Skip to main content

Ethics in Public Policy Making: The Case of Human Enhancement

Final Report Summary - EPOCH (Ethics in Public Policy Making: The Case of Human Enhancement)

Executive Summary:
The rationale behind the EPOCH project (http://epochproject.com) was that though EU policies often said to combine scientific insights with a normative framework, it is not clear what this normative framework looks like and from which sources it should be derived. The project addressed the questions of what type of ethical ‘expertise’ is needed for the development of public policies on new technologies and how this expertise should be included in the governance of these new technologies. The project aimed to deepen knowledge of the role of ethics in the governance of science and technology, focusing on ethical aspects of emerging technologies, specifically related to human enhancement.
On the basis of comparative analyses of current governance and normative frameworks at European and national level (including non-EU countries), the project applied a comprehensive approach to the governance of contentious developments in science, technology and society. This approach included guidance and strategic options for governance activities in Europe, but also specific proposals regarding public policies on selected enhancement technologies, focusing on physical enhancement in sport.
The project consortium consisted of partners from the UK (including the coordinator), Denmark, Germany, Netherlands, Italy, France, Slovenia, Canada and Singapore. The consortium included ethicists, philosophers, psychologists, lawyers, sociologists and political scientists. The work packages were clustered in three areas: 1) Ethics and governance of Science and Technology, 2) Human Enhancement and European Policy-making, 3) Challenges to regulatory and legal frameworks
The main methods used in the project included desk research, on-line surveys, interviews, workshops and a Final Conference. The main result was the development of practical guidance by way of strategic recommendations for the political and societal handling of normative issues of technological and biotechnological innovations, with a special look at suggestions and recommendations in regard with the use of these innovations for the purpose of human enhancement.
Other results include reports about the role of ethical expertise, on the role of national ethics committees and other national ethics advisory bodies, on the role of participatory activities and case studies highlighting these approaches, a state-of-the art on scientific and technological fields relevant for human enhancement, a report on the ethical debate on human enhancement, a report on the national debates on human enhancement and a report on existing policies in EU members states on human enhancement. There are also a large number of publications by EPOCH partners and EPOCH presentations details of which can be found on the website. Important outcomes:
• The project has resulted in more information in the work of national institutions of ethical policy advice, particularly national ethics committees, and in which way they have dealt with emerging bio -technologies;
• A better insight into the mechanisms of participatory frameworks, and of the way ethics can be integrated in these approaches;
• Better insight in the academic debate on the ethics of human enhancement;
• Updated information on the biomedical state-of-the-art and societal applications of enhancement technologies;
• Updated information on how institutions of ethical policy advice and policy making in EU member states deal with enhancement technologies;
• A regulatory framework to include the normative issues as researched in the project and the way these issues can be dealt with by legal and regulatory approaches.
• A guidance document how to incorporate ethical expertise in decision-making and regulation of emerging technologies, in particular technologies used for human enhancement.

Project Context and Objectives:
The overarching aim of EPOCH was to provide a better insight into the role of ethics, and of ethical expertise in particular, in European Union (EU) policies on science and technology. It set out to provide guidance on the development of European public policies on the topic of human enhancement and on the governance of contentious normative issues in science and technology. Taking into account the fact that EU policies often combine scientific insights with a normative framework not solely derived from ethical expertise, EPOCH addresses the questions of what type of ethical ‘expertise’ is needed for the development of public policies and how this expertise should be governed.

The working example throughout EPOCH is the case of human enhancement. In what follows a wide characterisation of ‘human enhancement’ is used: the improvement (involving alteration) of the human body, mind, or abilities/functions/performances beyond the species-typical level or statistically-normal range of functioning for an individual by using technology.This offers a contribution to a better insight on how to use ethical expertise in the policy-making process at the European and national levels and in particular how public policy should address the issue of human enhancement. EPOCH can then provide guidance relating to public policies on enhancement issues, and specific recommendations regarding the governance of physical enhancement and doping in sport.

From this specific example, progress can be made in formulating a comprehensive approach to the governance of ethically contentious developments in science and technology that takes into account the various new trends in this area. Guidance regarding the interrelations of science, technology, ethics and democracy can be generated by analysing recent tendencies in the governance of ethically controversial issues in science and technology from a comparative, multidisciplinary and comprehensive perspective.


The empirical turn in bioethics

One of the most important recent developments in academic bioethics is the ‘empirical turn,’ which saw an increase in empirical research on social and scientific issues in bioethics with the aim to inform normative reasoning. This tendency is widely embraced but, in the practice of policy advice on normative issues of science and technology, has not yet been fully realised. The use of expertise in the governance of ethically contentious issues in science and technology appears to be still marked by ‘empirical deficits’, in particular concerning social, cultural, economic and political aspects of the sciences and technologies in question, including in relation to very complex issues with a wide variety of social and cultural aspects, as with the topic of human enhancement. In some cases the emphasis on early engagement with ethical issues of new and emerging fields of science and technology apparently serve, above all, the ‘marketing’ of these fields. In nanotechnology, ‘converging technologies’ and synthetic biology, for example, those efforts which heavily rely on very speculative scenarios and visions have attracted strong criticism. Ethical writing based on weak scientific understanding, or hype, has provoked criticisms of the role played by ‘speculative ethics’ in this context.

However, there are also some fundamental criticisms and some sceptical views of the empirical turn. Some critics warn that bioethical research is too reliant on alleged ‘hard’ facts, with the result that the less value-sensitive expertise of other disciplines will lose sight of what is most important in ethical reflection, will tend to disguise political interests in the authority of alleged ‘scientific evidence’, and may even pave the way for a new kind of technocratic decision making.

The empirical turn in bioethics has also led to increased uncertainty about the role of moral theory in bioethics and the public role of the moral theory. This leads to the question whether bioethics is a sub-discipline of moral philosophy or a discipline in its own right. These internal problems of bioethics surface particularly in developing a close relationship with policy development. The scope for ethical expertise in making a difference in governance contexts is therefore related to fundamental problems relating to its disciplinary status and of the lack of shared methodologies by leading scholars and scientists in the field.

In parallel to the empirical turn in bioethics, science and technology studies have experienced a ‘normative turn’, and ethical issues of science and technology have gained more prominence in science and technology studies. These developments were closely related to the rise of participatory approaches in this area, and more recently an increased involvement of science and technology studies practitioners in governance activities closely tied to policy initiatives.

In order to improve the governance of normative issues in science and technology, such ‘dialogues across borders’ will be crucial. The success of this will partly depend on the institutional structures within which these dialogues operate.


Institutional aspects of the governance of science, technology and ethics

The institutional landscape of policy advice on ethical issues in science and technology has rapidly changed in the 2000s and displays a high degree of diversity. In Europe, France was the first to establish an ethics council with a general mandate in 1983, followed by Denmark in 1989, the Netherlands in 1999, and Germany in 2001. However, institutions such as the Slovenian National Medical Ethics Committee, which was founded in the 1970s at the University of Ljubljana and has a focus on biomedicine, play a similar role in their countries.

The participatory and public dialogue aspects of governance is also widely varied. In some countries, several institutions deal with ethical issues of science and technology and some specialise on public dialogue activities or other areas. In post-authoritarian societies, such institutions can play an important role for the rise of a new democratic civil society. The kinds of expertise integrated in these institutions varies too, but they are typically of interdisciplinary character, with natural scientists and other non-ethicists often chosen based on their evident interest in ethical issues. While some important comparative studies have been conducted on national ethics councils in Europe and beyond, some of the main questions remain and more comparative analysis is needed in order to gain new insights into the role of ethics in policies on science and technology in Europe and other world regions.


Participatory approaches in the governance of science and technology

There is also need for a comparative perspective of the use of participatory approaches to the governance of new and emerging fields of science and technology. Some EU Member States have a fairly long tradition of participatory activities in the governance of science and technology, with a recent boom of such activities. It is worth learning from cross-national and cross-cultural comparisons, and identifying good and possibly best practices while taking into account practical and theoretical limits to participative and deliberative democracy in the governance of science and technology. As in many other arenas, public deliberative and participatory activities in the governance of science and technology appear to suffer from a lack of political impact, or at least of transparent impact. A better connection to decision-making processes is needed in order to motivate citizens to take part in such activities and to realise truly responsive science and technology policies.

Some of the difficulties encountered in participatory exercises and some of their shortcomings are arguably not only related to organisational, institutional or procedural problems that could be resolved by more or less small-scale reforms and adjustments, or by stronger political commitments alone. Deeper theoretical problems relating to realising an inclusive governance of developments in science and technology are the deficits of traditional governance mechanisms of delegation to scientists and experts on one hand and politicians on the other. This raises the question whether our ‘representative democracy’, as it is organised now, is still able to deal with today’s socio-scientific controversies.


The case of human enhancement

Human enhancement is an apt focus for analysis and discussion of new challenges and chances in the governance of science and technology. Many human enhancement technologies are new, emerging or still visionary. Some may have the potential to radically alter human corporeality and intellect, and fundamental changes in the human condition.

There are several established means of enhancement, for example in sport, cosmetic surgery, enhancement for military purposes. Some are already significantly regulated. There are also highly radical and speculative features concerning emerging and possible future technologies for enhancement of human performance, new modes of man-machine interactions and even life extension. Such issues are framed in terms of ‘transhuman’ or ‘posthuman’ configurations of human-machine co-existence that relate to long-standing traditions in the European history of ideas.

In addition to the various philosophical and social questions about human enhancement are questions about what kinds of expertise ought to be employed in policy advice on normative issues of science and technology. A wide variety of empirical knowledge is needed to fully understand the impact of these technologies on society, and the expectations and visions shaping them: knowledge, for example, on general views of the topic at large within the population, on diverse cultural aspects ranging from literary and artistic representations to (sub) cultural practices involving major modifications of the human body, and on the actual prevalence of enhancement technologies in society. It may also be argued that the various tendencies veering towards an ‘enhancement society’ necessitate a re-orientation of ethics and an inclusion of different theories of society in the analysis and discussion.


Objectives

The EPOCH project served following primary objectives:

- To provide sophisticated, practically relevant, insight into the relationship between normative issues, ethical expertise and science and technology policy making; and
- To develop a framework, informed by multi-disciplinary perspectives, that can guide EU policy development in relation to a variety of issues concerning the use of science and technology for the purpose of human enhancement.


Project Results:
Description of the main results
Area 1: Ethics and Governance of Science and Technology
The following topics relating to the ethics and governance of science and technology were covered:
A1.1 The role of theoretical, ethical expertise and (bio-) ethicists in the governance of science and technology;
A1.2 The best possible models of governance of science and technology; and
A1.3 The models of functioning of ethical advisory bodies.

