Final Report Summary - PEGASUS (Public perception of genetically modified animals - science, utility and society)
Executive summary:
Abstract
The interdisciplinary European Commission (EC) consortium (the PEGASUS project) aimed to examine the issues raised by the development, implementation, and commercialisation of genetically modified (GM) animals, and derivative foods and pharmaceutical products. The results integrated existing social, (including existing public perception) environmental and economic knowledge regarding GM animals in order to formulate policy recommendations relevant to the new developments and applications of GM animals. The use of GM in farmed animals (aquatic, terrestrial, pharmaceutical) was mapped and reviewed. A foresight exercise was conducted to identity future developments. Three case studies (aquatic, terrestrial, and pharmaceutical) were applied to identify the issues raised, such as the advantages and disadvantages of GM animals from the perspectives of the production chain (economics, agrifood sector) and the life sciences (human and animal health, environmental impact, animal welfare, and sustainable production). Ethical and policy concerns were examined through application of the combined ethical matrix method and policy workshops. The case studies were also used to demonstrate best practice in public engagement in the policy process. As for any emerging area of GM technology, advantages and disadvantages were further qualified, and in the case of GM animals, the results suggest that these require a case-by-case analysis, taking into account public perceptions, ethical issues, the competitiveness of European Union (EU) animal production, and risk-benefit assessments that include human and animal health, environmental impact, and sustainable production considerations.
Highlights
- Public perceptions of GM animals are generally more negative than towards GM plants.
- GM animals are perceived more negatively if used for food than for pharmaceuticals.
- A case-by-case assessment of risks and benefits of GM animals is warranted.
- EU governance systems are reasonably well-prepared.
- More clarity is needed regarding the way in which different publics are engaged in GM animal technology.
- Public and stakeholder engagement exercises can be useful tools for informing policy development.
Project context and objectives:
The overall objective of the PEGASUS project is to provide support for future policy regarding the development, implementation and commercialisation of GM animals, (both terrestrial and aquatic) together with the foods and pharmaceutical products derived from them. Specific objectives have been developed to aid the EU policy assessment of the relevant research programmes and commercial application of these GM animals (both terrestrial and aquatic) together with the foods and pharmaceutical products derived from them. As well as identifying issues raised as part of the technology appraisal process, this work will also identify ethical concerns regarding their introduction, and societal barriers to commercialisation. These outcomes will contribute to and inform the EU's current work to further development the Knowledge-Based Bio Economy (KBBE) and contribute to obtainment of its strategic objectives.
The specific objectives of the PEGASUS project are:
- To identify by literature and expert interviews the most important current and future short-, medium-, and long-term technical developments in the area of genetic modification (trans genesis, (somatic and nucleus transfer cloning, gene therapy, deoxyribonucleic acid (DNA) vaccines, ribonucleic acid interference (RNAi), chimeras) applied to animals for food and pharmaceutics and the importance for the (future) competitiveness of the European animal production. This objective is related to milestone 1 in month 7.
- To provide insight into the economic dimensions (economic performance, chain governance) of using GM animals in the food and pharmaceutical production chain (feed industry, breeding industry, primary sector, processing industry, pharmaceutical industry) concentrated on three case studies, selected.
- To produce a literature overview and an expert consultation (10 interviews) of the risks and benefits (on issues as public health, animal health, animal welfare, environmental safety, sustainability, and agro biodiversity) associated with including GM animal products in the food and pharmaceutical chain (three case studies selected from the point of view of the life sciences.
- To identify consumer perceptions (different demographic groups, differences between EU Member States, cultural and contextual factors) associated with genetic modification in animals (both aquatic and terrestrial species) and derived food and pharmaceutical products by integrating national and European data.
- To collate the documented ethical concerns (positive as negative) raised by 4 stakeholder groups (breeders and farmers, scientists and food and pharmaceutical industry, non-governmental organisations (NGOs) and policy makers) in the Netherlands, Belgium, Hungary, United Kingdom (UK). A final multistakeholder group will be held in India. To categorise ethical themes and identify the relation to policy development and governance practice, based on 3 case studies (aqua, terrestrial and pharmaceutical).
- To identify policy gaps (national, (pan-) European, India and the United States of America (USA)) and recommend the policy options to be considered. Internet-, desk study and ten interviews with policy makers will test and refine the accuracy of the policy needs.
