Legal issues surrounding french research-focused Biobanks

Journal International de Bioethique

Volumn 20, Issue 3, 2009, Pages 69-86

  Commin, Virginie ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOETHICS; ETHICS; FRANCE; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PUBLIC HEALTH; RESEARCH; STANDARD;

BIOETHICS; BIOLOGICAL SPECIMEN BANKS; FRANCE; HUMANS; INFORMED CONSENT; PUBLIC HEALTH; RESEARCH;

EID: 77953113219     PISSN: 12877352     EISSN: 12877352     Source Type: Book Series    
DOI: 10.3917/jib.203.0069     Document Type: Conference Paper

References (65)

1. Bovenberg, J-A. (2006).DNA as personal property in J-A. Bovenberg (ed), Property Rights in blood, Genes and Data, naturally yours?. pp. 116-117. Leiden Boston: Martinus Nijhoff Publishers.
2. "personalized medicine could result from understanding the variation in DNA that makes humans different from one another in their susceptibility to disease, their physiological, mental and emotional response to physical, behavioural, and social environmental exposures and their response to medicinesin Fletcher, A. (2008). Governing DNA, Prospects and problems in the proposed large-scale United States population cohort study, in H. Gottweis, A. Petersen (ed), Biobanks: Governance in comparative perspective, pp. 114-115, London: Routledge.
3. Gottweis, H. and Petersen, A. (2008). Introduction in H. Gottweis, A. Petersen (ed), Biobank: Governance in comparative perspective, pp. 5-6, London: Routledge.
4. UK Biobank. Welcome to Uk biobank. Available at: http://www.ukbiobank.ac. uk/(accessed 3 April 2009).
5. Estonian Gene Biobank. Presentation. Available at: http://www. geenivaramu.ee/(accessed 3 April 2009).
6. st April 2009).
7. st April 2009).
8. st April 2009).
9. Association France Myopathie. association France myopathie deals with two biobanks in the field of rare diseases: banque du Généthon, a Dna bank. Available at http://www.genethon.fr/index. php?id=82
10. st April 2009);
11. st April 2009).
12. Thouvenin, D. (2005). Les banques de tissus et d'organes: les mots pour les dire, les règles pour les organiser. Les Petites affiches, February 18, 31-47.
13. st April 2008). The ministry of research, put in place this BRC committee in 2001, in charge of the monitoring of BRC network funding : "BRC are strategic infrastructure for biotechnologies. Quality and Traceabilty guarantees are indeed essential, especially in the field of genome analysis and post-genome studies processing: identification of gene of interest, diagnosis and therapeutic application, emerging diseases" (own translation).
14. Journal Libération. November 25, 2006. Interview of Georges Dagher, biological collection manager of French national institute of medical research. Available at http://www.liberation.fr/transversales/weekend/219254. FR.php (accessed 1st April). It covers public facilities but also private ones such as patient advocacy associations, firms etc. However, "In France, most of the facilities housing biobanks are public hospitals. Private collections remain rare".
15. Article L1245-2 (surgical waste and placenta) and L1241-5 (foetal tissues) of the public health code.
16. Thouvenin, D. (2005).La loi relative à la bioéthique ou comment accroître l'accès aux éléments biologiques d'origine humaine. Recueil Dalloz, 2, 116-121 & 3, 172-179.
17. Three kind of biobanks are regulated by the public health code: a) Article L1243-2 relates to therapeutic biobanks: the umbilical blood biobank network located in Saint-Louis Hospital (Paris), Besançon, and Bordeaux, for example, focuses on treating patients suffering from leukaemia
18. Article L1243-3 relates to scientific biobanks created by medical establishments for their own research purposes. Thus it mostly deals with the academic sector. For example, the institut national de la Santé et Recherche médicale (Inserm), or the institut national du Cancer which deals with tumour bank network but is also available to work with private sector entities such as pharmaceutical companies
19. Article L1243-4 relates to biobanks created to store human cells and tissues in order to transfer them to researchers for scientific purposes, as with the biobanque de Picardie, which is supplied by the Amiens hospital and which provides researchers with human biological samples and related data. Dividing biobanking practices into three parts appears rather artificial since their activities often overlap, but it is the way the French legal system regulates the biobanking sphere.
20. Specifically, the declaration process consists of several steps: • First, potential biobanks must submit their project declaration to the biomedical research committee in charge of the protection of individuals before declaring it to the Minister of Research. Researchers' projects have to comply with ethical and scientific guarantees that the Comité de Protection des Personnes examines during the declaration review • Second, they must submit their research project to the Minister of Research and to the head of the regional hospitalization office if the facility is in a health care institution, as provided by article L1243-3, paragraph 3 of the public health code. • Third, an independent administrative commission in charge of protecting personal data steps in by virtue of a specific law relating to data processing, Law no. 2004-806 of August 6, 2004. Its involvement is a logical requirement given that personal health data are associated with biological samples which can potentially lead to breaches of confidentiality, and because most research takes place in the field of genetics.