A1.1 THE ROLE OF THEORETICAL, ETHICAL EXPERTISE AND (BIO) ETHICISTS IN THE GOVERNANCE OF SCIENCE AND TECHNOLOGY
Zuzana Deans
Policy advisory bodies form a bridge between academia and policy environments and serve an important democratic role. They include think tanks and committees involved in public policy-making or advising on governance of science and biotechnologies. Their main functions include: drawing attention to relevant ethical issues; making sense of the various positions; harmonising academic findings with public values; and suggesting practical governance solutions. This is commonly a multi-professional, multi-disciplinary endeavour to which bioethicists contribute. EPOCH set out to ask how bioethics contributes to the process of public policymaking and whether professional ethicists can be considered experts in ethics. This leads to further questions about the methodology and academic status of bioethics. The findings are informed by existing academic literature and empirical qualitative data from semi-structured interviews with key figures in bioethics.
Bioethics is a relatively new area of academic study that has grown rapidly over the last fifty years. It has been multi-disciplinary from the start, originally stemming from philosophy and theology, and now also occupying scholars of anthropology, economics, epidemiology, health services research, history, law, medicine, nursing, philosophy, psychology, and sociology. The methods used in bioethics vary just as widely, and it is suggested bioethics should be considered a multi-disciplinary field of study rather than a discipline. The scope of this field of study is broad, with the ‘bio’ considered to encompass all practical ethical questions relating to the life sciences. The central aim of bioethics is to answer the question ‘what is the right thing to do in relation to life sciences?’. Philosophical inquiry, then, is regarded as the essential element in fulfilling this aim, with other disciplines contributing. Interestingly, there are many academics working in bioethics who do not consider themselves ‘bioethicists’, which may be further reason to suppose it is a field of study with academics identifying themselves primarily with their contributory disciplines.
One of the most prolific debates is over the relationship between empirical and philosophical investigations in bioethics. Restricting the analysis of bioethical issues to a purely philosophical approach can lead to a loss of meaningful context and relevance. A central feature of bioethics is that its conclusions are applicable and practical; it is not philosophy simpliciter that is essential, but rather practical philosophy. Attempts to close the gap between moral theory and the lived experience have seen a rise in empirical research into bioethical issues. There is some disagreement over whether empirical investigation with no normative content can be classed as bioethics if it is part of a wider project to answer bioethical questions, but there is general agreement that bioethical answers must contain normative justification as well as practical applicability.
This turn towards empirical approaches has led to increased uncertainty about the role of moral theory in bioethics, and in public policymaking. Moral theory does not give ready answers to practical problems, and the long-running debates about moral theory suggest none is definitive or wholly convincing. Because of their non-normative nature, purely empirical studies (including public consultations conducted by national ethics committees) do not necessarily give appropriate answers either. One of the major challenges for bioethics, then, is to close this methodological gap. This can be seen working in practice to some extent in those public policy bodies that employ a combination of public consultation and philosophical deliberation, though interviewees noted that the public consultations do not always produce new ideas, usually serving a useful role in providing illustrations of real-life cases and experiences. Furthermore, no clear account was given as to how the empirical data fed into normative conclusions. However, the democratic role of public consultation in policy advisory bodies is highly valued.
One account of the general means by which policy advisory bodies arrive at policy recommendations is: fact-finding, surveying possible positions and views in public consultations, and subjecting these to group deliberation and agreement. There was a range of models of agreement, including compromise, consensus, reaching the ‘sense of the meeting’ and the Polder model. When asked what skills and qualities they bring to policy advisory bodies, interviewees listed attributes enjoyed by (formally trained and non-formally trained) philosophers (e.g. ability to map key principles; clear thinking; skills in drawing out implications for analogous settled cases) as well as skills necessary for making progress in any type of committee (e.g. willingness to work with others with divergent ideas). It is believed that, in a UK context at least, policy advisory body members are usually selected for their neutrality and/ or willingness to see alternative perspectives rather than for any strongly-held views or as advocates or representatives for particular positions. It was suggested that formal knowledge of bioethics was important and useful because it allowed members to grasp the issues more quickly than the layman.
Policy advisory bodies typically comprise experts and lay members, with the assumption that the experts are authoritative on their specialist area. It is questionable whether an ethicist in a committee can legitimately be regarded as an expert in the same way as scientific or legal experts. This is because moral truth is arguably less easily accessible and verifiable than many other forms of knowledge, and there is a general reluctance to declare individuals ‘moral experts’. A useful distinction can be made between a descriptive expert in ethics (one with skills in reasoning and detailed knowledge of the relevant moral issues) and a normative expert in ethics (one with knowledge of what the right course of action is). These categories are paralleled with two types of authority: an authority and in authority, respectively. There is good reason to suppose that bioethicists can be an authority on relevant issues and debates in bioethics, and that they might be better equipped to arrive at sensible solutions to moral problems more quickly than the layperson, and are therefore non-normative ethics experts.
Interviewees indicated that some improvements could be made to bioethics by: increasing the scholarly rigour in academic bioethics (both philosophical and empirical methods); increasing unity between topics in bioethics when similar fundamental philosophical questions are being addressed; being more transparent about ideological influences on bioethics policy deliberations; extending the reach of bioethics beyond being Western-focused; integrating bioethics more strongly into research projects from the outset (most notably bioethics is often regarded as an ‘afterthought’).
The overall conclusions are that bioethics is a multi-disciplinary academic field of study, whose central set of methods is practical philosophy. Its primary aim is to answer the question ‘what is the right thing to do in relation to life sciences?’. In the realm of policy and practice, bioethics is one voice among many disciplines relevant to science and technology. Bioethics is simultaneously representative and advocatory, independent and objective. While a moralist account of normative ethical expertise is inappropriate, there certainly exist non-normative ethics experts. These are individuals well-versed in the relevant literature and debates and with the necessary skills in reasoning to deliberate, discuss and make policy recommendations relating to complex practical ethics issues.
A modest status of bioethics for influencing public policy is appropriate, and although improvements could be made to how bioethics is done, no higher authoritative status of the discipline should be expected. The limit of non-normative expertise, along with the socio-political structures of Western democratic societies, mean that bioethics is not politically authoritative, but it does have a valuable contribution to make in reporting, representing, assessing and advancing debate.


A1.2 BEST POSSIBLE MODELS OF GOVERNANCE OF SCIENCE & TECHNOLOGY
Ine van Hoyweghen, Laurens Landeweerd, Jessica Mesman and David Townend
Debates in both science and technology studies as well as ethics point in the direction of a complimentary and integrated approach to the governance of science and technology. On the basis of the literature review and interviews with stakeholders, the group from Maastricht argue that such new approaches should include the following perspectives: acknowledging complexity, defining governance as a process, and governance as a hybrid mix of expertises.
First, governance should move beyond the idea of governance as ‘quick fixes’ to ethical issues of science and technology. To do so, it may be necessary to acknowledge, and perhaps to embrace or make explicit, the idea that there are no clear-cut, well-defined and predictive/foreseeable solutions to be found. Furthermore, acknowledging complexity also means that governance should be less about defining clear-cut solutions, but more about making explicit the political issues that are at stake in science and technology. In this sense, governance becomes a process in which the ‘politicality’ of science and technology is made explicit, where all concerned actors express that there is de facto not one answer to provide.
‘Doing governance’ implies the space for making explicit what is moving all the different kinds of stakeholders on issues of science and technology. This means focusing less on ‘decision-making’, and more on identifying the shared values and interests we have in these issues. Governance stops being a means of implementing policy but is instead a process that needs to be collectively done.
Finally, one can perceive the emergence of new hybrid styles of governance, in which the role of expert knowledge is explicitly acknowledged, while the range of relevant forms of expertise is broadened.
Integrated approaches to governance which include both public participation, as well as ethical knowledge can be argued for. One example of an integrated approach is to take into account or directly engage end-users in the innovation process. In this approach, the development of novel technologies may be shaped by taking into account the role of users in different phases of the development, testing, and marketing of new technologies. A better integration and involvement of citizens, users, the public and stakeholders would make it possible to take societal concerns into account in the design-phase of science and technology.
In ethics, there is also a plea to complement old models of direct intervention by new non-hierarchical and decentralised approaches for governance of science and technology. The concept of ‘Responsible Research and Innovation’, as put forward by the European Commission for example, is such an attempt. It is triggered by reflection on different assessment methods in policy processes (e.g. technology assessment ethics committees). Again, it departs from a criticism on traditional forms of ethics of technology, which are overly preoccupied with the negative and unintended consequences of new science and technology, rather than their merits.
In this context, there is a perceived necessity for a shift towards defining at what society wants to get out of technology as well. This necessitates an assessment of the ‘right impacts’ of science and technology activities beforehand, rather than restricting these in hindsight. The focus here is on anticipating problems, taking into account wider social, ethical issues, as a form of ‘anticipatory governance’. A key element in the success of early societal consciousness of societal success during the building phase in research and innovation then is to be found in a timely investment of engagement of societal partners and the appropriate publics. This means such engagement should be planned neither be too late nor too early. Timeliness is very much dependent on the type of innovation in question, at which stage one can expect which applications for society, and at which stage such applications cannot yet be projected.
It is acknowledged that current governance of science and technology needs to get away from the rather limited rhetoric of safety. Currently, governance of science and technology is dominated by a risk-safety-and-precaution discourse. This already frames the ethical debate to a restricted series of topics, excluding important moral issues such as justice, welfare standards for marginalised groups, politics of exclusion, privacy, etc. We should not merely ask ‘is it unsafe?’, thereby putting this up as the only possible barrier for innovation, prioritising the economic game. This necessitates a governance discourse that does not restrict itself to the definition and implementation of regulation in the form of negative constraints for science and technology but also of positive aims in a societal setting. This necessitates arranging governance of science and technology in such a way that it serves as an incentive for right impact-innovations (in the societal sense).
Good governance should go beyond the mere illusion of caring by using participatory devices and ethical expert input as a scapegoat for moral acceptability. Current frameworks for governance direct innovation towards products that yield economic gain, which means, products for the more prosperous, dominant groups in European societies and on a global scale, products for the west. Developing countries and marginalised groups do not fall in the scope of governance as a result. Laying this bare, making this transparent as the actual agenda of governance is necessary to address such motivations and counter such effects. Awareness of such underlying agendas is a key element for good governance. For a just approach to governance of science and technology, we need to define what we owe to each other, and on what basis.
An important question is what kind of society is desirable? (rather than how can we facilitate innovation successfully?). Public participation has gradually come to be seen as a substantial element for just governance, but it is a tool to facilitate trust, as the authority of responsible expertise used to be in the past. This also implies a need to lay the foundations for a horizontal support surface for governance, in which solidarity on a European and global level is stressed over the existing vocabulary of rights in a vertical sense of the protection of citizens interests.