- To provide an integrated analysis of public concerns and preferences for the strategic development and application of genetic modification applied to animals, including the food and pharmaceutical products derived from them. To conduct a public engagement exercise as a citizen jury event (UK, Italy) that will ensure the consistency, timing, and understandability of the information about GM animals.
- To identify future European policy and research needs regarding GM animals by organising a workshop for end users and a mini symposium for policymakers and academics, specifically identifying areas regarding development, implementation and commercialisation of GM animals within the agrifood as pharmaceutical sector.
Project results:
The definition of genetic modification aligns with that provided by Directive 2001/18/EC. This definition includes techniques for introduction of recombinant DNA, transfer of heritable material through various artificial ways, and fusion of cells of different organisms that cannot be crossed in nature. In addition, there are various techniques for cloning animals, including embryo splitting, and the transfer of a nucleus from a donor cell into an enucleated oocyte. These techniques are not usually included in the same category as GM organisms (GMOs) by European regulators. This is not necessarily the case in other regulatory frameworks (e.g. the cloning of organisms new to New Zealand from imported cell materials).
The potential risks and benefits of GM animals, whether applied to food production or to other areas of application, such as pharmaceutical farming, have been recognised by governments, industry and NGOs as an important determinant of their potential future development. Substantial resources have been invested in national and regional initiatives relating to research and safety assessment of GM animals with the aim of managing human and animal health risk, and environmental impacts. Resources have also been dedicated to the analyses of activities which focus on the ethical dimensions of using GM animals in the food production and pharmaceutical sectors. As in any novel area of science, progress in the field of GM animals - from basic research, through the experimentation and testing phases, to the positioning of the final application in the marketplace and the development of the associated commercialisation strategy - is dependent on both the safety and the cultural acceptability of the processes and the products concerned.
An extensive literature regarding public perceptions and other socio-economic aspects of GM animals applied to food production and other areas of application is available. Similarly, there are many scientific publications relating to technological advances and potential economic impacts. This information cannot be translated into concrete policy support unless different disciplinary perspectives can be integrated into a coherent evidence base from which policy can be developed. The Pegasus projects adopts multidisciplinary approach, drawing on expertise from both the social and life sciences, to integrate scientific information into evidence for policy development, which can then be translated into policy options. Ethical dimensions and insights into the evolving international policy landscape must be taken into account in this process. Taken together, the integrated results imply that GM animals need to be considered on a case-by-case basis, independent of whether risk assessment, socio-economic impacts, or ethical issues are being considered. Due consideration should be taken of differences between different types of animals and the reasons for their modification. Not all assessments would apply to all cases, at least not for those within the agrifood sector. For example, research is needed which will enable examination of the welfare issues associated with handling and manipulating GM animals in general, although a case-by-case approach will be required as different types of animals and genetic modification may raise different welfare issues. Ensuring there is clarity regarding ethical 'boundaries' of decision-making processes may be an important element of any future GM animal licensing / policy process. As part of this more research into the socio-economic dimension of GM animal commercialisation, and how this contrasts with alternative approaches, may be required in order to optimise food chain and pharmaceutical benefits from innovations using both GM and non-GM animal technologies. Issues of social equity were also identified. Risk-benefit assessments should consider the impacts on all producing countries to ensure developed countries, (for example, EU Member States), do not reap the benefits of animal GM technologies, while exporting any health, environmental or socio-economic risks to other countries, in particular those which are economically developing.
In order to promote scientific and regulatory leadership in this area, the results indicate that it is important that the EU supports research to improve techniques for the generation of GM animals and the evaluation of the potential impacts which simultaneously take due account of the preferences of European citizens. It is suggested that, as a recommendation for best practice, this may also be relevant internationally. The results suggest this may translate into prioritisation of medical applications of GM animals, at least in the initial stages of an implementation and commercialisation trajectory. Given the reticence of pharmaceutical companies and other industry stakeholders to engage in research utilising GM animals, it may be useful to initially develop innovation through public funding if pharmaceutical applications are deemed a public good. Alternatively, such research might be advanced through facilitation of public-private partnerships.
