Final Report Summary - SYBHEL (Synthetic Biology for Human Health: Ethical and Legal Issues)
Executive Summary:
This is the final report of the SYBHEL Project and constitutes deliverable nineteen (D19) as per the SYBHEL Project’s Description of Work.
The SYBHEL Project consisted of four partners; The University of Zurich, The University of Deusto, The Rathenau Institute and was co-ordinated by the Centre for Ethics in Medicine at the University of Bristol. It was funded by the European Commission’s Science and Society Program- as part of the seventh framework.
The SYBHEL Project’s objective was to investigate the ethical, legal and policy issues that may be raised by synthetic biology in respect to human health and wellbeing. It was the first study of its kind to focus on this issue.
Synthetic biology (also known as synbio) is an ostensibly new field of science. This emerging field is interdisciplinary. It draws on a range of different disciplines from genetics, engineering and computing to other forms of biotechnology and biochemistry. Synthetic biology seeks to design and build new living systems and redesign existing biological systems at a molecular, cellular, tissue and organism level.
According to proponents, synthetic biology may lead to a wide range of new and radical technologies including applications that could have a significant impact on human health. Applications could include such things as devices for tissue repair or regeneration, personalised smart drugs, therapeutic vectors and new mechanisms for drug uptake or drug design.
The first section of this report describes the way in which the SYBHEL Project was organised. It outlines the key objectives of the project and the research conducted by SYBHEL partner’s individual work packages. Research was divided into five separate work packages; SynBio and the Definition and Creation of Life, What should a SynBioEthics for human health look like, Ethics and Synbio for Human Health and Well-Being, Regulation and Commercialisation of Synthetic Biology for Human Health and Public Policy on Synbio for human health.
The second section of this report details the central conclusions and policy recommendations of the individual work packages written by the respective work package leaders. These recommendations and conclusions are the result of SYBHEL Project research and workshops which culminated in work conducted at the 2012 SYBHEL Final Conference held at the British Library in London.
The third section of this report details the potential impact and the main dissemination activities of the SYBHEL Project. Since its inception, the SYBHEL project has been committed to the dissemination of its research and information on synthetic biology and human health. The project has used a variety of methods in order to engage and interact with as many types of people as possible. Methods have included web based blogs, twitter, film, science café’s, podcasts, conferences, workshops and academic publications.
The final section of this report details the SYBHEL project’s website and contact details. More information about the SYBHEL Project, including links to reports, papers, videos and podcasts can be found at www.sybhel.org. The SYBHEL project also has a twitter feed, viewable on the website. To contact the project via twitter please go to @SYBHEL_Project.
Project Context and Objectives:
The SYBHEL Project was set up in 2009 to investigate the ethical, legal and policy issues that might be raised by synthetic biology in respect to human health and wellbeing. The project consisted of four partners, The University of Zurich, The University of Deusto, The Rathenau Institute and was co-ordinated by the Centre for Ethics in Medicine at the University of Bristol
According to the original project remit, synthetic biology is an ostensibly new area of scientific research which seeks to design and build new living systems at a molecular, cellular, tissue and organism level. This emerging field draws on a range of different disciplines from genetics, engineering and computing to other forms of biotechnology and biochemistry. Proponents believe that synthetic biology research may lead to a wide range of new technologies, from biofuels, to new materials as well as revolutionary health and medical applications.
The SYBHEL Project was the first study to focus specifically on ethical, legal and policy the implications of synthetic biology in respect to human health and wellbeing.
According to the SYBHEL Project’s Description of Work the central objectives were to;
1. Carry out high quality ethical research and evaluation of synthetic biology acid will impact on human health and well-being.
2. Underpin research with a consistent awareness of the SYBHEL crosscutting themes, namely: the definition of synthetic biology; scientific research (including documenting and regularly updating the state-of-the-art); safety and justice.
3. Create a hub for researchers and policymakers interested in ethical, legal and social issues arising in synthetic biology as it applies to human health to meet and exchange ideas.
4. Debate and agreed recommendations for regulation and commercialisation of synthetic biology as it pertains to human health and well-being.
5. Determination a strategy for policy deliberation for synthetic biology and human health.
In order to fulfil these objectives the SYBHEL Project’s research was divided into a number of different work packages presided over by the partner institutions. The research objectives for the work packages were as follows
Work Package 2:
SynBio and the definition and creation of life
Work Package Leaders: Anna Deplazes-Zemp and Nicola Biller Adorno
This work package was led by the University of Zurich. Its key objectives were to;
• explore the ethical and philosophical implications of various definitions and concepts of ‘life’
• explore the ethical and philosophical implications of creating new lifeforms and artificial analogues to existing lifeforms as they apply to human health.
• Conduct an international and cross-cultural discussion on the indications of synthetic biology for human health and well-being.
Work Package 3:
What should a SynBioEthics for human health look like?
Work Package Leaders: A.M. Calladine, Ruud ter Meulen and Ainsley Newson.
This work package was led by the Centre for Ethics in Medicine, at the University of Bristol. Its central objectives were;
• to delineate the new ethical challenges posed by synthetic biology
• to document existing literature on methodology and bioethics and consider how this should apply to the particular challenges presented by synthetic biology.
• to explore and determine an appropriate methodology for ethical deliberation within synthetic biology
• to situate this debate in the context of scientific advances into synthetic biology for human health
Work Package 4:
Ethics and Synbio for Human Health and Well-Being
Work Package Leaders: Heather Bradshaw and Toby Murcott
This work package was led by the Centre for Ethics in Medicine, at the University of Bristol. Its central objectives were;
• to identify and document the scientific advances in synthetic biology that will have an application to human health and well-being
• to analyse new ethical challenges posed by synthetic biology techniques with special attention to drug development, drug targeting, biosynthesis, synthetic stem cells, vaccine development and live therapeutic agents, including the crosscutting theme of justice
• to consider how synthetic biology might influence also the philosophical concepts of health, disease, therapy and suffering, including gender aspects and analyse gender issues related to synthetic biology techniques with special attention to drug development, drug targeting, biosynthesis, synthetic stem cells, vaccine development and creating live therapeutic agents
Work Package Five
Regulation and Commercialisation of Synthetic Biology for Human Health
Work Package Leaders: Inigo de Miguel Berain and Carlos Romeo Casabona
This work package was led by the University of Deusto. Its central objectives were;
• to explore the current normative background informing regulation and commercialisation in synthetic biology for human health
• to explore the judicial issues that may be connected with synthetic biology including the legal impact of the general prohibition of commercialisation of human body parts and intellectual property aspects
• to explore the adequacy of applying other normative frameworks drawn from other technologies to synthetic biology for human health.
• to survey some general principles and options for regulating (or self-regulating) synthetic biology for human health in Europe, including an analysis of alternative options such as specific regulation or adaption of an existing framework; with regards to the cross-cutting theme of justice.
Work Package 6:
Public Policy on Synbio for human health.
Work Package Leaders: Conor Douglas and Dirk Stermeding
This work package was led by the Rathenau Institute. The central objectives were;
• to build on the outcomes of work packages 2-5 to yield insights into how the issues raised could be considered in EC policy
• to organise two workshops to deliberate policy issues in synthetic biology; one on a European scale and one for a global audience
• to locate these workshops in the context of up-to-date public debate on synthetic biology for human health, in light of new scientific developments
Project Results:
This section of the report details the central conclusions and policy recommendations of the individual work packages written by the respective work package leaders. These recommendations and conclusions are the result of work conducted at the 2012 SYBHEL Final Conference. Before the conference, experts considered draft recommendations proposed by individual partners and provided written comments. At the event the draft recommendations and expert comments were discussed in a series of breakout workshops. After the final conference the policy recommendations and conclusions were further refined drawing on the discussions and advice offered at the final conference.
WP6:
Public Policy on SynBio for Human Health
Dirk Stemerding and Conor Douglas
Objectives
It was our task in this work package to build on the outcomes of the work packages 2 – 5 to yield insight into how the ethical and legal issues raised could be considered in EC policy. To identify and deliberate policy issues in SynBio we organised two workshops, one focusing on the European context, the other on the global health context. For the first workshop on European Policy for the Governance of Ethical and Legal Issues of Synthetic Biology for Human Health, we prepared a discussion paper on which participants coming from different communities – SynBio, social science, ethics, policymaking, patient and public engagement organisations – were invited to comment. For the second workshop on Synthetic Biology for Global Health: a Policy Discussion, we prepared a background document on the basis of which we invited participants – from different expert communities, international organisations and global regions – to submit papers on various issues relating to the potential implications of SynBio for global health. Finally, we discussed our findings and draft recommendations during the SYBHEL final conference with a small group of policy experts familiar with the field of SynBio. The following preliminary considerations, final recommendations and concluding reflections are based on the findings from the two workshops and the responses we received during the final conference.
Preliminary considerations
Future uncertainties as a major challenge
The aim of the SYBHEL project was to consider the potential applications of SynBio for human health and to explore the ethical and legal issues they might raise. WP2 investigated how the aims and claims of SynBio relate to different philosophical and public understandings of ‘life’ and it discussed the potential significance of these different understandings for the future ethical, philosophical and societal assessment of SynBio. WP3 and WP4 focused on normative and conceptual issues raised by SynBio and public policy in the field of human health, including ways in which future advances in SynBio might influence or alter concepts of health, disease, therapy and suffering. WP5 explored the extent to which current (biotechnology) patent regimes will be constraining or enabling to future SynBio innovation for human health.
The issues raised in the work packages 2 – 5 relate to future developments of SynBio that are highly uncertain and to potential health applications that are only likely to appear on the market in a future time span of decades. The uncertainty about the specific future relevance and implications of SynBio for human health creates a major challenge for policymaking: how to deal with highly speculative and uncertain future issues in this field? As an emerging platform technology SynBio may enable a variety of future applications and we simply don’t know yet where exactly it will lead us. Moreover, the issues raised in regard to future health applications are mostly not specific for SynBio, but refer to more general developments and future visions we are already familiar with from other fields of (bio)technology. Given this general context and the findings from the two policy workshops, we have attempted to steer away in our recommendations from future consequences as the main concern to issues more immediately relating to current practices and experiences in the field of SynBio and (global) health.
Issues of more immediate concern
Issues of more immediate concern for EC policymaking in the field of synthetic biology and human health relate to governmental challenges of regulation on the one hand and to broader challenges of anticipatory governance on the other.
In regard to policies of regulation we need regulations that are adaptive to changing circumstances. One issue is that current regimes of regulation should be able to respond to new needs for risk assessment. Another issue is that current regimes of regulation may adversely affect potentially promising prospects for innovation in SynBio, which also raises the question how policies of regulation might serve to facilitate particular developments with potential (public) health benefits.
As an emerging science which is still in an early stage of research and development and which is characterized by future uncertainties, SynBio also needs more inclusive forms of anticipatory governance engaging a variety of actors from both science and society. One issue is the need for strategic choices in the field, whereby the future of SynBio should not only be considered as a series of potential (health) applications, but also as a series of platform technologies which may enable different trajectories of research and innovation. Another issue is the way in which conditions can be created for responsible research and innovation in the field of SynBio, involving a variety of stakeholders and publics in mutual learning about potential future (health) benefits and risks.
These general considerations form the background of our final recommendations in which we address different actors and communities, including the European Commission, regulatory agencies, research organisations, as well as a variety of other parties to be involved in anticipatory governance of SynBio. With these recommendations we seek to stimulate forms of policymaking which address current practices and experiences in the field and which combine adaptive forms of government regulation (‘hard law’) with forms of governance (‘soft law’) that encourage the commitment of both science and society to a forward looking and responsible development of SynBio, involving different normative positions and acknowledging potential risks without prematurely cutting off developments with potentially significant future (health) benefits.
Final recommendations
1. Recommendations to the European Commission and regulatory agencies concerning government regulation:
• European policies in GMO safety regulation, medicinal product regulation, and ethical review should address in an anticipatory mode new challenges resulting from future SynBio (health) applications
It is not clear to what extent current and well-developed GMO safety and medicinal product regulations in Europe are sufficient to deal with future health related developments in the field of SynBio. In more general terms this challenge has already been identified by the European Group on Ethics. In its opinion on synthetic biology of 2009 the EGE recommended that “The Commission should review the legislation applicable to synthetic biology and assess its relevance to address the issues raised by synthetic biology” (EGE 2009: 53). In the SYBHEL WP6 European Policy workshop and Final Conference the following issues have been identified as of special concern in the context of SynBio and human health.
GMO safety regulation
As the EGE already pointed out in its opinion on synthetic biology, the aim of this field is to produce “organisms with multiple traits from multiple organisms, and therefore it may be difficult to predict their properties” (EGE 2009: 49). The problem might even be more complicated as SynBio develops not only engineered bacteria but also engineered cells for introduction into humans. The current GM risk assessment paradigm operates on the assumption that small genetic modifications will not significantly affect the characteristics of the host organism. However, given the level of complexity in cell engineering and signalling between cells, small changes could have massive ramifications in the human body. As a result the current GM risk assessment paradigm might be highly questionable in its applications in the arena of SynBio and human health. Thus there is
• a need for dedicated investments in the development of risk assessment methods that match SynBio developments involving the construction of cells with multiple new traits and the introduction of engineered cells in the human body.
In developing new risk management approaches we also need to think about technological rather than regulatory fixes, that is, safety by design. Policy could be used, for example to require that any organism that could multiply uncontrollably in any application would not be approved without a genetic construct preventing uncontrolled reproduction.
The need for more advanced forms of risk assessment should be matched however to another concern expressed during the SYBHEL Final Conference discussion, which relates to the impact on innovation of the current system of GMO regulation. European GMO regulation has developed into a system which is very demanding and costly for innovators in the field, to such an extent that (especially small) innovators may lose interest to pursue potentially promising product developments based on genetic engineering. Maintaining the current system of GMO regulation may thus discourage future SynBio innovation, nibbing in the bud promising (health) applications with potential benefits for society. From this point of view, European policymaking is at the crossroads for reconsidering the architecture of the current regulatory system. In other words, there is
• a need to find a new and careful balance by simplifying the current system of GMO regulation in ways which, on the one hand, should facilitate innovation and, on the other hand, prioritize new emerging issues of risk assessment.
Regulation of medicinal products and devices
Health related research in SynBio will strengthen the current move to biologicals in medicinal product development, that is, to products based on compounds and cells derived from the human body. These products create new challenges for the assessment and market approval of medicinal products and particular categories of these products have been brought in Europe under a special regulatory regime for advanced therapy medicinal products (ATMPs). Currently biologically-derived products only account for 6% of all medicinal drugs on the market in Europe; however, such products may play an increasingly large role as they account for a much larger share of 40% of products in Phase III trials, and health related product innovation in SynBio may further add to this trend. Given limited experiences with the assessment and product approval of biologicals today, the European Medicines Agency (EMA) will have to face new regulatory challenges as a result of this future development. A most challenging issue in this context is the way in which future (synthetic) biologicals may increasingly combine different – pharmacological as well as mechanical – modes of action, thus more and more blurring the boundaries between distinct regulatory regimes established in Europe for drugs on the one hand, and medical devices on the other. To anticipate future developments in the field of (synthetic) biologicals and to strengthen the institutional preparedness of the EMA and other stakeholders in assessing these developments, there is
• a need to reconsider the current distinction between pharmaceuticals and devices in the process of medical product approval in Europe.
Other issues raised in the SYBHEL workshop discussions concern processes of translation from the laboratory to the clinic of (future) SynBio-based experimental treatments. Patient involvement and access to therapies at stages of translation from early experimental to established treatments may become a potential source of contention in the context of the interplay of commercial, individual, public and scientific interests in developing SynBio health applications. Moreover, clinical research needed to develop SynBio health technologies might entail a degree of risk beyond that usually associated with other forms of experimental treatment. Together these issues suggest a need to reconsider the ethical paradigms that apply to clinical research and experimental treatment (Sarah Chan, WP4 workshop paper). Especially important in this respect is a concern that was expressed in the WP6 European Policy workshop about the lack of transparency of the current system of ethical review of individual research projects on the EU level. In order to support broader ethical reflection on the challenges arising from the development of SynBio therapies and other emerging health technologies, there is
• a need to consider a more transparent process of ethical review, in which the results of research ethics evaluations are not only fed back to individual projects (as is the current practice within DG Research and Innovation), but to wider communities of researchers, patients, ethicists and social scientists.
2. Recommendations to the European Commission, and to European and national research policy and funding organisations, concerning anticipatory governance
• European policies should support options for anticipatory governance by fostering experiments focusing on the wider societal aims and concerns in regard to SynBio (and human health) and involving a variety of stakeholders and publics in mutual learning about potential future (health) benefits and risks
Options for anticipatory governance are especially important for an emerging science like SynBio which is in an early research stage of development, without clearly defined (health) products to which established regulations might apply. From a regulatory perspective, the field is still an ill-defined moving target. A central feature of SynBio is ‘cross-borderness’, the combination of approaches from a variety of disciplines – biology, engineering, physics, computer science, and chemistry. The field also involves communities of young students attracted by the international SynBio Genetically Engineered Machines competition (iGEM) as well as amateur Do-it-Yourself (DIY) or ‘garage’ SynBio communities. Cross-borderness implies new levels of complexity and unfamiliarity, not only in terms of the phenomena studied and engineered in the SynBio field, but also in terms of various disciplinary and cultural traditions crossing each other, each with its own norms, values, beliefs, and conventions with regards to risk. In the face of future uncertainty and cross-borderness, we not only need adaptive forms of government regulation, but also a flexible and evolving ‘art of governance’ involving the diversity of communities and stakeholders that are shaping the field (Zhang et al. 2011).
Even more important is an anticipatory art of governance which takes into account broader discourses of concern, involving deeply rooted convictions and values in society, which may be more decisive for the future social acceptance of SynBio than the more narrowly defined discourses of risk and regulation. Experiences in the UK with a public SynBio dialogue have shown that participants were not only concerned with risks and benefits of potential future applications, but also with the motivations of actors and stakeholders shaping the field, that is, the individual and societal goals and interests that drive research (Bhattachary et al. 2010). Another aspect that was emphasized in the WP6 workshop discussions is the need for a shift in focus in these broader discourses of concern from ‘hard’ impacts relating to tangible technological risks for human health and the environment, to ‘soft’ impacts relating to the complex and often unintended ways in which technologies may transform individual behaviours, public attitudes and values, social relationships, and economic balances of power.
