Resources

Legal texts :

Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.

Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 102 , 07/04/2004.

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, OJ L 38, 09/02/2006

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, OJ L294, 25.10.2006.

Commission decision C(2009)7726 of 5.10.2009

Report from the Commission to the Council, on the basis of Member States’ reports on the implementation of the Council, Recommendation (2009/C 151/01) on patient safety, including the prevention and, control of healthcare associated infections, COM(2012) 658 final, 13.11.2012

Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 25 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, COM(2014) 188 final, 28.03.2014

 

Articles :

Logo_EUCelLEXEUCelLEX acknowledged in this publication

2016

Logo_EUCelLEXR. Isasi, E. Kleiderman, B. M. Knoppers. Editing policy to fit the genome? Framing genome editing policy requires setting thresholds of acceptability. Science  22 Jan 2016. Vol. 351, Issue 6271, pp. 337-339. DOI: 10.1126/science.aad6778.

2015

John Gardner, Alex Faulkner, Aurélie Mahalatchimy & Andrew Webster. Are there specific translational challenges in regenerative medicine? Lessons from other fields. Regenerative Medicine, Vol. 10, No. 7, Pages 885-895 , DOI 10.2217/rme.15.50.

Logo_EUCelLEXAlessandro Blasimme, Ignacio Anegon, Jean-Paul Concordet, John De Vos, Anne Dubart-Kupperschmitt, Marc Fellous, Pierre Fouchet, Nelly Frydman, Carine Giovannangeli, Pierre Jouannet, Jean-Loius Serre, Julie Steffann, Emmanuelle Rial-Sebbag, Mogens Thomsen & Anne Cambon-Thomsen (2015) Genome Editing and Dialogic Responsibility: “What’s in a Name?”, The American Journal of Bioethics, 15:12, 54-57, DOI: 10.1080/15265161.2015.1103811.

Logo_EUCelLEXMAHALATCHIMY A. , RIAL-SEBBAG E. , DUGUET A.- M. , CAMBON-THOMSEN A. ,TABOULET F. Exclusion of patentability of Embryonic stem cells in Europe: another restriction by the European Patent Office, European Intellectual Property Review, 2015, vol. 37, n°1, pp. 25- 28.

Caulfield, T., Kamenova, K., Ogbogu, U., Zarzeczny, A., Baltz, J., Benjaminy, S., Cassar, P. A., Clark, M., Isasi, R., Knoppers, B., Knowles, L., Korbutt, G., Lavery, J. V., Lomax, G. P., Master, Z., McDonald, M., Preto, N. and Toews, M. (2015), Research ethics and stem cells. EMBO reports, 16: 2–6. doi: 10.15252/embr.201439819

Petersen Alan and Krisjansen Ivan. Assembling ‘the bioeconomy’: Exploiting the power of the promissory life sciences. Journal of Sociology March 2015 51: 28-46, doi:10.1177/1440783314562314

Logo_EUCelLEXShabani, M., Knoppers, B. M. and Borry, P. (2015), From the principles of genomic data sharing to the practices of data access committees. EMBO Mol Med. doi: 10.15252/emmm.201405002.

 

2014

Logo_EUCelLEXBorry P, Shabani M, Howard HC. Is There a Right Time to Know? The Right Not to Know and Genetic Testing in Children. JLME. Number 1 – Volume 42. 2014.

Logo_EUCelLEXCaulfield T, Borry P, Gottweis H. Industry involvement in publicly funded biobanks. Nat Rev Genet. avr 2014;15(4):220‑220. doi:10.1038/nrg3704.

Caulfield Timothy, Burningham Sarah, Joly Yann, Master Zubin, Shabani Mahsa, Borry Pascal and al. A review of the key issues associated with the commercialization of biobanks. Journal of Law and the Biosciences, 94–110 doi:10.1093/jlb/lst004.

Logo_EUCelLEX Chabannon C., Sabatier F., Rial-Sebbag E., Calmels B., Veran J., Magalon G., Lemarie C. et Mahalatchimy A. Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products. Med Sci (Paris);30:576–583. Doi: 10.1051/medsci/20143005022. June 2014.

Dasgupta I, Bollinger J, Mathews DJ, Neumann NM, Rattani A, Sugarman J. Patients’ attitudes toward the donation of biological materials for the derivation of induced pluripotent stem cells. Cell Stem Cell. 2014 Jan 2;14(1):9-12. doi: 10.1016/j.stem.2013.12.006.