An important conclusion was that the development, implementation, and (possible) commercialisation strategy for GM animals would need to assess what benefits of products are perceived to be substantial enough to outweigh perceived risks and negative attitudes. This may require research to identify information about what the public perceives to constitute a desirable benefit early enough in development to influence the design of the final product. In this context, attitudes may crystallise following the implementation of EU or international legislation, or following the commercialisation of the products of GM animals intended for consumer purchase, (in particular in the food sector, where public concern is greatest). Further tracking of perceptions and attitudes is warranted. In addition, greater understanding of consumer and / or citizen reactions to GM food and pharmaceutical products in potential markets (e.g. in Brazil, Russia, India and China (BRIC) countries) and in capacity building partner countries is important in order to refine trade and capacity building agreements developed between Europe, and international trading and development partners.
Labelling and consumer choice emerged as an important issue in relation to food in all regions where data were available. Although attitudes towards food related applications of GM animals appeared more positive in south-eastern Asia, the requirement for effective traceability and labelling was also high in this region. Following on from this, a certification system is needed to distinguish the products of GM animals from non-GM counterparts. This is a complex issue for regulators, specifically in terms of what labelling conditions and verification systems would be needed, but reflects societal expectations, and the conditions which will lead to successful economic exploitation of GM animals, in particular applied to food production. In line with current European legislation regarding other food products produced using GM, it is suggested that labels should indicate that a specific product has been produced using GM animals. Mechanisms to ensure effective traceability (e.g. through radiofrequency identification (RFID) tagging or other traceability testing) may be needed to develop and maintain consumer trust. It is also important to develop a labelling strategy in line with the WTO agri-food sector agreements. However, GM-animal-free labelling might emerge as a private initiative adopted by some companies. Labelling should also be applied to export products to countries where there is particular consumer demand for such traceability, such as south-eastern Asia. Traceability systems should enable labelling to be easily applied to pharmaceutical products may also be relevant, if societal demand suggests that this is appropriate. However, the societal requirement for the introduction of stricter regulations related to traceability and labelling systems for products obtained from GM animals will act to increase production costs, which will be offset by decreased production costs overall. Price reductions have potential to increase the producer and consumer acceptance, (assuming the reduction in price is passed on to the final consumer).
Increased consumer acceptability is also contingent on consumers identifying personal benefits to be associated with GM animals (such as those related to health) compared to benefits to the business sector. Thus, monoclonal antibodies produced using GM rabbits may be viable economically, as public acceptance of pharmaceutical products developed using GM animals will be more positive than those applied to food production.
Two issues relating to socio-economic economic impact and issues of equity were identified. The first relates to small and medium-sized enterprises (SMEs), identified as essential elements in European economic competiveness and provision of employment, as well as important generators of income in other parts of the world. As a consequence of the introduction of foods produced using GM animals reducing the prices of associated products in regional or international markets, businesses which do not adopt the technology may become non-competitive, unless they were able to charge a premium for non-GM derived equivalent products. Under these circumstances, financial or informational support to SMEs that could potentially suffer economic losses might be important to preserve the SME sector and maintain consumer choice. The second relates to developing and maintaining economic equity between developed and developing countries. Specifically, the EU and other regions where GM technology is relatively highly advanced should define appropriate tools to support high-quality GM animal pharmaceutical products to be available for therapies and treatments in developing countries, in particular in relation to patent enforcement and capacity building. Similar policies might apply to knowledge transfer regarding GM animals and food production. The successful implementation of such policies would require societal acceptance of pharmaceutical and food products derived from GM animals in both producer and end-user communities. Data are not available to assess local stakeholder and consumer concerns and priorities in many developing regions, research into citizen priorities and preferences within these communities may be required. If GM animals are adopted internationally, international organisations will be required to take a leading role in promoting the global harmonisation of relevant regulatory structures, in particular regarding the handling of the trade disputes that are expected to emerge may also be the responsibility of international organisations.
In terms of science, the EU might encourage the definition of different baseline scenarios for various GM animal species that could be debated and agreed by the national competent authorities. These could be used during the risk assessment process by the European Food Safety Authority (EFSA) or the European Medicines Authority (EMA). Duplication of effort across different EU Member States could be averted through the systematic collection of research data across Europe, and promotion of collaboration among existing research groups to maximise efficiency and the development of common research portfolios. When applicable, the specialisation of particular research teams with a common sharing of resources might be relevant, in particular within the pharmaceutical sector in the production of GM animals that improve the drug innovation process (e.g. disease models). Researchers should be encouraged to consider the minimum number of animals required for a study and whether existing GM animals could be used instead of developing a new GM animal line, in line with existing 3Rs policy (i.e. reduction, refinement, and replacement) of animal use in research. Such policies may also be relevant internationally. The pharmaceutical industry and medical sector generally should be encouraged to collaborate in the development of strategies to enable the benefits of pharmaceutical innovation to be delivered, perhaps through establishing private-public partnerships.
