Biobanks for research. Ethical and regulatory aspects in human biological samples collections in France Christine NOIVILLE CNRS / Paris 1 University

Introduction Biobanking: its significance in modern medical research Biobanking: its significance in modern medical research Collections of human biological samples (tissues, body fluids, DNA…) and related data (clinical, biological, genealogical…) Pathology oriented biobanks / populational biobanks Biobanking in France Biobanking in France biobanks abound : profusion of samples collections ; networks (Cancer National Institute, Eurobiobank…) special rules for control (declaration/authorization ; ethical review Board) bioethics principles (29 july 1994 law amended 6 august 2004: consent, gratuity, « non-patrimoniality »)

Introduction (2) Main ethical issues Main ethical issues CCNE / National Ethics Committee, advice n° 77 (20th March 2003) Protecting donors (I) Sharing the content and benefits of biobanks (II)

I. Protecting donors Consent General principles : General principles : informed consent always needed, either express (clinical trial - Opt in) or tacit (healthcare – Opt out) informed consent always needed, either express (clinical trial - Opt in) or tacit (healthcare – Opt out) No blanket consent: opposition right to new research programs No blanket consent: opposition right to new research programs Consent withdrawal Consent withdrawal Remaining issues : Remaining issues : Balance between donors’ protection and research needs Balance between donors’ protection and research needs right to know / not to know about the results of the research right to know / not to know about the results of the research

Confidentiality Confidentiality General rules : General rules : Biobanks must be declared or autorized (research with health data) by CNIL (national authority protecting privacy and personal data) Biobanks must be declared or autorized (research with health data) by CNIL (national authority protecting privacy and personal data) Identifying data must be encoded (exceptions, e.g. peculiarity of the research) Identifying data must be encoded (exceptions, e.g. peculiarity of the research) Commercial exploitation of identifying data is forbidden (13 august 2004 law on health insurance) ; transfer to employers or insurers (article L public health code / 4 march 2002 law) ; criminal sanctions (articles et criminal code) Commercial exploitation of identifying data is forbidden (13 august 2004 law on health insurance) ; transfer to employers or insurers (article L public health code / 4 march 2002 law) ; criminal sanctions (articles et criminal code) Remaining issues : Remaining issues : can courts and police authorities access samples and data for public security reasons ? can courts and police authorities access samples and data for public security reasons ? profiling whole groups of people profiling whole groups of people

II. Sharing the content and benefits of biobanks Access to biological samples Access to biological samples a source of unique biological samples and a powerful tool for research a source of unique biological samples and a powerful tool for research Public hospitals (APHP) / Health Research Institute (INSERM) conflict Public hospitals (APHP) / Health Research Institute (INSERM) conflict Collection value : necessity to recognize each protagonist’s added value (doctors, researchers, facilities hosting collections, firms…) Collection value : necessity to recognize each protagonist’s added value (doctors, researchers, facilities hosting collections, firms…) Property rights : limits of exclusive property as regards access imperative Property rights : limits of exclusive property as regards access imperative CCNE’s advice n°77 : invent a new legal concept that guaranties access CCNE’s advice n°77 : invent a new legal concept that guaranties access

Sharing benefits with donors ? Donors’ right to get a return if a product is developed with their samples ? Donors’ right to get a return if a product is developed with their samples ? US: John Moore case; France: donors have no property rights on their samples US: John Moore case; France: donors have no property rights on their samples Benefit sharing should be conceived in a collective and non financial manner. Benefit sharing should be conceived in a collective and non financial manner. Donors contribute to science altruistically // biobanks increasingly involve researchers, biotech firms and pharma companies which aim to profit by these donations. Donors contribute to science altruistically // biobanks increasingly involve researchers, biotech firms and pharma companies which aim to profit by these donations. Resources must be exploited in a way that favors donors’ interests. Resources must be exploited in a way that favors donors’ interests. Rules have been adopted in order to protect donors’ interests (patent rules preventing too large monopolies blocking research ; rules guarantying patients’ access to important patented medicines). Rules have been adopted in order to protect donors’ interests (patent rules preventing too large monopolies blocking research ; rules guarantying patients’ access to important patented medicines).

Conclusion Biobanking activities may proceed only if : Rights and obligations of all stakeholders (donors, researchers, facilities, industry…) are clearly addressed and regulated Rights and obligations of all stakeholders (donors, researchers, facilities, industry…) are clearly addressed and regulated They remain in line with french ethical values (consent, altruism) and with their very original aim (research, public health improvement). They remain in line with french ethical values (consent, altruism) and with their very original aim (research, public health improvement).