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Matthias Herdegen

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Matthias Herdegen

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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.

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Matthias Herdegen

Biotechnology has given rise to a close interaction of legal and ethical arguments. Religious beliefs and cultural differences could lead to conflicting approaches to topics such as in vitro fertilisation or pre-implantation diagnostics. In a secular state, regulatory decisions must be based on secular arguments. Still, religious beliefs and prevailing societal concepts or opinions influence regulatory approaches as to the status of early human life, the relative weight of competing interests and real or phantom risks. International law often requires regulatory decisions to be consistent and proportional. Thus, domestic regulatory choices should be based on common standards of rationality. Empirical criteria avoid subjectivism but should not entirely pre-empt value judgments. Still, socio-culturally entrenched values could pose severe difficulties to the development of international standards of bioethics. When international tribunals and other adjudicatory bodies overstretch international standards through an activist interpretation of international treaties, they may unduly narrow the corridor for democratic decisions at the national level. The standard of consistency preserves some deference to democratic choices.

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Matthias Herdegen

Different perceptions of risk can lead to different approaches to risk assessment and risk management. From a general perspective, a distinction can be drawn between two main regulatory approaches. First, the ‘product’ or ‘vertical’ approach, which centres on the features of a finalized biotech product. Second, the ‘process’ or ‘horizontal’ approach, which focuses on the production process rather than on the final product. These alternatives have played a fundamental role, for example, in the regulation of new methods of genetic engineering. Some international instruments additionally allow to take the socio-economic impact of some biotech products (e.g. living modified organisms) into account. Regulations are normally justified on objective, scientific criteria. However, scientific evidence does not always provide certainty about risks and thus leaves a corridor for policy choices. In international law, the precautionary principle covers restrictive measures in the face of potential risks which have not yet been established conclusively.

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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

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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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

As trade in biotech products grows, restrictive sanitary and phytosanitary measures as well as restrictions aimed at the protection of public morals turn into a salient issue in international trade law. The WTO Agreement establishes strict standards for scientifically sound risk assessment and risk management, leaving a limited corridor for the application of the precautionary principle. By contrast, the Cartagena Protocol on Biosafety and EU Law provide a broad corridor for social and economic considerations, which might fuel new controversies, e.g. as to genetically-modified crops. The interaction of these standards triggered international disputes, such as EC-Biotech before the WTO Dispute Settlement Body. Ethical debates surrounding biotech products might additionally pose new challenges to the interpretation and application of the GATT general exceptions. Beyond the WTO, new regional trade agreements have included provisions specifically tailored to address biotech products.