With respect to governance, stakeholders indicated that the EU should maintain its effort to harmonise regulation. Where regulatory implementation is difficult (e.g. the GMO comitology procedure), procedural changes should be explored. For example, inclusion of socio-economic factors in the European comitology procedure would potentially improve the transparency of dialogue with stakeholders and, consequently, the discussion between national competent authorities. Advisory bodies such as EFSA only report on the scientific risks of a given GM animal; and empowering institutions to provide information on the possible benefits, in addition to the possible risks, in their assessments (including GM animal applications) is important in the facilitation of innovation processes. Such changes in regulation within Europe would, of course, need to remain sensitive to the international context (i.e. WTO) and where appropriate work towards global harmonisation of regulations.
The need to involve the public in the debate about implementing and commercialising GM animals and their products is recognised, and public engagement mechanisms such as the citizen jury, and other deliberative processes, will potentially represent a useful approach to fine-tuning policy relating to GM animals. The 'deliberative space' created by the citizen jury methodology facilitates the kind of group interaction and depth of discussions needed to inform policy. However, a more geographically extensive application of the methodology is required, in order to include differences in countries and regions with different socio-historical approaches to technology regulation, and allow comparative analysis between these. The approach is better suited to the discussion of pre-formulated and realistic policy scenarios or options which are compatible with existing systems of policy making. For example, if the results are to be used explicitly to assess the relative merits of different policy outcomes or alternatives, these need to be translated from scientific outcomes to different policy options. An analysis of policy impact is needed in order to justify and optimise citizen engagement within the policy process. As a de minimis, the process by which such policy outputs are anticipated to have an impact on local, national, regional or international policy should be described, both in terms of process (i.e. how is the information to be translated and delivered to decision makers) and practice (i.e. what is the impact of such information on the policy process). This is in line with current thinking regarding the impacts of other forms of consultation on policy processes, for example in the context of expert consultations.
Potential impact:
The results have delivered data relevant to support policy with the development of an innovation strategy, taking into account the range of issues associated with GM animals from a life and social science perspective. As for any emerging area of technology, potential risks and benefits can be identified, and, in the case of GM animals, the evidence suggests that these require a case-by-case analysis. This is demonstrated by the different issues raised by the three case studies and the extrapolation to other examples of GM animals currently under development.
One issue is that, as a result of the research being conducted by a European research consortium, with the aim of supporting European policy development, many major events, works and issues that have emerged in the US have not been addressed. Discussion of these is beyond the scope of the current paper, and indeed these have been discussed extensively elsewhere. However, the international dimension merits further analysis in a global policy context, in particular in relation to regulatory harmonisation. A deciding factor regarding whether, and under what conditions, GM animals are to be introduced and commercialised will be societal acceptance, which will be contingent not only on risk perceptions or other value-based attitudes, but also the perceived benefits offered by specific applications. The issue of consumer choice (and implementation of effective traceability and labelling strategies) will also be important, in particular in relation to agri-food applications. In addition, equitable distribution of socio-economic benefits between producers and consumers, and between affluent and disadvantaged countries and regions is important.
Assuming appropriate risk assessments have been conducted (including those related to animal welfare and the impact of environmental release and / or escape), there appears to be little evidence that the introduction of GM animals for pharmaceutical production will be problematic from a societal perspective. Developing applications of GM animals for food use will be successful only if benefits align with public preferences. Communication about, and public engagement with, emerging policy is important, providing the goals of such activities are well thought through and the policy impact of such public engagement activities are explicitly assessed. In addition, harmonisation of European research activities is an important priority to avoid duplication of effort and unnecessary sacrifice of animals, as is global harmonisation of regulatory activities regarding international trade and development.
