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Meeting The Standard: an Overview of European Biobank Regulation and a Comparison to the Current South African Position

Meeting The Standard: an Overview of European Biobank Regulation and a Comparison to the Current... I. INTRODUCTION Due to fascinating new developments in biomedicine, such as stem cell therapy and tissue engineering, contemporary medicine is moving away from being a reactionary process to being a process focused on the maintenance of health by being personal, predictive, preventative and participatory.1 This means that medicine is moving away from traditional forms of treatment, to a point where treatment and experimentation almost merge, and thus it is moving away from the known forms of regulatory frameworks and mechanisms. In fact, the best method of regulating biomedicine is uncertain and will be subject to a process of trial and error for many years. This is true on a global scale and also on a local South African one. This regulatory process has stalled to some extent while each role player, whether an authority, institution, practitioner, researcher or even country, attempts to solve all the issues individually since this leads to a nonconformist and confusing mass of incoherent binding and nonbinding legal and ethical documents, guidelines and rules. This in turn hinders sharing of information, data and ultimately knowledge and subsequent development.2 A uniform system would Admitted Advocate of the High Court of South Africa. LLD candidate (University http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png African Journal of International and Comparative Law Edinburgh University Press

Meeting The Standard: an Overview of European Biobank Regulation and a Comparison to the Current South African Position

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Publisher
Edinburgh University Press
Copyright
© Edinburgh University Press 2015
Subject
Articles; African Studies
ISSN
0954-8890
eISSN
1755-1609
DOI
10.3366/ajicl.2015.0110
Publisher site
See Article on Publisher Site

Abstract

I. INTRODUCTION Due to fascinating new developments in biomedicine, such as stem cell therapy and tissue engineering, contemporary medicine is moving away from being a reactionary process to being a process focused on the maintenance of health by being personal, predictive, preventative and participatory.1 This means that medicine is moving away from traditional forms of treatment, to a point where treatment and experimentation almost merge, and thus it is moving away from the known forms of regulatory frameworks and mechanisms. In fact, the best method of regulating biomedicine is uncertain and will be subject to a process of trial and error for many years. This is true on a global scale and also on a local South African one. This regulatory process has stalled to some extent while each role player, whether an authority, institution, practitioner, researcher or even country, attempts to solve all the issues individually since this leads to a nonconformist and confusing mass of incoherent binding and nonbinding legal and ethical documents, guidelines and rules. This in turn hinders sharing of information, data and ultimately knowledge and subsequent development.2 A uniform system would Admitted Advocate of the High Court of South Africa. LLD candidate (University

Journal

African Journal of International and Comparative LawEdinburgh University Press

Published: Feb 1, 2015

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