Anticipatory governance implies the creation of multiple opportunities for interaction between science and society as a form of ‘extended interdisciplinarity’, on the one hand engaging communities of researchers with the social and ethical ramifications of their work and, on the other hand, involving a broad range of stakeholders and publics with issues that relate to current practices and strategies of SynBio research and innovation. Extended interdisciplinary also is promoted by the European Commission in terms of ‘responsible research and innovation’, with the aim to integrate and align societal needs and demands more upstream in the technological development process (Von Schomberg 2012 and forthcoming). The recent European call for Mobilisation and Mutual Learning Action Plans (MML’s) is a very interesting and significant initiative in this respect. During the WP6 workshop discussions different options have been proposed which might be supported by the European Commission as experiments in anticipatory governance, involving SynBio researchers and a variety of stakeholders and publics in mutual learning about the wider societal aims and concerns in regard to SynBio (and human health).
• Synbio road-mapping as a governance experiment supporting global health goals
The WP6 workshop on global health critically discussed ways in which SynBio might address important problems and goals of global public health and the conditions needed to achieve these aims. One way for SynBio to contribute to global health would be to target specific diseases with major global health impacts (like diarrheal diseases), as is the aim of the SynBio funding initiative of the Bill and Melinda Gates Foundation Grand Challenges for Global Health Explorations Grant Program. The other more generic and long-term way of addressing such issues would be to focus SynBio R&D on the construction of fundamental multi-purpose pathways in microbial cells, which may serve as platforms that can be tailored to many kinds of applications, using advanced tools for computer-aided design of genetic circuits. In this context it was proposed during the workshop to start a road-mapping exercise for SynBio in global health, to see how the development of a technical infrastructure, including multi-purpose platforms and tools, might be stimulated and coordinated for the next ten to fifteen years. Such a roadmap would not only need to create technical priorities, but also integrate those with research agendas and policy options, ensuring that such an infrastructure would be open, accessible and beneficial for all constructive interests in SynBio, thus stimulating pre-competitive cooperation in the field. It would have to be developed in an open process of community engagement, involving in a process of imaginative thinking, researchers, industry, funding agencies, international health and innovation policymaking organisations, NGOs and representatives of end-users in the field of global public health. Interestingly, the workshop participant from the OECD working party on biotechnology suggested that they might play a role in brokering such an activity, and the European Commission could play a role as well.
• Real-time TA as a governance experiment supporting responsible SynBio innovation
Real-time technology assessment aims at mutual learning about challenges relating to the future societal embedding and impacts of potential applications of synthetic biology. The focus of this approach is on the level of SynBio research projects, like those funded by the Grand Challenges for Global Health Explorations Grant Program or (health related) projects undertaken as part of the annual iGEM competition. Starting point for a real-time technology assessment is the articulation of future ‘application scenarios’ with the aim to engage researchers and a wider circle of relevant stakeholders in an interactive process of imaginative deliberation, considering options, needs, conditions and alternatives for future applications envisaged in particular projects. The iGEM community constitutes a particular interesting forum of young researchers for real-time TA experiments, on the basis of which especially promising iGEM projects might be selected for further investigation and funding, thus supporting responsible research and innovation in the SynBio field.
• Development of scenarios as a governance experiment supporting future imagination
The development of ‘techno-moral’ scenarios as a tool to stimulate imagination, reflection and debate in the context of real time TA, education and public engagement activities may be another way to support anticipatory governance in a highly uncertain field. While application scenarios focus on the prospects and challenges for innovation and related regulatory concerns, techno-moral scenarios highlight the wider transformative potential of SynBio in society, thus shifting the attention to ‘soft’ impacts. They invite audiences to imagine and appraise ways in which SynBio (health) applications might change our world, our ideas, values and ideals. As thought experiments techno-moral scenarios can be used to create a controlled environment for testing ideas and arguments about the future and to explore and clarify the underlying reasons, beliefs, values and concerns informing public debates about new and emerging science and technology (Calladine & Newson, WP3 discussion paper).
• Governance experiments supporting different approaches to intellectual property
In the SynBio research community there is much support for the development of a technical infrastructure that should be open, accessible and beneficial for all constructive interests in the field. However, as pointed out in WP5, an important and controversial question still remains: to what extent is it possible to create a robust and alternative open access system in a field in which it will be very costly to develop marketable innovations? From the WP6 Global Health workshop, we know that SynBio researchers who favour free access to knowledge relevant for global health, are facing institutional pressures from their university to pursue IP protection. Given the international IP debate – as discussed in the Future Scenarios report of the European Patent Office (EPO 2011) – there is a clear need for flexibility and room to manoeuvre and experiment with different approaches to IP and patenting. In a recent report on collaborative mechanisms for IP management in the life sciences the OECD (2011) indeed suggests a move away from ‘own to protect’ to ‘own and share’. Accordingly, the European Commission might seek to support initiatives from the research community and other parties considering alternative IP regimes and reward structures in SynBio and other fields (e.g. the Health Impact Fund).
Concluding reflections
In our final WP6 recommendations we have shifted the focus from potential future implications of SynBio for human health, to issues of government regulation and anticipatory governance that are of more immediate concern for European policymaking in regard to current practices and experiences in the field. This shift in focus is not only relevant in addressing policymaking institutions, but also suggests a need to reconsider established ways of understanding the ethical, legal and social implications (ELSI) of new and emerging science and technology. ELSI research is strongly predicated by a concern to protect society against harmful implications of science and technology and thus reproduces a long-standing division of labour in our society between promotors of new technology and critical responders (Garud & Ahlstrom 1997). In this light, our recommendations for experiments in anticipatory governance also imply a move in ELSI research towards a less antagonistic stance, contributing in a critical as well as collaborative way to discussions on how – and under what conditions – SynBio might address important problems and goals of human and global public health.
WP3:
What should a SynBioEthics for Health looklike?
A.M. Calladine
Objectives
Work Package Three (WP3) was entitled, What Should a SynBioEthics For Human Health Look Like? Its main objectives were;
• To delineate the new ethical challenges posed by synthetic biology
• To explore and determine an appropriate methodology for ethical collaboration within synthetic biology
In brief, we came to the conclusion that the premises and assumptions which formed the basis of the work package are highly problematic and questionable. That is to say, considerable doubt was cast over whether there was a need for a ‘SynBioEthics’, the ‘newness’ of the ethical challenges, the notion of determining an ‘appropriate methodology’ and the use and construction of ‘ethical frameworks’. Our suggestions below reflect and draw on these conclusions.
It is worth noting, that we do not consider these to be policy recommendations. This is because at present it is unclear what we are recommending policy for (or on), or whether new policies are actually required. And because we are a little unsure as to what public policy is (or perhaps we should say ought to be in terms of its nature and justification). We claim no expertise in public policy. Rather, please consider the points listed below the key issues and questions we think may be important and that perhaps policymakers ought to bear in mind while (or before) formulating policy in this area.
1. We shouldn’t treat synthetic biology in isolation but rather consider it in conjunction with other biotechnologies and issues concerning human health.
The emergence of synthetic biology has generated a great deal of hype and led to some rather extravagant claims. If we are to believe the claims made by some scientists, we may think that synthetic biology offers a panacea for many of society's ills. However, according to others synthetic biology may pose great dangers and could be something of a Pandora's Box. Of course, these sorts of claims help attract research funding for both scientists working in synthetic biology and the researchers interested in the supposedly new ethical, legal, social and policy issues it raises. However, beneath the hype it is rather unclear just what synthetic biology is (see footnote above), or whether it's really as new and radical as is often suggested.
As we have argued elsewhere, rather than considering synthetic biology as new, it perhaps makes more sense to think of it as a form or endpoint of genetic engineering. As such, it is rather doubtful whether synthetic biology, either in itself or in relation to human health really raises any new or distinct ethical issues. Synthetic biology seems to raise many of the same sorts of ethical questions as those raised by other biotechnologies. Of course, the newness or otherwise of ethical questions should not detract from their importance. The moral questions raised by synthetic biology, while familiar to other biotechnologies, are important and remain unresolved. However, it does raise the question of why we should treat synthetic biology in isolation or as a special case. We agree with our colleagues in WP2 that;
… most of the ethical or societal issues in synthetic biology for human health that we envisage today, are not raised by synthetic biology in general, but rather depend on the specific medical application. These issues generally overlap with similar issues raised in the context of other technologies… The discussion and regulation of these issues in synthetic biology and other technologies should thus be combined.
As such, we suggest that policymakers employ a joined up approach to policy making. They should consider synthetic biology in conjunction with other forms of biotechnology. The question of what constitutes human health and well-being should also not be considered in a narrow or isolated way. It seems likely that synthetic biology and other biotechnologies will have an impact on health and wellbeing that goes beyond the scope of what we may intuitively consider to be medical applications.
2. We recommend ongoing analysis of the normative and conceptual foundations of synthetic biology and human health - and public policy
We agree with our WP6 colleagues’ recommendation that policy should be empirically informed, and that empirical research in this area should be ongoing. However, we also suggest that ongoing empirical research, while valuable, is in itself insufficient without ongoing analysis of the normative and conceptual foundations of both synthetic biology and human health -- and public policy in general.
We found during our research for the SYBHEL Project that questions were raised over what policy is, and where it derives its justification from. There seems to be a degree of confusion or a failure to appreciate the essential normativity of public policy. The values underlying policy need to be accounted for, questioned and justified. Policymakers and policy documents often seem to employ a range of normative, interpretive concepts such as justice, responsibility and transparency in a rather unthinking way which lacks both clarity and justification. While such things as ‘listening exercises’ and ‘public consultation’ provide an important means of gauging public opinion, they cannot provide a normative justification in and of themselves.
Both public policy in general and public policy in respect of synthetic biology and human health raise a host of important foundational normative and conceptual questions. So while empirical research is valuable and necessary, questions about the ultimate goals, nature, legitimacy and justification of public policy cannot be answered by empirical methods. We suggest that political and legal philosophers may have much to offer in this area. And that these sorts of questions need to be considered and addressed on an ongoing basis when formulating public policy.
3. We recommend adopting a problem driven approach (including speculating about future potential problems) to synthetic biology and public policy
One approach to considering the moral questions generated by new technologies is to construct some sort of ethical framework which sets out some basic principles and then applies these principles to the case at hand in order to come to a conclusion. However, we have consistently argued against employing this sort of approach. We think that ethical frameworks may obscure important issues and can have a tendency to reduce complex and multifaceted questions in to little more than simple equations that require only a limited degree of calculation. As one of our SYBHEL workshop participants put it;
One of the issues with the whole concept of methodology might actually be that we tend to look at the standard normative frameworks that we want to apply to certain new technologies and this then delivers certain governance tools (you know the terminology). In the end you often wind up with a sort of standard picture, of standard arguments, using standard concepts... this has led to an intellectual and creative numbness to the actual practical issues that may arise from certain new technologies.
We suggest that rather than constructing ethical frameworks and applying them in a rather tick box fashion to a moral problem it would be more fruitful to consider a problem driven approach. That is, we should start with the problem and question, analyse and understand the issue in depth. The term ‘problem driven approach’ should not be interpreted as excluding potential or future problems. We should also speculate and consider future potential problems that may be raised by synthetic biology as it pertains to human heatlh. As mentioned above, this requires a process of ongoing analysis into the normative and conceptual issues raised by synthetic biology and human health. It also raises questions of how philosophy and philosophers can be best employed in the formulation of public policy.
Conclusion: Before making policy recommendations we should seek to understand.
As we have suggested, it is easy to get carried away with, or buy in to the hype surrounding synthetic biology. There is perhaps always a temptation when something ostensibly new and potentially powerful emerges to draw quick conclusions -- to feel that new policy is required and that new laws and strong regulations should be put in place. Maybe they do. But before (and while making) new policy recommendations perhaps we should heed Jonathan Wolff’s advice. Wolff, a philosopher who has worked in public policy, suggests that before advocating new policies we should; ‘seek to understand’. Drawing on his advice we think it may be beneficial to consider the following sorts of questions before coming up with policy recommendations for synthetic biology and human health:
(1) What, exactly, is the problem?
As we have mentioned, a good place to start is by clearly outlining the problem or issue at hand; what is the policy for, or on? We might discover in the process of elucidating ‘the problem’ that it is not really a problem at all (or not one that requires new policies or laws (2)). Or, we may find that rather than one problem we can distinguish between several different problems that raise different kinds of normative and empirical questions (3) and (4).
(2) What are the current policies, laws and regulations in the area and their history?
Before coming up with policy recommendations (and in the process of (1) ) it is probably beneficial to find out what the current policies, laws and regulations are in the general area of our inquiry. As we have suggested it may be the case that some of the issues we are concerned about with regards synthetic biology already fall within the remit of existing policy. We may also find there are lessons to be learnt from history by looking at past policy cases that are in some ways analogous to synthetic biology or the problem we are concerned with (public perception of GM foods for example).
(3) What other empirical information do we need before we come to decide on the problem?
In addition to the information about current and past policy (2) it seems likely that we will also require a range of other empirical information. For example information about current practice in synthetic biology, public perceptions, concerns and disagreements (4). Of course, what empirical information we need depends on the nature of the problem (1).
(4) What are the underlying normative and conceptual foundations on which our problem or recommendation rests?
Finally, as we have mentioned above in our key issues, we need to consider, interpret and clarify the underlying conceptual and normative architecture on which the problem (and if necessary, policy recommendation) rests and whether these values and concepts can be justified.
WP2:
Synthetic Biology: The definition and creation of life
Anna Deplazes
Objectives
The following recommendations are the result of our work for SYBHEL Work Package (WP) 2: “Synthetic Biology and the Definition and Creation of Life”. In this WP we have investigated how the aims and claims of synthetic biology are morally assessed from the point of view of people with different understandings of life. Thereby, we focused on philosophical positions but also considered religious conceptions. Moreover, we have analysed the conception of life propagated by synthetic biologists and there relation to other conceptions of life. We have also discussed the significance different understandings of life could have for the future ethical, philosophical and societal assessment of synthetic biology, for public engagement and education (including curricula of scientists and other experts). The results of these discussions and deliberations are summarized in the following recommendations.
1. We recommend that as synthetic biology progresses, any study of its ethical and societal aspects needs to keep critically analysing what different stakeholders in the debate have in mind when they refer to concepts such as ‘life’, ‘nature’, ‘artificiality’ or ‘health’ and what implications these different understandings have for the assessment of synthetic biology.
In many reports and comments on synthetic biology importance is given to the notion that this new field could lead to ‘synthetic life’ or ‘artificial organisms’. In doing so, the authors provide a specific interpretation of basic concepts such as ‘life’, ‘nature’, ‘artificiality’ without making this interpretation explicit. Another concept of this kind, which plays a particular role in the discussion of applications of synthetic biology for human health, is the concept of ‘health’ itself. A wide range of understandings, interpretations and applications characterizes these concepts. In what follows we will focus on the concept of ‘life’ as a paradigm of such contested basic concepts.
Our investigation of the role of the concept of life in reports and debates on synthetic biology showed that on the one hand, synthetic biology is based on a very specific understanding of life and living organisms as controllable standardized machines and as human-produced entities that serve human purposes but this understanding varies between different types of synthetic biology. On the other hand, the assessment of the aims and claims of synthetic biology by different people depends on the underlying understanding of life. Importantly, most philosophical and religious understandings of life are compatible with the views of synthetic biologists, but focus on other aspects of life, which synthetic biologists do not address. This is to say that propagating a non-scientific view on life does not necessarily mean opposition to synthetic biology.
The aim of the analysis of the role that different understandings of life play in the debate over synthetic biology is not to find one generally accepted interpretation of life. Instead, the aim is to take stock of the variety of understandings, to analyse changes, to point out the (changing) significance of certain understandings in the debate and to clarify misunderstandings based on different interpretations. With our project in WP2 we have aimed at contributing to this important task, but there is still much work to do.
Besides the contested basic concepts listed above the understanding of other significant concepts in the discussion such as ‘engineering’, ‘technology’, ‘design’, ‘machine’, ‘science’ or ‘synthetic biology’ itself, should also be analysed. In contrast to the mentioned contested basic concepts, these concepts are not traditionally interpreted in so many different ways. However, in the debate over synthetic biology their meaning may not be fixed . Moreover, it appears that these originally descriptive terms have a normative connotation in this debate, the profound implications of which stands in need of in-depth investigation.
2. We recommend that a democratic approach to the debate over synthetic biology include mutual engagement that is not restricted to participation processes in political decisions but includes dialogue events, which are not necessarily driven by the aim of informing policy. Such engagement should consider how diverse religious, philosophical and other non-scientific views in the public on basic concepts interact dynamically with the understandings of these concepts produced by synthetic biology.
Basic concepts such as the concept of ‘life’ are interpreted and understood in various different ways by the public. Scientific findings are one important influence on public opinions and views. An emergent technology and science with powerful advocates, such as synthetic biology, is likely to provide fertile ground for public interest in, and debate about how we should interpret the concept of ‘life’ and relate to living nature. Synthetic biology will inform certain public views on life but will be in contradiction with others. In order to facilitate the integration of synthetic biology with society a mutual engagement between scientists and other members of society should take place as soon as there is a demand for it. Therefore, platforms and opportunities for a two-way engagement should be ready. There have for, instance, been efforts to involve the public in discussions on synthetic biology by using art and films comics or literature . Another possibility would be books for children. Moreover, a card game has been developed to guide discussions on synthetic biology in small groups. Public discussions could also be initiated using social media, moderated evening debates in Café-scientitique-events, in public panel discussions, school outreaches or on lab visiting days. Furthermore, empirical studies about the integration of science in society should be fostered, reported in the media, and considered in policy making.
A discourse of this kind has previously been suggested by various social scientists as an approach to avoid social controversies, as sites of mutual learning and to do justice to a diverse understanding of science in the public. This approach will hopefully increase scientist’s understanding of their role in society and the expectations, hopes and worries that other members of society connect with the anticipated development of synthetic biology. For the other members of society, the discourse will provide an opportunity to express their expectations, hopes and worries, to receive responses from scientists and to differentiate their views on synthetic biology.
In order to facilitate such processes, we need more basic empirical research about the influence of emerging technologies on the understanding of basic concepts such as the concept of ‘life’ in society.
3. We recommend that education of scientists, practitioners in technology assessment and of the public include an introduction into the historical, philosophical, religious and social contexts of science. This should include the discussion of different understandings of basic concepts such as ‘life’, ‘nature’, ‘artificiality’ or ‘health’ and the implications of the fact that there are different views.