Contact details: Professor Lynn Frewer at Univeristy of Newcastle UNEW Lynn.Frewer@newcastle.ac.uk
List of websites: http://www.wageningenur.nl/en/project/Pegasus.htm
Abstract
The interdisciplinary European Commission (EC) consortium (the PEGASUS project) aimed to examine the issues raised by the development, implementation, and commercialisation of genetically modified (GM) animals, and derivative foods and pharmaceutical products. The results integrated existing social, (including existing public perception) environmental and economic knowledge regarding GM animals in order to formulate policy recommendations relevant to the new developments and applications of GM animals. The use of GM in farmed animals (aquatic, terrestrial, pharmaceutical) was mapped and reviewed. A foresight exercise was conducted to identity future developments. Three case studies (aquatic, terrestrial, and pharmaceutical) were applied to identify the issues raised, such as the advantages and disadvantages of GM animals from the perspectives of the production chain (economics, agrifood sector) and the life sciences (human and animal health, environmental impact, animal welfare, and sustainable production). Ethical and policy concerns were examined through application of the combined ethical matrix method and policy workshops. The case studies were also used to demonstrate best practice in public engagement in the policy process. As for any emerging area of GM technology, advantages and disadvantages were further qualified, and in the case of GM animals, the results suggest that these require a case-by-case analysis, taking into account public perceptions, ethical issues, the competitiveness of European Union (EU) animal production, and risk-benefit assessments that include human and animal health, environmental impact, and sustainable production considerations.
Highlights
- Public perceptions of GM animals are generally more negative than towards GM plants.
- GM animals are perceived more negatively if used for food than for pharmaceuticals.
- A case-by-case assessment of risks and benefits of GM animals is warranted.
- EU governance systems are reasonably well-prepared.
- More clarity is needed regarding the way in which different publics are engaged in GM animal technology.
- Public and stakeholder engagement exercises can be useful tools for informing policy development.
Project context and objectives:
The overall objective of the PEGASUS project is to provide support for future policy regarding the development, implementation and commercialisation of GM animals, (both terrestrial and aquatic) together with the foods and pharmaceutical products derived from them. Specific objectives have been developed to aid the EU policy assessment of the relevant research programmes and commercial application of these GM animals (both terrestrial and aquatic) together with the foods and pharmaceutical products derived from them. As well as identifying issues raised as part of the technology appraisal process, this work will also identify ethical concerns regarding their introduction, and societal barriers to commercialisation. These outcomes will contribute to and inform the EU's current work to further development the Knowledge-Based Bio Economy (KBBE) and contribute to obtainment of its strategic objectives.
The specific objectives of the PEGASUS project are:
- To identify by literature and expert interviews the most important current and future short-, medium-, and long-term technical developments in the area of genetic modification (trans genesis, (somatic and nucleus transfer cloning, gene therapy, deoxyribonucleic acid (DNA) vaccines, ribonucleic acid interference (RNAi), chimeras) applied to animals for food and pharmaceutics and the importance for the (future) competitiveness of the European animal production. This objective is related to milestone 1 in month 7.
- To provide insight into the economic dimensions (economic performance, chain governance) of using GM animals in the food and pharmaceutical production chain (feed industry, breeding industry, primary sector, processing industry, pharmaceutical industry) concentrated on three case studies, selected.
- To produce a literature overview and an expert consultation (10 interviews) of the risks and benefits (on issues as public health, animal health, animal welfare, environmental safety, sustainability, and agro biodiversity) associated with including GM animal products in the food and pharmaceutical chain (three case studies selected from the point of view of the life sciences.
- To identify consumer perceptions (different demographic groups, differences between EU Member States, cultural and contextual factors) associated with genetic modification in animals (both aquatic and terrestrial species) and derived food and pharmaceutical products by integrating national and European data.
- To collate the documented ethical concerns (positive as negative) raised by 4 stakeholder groups (breeders and farmers, scientists and food and pharmaceutical industry, non-governmental organisations (NGOs) and policy makers) in the Netherlands, Belgium, Hungary, United Kingdom (UK). A final multistakeholder group will be held in India. To categorise ethical themes and identify the relation to policy development and governance practice, based on 3 case studies (aqua, terrestrial and pharmaceutical).
- To identify policy gaps (national, (pan-) European, India and the United States of America (USA)) and recommend the policy options to be considered. Internet-, desk study and ten interviews with policy makers will test and refine the accuracy of the policy needs.