21. The Comité de protection des personnes is in charge of protecting those people involved in clinical trials and, by virtue of the Bioethics Act of August 6, 2004, is required to deliver an opinion on research projects dealing with human biological samples (article L1243-3, paragraph 3) after a scientific and ethical review.
22. The Ministry of Research can also suspend and even prohibit biobanking activities when ethical and/or scientific requirements are not fulfilled anymore.
23. Neurobiotec. Presentation. Available at http://www.neurobiotec.net/ (accessed 3 April 2009). neurobiotech is a biobank created in the field of neurological and psychiatric diseases by Hospices Civils de Lyon and institut national de la Santé et de la Recherche médicale (inserm).
24. Institut de Myologie. Presentation. Available at : http://www.institut- myologie.org/ewb-pages/r/recherche-banquestissus-equipe.php (accessed 3 April 2009). One of the most important is the research tissue bank created by patient organisation association Française contre la myopathie to conduct research on rare diseases. It has gathered approximately 23, 619 biological samples, out of which 7, 657 have been transferred to 161 research teams.
25. 25Biobanque de Picardie. Presentation. Available at http://www.biobanque- picardie.com/. (accessed 3 April 2009). Biobanque de Picardie has gathered approximatively 80, 000 biological samples for researchers' teams for a very large panel of diseases and know-how to drive studies based on straw-conserved material which "can be performed either on-site or in an external laboratory. The biobanque de Picardie R&D Laboratory is equipped for immunological and molecular biology techniques".
26. RNTECH Company. Presentation. Available at http://www.rntech.com (accessed 19 April 2009). For example, RNTECH is a private French company located in France dealing in transfers (for which it charges a fee) of biological samples, which are stored in a biobank located in a Romanian hospital. RNTECH is a leading biotechnology company in the field of early-stage digestive-tract cancer diagnostic tools, as well as treatment, discovery, and development.
27. By virtue of article L1243-4 of the public health code. Once authorization is given, for example, RNTECH which collects biological samples for the oncology field will charge for the transfer of samples to researchers and pharmaceutical companies. However, a biobank can also be authorised to transfer biological samples for free to a researcher who has created the collection housed in the biobank such as Biobanque de Picardie.
28. These principles are from the Bioethics acts: bioethics act no. 94-653 relating to the respect of the human body, and bioethics act no. 94-654 relating to the donation and use of human body elements and products, to medically assisted procreation, and to prenatal diagnostics of July 29, 1994 that have been modified by act no. 2004-800 relating to bioethics of August 6, 2004.
29. See also article 16-5 of the civil code which provides for the public order cancellation of patrimonial agreements: "Agreements that have the effect of bestowing a patrimonial value to the human body, its elements or products are void"; article 16-6 of the civil code: "No remuneration may be granted to a person who consents to an experimentation on himself, to the taking of elements off his body or to the collection of products thereof".
30. Planiol, M. (1946).Traité élémentaire de droit civil, L. G. D. J, 3ème Ed., p. 821: the heritage is a unit of rights and obligations of a person related to goods, which have an economic value. For example, the right to property, the right to succeed somebody, the duty for children to pay dead father's debts is patrimonial.
31. Article1243-4 of the public health code (2004) : "Every facility in charge of preservation, storage and preparation of human tissues and cells destined for transfer to a commercial activity for scientific purposes, including genetics, must obtain an authorization from the Minister of Research. An authorization is required under the same conditions for every facility which undertakes the preservation and preparation of human tissues and cells with the goal of coordinating free transfers for scientific purposes (⋯)." (own translation). It took time for legislators to explicitly admit the legitimacy of such transfers. In the first Bioethics Act of 1994, it was only implicitly acknowledged (article L672-10 of the public health code).
32. California Reporter 146, 793 P 2 d.479. moore vs. Regents of the university of California, July 9, 1990, 27. Available at www.protatecure.wustl. edu (accessed 21 May 2008). Moore's physician patented the cell lines derived from his patient's samples, obtained through splanectomy, in order to put them on the market. Although John Moore argued before the California state Supreme Court that his physician was not entitled to property rights over the derived-cell therapeutic products, the justices recognized the physician's intellectual property rights in light of the substantial amount of transformation work he had undertaken.
