Shawn Harmon is a Reader in Law who specialises in international and domestic medical law and jurisprudence, human rights and the regulation of new and emerging technologies, particularly those implicating human health and wellbeing, and the operation of law in dynamic and culturally contested settings. He has a particular interest in how high-level and deeply-held socio-moral values are expressed, operationalised in law and regulation, and experienced by groups and individuals acing in different settings.
Shawn's past and ongoing work has explored ethico-legal issues in medical practice, medical research, and biotech innovation, and the interaction of research and governance frameworks with other frameworks, including commercial, human rights, medical, and ethical frameworks. He has examined regulatory instruments in the biobank, stem cell research, and public health settings, adopting a comparative approach. Shawn's interest in interdisciplinarity, empirical research and the potential of the arts to challenge modes of governing and acting has led to a diverse range of projects, including those relating to stem cell research, biobanking, medical devices, public health, disability and digital worlds. His research has been funded by the ESRC, AHRC, IMI, Wellcome Trust, and UEDIN's Challenge Investment Fund, Moray Fund, KEI Fund, and Institute for Advanced Studies in Humanities.
Shawn is a co-founder and Deputy Director of the J Kenyon Mason Institute for Medicine, Life Sciences and Law, an interdisciplinary research institute located within the School of Law, and a Research Collaborator at the Technology Regulation Research Unit, Dalhousie U, Canada. He is Joint Editor-in-Chief of Medical Law International and former Editor-in-Chief of SCRIPTed – A Journal of Law, Technology & Society. Shawn teaches ‘Health, Research and Commercialisation’, 'Compassionate Care and the Law', ‘International Public Health Law and Ethics’, ‘Biotechnology, Law & Society’, ‘Risk and Regulation: Health and the Environment’, and he contributes to a range of other courses in different Schools. He is a Tutor on the ‘Medical Law & Ethics’ CPD programme. Shawn is a Fellow of the Higher Education Academy, and a member of the ESRC Peer Review College, and he has published in wide range of rigorous, peer-reviewed international journals, including those in law, the social sciences, and the arts.
Willingness to take Ph.D. students: Yes
Available Ph.D. research projects:
Shawn is happy to entertain PhD proposals in the areas of medical jurisprudence, compassionate care and the law, medical devices and/or the regulation of new technologies, and human rights and equality.
Qualified Barrister and Solicitor, Nova Scotia Barristers' Society, Canada
Certified Mediator and Alternative Dispute Resolution Practitioner
Trained Qualitative Researcher
Contemporary Issues in Medical Jurisprudence (Honours)
Edward Dove 'Promoting Health Research and Protecting Participants? The Impact of 'Next-Generation' Health Research Regulation on Research Ethics Committees'
Laura Downey 'Technological Challenges to Legal Norms in Health Care'
Nevena Kostova 'The Relationship between Copyright, Creators' Organisations and Business Models'
Books and Reports
Graeme Laurie, Shawn Harmon, Gerard Porter, Mason and McCall Smith's Law and Medical Ethics, (Oxford University Press, 2016)
Abstract: This classic textbook has provided students of medical law and ethics with a framework for exploring this fascinating subject for over 30 years. Providing coverage of all of the topics found on medical law courses, it gives an overview of the inter-relationship between ethical medical practice and the law.Medical law is significantly shaped by the courts, and as such this book provides extensive coverage of recent judicial decisions as well as statutory developments. This book has continually evolved to reflect changes in the law and shifting ethical opinions and the tenth edition continues to fulfil this remit.
Shawn Harmon, Mara Aum, Sky Chase, Kevin Allen, Fever Medicine, (Edinburgh Law School, 2013)
Shawn Harmon, Banking (on) the Brain: The Neurological in Culture, Law and Science, (Project Report, 2012)
Abstract: Through cross-disciplinary investigations and discussions around the governance of brain-banking (BBing), this Project (AH/J011495/1) explored interactions between science and culture, addressing questions pertaining to conceptions of the brain embedded within BB practice, the impacts of these on law, and the legal and cultural traction of the knowledge produced by BBing. This Project found that the brain is salient in legal debates around death and injury compensation, but it is treated like any other tissue/organ when it comes to science regulation. BBs are governed by de jure law and de facto regulation emerging from routinized practice and codes of conduct. Despite resonance of issues and concerns between BBs and other types of biobanks, dialogue about the ethical, legal and cultural aspects and implications of the work in these domains remains limited. More broadly, neurologic knowledge is contributing to the development of ‘neurolaw’ – a discursive realm within which there is often a poverty of understanding of both the scope and limits of neuroscience and BBs, and the practice and meanings of law. Regarding collaboration, this Project shows how the ambiguities and ambivalences that differences between intellectual traditions might produce can be leveraged to animate new interdisciplinary conversations, initiatives, and innovations.
Charlotte Waelde, Abbe Brown, Shawn Harmon, Proposed International Instrument on Limitations and Exceptions for Persons with Print Disabilities, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2011)
Abstract: Intellectual Property Office Consultation
Shawn Harmon, Fabiana Arzuaga, Graeme Laurie, Regenerative Medicine Regulation: Global Issues and Argentine Opportunities, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2011)
Abstract: Policy Brief 1:2011 Drawing on a 2-day interactive expert workshop held on 7-8 November 2011 at the ESRC Genomics Forum in Edinburgh under the Forum’s Bright Ideas Programme, and also drawing on interdisciplinary engagements between interested stakeholders in the Argentine and UK regenerative medicine field that have been ongoing for some four years, this Policy Brief explores key issues in the regulation of cellular products, and, drawing on the EU and UK experience, makes a number of recommendations for regulation in Argentina.
Shawn Harmon, Health Research Governance: Argentine Stakeholder Objectives, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2010)
Abstract: Drawing on empirical research conducted in Argentina through the ESRC-funded ‘GET: Social Values Project’ (see http://www.law.ed.ac.uk/ahrc/esrcvaluesproject/), this Policy Brief (1) offers a very brief overview of the biotechnology research setting in Argentina, (2) provides evidence of stakeholder views on the need for research regulation in the regenerative medicine setting, (3) provides evidence of stakeholder views on the desired content for research regulation in the regenerative medicine setting, and (4) offers some general recommendations for policy in this field.
Shawn Harmon, Guiding Values: Argentine Stem Cell Research and Regenerative Medicine, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2010)
Abstract: Drawing on empirical research conducted in Argentina through the ESRC-funded ‘GET: Social Values Project’ (see http://www.law.ed.ac.uk/ahrc/esrcvaluesproject/), this Policy Brief (1) highlights the importance of moral foundations to science and regulation, (2) provides evidence of Argentine stakeholder views on the appropriate source of moral values for science boundary-setting, (3) provides evidence of Argentine stakeholder views on the values most important to the governance of stem cell and regenerative medicine research, and (4) offers recommendations on how to incorporate this evidence into bioscience and health research policy options in Argentina.