A1.3 MODELS OF FUNCTIONING OF ETHICAL ADVISORY BODIES
Blanka Groboljsek, Toni Pustovrh and Franc Mali
Most European countries today feature at least one national-level institution, charged with the task of providing opinions and advice on the ethical implications of the new and emerging sciences and technologies. Their advice is intended for governmental institutions, interested stakeholders and, more and more frequently, the general public. Such institutions are usually defined more generally as Ethical Advisory Bodies (EABs) and more narrowly as National Ethics Committees (NECs).
The so-called ‘ethicisation’ process of the governance of science and technology in Europe is emerging primarily through the creation of a network of NECs. Over the past two and a half decades, most European countries have established advisory groups, ethics councils or committees at the national level. NECs have been charged with the task of formulating opinions and advice for the national decision-makers on ethical questions of science and its application, and in the first phase of development especially in regard to the biosciences and medicine. The creation of NECs merged with the first determination of the categories of values that have eventually entered ‘European ethics’. The European ‘ethical identity’ thus encompasses both an ethical and an epistemic vision. At the EU institutional level (European Commission, European Parliament, other EU bodies), these processes have been encouraged by several policy initiatives and policy instruments.
The impact of the new and emerging technologies, especially those connected with converging technologies, is expected to be wide ranging. On the one side are the expectations connected with the applications offering previously inaccessible capacities and capabilities to enhance individual and societal wellbeing. On the other are fears of potential negative influences on social structures and trends or possible unforeseen negative impacts on health, environment and safety. Although many of the risk issues of converging technologies are not yet apparent today, we are already at a point where we should endeavour to design suitable policy approaches in order to avoid future risks. Therefore it is very important to stimulate a debate within the civil society, as this can help bring broader ethical and social aspects to enter the wider debates about converging technologies, a necessary condition for arriving at a more responsible policy discourse in the light of recent science and technology developments.
Thus it is important to implement and strengthen the innovative mechanisms, which have been proposed to increase the social robustness of science and technology. These include various participatory and democratic governance arrangements, such as the use of social knowledge and mutual learning, and a strong engagement with a wider range of stakeholders and the general public in science and technology policymaking, intended to arrive at socially widely acceptable and desirable science and technology products. National EABs, originally established to deal with human bioethical questions, and novel issues arising from developments in human biosciences and medicine, are ideally situated to promote the development of some science and technology governance mechanisms that could increase the social robustness of science and technology products. But just as there are differences in the ways in which the directives of the EU are implemented in the diverse national sociopolitical systems of the various EU-member states, there are differences in the modes of functioning of different national EABs. Some are due to the sociopolitical and historical specificities that influenced their formation and development. Still others arise from innovative attempts to extend the scope of deliberation or from novel ways of strengthening the social governance of science. This institutional pluralism can be a source of strength, but it can also be a source of the various interpretations of the role of ethics of science in Europe.
EPOCH set out to provide tentative typologies for different models of functioning of EABs, based on a number of selected parameters. These include ways in which EABs attempt to institutionalise ethics into the policy making process and promote deliberation with the wider society, while also examining some of the advantages and disadvantages of individual models. The main conclusions regarding the typology of EABs in Europe are:
 a majority of the selected EU-Member States and Non-EU member countries have a centralised national EAB landscape, meaning that they possess a single, official national-level EAB, usually a NEC;
 a majority of the EABs can be classified into one of two categories. The first encompasses NECs, bodies charged with the task of formulating opinions and advice for the national decision-makers on moral questions of science and its application, especially in regard to the biosciences and medicine. The second includes research ethics committees, which primarily focus on the ethics of research and trial proposals and thus on patient rights, but also on broader questions connected with biotechnological and biomedical developments;
 a majority of EABs are independent public bodies that are not directly answerable to any public government or regulatory institution;
 a little more than half of the EABs choose their members in a fashion that reflects a plurality of worldviews and cultural diversity, while a little less than half do not choose members with this criterion in mind;
 a majority of EABs document minority and divergent opinions of their members in their opinion documents;
 practically all EABs publish their work results;
 in a majority of EABs, internal discussions are never open to the public, while in some, discussions are sometimes open to the public;
 a majority of the EABs organise events at which the public can attend. Only a minority does not organise such events;
 a majority of EABs do not employ any public participation mechanisms. Only a minority does employ such mechanisms;
 a little more than half of the EABs have produced opinion documents on Human Enhancement Technologies-related themes. A little less than half have produces no opinion documents on such themes;
 regarding a majority of EABs, political institutions are not officially required to take their work results into account;
 less than half of the EABs have stated that according to their knowledge, their work results have been discussed or used by political institutions;
 a minority of EABs have stated that their work results have been explicitly mentioned in legislation or in court orders.
Taking into account our selected parameters of ‘socially robust’ knowledge production and democratisation of the science and technology policymaking process, the presence of such structures and mechanisms is very unevenly distributed among the examined EABs. While some EABs feature practically all of the aforementioned mechanisms, others feature only a few or even none. In Europe there are some ‘hybrid forum’ EABs and some ‘technocratic’ EABs, while the majority lie somewhere on the spectrum between the two extremes.
Finally it seems salient to note that individual NECs are shaped by the cultural and societal environment in which they were formed and in which they developed up to the present, influenced by the zeitgeist of the times. It might therefore be difficult to take the model of a successful contemporary ‘hybrid forum’ and attempt to ‘artificially’ recreate it in other political and social climates and expect to achieve the same results.

Area 2: Human Enhancement and European Policy-Making
The following topics relating to human enhancement and European policy-making were covered:
A2.1 State-of-the art in scientific and technological fields relevant for human enhancement
A2.2 Human enhancement and ethics
A2.3 EU and international governance activities on human enhancement
A2.4 Ethical analysis in policies and governance of human enhancement

A2.1 STATE-OF-THE ART IN SCIENTIFIC AND TECHNOLOGICAL FIELDS RELEVANT FOR HUMAN ENHANCEMENT
Christopher Coenen, Arianna Ferrari and Gregor Wolbring
EPOCH set out to provide a structured overview of the state-of-the art in scientific and technological fields relevant to human enhancement and by already identifying a number of relevant trends and visions in cutting-edge research on human enhancement technologies. The focus is on cognitive enhancement and on physical enhancement, and also mood enhancement to a certain extent.
The domain of cognitive enhancement can be subdivided into the areas of pharmaceutical cognitive enhancers and invasive neurotechnologies, with non-invasive technologies being an important point of reference. Invasive neurotechnologies encompass not only all kinds of neurotechnological implants, since the surgery such implants require constitutes an intervention into the body, but also stimulation technologies, as these technologies also constitute an intervention into the body. The focus is on pharmacological cognitive enhancement for two reasons: first, pharmaceutical cognitive enhancers is an area in which non-therapeutic enhancements are widely discussed and, second, pharmaceutical cognitive enhancers has already received considerable attention in both academic and policy discourse on human enhancement and its ethical and societal implications, as well as (in some countries) in the mass media.
Pharmaceutical cognitive enhancement
Although there is extensive literature on ethical, legal and societal aspects of pharmaceutical cognitive enhancers, there is very scant empirical evidence of the effectiveness of these substances in healthy individuals. In fact, there were major problems in assessing the current state-of-the-art in this field due to the lack of data relating to these substances. A number of general conclusions about pharmaceutical cognitive enhancers can be drawn from the analysis:
• There is no evidence in the literature that any substance can enable a person to develop extraordinary (or superhuman) capabilities.
• In the existing literature it is not clear whether some substances could lead to a person to increase their particular cognitive ability beyond his/her own optimal level (i.e. when not suffering stress, repetitive conditions or sleep deprivation).
• There is growing evidence that it is not scientifically sound to speak of ‘cognitive enhancers’ for healthy individuals: if a substance can be proved to have an enhancing effect, this effect is always on a particular property of cognition, and is often differently interrelated with changes in other properties (which can also be detrimental).
• Comparative studies of different substances have found that each substance may produce different advantages (if any) depending on the cognitive demands of the task.
• Caffeine (600 mg), dextroamphetamine (20mg) and modafinil (400mg) have an equal effect on objective alertness and simple psychomotor performance for approximately 2-4 hours, although the side-effects and addiction potential of those substances vary substantially.
• Stimulants have sometimes a placebo effect; the mere expectation of receiving a stimulant can raise subjective arousal.
Early discourse on pharmaceutical cognitive enhancers focused on ethical issues and future uses of as yet non-existent drugs and thus to a large extent contributed only to what has been termed ‘speculative ethics’. While this highly speculative discourse continues, scientists, psychiatrists, other medical experts, philosophers, social scientists, science journalists, and researchers in the field of technology assessment have at the same time been drawing attention to and taking issue with the problematic features of discourse on pharmaceutical cognitive enhancers.
Regarding the societal relevance of their actual use, the first empirical data testifying to the illicit use of prescription drugs for cognitive enhancement date back to the beginning of the 2000s, and the practice continues among college students in the USA today. The majority of studies dealing with this issue concentrate on methylphenidate formulations, of which Ritalin has received the most attention. In general, doubts have been expressed concerning the extent to which these studies are representative of the entire population, since the students surveyed are not representative of the entire student population, not to mention of other age groups or social groups.
Very little is known about how likely it is that the use of the drugs in question for cognitive enhancement purposes will achieve broad public acceptance. There is some evidence that in the German-speaking part of Switzerland, a large majority of people objects to the use by healthy people and objects to legalisation of such a use.
One of the most important trends at the moment, at least with regard to governance aspects, pertains to academic discourse on the state of the art in pharmaceutical cognitive enhancers research and development as a whole: apparently, there is a trend towards challenging central assumptions often held in current discourse about the efficacy and societal relevance of pharmaceutical cognitive enhancers, and towards criticising, in particular, ethical discourse on the topic. This trend appears to be driven mainly by non-ethicists such as psychiatrists, neuroscientists, psychologists, social scientists and researchers in the field of technology assessment. More and more ethicists are taking this critique into account and have changed their positions, or at least the way they accentuate their descriptions of the state of the art in pharmaceutical cognitive enhancers research and development.
On the other hand – and no matter how the state of the art or future prospects of pharmaceutical cognitive enhancers research and development are assessed – it would be disquieting if governance activities, including advice to policy makers, were based on very different scientific assessments of the actual phenomenon. There would then be the risk that further discourse on pharmaceutical cognitive enhancers would take place, so to speak, in parallel worlds. There is already some evidence, however, that the trend in academic discourse is also reflected in governance activities.

Neurotechnological Cognitive Enhancement
Our definition of ‘neurotechnological enhancement’ encompasses not only all kinds of neurotechnological implants, but also those stimulation technologies which do not require surgery, as such body-external technologies also constitute an intervention into the body because the brain is stimulated by techno-scientific means.
Implants are mainly used for therapeutic purposes since they require surgery, with the usual attended risks. Given that most of these technologies are currently used only to treat very severe diseases or disorders and are only able to a minor extent to compensate for the loss in quality of life suffered by patients, it appears almost frivolous to speculate on the non-therapeutic use of such technologies to enhance the performance of people without serious health problems. Implanted neurotechnologies could come to be seen as attractive, at least in specialised application contexts such as ‘soldier enhancement’ or professional computer gaming.
Brain-computer interfaces, which can be implanted or used in body-external devices, do not stimulate the brain but use neural signals as input for purposes such as the control of machines. Brain-computer interfaces technologies are therefore not cognitive enhancers according to our definition, but they are important in this context since they appear to herald a new quality in human-machine interaction and can improve human performance significantly and in a way similar to the visions of human enhancement. Other neurotechnologies are applied as a means to enhance the cognitive faculties needed to use brain-computer interfaces technology. This could be used to monitor the cognitive workload of such professionals as pilots or air traffic controllers who have to interpret many different stimuli at the same time and perform the right actions based on that. Brain-computer interface technology may help to identify the information optimum of the users and thereby enhance their decision-making. This would also not constitute a cognitive enhancement in our definition but is relevant in this context. In a more visionary vein, brain-computer interfaces are sometimes discussed as means of cognitive enhancement, mainly in transhumanist discourse or in highly speculative ethics.
Some of the neurotechnologies most often discussed in discourse on human enhancement – such as deep brain stimulation – are clearly therapeutic or assistive at the present time and can only compensate for the disadvantages or deficits of their users to a minor extent.
The body-external brain stimulation technologies that appear to be most relevant are transcranial magnetic stimulation and transcranial direct current stimulation. Both belong to a field of research that has its roots in the 19th and 20th centuries and repeatedly experienced overlaps with pseudo-science. Recent advances in neuroscience and neurotechnology, however, have opened up new prospects of success in this area of research and development. While some of the technologies are only efficient when applied during sleep, others can be used during learning. Enhancing effects of body-external brain stimulation technologies that have been observed so far have only been transient improvements, however.
The most important conclusion is that the topic of cognitive enhancement by neurotechnological means should be scrutinised in much the same way as pharmacological cognitive enhancement was. It should also be pointed out, however, that neurotechnologies in a broader context appear to be more relevant to discourse on human enhancement: they appear to herald a societally significant change in the interrelations between humans and technology. No similar change is likely in the case of pharmacological cognitive enhancement since the use of cognitively stimulating substances is an age-old human practice and no ‘wonder drugs’ are in sight.

