EU. However, the most interesting part will be the continuing research which should give a relatively objective assessment of the welfare implications of transgenesis.
A three-part project, funded by Directorate-General XI (Environment) is being co-ordinated by European Centre for the Validation of Alternative Methods (ECVAM) in Italy. One part of the project is being carried out by Fund for the Replacement of Animals in Medical Experiments (FRAME) based at Nottingham in the UK. This will analyse a representative sample of transgenic animals, to evaluate the scientific reasons for their development and use and the likely benefits to come from that use. The likely animal welfare 'costs' of these same animal projects will also be assessed along with the potential for reducing this cost by the application of the principles of the three R's.
The second part of the project, which is aimed at the ethical evaluation of proposed transgenic animal projects, will be carried out by Dr Ben Mepham of the Centre for Applied Bioethics, at the University of Nottingham. Although this section of the project will concentrate on transgenesis in farm animals, it will take in the production of pharmaceutical proteins by transgenic animals and the production of animal organs for human transplantation. The ethical impact of these technologies will be explored against a set of principles which encompasses broader concerns such as public accountability and economics, as well as cost/benefit analyses relating to animal use.
Dr Mepham has made no secret of his concerns about transgenic animal technology. He co-authored a recent paper on "Transgenesis and animal welfare" published in the FRAME journal, ATLA. From an analysis of animal welfare implications of transgenesis within a 'broad ethical analysis', the paper concluded that a fundamental reappraisal of the method by which such research is approved may be required. In another recent editorial on transgenic xenotransplantation, Dr Mepham called for a moratorium on this technology while an ethical tribunal considered the wider implications of the whole issue.
The final part of the ECVAM co-ordinated project would be carried out by ECVAM itself and aims to provide an ethical analysis of the scientific use of transgenics in order to formulate recommendations for an EU legal framework. This would be based around a new type of cost-benefit system which would also take into account 'intrinsic concerns relating to the use of transgenic animals'
The ECVAM project appears to be taking a more critical approach to this issue. It gives the impression that it has already decided that there is a sufficient ethical and/or animal welfare problem associated with the creation and use of transgenic animals to justify the consideration of some type of legal measure within the EU. By comparison, the University of Utrecht project appears to be taking a more objective approach by analysing whether there is a welfare problem and how significant is the problem.