Beware of the commercialization of human cells and tissues: Situation in the European Union

Cell and Tissue Banking

Volumn 13, Issue 3, 2012, Pages 487-498

  Pirnay, Jean Paul ^a   Vanderkelen, Alain ^a   Ectors, Nadine ^b   Delloye, Christian ^c   Dufrane, Denis ^c   Baudoux, Etienne ^d   Van Brussel, Michel ^b   Casaer, Michael P ^b   De Vos, Daniel ^a   Draye, Jean Pierre ^a   Rose, Thomas ^a   Jennes, Serge ^a   Neirinckx, Pierre ^a   Laire, Geert ^e   Zizi, Martin ^a,f   Verbeken, Gilbert ^a  

^a QUEEN ASTRID MILITARY HOSPITAL   (Belgium)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^d UNIVERSITY OF LIÈGE   (Belgium)

^e Ministry of Defense   (Belgium)

^f FREE UNIVERSITY OF BRUSSELS   (Belgium)

Author keywords

Advanced therapy medicinal products; Directive; European Union; Globalization; Human cells and tissues; Quality and safety

Indexed keywords

DRUG;

ALLOTRANSPLANTATION; ARTICLE; ECONOMICS; EUROPEAN UNION; HEALTH CARE FACILITY; HUMAN; INTERNATIONAL COOPERATION; TECHNOLOGY;

EUROPEAN UNION; HUMANS; INTERNATIONALITY; PHARMACEUTICAL PREPARATIONS; TECHNOLOGY TRANSFER; TISSUE BANKS; TRANSPLANTATION, HOMOLOGOUS;

EID: 84867215580     PISSN: 13899333     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10561-012-9323-3     Document Type: Article

References (48)