A2.2 HUMAN ENHANCEMENT AND ETHICS
Jes Harfield and Ulrik Nissen
The debate about human enhancement and ethics has, like many such debates, a number of aspects which one could identify as ‘tilting at windmills’ – i.e. attacking imaginary enemies. One such attack or criticism is found under the theme ‘against perfection’ (Michael Sandel). It also surfaces in the anti-transhumanism segment of the debate. However, there seems to be a disproportionate focus on criticising the notion of perfectionism compared to efforts at defending it.
The concept or goal of perfection is seemingly not very important in the arguments and discussions of pro-enhancement advocates. Virtually none of them make use of the word other than to refer to the titles of works against perfection, and others explicitly condemn it. ‘Against perfection’ seems to be an argument against something that nobody is arguing for. It seems more credible to see the transhumanist agenda as an idea of on-going transformation and development of humans, of posthumans, of postposthumans etc.
There is in such a notion no final stage where perfection is achieved, only on-going enhancement of that which is. It is exactly part of transhumanism and clear in the writings of other pro-enhancement (or anti-anti-enhancement) advocates that they are very critical of essentialisms, indiscriminate of whether it pertains to the current human standard or some future possible essential perfection or telos.
The tone of the debate is another distinct feature of the academic discussions on human enhancement and ethics. Although philosophical and ethical debates in general are no strangers to strongly-worded disputes, the sheer tone of contempt and ridicule found in some of the academic literature on human enhancement sets the debate apart from the mainstream. This tone, unlike a fierce but sober quality typically found in, for example, philosophical ethics, does not contribute to the enhancement of academic discourse. Instead it leads writers and readers away from the core topics and distracts from the academically interesting aspects by ad hominem argumentations and name-calling. This rhetorical debate problem is not limited to one particular writer or one particular “side” in the ethical discussions on human enhancement.
Generally the use of certain descriptions or labels has a tendency to cloud the debate and the issues. ‘Transhumanism’, for example, is a terminology that only a few major writers – noticeably Nick Bostrom and Anders Sandberg – use to label themselves. Nonetheless, the term is also used to very broadly describe those who would use biotechnology to improve themselves by being more intelligent, stronger, and to live longer. This would include a number of writers who certainly do not support the official transhumanist agenda. The terminology around ‘bio-conservatism’ is also a questionable topic. In many texts, including this report, the label is used to identify and describe a group of thinkers whose writings and arguments derive from what would normally be considered conservative theory.
Related to both the tone and the trench warfare is the disagreement on the validity and usefulness of religious arguments and stand-points. It is a general theme in pro-enhancement criticism to include a denunciation of arguments of a religious nature. Such denouncements rarely include an argument as to why religious arguments are invalid but take this as a given. The denouncements are, furthermore, targeted at both writers who are openly using religious terminology and reasoning and writers whose theories gives rise to suspicions about religion on account of their terminology or argument-types or a combination of this and a known personal religious observance. Improving the debate on this point would, first and foremost, entail debaters being clear about religious arguments and criticisms of these. This would include a much more distinct general reasoning as to how and why religious arguments could or could not function in the debate on human enhancement and ethics.
One of the most heated parts of the debate has been over the concept of dignity. There is some evidence that the importance of the concept of dignity, especially in the conservative argumentation with (intended or unintended) religious associations, has weakened the discourse on this important topic. Dignity has for many writers become almost synonymous with religious or crypto-religious positions and as such disregarded as invalid. A notable exception to this view is Bostrom who presents us with not another dismissal of dignity’s importance but with a different angle – and thus a divergence from the ‘monopoly’ of certain groups.
Throughout the last three decades philosophy has witnessed a revival of virtue ethics. A revival which has rewardingly challenged the more predominant moral theories rooted in utilitarianism and deontology. Nonetheless, this has had limited spill-over effect on practical ethics and within the framework of human enhancement ethics almost none. This situation still holds in spite of prominent neo-Aristotelian writers such as Kass and Sandel publishing on human enhancement ethics. A few notable articles do, however, engage the ethical questions of human enhancement from a virtue ethical perspective. Virtue ethics will most likely not be the predominate ethical stance in the future academic debate on human enhancement. The prevailing focus on consequences and regulations is, for one, an obstacle to this. Nonetheless, there is certainly room for virtue ethics both as a way of developing valid ethical theories and as a rethinking of the fundamental tenets and assumptions of the current ethical debate.


A2.3 EU AND INTERNATIONAL GOVERNANCE ACTIVITIES ON HUMAN ENHANCEMENT
Christopher Coenen, Arianna Ferrari and Gregor Wolbring

EPOCH set out to report on the core of human enhancement discourse. The collection of information is therefore largely restricted to documents and activities which explicitly refer to this discourse and use the notion of ‘enhancement’ or corresponding terms in other languages. This means that governance activities that deal with human enhancement technologies, but do so outside the core of discourse on human enhancement, are usually not taken into account.
Our analysis shows that that there are:
(1) countries in which a large number of activities or high‐profile activities are taking place,
(2) countries in which there is lively academic discourse but governance activities are rare non‐existent, and
(3) countries in which both academic discussions and governance activities are very rare or not existent.
The first group of countries comprises Denmark, Germany, the Netherlands, Norway, the United Kingdom and Switzerland, the second and third group comprises Croatia, France, Italy, Poland, Serbia, Slovenia, and Spain. In the great majority of governance activities on human enhancement in Europe, reference is made to academic discourse or governance activities in the United States.
There exists a large number of activities on cognitive enhancement in which ethical aspects play a major or central role. It is too early, however, to identify trends in governance activities on cognitive enhancement issues in Europe. Academic discourse has changed significantly in very recent times – shifting from highly speculative discussions to a more evidence‐based discourse – but this has only rarely been taken into account by governance activities so far. Although some new publications by policy advisory institutions reflect this shift, it would be premature to define this as a new trend. The same holds true for the apparent related shift in academic discourse on cognitive enhancement from pharmacological to neurotechnological means of enhancement. Again, there are some new publications by policy advisory institutions here that appear to reflect this shift, yet it is also too early to say if this constitutes a trend.
A trend might be constituted by the fact that the enhancement of military performance is pursued in Europe to some degree. In early discourse explicitly focused on human enhancement (in the first half of the 2000s), it was pointed out that USA military research plays an important role in discussions and other activities on human enhancement and that military enhancement is an irrelevant topic in Europe. In the meantime, however, a small number of activities on this topic have been taking place in the EU.
It is interesting to note that recommendations made by policy advising institutions are often presented in the form of alternative routes of action tied to specific ethico‐political approaches or stances. This can be interpreted as a further sign of the cultural diversity in Europe with regard to the enhancement theme. This diversity is not restricted to differences between national cultures but encompasses cultural differences within countries. It also indicates that practices and visions of human enhancement are raising challenges that are related to unresolved questions in Europe’s common cultural history.


A2.4 ETHICAL ANALYSIS IN POLICIES AND GOVERNANCE OF HUMAN ENHANCEMENT

Christopher Coenen, Arianna Ferrari and Gregor Wolbring
The lack of a universally accepted definition of the term enhancement and the problematic distinction between enhancement and therapy is perceived as a major challenge for the ethical debate in the majority of governance documents on this topic. The term originates primarily from an academic context and is used to conceptualise changes in the goals of medical research due to new technological possibilities. With the rise of converging technologies, and in particular the NBIC vision (nano, bio, info, cogno convergence), enhancement has been defined by some as a general goal of techno-scientific development, not only in medicine or biology, and has been used as a concept to indicate the improvement of (human) performance. Although the academic debate soon recognised the impossibility of drawing a sharp line between therapeutic and nontherapeutic interventions, since the terms of reference (illness and health) are also not precisely defined and contain normative elements this criterion plays an important role in the governance of human enhancement technologies. The majority of reports by institutions on this topic stick with this distinction, defining human enhancement as the use of technologies in healthy individuals, i.e. the nontherapeutic use of these technologies.
The question of what human nature is, that is to say the anthropology beyond technological development, is discussed as a central ethical issue in the majority of the institutional reports and opinions concerning this issue. The academic bioethical discussion about human nature is characterised by a polarisation of positions between transhumanists and other radical promoters of the creation of biologically and technologically superior human beings, and those who stress that nature and character are morally valuable categories and rely on concepts such as finitude and humility, i.e. the inviolability of human nature.
The anthropological aspects of the significance of humankind and its relationship with technologies concern not only the individual but also society as a whole. Moreover, broader societal processes, such as changes in the health system, are relevant to the topic of human enhancement.
One of the major challenges for the governance of new and emerging technologies is posed by the fact that different ethical values co-exist, with the result that a technology may be differently evaluated in society. Ethical pluralism is not explicitly addressed as a theoretical problem in institutional reports, but is implicitly taken into consideration in the formulation of policy recommendations. In this respect three major trends can be identified in the way the analysed reports issue policy recommendations for governance:
• In some cases, policy recommendations opt clearly for a particular type of regulation.
• In other cases, the presence of different ethical views is openly declared and different governance frameworks (or different recommendations) are formulated.
• In other cases, reports list different ethical arguments, acknowledge the possibility of different regulatory frameworks and conclude with open questions which should be addressed in order to clarify political decisions.

In the discussion on human enhancement technologies, different kinds of intuitions are critically considered in various governance activities. The role of intuition and of rational arguments in ethical argumentation is a matter of controversy on the academic level. In these activities, intuitions are often quoted in the ethical discussion, but without any deep critical reflection on their role in the construction of the ethical arguments and without referring to the origin of such intuitions. In many cases, ethical intuitions are generated or largely influenced by the media debate, although this is not explicitly taken into account in institutional reports.
Since enhancement is a complex, multifaceted phenomenon that indicates a variety of technologies whose efficacy in augmenting performance has been only partly demonstrated (especially in the field of physical enhancement), speculation about what these technologies could do in future and which kind of ethical issues we will be confronted with play a major role in the governance debate. Indeed, a major challenge for the governance of ethically controversial technologies is to make sure that the ethical reflection does not come too late. Although the visionary element is mentioned in all institutional reports, the ways in which it is taken into account differ. In this respect two major trends can be identified:
• The reference to the future and to visions of increasing human performance by technological means is seen as a possible future scenario and is analysed by means of foresight.
• Although a lack of evidence of efficacy or a lack of empirical studies of certain effects of some technologies is stated as pertaining to the current technological development (see mostly the discussion on cognitive enhancement), the discussion of the ethical issues as well as the formulation of governance recommendations is framed by the idea that these technologies will be developed sooner or later and will thus become a concrete and urgent issue needing to be faced.
A typical characteristic of the liberal framework in the assessment of technology is the question of whether we have good reason to limit the freedom of choice, i.e. whether there are legitimate reasons for preventing individuals from making their own decisions. This kind of approach is reflected in the discussion about whether there are intrinsic ethical reasons to argue against human enhancement technologies, like when a particular technology violates commonly accepted values such as human dignity or empathy.
The ethical discussion of human enhancement technologies in governance activities is framed in the majority of cases in the same way as the academic debate, although the issues taken into consideration generally appear simplified and not deeply analysed. This may be partly due to the nature of the institutional reports, which of course have to be shorter and more incisive than long academic publications, and because in many cases the experts who write the reports are also academic scholars. This is evident in the fact that anthropological and societal questions very much reflect the positions expressed in the academic literature. In particular, the debate on issues such as human nature or authenticity reflects the same arguments – sometimes in much simplified form – as the academic literature. With a few exceptions, however, there is no broad reflection on the role of ethical issues in the governance of enhancement technologies, such as the question of which role normative beliefs concerning certain issues should play in shaping technological development.