Shawn Harmon, Human Bodies in Medicine and Research: Response to the Nuffield Council Consultation, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2010)
Abstract: The following represents a Response to the Consultation. Registered in April 2010, the Response engages with just some of the themes articulated and questions posed in the Consultation Paper. In particular, it addresses the questions of core values and possible governance structures applicable to the tissue and organ procurement setting. The views expressed herein reflect the author’s personal opinions, and do not necessarily reflect any wider views or opinions of colleagues in SCRIPT or Innogen, the School of Law, or the University of Edinburgh.
Shawn Harmon, Ambition and Ambivilence: Engagement and Policy Dialogues in Argentina, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2010)
Abstract: Drawing on empirical research conducted in Argentina through the ESRC-funded ‘GET: Social Values Project’ (see http://www.law.ed.ac.uk/ahrc/esrcvaluesproject/), this Policy Brief (1) places stem cell and regenerative research in the broader bioscience and health research context, (2) provides evidence of Argentine stakeholder views on the state and value of public engagement in this field, and their desires with respect to science democracy, and (3) offers insights into how this evidence is relevant to bioscience and health research policy options in Argentina.
Graeme Laurie, Shawn Harmon, Genomic Medicine: Response to House of Lords Science and Technology Committee, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Shawn Harmon, Graeme Laurie, The Regulation of Human Tissue and Regenerative Medicine In Argentina: Making Experience Work, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Shawn Harmon, Graeme Laurie, Fabiana Arzuaga, Regulation of Clinical Research Involving Stem Cells: Towards the Construction of a Regulatory Model for Argentina Learning from the Experiences of the United Kingdom, (SCRIPT, 2008)
Abstract: Report on a workshop organised by the University of Edinburgh and the Agency for the Promotion and Science & Technology, Buenos Aires, Argentina 29-30 November 2007 on a stem cell research governance scheme in Argentina.
Shawn Harmon, Risk, Innovation, Diversity, Complexity: Policy Options and Objectives for Stem Cell Regulation, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Abstract: Drawing on the empirical research conducted at InnoGen and research undertaken at SCRIPT, this Policy Brief places stem cell research in the broader bioscience and health research context, highlights what have proven to be effective policy approaches in Europe, identifies some core issues in translating policy objectives into legal regulation, and offers several recommendations to facilitate the design of effective human tissue (and stem cell) regulation in Argentina.
Shawn Harmon, 'Abortion and conscientious objection: Doogan - A missed opportunity for an instructive rights-based analysis', (2016), Medical Law International, pp 1-31
Abstract: Abortion is considered by some to be a morally questionable intervention, one which entitles the healthcarer to exercise conscientious objection so as to opt out of acting. The healthcarer’s right to do so was recently considered by the UK Supreme Court in Greater Glasgow Health Board v Doogan & Wood, a case which set some boundaries on conscientious objection but which failed to engage holistically with the foundation of conscientious objection and its position relative to the competing right to adequate healthcare, a failure which must be seen as a lost opportunity given the manifold threats to timely access to abortion. This paper fills the lacunae. After noting the weaknesses in the Doogan judgment, it justifies the adoption of a more robust approach by the UKSC, and then analyses the moral and rights foundations of abortion and conscientious objection, noticing as it does the growing practical problem that is the expansion and misuse of conscientious objection in women’s health (i.e., its deployment as a barrier to women seeking lawful abortion services). It concludes that courts everywhere, but particularly in jurisdictions that are widely persuasive, such as the UK, when faced with the opportunity to pronounce on the right to abortion and the operation of conscientious objection, should take full advantage, and in doing so should adopt a critical and restrictive approach to its availability in the healthcare context.
Shawn H.E. Harmon, Gill Haddow, Leah Gilman, 'New risks inadequately managed: The case of smart implants and medical device regulation', (2016), Law, Innovation and Technology, Vol 7, pp 231-252
Abstract: Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.
Gill Haddow, Shawn H. E. Harmon, Leah Gilman, 'Implantable Smart Technologies (IST): Defining the ‘Sting’ in Data and Device', (2015), Health care analysis
Shawn Harmon, Dinar Kale, 'Regulating in developing countries: Multiple roles for medical research and products regulation in Argentina and India', (2015), Technology in Society, Vol 43, pp 10-22
Abstract: This paper engages with the complex relationship between innovation and human health and the role of regulation in bringing the two together, and, in doing so, facilitating inclusive innovation in emerging economies. After outlining the contested role of regulation, we provide two case studies: regenerative medicine regulation in Argentina, and medical devices regulation in India. While these empirically-based case studies examine different scientific sectors in different jurisdictions and therefore have different contextual foundations, they demonstrate the important link between regulatory policies and the successful promotion of innovation. Through them we challenge the oft-repeated complaint that regulation stifles innovation, demonstrating that both a lack of regulation (Argentina) and poorly conceived regulation (India) are equally damaging to innovation, to actor wellbeing, and, ultimately, to human health. We argue that devising new forms of regulation can facilitate increased innovation and thus improved technological (and economic) competitiveness (ie: social/regulatory innovation can lead to improved technological/scientific innovation).
Shawn Harmon, Lawrence Gostin, Liz Grant, John Gillies, Graeme Laurie, 'Imagining global health with justice: Ebola, impoverished people and health systems', (2015), Medical Law International, Vol 15, pp 3-18
Shawn Harmon, 'The Invisibility of Disability: Using Dance to Shake from Bioethics the Idea of ‘Broken Bodies’', (2015), Bioethics, Vol 29, pp 488–98
Abstract: Complex social and ethical problems are often most effectively solved by engaging them at the messy and uncomfortable intersections of disciplines and practices, a notion that grounds the InVisible Difference project, which seeks to extend thinking and alter practice around the making, status, ownership, and value of work by contemporary dance choreographers by examining choreographic work through the lenses of law, bioethics, dance scholarship, and the practice of dance by differently-abled dancers. This article offers a critical thesis on how bioethics has come to occupy a marginal and marginalizing role in questions about the differently-abled body. In doing so, it has rendered the disabled community largely invisible to and in bioethics. It then defends the claim that bioethics – as a social undertaking pursued collaboratively by individuals from different disciplines – must take much better notice of the body and the embodied individual if it is to better achieve its ends, which include constructing a moral and just society. Finally, this article considers how the arts, and specifically dance (and here dance by differently-abled dancers), provides us with rich evidence about the body and our ability to respond positively to normally ‘othered’ bodies. It concludes that greater attention to empirical evidence like that being generated in InVisible Difference will help to expand the reach and significance of bioethics, and thereby its relevance to (and consciousness of) important questions about the status of bodies and bodily differences, which must be considered as central to its ambitions.