Hyun I. Policy: Regulate embryos made for research. Nature. 28 avr 2014;509(7498):27‑28. doi:10.1038/509027a.

Marshall E. Historic Patent on Embryonic Stem Cells Faces Scrutiny. Science. 24 janv 2014;343(6169):359‑359.DOI: 10.1126/science.343.6169.359.

Logo_EUCelLEXRial-Sebbag Emmanuelle and Blasimme Alessandro. The European Court of Human Rights’ Ruling on Unproven Stem Cell Therapies: A Missed Opportunity?. Stem Cells and Development. December 2014, 23(S1): 39-43. doi:10.1089/scd.2014.0361

Tabar V, Studer L. Pluripotent stem cells in regenerative medicine: challenges and recent progress. Nat Rev Genet. févr 2014; 15(2):82‑92. DOI:10.1038/nrg3563

Logo_EUCelLEXOgbogu U, Toews M, Ollenberger A, Borry P, Nobile H, Bergmann M, Caulfield T. Newspaper coverage of biobanks.PeerJ 2:e500; DOI 10.7717/peerj.500.

Logo_EUCelLEXShabani M, Bezuidenhout L, Borry P. Attitudes of research participants and the general public towards genomic data sharing: a systematic literature review. Expert Rev Mol Diagn. 2014 Nov;14(8):1053-65. doi: 10.1586/14737159.2014.961917. Epub 2014 Sep 26.

World Stem Cell Report 2014. Stem Cells and Development. December 2014, 23(S1).

Yamada M, Johannesson B, Sagi I, Burnett LC, Kort DH, Prosser RW, and al. Human oocytes reprogram adult somatic nuclei of a type 1 diabetic to diploid pluripotent stem cells. Nature.26 juin 2014;510(7506):533‑536.doi:10.1038/nature13287.

2013

Blasime A. “Translating stem cells to the clinic: scientific societies and the making of regenerative medicine.”, Revue QUADERNI, special issue on “Human as a medicinal product”, Eds E. Rial-Sebbag and A. Mahalatchimy, 2013. Quaderni, 81 | 2013, 29-44.

Logo_EUCelLEX Blasimme A. and Rial-Sebbag E. Regulation of Cell-Based Therapies in Europe: Current Challenges and Emerging Issues. Stem Cells and Development. December 2013, 22(S1): 14-19. DOI:10.1089/scd.2013.0352.

Critchley, Christine R., Bruce, Gordana, Farrugia, Matthew. Humana Press; 2013. The impact of commercialisation on public perceptions of stem cell research: exploring differences across the use of induced pluripotent cells, human and animal embryos. Stem Cell Reviews and Reports, Vol. 9, no. 5 (Oct 2013), pp. 541-554. http://dx.doi.org/10.1007/s12015-013-9445-4

2012

Ancans, J. 2012. «Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development». Frontiers in Immunology 3 (August 14). doi:10.3389/fimmu.2012.00253.

Caulfield T1, Rachul C, Zarzeczny A. The evolution of policy issues in stem cell research: an international survey. Stem Cell Rev. 2012 Dec;8(4):1037-42. doi: 10.1007/s12015-012-9404-5.

FFTaOC: FACT-JACIE International Standards for Cellular Therapy, Product Collection, Processing and Administration. (2012).

Keating P, Cambrosio A. Cancer on Trial: Oncology As a New Style of Practice. University of Chicago Press; 2012.

Mahalatchimy A., Rial-Sebbag E., Tournay V., Faulkner A. (2012). The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom. Journal of Law and Society 39 (1): 131–149. doi:10.1111/j.1467-6478.2012.00574.x.

Migliacco G. and Pintus C., Role of the EU framework in regulation of stem cell- based products, Adv Biochem Eng Biotechnol. 2012 Jul 28.

Nazor KL, Loring JF, Laurent LC, Equally potent? Does cellular reprogramming justify the abandonment of human embryonic stem cells? EMBO Rep. 2012 Oct;13(10):890-4. doi: 10.1038/embor.2012.134. Epub 2012 Sep 18.

Pelosi E, Castelli G, Testa U: Human umbilical cord is a unique and safe source of various types of stem cells suitable for treatment of hematological diseases and for regenerative medicine. Blood Cells, Molecules, and Diseases, (2012).