Area 3: Challenges to Regulatory and Legal Frameworks
The following topics relating to challenges to regulatory and legal frameworks were covered:
A3.1 Barriers and contributions of policies regarding doping and physical enhancement;
A3.2 Models to incorporate ethical advice in the governance of human enhancement;
A3.3 Participatory and deliberative approaches on participatory activities in European science and technology governance
A3.4 Understanding EU governance, policies and regulatory structures in a global context

A3.1 BARRIERS AND CONTRIBUTIONS OF POLICIES REGARDING DOPING AND PHYSICAL ENHANCEMENT
Mike McNamee
EPOCH aimed to explore a range of issues concerning physical enhancement, focusing on doping and anti doping policy. The objectives were to explore the barriers and enablers of good policy development and implementation with respect to: educational versus punitive agendas; relationships with intelligence-led criminal agencies and techniques with respect to doping testing; governmental relations with respect to criminalisation; sports federation support for anti doping policy; and athlete’s perspectives of compliance. The findings were informed by existing literature and empirical qualitative interviews with individuals from key anti doping organisations and actors in anti doping mainly in Europe, but also from Scandinavia and North America.
The World Anti Doping Agency (WADA) was established in 1999. It developed and published its World Anti Doping Code (WADC) in 2003. The Code, which is the heart of global anti doping policy, was amended in 2009. It is currently in its second phase of its second revision. Version 3 of the WADC will take effect in 2015.
No clear picture emerged from National Anti Doping Organisations (NADOs) regarding the extent to which anti doping policy should extend from sport to broader social domains. Examples of attempts to extend anti doping policy into society include Denmark and Cyprus. Denmark initiated such a law in 1996) that introduced a system of placing smiley and unhappy faces on the front doors of its public fitness gyms and sports clubs, which indicate that anti doping control officers are entitled to come in and test members of the public who are training there. Cyprus passed a law that allows for testing of all athletes for doping control purposes, extending the scope of the law beyond elite athletes. Both appear to be of mere symbolic value. There was little enthusiasm from NADO participants. One NADO/WADA participant, however, argued that political will was all that was required. As an exemplar, they cited the regulation of tobacco in public places as an effective public health achievement in the drug field.
Two closely connected issues dominated code-related issues: cannabinoids/marijuana and the spirit of sport. Many interviewees said that cannabinoids/marijuana are only an issue for NADOs because of political pressures. It was often related to the role model element of the Spirit of Sport criterion. Given that individual States supply 50% of WADA funding this would be difficult to countermand. Moreover, many said that the evidence base against these products is not strong. This, however, is acknowledged to be true of many substances on the prohibited list. A general lack of transparency for inclusion here was widely reported. Some NADO members, notably those with medical backgrounds, felt there was a health justification for the presence of cannabinoids/marijuana on the list. Many NADO participants wished the spirit of sport criterion to be removed from the criteria that are used to determine whether a substance or process should be included on the prohibited list. This would effectively medicalise doping, since it would render the two criteria to be performance enhancement (or potential) and harm to athletes (or potential). It would also scientise the process. Though (often unacknowledged) normative judgments are required regarding how much and what kinds of harm are to be counted, the more prominent ethical notion within WADC and policy discussion is the spirit of sport criterion. Surprisingly, it appears rarely to be used in practice (addressed further below). A final point regarding the Code relates to NADO participants who noted a distinction between those athletes who commit an Anti Doping Rule Violation inadvertently versus those who do so intentionally. This is directly relevant to issues of harmonisation and strict liability.
All participants, except one, noted the need for ethical expertise to be utilised. This is particularly noteworthy since, although WADA has a subcommittee of Ethical Experts, the view that they were more or less moribund (except for a lively discussion in 2006 on hypoxic chambers) was universal. Nevertheless, several NADOs interviewed had actually commissioned research or consultancy by such experts. It is noteworthy that the representative from CAS strongly argued for the use of ethical experts in the formulation and deployment of anti doping policy.
Several key issues arose in relation to Governance where Compliance, Effectiveness and Harmonisation were dominant. All NADO participants registered their dissatisfaction (at times anger) with the WADA Compliance report. The reporting of near total compliance by Anti Doping Organisations (ADOs), including a minority of IFs who are evidently not compliant, was commented on with universal negativity by NADO representatives. The need for greater qualitative evaluations was reported. With respect to effectiveness, the understanding that smaller and/or poorly funded NADOs could only be effective to the extent that funds permitted it. WADA representatives discussed the development of minimal standards, which would assist Compliance and enhance effectiveness. One WADA representative noted that guidance on how most effectively to allocate scarce resources was being developed but no NADO mentioned awareness of such. The possibility of different approaches, according to resources, sits uneasily with the idea of harmonisation of anti doping policy. WADAs policy comprises both International Standards for laboratory based work that are precise and prescriptive, and Guidelines, including sanctions, that are more loosely interpreted by ADOs. The variability brought problems and, while deemed necessary by all interviewees, many noted the injustices that arose from differences of interpretation. It was also noted that WADA had on occasion taken a NADO to CAS to arbitrate for higher sanctions, which did not bode well for unified and coherent anti doping stances. The engagement of the medical entourage in doping was raised frequently. Both NADOs and WADA lamented the inability of individual national medical associations to employ stronger regulatory measures against their members. Finally, one athlete union representative noted the lack of meaningful athlete participation in the policy development, leading to a hierarchical approach.

Within this node, the failure of State parties to regulate nutritional supplements was most widely reported as a medical issue. Many NADOs argued that these enhancement products should be targeted by the EU and, furthermore, that it should be easier to develop regulatory frameworks here (especially in relation to labeling) than in other parts of the world, especially North America.
Testing issues covers a large variety of elements, among which Privacy, Registered Testing Pool, and Whereabouts requirements (which are deeply interrelated), and Strict Liability dominated. Only those in the RTP are subject to full whereabouts demand but not all of these athletes are subject to blood profiling which is a more accurate medium for doping controls. Moreover, the Whereabouts system is still under dispute within the EU and at least one problem is the different understandings of the nature and scope of privacy claims. Issues of consent and data protection were reported by interviewees from more than one sector of the sample. Moreover, several participants across different sectors of the sample argued for both selective testing and a de-emphasis on out of competition testing in certain sports which was wasteful of resources and a disproportionate burden on athletes where out of competition testing was unnecessary. Both points clearly resonate with harmonisation issues noted above. Very significant differences existed in the size of Registered Testing Pools across Europe, which did not appear justified. An athlete’s inclusion on the Registered Testing Pool also opens up the possibility of filing inaccurate whereabouts which can lead to suspension under the conditions of Strict Liability. This theme relates also to the use of intelligence gathering for risk-assessment of selected athletes, which is not standardised and in need of greater co-ordination.
It is clear that the key issues identified above must be the subject of further discussion and research inter alia in the Code review process - the key themes are closely interwoven in policy and practice. Support for the further expansion of anti doping policy into civil society was not significant. There was strong support for regulatory development in relation to nutritional supplements.
Issues concerning governance were the most frequently reported aspects of anti doping policy. Clearly harmonisation of RTPs, the challenges of athlete legitimation, of different data sharing agreements, the balance of in and out of competition testing, the deployment of selective testing protocols, and the understandings of proportionality and privacy are varied and contested. Each of these issues merit further study.
The necessity of making ethical judgments in the construction of the Prohibited List, with respect to products and process that are (potentially) harmful and whose use is (potentially) against the Spirit of Sport criteria, means that the failure to meaningfully employ ethical expertise is significant. This is heightened when the discourse around doping is itself so highly moralised. Such discourse would be inappropriate if anti doping policy and discourses were medicalised, i.e. centered on performance enhancement/health. A more robust and transparent integration of ethical expertise into anti doping policy is necessary.
Finally, the metaphor of harmonisation, running right through WADA policy, is in need of more careful conceptual and ethical analysis. Many participants noted significant differences in deploying anti doping policy. The role of WADA and of regional NADOs should be clarified in order to more precisely demarcate boundaries of good practice - relative to vastly differing demands and resources - in order to achieve a more just policy terrain for athletes falling under anti doping controls.

