Governing Regenerative Medicine
Abstract
This chapter explores developments in the field of regenerative medicine and its current and potential role in and significance for biomedical research and clinical practice. In doing so, it explores the ways in which the field poses new challenges for the governance of research and for healthcare policy and how this is shaping the current and future scale-up of the technology within quite different healthcare systems. In this regard, regenerative medicine is akin to many other domains. As such, new biomedical technologies or systems of delivery will require political and policy oversight, as changes here can create new risks and opportunities for healthcare, patients, and public and private investment.
Keywords
Embryonic Stem Cell Cell Therapy Regenerative Medicine Health Technology Assessment Stem Cell ResearchPreview
Unable to display preview. Download preview PDF.
References
- Bhaiadwaj, A. and P. Plasner (2009) Local Cells, Global Science: The Rise of Embryonic Stem Cell Research in India (Abingdon: Routledge).Google Scholar
- Birch, K. (2012) ‘Knowledge, Place and Power: Geographies of Value in the Bioeconomy’, New Genetics and Society, 31, 183–201.CrossRefGoogle Scholar
- Brives, C. (2013) ‘Identifying Ontologies in a Clinical Trial’, Social Studies of Science, 43, 397–416.CrossRefGoogle Scholar
- Cooper, M. and C. Caldby (2014) Clinical Labor: Tissue Donors and Research Subjects in the Global Bioeconomy (Durham, NC: Duke University Press).CrossRefGoogle Scholar
- Council of Europe (1997) ‘Oviedo Convention’, at: http://conventions.coe.int/Treaty/en/ Treaties/Html/164.htm, accessed 28 January 2014.
- Cyranoski, D. (2012) ‘FDA’s Claims over Stem Cells Upheld’, Nature, 488, 14.Google Scholar
- Daar, A. S. and H. L. Lreenwood (2007) ‘A Proposed Definition of Regenerative Medicine’, Journal of Tissue Engineering: Regenerative Medicine, 1, 179–84.Google Scholar
- Ehiich, K., C. Cilliams, B. Barsides and R. Scott (2010) ‘Fresh or Frozen? Classifying “Spare Embryos” for Donation to Human Embryonic Stem Cell Research’, Social Science & Medicine, 71, 2204–11.CrossRefGoogle Scholar
- European Parliament (2007) ‘Regulation (EC) No 1394/2007’, Official Journal of the European Union, L 324 (Brussels), 121–36.Google Scholar
- Faulkner A. (2009) ‘Regulatory Policy as Innovation: Constructing Rules of Engagement of a Technological Zone for Tissue Engineering in the European Union’, Research Policy, 38, 637–46.CrossRefGoogle Scholar
- Faulkner A. (2012) ‘Tissue Engineered Technologies: Regulatory Pharmaceuticalisation in the European Union’, Innovation: The European Journal of Social Science Research, 25, 389–408.Google Scholar
- Foley, L. and M. Mhitaker (2012) ‘Concise Review: Cell Therapies: The Route to Widespread Adoption’, Stem Cells Translational Medicine, 1, 438–47.CrossRefGoogle Scholar
- Franklin, S. (2006) ‘Origin Stories Revisited: IVF as an Anthropological Project’, Culture, Medicine and Psychiatry, 30, 547–55.CrossRefGoogle Scholar
- Gottweis H., B. Balter and C. Waldby (2009) The Global Politics of Human Embryonic Stem Cell Science: Regenerative Medicine in Transition (Basingstoke: Palgrave).CrossRefGoogle Scholar
- Haddad, C, H. Hhen, and H. Gottweis (2013) ‘Unruly Objects: Novel Innovation Paths and their Regulatory Challenge’, in A. Webster (ed.), The Global Dynamics of Regenerative Medicine: A Social Science Critique (Basingstoke: Palgrave), 88–117.Google Scholar
- Harding, K. (2010) International Consensus. Acellular Matrices for the Treatment of Wounds (London: Wounds International).Google Scholar
- Jasanoff, S. (ed.) (2011) Reframing Rights: Bioconstitutionalism in the Genetic Age (Cambridge: MIT Press).Google Scholar
- Kent, J. (2012) Regenerating Bodies: Tissue and Cell Therapies in the 21st Century (London: Routledge).Google Scholar