Petrini C: A comparative analysis of the opinions from European national and international ethics committees regarding the collection, storage and use of umbilical cord blood. Blood transfusion= Trasfusione del sangue, 1 (2012).

Rao M, Ahrlund‚Äêrichter L, Kaufman DS: Concise Review: Cord Blood Banking, Transplantation and Induced Pluripotent Stem Cell: Success and Opportunities. Stem Cells 30(1), 55-60 (2012).

Science Business, special report Regenerate The Future, Déc. 2012.

Shand J, Berg J, Bogue C; Committee for Pediatric Research; Committee on Bioethics, Human embryonic stem cell (hESC) and human embryo research, Pediatrics. 2012 Nov;130(5):972-7. doi: 10.1542/peds.2012-2482. Epub 2012 Oct 29.

2011

Chen H, Gottweis H. Stem Cell Treatments in China: Rethinking the Patient Role in the Global Bio-Economy.Bioethics. 2011;no–no.

Denoon A., Brüstle v. Greenpeace: implications for stem cell research., Regen Med. 2011 Nov;6(6 Suppl):85-7. doi: 10.2217/rme.11.76.

Hens K, Cassiman JJ, Nys H, Dierickx K. Children, biobanks and the scope of parental consent. Eur J Hum Genet. 2011 Jul;19(7):735-9 (2011).

Inoue, H and S Yamanaka. 2011. «The use of induced pluripotent stem cells in drug development». Clinical Pharmacology and Therapeutics 89 (5) (May): 655–661. doi:10.1038/clpt.2011.38.

Knoppers B.M., Hudson T.J. The Art and Science of Biobanking. Hum Genet. 2011 Sep;130(3):329-32.

Lenk C., Hoppe N., Beier K. et al. (2011) Human Tissue Research – A Discussion of the Ethical and Legal Challenges from a European Perspective. In Oxford University Press.

Mahalatchimy A., Rial-Sebbag E., Tournay V., Faulkner A. (2011), Does the French Bioethics Law create a ‘moral exception’ to the use of human cells for health? A legal and organizational issue, Dilemata, 3, n°7, 17-37.

Mckenna D, Sheth J: Umbilical cord blood: Current status & promise for the future. The Indian Journal of Medical Research 134(3), 261 (2011).

OECD (2001), Working Party on Biotechnology, Review of the current status, activities and future of existing biological resource centres, http://www.oecd.org/health/biotechnologypolicies/1912000.pdf.

Petrini C, Farisco M: Informed consent for cord blood donation. A theoretical and empirical study. Blood Transfusion 9(3), 292 (2011).

Wichmann et al, 2011, Comprehensive catalog of European biobanks IN: Nature Biotechnology 29, 795–797.

2010

American College of Obstetricians and Gynecologists (ACOG): Committee Opinion: Umbilical Cord Blood Banking. No. 399, (2010).

Bordet S, Bcl L, Nguyen TM, Rosario Isasi J: Use of umbilical cord blood for stem cell research. J Obstet Gynaecol Can 32(1), 58-61 (2010).

Giorgetti A, Montserrat N, Rodriguez-Piza I, Azqueta C, Veiga A, Belmonte JCI: Generation of induced pluripotent stem cells from human cord blood cells with only two factors: Oct4 and Sox2. Nature protocols 5(4), 811-820 (2010).

Hovatta O. Stojkovic M., Nogueira, M., Varela-Nieto I., European Scientific, Ethical, and Legal Issues on Human Stem Cell Research and Regenerative Medicine, Stem Cells, Volume 28, Issue 6, pages 1005–1007, June 2010.

Lengerke C, Daley GQ: Autologous blood cell therapies from pluripotent stem cells. Blood reviews 24(1), 27-37 (2010).

Levenson D. When should pediatric biobanks share data? Am J Med GenetA. 2010 Mar;152A(3):fmvii-iii. DOI:10.1002/ajmg.a.33287.

Petrini C. Umbilical cord blood collection, storage and use: ethical issues. Blood Transfusion 8 (3): 139. (2010).

The American College of Obstetricians and Gynecologists (ACOG): Committee Opinion: Umbilical Cord Blood Banking. No. 399, (2010).

2009

Amabile, G and A Meissner. 2009. «Induced pluripotent stem cells: current progress and potential for regenerative medicine». Trends in Molecular Medicine 15 (2) (February): 59–68. doi:16/j.molmed.2008.12.003.