Scientific findings and models provide important explanations of life, which are particularly accessible due to their falsifiability and applicability in technology. But even within science, different disciplines with different research focuses and different methodologies provide different explanations and definitions of life. Science exists within in a sociological and historical context, which influences how science is done and interpreted. Moreover, there are many important questions about the world and -more specifically- about life that cannot be addressed by scientific methods. These include questions about the particularity, value, meaning or significance of life. For instance philosophers, ethicists or theologians are concerned with these types of questions. Scientific explanations may be sufficient for the work of a scientist in the lab. But, these views can be complemented by other understandings of life in discussions about the idea that life could be artificial or of the relation between synthetic biology and religious or philosophical views on life. Synthetic biology, like other sciences, can only address empirical questions, questions of value or issues of belief are beyond its remit, because if there were such ‘mystery’ this would not be approachable by scientific methods.
Besides an introduction to ethics, the curriculum of synthetic biologists and other scientists should include courses, in which some insights of philosophy of science and science and technology studies about the impact of social and cultural values on scientific research are introduced. This should encourage future synthetic biologists to deliberate about the role of science in explaining the world. In addition, in order to sensitize practicing scientists, science journalists, social scientists and philosophers to these issues, the relation between scientific explanations and other explanations should be discussed more. Synthetic biology is a model to many other fields in how ethical and safety/security aspects of this field are discussed in scientific journals and at scientific conferences. This discussion could easily be expanded by the discussion of the relation of different types of explanations and of the societal, historical and philosophical context of science.
Importantly, public education too, should provide an understanding for the relation between scientific, philosophical and religious interpretations of life. For this purpose, in public information events the implications of synthetic biology for the general understanding of basic concepts such as the concept of ‘life’ should be discussed and philosophers, ethicists and theologians should appear side by side with scientists. It has to be clarified that scientific explanations provide answers only to scientific questions about the functioning of living organisms but not to questions about the value, meaning or significance of life. This will help the public to integrate these scientific views into their own view of ‘life’ and clarify that the successes of synthetic biology do not dismiss questions about particularity, value, meaning or significance of life -questions, which have occupied people from the early beginning of humanity- as irrelevant and foolish. It should also show that to give weight to philosophical or religious explanations of life does not necessarily imply opposition to synthetic biology.
WP4:
Synbio for Human Health and Wellbeing
Heather Bradshaw
Objectives
The following recommendations are the result of our work for SYBHEL Work Package (WP) 4 “Ethics and Synthetic Biology for Human Health and Well-Being”. WP4 was assigned three main tasks. The first was identifying and documenting scientific advances in Synthetic Biology with applications for human health and well-being, such as live therapeutic agents. The second was reviewing and analysing ethical issues raised by laboratory and clinical (commercial) synthetic biology techniques. “Ethical” specifically included issues of justice raised by gender or analogous factors e.g. genetic variation. The third task was to consider how synthetic biology might influence or alter the philosophical concepts of health, disease, therapy and suffering.
1. We caution those who make decisions about healthcare distribution against relying for justification on conceptual accounts of health and disease which equate healthy with natural. Accounts in which this mistake is obscured through concepts of function which refer to “natural” evolution should also be avoided. The development of alternative, consistent, conceptual structures based on reported well-being should be encouraged. This is because they can provide a coherent, just foundation for healthcare distribution and access.
The conceptual structure on which we commonly base classifications of moral status, the balancing of interests between entities, and our legal justifications was developed to fit a set of things that actually exist in which the animate and the inanimate were clearly distinguishable and, generally in Europe, culturally distinguished. As the academic papers of Workpackage 4 argue, the types of entity produced by synthetic biology, are among the technological developments which cannot be classified according to the traditional European conceptual structure. (The expert advice emphasized that synthetic biology is no different to parts of robotics, artificial intelligence research and human-machine interfaces in this respect.) Accordingly, ethical and legal classifications and justifications based on this structure are ineffective for regulation of the new types of entity.
In the case of synthetic biology for human health many relevant concepts such as health, disease/disorder, artificial, artefact, machine, and life in turn refer to the concept of function. Function has often been interpreted naturalistically, in terms of what an organ or behaviour has evolved for within a naturally evolved distinct species. This allows the use of naturalistic interpretations of health, disease etc. which are often convenient for policy because they can be quantified in terms of statistics for clearly defined species-groups (called reference or comparison classes). Naturalistic concepts therefore appear to be objective and independent of political preferences or ethical values (although some research argues that the objectivity is illusory ).
The new types of thing which exist cannot be neatly classified into species, or into the old conceptual classes of animate/inanimate etc. Reference (or comparison) classes cannot be even apparently objectively determined, but now must always involve an explicit value-based choice. This is especially the case for healthcare. Diseases and disabilities have previously been defined as requiring therapy by reference to species norms. This is in conflict with subjective reports of e.g. congenital Deafness as not requiring therapy and not being a disease or disability.
The human-viral hybrids created by use of live therapeutic agents are particularly inappropriate for ethical classification under traditional conceptual systems such as those defended in, for example, Ricoeur’s work. This applies whether the live agent is used to treat existing pathology as in the JX-594 clinical trial, or for preventative purposes when there is no existing disease condition.
Clear, consistent, well-justified regulation is needed to maximise innovation and economic benefit. Such regulation requires coherent and consistent conceptual systems appropriate for entities like human-synthetic-biology hybrids, artefactual organisms, and autonomous machines. These conceptual systems should differentiate between entities on ethically relevant grounds, not on arbitrary and outmoded ideas of “the natural as the good”. Ethically relevant grounds are likely to include indicators of subjective well-being, intrinsic interests and/or possibly capacities/abilities.
2. We recommend that there is investment in research on ethical, publically acceptable distribution of contagion risks. The reduction and control of 3rd party contagion risks in commercial applications of synthetic biology should be concomitant with continued funding of synthetic biology research.
There are not a large number of applications of synthetic biology for human health yet. But one product which is already undergoing clinical trials raises a problem of justice which needs to be addressed to secure public acceptance. The JX-594 live therapeutic agent uses the vaccinia virus as the chassis or vector for synthetic, modified DNA. Although in this case the vaccinia’s original DNA is modified it is not removed and other parts of the cell remain intact. Indeed, aspects of vaccinia’s unmodified behaviour are essential to JX-594’s therapeutic effectiveness. For example, the ability to spread quickly through the human blood stream and to survive attacks from the human immune system while in the blood.
But vaccinia in other therapeutic applications, such as its traditional use as the main agent in smallpox vaccination, is controversial. This is because it causes serious illness and occasionally fatalities in a significant proportion of the population. Moreover, those who are susceptible can contract vaccinia infections from people treated with vaccinia who are themselves symptomless. Further, susceptible people may not know they are at risk and so may be unaware that they should take precautions. From work on smallpox vaccination it seems that approximately 20-40% of the population of Western countries may be at particular risk from vaccinia.
We emphasize that the risk from JX-594 and vaccinia is not just to the patient. It is also to non-consenting 3rd parties. Where 3rd party risk is present, for example with automobiles or aeroplanes, usually we adopt more stringent product safety testing and measures. Unlike excreted live polio virus after polio vaccination for infants, which can be infectious to non-vaccinated persons, with vaccinia it is not just intimate carers (themselves already vaccinated) who are at risk but also other adults who may have no direct contact with the patient. Indirect contact via fomites is sufficient to transmit vaccinia.
The third party risk from vaccinia chassis affects particularly all those with the atopic syndrome (asthma, allergies, eczema), transplant recipients, and all those with diminished immune system function such as carriers of the AIDS virus and persons with genetic immune conditions. The incidence of atopy is considered to have risen significantly (from an estimated 4% to approximately 20% of the population) since vaccinia was widely used for smallpox vaccination, and most of those born since 1980 (when the smallpox vaccination campaign ended) will be entirely naïve to vaccinia. Putting such persons at extra risk constitutes an unethical form of genetic discrimination. We recommend that any clinical or commercial product of this nature be subject to regulation by industry independent bodies in the same way as other technologies posing 3rd party risks are regulated today but with particular attention to the potentially discriminatory effects of technologies which with genetically specific risks.
3. We recommend that synthetic biology research should not be held up by concerns about synthetic biology exceptionalism. Synthetic biology should be regulated like any other commercial engineering endeavour.
Many of the ethical issues raised by synthetic biology are common to other converging technologies. A range of challenges to the concept of e.g. health are also raised by other applications of modern bio-technology and engineering such as chimeras, brain machine interfaces, robots, and stem cell hybrids. All of these require conceptual re-alignment to fit the new types of thing they represent. Synthetic biology requires similar treatment. We do not see this as reason to single out synthetic biology for different regulation from other members of this group of technologies.
On the contrary, we suggest that there are ethical reasons for adapting successful, tried and tested regulatory practices already in use for twentieth century, engineered commercial products to synthetic biology and products arising from related converging technologies. These regulatory practices, including industry independent oversight and certification bodies for example, have arisen in reaction to accidents, product failures and the resulting negative public responses and have made the technologies they regulate largely uncontroversial and acceptable to the majority of the public.
Further, the independent nature of these bodies and the regulation of these industries has itself arisen as a solution to ethical problems of cooperation and externalities within the regulated industries. Human cooperation can be understood as a core problem of ethics. There is thus ethical justification for including commercial synthetic biology products (though possibly not pure research applications of synthetic biology) within the group of engineering industries so regulated.
General conclusion
Where synthetic biology and other converging technologies may be considered to differ ethically from these older engineered products is in their potential to produce entities which have interests of their own, which we are ethically required to balance against human interests, as mentioned under Recommendation 1. This point cannot be fully addressed without the further development of an adequate conceptual system and a new justification for the allocation of moral status. These are issues on which SYBHEL has produced foundational work.
WP5:
Commercialisation and Regulation of Synbio
Inigo de Miguel
Objectives
The overall objective of Work Package (WP) 5 of the SYBHEL project was to develop a juridical analysis of the relationship between SynBio for human health and intellectual property rights which may be helpful to whoever will have to make rulings on it and also for relevant professionals (for example, scientists and jurists). During the last years, we have investigated whether the evolution of Synbio will need a change in our current IP framework. We have explored the current normative background informing regulation and commercialization in SynBio for human health; the juridical issues that may be connected with SynBio, including the legal impact of the general prohibition of commercialization of human body parts and intellectual property aspects; or the adequacy of applying other normative frameworks drawn from other technologies to SynBio for human health. In order to do so, we have organized two international workshops, attended by almost twenty legal experts in Synbio and IP from different countries and continents. The results of these discussions and deliberations are summarized in the following recommendations.
1. There are no new ethical or legal issues arising from Synbio that require root and branch reform (or other sorts of reform), but governance needs to be flexible enough to accommodate such problems if they arise.
There are no reasons to think that sybio related to human health might raise ethical or legal issues which make it necessary to change the currently existing legal framework. Of course, it might happen that in the future some new circumstances arise, recommending the inclusion of some new restrictions in the list of inventions which should not be patented keeping in mind the “moral clauses” which are usually a fundamental part of our regulation. In that case, it would be recommendable to address a modification of the Biotech Patent Directive (98/44/EC), modifying its articles 5 or 6, for instance, to include new exceptions to patentability, which could also be incorporated into Rule 23d of the EPC.
It is, however, important to keep in mind that this kind of changes might last a long time. Thus, it seems to us recommendable to settle some legal tools able to face those issues in the meantime, so as it could be possible to adopt preventive measures when moral risks are clearly identified. An open interpretation of the moral clause might be useful in order to do so.
2. Key concepts of patenting system, such as novelty, inventive step and industrial application should be revisited, so us to improve the efficiency of the system.
There is a potential problem that Synbio patenting will follow a line that has been seen in relation to other aspects of biotechnology. This can cause a discrediting of the patent process, and can have industrial implications by causing blocking of industrial development and advance by a misuse of patent monopolies. Synbio invites us to revisit, for Synbio and for other areas of biotechnology IP, what the appropriate criteria should be for each of the elements of patentability: novelty, inventive step, and industrial application, and also the discovery/invention distinction.
This is something that is already being undertaken on a case-by-case basis in litigation, but it is a matter of public policy that should be determined at the political level in democracies.
3. Underpinning the successful operation of the patent system is an effective information transfer system. This is an area that requires reform.
Researchers usually find it really hard to know if an invention has already been patented or not. In order to ensure that this emerging technology functions correctly, new measures will need to be adopted in order to ensure greater accessibility to information about existing patents. This is more concerned with classification and search systems than the data contained in patent applications. Researcher training in these skills is important in order to avoid accidental infractions.
4. It is important to orientate the Synbio market in order to avoid a general blockage due to the use of the patenting blockage right. Patenting system should also be complemented by alternative tools.
Patenting is a “blind” mechanism. Patent Offices have not been vested with the task of taking into account the economic effects of granting patents in specific areas and restricting the field of patentable subject-matter accordingly. This means that the current patenting system could assist or hinder the development of Synbio related to human health.
This is why it is important, on one hand, to encourage those involved in this industry to behave appropriately in order to prevent a general blockage of the entire system being caused. In an ideal scenario, patents on devices should coexist with highly-standardised, freely-accessible parts that are patent-free. Obviously, it is not easy to find a formula to enable this to occur. Different tools may be of assistance in this regard, such as:
• stimulating cross-licenses between different companies;
• introducing clauses limiting private ownership in grant agreements when this private ownership may be contrary to public interest (remember the case of BCR);
• in exceptional cases, the possibility of governments executing licences that appeal to public interest could be very useful in order to obtain corporate agreements, especially in the case of the health market, due to the nature of the interests at stake;
• the intervention of Competition Commissions when a patent creates a situation of dramatic blockage or when it affords someone a position of monopoly;
On the other hand, it would seem reasonable to complement the current legal framework by designing new legal tools able to address new and interesting approaches to the issue of intellectual property rights.
On this point, it is important to highlight that patenting is not the only way to protect intellectual property rights. Open source has shown to be extremely useful in the case of software. Obviously, the Synbio market related to human health does not have much to do with the software market. As is commonly known, the costs needed to write a computer code are much lower than those involved in a Synbio development. However, it is possible to conceive that, in the future, alternative tools might be created in order to conciliate private property and commercial profit with open information without using the patent system. Laws should be flexible enough to stimulate these initiatives by providing an appropriate framework for them.
References (by work package and in WP text order)
References
WP6
Bhattachary, D. et al. (2011) Synthetic Biology Dialogue. An independent review commissioned by the Biotechnology and Biological Sciences Research Council (BBSRC). Accessible at: http://www.bbsrc.ac.uk/web/FILES/Reviews/1006-synthetic-biology-dialogue.pdf
Calladine, A.M. and Newson, A. (2011) Synthetic Biology & Human Health - On the importance of thinking about the future (& some thoughts on the ways we ought to think about it). Discussion Paper for SYBHEL WP3 Workshop Conceptual Foundations, Methodology and Ethical Frameworks, Bristol, 28-29 June 2011
Chan, S. (2012), Developing health technologies from SynBio: the ethics of experimental treatment. Paper presented at SYBHEL WP4 Workshop Synthetic Biology and Human Health: Choosing Cure or Continuity, The Hague, 6 February 2012
EGE (2009) Opinion 25 on Synthetic Biology. Luxembourg: Publications Office of the European Union. European Group on Ethics of Science and Technology. Accessible at: http://ec.europa.eu/bepa/european-group-ethics/docs/opinion25_en.pdf
EPO (2011) Scenarios for the future. How might IP regimes evolve by 2025? What global legitimacy might such regimes have? European Patent Office. Accessible at: http://documents.epo.org/projects/babylon/eponet.nsf/0/63A726D28B589B5BC12572DB00597683/$File/EPO_scenarios_bookmarked.pdf
Garud, R. and Ahlstrom, D. (1997) Technology assessment: a socio-cognitive perspective. Journal of Engineering and Technology Management, 14: 25-48
OECD (2011) Collaborative mechanisms for intellectual property management in the life sciences. Organisation for Economic Co-operation and Development. Accessible at: http://www.oecd.org/sti/biotechnologypolicies/48665248.pdf
Von Schomberg, R. (2012) Prospects for Technology Assessment in a framework of responsible research and innovation. In: M. Dusseldorp and R. Beecroft (eds). Technikfolgen abschätzen lehren: Bildungspotenziale transdisziplinärer Methoden, Wiesbaden: Vs Verlag, pages 39-61
Von Schomberg, R. ( 2013) A vision of responsible innovation. In: R. Owen, M. Heintz and J. Bessant (eds.) Responsible Innovation. London: John Wiley, forthcoming
Zhang, J.Y. Marris, C. and Rose N. (2011) The transnational governance of synthetic biology – Scientific uncertainty, cross-borderness and the ‘art’ of governance. BIOS Working Paper. No. 4, London School of Economics. Accessible at: http://www2.lse.ac.uk/BIOS/publications/Working%20Papers/WP4TransnationalGovernance.pdf
WP3
Aldhous, P. (2007). Interview: Sleep when you're dead. New Scientist, Reed Business Information Ltd.
Calladine A. M. and R. t. Meulen (2012) , ‘Defining Synthetic Biology’, Encyclopaedia of Applied Ethics, Elsevier, p. 281-288.
Calladine A.M. (2011) Conceptual Foundations, Methodology and Ethical Frameworks. SYBHEL Project Report.
Calladine, A.M. (2010) How should bioethics respond to synthetic biology. SYBHEL Project Report.
Calladine, A. M. and R. t. Meulen (2010). "Synthetic biology & human health: Some initial thoughts on the ethical questions and how we ought to approach them." Law and the Human Genome Review 32: 119-141
Dworkin, R. (1977). Law as a System of Rules in The Philosophy of Law. Oxford University Press.
Newson, A (2009) SYBHEL Project Description of Work.
Wolff, J. (2011). Ethics and Public Policy: A Philosophical Inquiry. Oxford, Routledge.
WP2
Bedau M, Church G, Rasmussen S, Caplan A, Benner S, Fussenegger M, Collins J, Deamer D (2010) Life after the synthetic cell. Nature 465: 422-424
Davies S, McCallie E, Simonsson E, Lehr JL, Duensing S (2009) Discussing dialogue: perspectives on the value of science dialogue events that do not inform policy. Public Understand Sci 18: 338–353
Deplazes-Zemp A (2011) The Conception of Life in Synthetic Biology. Science and engineering ethics
Elowitz M, Lim WA (2010) Build life to understand it. Nature 468: 889-890
Morange M (2009) A new revolution? The place of systems biology and synthetic biology in the history of biology. EMBO Rep 10 Suppl 1: S50-53
Nisbet MC, Scheufele DA (2009) What's next for science communication? Promising directions and lingering distractions. Am J Bot 96: 1767-1778
Rusk N (2010) Advent of synthetic life. Nat Methods 7: 487
Wynne B (1992) Misunderstood misunderstanding: social identities and public uptake of science. Public Understand Sci 1
Zhang X (2010) From synthetic genome to creation of life. Protein Cell 1: 501-502
WP5
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CHRISTOPHER BOORSE, "Concepts of Health" in "Health Care Ethics", Van De Veer, Donald (Ed), 359-393, (1987).
