Purity and the dangers of regenerative medicine: Regulatory innovation of human tissue-engineered technology

Social Science and Medicine

Volumn 63, Issue 9, 2006, Pages 2277-2288

  Faulkner, Alex ^a   Kent, Julie ^b   Geesink, Ingrid ^c   FitzPatrick, David ^d  

^a Department of Sociology   (United Kingdom)

^b UNIVERSITY OF THE WEST OF ENGLAND   (United Kingdom)

^c CARDIFF UNIVERSITY   (United Kingdom)

^d UNIVERSITY COLLEGE DUBLIN   (Ireland)

Author keywords

Classification; European Union; Health policy; Human tissue technology; Innovation; Regenerative medicine; Regulation

Indexed keywords

COMMERCIALIZATION; GENETIC ENGINEERING; HEALTH CARE; HEALTH POLICY; INNOVATION; MARKET; MEDICINE; POLLUTION; REGULATORY APPROACH;

ARTICLE; BIOTECHNOLOGY; CLASSIFICATION; EUROPEAN UNION; EVIDENCE BASED PRACTICE; HEALTH CARE POLICY; HUMAN; HUMAN TISSUE; POLICY; REGENERATIVE MEDICINE; TISSUE ENGINEERING; UNITED KINGDOM;

EURASIA; EUROPE; EUROPEAN UNION; UNITED KINGDOM; WESTERN EUROPE;

EID: 33748570492     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.socscimed.2006.06.006     Document Type: Article

References (50)