A3.2 MODELS TO INCORPORATE ETHICAL ADVICE IN THE GOVERNANCE OF HUMAN ENHANCEMENT
Simone Arnaldi, Fabio Grigenti, Francesca Marin, Elena Pariotti
EPOCH set out to give an outline of the main features of the EU legal approach to the field of ‘human enhancement’, trying to underline advantages and shortcoming or challenges in the law already in force; to sum up outcomes of the inquiry on the characteristics of ethical advice and on its both de facto and desirable role with regard to the governance challenges in the field of human enhancement; and to devise some starting points for a suitable model of governance for human enhancement.
A wide characterisation of human enhancement is presently more useful due to the current stage of human enhancement technologies and human enhancement practices, in which the feasibility of the forms of enhancing interventions is not still clear and could not really orient the lawfulness and ethical acceptability tests.
In exploring the legal approaches to human enhancement, the following domains of inquiry were identified: consumer protection, biomedicine (e.g. research and development in pharmaceuticals, medical devices and products for advanced therapies; transplantations, genetics, etc.), workers’ rights and occupational health (e.g. genetic testing in workplace; human resource management; workers’ health protection, etc.), intellectual property and human rights.
Concerning consumer protection the analysis aims to identify if new therapies, which derive from a technological production process and the desire to achieve enhancement for consumers, give rise to specific or new challenges in terms of safety and information in comparison to all new combined medical products. ’Safety’ has become a key concept in European consumer policies. Looking at innovative products, it is important to explore the nature of risk and to develop a new terminology to differentiate risks according to whether they are: (i) totally unexpected risks; (ii) potential but still unexpected risks; or (iii) suspected identified defects. The question needs to be asked -should regulations be based on hazard classification or risk assessment? Directive 2001/95/EC gives a generic definition of a ‘safe product’. To be safe, products must comply with the definition contained in Art. 2 lett. (b).
The EU subscribes to both evidence-based policy-making and a more flexible, precautionary-oriented approach. It is crucially important to identify when there is a situation of risk and when there is a situation of hazard assessment. Hazards are only the initial part of the risk analysis process. Risk implies scientific evidence that is sufficient, even from a statistical point of view, to legitimate a precise percentage of future damage. The current legal approaches to consumer safety are seller-oriented, i.e. risk-utility test (USA) and (buyer-oriented) consumer expectations test (EU).
The test established in the EU Council Directive 85/374/EEC of 25 July 1985 has been criticised for being characterised by a high level of subjectivity and to focus on subjective consumer knowledge too much. The central role of the duty to inform becomes apparent. A traditional tool to execute the duty to warn is, first of all, the label. The recently introduced Rapid Alert System for non-food Consumer Products (RAPEX) is a post-market tool of safety and information control. The aim of RAPEX is to ensure efficient dissemination of information to all Member States to allow rapid action to be taken against consumer products in the market, which present serious risks to the health and safety of consumers.
The first issue raised by enhancement research is the identification of information for disclosure in consent and public information. This implies that enhancement benefits are set out in the initial risk-benefit evaluation. It is important to keep the public informed about developments in human enhancement technologies.
In the biomedical field, different regulations and different issues arise according to the phase of research and development process (e.g. research; clinical use; market development) and the technology/product used (e.g. commercialised pharmaceuticals v. illegal drugs; commercialised pharmaceuticals v. experimental ones; class I medical devices v. class IV nano-medical devices; germline interventions v. somatic one).
It can be useful to distinguish between issues regarding the individuals involved in research, development and use of biomedical tools, and issues regarding broad consequences on the environment and society.
Other elements having an impact on the content of (both national and EU) normative rules are the relations between the biomedical application and the human body and the purposes for which the tool is used: while therapeutic uses of biomedical tools are usually not only legally permitted, but also pursued, other uses can be more controversial or also legally banned.
The principles involved in the biomedical field are: quality, safety and efficacy, freedom of research, freedom to conduct a business. The most important issue here is the risk/benefits ratio, according to the high degree of complexity, uncertainty and ambiguity of research and development of this particular kind of technology. Safety and security are still important but also other values are to be taken into consideration such as environmental or embryo protection; animal welfare protection; and responsibilities to future generations.
The off-label use of drugs, from a legal point of view, is a problem that must be left to the doctor-patient relationship, but there are some rules that narrow the possibilities of legally admissible choices: the off-label use must be therapeutic and the non-therapeutic prescription of a pharmaceutical will then have an impact on civil and criminal liability of the physician.
It was identified that there is the need to distinguish between the different stages of the biomedical field and biomedical interventions on human beings. The three stages are research, clinical development and marketing.
Regulating clinical development and marketing of specific products or dangerous substances is relatively easy; regulating research (especially lab research) can be more difficult. In this context, the more explicit rule dealing with ‘non-therapeutic enhancement’, contained in Point 4.1.16 of the EU Commission Recommendation C(2008)424 final, seems to be quite problematic. As far as normative relevant definitions are concerned, how to distinguish between non-therapeutic and therapeutic enhancement; how to determine when the research is ‘solely’ (vs partially) aimed for ‘unlawful’ enhancement of human body performance?
The advantages of the EU approach are the possibility for regulation to rely on common values and principles, and that sector legislation on biomedical products and, more generally on consumers protection, has developed more and more consolidated rules addressing safety and information concerns. The implementation of current medicinal product regulation in order to deal with new risks would then be a good starting point when dealing with human enhancement technologies.
A number of challenges to the EU legal regulation were identified and included: the dilemmas of choice concerning the legal consequences in assessing each product/application; whether to pursue, permit or prohibit the research and development of non therapeutic applications?
o Are they to be included or excluded from the definition of ‘medicinal product’/’medicinal device’? If yes, safety and efficacy requirements will apply. But these requirements are targeted for therapeutic consequences. If not, non therapeutic applications will tend to be out of control.

o Are they to be included or excluded from the domain of medical care professions? If yes, then we take them away from the physician-patient relationship and from the physician’s responsibility; if not, then new approaches are needed.

Human enhancement affects workers’ rights and employers’ behavior in a number of different ways. For example, genetic tests and information become more precise and useful, cheaper and easier to access and the risk of discriminatory use arises, the better screening of enhancement technology applications could modify Human Resource Management, broader intelligence technologies, micro and nano-body implants, and brain-machine interfaces create new way of evaluating performance, workplaces and workers controls, the off-label use of drugs can affect the competition for work, advances in physiological and neurocognitive science research aim to more effectively combine human and machine capabilities, and personal and health data processing is linked with discriminatory behaviours or practices based on personal profiling process.
At the International, European and national level the principles of equality and privacy have received recognition and protection - in employment contracts and personal data processing. All abuses or misuses are prohibited. Nevertheless, it seems that specific regulations should be envisaged considering new issues emerging from scientific and technological development.
The inquiry of the possibility to regulate and approach human enhancement from the point of view of human rights law and its judicial application shows that human dignity is connected to ethical pluralism; human enhancement affects the principle of autonomy, understood as the exercise of freedom of choice, in non-medical treatments and gives rise to the need for setting limits to this principle; emphasises the need for giving concrete meaning and protection to the right to health (as a rule characterised by a broad range of meanings) in specific domains and cases.
When considering ethical advice and governance we should distinguish between descriptive and normative levels of analysis. Under the descriptive level, the following issues are to be addressed: The role played by ethical committees on human enhancement, the need to talk about an institutionalisation of ethical advice, what are the features of this institutionalisation, what is the relationship between ethical advice and public involvement and finally, what is the relationship between ethical advice and legal regulation?
On the descriptive level EPOCH has achieved the following outcomes:
- Endorsement and relationship with political authority: A problem can be envisaged here, dealing with the fact that the ethical advisory bodies advise the government or parliament, but at the same time the representatives of these political institutions participate as ‘consultants’ in ethical advisory bodies.

- Pluralism and ethical advice: members are chosen so that they can be representative of the several ethical views within the society more than according to the expertise criterion. Moreover, mostly the ethical advisory bodies publish minority or dissenting opinions.

- Participation of the public and the path towards a ‘civic epistemology’: Discussion of the ethical advisory bodies are almost never open to the public; a majority of the ethical advisory bodies organise events which the public can attend; for the most part ethical advisory bodies do not employ any type of public participatory mechanism (due to the lack of a clear understanding of the public’s role in discussion science and technology issues; theoretical limits to participative and deliberative democracy in the governance of science and technology; need for additional funds).

At the normative level, the question is: What should the role of ethics be in anticipatory and participatory governance of human enhancement? Both the descriptive and the normative level of analysis are addressed in light of the following key-concepts: human dignity, self-determination, personal integrity, privacy, non-discrimination, health, safety, freedom of research.
According to the analysis, the main issues to be addressed when discussing a suitable model of governance for human enhancement are the following:
- Is therapy vs. enhancement a conceptual distinction or a normative dichotomy? Is the conceptual distinction between therapy and enhancement sound? Is the distinction between therapy and enhancement suitable/useful/effective when tackling with normative issues on human enhancement?

- What is the role of the notion of human dignity? Though from a normative point of view the handling of human enhancement necessarily implies balancing among several principles and rights, the principle of human dignity seems to play pivotal role. Even once we have detached the notion of dignity from any religious or essentialist perspective and placed it within the framework of the shared values of a given community, this notion still needs to be clarified. The content and the justifications of the principle of human dignity need to be clarified with strict reference to human enhancement normative challenges.

- What are the problems with references to post/transhumanism? Some (feasible) applications of convergent technologies that can have enhancement outcomes make it necessary to address the debate on the notion of human nature and on its potential reconceptualisation. This may lead to a ‘paradigm shift’ in ethics: from the focus on consequences and applications to the focus on the very notion of human nature.

- Besides substantial issues relating to the definition of human nature, unfair access to human enhancement technologies as a potential cause of inequalities, is still on the agenda and measures for controlling consequences and avoiding discrimination caused by enhancement interventions should be considered.

It should be noted that, even if such applications were not feasible, the pervasive reference to them in the public debate could affect the approach to enhancement as a whole. From a regulatory point of view, it would be important to construe governance mechanisms so that they could take regulation away from both techno-terrorism and techno-optimism.
- the analysis of the literature on ethics and governance of science and technology shows that bioethics has transformed from academic expertise to expertise on governance. The institutionalisation of ethics in EU has made ethics also a stakeholder in its own right. For governance of science and technology being able to gain the trust of the public, it demands for more than the input of professional bioethics experts and namely it calls for a stronger role of the public beyond the one-way communication approach between scientists, on the one hand, and public and policy makers, on the other.

- Starting from the idea of the co-evolution of science, technology and society and from the need for bi-directional communication between science and technology and society, the most suitable procedural suggestions seem to stem from the model of anticipatory governance. This is a governance model that can at least try to pursue a responsible innovation, understood as a transparent and interactive process, in which social actors and innovators look at social desirability of innovative process (or product or effects). This model has the following desirable characteristics:

o tends to incorporate the reference to ethical principles in the design process of technology, by fostering better integration of ethics at the core of scientific development itself and can increase social-ethical reflexivity;

o allows continuous feedback from society;

o promotes knowledge assessment procedures to assess the quality of information within the policy process.