CHRISTOPHER BOORSE, A Rebuttal on Functions, in Functions: New Essays in the Philosophy of Psychology and Biology (Andre Ariew ed. 2002).
CHRISTOPHER BOORSE, On the distinction between disease and illnes, in Health, Disease and Illness: Concepts in medicine (Arthur L.; Caplan, et al. eds., 2004).
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ELSELIJN KINGMA, Paracetamol, Poison, and Polio: Why Boorse's Account of Function Fails to Distinguish Health and Disease, 61 British Journal for the Philosophy of Science. Je (2010).
STUART BLUME, Histories of Cochlear Implantation, 49 Social Science and Medicine 1257(1999).
STUART BLUME, Land of Hope and Glory, 25 Science, Technology and Human Values 139(2000).
PADDY LADD, Understanding deaf culture: in search of deafhood (Multilingual Matters. 2003).
H G BRADSHAW, Synthetic biology and human health: choosing cure or continutiy (2012).
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Potential Impact:
The SYBHEL Project has provided the first focused analysis of the ethical, legal and policy implications of synthetic biology in respect to human health and well-being. We believe that the research conducted will be of significant value to the scientific, academic and policy-making communities within the EU. Our research should provide a firm foundation for further research and deliberation not only on the ethical and legal issues that might be raised by synthetic biology in respect to human health but also in terms of regulation and policy.
As the policy recommendations and conclusions in the previous section attest, what synthetic biology is (its definition), and what it may make possible in the future are currently subject to deep uncertainty. It is difficult to give a non arbitrary definition of synthetic biology. For example, we might ask that while some techniques may be new, how is ‘synthetic biology’ different from certain conceptions of genetic engineering in terms of motivation and intent? And so far synthetic biology (depending on its definition) has produced very little in terms of actual ‘health’ applications. What counts (or will count) as synthetic biology is in flux. The boundaries of the concept of synthetic biology cannot be drawn in a clear and coherent way. We think the issue of definition will become an increasingly pressing question in terms of law and policy. After all, how can we draft laws or formulate policy and regulations on ‘synthetic biology’ if we have no clear idea of what ‘it’ is or what sort of activity falls within its remit?
Of course, for the purposes of law and policy, we may find that ‘synthetic biology’ is too nebulous and disparate a category to be considered in a singular definitional sense. It may make more sense to consider a range of different definitional synthetic ‘biologies’, which overlap with other forms of biotechnology, covering a range of activities, techniques or approaches. It is also rather probable that some, perhaps many, of the things that we are concerned about (in terms of safety and risk) already fall (or should be interpreted as falling) within the remit of existing laws, policy and regulation (on for example from other forms of existing biotechnology such as lab safety, GMO’s or genetic engineering).
Many emerging technologies, including synthetic biology, insofar as we do have a clear idea of what it is, raise similar ethical issues. As such, we should not consider synthetic biology as exceptional or treat it in isolation. We should consider its ethical, legal and policy issues in conjunction with other biotechnologies and issues concerning human health (again, the concept of ‘health’ is contested and what constitutes a health application should be broadly construed). However, it seems likely that synthetic biology, in conjunction with other forms of biotechnology, may have a significant impact on medicine and people’s everyday lives and health in the future.
While we have argued that synthetic biology may not raise any new or unique ethical issues, the claim that synthetic biology does not raise any new ethical questions does not mean that synthetic biology does not raise any ethical questions or that the ethical questions raised are unimportant, uninteresting or in any way resolved. Synthetic biology, in conjunction with other forms of biotechnology raises many complex philosophical, ethical, legal and policy questions.
Of course, we should question whether the issue of the ‘newness’ or ‘novelty’ of an emerging technology such as synthetic biology is what we should be focussing on in terms of ethics. The likelihood of any ethical question ever being wholly original, novel or unprecedented just because it is being discussed in response to a new technology seems rather unlikely. Obviously this depends on how we choose to interpret the notions of ‘newness’ and ‘novelty’. But it would appear to be rather probable, given the nature of value and the long history of philosophy, that most ethical issues have precedents or have appeared in older analogous forms, or draw on values and concepts that have already been thought about before.
It is difficult to see why a lack of novelty should be considered as disadvantageous to ethical analysis in synthetic biology or even as a relevant issue. That the ethical problems and issues raised by synthetic biology are likely to have past analogues provides a valuable resource to draw on, challenge and reinterpret. That these questions are not new does not and should not detract from their importance. The moral questions raised by synthetic biology are important and ongoing. Some of these questions will be more urgent in the short-term than others (for example issues of risk, safety and dual use). However, some of the other ethical questions (such as those concerning human enhancement, radical life extension and the moral status of synthetic life) may have a more significant impact in the future. What is important is that we begin to consider, speculate and think about these moral issues and the possible future trajectory of synthetic biology before it leaves the confines of the laboratory. We need to have measures in place in order to ensure that the possible future applications of synthetic biology have a largely beneficial impact on people's lives and the general fabric and wellbeing of society.
In terms of potential impact, as has been made clear in the recommendations and conclusions section above, we would like the SYBHEL Project to have an influence on the way in which ELSI and policy research is conducted and conceived in the future. As we have argued throughout the project, ELSI research, its funding and the subsequent policy considerations of new technologies, such as synthetic biology, has often followed a rather formulaic, standardised and moribund path.
There seems to be a problem in bioethics and ELSI research in focusing on ‘novelty’ and ostensibly new and emerging fields of science which both trivialises and ignores the real moral (and social) issues. As Ashcroft and Dawson have both claimed;
...the tendency in the field to take a new sexy science, coin a neologism, start a journal and a society, and bid for Centre funding, speaks to a certain formalism in the development of the field. A standard strategy seems to exist for claiming a terrain for bioethics and fixing credentials. This has evident consequences not only for how the intellectual work is done, but also efforts to influence policy, generate public engagement and political activity, and secure funding and academic tenure.
Over the course of the history of bioethics certain topics have moved in and out of fashion: in the 1970s it was euthanasia and abortion, in the 1980s genetics, in the 1990s stem cells and reproductive technologies, and in the 2000s enhancement and data/tissue storage. However, these trends always have the same dynamic: a new issue is discovered by a few enthusiasts, there is a burst of activity, and then things move on to the next topic. The really depressing thing, though, is that despite the regular change in subject matter, bioethics remains disappointingly, familiar.
There is a danger that research in to the ethical, legal and policy issues of synthetic biology and human health could become just another ELSI fad. We think that concentrating on specific new and emerging technologies and creating sub-disciplines and constructing ‘new’ ethical frameworks is deeply problematic.
The problem of ethical frameworks
For example ethical frameworks often have the effect of stultifying debates over this important emerging area of research. A framework, by its very definition is restrictive and constraining. It obscures while it contains a particular view. It prescribes what is to be focused on at the expense of what lies beyond the frame. It tells us what we should be looking at, and by the nature of a frame how we ought to view it. This seems to be contrary to deep philosophical reflection. It seems plausible that by prescribing a certain framework, no matter how intricate or expansive, we run the risk of missing out on the bigger picture, of failing or missing important philosophical and moral questions that lie beyond its boundaries or questioning the reasons behind the existence of the particular frame that has been constructed.
SynBioEthics: The problem of new subsections of bioethics.
One of the dangers of ever multiplying subsections of bioethics is that rather than the necessary, in-depth and thoughtful consideration of the moral questions posed by a new technology it becomes about the establishment of the sub-discipline itself. There is a concern that this focus can have a tendency towards being myopic and inward. It risks being disconnected and ouroboric, or at least not substantively engaged with the issues it is purportedly concerned with.
There is a danger that the creation of a new sub-discipline simply becomes an exercise in political terrain grabbing, formalism, processes, codification and the establishment of new frameworks and rules. The focus on, and the implementation of, such structures seems likely to draw attention away from the real issues and serves only to inhibit and constrict ethical debate over synthetic biology rather than advance it. We may also think that such formalism is contrary to the very essence and value of philosophy.
Beyond providing a term that can be used as informal linguistic shorthand to refer to a general area of research interest, it is difficult to see what meaningful use or purpose is served by the establishment (or indeed analysis) of ever more sub-disciplines in bioethics. Indeed it is not clear why we should treat the moral questions generated by a specific issue any differently from any other moral question, or moral questions in general.
The standardised ELSI approach: the problem of McEthics©
The problem with usual approaches to ELSI research is that it often leads to a sort of McDonaldsiation of complex philosophical and ethical issues. During SYBHEL workshops it was felt that we should avoid, and be on our guard against simplistic ‘tick box’, ‘check list’ or ‘toolbox’ approaches to ethics which wrongly reduce or conceive of ethics as some sort of risk assessment exercise in calculating probabilities or a formalised, standardised and mechanical process of box-ticking against a list of unquestioned and under analysed principles and concepts.
A different more imaginative and thoughtful approach is required.
As is reflected in the recommendations and conclusions section above, the way in which some ELSI research is conducted needs to change. There should be a move away from focusing on novelty, individual biotechnologies, methodology, the construction of ethical frameworks, and creating ever more subsections of bioethics. Rather, what is needed is a more thoughtful, holistic and imaginative approach to considering the ethical issues that may be raised by emerging technologies. As the SYBHEL Project has argued, rather than constructing and employing a standardised approach, we should draw on our imaginations to speculate on and consider the ethical issues and problems that may arise in the future. We should consider these issues in more depth. We need to consider and interpret the underlying conceptual architecture and think in detail about the sorts of questions and problems that we ought to be answering –regardless of whether they are new or novel.
The issues raised by synthetic biology require a collaborative and interdisciplinary response. It is important that philosophers, ethicists and social scientists work together and collaborate with scientists working in synthetic biology. Social science research in this area is important and should be on going. Public policy should be empirically informed. However, we also suggest that ongoing empirical research, while valuable, is in itself insufficient without ongoing analysis of the normative and conceptual foundations of both synthetic biology and human health, and public policy in general. In terms of synthetic biology, as the SYBHEL Project has argued, certain conceptions such as life, health and synthetic biology itself may be called in to question and require reinterpretation.
The SYBHEL Project has raised questions over what policy is, and ought to be, and where it derives its justification from. There seems to be a degree of confusion or a failure to appreciate the essential normativity of public policy. The values underlying policy also need to be accounted for, questioned and justified. Policymakers and policy documents often seem to employ a range of normative, interpretive concepts such as justice, responsibility and transparency in a rather unthinking way which lacks both clarity and justification. While such things as ‘listening exercises’ and ‘public consultation’ provide an important means of gauging public opinion, they cannot provide a normative justification in and of themselves.
Both public policy in general and public policy in respect of synthetic biology and human health raise a host of important foundational normative and conceptual questions. So while empirical research is valuable and necessary, questions about the ultimate goals, nature, legitimacy and justification of public policy cannot be answered by empirical methods. We suggest that political and legal philosophers may have much to offer in this area. And that these sorts of questions need to be considered and addressed on an ongoing basis when formulating public policy.
Finally, considering the ELSI issues of emerging technology should be collaborative in the sense that it actively engages and interacts with the public(s) and members of civil society. The emerging science of synthetic biology could revolutionise industry and medicine. It may have a significant impact on society and the lives of both living people and future generations. Because of its potential power and the range of technologies and applications that synthetic biology could generate, it is, and will increasingly become, an important and perhaps controversial public issue. It is essential that the public is made aware of, considers, and is consulted about, the potential and power of synthetic biology while it is still in its emergent phase.
Public education, engagement and debate of both the science and the ethical and social issues that might be raised by synthetic biology are crucial. The question is; how can we engage and stimulate public debate about the ethical, social and legal issues posed by synthetic biology? How can we connect in a meaningful way with as wide a section of the public as possible? Traditional methods of public engagement such as science cafes, public lectures, science training and sending theatre groups in to schools all have value (and should be pursued). However, in today's increasingly online multimedia environment the use of more novel and imaginative methods may provide new opportunities and should also be considered and employed.
The imaginative use of the arts, multimedia and online networks have the potential to reach a wide audience in a way which is both highly engaging and interactive as well as being economical. The creative use of such technology promises to transform public engagement into a process that is not just linear – a one or two way flow of information, with the public assuming the role of a predominantly passive audience. But rather, by using the power of the arts, multimedia, and online networks there is the potential for the public to become producers and co-creators of knowledge and ideas, rather than simply commenting consumers of information.
Employing new techniques and presenting the public with information in an interactive forum may enable people to assume a new role. It may create the opportunity for the public to participate not only in the direction of the science of synthetic biology and the technologies it may make possible but also contribute to the formation of public policy - the way in which the science and technologies of synthetic biology should be regulated (if indeed further laws and regulation are required).
Dissemination Activities:
Since the SYBHEL Project’s inception in 2009, dissemination of research, ideas and information on synthetic biology and human health was considered a key issue. The project used a variety of media and methods in order to engage and interact with as many types of people as possible, from academics and policy makers to members of civil society. Methods have included websites, web based blogs, twitter, film, science café’s, podcasts, conferences, workshops and academic publications. A full list of dissemination activities is documented in Table A2 of the report.
Workshops
The SYBHEL Project has organized ten workshops and a conference in the three years.
Workshops have been held in locations across the EU including Bristol, Bilbao, Brussels, The Hague and Zurich culminating in The SYBHEL Final Conference which was held at the British Library in London. The SYBHEL workshops have been an integral part of project in terms of dissemination, research and academic collaboration. The experts invited to these events came from a wide range of disciplines and included synthetic biologists, philosophers, social scientists, bioethicists, theologians and policy makers.
Workshop participants not only came from across the EU but also experts from around the globe, including the US, China and India. Invited participants were asked to submit and present original and substantial papers of over 2500 words. These papers and subsequent workshop analysis were collected together in workshop booklets. Many of these papers have been further revised and submitted to journals.
There are plans to publish book length collections of revised SYBHEL workshop submissions in the future.
The SYBHEL Project organized the following workshops
Zurich Workshops
• (WP2) Ethics of Synthetic Life- An Intercultural Dialogue
• (WP3) How should bioethics respond to synthetic biology?
Bilbao Workshops
• (WP4) Ethics and Clinical applications of Synthetic biology: An Interdisciplinary Dialogue
• (WP5) Synthetic Biology & Human Health: The legal and ethical questions of property and patenting
Brussels Workshops
• (WP6) European Policy for the Governance of Ethical and Legal Issues of Synthetic Biology for Human Health
Bristol Workshops
• (WP3) Conceptual Foundations, Methodology and Ethical Frameworks
• (WP2) Synthetic biology & human health: Ethical and regulatory questions raised by the aim of producing new life forms
The Hague Workshops
• (WP4) Synthetic biology & human health: choosing cure or continuity
• (WP6) Synthetic Biology for Global Health: a Policy Discussion
• (WP5) Synthetic biology & human health: The principles and problems underlying patenting and regulation
London Final Conference
• The SYBHEL Project Final Conference: Policy Recommendations, Key Issues and Further Questions
Website
The SYBHEL website was launched soon after the project commenced in 2009. It can be found online at www.sybhel.org. The SYBHEL website and logo was designed by Alex Calladine. It used a php format to facilitate a dynamic, interactive space that could be accessed and updated by all the SYBHEL partners as well as allowing other registered web users to comment and vote. Furthermore, the design enabled the website to host and stream video from other sites, such as youtube and vimeo, provide podcasts and link to the SYBHEL Project twitter stream (@SYBHEL_Project).
A number of videos and podcasts were produced by the project. The website was regularly updated and featured blogs on a range of issues from the SYBHEL Project partners.
Film
In an effort to engage with the public and disseminate information and ideas about synthetic biology and human health the SYBHEL Project made extensive use of film and video.
Alex Calladine produced a short documentary film The Thread of Life which was short listed for the Bio:fiction Film festival (http://bio-fiction.com). The film contained interviews with SYBHEL partners and external experts in bioethics, STS and philosophy.
In addition, over twenty film interviews, featuring experts in the scientific, philosophical, legal and social have been produced and made available through the SYBHEL website and the SYBHEL vimeo channel. Many of the videos have also been advertised on twitter. At the time of writing this report the SYBHEL videos have attracted over 2000 views.
Short Story Competition
In 2010 the SYBHEL Project launched a multimedia short story competition with the aim of imaginatively investigating public attitudes towards synthetic biology. The competition was advertised on the SYBHEL website (http://sybhel.org/?p=761) twitter and a number of other websites including the Journal for Medical Ethics. The competition attracted entries and interest from across the globe. The short listed authors came from a diverse range of backgrounds and included medical students, a science journalist, a published novelist and a Professor interested in Post-Marxist Approaches to Working Class Literature.
Alex Calladine collected the stories together and produced an ebook which was made available for free on the SYBHEL website, and published on Amazon.com. The competition winner was voted for by the public through the SYBHEL website. Over 585 votes were cast.
List of Websites:
More information about the SYBHEL Project can be found online at www.sybhel.org. The SYBHEL website was designed to be an interactive hub providing information on the ethical, legal and policy issues of synthetic biology and human health to researchers, policy makers and the general public. The website contains not only articles and blogs but also videos and podcasts produced by (and featuring) the SYBHEL Project partners. SYBHEL videos can also be found online on youtube and the Project’s vimeo channel http://vimeo.com/user5259198
The SYBHEL project also has a twitter feed, viewable on the website. To contact the project via twitter go to @SYBHEL_Project.
This is the final report of the SYBHEL Project and constitutes deliverable nineteen (D19) as per the SYBHEL Project’s Description of Work.
The SYBHEL Project consisted of four partners; The University of Zurich, The University of Deusto, The Rathenau Institute and was co-ordinated by the Centre for Ethics in Medicine at the University of Bristol. It was funded by the European Commission’s Science and Society Program- as part of the seventh framework.
The SYBHEL Project’s objective was to investigate the ethical, legal and policy issues that may be raised by synthetic biology in respect to human health and wellbeing. It was the first study of its kind to focus on this issue.
