1

Laurence LwoffDGI - Human Rights DirectorateCouncil of Europehttp://www.coe.int/bioethics

Human Rights in BiomedicineBioethics

Biobanks

Introduction

• Objective of CoE activities in bioethics:

Protection of human rights in the field of biology and medicine

• Pioneering work of the Council of Europe – Continues to be unique by its human rights approach

• Legal corpus adopted: reference at European, as well as global level

Convention on Human Rights and Biomedicine (CETS No. 164, 1997)

and its Additional Protocols

• Case law of ECHR developing on bioethical issues

www.coe.int/bioethics 2

Developments in biomedical field

• Scientific and technological developments:

• Acquisition of new knowledge

• Development of applications

• Source of important potential benefits for human beings, in particular for human health

• Possible challenges for human rights

– Raising issues with transversal relevance

Health-related data• Increased value of biological materials in the biomedical field

• Increased storage of biological materials for future uses in « biobanks »:

– Specific uses often not known at time

of removal

– Materials most often identifiable

• Biological materials are source of health-related personal data“In addition to the highly personal nature of cellular samples, the Court notes that they contain much sensitive information about an individual, including information about his or her health. Moreover, samples contain a unique genetic code of great relevance to both the individual and his relatives.”

(S. and Marper v. the United Kingdom [GC] Applications nos. 30562/04 and 30566/044, 4 December 2008) 4

• Main concerns

– Protection of private life

• Consent

• Protection of sensitive personal data

– Management of samples and associated personal data

– Access by third parties

• Current work (Committee on Bioethics (DH-BIO))

– Re-examination of Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin

– Public consultation carried out

– Cooperation with the T-PD

Objective reinforcing the legal framework for the protection of

human rights5

www.coe.int/bioethics