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  • Final Report Summary - CLONING IN PUBLIC (Farm animal cloning and the public. A project to facilitate a European public debate and to make recommendations on regulation and on guidelines ...)

Final Report Summary - CLONING IN PUBLIC (Farm animal cloning and the public. A project to facilitate a European public debate and to make recommendations on regulation and on guidelines ...)

The aims of the CLONING IN PUBLIC project were:
(a) to develop recommendations on the preparation of European regulation and of guidelines covering research and applications of farm animal cloning; (b) to stimulate informed public debate across Europe on these issues involving key stakeholders, university students and representatives of the general public.

These aims have been of equal importance. They are also interrelated, because to serve their purpose, regulations and guidelines must take public concerns into account. In addition, stimulating, informing and reporting public debate is part of the more general, long-term aim of improving communication between science, civil society and European authorities at different levels, and hence facilitating discussion of European public affairs connected with science and technology.

The thematic scope of the project extended to both agricultural and biomedical applications of farm animal cloning. In the agricultural sector, cloning can be used as a tool within farm animal breeding. In biomedical research, a wide range of potential applications of farm animal cloning are now being explored. These applications include the production of genetically identical animals for research purposes, and the use of cell nuclear transfer as method of producing genetically modified animals. Apart from being used for research purposes, such animals may also be used as so-called ‘bio-reactors' to produce valuable proteins. Thus the project has examined only animal biotechnologies in which the use of cell nuclear transfer is an essential part and only applications of these technologies to farm animal species. For example, neither triploid fish nor genetically modified mice for use in research have been covered by the project.

The geographical scope of the project was cross-European and included EU Member States and associated countries. A wider international perspective was also included where this was relevant from an EU point of view: for example, regarding trade, international law and the ability of the EU to be competitive in economic and technological terms.

The partners in CLONING IN PUBLIC have prepared a number of reports on the technical, legal and ethical aspects of farm animal cloning and organised two international workshops, an international conference, a preparatory workshop and a public meeting. The final outcome is a report giving the recommendations of the project to the EU commission and other interested parties about the future regulation of the technology.

The two first reports evaluate the state of the art of the technology; assessed the importance and timeframe for the suggested applications of the technology and, through in-depth interviews with scientists, seek to draw a realistic picture of the problems facing the development of the technology and the expectations within the research environment to the technology. The technical review report has been published in a slightly edited version in animal reproduction science.

Two further reports evaluate the existing legislative framework within the European Member States, the European Union and wider and examine how farm animal cloning might be regulated within the existing legislative framework. Other legislative scenarios are laid out and the reports seek to examine the strengths and weaknesses of different approaches to regulating the technology.

One report evaluates the existing knowledge of public attitudes towards farm animal cloning, and a further report systematically analyses the different ethical concerns typically discussed in the literature.

The findings presented in these reports have been discussed with experts within various fields and with stakeholder representatives from biotechnology companies, industrial organisations, animal welfare organisations, student organisations etc. at two international workshops held in Seville and Prague. The main aim of these workshops has been to listen to comments and different views and ensure that the reports cover a wide range of possibilities and challenges within farm animal cloning.

The reports have formed the knowledge base for the final stages of the project where the findings:
(1) were sought and brought into the public discussion through articles in newspapers and magazines;
(2) formed the foundation for the recommendations to the EU Commission and other interested parties on the regulation and on guidelines for research and applications of farm animal cloning. The draft recommendations were discussed and revised at a participatory conference in Brussels November 2006 where experts, stakeholders, citizen representatives and EU-officials participated. A revised edition of the report was then sent to the commission as the concluding action of the project.

The two end results of the project are:
A: the body of knowledge and reflections built up and made publicly available at the website as a background for an informed public debate about the technology;

B: the conclusions of the project presented in the final recommendations report to the EU commission.

It is the overall conclusion of the project that the EU would be left with difficult processes of decision-making if the cloning of farm animals were to take place in agricultural production in countries outside (likely) or within (at present unlikely) the EU. Whether a decision is made to rely on existing regulation or to introduce new, specifically targeted legislation, concerns about both free trade and social acceptability in Europe will have to be negotiated.

Three main areas of application have been identified. First, cloning techniques are already in use in basic research, i.e. research aimed at the acquisition of new knowledge about fundamental, biological mechanisms. Second, cloning techniques are also being used in biomedicine to develop new medicines and treatments. Third, cloning may in future be used for agricultural purposes - that is, in the production of meat and dairy products - with the aim of making agricultural production more efficient. The first two of these areas of application represent developments that are either already taking place or are in the offing on a global scale.

The third area of application is controversial. It represents for the time being a possible development that may take place in some parts of the world but not in others - a development, then, that may give rise to international conflicts over trade. Specifically, there are indications that cloning techniques may be put to use in agricultural production in the USA but not in the EU. This challenging eventuality must be squarely faced by those considering the regulatory options in the EU.

At present, there is no specific regulation on the cloning of farm animal species in the EU. Thus, at European level animal cloning is now governed only by a rather complex, indirect regulatory patchwork, incorporating general controls on, for instance, the treatment of experimental animals in research, the treatment of production animals in agriculture, and the protection of human health and the free choice of consumers. Much the same is true in individual Member States. Only one country, Denmark, has added specific legislation on animal cloning. When considering whether this is a satisfactory state of regulatory affairs, possible developments in the practical uses of cloning must, of course, be taken into account. These developments must be examined in the light of wider issues of trade and social acceptability in the EU.

One regulatory option would be to live with the present EU regulation, possibly with a few amendments. This may well suffice, given the assumption that animals would only be cloned for basic research and biomedical purposes. For legislation on the uses of animals for such purposes is already in place in the EU. Against this background, the use of public resources to introduce and implement new specific regulation could be seen as wasteful. The caveat, however, would be that the cloning of animals might give rise to renewed public debate on the adequacy of the existing regulation, and on whether, for instance, that regulation provides sufficient protection for animal integrity.

Internal conflicts within the EU might develop, as they also might in the - at present unlikely - event that the cloning of animals is introduced into agricultural production within the EU. Groups of citizens, and even some Member States, would be likely to resist the import and/or marketing (labelled or unlabelled) of cloned animals and their products. This would prompt discussion of the question whether ethical concerns other than those relating to risk should be given regulatory force. It is possible that such ethical concerns would relate to utility, to the protection of traditional agriculture and to the integrity and naturalness of animals. Individual Member States might choose to regulate, as far as possible, along such lines.

The other regulatory option is to introduce specifically targeted EU legislation on the cloning of farm animal species. This could make sense given the combined assessment:
(i) that the cloning in question will be used for commercial agricultural purposes,
(ii) that - although this might give rise to international trade disputes - ethical concerns other than those relating to risk should be taken into account to ensure that the application of cloning techniques is socially acceptable in a European context.

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