Synthetic biology (also known as synbio) is an ostensibly new field of science. This emerging field is interdisciplinary. It draws on a range of different disciplines from genetics, engineering and computing to other forms of biotechnology and biochemistry. Synthetic biology seeks to design and build new living systems and redesign existing biological systems at a molecular, cellular, tissue and organism level.
According to proponents, synthetic biology may lead to a wide range of new and radical technologies including applications that could have a significant impact on human health. Applications could include such things as devices for tissue repair or regeneration, personalised smart drugs, therapeutic vectors and new mechanisms for drug uptake or drug design.
The first section of this report describes the way in which the SYBHEL Project was organised. It outlines the key objectives of the project and the research conducted by SYBHEL partner’s individual work packages. Research was divided into five separate work packages; SynBio and the Definition and Creation of Life, What should a SynBioEthics for human health look like, Ethics and Synbio for Human Health and Well-Being, Regulation and Commercialisation of Synthetic Biology for Human Health and Public Policy on Synbio for human health.
The second section of this report details the central conclusions and policy recommendations of the individual work packages written by the respective work package leaders. These recommendations and conclusions are the result of SYBHEL Project research and workshops which culminated in work conducted at the 2012 SYBHEL Final Conference held at the British Library in London.
The third section of this report details the potential impact and the main dissemination activities of the SYBHEL Project. Since its inception, the SYBHEL project has been committed to the dissemination of its research and information on synthetic biology and human health. The project has used a variety of methods in order to engage and interact with as many types of people as possible. Methods have included web based blogs, twitter, film, science café’s, podcasts, conferences, workshops and academic publications.
The final section of this report details the SYBHEL project’s website and contact details. More information about the SYBHEL Project, including links to reports, papers, videos and podcasts can be found at www.sybhel.org. The SYBHEL project also has a twitter feed, viewable on the website. To contact the project via twitter please go to @SYBHEL_Project.
Project Context and Objectives:
The SYBHEL Project was set up in 2009 to investigate the ethical, legal and policy issues that might be raised by synthetic biology in respect to human health and wellbeing. The project consisted of four partners, The University of Zurich, The University of Deusto, The Rathenau Institute and was co-ordinated by the Centre for Ethics in Medicine at the University of Bristol
According to the original project remit, synthetic biology is an ostensibly new area of scientific research which seeks to design and build new living systems at a molecular, cellular, tissue and organism level. This emerging field draws on a range of different disciplines from genetics, engineering and computing to other forms of biotechnology and biochemistry. Proponents believe that synthetic biology research may lead to a wide range of new technologies, from biofuels, to new materials as well as revolutionary health and medical applications.
The SYBHEL Project was the first study to focus specifically on ethical, legal and policy the implications of synthetic biology in respect to human health and wellbeing.
According to the SYBHEL Project’s Description of Work the central objectives were to;
1. Carry out high quality ethical research and evaluation of synthetic biology acid will impact on human health and well-being.
2. Underpin research with a consistent awareness of the SYBHEL crosscutting themes, namely: the definition of synthetic biology; scientific research (including documenting and regularly updating the state-of-the-art); safety and justice.
3. Create a hub for researchers and policymakers interested in ethical, legal and social issues arising in synthetic biology as it applies to human health to meet and exchange ideas.
4. Debate and agreed recommendations for regulation and commercialisation of synthetic biology as it pertains to human health and well-being.
5. Determination a strategy for policy deliberation for synthetic biology and human health.
In order to fulfil these objectives the SYBHEL Project’s research was divided into a number of different work packages presided over by the partner institutions. The research objectives for the work packages were as follows
Work Package 2:
SynBio and the definition and creation of life
Work Package Leaders: Anna Deplazes-Zemp and Nicola Biller Adorno
This work package was led by the University of Zurich. Its key objectives were to;
• explore the ethical and philosophical implications of various definitions and concepts of ‘life’
• explore the ethical and philosophical implications of creating new lifeforms and artificial analogues to existing lifeforms as they apply to human health.
• Conduct an international and cross-cultural discussion on the indications of synthetic biology for human health and well-being.
Work Package 3:
What should a SynBioEthics for human health look like?
Work Package Leaders: A.M. Calladine, Ruud ter Meulen and Ainsley Newson.
This work package was led by the Centre for Ethics in Medicine, at the University of Bristol. Its central objectives were;
• to delineate the new ethical challenges posed by synthetic biology
• to document existing literature on methodology and bioethics and consider how this should apply to the particular challenges presented by synthetic biology.
• to explore and determine an appropriate methodology for ethical deliberation within synthetic biology
• to situate this debate in the context of scientific advances into synthetic biology for human health
Work Package 4:
Ethics and Synbio for Human Health and Well-Being
Work Package Leaders: Heather Bradshaw and Toby Murcott
This work package was led by the Centre for Ethics in Medicine, at the University of Bristol. Its central objectives were;
• to identify and document the scientific advances in synthetic biology that will have an application to human health and well-being
• to analyse new ethical challenges posed by synthetic biology techniques with special attention to drug development, drug targeting, biosynthesis, synthetic stem cells, vaccine development and live therapeutic agents, including the crosscutting theme of justice
• to consider how synthetic biology might influence also the philosophical concepts of health, disease, therapy and suffering, including gender aspects and analyse gender issues related to synthetic biology techniques with special attention to drug development, drug targeting, biosynthesis, synthetic stem cells, vaccine development and creating live therapeutic agents
Work Package Five
Regulation and Commercialisation of Synthetic Biology for Human Health
Work Package Leaders: Inigo de Miguel Berain and Carlos Romeo Casabona
This work package was led by the University of Deusto. Its central objectives were;
• to explore the current normative background informing regulation and commercialisation in synthetic biology for human health
• to explore the judicial issues that may be connected with synthetic biology including the legal impact of the general prohibition of commercialisation of human body parts and intellectual property aspects
• to explore the adequacy of applying other normative frameworks drawn from other technologies to synthetic biology for human health.
• to survey some general principles and options for regulating (or self-regulating) synthetic biology for human health in Europe, including an analysis of alternative options such as specific regulation or adaption of an existing framework; with regards to the cross-cutting theme of justice.
Work Package 6:
Public Policy on Synbio for human health.
Work Package Leaders: Conor Douglas and Dirk Stermeding
This work package was led by the Rathenau Institute. The central objectives were;
• to build on the outcomes of work packages 2-5 to yield insights into how the issues raised could be considered in EC policy
• to organise two workshops to deliberate policy issues in synthetic biology; one on a European scale and one for a global audience
• to locate these workshops in the context of up-to-date public debate on synthetic biology for human health, in light of new scientific developments
Project Results:
This section of the report details the central conclusions and policy recommendations of the individual work packages written by the respective work package leaders. These recommendations and conclusions are the result of work conducted at the 2012 SYBHEL Final Conference. Before the conference, experts considered draft recommendations proposed by individual partners and provided written comments. At the event the draft recommendations and expert comments were discussed in a series of breakout workshops. After the final conference the policy recommendations and conclusions were further refined drawing on the discussions and advice offered at the final conference.
WP6:
Public Policy on SynBio for Human Health
Dirk Stemerding and Conor Douglas
Objectives
It was our task in this work package to build on the outcomes of the work packages 2 – 5 to yield insight into how the ethical and legal issues raised could be considered in EC policy. To identify and deliberate policy issues in SynBio we organised two workshops, one focusing on the European context, the other on the global health context. For the first workshop on European Policy for the Governance of Ethical and Legal Issues of Synthetic Biology for Human Health, we prepared a discussion paper on which participants coming from different communities – SynBio, social science, ethics, policymaking, patient and public engagement organisations – were invited to comment. For the second workshop on Synthetic Biology for Global Health: a Policy Discussion, we prepared a background document on the basis of which we invited participants – from different expert communities, international organisations and global regions – to submit papers on various issues relating to the potential implications of SynBio for global health. Finally, we discussed our findings and draft recommendations during the SYBHEL final conference with a small group of policy experts familiar with the field of SynBio. The following preliminary considerations, final recommendations and concluding reflections are based on the findings from the two workshops and the responses we received during the final conference.
Preliminary considerations
Future uncertainties as a major challenge
The aim of the SYBHEL project was to consider the potential applications of SynBio for human health and to explore the ethical and legal issues they might raise. WP2 investigated how the aims and claims of SynBio relate to different philosophical and public understandings of ‘life’ and it discussed the potential significance of these different understandings for the future ethical, philosophical and societal assessment of SynBio. WP3 and WP4 focused on normative and conceptual issues raised by SynBio and public policy in the field of human health, including ways in which future advances in SynBio might influence or alter concepts of health, disease, therapy and suffering. WP5 explored the extent to which current (biotechnology) patent regimes will be constraining or enabling to future SynBio innovation for human health.
The issues raised in the work packages 2 – 5 relate to future developments of SynBio that are highly uncertain and to potential health applications that are only likely to appear on the market in a future time span of decades. The uncertainty about the specific future relevance and implications of SynBio for human health creates a major challenge for policymaking: how to deal with highly speculative and uncertain future issues in this field? As an emerging platform technology SynBio may enable a variety of future applications and we simply don’t know yet where exactly it will lead us. Moreover, the issues raised in regard to future health applications are mostly not specific for SynBio, but refer to more general developments and future visions we are already familiar with from other fields of (bio)technology. Given this general context and the findings from the two policy workshops, we have attempted to steer away in our recommendations from future consequences as the main concern to issues more immediately relating to current practices and experiences in the field of SynBio and (global) health.
Issues of more immediate concern
Issues of more immediate concern for EC policymaking in the field of synthetic biology and human health relate to governmental challenges of regulation on the one hand and to broader challenges of anticipatory governance on the other.
In regard to policies of regulation we need regulations that are adaptive to changing circumstances. One issue is that current regimes of regulation should be able to respond to new needs for risk assessment. Another issue is that current regimes of regulation may adversely affect potentially promising prospects for innovation in SynBio, which also raises the question how policies of regulation might serve to facilitate particular developments with potential (public) health benefits.
As an emerging science which is still in an early stage of research and development and which is characterized by future uncertainties, SynBio also needs more inclusive forms of anticipatory governance engaging a variety of actors from both science and society. One issue is the need for strategic choices in the field, whereby the future of SynBio should not only be considered as a series of potential (health) applications, but also as a series of platform technologies which may enable different trajectories of research and innovation. Another issue is the way in which conditions can be created for responsible research and innovation in the field of SynBio, involving a variety of stakeholders and publics in mutual learning about potential future (health) benefits and risks.
These general considerations form the background of our final recommendations in which we address different actors and communities, including the European Commission, regulatory agencies, research organisations, as well as a variety of other parties to be involved in anticipatory governance of SynBio. With these recommendations we seek to stimulate forms of policymaking which address current practices and experiences in the field and which combine adaptive forms of government regulation (‘hard law’) with forms of governance (‘soft law’) that encourage the commitment of both science and society to a forward looking and responsible development of SynBio, involving different normative positions and acknowledging potential risks without prematurely cutting off developments with potentially significant future (health) benefits.
Final recommendations
1. Recommendations to the European Commission and regulatory agencies concerning government regulation:
• European policies in GMO safety regulation, medicinal product regulation, and ethical review should address in an anticipatory mode new challenges resulting from future SynBio (health) applications
It is not clear to what extent current and well-developed GMO safety and medicinal product regulations in Europe are sufficient to deal with future health related developments in the field of SynBio. In more general terms this challenge has already been identified by the European Group on Ethics. In its opinion on synthetic biology of 2009 the EGE recommended that “The Commission should review the legislation applicable to synthetic biology and assess its relevance to address the issues raised by synthetic biology” (EGE 2009: 53). In the SYBHEL WP6 European Policy workshop and Final Conference the following issues have been identified as of special concern in the context of SynBio and human health.
GMO safety regulation
As the EGE already pointed out in its opinion on synthetic biology, the aim of this field is to produce “organisms with multiple traits from multiple organisms, and therefore it may be difficult to predict their properties” (EGE 2009: 49). The problem might even be more complicated as SynBio develops not only engineered bacteria but also engineered cells for introduction into humans. The current GM risk assessment paradigm operates on the assumption that small genetic modifications will not significantly affect the characteristics of the host organism. However, given the level of complexity in cell engineering and signalling between cells, small changes could have massive ramifications in the human body. As a result the current GM risk assessment paradigm might be highly questionable in its applications in the arena of SynBio and human health. Thus there is
• a need for dedicated investments in the development of risk assessment methods that match SynBio developments involving the construction of cells with multiple new traits and the introduction of engineered cells in the human body.
In developing new risk management approaches we also need to think about technological rather than regulatory fixes, that is, safety by design. Policy could be used, for example to require that any organism that could multiply uncontrollably in any application would not be approved without a genetic construct preventing uncontrolled reproduction.
The need for more advanced forms of risk assessment should be matched however to another concern expressed during the SYBHEL Final Conference discussion, which relates to the impact on innovation of the current system of GMO regulation. European GMO regulation has developed into a system which is very demanding and costly for innovators in the field, to such an extent that (especially small) innovators may lose interest to pursue potentially promising product developments based on genetic engineering. Maintaining the current system of GMO regulation may thus discourage future SynBio innovation, nibbing in the bud promising (health) applications with potential benefits for society. From this point of view, European policymaking is at the crossroads for reconsidering the architecture of the current regulatory system. In other words, there is
• a need to find a new and careful balance by simplifying the current system of GMO regulation in ways which, on the one hand, should facilitate innovation and, on the other hand, prioritize new emerging issues of risk assessment.
Regulation of medicinal products and devices
Health related research in SynBio will strengthen the current move to biologicals in medicinal product development, that is, to products based on compounds and cells derived from the human body. These products create new challenges for the assessment and market approval of medicinal products and particular categories of these products have been brought in Europe under a special regulatory regime for advanced therapy medicinal products (ATMPs). Currently biologically-derived products only account for 6% of all medicinal drugs on the market in Europe; however, such products may play an increasingly large role as they account for a much larger share of 40% of products in Phase III trials, and health related product innovation in SynBio may further add to this trend. Given limited experiences with the assessment and product approval of biologicals today, the European Medicines Agency (EMA) will have to face new regulatory challenges as a result of this future development. A most challenging issue in this context is the way in which future (synthetic) biologicals may increasingly combine different – pharmacological as well as mechanical – modes of action, thus more and more blurring the boundaries between distinct regulatory regimes established in Europe for drugs on the one hand, and medical devices on the other. To anticipate future developments in the field of (synthetic) biologicals and to strengthen the institutional preparedness of the EMA and other stakeholders in assessing these developments, there is
• a need to reconsider the current distinction between pharmaceuticals and devices in the process of medical product approval in Europe.
Other issues raised in the SYBHEL workshop discussions concern processes of translation from the laboratory to the clinic of (future) SynBio-based experimental treatments. Patient involvement and access to therapies at stages of translation from early experimental to established treatments may become a potential source of contention in the context of the interplay of commercial, individual, public and scientific interests in developing SynBio health applications. Moreover, clinical research needed to develop SynBio health technologies might entail a degree of risk beyond that usually associated with other forms of experimental treatment. Together these issues suggest a need to reconsider the ethical paradigms that apply to clinical research and experimental treatment (Sarah Chan, WP4 workshop paper). Especially important in this respect is a concern that was expressed in the WP6 European Policy workshop about the lack of transparency of the current system of ethical review of individual research projects on the EU level. In order to support broader ethical reflection on the challenges arising from the development of SynBio therapies and other emerging health technologies, there is
• a need to consider a more transparent process of ethical review, in which the results of research ethics evaluations are not only fed back to individual projects (as is the current practice within DG Research and Innovation), but to wider communities of researchers, patients, ethicists and social scientists.
2. Recommendations to the European Commission, and to European and national research policy and funding organisations, concerning anticipatory governance
• European policies should support options for anticipatory governance by fostering experiments focusing on the wider societal aims and concerns in regard to SynBio (and human health) and involving a variety of stakeholders and publics in mutual learning about potential future (health) benefits and risks
Options for anticipatory governance are especially important for an emerging science like SynBio which is in an early research stage of development, without clearly defined (health) products to which established regulations might apply. From a regulatory perspective, the field is still an ill-defined moving target. A central feature of SynBio is ‘cross-borderness’, the combination of approaches from a variety of disciplines – biology, engineering, physics, computer science, and chemistry. The field also involves communities of young students attracted by the international SynBio Genetically Engineered Machines competition (iGEM) as well as amateur Do-it-Yourself (DIY) or ‘garage’ SynBio communities. Cross-borderness implies new levels of complexity and unfamiliarity, not only in terms of the phenomena studied and engineered in the SynBio field, but also in terms of various disciplinary and cultural traditions crossing each other, each with its own norms, values, beliefs, and conventions with regards to risk. In the face of future uncertainty and cross-borderness, we not only need adaptive forms of government regulation, but also a flexible and evolving ‘art of governance’ involving the diversity of communities and stakeholders that are shaping the field (Zhang et al. 2011).
Even more important is an anticipatory art of governance which takes into account broader discourses of concern, involving deeply rooted convictions and values in society, which may be more decisive for the future social acceptance of SynBio than the more narrowly defined discourses of risk and regulation. Experiences in the UK with a public SynBio dialogue have shown that participants were not only concerned with risks and benefits of potential future applications, but also with the motivations of actors and stakeholders shaping the field, that is, the individual and societal goals and interests that drive research (Bhattachary et al. 2010). Another aspect that was emphasized in the WP6 workshop discussions is the need for a shift in focus in these broader discourses of concern from ‘hard’ impacts relating to tangible technological risks for human health and the environment, to ‘soft’ impacts relating to the complex and often unintended ways in which technologies may transform individual behaviours, public attitudes and values, social relationships, and economic balances of power.
Anticipatory governance implies the creation of multiple opportunities for interaction between science and society as a form of ‘extended interdisciplinarity’, on the one hand engaging communities of researchers with the social and ethical ramifications of their work and, on the other hand, involving a broad range of stakeholders and publics with issues that relate to current practices and strategies of SynBio research and innovation. Extended interdisciplinary also is promoted by the European Commission in terms of ‘responsible research and innovation’, with the aim to integrate and align societal needs and demands more upstream in the technological development process (Von Schomberg 2012 and forthcoming). The recent European call for Mobilisation and Mutual Learning Action Plans (MML’s) is a very interesting and significant initiative in this respect. During the WP6 workshop discussions different options have been proposed which might be supported by the European Commission as experiments in anticipatory governance, involving SynBio researchers and a variety of stakeholders and publics in mutual learning about the wider societal aims and concerns in regard to SynBio (and human health).