A3.3 PARTICIPATORY AND DELIBERATIVE APPROACHES ON PARTICIPATORY ACTIVITIES IN EUROPEAN SCIENCE AND TECHNOLOGY GOVERNANCE
Philippe Descamps and Bernard Reber
Two sub-objectives of EPOCH were: (1) to identify theoretical deadlocks and practical shortcomings of Participatory Technological Assessment in general and in particular when bioethical issues are discussed (2) to develop guidelines and strategic options to improve participatory and deliberative approaches for discussing controversial technologies. Two case studies (the Etats Généraux de la Bioéthique in France and the first pan-European citizen deliberation Meeting of Minds (2005-2006) on the future of brain research) were analysed for this purpose.
The politicisation of technology assessment activities by integrating participatory elements has its origins in the recognition that the state is accountable to often conflicting demands: new developments in science and technology put public authorities under pressure as they are faced with uncertainty about the consequences of these developments and with a plurality of values and interests. In this sense, the development of participative technological assessment arrangements is a partial response to the wider problem of the legitimacy and scope of state authority.
Much creativity has been shown by scholars and practitioners to outline participatory mechanisms for responding to hosts of different though interlinked goals but less creativity has been shown in devising a set of criteria for the ‘secondary assessment’ of participatory technological assessment activities, i.e. the evaluation of assessment experiments by external researchers. These attempts can be grouped into four broad conceptual strands. Firstly, discourse ethics has been operationalised in a set of criteria including equality, enlightenment, fairness, open-mindedness, authenticity, transparency, legitimacy. Secondly, approaches inspired by procedural justice stress that research on participatory processes should focus on the characterisation of the main criteria which allow a relevant evaluation of the fairness of decision-making, as there is a direct link between fairness of procedures and legitimacy of decisions. Thirdly, alternative notions and theories of democracy bring with them alternative views of successful participation. By promoting participation itself in decision-making, theories of participatory democracy may rather insist on involvement, presence and information of a large-scale public. Theories of deliberative democracy, which frame democratic decision in terms of a process of reasoned deliberation among equals, may emphasise the role of education, information and argumentation for the evaluation of participatory process. The notion of dialogic democracy may emphasise elements like: legislation encouraging the sustainability of associations, spaces where the different groups concerned with a question may meet, media coverage and state involvement which makes possible group discussions. There have been also attempts to define a set of criteria independently from a general theory of democratic processes, focusing more on the direction and type of communication flows, emphasising the conditions of legitimacy and quality of participatory processes. A close view to these lists of criteria demonstrates that they are not specific to participatory technological assessment. They are mostly democracy oriented, ignoring the ethical and scientific controversies that provoke these institutional innovations.
The main practical problems in participative bioethical assessment arise from the relationship between the participatory technological assessment’s activities and its goals. The richness of participatory technological assessment in terms of mechanisms on one hand and of tasks assigned to such procedures on the other hand are an asset, but a consistent relation between participatory technological assessment activities and the specific goals assigned to them is needed. As there may be different goals, different procedures may be differently apt for reaching such goals.
Outcomes of participatory exercises may similarly vary. Indeed, the general implicit form of outcomes is consensus, often expressed in a final report. Consensus however, is not the only source of information and often forces the participants to give up with their position due to a tight time. Exploration of divergences and differences (of values, knowledge, perspectives) may be equally rewarding in terms of social learning.
Evaluation of participatory exercises by external researchers (‘secondary assessments’) are often poor and fuzzy. The main difficulty pointed out in secondary assessments is that the organisers do not respect the design nor the specifications of the used devices. This affects in turn the possibility to assess the exercises against a set of clear procedural criteria that are a requirement to ensure the quality of the process.
Institutional integration of those experiments, which are often very confined, is a critical condition of their impact. Having a low impact on other institutions, although drawing much media attention, they are either legislative or executive. Paradoxically, should they be consistent or even perennial, they would destabilise the existing authority bodies.
Ethical expertise, its nature, and role is controversial in participatory technological assessment, which implicitly value the common moral preferences of citizens more than reflexive ethics or which are implicitly intuitionist, thinking we cannot give any moral justifications grounded in (ethical) expert judgement. Also, when ethical expertise is recognised, at least through the engagement of applied ethicists, its frequent monist attitude, defending and justifying only one position, is hardly adaptable to the context of participatory exercises. The practical organisation of participatory technological assessment exercises has to deal also with religious moral traditions. The selection of experts from different religions raise a ‘status’ issue. Are such experts moral theologians, or legitimate representatives, or representatives of a majority believers (from their home country or even globally)? The space occupied by secularism (or humanism) and the choice of secular representatives from various historical schools of thoughts encounters similar difficulties. More generally, the choice of the participants in PBA is crucial and more conflicting because of the ethical substance of the controversy. Should they be representatives, stakeholders, affected people (sometimes not born, future generations) or neutral? With the French Etats Generaux de Bioéthique, it was decided in advance to avoid strong ethical positions from citizens, thus promoting implicitly the majority position.
The first theoretical problem lies in the choice of the political theories needed to produce criteria for secondary assessments. Indeed, these theories and criteria will contribute to the design of the device and to the debates. Based on the importance of bioethical issues, the deliberative democracy frame is more appropriate than only that of participative democracy. It goes beyond the inclusiveness of citizens or affected people, allowing participants to recognise, select or produce justifications for their own choices.
As justifications are central in deliberative democracy, a second theoretical problem concerns the very definition of an argument. A look at the practice of participatory technological assessment and participatory bioethical assessment shows also that, while it is difficult to find formally comprehensive arguments in concrete debates, the function of the arguments vary in relation to their communicative context: they plea, mediate, inquiry. The latter conception may be more appropriate for interdisciplinary contexts where debates are faced with uncertainty about the consequences of these developments and with a plurality of values and interests about them.
A second theoretical problem is the need to match inter- and intra-disciplinary dialogue of descriptive disciplines with moral pluralism of moral theories.

A3.4 UNDERSTANDING EU GOVERNANCE, POLICIES AND REGULATORY STRUCTURES IN A GLOBAL CONTEXT
Benjamin Capps and Lisbeth Nielsen
The governance of science within the EU ensures that it proceeds in accordance with good principles. These may be absent from other regions. EPOCH set out to organise a workshop (and publish the papers presented) to gain insight into the global structures of governance, and to create awareness of the kinds of debates occurring elsewhere. Our principle finding was that outside the EU and USA, with few exceptions, a defined ‘enhancement’ debate is far less developed. In respect to regulatory structures, they either follow paradigms for the non-specific regulation of drugs, devices and products, or else are entirely absent (at least in a sense that existing laws do not obviously apply to what might be considered as an enhancement technology). In terms of policy debate, high level deliberation seems to be limited to understanding the mechanisms of a given technology, such as the various applications of neuroscience, but with little developed in the way of ethical analysis or social impact. Where ethical debate is occurring, the topics are often different to those prominent in the established enhancement literature – sex change for instance. Up to now, such topics have been widely conceptualised in academic work, but often only outside the therapy-enhancement paradigm.
As far as we are aware, there are no national regulations that refer explicitly to ‘enhancement’. The regulatory picture can be simplified as thus: as noted above (A3.2) drugs (i.e. pharmaceuticals) used for enhancement purposes are likely to come under various medicines acts. Devices (e.g. neurotechnologies), or at least those intended for medical use, will be covered by licensing frameworks. Products outside this may or may not be covered by consumer protection. There may be some tasks or activities, or groups, which require special attention – such as in sport – and where different paradigms of regulation or oversight are necessary. But this begs the question as to how we ought to regulate the use of enhancement technologies (is there a consensus on what is good in good governance?); what kinds of special expression communities want to make in respect to access and use; and in particular, how will developments outside Europe impact EU governance policies (or vice versa)?
There is, of course, a great deal to be said about how ideas of rights and wrong (or ethics) make their way into regulation; whether regulation can be broken down into purposes and mechanisms; or whether the coextensive theories of governance are where we should look to control enhancement technologies – this final distinctions indicates the wider ‘regulatory environment’ beyond issues of law and it use by regulators and impacts on regulatees, to cultural and social determinants of ‘good governance’. In respect to regulation, a great deal has been written about what is working or otherwise (often with reference to an alleged ‘epidemic’ of illegal use).
Governance is much wider than regulation: it involves values and agendas beyond the purpose of law, and in so far as it concerns subjecting human conduct to the governance of rule, is part of, and cannot be separated from the moral enterprise. There are a number of models that more or less take this task to hand. So, understanding EU governance – finding out which model is best suited to purposes of EU governance – will be trying them out; a long term project of unpacking regulatory ideas of social order, coordination and cooperation. In the global context, such a task becomes highly complex because one will find many legal structures (and different governance frameworks raising issues of inclusivity in respect to publics, culture and customs) which have important similarities and differences. Many of these structures with resist simplification; and moreover, will be misunderstood or misconstrued unless informants can be found and engaged within these regimes. That is not the only barrier: in many jurisdictions and regions (such as South East Asia), ‘enhancement’ is not an established term in deliberations (and outside Australasia, not often found in academic literature), and neither are the kinds of drugs and technologies the same one’s being talked about. The reasons for this are not clear. This might be a simple case of catch up (requiring normal seeding activities or market availability to get the debate moving); however, it is plausible that in distinct regions the enhancement debate is limited to what is present and possible, or even what is relevant. In less economically stable countries, ‘basic’ technologies and interventions, some of which are closely related to public health and improvements in basic wellbeing, are more likely to be the focus of such debates; while in the EU, a distinction between enhancement technologies and say, clean water, is more likely to be made. This reflects a fundamental disparity in current and future access to technologies across nations and regions. It is clear that more needs to be done to empirically understand the dynamics of technology development, access and use in divergent regions. Moreover, there is a need for more research into various cultural and societal aspects that are determining perceptions of specific enhancement technologies and peoples’ reluctance or desire to embrace them. It is also apparent that the research being led in ‘enhancement savvy’ countries must not only look to understand important factors that shape the perspectives and use of enhancements outside their own heuristic groups (which may be as extensive as their own countries), but also to ensure that they do so with a high level of integrity (such as in publications) to ensure a balanced communication of the scientific prospects as well as the ethical implications. The tendency for the ‘discourse of enhancement’ to claim that such technologies will change everything (for the better) is, in particular, something to avoid (and indeed, lacks credibility).
The most significant task will be anchoring any semblance of a global strategy(s) with respect to enhancement technologies. (And more broadly, we are not convinced that a probable case has been made that necessitates such an approach; harmonisations may not be within reach or even desired – although that is not to say that such a case cannot be justified.) One launching point for this debate might be eschewing ideas of procedure and public interest (and public good), and how this can be modelled via principles for safeguarding individual interests. But perhaps, all that can be achieved in this respect is the articulation, at a most basic level, of ideas about the Rule of Law, due process, or even enabling conventions on international human rights. In our attempts to locate regulatory cosmopolitanism and respect universal values, it is likely that we will become bogged down in legitimate local differences. Thus, although normative pluralism will be expected – how ideas of regulation emerge from these will also be effected by economic equalities, degrees of social tolerance and exclusion, and environmental and/or other catastrophic events. The risk is that attempts to frame global governance become fragmented, segmented and disjointed. Assumptions about the applicability of EU policies, goals and ambitious should be avoided. For example, publics will – for one reason or another – often be excluded from policy debate in some regions because bioethics (and principally political) debate may not be driven by the same ideas of consensus, compromise and convergence – terms that convey a procedural or civic epistemology that may be more relevant to the EU than other regions. In economically established nations outside those normally represented in prevailing bioethics literature, there may be social values that are not captured by terms such as ‘solidarity’ or ‘human rights’. We have in mind here communitarian values such as that reflected in the ‘Asian Values’ debate.
This is a very extensive regulatory environment to comprehend – one that is turbulent and potentially acrimonious – yet surely the grounds for embarking on such a project will begin with a goodwill intention to frame global governance upon issues that really matter; not just narrow conceptions of freedoms and liberties, but also wider (and more inclusive) matters of international justice. For some communities, these might be the issues to tackle – ‘enhancement’ is not simply a matter of choice, because such an option is out of reach for many (if not the majority), and access to education, sanitation and basic medicines might be the real improvements strived for.


Potential Impact:
During the project, the EPOCH consortium has also undertaken a wide variety of dissemination activities, targeting different groups and publics. The EPOCH Newsletters have been published at the website and sent to a large number of experts and stakeholders who are interested in the topics and results of the project. EPOCH results have been presented and discussed at several international and national conferences and workshops as well as in a variety of academic publications. The dissemination activities also included presentations at events which targeted specific stakeholder and social groups (e.g. churches and social workers).
The dissemination of the results of the project will be presented as follows:
1. The project website
2. Newsletters (5) published on the website
3. Research briefings on the website
4. Academic publications (Peer reviewed Journals, Academic Volume)
5. Presentations at scientific conferences
6. EPOCH conference in Singapore
7. Final Conference
8. Executive Summary
9. Set of recommendations

1) The project website http://epochproject.com was set up in January 2012 when the project manager started in post. The website was regularly updated with information about the project, including newsletters, research briefing , and public presentations and conference by the EPOCH partners. The website also included a repository which was accessible for the partners only and was password protected. This section provided short comments and information on co-ordination activities during the period in question, such as communication between beneficiaries, possible co-operation with other projects/programmes etc. The website also contained.

2) The newsletters (published on the website) provided information on EPOCH workshops and activities as well as publications from EPOCH (or related to EPOCH) and presentations by the partners.


3) The project website contained briefings about the research activities of the partners, including articles and presentations. This list was regularly updated.

