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Global Genes, Local Concerns

Legal, Ethical, and Scientific Challenges in International Biobanking

Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
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Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

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Brian J. Clark and Tina Bossow

In the context of this chapter, “bioscience industries” refers to companies involved in research, development and manufacturing of products that improve diagnosis, treatment, or prevention of human diseases, or the provision of enabling technologies or services in support of the same aims. This diverse grouping includes the pharmaceutical, diagnostics, biotechnology, and research and development services industries. Many companies within the bioscience industries use biological samples derived from humans (“human biosamples”) in their research, development, or manufacturing processes and some finished products may contain human biosample components. While the for-profit business model of commercial companies sometimes leads to mistrust and questions over their legitimacy as users of human biosamples (HBS), such companies are and will remain essential for the discovery, development, and delivery of innovations in healthcare that are of benefit for populations. Therefore, the legitimacy of the bioscience industries as valid users of HBS for purposes intended to deliver public benefit should not be in doubt. Instead, the pivotal question should be whether the bioscience industries can demonstrate that they use HBS in ways that are socially responsible, ethical, compliant with applicable laws or regulations, and safe, such that they merit access to precious HBS. In fact, this same question should equally apply to any user of HBS, whether a for-profit industrial user or a not-for profit or public institutional user. All users should be able to demonstrate that they are legitimate and responsible users of HBS.

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Matthias Herdegen

A growing number of human rights treaties contain provisions specifically addressing biotechnological concerns. Human rights bodies constantly deal with biotech-related cases. Human dignity has inspired and guided the development of human rights in this area. Many human rights have a bioethical dimension. The right to life involves fundamental bioethical questions, such as the beginning of human life and the personhood of embryos. Biomedical research is linked to the protection of health. The right to adequate food may lead to an enhancement of support for agricultural research. The respect for personal autonomy requires respect for the principle of informed consent in biomedical and genetic research. The right to privacy protects confidentiality of genetic data and the individual’s right to know (or not to know) about the results of genetic tests. The right to family life might also be a relevant factor in the management of genetic data. Finally, biotechnology raises new risks of discrimination (e.g. discrimination based on genetic features).

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Matthias Herdegen

Biodiversity is the source of genetic resources capable of being used in industrial processes. While the exploitation of genetic recourses has been dominated by industrialized countries, the world’s most biodiverse regions correspond to developing or emerging economies. The Convention on Biological Diversity has sought to strike a balance between the ‘global north’ and the ‘global south’ in this sensitive area, seeking to counter the unfair appropriation of genetic resources. In this vein, it introduces mechanisms of access and benefit sharing (ABS). The Nagoya Protocol on Access and Benefit Sharing facilitates the implementation of these mechanisms. Further steps towards a fair use of genetic resources have been taken in the context of the FAO. The FAO Seed Treaty seeks to line the FAO regime for plant genetic resources with the Convention on Biological Diversity. In this context, the rights of indigenous peoples are an important concern which includes the protection of traditional indigenous knowledge.

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Matthias Herdegen

Biotechnology poses significant challenges to States, international organisations and the international community at large. Differing risk perceptions and varying levels of risk aversion influence regulation of biotechnology. Normative, ethical and technical standards justify and limit regulatory decisions. In the long run, regulatory choices may affect consumers’ preferences. Still, the individual’s choices in favour or against biotech products are rooted on personal freedom and autonomy. In this subjective realm, preferences require no objective justification.

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Matthias Herdegen

Socio-political, ethical and legal debates have always surrounded biomedicine. Reproductive medicine and, particularly, in vitro fertilisation, remain fields of legal and ethical controversy. Other contested areas are the use of human embryos for scientific research or therapeutic purposes, somatic gene therapy, and interventions in the germ line. Particular concern has arisen from the possibility of human cloning. In this regard, many jurisdictions distinguish between “reproductive” cloning leading to the creation of an identical human being, on the one hand, and “therapeutic” cloning on the other hand. These areas provide ample material for the delicate interplay between domestic and international law. .

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Matthias Herdegen

GMOs and other achievements of agricultural research have raised significant concerns among the population of many States. The precautionary principle has made it possible for States to adopt measures aimed at safeguarding the environment against potentially harmful products or activities, where available scientific information does not yet provide conclusive proof of risk. International instruments have addressed the complex relationship between environmental protection and biotechnology. Examples are provided by the Convention on Biological Diversity and the Cartagena Protocol on Biosafety, which contain specific provisions on GMOs. Another important element of the system is the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress, which addresses damages related to the transboundary movement of LMOs. The coexistence of organic, conventional and GM agriculture has given rise to regulatory responses, such as the attempt of EU member States to create ‘GMO free zones’ or the possible prohibition to cultivate GM crops in certain areas despite their approval by competent authorities.

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The International Law of Biotechnology

Human Rights, Trade, Patents, Health and the Environment

Matthias Herdegen

Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.
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Matthias Herdegen

Biotechnology significantly contributes to economic development as well as to the improvement of life quality. From an international and comparative perspective, biotechnological products and processes give rise to a broad range of regulatory issues which range from human rights to international trade law. Legal responses reflect intense scientific and ethical debates. Green biotechnology modernizes agricultural processes, increasing the quality of the products that reach consumers. Red biotechnology helps develop new vaccines and other pharmaceutical products. White biotechnology has transformed entire industries through the use of living organisms (e.g. bacterial enzymes or biomass) in industrial processes and energy production. Grey biotechnology fosters environmental protection and accelerates recovery of damaged ecosystems. Blue biotechnology improves the utilisation of marine resources.