• Synbio road-mapping as a governance experiment supporting global health goals
The WP6 workshop on global health critically discussed ways in which SynBio might address important problems and goals of global public health and the conditions needed to achieve these aims. One way for SynBio to contribute to global health would be to target specific diseases with major global health impacts (like diarrheal diseases), as is the aim of the SynBio funding initiative of the Bill and Melinda Gates Foundation Grand Challenges for Global Health Explorations Grant Program. The other more generic and long-term way of addressing such issues would be to focus SynBio R&D on the construction of fundamental multi-purpose pathways in microbial cells, which may serve as platforms that can be tailored to many kinds of applications, using advanced tools for computer-aided design of genetic circuits. In this context it was proposed during the workshop to start a road-mapping exercise for SynBio in global health, to see how the development of a technical infrastructure, including multi-purpose platforms and tools, might be stimulated and coordinated for the next ten to fifteen years. Such a roadmap would not only need to create technical priorities, but also integrate those with research agendas and policy options, ensuring that such an infrastructure would be open, accessible and beneficial for all constructive interests in SynBio, thus stimulating pre-competitive cooperation in the field. It would have to be developed in an open process of community engagement, involving in a process of imaginative thinking, researchers, industry, funding agencies, international health and innovation policymaking organisations, NGOs and representatives of end-users in the field of global public health. Interestingly, the workshop participant from the OECD working party on biotechnology suggested that they might play a role in brokering such an activity, and the European Commission could play a role as well.
• Real-time TA as a governance experiment supporting responsible SynBio innovation
Real-time technology assessment aims at mutual learning about challenges relating to the future societal embedding and impacts of potential applications of synthetic biology. The focus of this approach is on the level of SynBio research projects, like those funded by the Grand Challenges for Global Health Explorations Grant Program or (health related) projects undertaken as part of the annual iGEM competition. Starting point for a real-time technology assessment is the articulation of future ‘application scenarios’ with the aim to engage researchers and a wider circle of relevant stakeholders in an interactive process of imaginative deliberation, considering options, needs, conditions and alternatives for future applications envisaged in particular projects. The iGEM community constitutes a particular interesting forum of young researchers for real-time TA experiments, on the basis of which especially promising iGEM projects might be selected for further investigation and funding, thus supporting responsible research and innovation in the SynBio field.
• Development of scenarios as a governance experiment supporting future imagination
The development of ‘techno-moral’ scenarios as a tool to stimulate imagination, reflection and debate in the context of real time TA, education and public engagement activities may be another way to support anticipatory governance in a highly uncertain field. While application scenarios focus on the prospects and challenges for innovation and related regulatory concerns, techno-moral scenarios highlight the wider transformative potential of SynBio in society, thus shifting the attention to ‘soft’ impacts. They invite audiences to imagine and appraise ways in which SynBio (health) applications might change our world, our ideas, values and ideals. As thought experiments techno-moral scenarios can be used to create a controlled environment for testing ideas and arguments about the future and to explore and clarify the underlying reasons, beliefs, values and concerns informing public debates about new and emerging science and technology (Calladine & Newson, WP3 discussion paper).
• Governance experiments supporting different approaches to intellectual property
In the SynBio research community there is much support for the development of a technical infrastructure that should be open, accessible and beneficial for all constructive interests in the field. However, as pointed out in WP5, an important and controversial question still remains: to what extent is it possible to create a robust and alternative open access system in a field in which it will be very costly to develop marketable innovations? From the WP6 Global Health workshop, we know that SynBio researchers who favour free access to knowledge relevant for global health, are facing institutional pressures from their university to pursue IP protection. Given the international IP debate – as discussed in the Future Scenarios report of the European Patent Office (EPO 2011) – there is a clear need for flexibility and room to manoeuvre and experiment with different approaches to IP and patenting. In a recent report on collaborative mechanisms for IP management in the life sciences the OECD (2011) indeed suggests a move away from ‘own to protect’ to ‘own and share’. Accordingly, the European Commission might seek to support initiatives from the research community and other parties considering alternative IP regimes and reward structures in SynBio and other fields (e.g. the Health Impact Fund).
Concluding reflections
In our final WP6 recommendations we have shifted the focus from potential future implications of SynBio for human health, to issues of government regulation and anticipatory governance that are of more immediate concern for European policymaking in regard to current practices and experiences in the field. This shift in focus is not only relevant in addressing policymaking institutions, but also suggests a need to reconsider established ways of understanding the ethical, legal and social implications (ELSI) of new and emerging science and technology. ELSI research is strongly predicated by a concern to protect society against harmful implications of science and technology and thus reproduces a long-standing division of labour in our society between promotors of new technology and critical responders (Garud & Ahlstrom 1997). In this light, our recommendations for experiments in anticipatory governance also imply a move in ELSI research towards a less antagonistic stance, contributing in a critical as well as collaborative way to discussions on how – and under what conditions – SynBio might address important problems and goals of human and global public health.
WP3:
What should a SynBioEthics for Health looklike?
A.M. Calladine
Objectives
Work Package Three (WP3) was entitled, What Should a SynBioEthics For Human Health Look Like? Its main objectives were;
• To delineate the new ethical challenges posed by synthetic biology
• To explore and determine an appropriate methodology for ethical collaboration within synthetic biology
In brief, we came to the conclusion that the premises and assumptions which formed the basis of the work package are highly problematic and questionable. That is to say, considerable doubt was cast over whether there was a need for a ‘SynBioEthics’, the ‘newness’ of the ethical challenges, the notion of determining an ‘appropriate methodology’ and the use and construction of ‘ethical frameworks’. Our suggestions below reflect and draw on these conclusions.
It is worth noting, that we do not consider these to be policy recommendations. This is because at present it is unclear what we are recommending policy for (or on), or whether new policies are actually required. And because we are a little unsure as to what public policy is (or perhaps we should say ought to be in terms of its nature and justification). We claim no expertise in public policy. Rather, please consider the points listed below the key issues and questions we think may be important and that perhaps policymakers ought to bear in mind while (or before) formulating policy in this area.
1. We shouldn’t treat synthetic biology in isolation but rather consider it in conjunction with other biotechnologies and issues concerning human health.
The emergence of synthetic biology has generated a great deal of hype and led to some rather extravagant claims. If we are to believe the claims made by some scientists, we may think that synthetic biology offers a panacea for many of society's ills. However, according to others synthetic biology may pose great dangers and could be something of a Pandora's Box. Of course, these sorts of claims help attract research funding for both scientists working in synthetic biology and the researchers interested in the supposedly new ethical, legal, social and policy issues it raises. However, beneath the hype it is rather unclear just what synthetic biology is (see footnote above), or whether it's really as new and radical as is often suggested.
As we have argued elsewhere, rather than considering synthetic biology as new, it perhaps makes more sense to think of it as a form or endpoint of genetic engineering. As such, it is rather doubtful whether synthetic biology, either in itself or in relation to human health really raises any new or distinct ethical issues. Synthetic biology seems to raise many of the same sorts of ethical questions as those raised by other biotechnologies. Of course, the newness or otherwise of ethical questions should not detract from their importance. The moral questions raised by synthetic biology, while familiar to other biotechnologies, are important and remain unresolved. However, it does raise the question of why we should treat synthetic biology in isolation or as a special case. We agree with our colleagues in WP2 that;
… most of the ethical or societal issues in synthetic biology for human health that we envisage today, are not raised by synthetic biology in general, but rather depend on the specific medical application. These issues generally overlap with similar issues raised in the context of other technologies… The discussion and regulation of these issues in synthetic biology and other technologies should thus be combined.
As such, we suggest that policymakers employ a joined up approach to policy making. They should consider synthetic biology in conjunction with other forms of biotechnology. The question of what constitutes human health and well-being should also not be considered in a narrow or isolated way. It seems likely that synthetic biology and other biotechnologies will have an impact on health and wellbeing that goes beyond the scope of what we may intuitively consider to be medical applications.
2. We recommend ongoing analysis of the normative and conceptual foundations of synthetic biology and human health - and public policy
We agree with our WP6 colleagues’ recommendation that policy should be empirically informed, and that empirical research in this area should be ongoing. However, we also suggest that ongoing empirical research, while valuable, is in itself insufficient without ongoing analysis of the normative and conceptual foundations of both synthetic biology and human health -- and public policy in general.
We found during our research for the SYBHEL Project that questions were raised over what policy is, and where it derives its justification from. There seems to be a degree of confusion or a failure to appreciate the essential normativity of public policy. The values underlying policy need to be accounted for, questioned and justified. Policymakers and policy documents often seem to employ a range of normative, interpretive concepts such as justice, responsibility and transparency in a rather unthinking way which lacks both clarity and justification. While such things as ‘listening exercises’ and ‘public consultation’ provide an important means of gauging public opinion, they cannot provide a normative justification in and of themselves.
Both public policy in general and public policy in respect of synthetic biology and human health raise a host of important foundational normative and conceptual questions. So while empirical research is valuable and necessary, questions about the ultimate goals, nature, legitimacy and justification of public policy cannot be answered by empirical methods. We suggest that political and legal philosophers may have much to offer in this area. And that these sorts of questions need to be considered and addressed on an ongoing basis when formulating public policy.
3. We recommend adopting a problem driven approach (including speculating about future potential problems) to synthetic biology and public policy
One approach to considering the moral questions generated by new technologies is to construct some sort of ethical framework which sets out some basic principles and then applies these principles to the case at hand in order to come to a conclusion. However, we have consistently argued against employing this sort of approach. We think that ethical frameworks may obscure important issues and can have a tendency to reduce complex and multifaceted questions in to little more than simple equations that require only a limited degree of calculation. As one of our SYBHEL workshop participants put it;
One of the issues with the whole concept of methodology might actually be that we tend to look at the standard normative frameworks that we want to apply to certain new technologies and this then delivers certain governance tools (you know the terminology). In the end you often wind up with a sort of standard picture, of standard arguments, using standard concepts... this has led to an intellectual and creative numbness to the actual practical issues that may arise from certain new technologies.
We suggest that rather than constructing ethical frameworks and applying them in a rather tick box fashion to a moral problem it would be more fruitful to consider a problem driven approach. That is, we should start with the problem and question, analyse and understand the issue in depth. The term ‘problem driven approach’ should not be interpreted as excluding potential or future problems. We should also speculate and consider future potential problems that may be raised by synthetic biology as it pertains to human heatlh. As mentioned above, this requires a process of ongoing analysis into the normative and conceptual issues raised by synthetic biology and human health. It also raises questions of how philosophy and philosophers can be best employed in the formulation of public policy.
Conclusion: Before making policy recommendations we should seek to understand.
As we have suggested, it is easy to get carried away with, or buy in to the hype surrounding synthetic biology. There is perhaps always a temptation when something ostensibly new and potentially powerful emerges to draw quick conclusions -- to feel that new policy is required and that new laws and strong regulations should be put in place. Maybe they do. But before (and while making) new policy recommendations perhaps we should heed Jonathan Wolff’s advice. Wolff, a philosopher who has worked in public policy, suggests that before advocating new policies we should; ‘seek to understand’. Drawing on his advice we think it may be beneficial to consider the following sorts of questions before coming up with policy recommendations for synthetic biology and human health:
(1) What, exactly, is the problem?
As we have mentioned, a good place to start is by clearly outlining the problem or issue at hand; what is the policy for, or on? We might discover in the process of elucidating ‘the problem’ that it is not really a problem at all (or not one that requires new policies or laws (2)). Or, we may find that rather than one problem we can distinguish between several different problems that raise different kinds of normative and empirical questions (3) and (4).
(2) What are the current policies, laws and regulations in the area and their history?
Before coming up with policy recommendations (and in the process of (1) ) it is probably beneficial to find out what the current policies, laws and regulations are in the general area of our inquiry. As we have suggested it may be the case that some of the issues we are concerned about with regards synthetic biology already fall within the remit of existing policy. We may also find there are lessons to be learnt from history by looking at past policy cases that are in some ways analogous to synthetic biology or the problem we are concerned with (public perception of GM foods for example).
(3) What other empirical information do we need before we come to decide on the problem?
In addition to the information about current and past policy (2) it seems likely that we will also require a range of other empirical information. For example information about current practice in synthetic biology, public perceptions, concerns and disagreements (4). Of course, what empirical information we need depends on the nature of the problem (1).
(4) What are the underlying normative and conceptual foundations on which our problem or recommendation rests?
Finally, as we have mentioned above in our key issues, we need to consider, interpret and clarify the underlying conceptual and normative architecture on which the problem (and if necessary, policy recommendation) rests and whether these values and concepts can be justified.
WP2:
Synthetic Biology: The definition and creation of life
Anna Deplazes
Objectives
The following recommendations are the result of our work for SYBHEL Work Package (WP) 2: “Synthetic Biology and the Definition and Creation of Life”. In this WP we have investigated how the aims and claims of synthetic biology are morally assessed from the point of view of people with different understandings of life. Thereby, we focused on philosophical positions but also considered religious conceptions. Moreover, we have analysed the conception of life propagated by synthetic biologists and there relation to other conceptions of life. We have also discussed the significance different understandings of life could have for the future ethical, philosophical and societal assessment of synthetic biology, for public engagement and education (including curricula of scientists and other experts). The results of these discussions and deliberations are summarized in the following recommendations.
1. We recommend that as synthetic biology progresses, any study of its ethical and societal aspects needs to keep critically analysing what different stakeholders in the debate have in mind when they refer to concepts such as ‘life’, ‘nature’, ‘artificiality’ or ‘health’ and what implications these different understandings have for the assessment of synthetic biology.
In many reports and comments on synthetic biology importance is given to the notion that this new field could lead to ‘synthetic life’ or ‘artificial organisms’. In doing so, the authors provide a specific interpretation of basic concepts such as ‘life’, ‘nature’, ‘artificiality’ without making this interpretation explicit. Another concept of this kind, which plays a particular role in the discussion of applications of synthetic biology for human health, is the concept of ‘health’ itself. A wide range of understandings, interpretations and applications characterizes these concepts. In what follows we will focus on the concept of ‘life’ as a paradigm of such contested basic concepts.
Our investigation of the role of the concept of life in reports and debates on synthetic biology showed that on the one hand, synthetic biology is based on a very specific understanding of life and living organisms as controllable standardized machines and as human-produced entities that serve human purposes but this understanding varies between different types of synthetic biology. On the other hand, the assessment of the aims and claims of synthetic biology by different people depends on the underlying understanding of life. Importantly, most philosophical and religious understandings of life are compatible with the views of synthetic biologists, but focus on other aspects of life, which synthetic biologists do not address. This is to say that propagating a non-scientific view on life does not necessarily mean opposition to synthetic biology.
The aim of the analysis of the role that different understandings of life play in the debate over synthetic biology is not to find one generally accepted interpretation of life. Instead, the aim is to take stock of the variety of understandings, to analyse changes, to point out the (changing) significance of certain understandings in the debate and to clarify misunderstandings based on different interpretations. With our project in WP2 we have aimed at contributing to this important task, but there is still much work to do.
Besides the contested basic concepts listed above the understanding of other significant concepts in the discussion such as ‘engineering’, ‘technology’, ‘design’, ‘machine’, ‘science’ or ‘synthetic biology’ itself, should also be analysed. In contrast to the mentioned contested basic concepts, these concepts are not traditionally interpreted in so many different ways. However, in the debate over synthetic biology their meaning may not be fixed . Moreover, it appears that these originally descriptive terms have a normative connotation in this debate, the profound implications of which stands in need of in-depth investigation.
2. We recommend that a democratic approach to the debate over synthetic biology include mutual engagement that is not restricted to participation processes in political decisions but includes dialogue events, which are not necessarily driven by the aim of informing policy. Such engagement should consider how diverse religious, philosophical and other non-scientific views in the public on basic concepts interact dynamically with the understandings of these concepts produced by synthetic biology.
Basic concepts such as the concept of ‘life’ are interpreted and understood in various different ways by the public. Scientific findings are one important influence on public opinions and views. An emergent technology and science with powerful advocates, such as synthetic biology, is likely to provide fertile ground for public interest in, and debate about how we should interpret the concept of ‘life’ and relate to living nature. Synthetic biology will inform certain public views on life but will be in contradiction with others. In order to facilitate the integration of synthetic biology with society a mutual engagement between scientists and other members of society should take place as soon as there is a demand for it. Therefore, platforms and opportunities for a two-way engagement should be ready. There have for, instance, been efforts to involve the public in discussions on synthetic biology by using art and films comics or literature . Another possibility would be books for children. Moreover, a card game has been developed to guide discussions on synthetic biology in small groups. Public discussions could also be initiated using social media, moderated evening debates in Café-scientitique-events, in public panel discussions, school outreaches or on lab visiting days. Furthermore, empirical studies about the integration of science in society should be fostered, reported in the media, and considered in policy making.
A discourse of this kind has previously been suggested by various social scientists as an approach to avoid social controversies, as sites of mutual learning and to do justice to a diverse understanding of science in the public. This approach will hopefully increase scientist’s understanding of their role in society and the expectations, hopes and worries that other members of society connect with the anticipated development of synthetic biology. For the other members of society, the discourse will provide an opportunity to express their expectations, hopes and worries, to receive responses from scientists and to differentiate their views on synthetic biology.
In order to facilitate such processes, we need more basic empirical research about the influence of emerging technologies on the understanding of basic concepts such as the concept of ‘life’ in society.
3. We recommend that education of scientists, practitioners in technology assessment and of the public include an introduction into the historical, philosophical, religious and social contexts of science. This should include the discussion of different understandings of basic concepts such as ‘life’, ‘nature’, ‘artificiality’ or ‘health’ and the implications of the fact that there are different views.
Scientific findings and models provide important explanations of life, which are particularly accessible due to their falsifiability and applicability in technology. But even within science, different disciplines with different research focuses and different methodologies provide different explanations and definitions of life. Science exists within in a sociological and historical context, which influences how science is done and interpreted. Moreover, there are many important questions about the world and -more specifically- about life that cannot be addressed by scientific methods. These include questions about the particularity, value, meaning or significance of life. For instance philosophers, ethicists or theologians are concerned with these types of questions. Scientific explanations may be sufficient for the work of a scientist in the lab. But, these views can be complemented by other understandings of life in discussions about the idea that life could be artificial or of the relation between synthetic biology and religious or philosophical views on life. Synthetic biology, like other sciences, can only address empirical questions, questions of value or issues of belief are beyond its remit, because if there were such ‘mystery’ this would not be approachable by scientific methods.