33. Skene, L. (2002). Ownership of human tissue and the law. Human Genetics, 3, 145-148. See also the Washington University versus Catalona, august 20, 2007: the judges have entitled the University housing a collection of prostatic samples to a property right, to the detriment of the physician who had set it up over years in University of Washington St. Louis. Available at:http://prostatecure.wust.edu/t (accessed 3 April 2009).
34. Interview with G. Dagher, January y2007, tin charge of biological collections at Inserm.
35. Aliquot tubes are used when sample fragments are placed in several tubes or flakes in order to optimize research uses.
36. Bayer, E. (2003). Les choses humaines. Toulouse : Law thesis, Université de Droit.
37. Article L1211-2 §1 of the public health code: "Human body parts and products may not be collected, regardless of prior donor consent. This consent is revocable at any time." (own translation).
38. Article L1211-2§2 of the public health code: "The use of human body elements and products for medical or scientific purposes different than the initial ones it had been extracted or collected for is possible, except in case of objection expressed by the individual concerned by the removal or collection (⋯) " (own translation).
39. Article L1245-2 of the public health code: "Tissues, cells and products of the human body, removed during surgery undertaken in the interest of the patient, as well as the placenta, may be used for therapeutic and scientific purposes, except if the patient objects to it after s/he was informed of its scientific purposes" (own translation).
40. Commission Nationale Informatique et Libertés (CNIL). Loi informatique et Libertés (of January 6, 1978 amended by act of august 6, 2004 relating to the protection of personal data). Available at http://www.cnil.fr/fileadmin/documents/uk/78-17VA.pdf (accessed 25 May 2009).
41. Two data-access scenarios have been written into the law: researchers wishing to collect data to conduct research (article 54 of the law on data processing and liberties), and researchers wishing to obtain from doctors or researchers, data that have been already collected for a research project (articles 54 and 55). Accessing the data requires an application to the CNIL, which then decides within two months (no response means that the application has been denied by virtue of article 54).
42. Under the terms of article 54, the application is first submitted to the Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé" (a medical research data-processing advisory committee), established by the Research Ministry and composed of members skilled in the fields of medical research, epidemiology, genetics, and biostatistics. But in practice, this committee does not have any real power, and it is CNIL which is empowered to review the confidentiality aspects of scientific projects. The advisory committee is a vestige of the French law of July 1, 1994 (article 40-1) and lawmakers in search of a solution largely emptied it of its power by legislating that a lack of response from the committee means approval of the scientific project, according to an interview with J-C Hebert, Inserm legal department, May 5, 2007.
43. Article 57: "The individuals from whom personal data are obtained, or whose data is transmitted, shall before the start of the processing of these data, be informed individually of: (1) the nature of the transmitted information; (2) the purpose of the data processing; (3) the individuals or legal entities who are the recipients of the data; (4) the right of access and the rectification provided for in articles 39 (right of access) and 40 (right of rectification); (5) the right to object provided for in the first (objection to the lifting of professional secrecy) and third (refusal of processing after death) paragraphs of article 56 or, in the case provided for in the second paragraph of the article, the obligation to obtain their consent (⋯) ".
44. The data coding requirement is explicitly required only when data transmission from physicians to researchers falls under the terms of article 55, paragraph 2: "Data leading to individuals' identification must be coded prior to their transmission (⋯) ".
45. Ministère de la Recherche. Discours. Available at http://www.recherche.gouv.fr/discours/2001/crbiod.htm (accessed 1 April 2009). Relating to this topic, the OECD has set out very interesting recommendations, such as a charter on Biological Resources Centres (BRCs), which states in the preamble that "BRCs have a vocation to preserve the biological inheritance and to make available these biological samples of general interest (⋯) ".
46. http://www.afm-france.org/.
47. See also M. Dupont, Recueillir, conserver et utilise des échantillons biologiques humains à l'hôpital, Assistance Publique des Hôpitaux de Paris, Lamarre, 2008, pp. 192.
48. Bellivier, F. and Noiville C. (2006). Contrats et vivant. Paris: L. G. D. J. pp. 165-66.