Shawn Harmon, 'In search of global health justice: A need to reinvigorate institutions and make international law', (2015), Health care analysis, Vol 23, pp 352-375
Abstract: The recent outbreak of Ebola in West Africa has killed thousands of people, including healthcare workers. African responses have been varied and largely ineffective. The WHO and the international community’s belated responses have yet to quell the epidemic. The crisis is characteristic of a failure to properly comply with the International Health Regulations 2005. More generally, it stems from a failure of international health justice as articulated by a range of legal institutions and instruments, and it should prompt us to question the state and direction of approaches to the governance of global public health. This paper queries what might be done to lift global public health as a policy arena to the place of prominence that it deserves. It argues that there are at least two critical reasons for the past, present and easily anticipated future failings of the global public health regime. After exploring those, it then articulates a new way forward, identifying three courses of action that might be adopted in realising better health outcomes and global health justice, namely value, institutional and legal reform.
Shawn Harmon, Abbe Brown, Charlotte Waelde, Sarah Whatley, 'Validation and Virtuosity: Perspectives on Difference and Authorship/Control in Dance', (2015), Choreographic Practices, Vol 6
Abstract: This article brings together two different perspectives, dance and law, to ask questions about authorship and ownership in disabled dance. The focus is on Caroline Bowditch’s short film project, A Casting Exploration, in which she is recast as the female dancer in a duet section from Joan Cleville’s choreography for Scottish Dance Theatre, Love Games. We explore what medical law, human rights law and intellectual property law might say about Bowditch’s role. We show how the film project raises questions about the aesthetic properties of the double duet, the politics of sameness and difference, and who can claim ‘ownership’ of the dance.
Shawn Harmon, 'Graphic and Novel: An Arts and Law Project', (2014), SCRIPTed, Vol 11, pp 132-136
Shawn Harmon, Aisling McMahon, 'Banking (on) the Brain: From Consent to Authorisation and the Transformative Potential of Solidarity', (2014), Medical Law Review, Vol 22, pp 572-605
Abstract: Modern technologies and biomedicine ambitions have given rise to new models of medical research, including population biobanking. One example of biobanking is brain banking, which refers to the collection and storage of brain and spinal cord samples for research into neurological diseases. Obviously, brain banking involves taking brains and tissue from deceased people, a fact which complicates the role of recruiters and makes consent a poor tool for stakeholders. After contextualising brain banking and considering the public health issues at stake, this article explores the legal definitions and demands of, and actual processes around, consent in England/Wales/Northern Ireland and authorisation in Scotland, articulating and evaluating their conceptual and practical differences. It then argues for an expanded but improved operation of ‘authorisation’ in the brain banking (and broader biobanking) setting, adopting ‘solidarity’ as our foundation and the improvement of the ‘public good’ our objective.
Shawn Harmon, Charlotte Waelde, Sarah Whatley, 'Disabled Dance: Grounding the Practice in the Law of ‘Cultural Heritage’', (2014), Web Journal of Current Legal Issues, Vol 20, pp 370
Abstract: The arts, including dance, hold great importance in society. The InVisible Difference project seeks to extend thinking and alter practice around the making, status, ownership, and value of work by contemporary dance choreographers, focusing on that made and performed by differently-abled individuals. This paper considers the position of disabled dance in law and society by asking the overarching question: Is disabled dance a part of our ‘cultural heritage’? This is an important question because it will, or ought to, have both legal and social consequences for this art-form moving forward. First, we examine the legal definition of ‘cultural heritage’ as it has developed in international human rights law and practice. Second, we consider whether disabled dance does or could fit into that definition and therefore claim the protections and potential benefits of that capture. Finally, we consider what might be done under the directive legal instruments that bear on this setting, focusing on the Convention on the Rights of Persons with Disabilities (2006).
Shawn Harmon, Graeme Laurie, Gill Haddow, 'Governing Risk, Engaging Publics, and Engendering Trust: New Horizons for Law and Social Science?', (2013), Science and Public Policy, Vol 40, pp 25-33
Abstract: Modern biosciences require governance frameworks capable of simultaneously managing risk, coping with uncertainty, combating ambivalence, and building trust, while encouraging the delivery of those instrumental outputs that we value/demand. This multi-dimensional task makes the design and delivery of good governance frameworks extremely difficult. Efforts to date have, by and large, failed, particularly where the law has been relied on. Preoccupation with risk has tended to shape regulatory systems, but the conception of risk relied on is deficient, and its use is often oriented to support precautionary approaches in the absence of ‘evidence’. Our collaborative efforts lead us to suggest that more robust mechanisms need to be deployed which reveal and promote interactions with a fuller gamut of risks. We argue for a reflexive mode of governance which addresses the dynamic nature of science and uses the law more effectively as a value- and institution-framing mechanism.
Shawn Harmon, Shang-Yung Yen, Shu-Mei Tang, 'Nanotechnologies: Big Governance Issues for the Science of Small (in Taiwan and Beyond)', (2013), Far East Journal of Psychology and Business, Vol 11, pp 50-72
Abstract: Nanotechnology is the new(est) star in the high technologies sky. Although there are a growing number of academic, policy and industry reports exploring nanotechnology, and although some nano-materials and nano-particle-reliant products are being produced, nanotechnologies remain technologies of promise with many questions yet to be answered about their nature, appropriate development, and optimal social and commercial deployment.Bearing the early nature of this interdisciplinary science in mind, this paper explores some of the essential issues relating to regulation of nanotechnologies, with an emphasis on Taiwan. After briefly reviewing the state of, and hopes for, the science, this paper examines two key regulatory arenas – that of risk management, and that of value/market creation – with which policymakers in Taiwan and beyond must come to grips if the field is to evolve in a desirable manner. After highlighting the challenges represented by both for nanotech regulation, it offers some recommendations for the improvement of the regulatory setting, not only in Taiwan but more broadly.
Shawn Harmon, Gill Haddow, 'Banking (on) the Brain: The Neurological in Culture, Law and Science', (2012), Medical Law International, Vol 12, pp 79-91
Shawn Harmon, Kuan-Hsun Chen, 'Medical Research Data-Sharing: The 'Public Good' and Vulnerable Groups', (2012), Medical Law Review, Vol 20, pp 516-39
Abstract: One of the moral tests of governments is how they treat those in the twilight of life (the elderly). As such, it is important not only to take care of the needs of the elderly, but also to place their reality in the forefront of deliberations and actions. Now that we are in the so-called century of biology, we must ensure that the newly transformed and increasingly relied on biosciences not only respond to the needs of the elderly but also reflect the reality of the elderly. While many arguments can be made in support of increased data-sharing in biomedical research (and indeed within and across healthcare systems more generally), there are some persuasive age-based arguments that might serve to encourage science regulators, through both funding structures and the law, to fundamentally reshape the research environment so as to enhance its potential to achieve public goods such as improved health and more effective healthcare systems. In this paper, after noting the new research model arising from population genomics, with its intense data needs, we advance three age-based arguments, in favour of increased and improved data-sharing, and we conclude with some brief observations about how increased data-sharing might be achieved.