- To provide an integrated analysis of public concerns and preferences for the strategic development and application of genetic modification applied to animals, including the food and pharmaceutical products derived from them. To conduct a public engagement exercise as a citizen jury event (UK, Italy) that will ensure the consistency, timing, and understandability of the information about GM animals.
- To identify future European policy and research needs regarding GM animals by organising a workshop for end users and a mini symposium for policymakers and academics, specifically identifying areas regarding development, implementation and commercialisation of GM animals within the agrifood as pharmaceutical sector.
Project results:
The definition of genetic modification aligns with that provided by Directive 2001/18/EC. This definition includes techniques for introduction of recombinant DNA, transfer of heritable material through various artificial ways, and fusion of cells of different organisms that cannot be crossed in nature. In addition, there are various techniques for cloning animals, including embryo splitting, and the transfer of a nucleus from a donor cell into an enucleated oocyte. These techniques are not usually included in the same category as GM organisms (GMOs) by European regulators. This is not necessarily the case in other regulatory frameworks (e.g. the cloning of organisms new to New Zealand from imported cell materials).
The potential risks and benefits of GM animals, whether applied to food production or to other areas of application, such as pharmaceutical farming, have been recognised by governments, industry and NGOs as an important determinant of their potential future development. Substantial resources have been invested in national and regional initiatives relating to research and safety assessment of GM animals with the aim of managing human and animal health risk, and environmental impacts. Resources have also been dedicated to the analyses of activities which focus on the ethical dimensions of using GM animals in the food production and pharmaceutical sectors. As in any novel area of science, progress in the field of GM animals - from basic research, through the experimentation and testing phases, to the positioning of the final application in the marketplace and the development of the associated commercialisation strategy - is dependent on both the safety and the cultural acceptability of the processes and the products concerned.
An extensive literature regarding public perceptions and other socio-economic aspects of GM animals applied to food production and other areas of application is available. Similarly, there are many scientific publications relating to technological advances and potential economic impacts. This information cannot be translated into concrete policy support unless different disciplinary perspectives can be integrated into a coherent evidence base from which policy can be developed. The Pegasus projects adopts multidisciplinary approach, drawing on expertise from both the social and life sciences, to integrate scientific information into evidence for policy development, which can then be translated into policy options. Ethical dimensions and insights into the evolving international policy landscape must be taken into account in this process. Taken together, the integrated results imply that GM animals need to be considered on a case-by-case basis, independent of whether risk assessment, socio-economic impacts, or ethical issues are being considered. Due consideration should be taken of differences between different types of animals and the reasons for their modification. Not all assessments would apply to all cases, at least not for those within the agrifood sector. For example, research is needed which will enable examination of the welfare issues associated with handling and manipulating GM animals in general, although a case-by-case approach will be required as different types of animals and genetic modification may raise different welfare issues. Ensuring there is clarity regarding ethical 'boundaries' of decision-making processes may be an important element of any future GM animal licensing / policy process. As part of this more research into the socio-economic dimension of GM animal commercialisation, and how this contrasts with alternative approaches, may be required in order to optimise food chain and pharmaceutical benefits from innovations using both GM and non-GM animal technologies. Issues of social equity were also identified. Risk-benefit assessments should consider the impacts on all producing countries to ensure developed countries, (for example, EU Member States), do not reap the benefits of animal GM technologies, while exporting any health, environmental or socio-economic risks to other countries, in particular those which are economically developing.
In order to promote scientific and regulatory leadership in this area, the results indicate that it is important that the EU supports research to improve techniques for the generation of GM animals and the evaluation of the potential impacts which simultaneously take due account of the preferences of European citizens. It is suggested that, as a recommendation for best practice, this may also be relevant internationally. The results suggest this may translate into prioritisation of medical applications of GM animals, at least in the initial stages of an implementation and commercialisation trajectory. Given the reticence of pharmaceutical companies and other industry stakeholders to engage in research utilising GM animals, it may be useful to initially develop innovation through public funding if pharmaceutical applications are deemed a public good. Alternatively, such research might be advanced through facilitation of public-private partnerships.