49. The Catalona case deals with a conflict of interest between Dr. Catalona and Washington University, which housed the biological sample collections built thanks to the consent of Dr. Catalona's patients suffering from prostate cancer. Research had produced promising therapeutic products to help cure prostate cancer. Dr. Catalona decided to leave Washington University, where he had worked and stored his collection for years, but the University argued it had property rights over the collection since it had managed and looked after it during that time. The judge ruled that, according to Missouri state law: • Dr Catalona could not be the owner because his employment contract stated that he had given up such rights. • Donors could not be the owners, according to the Moore case. The judges' ruling is obviously the least bad solution since recognizing physicians' property rights over collections would tend to lead to their dispersal over time. Nevertheless, it is unfair to physicians who spend years building them. Moreover, there is nothing to stop a university from breaking up or even destroying such a collection.
50. Indeed, the CCNE was created by presidential decree no. 83-132 on February 23, 1983, and article 2 states that the CCNE can be called on to make a recommendation by the president of one of the houses of parliament or a cabinet member.
51. Comité Consultatif National d'Ethique (CCNE). Recommendation no. 77: ethical issues raised by collections of biological material and related data: "biobanks", "biolibraries". Available at http://www.ccne-ethique.fr/docs/en/avis077.pdf (accessed 4 April 2009).
52. However, we can refer to case law from the 1990s because it deals with biological material storage activities, albeit in an indirect way as it applies not to the field of scientific research but to assisted reproduction. It is the case law from the Tribunal de Grande instance de Toulouse (T. G. I Toulouse, March 26, 1991, in J. C. P 1992, II, 21807, note P. Pedrot)
53. and from the Tribunal de Grande instance de Rennes (T. G. I Rennes, June 30, 1993, in JCP 1994, II, 22250, note C. Neirinck). The case relates to CECOS, a national facility in charge of sperm and egg storage, which refused to allow a deceased man's spouse to transfer his sperm (T. G. I Toulouse) or fertilized egg (T. G. I Rennes) due to her husband's refusal for post-mortem transfers when he was still alive. His spouse took CECOS to court, where it was ruled that CECOS had neither the right to do with the sperm as they saw fit nor could it destroy the sperm. Yet this would have been a logical consequence to the refusal of post-mortem transfer by the husband. We can infer that judges consider CECOS to be the guardian of human material, which is reminiscent of the National Ethics Committee's stance. We also note that judges gave an essential part to deceased's will without endowing him with property right over his sperm. They skilfully circumvented the issue of ownership by basing their ruling on the contract agreed to by the deceased spouse and CECOS.
54. Article L1211-2, paragraph 2: " (⋯) It can be dispensed from the obligation to inform when finding the individual in question is impossible, or when one of the advisory committees in charge of the protection of individuals (⋯), in consultation with the person responsible for the research, does not believe the information to be necessary" (own translation).
55. The National Cancer Institute (INCa).Les tumorothèques hospitalières, recommandation à l'usage des cliniciens et des chercheurs. Available at http://www.e-cancer.fr/Espacetumorotheques/ Introduction/op-1-it-681-la-1-ve-1.html (accessed 24 May 2009).
56. See moore and Greenberg cases, where it was ruled that donors could not share the benefits of products derived from their biological samples; whereas researchers are entitled to intellectual property rights over these biological products - in moore vs. Regents of California, July 9, 1990, 271, California Reporter 146, 793 P2 d.479;
57. Greenberg et al. vs. miami Children's Hospital Research institute, Inc. 264 F. Supp. 2 d1064.
58. Boris, B. (2007). Tissue banking: Patients' views and expectations in a regulated environment - Does this help the patient? Part 2 - Patient views and expectations, Biopathology, 74, 223-226: "Patients may be willing to have their tissues used for research but not for commercial uses".
59. Caze de Mongolfier, S. Collecte, stockage, et utilisation des produits du corps humain dans le cadre des recherches en génétique : état des lieux historique, éthique et juridique, analyse des pratiques au sein des biothèques. Available at : http://www.ethique. inserm.fr/inserm/ethique.nsf/1d74e2daceb53478c125706100564aea/ 933a7f5b352f398ac12570a500515255/$FILE/Pr%C3%A 9sentation%20orale.pdf (Accessed 23 May 2007).
60. An insurance company could illicitly use such data to deny health coverage, for instance.
61. This is especially true of those people who donate samples multiple times over the life of the research project, which can last years.
62. See for example the well-known Human Genome project in Human Genome Project. Presentation. Available at: http://www.ornl.go.gov/sci/techresources/ Human-Genome/home.sh (accessed 25 May 2009)
63. as well as UK Biobank in UK Biobank. Wellcome to Uk biobank. Available at: http://www.ukbiobank.ac.uk/(accessed 25 May 2009).
64. Mayrhofer, M. (2008).Patients' organisation as (un) usual suspects in biobanking, in H. Gotweiss, A. Petersen (Ed), Governance comparative perspectives, pp. 71-87, London: Routlledge.
65. Article 19 Oversight of population biobanks, § 1: "Each population biobank should be subject to independent oversight, in particular to safeguard the interests and rights of the people concerned by the biobank activities".