Besides an introduction to ethics, the curriculum of synthetic biologists and other scientists should include courses, in which some insights of philosophy of science and science and technology studies about the impact of social and cultural values on scientific research are introduced. This should encourage future synthetic biologists to deliberate about the role of science in explaining the world. In addition, in order to sensitize practicing scientists, science journalists, social scientists and philosophers to these issues, the relation between scientific explanations and other explanations should be discussed more. Synthetic biology is a model to many other fields in how ethical and safety/security aspects of this field are discussed in scientific journals and at scientific conferences. This discussion could easily be expanded by the discussion of the relation of different types of explanations and of the societal, historical and philosophical context of science.
Importantly, public education too, should provide an understanding for the relation between scientific, philosophical and religious interpretations of life. For this purpose, in public information events the implications of synthetic biology for the general understanding of basic concepts such as the concept of ‘life’ should be discussed and philosophers, ethicists and theologians should appear side by side with scientists. It has to be clarified that scientific explanations provide answers only to scientific questions about the functioning of living organisms but not to questions about the value, meaning or significance of life. This will help the public to integrate these scientific views into their own view of ‘life’ and clarify that the successes of synthetic biology do not dismiss questions about particularity, value, meaning or significance of life -questions, which have occupied people from the early beginning of humanity- as irrelevant and foolish. It should also show that to give weight to philosophical or religious explanations of life does not necessarily imply opposition to synthetic biology.
WP4:
Synbio for Human Health and Wellbeing
Heather Bradshaw
Objectives
The following recommendations are the result of our work for SYBHEL Work Package (WP) 4 “Ethics and Synthetic Biology for Human Health and Well-Being”. WP4 was assigned three main tasks. The first was identifying and documenting scientific advances in Synthetic Biology with applications for human health and well-being, such as live therapeutic agents. The second was reviewing and analysing ethical issues raised by laboratory and clinical (commercial) synthetic biology techniques. “Ethical” specifically included issues of justice raised by gender or analogous factors e.g. genetic variation. The third task was to consider how synthetic biology might influence or alter the philosophical concepts of health, disease, therapy and suffering.
1. We caution those who make decisions about healthcare distribution against relying for justification on conceptual accounts of health and disease which equate healthy with natural. Accounts in which this mistake is obscured through concepts of function which refer to “natural” evolution should also be avoided. The development of alternative, consistent, conceptual structures based on reported well-being should be encouraged. This is because they can provide a coherent, just foundation for healthcare distribution and access.
The conceptual structure on which we commonly base classifications of moral status, the balancing of interests between entities, and our legal justifications was developed to fit a set of things that actually exist in which the animate and the inanimate were clearly distinguishable and, generally in Europe, culturally distinguished. As the academic papers of Workpackage 4 argue, the types of entity produced by synthetic biology, are among the technological developments which cannot be classified according to the traditional European conceptual structure. (The expert advice emphasized that synthetic biology is no different to parts of robotics, artificial intelligence research and human-machine interfaces in this respect.) Accordingly, ethical and legal classifications and justifications based on this structure are ineffective for regulation of the new types of entity.
In the case of synthetic biology for human health many relevant concepts such as health, disease/disorder, artificial, artefact, machine, and life in turn refer to the concept of function. Function has often been interpreted naturalistically, in terms of what an organ or behaviour has evolved for within a naturally evolved distinct species. This allows the use of naturalistic interpretations of health, disease etc. which are often convenient for policy because they can be quantified in terms of statistics for clearly defined species-groups (called reference or comparison classes). Naturalistic concepts therefore appear to be objective and independent of political preferences or ethical values (although some research argues that the objectivity is illusory ).
The new types of thing which exist cannot be neatly classified into species, or into the old conceptual classes of animate/inanimate etc. Reference (or comparison) classes cannot be even apparently objectively determined, but now must always involve an explicit value-based choice. This is especially the case for healthcare. Diseases and disabilities have previously been defined as requiring therapy by reference to species norms. This is in conflict with subjective reports of e.g. congenital Deafness as not requiring therapy and not being a disease or disability.
The human-viral hybrids created by use of live therapeutic agents are particularly inappropriate for ethical classification under traditional conceptual systems such as those defended in, for example, Ricoeur’s work. This applies whether the live agent is used to treat existing pathology as in the JX-594 clinical trial, or for preventative purposes when there is no existing disease condition.
Clear, consistent, well-justified regulation is needed to maximise innovation and economic benefit. Such regulation requires coherent and consistent conceptual systems appropriate for entities like human-synthetic-biology hybrids, artefactual organisms, and autonomous machines. These conceptual systems should differentiate between entities on ethically relevant grounds, not on arbitrary and outmoded ideas of “the natural as the good”. Ethically relevant grounds are likely to include indicators of subjective well-being, intrinsic interests and/or possibly capacities/abilities.
2. We recommend that there is investment in research on ethical, publically acceptable distribution of contagion risks. The reduction and control of 3rd party contagion risks in commercial applications of synthetic biology should be concomitant with continued funding of synthetic biology research.
There are not a large number of applications of synthetic biology for human health yet. But one product which is already undergoing clinical trials raises a problem of justice which needs to be addressed to secure public acceptance. The JX-594 live therapeutic agent uses the vaccinia virus as the chassis or vector for synthetic, modified DNA. Although in this case the vaccinia’s original DNA is modified it is not removed and other parts of the cell remain intact. Indeed, aspects of vaccinia’s unmodified behaviour are essential to JX-594’s therapeutic effectiveness. For example, the ability to spread quickly through the human blood stream and to survive attacks from the human immune system while in the blood.
But vaccinia in other therapeutic applications, such as its traditional use as the main agent in smallpox vaccination, is controversial. This is because it causes serious illness and occasionally fatalities in a significant proportion of the population. Moreover, those who are susceptible can contract vaccinia infections from people treated with vaccinia who are themselves symptomless. Further, susceptible people may not know they are at risk and so may be unaware that they should take precautions. From work on smallpox vaccination it seems that approximately 20-40% of the population of Western countries may be at particular risk from vaccinia.
We emphasize that the risk from JX-594 and vaccinia is not just to the patient. It is also to non-consenting 3rd parties. Where 3rd party risk is present, for example with automobiles or aeroplanes, usually we adopt more stringent product safety testing and measures. Unlike excreted live polio virus after polio vaccination for infants, which can be infectious to non-vaccinated persons, with vaccinia it is not just intimate carers (themselves already vaccinated) who are at risk but also other adults who may have no direct contact with the patient. Indirect contact via fomites is sufficient to transmit vaccinia.
The third party risk from vaccinia chassis affects particularly all those with the atopic syndrome (asthma, allergies, eczema), transplant recipients, and all those with diminished immune system function such as carriers of the AIDS virus and persons with genetic immune conditions. The incidence of atopy is considered to have risen significantly (from an estimated 4% to approximately 20% of the population) since vaccinia was widely used for smallpox vaccination, and most of those born since 1980 (when the smallpox vaccination campaign ended) will be entirely naïve to vaccinia. Putting such persons at extra risk constitutes an unethical form of genetic discrimination. We recommend that any clinical or commercial product of this nature be subject to regulation by industry independent bodies in the same way as other technologies posing 3rd party risks are regulated today but with particular attention to the potentially discriminatory effects of technologies which with genetically specific risks.
3. We recommend that synthetic biology research should not be held up by concerns about synthetic biology exceptionalism. Synthetic biology should be regulated like any other commercial engineering endeavour.
Many of the ethical issues raised by synthetic biology are common to other converging technologies. A range of challenges to the concept of e.g. health are also raised by other applications of modern bio-technology and engineering such as chimeras, brain machine interfaces, robots, and stem cell hybrids. All of these require conceptual re-alignment to fit the new types of thing they represent. Synthetic biology requires similar treatment. We do not see this as reason to single out synthetic biology for different regulation from other members of this group of technologies.
On the contrary, we suggest that there are ethical reasons for adapting successful, tried and tested regulatory practices already in use for twentieth century, engineered commercial products to synthetic biology and products arising from related converging technologies. These regulatory practices, including industry independent oversight and certification bodies for example, have arisen in reaction to accidents, product failures and the resulting negative public responses and have made the technologies they regulate largely uncontroversial and acceptable to the majority of the public.
Further, the independent nature of these bodies and the regulation of these industries has itself arisen as a solution to ethical problems of cooperation and externalities within the regulated industries. Human cooperation can be understood as a core problem of ethics. There is thus ethical justification for including commercial synthetic biology products (though possibly not pure research applications of synthetic biology) within the group of engineering industries so regulated.
General conclusion
Where synthetic biology and other converging technologies may be considered to differ ethically from these older engineered products is in their potential to produce entities which have interests of their own, which we are ethically required to balance against human interests, as mentioned under Recommendation 1. This point cannot be fully addressed without the further development of an adequate conceptual system and a new justification for the allocation of moral status. These are issues on which SYBHEL has produced foundational work.
WP5:
Commercialisation and Regulation of Synbio
Inigo de Miguel
Objectives
The overall objective of Work Package (WP) 5 of the SYBHEL project was to develop a juridical analysis of the relationship between SynBio for human health and intellectual property rights which may be helpful to whoever will have to make rulings on it and also for relevant professionals (for example, scientists and jurists). During the last years, we have investigated whether the evolution of Synbio will need a change in our current IP framework. We have explored the current normative background informing regulation and commercialization in SynBio for human health; the juridical issues that may be connected with SynBio, including the legal impact of the general prohibition of commercialization of human body parts and intellectual property aspects; or the adequacy of applying other normative frameworks drawn from other technologies to SynBio for human health. In order to do so, we have organized two international workshops, attended by almost twenty legal experts in Synbio and IP from different countries and continents. The results of these discussions and deliberations are summarized in the following recommendations.
1. There are no new ethical or legal issues arising from Synbio that require root and branch reform (or other sorts of reform), but governance needs to be flexible enough to accommodate such problems if they arise.
There are no reasons to think that sybio related to human health might raise ethical or legal issues which make it necessary to change the currently existing legal framework. Of course, it might happen that in the future some new circumstances arise, recommending the inclusion of some new restrictions in the list of inventions which should not be patented keeping in mind the “moral clauses” which are usually a fundamental part of our regulation. In that case, it would be recommendable to address a modification of the Biotech Patent Directive (98/44/EC), modifying its articles 5 or 6, for instance, to include new exceptions to patentability, which could also be incorporated into Rule 23d of the EPC.
It is, however, important to keep in mind that this kind of changes might last a long time. Thus, it seems to us recommendable to settle some legal tools able to face those issues in the meantime, so as it could be possible to adopt preventive measures when moral risks are clearly identified. An open interpretation of the moral clause might be useful in order to do so.
2. Key concepts of patenting system, such as novelty, inventive step and industrial application should be revisited, so us to improve the efficiency of the system.
There is a potential problem that Synbio patenting will follow a line that has been seen in relation to other aspects of biotechnology. This can cause a discrediting of the patent process, and can have industrial implications by causing blocking of industrial development and advance by a misuse of patent monopolies. Synbio invites us to revisit, for Synbio and for other areas of biotechnology IP, what the appropriate criteria should be for each of the elements of patentability: novelty, inventive step, and industrial application, and also the discovery/invention distinction.
This is something that is already being undertaken on a case-by-case basis in litigation, but it is a matter of public policy that should be determined at the political level in democracies.
3. Underpinning the successful operation of the patent system is an effective information transfer system. This is an area that requires reform.
Researchers usually find it really hard to know if an invention has already been patented or not. In order to ensure that this emerging technology functions correctly, new measures will need to be adopted in order to ensure greater accessibility to information about existing patents. This is more concerned with classification and search systems than the data contained in patent applications. Researcher training in these skills is important in order to avoid accidental infractions.
4. It is important to orientate the Synbio market in order to avoid a general blockage due to the use of the patenting blockage right. Patenting system should also be complemented by alternative tools.
Patenting is a “blind” mechanism. Patent Offices have not been vested with the task of taking into account the economic effects of granting patents in specific areas and restricting the field of patentable subject-matter accordingly. This means that the current patenting system could assist or hinder the development of Synbio related to human health.
This is why it is important, on one hand, to encourage those involved in this industry to behave appropriately in order to prevent a general blockage of the entire system being caused. In an ideal scenario, patents on devices should coexist with highly-standardised, freely-accessible parts that are patent-free. Obviously, it is not easy to find a formula to enable this to occur. Different tools may be of assistance in this regard, such as:
• stimulating cross-licenses between different companies;
• introducing clauses limiting private ownership in grant agreements when this private ownership may be contrary to public interest (remember the case of BCR);
• in exceptional cases, the possibility of governments executing licences that appeal to public interest could be very useful in order to obtain corporate agreements, especially in the case of the health market, due to the nature of the interests at stake;
• the intervention of Competition Commissions when a patent creates a situation of dramatic blockage or when it affords someone a position of monopoly;
On the other hand, it would seem reasonable to complement the current legal framework by designing new legal tools able to address new and interesting approaches to the issue of intellectual property rights.
On this point, it is important to highlight that patenting is not the only way to protect intellectual property rights. Open source has shown to be extremely useful in the case of software. Obviously, the Synbio market related to human health does not have much to do with the software market. As is commonly known, the costs needed to write a computer code are much lower than those involved in a Synbio development. However, it is possible to conceive that, in the future, alternative tools might be created in order to conciliate private property and commercial profit with open information without using the patent system. Laws should be flexible enough to stimulate these initiatives by providing an appropriate framework for them.
References (by work package and in WP text order)
References
WP6
Bhattachary, D. et al. (2011) Synthetic Biology Dialogue. An independent review commissioned by the Biotechnology and Biological Sciences Research Council (BBSRC). Accessible at: http://www.bbsrc.ac.uk/web/FILES/Reviews/1006-synthetic-biology-dialogue.pdf
Calladine, A.M. and Newson, A. (2011) Synthetic Biology & Human Health - On the importance of thinking about the future (& some thoughts on the ways we ought to think about it). Discussion Paper for SYBHEL WP3 Workshop Conceptual Foundations, Methodology and Ethical Frameworks, Bristol, 28-29 June 2011
Chan, S. (2012), Developing health technologies from SynBio: the ethics of experimental treatment. Paper presented at SYBHEL WP4 Workshop Synthetic Biology and Human Health: Choosing Cure or Continuity, The Hague, 6 February 2012
EGE (2009) Opinion 25 on Synthetic Biology. Luxembourg: Publications Office of the European Union. European Group on Ethics of Science and Technology. Accessible at: http://ec.europa.eu/bepa/european-group-ethics/docs/opinion25_en.pdf
EPO (2011) Scenarios for the future. How might IP regimes evolve by 2025? What global legitimacy might such regimes have? European Patent Office. Accessible at: http://documents.epo.org/projects/babylon/eponet.nsf/0/63A726D28B589B5BC12572DB00597683/$File/EPO_scenarios_bookmarked.pdf
Garud, R. and Ahlstrom, D. (1997) Technology assessment: a socio-cognitive perspective. Journal of Engineering and Technology Management, 14: 25-48
OECD (2011) Collaborative mechanisms for intellectual property management in the life sciences. Organisation for Economic Co-operation and Development. Accessible at: http://www.oecd.org/sti/biotechnologypolicies/48665248.pdf
Von Schomberg, R. (2012) Prospects for Technology Assessment in a framework of responsible research and innovation. In: M. Dusseldorp and R. Beecroft (eds). Technikfolgen abschätzen lehren: Bildungspotenziale transdisziplinärer Methoden, Wiesbaden: Vs Verlag, pages 39-61
Von Schomberg, R. ( 2013) A vision of responsible innovation. In: R. Owen, M. Heintz and J. Bessant (eds.) Responsible Innovation. London: John Wiley, forthcoming
Zhang, J.Y. Marris, C. and Rose N. (2011) The transnational governance of synthetic biology – Scientific uncertainty, cross-borderness and the ‘art’ of governance. BIOS Working Paper. No. 4, London School of Economics. Accessible at: http://www2.lse.ac.uk/BIOS/publications/Working%20Papers/WP4TransnationalGovernance.pdf
WP3
Aldhous, P. (2007). Interview: Sleep when you're dead. New Scientist, Reed Business Information Ltd.
Calladine A. M. and R. t. Meulen (2012) , ‘Defining Synthetic Biology’, Encyclopaedia of Applied Ethics, Elsevier, p. 281-288.
Calladine A.M. (2011) Conceptual Foundations, Methodology and Ethical Frameworks. SYBHEL Project Report.
Calladine, A.M. (2010) How should bioethics respond to synthetic biology. SYBHEL Project Report.
Calladine, A. M. and R. t. Meulen (2010). "Synthetic biology & human health: Some initial thoughts on the ethical questions and how we ought to approach them." Law and the Human Genome Review 32: 119-141
Dworkin, R. (1977). Law as a System of Rules in The Philosophy of Law. Oxford University Press.
Newson, A (2009) SYBHEL Project Description of Work.
Wolff, J. (2011). Ethics and Public Policy: A Philosophical Inquiry. Oxford, Routledge.
WP2
Bedau M, Church G, Rasmussen S, Caplan A, Benner S, Fussenegger M, Collins J, Deamer D (2010) Life after the synthetic cell. Nature 465: 422-424
Davies S, McCallie E, Simonsson E, Lehr JL, Duensing S (2009) Discussing dialogue: perspectives on the value of science dialogue events that do not inform policy. Public Understand Sci 18: 338–353
Deplazes-Zemp A (2011) The Conception of Life in Synthetic Biology. Science and engineering ethics
Elowitz M, Lim WA (2010) Build life to understand it. Nature 468: 889-890
Morange M (2009) A new revolution? The place of systems biology and synthetic biology in the history of biology. EMBO Rep 10 Suppl 1: S50-53
Nisbet MC, Scheufele DA (2009) What's next for science communication? Promising directions and lingering distractions. Am J Bot 96: 1767-1778
Rusk N (2010) Advent of synthetic life. Nat Methods 7: 487
Wynne B (1992) Misunderstood misunderstanding: social identities and public uptake of science. Public Understand Sci 1
Zhang X (2010) From synthetic genome to creation of life. Protein Cell 1: 501-502
WP5
JEROME C. WAKEFIELD, Diagnosing DSM-IV—Part I: DSM-IV and the concept of disorder, 35 Behaviour Research and Therapy (1997).
JEROME C. WAKEFIELD, Disorder as harmful dysfunction: A conceptual critique of DSM-III-R's definition of mental disorder, 99 Psychological Review (1992).
DAN J. STEIN, et al., What is a Mental/Psychiatric Disorder? From DSM-IV to DSM-V, 40 Psychological Medicine 1759(2010).