An important conclusion was that the development, implementation, and (possible) commercialisation strategy for GM animals would need to assess what benefits of products are perceived to be substantial enough to outweigh perceived risks and negative attitudes. This may require research to identify information about what the public perceives to constitute a desirable benefit early enough in development to influence the design of the final product. In this context, attitudes may crystallise following the implementation of EU or international legislation, or following the commercialisation of the products of GM animals intended for consumer purchase, (in particular in the food sector, where public concern is greatest). Further tracking of perceptions and attitudes is warranted. In addition, greater understanding of consumer and / or citizen reactions to GM food and pharmaceutical products in potential markets (e.g. in Brazil, Russia, India and China (BRIC) countries) and in capacity building partner countries is important in order to refine trade and capacity building agreements developed between Europe, and international trading and development partners.
Labelling and consumer choice emerged as an important issue in relation to food in all regions where data were available. Although attitudes towards food related applications of GM animals appeared more positive in south-eastern Asia, the requirement for effective traceability and labelling was also high in this region. Following on from this, a certification system is needed to distinguish the products of GM animals from non-GM counterparts. This is a complex issue for regulators, specifically in terms of what labelling conditions and verification systems would be needed, but reflects societal expectations, and the conditions which will lead to successful economic exploitation of GM animals, in particular applied to food production. In line with current European legislation regarding other food products produced using GM, it is suggested that labels should indicate that a specific product has been produced using GM animals. Mechanisms to ensure effective traceability (e.g. through radiofrequency identification (RFID) tagging or other traceability testing) may be needed to develop and maintain consumer trust. It is also important to develop a labelling strategy in line with the WTO agri-food sector agreements. However, GM-animal-free labelling might emerge as a private initiative adopted by some companies. Labelling should also be applied to export products to countries where there is particular consumer demand for such traceability, such as south-eastern Asia. Traceability systems should enable labelling to be easily applied to pharmaceutical products may also be relevant, if societal demand suggests that this is appropriate. However, the societal requirement for the introduction of stricter regulations related to traceability and labelling systems for products obtained from GM animals will act to increase production costs, which will be offset by decreased production costs overall. Price reductions have potential to increase the producer and consumer acceptance, (assuming the reduction in price is passed on to the final consumer).
Increased consumer acceptability is also contingent on consumers identifying personal benefits to be associated with GM animals (such as those related to health) compared to benefits to the business sector. Thus, monoclonal antibodies produced using GM rabbits may be viable economically, as public acceptance of pharmaceutical products developed using GM animals will be more positive than those applied to food production.
Two issues relating to socio-economic economic impact and issues of equity were identified. The first relates to small and medium-sized enterprises (SMEs), identified as essential elements in European economic competiveness and provision of employment, as well as important generators of income in other parts of the world. As a consequence of the introduction of foods produced using GM animals reducing the prices of associated products in regional or international markets, businesses which do not adopt the technology may become non-competitive, unless they were able to charge a premium for non-GM derived equivalent products. Under these circumstances, financial or informational support to SMEs that could potentially suffer economic losses might be important to preserve the SME sector and maintain consumer choice. The second relates to developing and maintaining economic equity between developed and developing countries. Specifically, the EU and other regions where GM technology is relatively highly advanced should define appropriate tools to support high-quality GM animal pharmaceutical products to be available for therapies and treatments in developing countries, in particular in relation to patent enforcement and capacity building. Similar policies might apply to knowledge transfer regarding GM animals and food production. The successful implementation of such policies would require societal acceptance of pharmaceutical and food products derived from GM animals in both producer and end-user communities. Data are not available to assess local stakeholder and consumer concerns and priorities in many developing regions, research into citizen priorities and preferences within these communities may be required. If GM animals are adopted internationally, international organisations will be required to take a leading role in promoting the global harmonisation of relevant regulatory structures, in particular regarding the handling of the trade disputes that are expected to emerge may also be the responsibility of international organisations.
In terms of science, the EU might encourage the definition of different baseline scenarios for various GM animal species that could be debated and agreed by the national competent authorities. These could be used during the risk assessment process by the European Food Safety Authority (EFSA) or the European Medicines Authority (EMA). Duplication of effort across different EU Member States could be averted through the systematic collection of research data across Europe, and promotion of collaboration among existing research groups to maximise efficiency and the development of common research portfolios. When applicable, the specialisation of particular research teams with a common sharing of resources might be relevant, in particular within the pharmaceutical sector in the production of GM animals that improve the drug innovation process (e.g. disease models). Researchers should be encouraged to consider the minimum number of animals required for a study and whether existing GM animals could be used instead of developing a new GM animal line, in line with existing 3Rs policy (i.e. reduction, refinement, and replacement) of animal use in research. Such policies may also be relevant internationally. The pharmaceutical industry and medical sector generally should be encouraged to collaborate in the development of strategies to enable the benefits of pharmaceutical innovation to be delivered, perhaps through establishing private-public partnerships.