Shawn Harmon, 'From conflicting narratives to legal conflicts: Patenting and irreconcilable differences on the idea of ‘biovalue’', (2012), Medical Law International, Vol 12, pp 191-203
Abstract: Life sciences innovation has prompted both optimism and angst, and has been the subject of intensive economic and commercial activity. That activity has been supported by legal institutions and mechanisms in the form of intellectual property law deployments. However, recent jurisprudence has put the unaltered pursuit of commercial gain in the life sciences into some (slight) doubt, and has reinvigorated the so-called `life patents' debate. This paper considers these recent judicial developments, focusing in particular on how different narratives and approaches to biovalue have coloured litigant approaches. It goes on to consider briefly what these cases and the divergent world views represented within them might mean for the regulation of life science commercial practices moving forward.
Shawn Harmon, Aisling McMahon, 'Banking (On) the Brain: A Report on the Legal and Regulatory Concerns', (2012), SCRIPTed, Vol 9, pp 376-83
Shawn Harmon, 'Peering from the Shadows: Stem Cell Research and the Quest for Regulation in Argentina', (2012), Stem Cell Reports, Vol 8, pp 640-46
Abstract: Science has long been contentious and disruptive. Where it threatens entrenched powers, it has been muzzled, discredited, or simply outlawed. The pursuit of scientific research in social settings where bodies traditionally suspicious of science are politically powerful is doubly challenging when democratic traditions are weak or participative opportunities few, for then there is less opportunity to call upon the informed public to generate support which might circumnavigate the barriers created by these powers. In such situations, researchers can become isolated and marginalised, and potentially fruitful avenues of inquiry can be close off, and science can go ‘underground’ removing it from professional and public scrutiny alike. Drawing on evidence generated in the GET: Social Values Project, this paper considers the Argentine context and the general position of Argentine stem cell researchers as perceived by those researchers and non-researchers who are close to the field. In doing so, it argues that there is an important role for the law in supporting researchers and correcting the science environment, which, in Argentina, lacks transparency, dialogical spaces, appropriate policy influence, and more.
Abbe Brown, Charlotte Waelde, Shawn Harmon, 'Do You See What I See?: Disability, Technology, Law and the Experience of Culture', (2012), International Review of Intellectual Property and Competition Law, Vol 43, pp 901-930
Graeme Laurie, Shawn Harmon, Fabiana Arzuaga, 'Foresighting Futures: Law, New Technologies, and the Challenges of Regulating for Uncertainty', (2012), Law, Innovation and Technology, Vol 4, pp 1-33
Abstract: This paper is concerned with making law more effective in its social operation and in its relationship with dynamic, complex and uncertain science. It explores how we might better regulate by considering the concept and role of 'legal foresighting'. It argues that legal foresighting is eminently justifiable and needs to be expanded, enhanced, and vastly improved. It offers a framework for performing legal foresighting in the face of new and emerging technologies, drawing in particular on the authors' experience in the bioscience and biotechnologies context.
Shawn H. E. Harmon, Shang-Yun Yen, Shu-Mei Tang, 'Invigorating 'Nanoethics': Recommendations for Improving Deliberations in Taiwan and Beyond', (2011), NanoEthics, Vol 5, pp 309-18
Abstract: Nanotechnology is the new(est) star in the high technologies sky. While nanotechnologies remain technologies of promise and potential, a growing number of nano-materials and nano-particle-reliant products are being produced. And although a growing number of academic, policy and industry reports are exploring nanotechnologies, there are very few genuine ethical assessments of nanotechnologies as they exist and might evolve in the coming years. Many questions have yet to be answered about the nature, development, and social and commercial deployment of nanotechnologies and what that means for the human condition and the preservation of our core values. We argue that the early and potentially risky nature of this interdisciplinary science does not justify a blinkered focus on risk assessment and management to the detriment of deep and ranging ethical evaluations. Much improved ethics evaluations must be undertaken, particularly in Taiwan where very little has happened despite grand expectations for, and funding of, the science. In this paper, we uncover the development imperatives for nanotechnologies, demonstrate the paucity of genuine nanoethics exercises, outline key questions for stakeholders undertaking nanoethisc exercises to consider, and we articulate some preliminary actions for Taiwan (and other similarly situated jurisdictions) to take.
Shawn Harmon, 'Book Review of Lawyers' Medicine: The Legislature, the Courts & Medical Practice, 1760-2000', (2011), European Journal of Health Law, Vol 18, pp 107-11
Nayha Sethi, Shawn Harmon, 'Preserving Life and Facilitating Death: What Role for Government after Haas v Switzerland?', (2011), European Journal of Health Law, Vol 18, pp 355-64
Shawn Harmon, 'Ambition and Ambivalence: Encouraging a "Sci-Tech" Culture in Argentina through Engagement and Regulatory Reform', (2011), Studies in Ethics, Law and Technology, Vol 5, pp 1-26
Abstract: Science matters. Science matters to the development of knowledge, to the sustainability of development, and to the shaping of social mores. Countries transitioning from developing to developed must be prepared to make science work for them and to forge a vision to become competitors in some aspects of science innovation. Drawing on data generated by the “Governing Emerging Technologies: Social Values and Stem Cell Regulation in Argentina” Project (ESRC Award No. RES-000-22-2678), this paper (1) places the current Argentine bioscience setting in context by reviewing the development of biosciences in Argentina, (2) explores understandings of the social dimensions of bioscience innovation in Argentina and the possibilities of enhancing public support for science, and (3) offers some preliminary thoughts on a model for socio-legal activity directed at encouraging social engagement with and the uptake of high technologies in Argentina (i.e., the possibilities for generating a positive and facilitative “sci-tech culture” in Argentina).
Shawn H. E. Harmon, Graeme Laurie, 'Yearworth v. North Bristol NHS Trust: Property, Principles, Precedents and Paradigms', (2010), Cambridge Law Journal, Vol 69, pp 476-93
Shawn Harmon, 'Hidden Battles and Stem Cell Research in Argentina: A Response to Salles and Luna', (2010), Developing World Bioethics, Vol 10, pp 111-12
Shawn Harmon, 'Regulation of Stem Cell and Regenerative Science: Stakeholder Opinions, Plurality and Actor Space in the Argentine Social/Science Setting', (2010), Law, Innovation and Technology, Vol 2, pp 95-114
Abstract: This paper articulates in broad terms a model bioscience environment and its primary constituent parts, which include bioscience policy and regulation, technology deployment and stakeholder engagement, and science innovation systems. Then, having reference to empirical data generated by the GET: Social Values Project, it offers an explanation of how the Argentine environment departs from that ideal model. Finally, focusing on one constituent part of the environment – the policy and regulatory space – it reports on Argentine stakeholder opinions and desires and what these mean for the potential to adopt facilitative regulation in Argentina. It concludes that the Argentine scientific environment is sub-optimal and poorly equipped to deal effectively and positively with the plurality of ideas that people have for both the trajectory of science and its regulation. It ends with a call for further research which broadens the evidence base and thereby facilitates the improvement of the social/science environment and its constituent parts.