CHRISTOPHER BOORSE, "Concepts of Health" in "Health Care Ethics", Van De Veer, Donald (Ed), 359-393, (1987).
CHRISTOPHER BOORSE, A Rebuttal on Functions, in Functions: New Essays in the Philosophy of Psychology and Biology (Andre Ariew ed. 2002).
CHRISTOPHER BOORSE, On the distinction between disease and illnes, in Health, Disease and Illness: Concepts in medicine (Arthur L.; Caplan, et al. eds., 2004).
ELSELIJN KINGMA, What Is It to Be Healthy?, 67 Analysis. Ap (2007).
ELSELIJN KINGMA, Paracetamol, Poison, and Polio: Why Boorse's Account of Function Fails to Distinguish Health and Disease, 61 British Journal for the Philosophy of Science. Je (2010).
STUART BLUME, Histories of Cochlear Implantation, 49 Social Science and Medicine 1257(1999).
STUART BLUME, Land of Hope and Glory, 25 Science, Technology and Human Values 139(2000).
PADDY LADD, Understanding deaf culture: in search of deafhood (Multilingual Matters. 2003).
H G BRADSHAW, Synthetic biology and human health: choosing cure or continutiy (2012).
PAUL RICOEUR, Oneself as Another (Kathleen Blamey trans., The University of Chicago Press. 1994).
BLYTHE D HUGHES CM, YU L, RAMANI R, JORDAN C, EDWARDS C, ET AL., Vaccinia virus infections in martial arts gym, Maryland, USA, 2011 Apr Emerg Infect Dis [serial on the Internet] (2008).
GREGORY E. YOUNG , et al., Secondary and tertiary transmission of vaccinia virus from US military service member, 17 EID (2011).
J MARCINAK, et al., Household transmission of vaccinia virus from contact with a military smallpox vaccinee - Illinois and Indiana, 2007, 56 MMWR (Morbidity and Mortality Weekly Report) 478(2007).
JEFFREY S. HALSELL, et al., Myopericarditis Following Smallpox Vaccination Among Vaccinia-Naive US Military Personnel, 289 JAMA: The Journal of the American Medical Association (2003).
Potential Impact:
The SYBHEL Project has provided the first focused analysis of the ethical, legal and policy implications of synthetic biology in respect to human health and well-being. We believe that the research conducted will be of significant value to the scientific, academic and policy-making communities within the EU. Our research should provide a firm foundation for further research and deliberation not only on the ethical and legal issues that might be raised by synthetic biology in respect to human health but also in terms of regulation and policy.
As the policy recommendations and conclusions in the previous section attest, what synthetic biology is (its definition), and what it may make possible in the future are currently subject to deep uncertainty. It is difficult to give a non arbitrary definition of synthetic biology. For example, we might ask that while some techniques may be new, how is ‘synthetic biology’ different from certain conceptions of genetic engineering in terms of motivation and intent? And so far synthetic biology (depending on its definition) has produced very little in terms of actual ‘health’ applications. What counts (or will count) as synthetic biology is in flux. The boundaries of the concept of synthetic biology cannot be drawn in a clear and coherent way. We think the issue of definition will become an increasingly pressing question in terms of law and policy. After all, how can we draft laws or formulate policy and regulations on ‘synthetic biology’ if we have no clear idea of what ‘it’ is or what sort of activity falls within its remit?
Of course, for the purposes of law and policy, we may find that ‘synthetic biology’ is too nebulous and disparate a category to be considered in a singular definitional sense. It may make more sense to consider a range of different definitional synthetic ‘biologies’, which overlap with other forms of biotechnology, covering a range of activities, techniques or approaches. It is also rather probable that some, perhaps many, of the things that we are concerned about (in terms of safety and risk) already fall (or should be interpreted as falling) within the remit of existing laws, policy and regulation (on for example from other forms of existing biotechnology such as lab safety, GMO’s or genetic engineering).
Many emerging technologies, including synthetic biology, insofar as we do have a clear idea of what it is, raise similar ethical issues. As such, we should not consider synthetic biology as exceptional or treat it in isolation. We should consider its ethical, legal and policy issues in conjunction with other biotechnologies and issues concerning human health (again, the concept of ‘health’ is contested and what constitutes a health application should be broadly construed). However, it seems likely that synthetic biology, in conjunction with other forms of biotechnology, may have a significant impact on medicine and people’s everyday lives and health in the future.
While we have argued that synthetic biology may not raise any new or unique ethical issues, the claim that synthetic biology does not raise any new ethical questions does not mean that synthetic biology does not raise any ethical questions or that the ethical questions raised are unimportant, uninteresting or in any way resolved. Synthetic biology, in conjunction with other forms of biotechnology raises many complex philosophical, ethical, legal and policy questions.
Of course, we should question whether the issue of the ‘newness’ or ‘novelty’ of an emerging technology such as synthetic biology is what we should be focussing on in terms of ethics. The likelihood of any ethical question ever being wholly original, novel or unprecedented just because it is being discussed in response to a new technology seems rather unlikely. Obviously this depends on how we choose to interpret the notions of ‘newness’ and ‘novelty’. But it would appear to be rather probable, given the nature of value and the long history of philosophy, that most ethical issues have precedents or have appeared in older analogous forms, or draw on values and concepts that have already been thought about before.
It is difficult to see why a lack of novelty should be considered as disadvantageous to ethical analysis in synthetic biology or even as a relevant issue. That the ethical problems and issues raised by synthetic biology are likely to have past analogues provides a valuable resource to draw on, challenge and reinterpret. That these questions are not new does not and should not detract from their importance. The moral questions raised by synthetic biology are important and ongoing. Some of these questions will be more urgent in the short-term than others (for example issues of risk, safety and dual use). However, some of the other ethical questions (such as those concerning human enhancement, radical life extension and the moral status of synthetic life) may have a more significant impact in the future. What is important is that we begin to consider, speculate and think about these moral issues and the possible future trajectory of synthetic biology before it leaves the confines of the laboratory. We need to have measures in place in order to ensure that the possible future applications of synthetic biology have a largely beneficial impact on people's lives and the general fabric and wellbeing of society.
In terms of potential impact, as has been made clear in the recommendations and conclusions section above, we would like the SYBHEL Project to have an influence on the way in which ELSI and policy research is conducted and conceived in the future. As we have argued throughout the project, ELSI research, its funding and the subsequent policy considerations of new technologies, such as synthetic biology, has often followed a rather formulaic, standardised and moribund path.
There seems to be a problem in bioethics and ELSI research in focusing on ‘novelty’ and ostensibly new and emerging fields of science which both trivialises and ignores the real moral (and social) issues. As Ashcroft and Dawson have both claimed;
...the tendency in the field to take a new sexy science, coin a neologism, start a journal and a society, and bid for Centre funding, speaks to a certain formalism in the development of the field. A standard strategy seems to exist for claiming a terrain for bioethics and fixing credentials. This has evident consequences not only for how the intellectual work is done, but also efforts to influence policy, generate public engagement and political activity, and secure funding and academic tenure.
Over the course of the history of bioethics certain topics have moved in and out of fashion: in the 1970s it was euthanasia and abortion, in the 1980s genetics, in the 1990s stem cells and reproductive technologies, and in the 2000s enhancement and data/tissue storage. However, these trends always have the same dynamic: a new issue is discovered by a few enthusiasts, there is a burst of activity, and then things move on to the next topic. The really depressing thing, though, is that despite the regular change in subject matter, bioethics remains disappointingly, familiar.
There is a danger that research in to the ethical, legal and policy issues of synthetic biology and human health could become just another ELSI fad. We think that concentrating on specific new and emerging technologies and creating sub-disciplines and constructing ‘new’ ethical frameworks is deeply problematic.
The problem of ethical frameworks
For example ethical frameworks often have the effect of stultifying debates over this important emerging area of research. A framework, by its very definition is restrictive and constraining. It obscures while it contains a particular view. It prescribes what is to be focused on at the expense of what lies beyond the frame. It tells us what we should be looking at, and by the nature of a frame how we ought to view it. This seems to be contrary to deep philosophical reflection. It seems plausible that by prescribing a certain framework, no matter how intricate or expansive, we run the risk of missing out on the bigger picture, of failing or missing important philosophical and moral questions that lie beyond its boundaries or questioning the reasons behind the existence of the particular frame that has been constructed.
SynBioEthics: The problem of new subsections of bioethics.
One of the dangers of ever multiplying subsections of bioethics is that rather than the necessary, in-depth and thoughtful consideration of the moral questions posed by a new technology it becomes about the establishment of the sub-discipline itself. There is a concern that this focus can have a tendency towards being myopic and inward. It risks being disconnected and ouroboric, or at least not substantively engaged with the issues it is purportedly concerned with.
There is a danger that the creation of a new sub-discipline simply becomes an exercise in political terrain grabbing, formalism, processes, codification and the establishment of new frameworks and rules. The focus on, and the implementation of, such structures seems likely to draw attention away from the real issues and serves only to inhibit and constrict ethical debate over synthetic biology rather than advance it. We may also think that such formalism is contrary to the very essence and value of philosophy.
Beyond providing a term that can be used as informal linguistic shorthand to refer to a general area of research interest, it is difficult to see what meaningful use or purpose is served by the establishment (or indeed analysis) of ever more sub-disciplines in bioethics. Indeed it is not clear why we should treat the moral questions generated by a specific issue any differently from any other moral question, or moral questions in general.
The standardised ELSI approach: the problem of McEthics©
The problem with usual approaches to ELSI research is that it often leads to a sort of McDonaldsiation of complex philosophical and ethical issues. During SYBHEL workshops it was felt that we should avoid, and be on our guard against simplistic ‘tick box’, ‘check list’ or ‘toolbox’ approaches to ethics which wrongly reduce or conceive of ethics as some sort of risk assessment exercise in calculating probabilities or a formalised, standardised and mechanical process of box-ticking against a list of unquestioned and under analysed principles and concepts.
A different more imaginative and thoughtful approach is required.
As is reflected in the recommendations and conclusions section above, the way in which some ELSI research is conducted needs to change. There should be a move away from focusing on novelty, individual biotechnologies, methodology, the construction of ethical frameworks, and creating ever more subsections of bioethics. Rather, what is needed is a more thoughtful, holistic and imaginative approach to considering the ethical issues that may be raised by emerging technologies. As the SYBHEL Project has argued, rather than constructing and employing a standardised approach, we should draw on our imaginations to speculate on and consider the ethical issues and problems that may arise in the future. We should consider these issues in more depth. We need to consider and interpret the underlying conceptual architecture and think in detail about the sorts of questions and problems that we ought to be answering –regardless of whether they are new or novel.
The issues raised by synthetic biology require a collaborative and interdisciplinary response. It is important that philosophers, ethicists and social scientists work together and collaborate with scientists working in synthetic biology. Social science research in this area is important and should be on going. Public policy should be empirically informed. However, we also suggest that ongoing empirical research, while valuable, is in itself insufficient without ongoing analysis of the normative and conceptual foundations of both synthetic biology and human health, and public policy in general. In terms of synthetic biology, as the SYBHEL Project has argued, certain conceptions such as life, health and synthetic biology itself may be called in to question and require reinterpretation.
The SYBHEL Project has raised questions over what policy is, and ought to be, and where it derives its justification from. There seems to be a degree of confusion or a failure to appreciate the essential normativity of public policy. The values underlying policy also need to be accounted for, questioned and justified. Policymakers and policy documents often seem to employ a range of normative, interpretive concepts such as justice, responsibility and transparency in a rather unthinking way which lacks both clarity and justification. While such things as ‘listening exercises’ and ‘public consultation’ provide an important means of gauging public opinion, they cannot provide a normative justification in and of themselves.
Both public policy in general and public policy in respect of synthetic biology and human health raise a host of important foundational normative and conceptual questions. So while empirical research is valuable and necessary, questions about the ultimate goals, nature, legitimacy and justification of public policy cannot be answered by empirical methods. We suggest that political and legal philosophers may have much to offer in this area. And that these sorts of questions need to be considered and addressed on an ongoing basis when formulating public policy.
Finally, considering the ELSI issues of emerging technology should be collaborative in the sense that it actively engages and interacts with the public(s) and members of civil society. The emerging science of synthetic biology could revolutionise industry and medicine. It may have a significant impact on society and the lives of both living people and future generations. Because of its potential power and the range of technologies and applications that synthetic biology could generate, it is, and will increasingly become, an important and perhaps controversial public issue. It is essential that the public is made aware of, considers, and is consulted about, the potential and power of synthetic biology while it is still in its emergent phase.
Public education, engagement and debate of both the science and the ethical and social issues that might be raised by synthetic biology are crucial. The question is; how can we engage and stimulate public debate about the ethical, social and legal issues posed by synthetic biology? How can we connect in a meaningful way with as wide a section of the public as possible? Traditional methods of public engagement such as science cafes, public lectures, science training and sending theatre groups in to schools all have value (and should be pursued). However, in today's increasingly online multimedia environment the use of more novel and imaginative methods may provide new opportunities and should also be considered and employed.
The imaginative use of the arts, multimedia and online networks have the potential to reach a wide audience in a way which is both highly engaging and interactive as well as being economical. The creative use of such technology promises to transform public engagement into a process that is not just linear – a one or two way flow of information, with the public assuming the role of a predominantly passive audience. But rather, by using the power of the arts, multimedia, and online networks there is the potential for the public to become producers and co-creators of knowledge and ideas, rather than simply commenting consumers of information.
Employing new techniques and presenting the public with information in an interactive forum may enable people to assume a new role. It may create the opportunity for the public to participate not only in the direction of the science of synthetic biology and the technologies it may make possible but also contribute to the formation of public policy - the way in which the science and technologies of synthetic biology should be regulated (if indeed further laws and regulation are required).
Dissemination Activities:
Since the SYBHEL Project’s inception in 2009, dissemination of research, ideas and information on synthetic biology and human health was considered a key issue. The project used a variety of media and methods in order to engage and interact with as many types of people as possible, from academics and policy makers to members of civil society. Methods have included websites, web based blogs, twitter, film, science café’s, podcasts, conferences, workshops and academic publications. A full list of dissemination activities is documented in Table A2 of the report.
Workshops
The SYBHEL Project has organized ten workshops and a conference in the three years.
Workshops have been held in locations across the EU including Bristol, Bilbao, Brussels, The Hague and Zurich culminating in The SYBHEL Final Conference which was held at the British Library in London. The SYBHEL workshops have been an integral part of project in terms of dissemination, research and academic collaboration. The experts invited to these events came from a wide range of disciplines and included synthetic biologists, philosophers, social scientists, bioethicists, theologians and policy makers.
Workshop participants not only came from across the EU but also experts from around the globe, including the US, China and India. Invited participants were asked to submit and present original and substantial papers of over 2500 words. These papers and subsequent workshop analysis were collected together in workshop booklets. Many of these papers have been further revised and submitted to journals.
There are plans to publish book length collections of revised SYBHEL workshop submissions in the future.
The SYBHEL Project organized the following workshops
Zurich Workshops
• (WP2) Ethics of Synthetic Life- An Intercultural Dialogue
• (WP3) How should bioethics respond to synthetic biology?
Bilbao Workshops
• (WP4) Ethics and Clinical applications of Synthetic biology: An Interdisciplinary Dialogue
• (WP5) Synthetic Biology & Human Health: The legal and ethical questions of property and patenting
Brussels Workshops
• (WP6) European Policy for the Governance of Ethical and Legal Issues of Synthetic Biology for Human Health
Bristol Workshops
• (WP3) Conceptual Foundations, Methodology and Ethical Frameworks
• (WP2) Synthetic biology & human health: Ethical and regulatory questions raised by the aim of producing new life forms
The Hague Workshops
• (WP4) Synthetic biology & human health: choosing cure or continuity
• (WP6) Synthetic Biology for Global Health: a Policy Discussion
• (WP5) Synthetic biology & human health: The principles and problems underlying patenting and regulation
London Final Conference
• The SYBHEL Project Final Conference: Policy Recommendations, Key Issues and Further Questions
Website
The SYBHEL website was launched soon after the project commenced in 2009. It can be found online at www.sybhel.org. The SYBHEL website and logo was designed by Alex Calladine. It used a php format to facilitate a dynamic, interactive space that could be accessed and updated by all the SYBHEL partners as well as allowing other registered web users to comment and vote. Furthermore, the design enabled the website to host and stream video from other sites, such as youtube and vimeo, provide podcasts and link to the SYBHEL Project twitter stream (@SYBHEL_Project).
A number of videos and podcasts were produced by the project. The website was regularly updated and featured blogs on a range of issues from the SYBHEL Project partners.
Film
In an effort to engage with the public and disseminate information and ideas about synthetic biology and human health the SYBHEL Project made extensive use of film and video.
Alex Calladine produced a short documentary film The Thread of Life which was short listed for the Bio:fiction Film festival (http://bio-fiction.com). The film contained interviews with SYBHEL partners and external experts in bioethics, STS and philosophy.
In addition, over twenty film interviews, featuring experts in the scientific, philosophical, legal and social have been produced and made available through the SYBHEL website and the SYBHEL vimeo channel. Many of the videos have also been advertised on twitter. At the time of writing this report the SYBHEL videos have attracted over 2000 views.
Short Story Competition
In 2010 the SYBHEL Project launched a multimedia short story competition with the aim of imaginatively investigating public attitudes towards synthetic biology. The competition was advertised on the SYBHEL website (http://sybhel.org/?p=761) twitter and a number of other websites including the Journal for Medical Ethics. The competition attracted entries and interest from across the globe. The short listed authors came from a diverse range of backgrounds and included medical students, a science journalist, a published novelist and a Professor interested in Post-Marxist Approaches to Working Class Literature.
Alex Calladine collected the stories together and produced an ebook which was made available for free on the SYBHEL website, and published on Amazon.com. The competition winner was voted for by the public through the SYBHEL website. Over 585 votes were cast.
List of Websites:
More information about the SYBHEL Project can be found online at www.sybhel.org. The SYBHEL website was designed to be an interactive hub providing information on the ethical, legal and policy issues of synthetic biology and human health to researchers, policy makers and the general public. The website contains not only articles and blogs but also videos and podcasts produced by (and featuring) the SYBHEL Project partners. SYBHEL videos can also be found online on youtube and the Project’s vimeo channel http://vimeo.com/user5259198
The SYBHEL project also has a twitter feed, viewable on the website. To contact the project via twitter go to @SYBHEL_Project.