With respect to governance, stakeholders indicated that the EU should maintain its effort to harmonise regulation. Where regulatory implementation is difficult (e.g. the GMO comitology procedure), procedural changes should be explored. For example, inclusion of socio-economic factors in the European comitology procedure would potentially improve the transparency of dialogue with stakeholders and, consequently, the discussion between national competent authorities. Advisory bodies such as EFSA only report on the scientific risks of a given GM animal; and empowering institutions to provide information on the possible benefits, in addition to the possible risks, in their assessments (including GM animal applications) is important in the facilitation of innovation processes. Such changes in regulation within Europe would, of course, need to remain sensitive to the international context (i.e. WTO) and where appropriate work towards global harmonisation of regulations.
The need to involve the public in the debate about implementing and commercialising GM animals and their products is recognised, and public engagement mechanisms such as the citizen jury, and other deliberative processes, will potentially represent a useful approach to fine-tuning policy relating to GM animals. The 'deliberative space' created by the citizen jury methodology facilitates the kind of group interaction and depth of discussions needed to inform policy. However, a more geographically extensive application of the methodology is required, in order to include differences in countries and regions with different socio-historical approaches to technology regulation, and allow comparative analysis between these. The approach is better suited to the discussion of pre-formulated and realistic policy scenarios or options which are compatible with existing systems of policy making. For example, if the results are to be used explicitly to assess the relative merits of different policy outcomes or alternatives, these need to be translated from scientific outcomes to different policy options. An analysis of policy impact is needed in order to justify and optimise citizen engagement within the policy process. As a de minimis, the process by which such policy outputs are anticipated to have an impact on local, national, regional or international policy should be described, both in terms of process (i.e. how is the information to be translated and delivered to decision makers) and practice (i.e. what is the impact of such information on the policy process). This is in line with current thinking regarding the impacts of other forms of consultation on policy processes, for example in the context of expert consultations.
Potential impact:
The results have delivered data relevant to support policy with the development of an innovation strategy, taking into account the range of issues associated with GM animals from a life and social science perspective. As for any emerging area of technology, potential risks and benefits can be identified, and, in the case of GM animals, the evidence suggests that these require a case-by-case analysis. This is demonstrated by the different issues raised by the three case studies and the extrapolation to other examples of GM animals currently under development.
One issue is that, as a result of the research being conducted by a European research consortium, with the aim of supporting European policy development, many major events, works and issues that have emerged in the US have not been addressed. Discussion of these is beyond the scope of the current paper, and indeed these have been discussed extensively elsewhere. However, the international dimension merits further analysis in a global policy context, in particular in relation to regulatory harmonisation. A deciding factor regarding whether, and under what conditions, GM animals are to be introduced and commercialised will be societal acceptance, which will be contingent not only on risk perceptions or other value-based attitudes, but also the perceived benefits offered by specific applications. The issue of consumer choice (and implementation of effective traceability and labelling strategies) will also be important, in particular in relation to agri-food applications. In addition, equitable distribution of socio-economic benefits between producers and consumers, and between affluent and disadvantaged countries and regions is important.
Assuming appropriate risk assessments have been conducted (including those related to animal welfare and the impact of environmental release and / or escape), there appears to be little evidence that the introduction of GM animals for pharmaceutical production will be problematic from a societal perspective. Developing applications of GM animals for food use will be successful only if benefits align with public preferences. Communication about, and public engagement with, emerging policy is important, providing the goals of such activities are well thought through and the policy impact of such public engagement activities are explicitly assessed. In addition, harmonisation of European research activities is an important priority to avoid duplication of effort and unnecessary sacrifice of animals, as is global harmonisation of regulatory activities regarding international trade and development.
Contact details: Professor Lynn Frewer at Univeristy of Newcastle UNEW Lynn.Frewer@newcastle.ac.uk
List of websites: http://www.wageningenur.nl/en/project/Pegasus.htm