Shawn Harmon, 'Ayelet Shachar, The Birthright Lottery: Citizenship and Global Inequality', (2010), Social and Legal Studies, Vol 19, pp 131-33
Shawn Harmon, 'Review of The Body in Bioethics by Alastair V Campbell ', (2010), SCRIPTed, Vol 7, pp 226-229
Shawn H. E. Harmon, 'Body Blow: Mature Minors and the Supreme Court of Canada’s Decision in AC v. Manitoba (Director of Child & Family Services)', (2010), McGill Journal of Law and Health, Vol 4, pp 83-96
Shawn H. E. Harmon, Na-Kyoung Kim, 'Acceptance, Modification and Rejection of Paternalism in Korean Medical Law ', (2010), Balsaeng'gwa saengsig, Vol 14, pp 143-154
Abstract: This article analyzes two leading Korean cases which led to opposite conclusions: the Boramae Hospital Case (Korean Supreme Court 2002 Do 995) and the Shinchon Severance Hospital Case (Korean Supreme Court 2009 Da 17471). In doing so, it pays particular attention to the acceptance, modification, and rejection of paternalism, specifically 'physician paternalism' and 'familial paternalism', both of which have long and strongly influenced the Korean medical environment. In Boramae Hospital the Court emphasized the obligation of the physician in terms of the life of the patient (eg: protecting and preserving the life and welfare of the patient). Its position seemed to be based on the traditional physician paternalism which presupposes the ability of physicians to identify right and wrong choices according to natural laws. However, the Court saw itself as the final arbiter of who identifies and determines the real world content and consequences of that natural law. In short, the Court elevated itself to the supreme guardian of the patient, and held that its decision cannot be overruled by that of the patient's family. So without specifically referring to the importance of the family and the role of familial decisions, both long-observed traditions in medical decision-making in Korea, the Court shifted away from familial paternalism. In Shinchon Severance Hospital, the Court explained the meaning of the patient's powers of self-rulemore concretely, explaining its scope and substance in greater detail. The Court held that one can exercise the right of self-rule, even over issues such as death, in the form of 'previous medical directions'. However, this case does not represent a wholesale acceptance of medical autonomy (ie: it does not accept self-rule unconditionally). Rather, the Court accepted the importance of the opinions and decision of physicians and of the Hospital Ethics Commission, and the Court still retained to itself the authority to review and make alterations to 'material' decision. The Court did not overlook the importance of the decision of the patient's family, but it also did not relinquish its status as supreme guardian, emphasizing the 'objective' nature of a decision from the court.
Shawn H. E. Harmon, 'Yearworth v. North Bristol NHS Trust: A Property Case of Uncertain Significance?', (2010), Medicine, Health Care & Philosophy, Vol 13, pp 343-50
Abstract: It has long been the position in law that, subject to some minor but important exceptions, property cannot be held in the human body, whether living or dead. In the recent case of Yearworth and Others v North Bristol NHS Trust, however, the Court of Appeal for England and Wales revisited the property debate and threw into doubt a number of doctrines with respect to property and the body. This brief article analyses Yearworth, (1) reviewing the facts and the Court’s decision with respect to the originators’ proprietary and contractual interests in their body and bodily products, (2) considering the significance of relying on property and its use a legal metaphor, (3) questioning the scope of the property right created, and (4) querying whether an alternate conceptual approach to extending rights and a remedy was warranted. It concludes that, while Yearworth engages with, and impacts on, important theoretical and practical issues—from legal, healthcare and research perspectives—it does not offer a great deal of guidance and, for that reason, its precedential significance is in doubt.
Shawn H. E. Harmon, 'Consent and Conflict in Medico-Legal Decision-Making at the End of Life: A Critical Issue in the Canadian Context', (2010), University of New Brunswick Law Journal, Vol 60, pp 208-229
Shawn H. E. Harmon, Chunshui Wang, Jing Bai, 'Organ Transplantation in China and Beyond: Addressing the ‘Access Gap’', (2010), Medical Law International, pp 191-216
Shawn Harmon, 'Review of Reinventing Data Protection? ', (2010), Studies in Ethics, Law and Technology, Vol 4
Gill Haddow, Ann Bruce, Jane Calvert, Shawn Harmon, Wendy Marsden, 'Not "Human" Enough to be Human but not "Animal" Enough to be Animal - the Case of the HFEA, Cybrids and Xenotransplantation in the UK ', (2010), New Genetics and Society, Vol 29, pp 3-17
Abstract: Innovations in scientific and medical technologies, such as xenotransplantation and admixed embryos, invariably become the target of regulatory agencies and often demand new regulatory frameworks. In making decisions associated with these innovations, it is sometimes necessary for regulators to adopt certain positions about the status and significance of the human–animal embryo or body. In the UK, the regulatory and advisory bodies involved in the sphere of human/non-human transfer and exchange of material are: (1) the Human Fertilisation and Embryology Authority (HFEA); (2) the (defunct) UK Xenotransplantation Interm Regulatory Authority; and (3) the Home Office's Animal Procedures Committee (APC). In this article, we critically examine the reasons for the HFEA's involvement in regulating and advising in research which uses admixed embryos, given that the HFEA's remit is the government's fertility watchdog regulating in the area of human embryos. This expansion, we argue, was partly due to pressure from pro-cybrid supporters and the need to fill an institutional void left by the decommissioning of UKXIRA. Ironically, specific institutions such as UKXIRA may have been better placed to deal with animal–human fusions.
Shawn Harmon, Yolande Stolte, 'Review of 100 Poems by SS Prasad ', (2010), SCRIPTed, Vol 7, pp 588
Shawn Harmon, 'Multicultural Jurisprudence: Comparative Perspectives on the Cultural Defense', (2010), Social and Legal Studies, Vol 20, pp 557-61
David Castle, Peter WB Phillips, Abbe Brown, Keith Culver, Daniela Castrataro, Tania Bubela, Shawn Harmon, Graham Dutfield, Patricia Barclay, 'Knowledge Management and the Contextualisation of Intellectual Property Rights in Innovation Systems ', (2010), SCRIPTed, Vol 7, pp 32-50
Abstract: Wealth creation and the assessment of prosperity are increasingly tied to science and technology based innovation. Knowledge drives innovation, but knowledge is intangible and defies easy management using methods developed to create, track, value and account for tangible assets. Inventors, innovators, venture capitalists, companies, governments and civil society all have a stake in the management of knowledge, and recognise the magnitude of the challenge behind any demand for effective management of innovation systems. For these and related reasons, formal law-based systems for intellectual property management have come to the fore, demonstrating that innovation is indeed occurring. Intellectual property, particularly patents, have a multiplicity of functions as countable inputs and outputs of innovation systems, exchange tokens, social signals, factors in the coordination of innovation, strategic building blocks in securing competitive market positions, and so on. Patents are so central to conceptions of innovation that entire innovation systems are being conceived in terms of the dynamics of intellectual property protection.Whether patents can be relied upon to serve all of the functions demanded of them, and whether there is a need to reconceptualise innovation systems was the question put to a group of Scottish and Canadian experts. Recognising that critiques of patenting, and especially licensing behaviour, have in recent years gained notoriety as alternatives such as open-source and patent pools are considered and tested, the workshop participants explored a path that is less often taken. The less common, alternative, approach to intellectual property views it as one among other kinds of intangible asset requiring active management. Although an extensive knowledge management literature exists, it has not effectively located formal intellectual property management within the broader and more important exercise of knowledge generation and management.The exploration of these themes begins with a discussion of the advent of knowledge-based economies in which the management of intellectual assets is a serious challenge. Intellectual property rights are but one type of knowledge asset, and there is a broader context of intangible asset management that is easily lost when attention is paid exclusively to intellectual property rights. How this happens is explained in the third section, in which the over-reliance on intellectual property rights as a metric of innovation is discussed. The several problems discussed in this section, combined with the discussion of knowledge management from the preceding section, sets the context for a new conception of intellectual property rights as a type of managed knowledge in innovation systems. By contextualising and deemphasising the role of intellectual property rights – the ‘un-IP’ heuristic – a set of alternative priorities emerges regarding the management of knowledge in innovation systems. These eight themes are discussed in detail in the latter half of the paper, and lead to some general conclusions about how knowledge management and innovation systems ought to be construed, and how intellectual property rights within such systems should be interpreted, as well as suggestions for the direction of future research.