1. Anonymous. Tissue Engineering. Nature Biotechnology 18 Suppl. (2000) IT56-58
2. Appadurai A. Disjuncture and difference in the global cultural economy. Theory, Culture and Society 7 2-3 (1990) 295-310
3. Barry A. Political machines: Governing a technological society (2003), Athlone Press, London
4. Bock, A. K., Ibarreta, D., & Rodriguez-Cerezo, E. (2003). Human tissue-engineered products: Today's market and future prospects-synthesis report EUR 21000 EN. Institute for Prospective Technological Studies IPTS and Joint Research Centre EC.
5. Bowker G.C., and Leigh Star S. Sorting things out: Classification and its consequences (2000), MIT Press, Cambridge
6. Brown N., and Michael M. Risky Creatures: Institutional species boundary change in biotechnology regulation. Health, Risk and Society 6 3 (2004) 207-222
7. Brown N., and Webster A. New medical technologies and society-reordering life (2004), Polity Press, Cambridge
8. Brown N., Faulkner A., Kent J., and Michael M. Regulating hybrids: 'Making a Mess' and 'Cleaning Up in tissue engineering and transpecies transplantation. Social Theory & Health 4 1 (2006) 1-24
9. Buckley A.D. Walls within walls: Religion and rough behaviour in an Ulster community. Sociology 18 1 (1984) 19-32
10. Bud R. In the engine of industry: Regulators of biotechnology, 1970-1986. In: Bauer M. (Ed). Resistance to new technology: Nuclear power, information technology and biotechnology (1995), Cambridge University Press, Cambridge 293-310
11. Cox, M., & Tinkler, J. (2000). Biomaterials regulation: innovative products-outgrowing the European Framework? Action for Biomaterials, May 2000, The Biomaterials Partnership.
12. Department of Health. Guidance on the microbiological safety of human organs, tissues and cells used in transplantation, advisory committee on the microbiological safety of blood and tissues for transplantation (2000), Department of Health, London
13. Department of Health. A code of practice for tissue banks providing tissues of human origin for therapeutic purposes (2001), Department of Health, London
14. Douglas M. Purity and danger: An analysis of concepts of pollution and taboo (1966), Routledge & Kegan Paul, London
15. EC (European Commission). (2004). Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal, L102, 48-58.
16. EC (European Commission) DG Enterprise. (2004). Proposal for a harmonised regulatory framework on human tissue engineered products: DG Enterprise Consultation Paper, 6 April 2004. Presented at stakeholders' conference, 16 April 2004, Brussels.
17. EC (European Commission) DG Enterprise & Industry. (2005). Human tissue engineering and beyond: proposal for a community regulatory framework on advanced therapies. Consultation paper. European Commission, 4 May 2005. 〈http://pharmacos.eudra.org/F2/advtherapies/docs/ConsultationPaper-AdvancedTherapies-2005-May-04.pdf〉 [accessed July 2005].
18. EC (European Commission) DG Sanco. (2003). Amended proposal for a European and Council Directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells. COM (2003) 340 final May 2003. 〈http://europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0340en01.pdf〉
19. EC (European Commission) Health & Consumer Protection Directorate-General. (2004). Draft: Technical requirements for the donation procurement and testing of human tissues and cells (03.08.2004).
20. EC (European Commission) Health & Consumer Protection Directorate-General. (2005). Draft: Technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (29.03.2005).
21. EGE (1998). European Group on Ethics in Science and New Technologies. Ethical aspects of human tissue banking. Opinion no.11. Brussels: European Commission.
22. ERA Consulting. Discussion forum: Development and regulation of cell-based therapies. Report of meeting (2003), ERA Consulting, London
23. EU (2003). Parliament debate on the proposal for a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells. Strasbourg 9 April 2003. http://www.europarl.europa.eu/activities/expert/cre/search/go.do [Accessed June 2006].'
24. EUCOMED. (2003). Eucomed response to European Commission DG Enterprise consultation document 'Need for a legislative framework for Human tissue engineering and tissue-engineered products'. 〈http://www.eucomed.be.org/?x+4&y=11&z=218〉 [accessed January 2003].
25. EuropaBio. (2004). EuropaBio feedback on commission's consultation paper on tissue engineered products legislation. 〈http://www.europabio.org/positions/Posengineering.doc〉 [accessed July 2005].
26. Faulkner A. 'Strange bedfellows' in the laboratory of the NHS? An analysis of the new science of health technology assessment. In: Elston M.-A. (Ed). Sociology of medical science and technology (1997), Blackwell, Oxford 197-223
27. Faulkner A., Geesink I., Kent J., and FitzPatrick D. Human tissue engineered products-drugs or devices?. British Medical Journal 326 (2003) 1159-1160
28. Faulkner A., and Kent J. Innovation and regulation in human implant technologies: developing comparative approaches. Social Science & Medicine 53 (2001) 895-913
29. Faulkner, A., Kent, J., Geesink, I., & FitzPatrick, D. (2004). Purity and the dangers of innovative therapies: Re-ordering regulation and governance in the shaping of tissue-engineered medical technology. Paper presented to EASST/4S conference 'Public Proofs', École des Mines, Paris.
30. In: Franklin S., and Lock M. (Eds). Remaking life and death-towards an anthropology of the biosciences (2003), SAR Press, Santa Fe
31. Gabe J. Medicine, health and risk: The need for a sociological approach. In: Gabe J. (Ed). Health, medicine and risk: Sociological approaches (1995), Blackwell, Oxford 1-18
32. Geesink, I., Faulkner, A., Kent, J., & FitzPatrick, D. (forthcoming). Technoscience and frames of risk in the regulation of tissue engineered technologies in Europe. Science as Culture, in review.
33. Hogle, L. (2005). Emerging forms of evidence in regenerative medicine. Presentation to innovative health technologies workshop at health technology assessment international annual conference, 20-22 June 2005, Rome.
34. Jallali, N. (2003). Tissue engineered products need improvements in quality. British Medical Journal. 〈http://bmj.bmjjournals.com/cgi/eletters/326/7400/1159#33239〉; 12 June 2003 [rapid response, accessed 18.06.04].
35. Kent J., Faulkner A., Geesink I., and FitzPatrick D. Towards governance of human tissue engineered technologies in Europe: Framing the case for a new regulatory regime. Technological Forecasting and Social Change 73 1 (2006) 41-60
36. Kent J., Faulkner A., Geesink I., and FitzPatrick D. Culturing cells, reproducing and regulating the self. Body & Society 12 2 (2006) 1-23
37. Kong, Y. T. (2003). The need to regulate human tissue engineered products: ophthalmology perspective. British Medical Journal. 〈http://bmj.bmjjournals.com/cgi/eletters/326/7400/1159#32999〉; 5 June 2003 [rapid response, accessed 18.06.04].
38. Lehoux P., and Blume S.S. Technology assessment and the sociopolitics of health technologies. Journal of Health Policy, Politics and Law 25 6 (2000) 1083-1120
39. Majone G. The new European agencies: Regulation by information. Journal of European Public Policy 4 2 (1997) 262-275
40. May C., Mort M., Mair F., and Williams T. Factors affecting the adoption of tele-healthcare in the United Kingdom: The policy context and the problem of evidence. Health Informatics Journal 7 (2001) 131-134
41. MDA (Medical Device Agency). A code of practice for the production of human-derived therapeutic products (2002), Department of Health, London
42. Moreira T. Diversity in clinical guidelines: the role of repertoires of evaluation. Social Science & Medicine 60 9 (2005) 1975-1985
43. Prentice, D. A. (2003). Scientific basis for cell and tissue therapy. Presentation to public hearing on the proposal for a directive of on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells, January 2003, Brussels. 〈http://www.eutop.de/ct/〉 [accessed February 2003].
44. Reimann, A. (2003). Statement provided at the hearing on the patient view to the proposed directive on quality and safety of human tissues and cells, 29 January 2003, Brussels. 〈http://www.eutop.de/ct/〉 [accessed February 2003].
45. Strathern M. Property, substance and effect: Anthropological essays on persons and things (1999), Athlone Press, London
46. Timmermans S., and Berg M. The gold standard: The challenge of evidence-based medicine and standardization in health care (2003), Temple University Press, Philadelphia
47. Traynor M. The oil crisis, risk and evidence-based practice. Nursing Inquiry 9 (2002) 162-169
48. UKXIRA (United Kingdom Xenotransplantation Interim Regulatory Authority). (2003). The UKXIRA fifth annual report, January 2002-September 2003. London: Department of Health.
49. Vogel, D. (2001). The new politics of risk regulation in Europe. CARR discussion paper no. 3, August 2001. London: LSE. 〈http://www.lse.ac.uk/Depts/carr/Publications_folder_web_files/Disspaper3.pdf〉 [accessed September 2003].
50. Welsh I., and Evans R. Xenotransplantation: Risk, regulation and surveillance. New Genetics and Society 18 2/3 (1999) 197-217