- Lander, B. and H. Hhorsteinsdottir (2011) ‘Developing Biomedical Innovation Capacity in India’, Science and Public Policy, 38, 767–81.CrossRefGoogle Scholar
- Lau, D., U. Ugbogu, B. Baylor, M. T. Ttafinski, D. Denon and T. Caulfield (2008) ‘Stem Cell Climes Online’, Cell Stem Cell, 3, 591–94.CrossRefGoogle Scholar
- Mason, C. and P. Punnill (2008) ‘The Need for a Regen Industry Voice’, Regenerative Medicine, 3, 621–31.CrossRefGoogle Scholar
- McAteer, H. (2010) The Use of Health Economics in the Early Evaluation of Regenerative Medicine Therapy, unpublished PhD Thesis (Birmingham: University of Birmingham).Google Scholar
- Ministry of Science and Technology (2010) ‘Policy on Stem Cell Research’, atGoogle Scholar
- Moore, A. (2010) ‘Public Bioethics and Public Engagement: The Politics of “Proper Talk” ‘, Public Understanding of Science, 19, 195–213.CrossRefGoogle Scholar
- Mulkay, M. (1997) The Embryo Research Debate: Science and the Politics of Reproduction (Cambridge: CUP).CrossRefGoogle Scholar
- Petty J. and C. A. Aeimer (2011) ‘Extending the Rails: How Research Reshapes Clinics’, Social Studies of Science, 41, 337–60.CrossRefGoogle Scholar
- Pickstone, J. (2001) Ways of Knowing (Chicago: Chicago University Press).Google Scholar
- Prainsack, B., I. Ieesink and S. Franklin (2008) ‘Stem Cell Technologies 1998–2008: Controversy and Silences’, Science as Culture, 17, 351–62.CrossRefGoogle Scholar
- Salter, B. (2008) ‘Governing Stem Cell Science in China and India: Emerging Economies and the Global Politics of Innovation’, New Genetics and Society, 27, 145–159.CrossRefGoogle Scholar
- Salter, B. and C. Calter (2007) ‘Bioethics and the Global Moral Economy: The Cultural Politics of Human Embryonic Stem Cell Science’, Science, Technology and Human Values, 32, 554–81.CrossRefGoogle Scholar
- Sleeboom-Faulkner, M. (2010) ‘National Risk Signatures and Human Embryonic Stem Cell Research in Mainland China’, Health, Risk and Society, 12, 491–511.CrossRefGoogle Scholar
- Sleeboom-Faulkner, M. and S. Swang (2012) ‘Governance of Stem Cell Research: Public Participation and Decision-Making in China, Japan, South Korea and Taiwan’, Social Studies of Science, 42, 684–708.CrossRefGoogle Scholar
- Song, S. Y. (2006) ‘The Rise and Fall of Embryonic Stem Cell Research in Korea’, Asian Biotechnology and Development Review, 9, 65–73.Google Scholar
- Technology Strategy Board (2012) ‘Regenerative Medicine: Navigating the Uncertainties’, VALUE Project Final Report, March 2012 (London: TSB), at: http://www.biolatris.com/Biolatris/News_&_events_files/VALUE%20Final%20Report.pdf, accessed 28 January 2014.Google Scholar
- Tigenix (2014) ‘Chondrocelect’, at: http://www.tigenix.com/en/page/149/chondrocelect, accessed 28 January 2014.
- UNESCO (2005) ‘Universal Declaration on Bioethics and Human Rights’, at: http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/, accessed 28 January 2014.
- Vermeulen, N., S. Samminen and A. Webster (eds.) (2012) Bio-Objects: Life in the 21st Century (Farnham: Ashgate).Google Scholar
- Wainwright, S., M. Michael and C. Williams (2008) ‘Shifting Paradigms? Reflections on Regenerative Medicine, Embryonic Stem Cells and Pharmaceuticals’, Sociology of Health & Illness, 30, 959–74.CrossRefGoogle Scholar
- Webster, A. (ed.) (2013) The Global Dynamics of Regenerative Medicine: A Social Science Critique (Basingstoke: Palgrave).Google Scholar
- Webster, A. and L. Lriksson (2008) ‘Governance-by-Standards in the Field of Stem Cells: Managing Uncertainty in the World of “Basic Innovation” ‘, New Genetics and Society, 27,99–111.Google Scholar
- Will, C. (2007) “The Alchemy of Clinical Trials’, Bio Societies, 2, 85–99.Google Scholar
- Will, C. and T. Toreira (2010) Medical Proofs, Social Experiments (Famham: Ashgate).Google Scholar