Shawn Harmon, Wiebke Abel, 'Technology Convergence: Governance and Gaps in the Era of Enhancement (or “ZombAIs ante Portas!”)', (2010), SCRIPTed, Vol 7, pp 338-350
Abstract: The term “zombie” has been defined variously as “a mechanically driven human corpse,”1 “a supernatural power or spell that … can enter into and reanimate a corpse, and a corpse revived in this way”,2 and “a person who is or appears to be lifeless, apathetic, or totally lacking in independent judgment; automaton”.3 Drawing on these definitions, a “zombAI” might be described as “an otherwise inert artificial intelligence-controlled human being.” Just as human zombies are very real,4 so zombAIs may (in future) become a reality. But what issues are thrown up by zombAIs? Is the law equipped to deal with them? What sort of reforms might be needed to govern them appropriately? This paper undertakes a very preliminary – indeed speculative – exploration of some of the issues implicated by the convergence of several high technologies and their potential to create zombAIs. After framing the assessment via a fictional scenario, we consider the state and trajectory of medical biotechnologies, nanotechnologies and artificial intelligence (AI), arguing that their convergence will lead to zombAIs and the scenario offered. Next, we identify some key social, ethical and legal issues raised by the scenario before querying the capacity of existing regulatory instruments to address these issues (i.e. to address the development of moral machines and intelligent implants). We conclude that there is a need for more “joined-up” regulation to govern such convergences, which will see the science fiction of today (both utopian and dystopian) become a reality.
Ann Bruce, Shawn H. E. Harmon, 'Discursive Typologies and Moral Values in Stem Cell Politics, Regulation and Commercialisation: Some Preliminary Observations', (2009), Journal of International Biotechnology Law, Vol 6, pp 61-66
Abstract: Great importance is attached to, and great controversy surrounds, biotechnology generally and stem cell research more specifically, particularly human embryonic stem cell research. Given its position at the vanguard of innovations in theoretical and applied human healthcare science, and as a source of political conflict and achievement, it is useful to examine attitudes toward, and actions around, embryonic stem cell research. This article conceives of three discursive typologies and explores their deployment in three different settings or sites in the life or progress of embryonic stem cell research, namely, the political (determining legal boundaries), the hybrid (identifying and enforcing boundaries for laboratory research), and the administrative (enforcing boundaries in the commercial context), the intention being to determine whether these typologies are consistent and what moral values their use supports. This article concludes that the typologies are deployed to varying degrees in the different sites, and with varying degrees of success. Although this might be expected, and not altogether unwarranted, given the different roles and objectives of the primary institutions at each site, the current prevalence of the typologies suggests that these institutions might not be operating optimally from the democracy enhancement and transparency points of view.
Timothy Caulfield, Amy Zarzeczny, Jennifer McCormick, Tania Bubela, Christine Critchley, Edna Einsiedel, Jacques Galipeau, Shawn Harmon, Michael Huynh, Insoo Hyun, Judy Illes, Rosario Isasi, Yann Joly, Graeme Laurie, Geoff Lomax, Holly Longstaff, Michael McDonald, Charles Murdoch, Ubaka Ogbogu, Jason Owen-Smith, Shaun Pattinson, Shainur Premji, Barbara Tigerstrom, David E. Winickoff, 'The Stem Cell Research Environment: A Patchwork of Patchworks', (2009), Stem Cell Reports, Vol 5, pp 82-88
Abstract: Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.
Shawn Harmon, 'Semantic, Pedantic or Paradigm Shift?: Recruitment, Retention and Property in Modern Population Biobanking', (2009), European Journal of Health Law, Vol 16, pp 27-43
Abstract: Evolving uses of human biological material, including their collection and retention in biobanks and their distribution to diverse projects, are sites of great tension from the human rights perspective. In the medical-legal setting, these rights are often protected and realised through consent practices. In the biobank setting, there endures a widely shared concern over consent, and the many divergent ways it is fashioned and deployed. This article reconsiders consent in the biobank setting, first, addressing the theoretical foundation of consent and its deployment in the broader medical context, second, examining the nature of biobanks and the uncomfortable position of consent therein, and finally, offering a means of approaching recruitment and retention in the biobank setting which is sensitive to originator interests, including human dignity, doing so within the rubric of a property model.
Shawn Harmon, 'International Public Health Law: Not so Much WHO as Why, and Not Enough WHO and Why Not?', (2009), Medicine, Health Care & Philosophy, Vol 12, pp 245-55
Shawn Harmon, 'New Technologies and Moral Duties: Valuing the Person as a Means to an End', (2009), Science as Culture, Vol 18, pp 505-10
Shawn Harmon, 'Regenerative Medicine Governance: Report of the Workshop on Governance of Research Using Human Embryonic Tissue', (2009), SCRIPTed, Vol 6, pp 729-740
Shawn Harmon, 'Of Plants and People: Why Do We Care About Dignity?', (2009), EMBO Reports, Vol 10, pp 1-3
Shawn H. E. Harmon, Na-Kyoung Kim, 'Medical Research Governance in Korea: The New Bioethics and Biosafety Amendment Bill or ‘Inertia Reiterated'', (2008), SCRIPTed, Vol 5, pp 575-582
Shawn Harmon, 'Review of Gene Patents and Public Health, by Geertrui Van Overwalle, ed. ', (2008), SCRIPTed, Vol 5, pp 614-18
Shawn H. E. Harmon, Na-kyoung Kim, 'A Tale of Two Standards: Drift and Inertia in Modern Korean Medical Law', (2008), SCRIPTed, Vol 5, pp 267-93
Shawn Harmon, 'Ethical Rhetoric: Genomics and the Moral Content of UNESCO’s ‘Universal’ Declarations', (2008), Journal of Medical Ethics, Vol 34, pp e24
Shawn Harmon, 'Ethics and the Law of Intellectual Property: Current Problems in Politics, Science and Technolology', (2008), Medicine, Health Care & Philosophy, Vol 11, pp 237-246
Shawn Harmon, 'Emerging Technologies and Developing Countries: Stem Cell Research Regulation and Argentina', (2008), Developing World Bioethics, Vol 8, pp 138-50
Shawn Harmon, 'Biotechnology Innovation and Patenting in the Developing World: China – A Giant Among Nations?', (2007), ICFAI Journal of Intellectual Property Rights, Vol 12, pp 72-85
Abstract: The mantra of pro-patenting stakeholders is that intellectual property rights, and in particular patent rights, promote innovation. But can this claim be supported? And is it always true? This article analyses the claim within the context of the developing world and healthcare settings. Having articulated the special case that medical patents represent in the developing world, it goes on to consider the patent regime in China, outlining the content of the modern Chinese patent law with a view to assessing how it reflects China’s economic and healthcare situation, and identifying what other developing countries might take from it.
