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International Standard Setting in Biomedicine – Foundations and New Challenges

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Vöneky, S. International Standard Setting in Biomedicine – Foundations and New Challenges. German Yearbook of International Law, 61(1), 131-151. https://doi.org/10.3790/gyil.61.1.131
Vöneky, Silja "International Standard Setting in Biomedicine – Foundations and New Challenges" German Yearbook of International Law 61.1, 2018, 131-151. https://doi.org/10.3790/gyil.61.1.131
Vöneky, Silja (2018): International Standard Setting in Biomedicine – Foundations and New Challenges, in: German Yearbook of International Law, vol. 61, iss. 1, 131-151, [online] https://doi.org/10.3790/gyil.61.1.131

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International Standard Setting in Biomedicine – Foundations and New Challenges

Vöneky, Silja

German Yearbook of International Law, Vol. 61 (2018), Iss. 1 : pp. 131–151

1 Citations (CrossRef)

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Author Details

Silja Vöneky, (Co-)Director of the Institute for Public Law and the Professor of Public International Law, Comparative Law, and Ethics of Law and associated member of the Institute for Philosophy of Law at the University of Freiburg.

Cited By

  1. Brain Organoids in Research and Therapy

    Global Harmonization of Legal Standards for Brain Organoid Research and Therapy?

    Voeneky, Silja

    2022

    https://doi.org/10.1007/978-3-030-97641-5_12 [Citations: 4]

Abstract

This article examines current challenges for a normative framework regulating biomedicine, including those arising from the use of big data and machine learning tools, and from the use of the CRISPR/Cas-9 technology, as for instance gene drives. The article focusses on the question of legitimate standard setting and takes into account both “hard” and “soft” law as well as private rule making. This includes international treaties and declarations in the area of human rights law and environmental law, such as the International Covenant on Civil and Political Rights, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, the Rio Declaration on Environment and Development, and, more specifically, the UNESCO Declaration on Bioethics and Human Rights. The author argues that, as instruments of biotechnology and biomedicine merge, international environmental law has to be interpreted in the light of human rights law. In order to adapt to new challenges, the article calls for a humanisation of international environmental law and, because of the ongoing disruptive technological development, argues that further legitimate standard setting is required.

Table of Contents

Section Title Page Action Price
Silja Vöneky: International Standard Setting in Biomedicine – Foundations and New Challenges 1
Abstract 1
I. Introduction 2
II. Foundations and Current Questions of Legitimate Standard Setting 4
A. Human Rights Treaties 4
B. International Environmental Law: Treaties, Soft Law Rules, and a Proposal for a ‘Humanisation’ of International Environmental Law 7
C. Key Elements of Legitimate Standard Setting in Biomedicine 1
D. UNESCO Soft Law 1
1. Procedural Aspects 1
2. Substantive Rules 1
3. UNESCO as Future Actor 1
III. First Results and Open Questions 1
IV. Private Rule-Making and Codes of Conduct 1
V. Pressing Problems in Biomedicine – the Need for New International Legitimate Standard Setting 1