1. AFSSAPS Alert Department (2008) Alert regarding an AFSS-APS request for recall of bone products supplied by 'Ost-Developpement'. http://www.eatb.org/ media/uploads/ ost-developpement.pdf. Accessed 3 Apr 2012
2. Akst J (2010) Key cancer patents killed. The scientist. http://www.the-scientist.com/blog/display/57265/. Acces-sed on 3 Apr 2012
3. Birger J (2006) Give me some skin. Fortune Magazine. http://money.cnn. com/magazines/fortune/fortune-archive/2006/ 09/04/8384735/index.htm. Accessed 3 Apr 2012
4. Blakeslee S (2002) Lack of oversight in tissue donation raising concerns. The New York Times. http://www.nytimes.com/2002/01/20/us/lack-of-oversight-in- tissue-donation-raising-concerns.html?pagewanted=all&src=pm. Accessed 3 Apr 2012
5. Blasszauer B (1997) Petty corruption in health care. J Med Ethics 23:133-134
6. Brand A, Rebulla P, Engelfriet CP, Reesink HW, Beguin Y, Baudoux E, Kögler G, Ebrahimi M, Grazzini G, Costa AN, Bosi A, Sacchi N, Lombardini L, Pupella S, Lecchi L, Garcidueñas ED, van Beckhoven JM, de Wit HJ, Fibbe WE, Zhiburt EB, Bart T, Beksaç M, Navarrete C, Regan F (2008) Cord blood banking. Vox Sang 95:335-348
7. Bruno JJ 2nd, Senderoff DM, Fracchia JA, Armenakas NA (2007) Reconstruction of penile wounds following com-plications of AlloDerm-based augmentation phalloplasty. Plast Reconstr Surg 119:1e-4e
8. Chrisafis A (2011) French government 'to order women to remove defective breast implants'. The Guardian. http:// www.guardian.co.uk/world/2011/dec/20/ french-remove-breast-implants-silicone. Accessed 3 Apr 2012
9. Collins S (2001) Tissue Banks: Is the Federal Government's Oversight Adequate? Hearing before the Committee on Governmental Affairs. US Senate Diane Pub Co, Washington
10. Council of Europe (2009) Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs. Joint Council of Europe/United Nation study. http://www.coe.int/t/dghl/monitoring/ trafficking/ docs/news/OrganTrafficking-study.pdf. Accessed 4 Apr 2012
11. De Corte P, Verween G, Verbeken G, Rose T, Jennes S, De Coninck A, Roseeuw D, Vanderkelen A, Kets E, Haddow D, Pirnay JP (2012) Feeder layer- and animal product-free culture of neonatal foreskin keratinocytes: improved per-formance, usability, quality and safety. Cell Tissue Bank 13:175-189
12. de Kort W, Verhagen C (2008) Why money should not be the first (t)issue. ISBT Sci Ser 3:213-216
13. Farrugia A (2000) When do tissues become products? Regula-tory oversight ofemerging biological therapies. Cell Tissue Bank 7:325-335
14. Faulkner A, Kent J, Geesink I, FitzPatrick D (2006) Purity and the dangers of regenerative medicine: regulatory innova-tion of human tissue-engineered technology. Soc Sci Med 63:2277-2288
15. Federaal Agentschap voor Geneesmiddelen en Gezondheids-producten (2009) Ministerieel Besluit tot vaststelling van de prijs van menselijk lichaamsmateriaal. Staatsblad, 23 oktober 2009. http://staatsbladclip.zita.be/ staatsblad/wetten/ 2009/10/23/wet-2009018418.html. Accessed 3 Apr 2012
16. Fehily D (2011) Vigilance and surveillance of substances of human origin\-The SOHO V&S project. In: 6th World Congress in Tissue Banking, Barcelona
17. Friedman M (1970) The social responsibility of business is to increase its profits. New York Times Magazine. http://www.colorado.edu/studentgroups/ libertarians/issues/friedman-soc-resp-business.html. Accessed 4 Apr 2012
18. Henkel J (1994) Safeguarding human tissue transplants. FDA Consum Mag 28:9-13
19. Hermans MH (2011) Preservation methods of allografts and their (lack of) influence on clinical results in partial thickness burns. Burns 37:873-881
20. Hoeyer K (2010) An anthropological analysis of European Union (EU) health governance as biopolitics: the case of the EU tissues and cells directive. Soc Sci Med 70: 1867-1873
21. Hunter D, Oultram S (2008) The challenge of ''sperm ships'': the need for the global regulation of medical technology. J Med Ethics 34:552-556
22. Hurt H (2010) King of beers, and a slippery throne. The New YorkTimes.http://www.nytimes.com/2010/10/17/business/17shelf.html?ref= beerindustry. Accessed 3 Apr 2012
23. Imahara SD, Klein MB (2009) Skin grafts. In: Orgill D, Blanco C (eds) Biomaterials for treating skin loss. Woodhead Publishing and CRC Press LLC, Cambridge
24. Kearney J (2011) Tissue engineering. In: 6th World Congress in Tissue Banking, Barcelona
25. Keller M, Grill M (2009) Inside a creepy global body parts business. Spiegel Online. http://www.spiegel.de/international/europe/0,1518,druck-645375, 00.html. Accessed 4 Apr 2012
26. Kirkland M (2010) The precautionary principle: a double edged sword? Cell Tissue Bank 11:217-224
27. Kishore RR (2005) Human organs, scarcities, and sale: morality revisited. J Med Ethics 31:362-365
28. Lenk C, Beier K (2012) Is the commercialisation of human tissue and body material forbidden in the countries of the European Union? J Med Ethics 38:342-346
29. Levitt T (1983) The globalization of markets. Harv Bus Rev 61:92-102
30. Marcus C (1985) Spectre of commercialism dominates transplant symposium. Can Med Assoc J 133:314-317
31. McMichael P (2001) The impact of globalisation, free trade and technology on food and nutrition in the new millennium. Proc Nutr Soc 60:215-220
32. Mortimer D (2005) A critical assessment of the impact of the European tissues and cells directive (2004) on laboratory practices in assisted conception. Reprod Biomed Online 11:161
33. Norman BP (2000) Controversy: do corporations have any responsibility beyond making a profit? J Mark Moral 3:1-3
34. Perlman E (2011) The cheese police. The world on cheese culture. http://culturecheesemag.com/spring-2011-fda-special. Accessed 3 Apr 2012
35. Pirnay JP, Vanderkelen A, Zizi M, De Vos D, Rose T, Laire G, Ectors N, Verbeken G (2010) Human cells and tissues: the need for a global ethical framework. Bull World Health Organ 88:870-872
36. Rahmanian-Schwarz A, Beiderwieden A, Willkomm LM, Amr A, Schaller HE, Lotter O (2011) A clinical evaluation of Biobrane and Suprathel in acute burns and reconstruc-tive surgery. Burns 37:1343-1348
37. Redfern M, Keeling JW, Powell E (2001) The Royal Liverpool children's inquiry report. HMSO, London
38. Schumer C (2007) A bill to improve the oversight and regulation of tissue banks and the tissue donation process, and for other purposes. Bill introduced in the Senate of the United States. http://www.opencongress.org/bill/110-s1479/ text. Accessed 3 Apr 2012
39. Simoens S (2009) Health economics of market access for bio-pharmaceuticals and biosimilars. J Med Econ 12:211-218
40. Smith KE, Fooks G, Collin J, Weishaar H, Mandal S, Gilmore AB (2010) ''Working the system''\-British American Tobacco's influence on the European Union Treaty and it's implications for policy: an analysis of internal tobacco industry documents. PLoS Med 7:e1000202
41. Spurgeon B (2008) French doctors are tried for treating children with infected growth hormone. BMJ 336:348-349
42. Steering Committee of the Istanbul Summit (2008) Organ traf-ficking and transplant tourism and commercialism: the Declaration of Istanbul. Lancet 372:5-6
43. Terino EO (1998) Alloderm acellular dermal graft: applications in esthetic and reconstructive soft tissue augmentation. In: Klein AW (ed) Tissue augmentation in clinical practice: procedures and techniques. Marcel Dekker Inc, New York, pp 349-379
44. TiGenix (2011) Business and financial update for the first quarter of 2011. http://www.tigenix.com/public/uploads/ pdf/en/f4ef44fe35c66c1.75077632- 2011-05-19-EN.pdf. Accessed 3 Apr 2012
45. Van Veen E-B, Lamers C (2006) Research integrity: selling the stem cell dream stopped in the Netherlands. Telegraft 13:7-8
46. Waltz E (2006) The body snatchers. Nat Med 12:487-488
47. World Health Organization Europe (2008). Guidance on developing quality and safety strategies with a health sys-tem approach. http://www.euro.who.int/ data/assets/pdf-file/0011/96473/E91317.pdf. Accessed 3 Apr 2012
48. Yessian (2001) Informed consent in tissue donation - expecta-tions and realities. Office of Inspector General, Department of Health and Human Services, Washington, DC http://www.fda.gov/OHRMS/DOCKETS/ac/01/briefing/3736 b2-02.pdf. Accessed 3 Apr 2012