Shawn Harmon, 'Imagining Argentina: From the Moral to the Legal in Cloning and Stem Cell Research Governance in Argentina', (2007), Panóptica, Vol 2, pp 1-16
Abstract: Given its intimate relationship to the human body, genomic innovation implicates diverse ethical issues, and this is particularly so with respect to human stem cell research, which relies on material harvested from the body. This paper outlines the domestic and international social setting within which stem cell research and cloning debates are held, explores the contested ethical positions articulated in response to stem cell research and cloning, then considers whether and how the moral values underlying those positions are dealt with in Argentina’s governance of this science. Ultimately, these values are not well embodied in the very limited and minimalist Argentine regulation which exists.
Shawn Harmon, 'Solidarity: A (New) Ethic for Global Health Policy', (2006), Health care analysis, Vol 14, pp 215-236
Abstract: This article explores solidarity as an ethical concept underpinning rules in the global health context. First, it considers the theoretical conceptualisation of the value and some specific duties it supports (ie: its expression in the broadest sense and its derivative action-guiding duties). Second, it considers the manifestation of solidarity in two international regulatory instruments. It concludes that, although solidarity is represented in these instruments, it is often incidental. This fact, their emphasis on other values and their internal weaknesses diminishes the action-guiding impact of the solidarity rules. The global health and human subject research scene needs a completely new instrument specifically directed at means by which solidarity can be achieved, and a reformed infrastructure dedicated to realising that value.
Shawn Harmon, 'Council of Europe: The Recommendation on Research on Biological Materials of Human Origin: Another Brick in the Wall', (2006), European Journal of Health Law, Vol 13, pp 293-301
Renate Gertz, Shawn Harmon, Graeme Laurie, Geoff Pradella, 'Developments in Medical Law in the United Kingdom in 2005 and 2006 ', (2006), European Journal of Health Law, Vol 13, pp 143-158
Abstract: This article highlights and summarises the key developments in medical law in the jurisdictions of the United Kingdom in 2005 and to April 2006. Topics are mental health and mental capacity, data protection, freedom of information and the impact on health data, the Human Tissue Act, genetic research databanks, Human Fertilisation and Embryology Act--Review of the legislation, consultations and related case law, developments in embryo and embryonic stem cell research, clinical trials and human subject research, medical futility, and physician assisted dying.
Shawn Harmon, 'From Engagement to Re-Engagement: The Expression of Moral Values in Patenting Proceedings, Present and Future', (2006), European Law Review, Vol 31, pp 642-666
Shawn Harmon, 'The Recommendation on Research on Biological Materials of Human Origin: Another Brick in the Wall', (2006), European Journal of Health Law, Vol 13, pp 293-310
Shawn Harmon, 'A Penny For Your Thoughts, A Pound For Your Flesh: Implications of Recognizing Property in Human Body Parts', (2006), Medical Law International, Vol 7, pp 329-54
Abstract: The implications of recognizing property in our own excised body parts are vast and far reaching, involving ethical, legal and practical issues that cut across many aspects of modem social intercourse and legal regulation. Arguments both for and against such recognition are well rehearsed; enough has been written to fill a small library, or at least a large bookshelf. A significant portion of the work considers the role and impact of such recognition on human dignity. Indeed, given the special status accorded the human body, it is impossible to avoid human dignity and its interaction with the various choices presented by the adoption of a property model. However, reference to this general ethical value is of little assistance. Here, the ethical foundation of a property model is considered within the context of medical ethical four principles, namely autonomy, beneficence, non-maleficence and justice. If such a model promotes these principles, it can be ethically defended. The primary implication of recognizing property in our own excised body parts — the emergence of transactions relating to such parts as between originators and third parties — is assessed against these principles and found to be ethically defensible. In the course of that assessment, many of the derivative implications of adopting such a system (procurement, risk, allocation) are discussed. The necessary alterations to or limitations of the more purely property law principles are also briefly considered, namely issues of title, transfer, valuation and quality. The paper concludes that a property model is ethically supported and legally manageable, and, despite the near impossibility of seeing it come to fruition, it may be the only way to truly engage potential “donors” and recognize in them the same value and rights currently enjoyed by other actors in the body part industry.
Shawn Harmon, 'The Significance of UNESCO’s Universal Declaration on the Human Genome and Human Rights ', (2005), SCRIPTed, Vol 2, pp 18-47
Shawn Harmon, 'Not Foresighting, Not Answering Using Graphic Fiction to Interrogate Social and Regulatory Issues in Biomedicine' in Thomas Giddens (ed.) Graphic Justice (Routledge 2015) 71-88
Shawn Harmon, 'Genetics Legal Issues' in James Wright (ed.) International Encyclopaedia of the Social and Behavioural Sciences (Elsevier Oxford 2015) 1001-1008
Abstract: The legal challenges of emerging genetic practices are numerous and fundamental. Not only has genetics destabilized concepts of personhood, community, health, and disease, but also it has complicated the regulation of many fields, throwing into question settled concepts and mechanisms. This article highlights a range of live legal issues and then focuses on issues found in four settings: newly emerging research models, commercial practices associated with genetics, food security, and the practice of law. It concludes by suggesting that we are little closer to determining the appropriate role and form of law in relation to genetics than we were a decade ago.