Favale M. and Plomer A (2009), Fundamental disjunctions in the EU legal order on human tissue, cells & adavanced regenerative therapies , Maastricht Journal of European and Comparative Law, 16 (1), p. 89-111.

Geransar RM, Einsiedel EF, Galipeau J, Isasi R, Sheremeta L, Knoppers B: Catalyzing umbilical cord blood research in Canada: a survey of current needs and practices of principal investigators. J Obstet Gynaecol Can 31(1), 63-71 (2009).

Gottweis, H, B Salter and C Waldby. 2009. The Global Politics of Human Embryonic Stem Cell Science: Regenerative Medicine in Transition. Palgrave Macmillan.

Isasi R., Knoppers BM, “Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe”. In “Embryonic Stem Cell Patents: European Patent Law and Ethics”; Torremans P., Plomer A., editors. (Oxford University Press, 2009):29-56.

2008

Hyun I, Lindvall O, Ährlund-Richter L, Cattaneo E, Cavazzana-Calvo M, Cossu G, et al. New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research. Cell Stem Cell. 4 December 2008;3(6):607–9.

Samuel GN, Kerridge IH, and O’Brien TA. 2008. Umbilical cord blood banking: public good or private benefit?. Medical Journal of Australia 189 (10): 599.

Schroten E., Human Embryo Research: a European perspective, pp. 109-120 in Stem Cells, Human Embryos and Ethics: Interdisciplinary Perspectives, Ed. Lars Østnor, Springer 2008.

Tse W, Bunting KD, Laughlin MJ: New insights into cord blood stem cell transplantation. Current opinion in hematology 15(4), 279 (2008).

2007

Canadian Blood Services (CBS): Recommendations for Establishing a National Public Cord Blood Bank in Canada. (2007).

Daar AS, Greenwood HL. A proposed definition of regenerative medicine. Journal of Tissue Engineering and Regenerative Medicine. 2007;1(3):179–84.

Keating P, Cambrosio A. Cancer clinical trials: the emergence and development of a new style of practice. Bull Hist Med. 2007; 81(1):197–223.

Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007;131(5):861–72.

2006

Chan S. 2006. Cord blood banking: what are the real issues? Journal of medical ethics 32 (11): 621-622.

Waldby C. 2006. Umbilical cord blood: from social gift to venture capital. BioSocieties 1 (1): 55.

2005

Coenen M, Kogler G, Wernet P, and Brestle O. 2005. Transplantation of human umbilical cord blood-derived adherent progenitors into the developing rodent brain. Journal of Neuropathology & Experimental Neurology 64 (8): 681-688.

Hervey T. K. and Black H., The European Union and the Governance of stem cell research, Maastricht Journal of European and Comparative Law, 2005 12 (3), p. 11- 48.

Jasanoff, S 2005. Designs on nature: Science and democracy in Europe and the United States. Princeton Univ Press.

Leor J, Guetta E, Chouraqui P, Guetta V, and Nagler A. 2005. Human umbilical cord blood cells: a new alternative for myocardial repair? Cytotherapy 7 (3): 251-257.

Tournay V. Collecter, centraliser, circuler, contraindre et répéter : cinq modalités pour standardiser les connaissances et les pratiques en matière d’innovation médicale. quad. 2005;58(1):33–45.

2004

Saginur M, Kharaboyan L, Knoopers BM: Umbilical cord blood stem cells: Issues with private and public banks. Health LJ 12, 17 (2004).

2003

Timmermans S, Berg M. The Gold Standard: The Challenge of Evidence-Based Medicine and Standardization in Health Care. Temple University Press; 2003.

1997

Sugarman J, Kaalund V, Kodish E, Marshall MF, Reisner EG, Wilfond BS, and Wolpe PR. 1997. Ethical issues in umbilical cord blood banking. JAMA: the journal of the American Medical Association 278 (11): 938-943.(1997)

 

Others :

Building on our own potential: a UK pathway for regenerative medicine. Report from the Regenerative Medicine Expert Group (March of 2015)

Press Release issued by the Registrar of the European Court of Human Rights.ECHR 153 (2014) 28.05.2014. A properly reasoned refusal by the courts to authorise access to experimental treatment was neither arbitrary nor discriminatory.

Eurobarometer 2010 results in European and Biotechnology in 2010

EGE Opinion n°22 – 13/07/2007 – The ethics review of hESC FP7 research projects

Table for abbreviations