4) The participants in EPOCH have published a number of peer reviewed articles:

• Franc Mali & Toni Pustovrh & Blanka Groboljsek & Christopher Coenen, ‘National Ethics Advisory Bodies in the Emerging Landscape of Responsible Research and Innovation’, Nanoethics (2012) 6:167–184 DOI 10.1007/s11569-012-0157-z

• Arianna Ferrari & Christopher Coenen & Armin Grunwald, ‘Visions and Ethics in Current Discourse on Human Enhancement’, Nanoethics (2012) 6:215–229 DOI 10.1007/s11569-012-0155-1

• Christopher Coenen and Arianna Ferrari ‘Ethics in Policy-Making: The Case of Human Enhancement’ Technikfolgenabschätzung. Theorie und Praxis, (2012), 21(3), 80-85

• Special Issue of the Asian Bioethics Review, 2012, Volume 4, Issue 4, pp.251-398 with the following contributions

Benjamin J. Capps, Ruud Ter Meulen, Lisbeth Witthøfft Nielson,
Human Enhancement Technologies:Understanding Governance, Policies and Regulatory Structures in the Global Context
pp. 251-258 | DOI: 10.1353/asb.2012.0038
Benjamin J. Capps, Gordon Stirrat, Lisbeth Witthøfft Nielson
A Brief Critique of Two Claims about the Social Value of Biotechnological Enhancements
pp. 259-271 | DOI: 10.1353/asb.2012.0041
Calvin W.L Ho
Enhancement (of What?) in Aesthetic Medicine
pp. 272-282 | DOI: 10.1353/asb.2012.0043
Soraj Hongladarom
Sex Change Surgery: Therapy or Enhancement?
pp. 283-292 | DOI: 10.1353/asb.2012.0031
Gregor Wolbring
Ethical Theories and Discourses through an Ability Expectations and Ableism Lens: The Case of Enhancement and Global Regulation
pp. 293-309 | DOI: 10.1353/asb.2012.0033
Bradley Partridge
Students and “Smart Drugs”: Empirical Research Can Shed Light on Enhancement Enthusiasm
pp. 310-319 | DOI: 10.1353/asb.2012.0035
Tamami Fukushi
Ethical Practice in the Era of Advanced Neuromodulation
pp. 320-329 | DOI: 10.1353/asb.2012.0037
John Elliott
On Not Reinventing the Wheel: Need We See the Governance of Research in Neuroscience as Somehow Special?
pp. 330-343 | DOI: 10.1353/asb.2012.0040
Roger Brownsword
Five Principles for the Regulation of Human Enhancement
pp. 344-354 | DOI: 10.1353/asb.2012.0042
Robert Sparrow
A Child’s Right to a Decent Future?: Regulating Human Genetic Enhancement in Multicultural Societies
pp. 355-373 | DOI: 10.1353/asb.2012.0030
Michael J. McNamee
The Spirit of Sport and the Medicalisation of Anti-Doping: Empirical and Normative Ethics
pp. 374-392 | DOI: 10.1353/asb.2012.0032
Ruth Chadwick
Enhancement: A Short Comment
pp. 393-398 | DOI: 10.1353/asb.2012.0034

Peer reviewed publications in preparation:
• Zuzana Deans and Ruud ter Meulen, The role of bioethics in public policy-making on new biotechnologies, Science and Public Policy, Special Issue,
• Laurens Landeweerd, Ine van Hoyweghen, David Townend, Jessica Mesman, Best possible models of Science and Technology

5) Presentations at scientific conferences

• Camporesi, S. and McNamee, M.: Compensation for injuries in professional guinea pigs: The clinical trial and elite sports contexts , International Association for the Phi-losophy of Sport, Annual Conference 12-6 Sept. University of Porto
• Deans, Z.: In defence of codes of ethics, Ideals and Reality in Social Ethics, University of Wales, Newport April 2012
• Deans, Z.: The Voices of Bioethicists. Presentation at EACME conference, Bristol, September 2012
• Ferrari, Arianna (Karlsruhe Institute of Technology, Institute of Technology Assessment and Systems Analysis): Ethics and technological visions in the case of cognitive enhancement: a complicated relationship, Anthropos Café, bâtiment Amphipôle, Université de Lausanne, Metro UNIL-Sorge, March 2, 2011
• Ferrari, A., Coenen, Chr. The challenge of technological visions for the bioethical discourse: the case of human enhancement, Presentatio at the Annual EACME Conference, Istanbul 15-17 September 2011
• Groboljsek, Blanka; Pustovrh, Toni; Mali, Franc (University of Ljubljana, Faculty of Social Sciences): Ethical advisory institutions in advanced S&T policymaking: public participation and policymaking functions. The Conference of European Sociological Association, Geneva, September 7-10, 2011
• Groboljšek, B., and Mali, F.: Nekatere etične dileme in vprašanja biotehnološkega razvoja v Evropi *Some ethical dilemmas and issues on biotechnological development in Europe+. Družbosl. razpr. (Tisk. izd.). *Tiskana izd.+, letn. 27, št. 68, str. 7-24, December 2011
• Mali, F.: Predstavitev rezultatov raziskave Etika in javna politika: primer krepitve človeka Presentation of the survey results on Ethics and public policy: the case of human enhancement.J. V. Bernik, Ivan (ur.). Tri desetletja spreminjanja slovenske družbe : zbornik povzetkov. Ljubljana: Slovensko sociološko društvo,7-10 September 2011
• Mali, Franc; Groboljsek, Blanka; Pustovrh, Toni (University of Ljubljana, Faculty of Social Sciences): Policy impacts of ethical advisory bodies on the social regulation of biotechnology. 10th Annual IAS-STS Conference “Critical Issues in Science and Technology Studies”, Graz, May 2-3, 2011
• McNamee, M.: Century, International Convention on Science, Education, Medicine and Sport (Pre Olympic Scientific Congress) Glasgow, July 2012
• McNamee, M., Tarasti, L.: Ethical and legal peculiarities in anti doping control, Inter-national Convention on Science, Education, Medicine and Sport (Pre Olympic Scientific Congress) Glasgow, July 2012
• McNamee, M.: Genetic enhancement across social spheres: some ethical concerns, International Convention on Science, Education, Medicine and Sport (Pre Olympic Scientific Congress) Glasgow, July 2012
• McNamee, M.: Better than well? Enhancement as a goal for medicine in the 21st Century? Medical School, University of Otago, New Zealand, April 2012
• McNamee, M.: Gene transfer for pain tolerance: A tool to cope with the intractable, or an unethical endurance-enhancing technology?, Bioethics Centre, University of Otago, New Zealand, April 2012
• Meulen, Ruud ter, Ethical and philosophical issues of human enhancement at 'The Quest for Perfection: The Future of Medicine/Medicine of the Future', Annual Societas Ethica Conference, Lugano, 25-28 August.
• Meulen, R. Ter, Deans, Z. Yates, J. The role of bioethics in public policy-making on new biotechnologies, PRESCIENT conference, Berlin, November 29, 2012
• Reber, B.: Governance of nanotechnologies, presentation, Montreal, Canada, October 03-04 2011.
• Reber, B. : Ethique technologique et éthique de l’environnement, la carpe et le lapin, presentation, International Symposium on Eco-Ethics, Paris, October 24-29 2011.
• Reber, B. et al.: presentation, 3th meeting of Interdisciplinary Approaches of the Moral Reasoning in Context, Centre de Recherche en Ethique de l’Université de Montréal, December 08-09 2011.
• Yates, J., Deans, Z., Meulen, R. Ter, The empirical return: a model for including public discourse in bioethics, Presentation at the Annual EACEM conference Istanbul, 15-17 September 2011


Special Session dedicated to EPOCH:

‘The role of ethics in public policy-making. The Case of Human Enhancement EPOCH’, World Congress of the International Association of Bioethics IAB, Rotterdam, June 26-30, 2012 with the following presentations:
1) Whether and how to involve public ethical discourse in public policymaking Zuzana Deans
2) The challenge of technological visions for bioethical discourse: the case of cognitive enhancement Arianna Ferrari
3) The role of national ethics committees and the governance of emerging biotechnologies. Franc Mali/ Toni Pustovrh/ Blanka Groboljsek
4) Audience and Speakers Discussion led by Ruud ter Meulen


6) Conference EPOCH in Singapore, June 7-8 2012
The purpose of the conference was to explore the complexities of policies in respect to enhancement biotechnologies. The programme consisted of an opening session, followed by three core sessions focusing on: Enhancement and the Human Body; Enhancement Technologies and Policy; Enhancement and the Brain. The conference finished with a roundtable discussion focusing on Enhancement Technologies and Global Regulation. The conference programme features 13 prominent speakers. Each session included three presentations. Each session included time for both Q&A and plenary discussion. The conference had 28 participants registered. The participants list included experts from Canada as well as from several countries within the European and the Asian region. Four working questions were presented by the Work Package leader Dr. Benjamin Capps at the beginning of the conference: What are the principles of ‘good governance’? What are the debates about, where technologies are more or less in common reach of the public? How to manage international value conflicts? How will developments outside Europe impact EU governance policies? These four working questions were brought in again at the final panel discussion. Furthermore, a questionnaire was distributed among the participants and speakers after the conference for feed back as to whether the conference had achieved its goals in addressing these questions. The Singapore conference was a success. Overall, the conference achieved its goal in terms of addressing the four working questions. The conference discussion focused on issues such as principles for ‘good governance’, and raised issues of access and wider use of enhancements in the population. Another focus area for the discussion was developments outside Europe and it was clear from the discussion that in terms of global governance, value conflicts, and cultural diversities are likely to be a major challenge in any attempt to harmonize regulatory approaches through international regulations. The conference presentations were published in a special issue of the Asian Bioethics Review (December 2012), see above.
7) Final Conference in Padua, September 6-7, 2012

The final conference of the EPOCH project titled – The Coming Epoch of Enhancement Societies? The Challenge of Human Enhancement to Regulation, Ethics, and Public Policy was held at the University of Padua (Palazzo del Bo – Via VIII Febbraio 2, 35122 Padova) on Thursday 6th and Friday 7th September 2012.
The EPOCH Final Conference was meant to present and discuss EPOCH project’s results. The conference gathered together academia, decision-makers and members of society to generate new insights into the role of ethical expertise in European policy making on new and emerging science and technologies, and to discuss possible and desirable governance models of human enhancement technologies.The conference brought together the members of EPOCH project. Unfortunately the partner Calgary had to apologize for the meeting. External experts from EU and non-EU countries, most of them addressed by EPOCH partners before the conference, were also attending the meeting.
The conference was partly live streamed on the Italian science communication portal Triwù (http://www.triwu.it/) and the full conference is downloadable on the same website (http://www.triwu.it/triwumagazine/-/asset_publisher/6Zu2/content/le-implicazioni-morali-della-bionica). The Association of Industrialists of the Veneto Region granted the patronage to the event. ). The conference was featured in Moebius, the weekly science communication show of the national radio station Radio 24 . The program also discussed the topic of human enhancement (on air: 1-2 September 2012). A report of the conference can be found in the list of deliverables.

8) Executive summary
The executive summary captures the key messages and insights derived from the results of the EPOCH project, focusing on governance of enhancement and on ethics in science and technology policy. It is designed for use by decision and opinion makers and a broader public. The summary can be found in the list of deliverables.

9) Set of recommendations: the EPOCH guidance

The EPOCH Guidance provides guidance to policy makers and stakeholders on how to deal with ethical issues in the governance of science and technology, with a special view to the role of institutions of policy advice and to the governance of human enhancement. The version submitted as Deliverable DL 11.3 will be sent to a large number of experts who have been involved in EPOCH activities or are working in areas relevant for the topics of EPOCH. These experts will be invited to review and comment on the present draft. On the basis of this feedback a final version of the EPOCH Guidance will be produced and published by the EPOCH consortium.



List of Websites:
http://epoch.com