Graeme Laurie, Shawn Harmon, 'Through the Thicket and Across the Divide Successfully Navigating the Regulatory Landscape in Life Sciences Research' in Emilie Cloatre, Martyn Pickersgill (ed.) Knowledge, Technology and Law (Routledge 2014) 121-36
Shawn Harmon, Dinar Kale, 'A View Against the Grain? The Role of Regulation in Argentine and Indian Bioscience Innovation' in 2nd Joint BISA-ISA International Conference (The Open University 2012) 18
Abstract: This paper engages with the complex relationship between innovation and human health and the role of regulation in bringing the two together, and, in doing so, facilitating sustainable development in emerging economies within the context of increasingly globalised markets and practices. After outlining the contested role of regulation in fields reliant on innovation, we provide two case studies derived from our empirical research into regenerative medicine regulation (in Argentina) and medical devices regulation (in India). While these case studies examine different scientific sectors in very different jurisdictions and therefore have very different factual foundations, they both demonstrate the important link between regulatory policies and innovation promotion. Through these case studies we challenge the oft-repeated complaint that regulation stifles innovation. We demonstrate that both a lack of regulation (Argentina) and poorly conceived regulation (India) are equally damaging to innovation, to actor wellbeing, and, ultimately, to human health.
Shawn Harmon, 'Governing Reproductive Treatment and Research From the Moral to the Political to the Legal - and Back Again? Or ‘There and Back Again, a Regulator’s (Hobbit’s) Odyssey (Holiday)’' in Catherine Lyall, James Smith, Theo Papaioannou (ed.) Limits to Governance (Ashgate Publishing 2009) 79-106
Shawn Harmon, 'Motivating Values and Regulatory Models for Emerging Technologies Stem Cell Research Regulation in Argentina and the United Kingdom' in Michael Freeman (ed.) Law and Bioethics (Oxford University Press 2008) 147-76
Abstract: This chapter considers and compares the stem cell research (SCR) regulation of two different jurisdictions: Argentina, a southern developing country and technology importer with aspirations to become an SCR power, and the United Kingdom, a northern developed country and recognized SCR leader. In addition to exposing the content and characterizing the model of the regulation adopted in each jurisdiction, the chapter considers how (and whether) the values have manifested within the regulation, and how (and whether) the regulation enhances or realizes these values ‘on the ground’ (i.e., do they translate these moral values into binding action guiding-legal rules?). It is shown that the morality of SCR remains contested, and so long as this situation endures, the chance of formal legal harmonization of substantive practices remains remote.
Shawn Harmon, Renate Gertz, Geoff Pradella, 'Ethico-Legal Issues in Genetics ' in Alan Wright, Nicholas Hastie (ed.) Genes and Common Disease (Cambridge University Press 2007) 176-198
Graeme Laurie, Shawn Harmon, 'Through the Thicket and Across the Divide: Successfully Navigating the Regulatory Landscape in Life Sciences Research' 2013
Abstract: This chapter addresses the considerable problems that arise within and between regulatory regimes when there is a failure to implement intelligent design that is responsive to the realities of life sciences research. We argue that a root cause of these problems is the dichotomization of regulatory regimes as between tissue and data and the creation of a non-nexus between bodies of knowledge and legal responses to technological developments. The result is a regulatory thicket and a net failure to deliver effective, efficient and proportionate regimes. Taking the UK and European context as its example, this chapter argues for a collapse in the distinction between tissue and data and for more fluid and reflexive governance systems that not only embody interdisciplinary intelligent design but are also constructed around legal architectures that are responsive to changing scientific and social mores. This requires less, not more, proscription from law.
Shawn Harmon, 'Yearworth v. North Bristol NHS Trust: A Property/Medical Case of Uncertain Significance?' 2011
Shawn Harmon, 'A Penny for your Thoughts, A Pound for your Flesh: Implications of Recognizing Property Rights in our own Excised Body Parts' 2011
Shawn Harmon, 'Emerging Technologies and Developing Countries: Stem Cell Research (and Cloning) Regulation and Argentina' 2011
Shawn Harmon, 'Solidarity: A (New) Ethic for Global Health Policy' 2011
Shawn Harmon, 'Ethical Rhetoric: Genomics and the Moral Content of UNESCO's "Universal" Declarations' 2011
Shawn Harmon, 'From Engagement to Re-Engagement: The Expression of Moral Values in European Patent Proceedings, Present and Future' 2011
Shawn Harmon, 'Semantic, Pedantic or Paradigm Shift?: Recruitment, Retention and Property in Modern Population Biobanking' 2011
Shawn Harmon, 'A Tale of Two Standards: Drift and Inertia in Modern Korean Medical Law' 2009
Abstract: Like all nations, the national character of Korea has been shaped by a variety of geographic and historical factors. Some of the characteristics that have emerged from Korea’s experience are ‘familism’ and ‘scientism’, both of which have had, and are having, a fundamental impact on the content and application of medical law. These phenomena, combined with recent events both inside Korea (eg: a physicians’ strike (2000) and the more important Hwang scandal (2005)) and outwith (eg: the spread of ‘informed consent’ (1980s), the commencement of the Human Genome Project (1990), and the cloning of Dolly the Sheep (1997)), have contributed to a flurry of recent governance activity in Korea. Given the latest legislative proposals offered, we explore two areas of Korean medical law with a view to exposing their trajectories. First, we examine the governance of the patient-physician relationship in the clinical setting, paying particular attention to consent and to liability. Second, we examine the legal-ethical control of biotech research in the medical research setting, paying particular attention to consent, quality control and limits. We conclude that these two arenas appear to be traveling down two dramatically different (if not divergent) roads; in the case of the former, drifting away from traditional practices, and in the case of the latter, remaining mired in imbalance and dominated by antithetical interests.
Shawn Harmon, 'Values, Hopes and Concerns ' 2010
Abstract: Report on the ‘GET : Governing emerging technologies : social values and stem cell regulation in Argentina' project for the Advisory Commission on Regenerative Medicine and Cellular Therapies (and invited participants).
Shawn Harmon, Shang-Yung Yen, 'Trust and Legitimacy in Taiwan Biobank: The Significance of Aboriginal Involvement' 2010
Shawn Harmon, 'UK Biobank: Fostering Public Trust Through Innovative Ethical Governance' 2010
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Adult Stem Cells: The Science' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Adult Stem Cells: Ethics & Issues' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - The Policy-Making Process' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Moral/Social Values' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Foetal Stem Cells: Ethics & Issues' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Embryonic Stem Cells: Ethics & Issues' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Embryonic Stem Cells: The Science' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regenerative and Cellular Sciences: An Interactive Workshop - Foetal Stem Cells: The Science' presented at Argentina Stem Cell Commission & GET: Social Values Project, "Regenerative and Cellular Sciences: An Interactive Workshop" Buenos Aires Argentina 2009
Shawn Harmon, 'Regulatory Models for Emerging Technologies: Stem Cell Research Regulation in Argentina and the UK' presented at Researching the Public Interest and Health Workshop Edinburgh United Kingdom 2008
Abstract: Presented at: University of Edinburgh, 'Researching the Public Interest and Health' (Workshop, 3 March 2008)
Shawn Harmon, 'Argentina Unbound: Governing Emerging Technologies: Social Values in Stem Cell Regulation in Argentina' 2008
Abstract: Presented at:European Association of Health Law, 'The Future of Health Law in Europe' (Conference, 10-11 April 2008, Edinburgh) U. of Edinburgh, 'Researching the Public Interest and Health' (Workshop, 3 March 2008, Edinburgh)