Macquarie University
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Biotechnology under the WTO: balancing free trade and biosafety

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posted on 2022-08-17, 23:55 authored by Alessandra Guida

Biotechnology is sometimes regarded as a panacea for modern-day challenges, such as feeding a growing world population. Trading biotech products can offer significant economic opportunities, while also presenting risks of significant harm to human health and the environment (ie, biosafety). These risks and benefits are characterised by a range of uncertainties. Trading biotech products magnifies these risks and benefits globally. The World Trade Organization (WTO) is responsible for trade rules covering much of the world and resolving trade disputes between its member states. To enhance free trade and, at the same time, ensure biosafety, it is critically important that WTO judicial bodies strike a reasoned balance between trade and non-trade values. This requires decision-makers to balance the interests in trading biotechnology with those of ensuring biosafety, under conditions of uncertainty. This thesis examines how WTO judicial bodies attempt to achieve such a balance. In so doing, it explores the extent to which proportionality analysis and the precautionary principle can assist in balancing biosafety and free trade in biotech products. This study identifies epistemic issues stemming from the uncertainties surrounding the international trade of biotech products. It also reveals normative lacunae in the existing regulation of biotechnology under the WTO framework, along with weaknesses in the judicial examination of biotechnology legal disputes. This thesis offers insights into how WTO law could better achieve a balance between trade interests and biosafety and effectively pursue the goal of sustainable development. It does so by providing suggestions to fill several gaps left by WTO law, and by demonstrating that proportionality analysis and the precautionary principle can be appropriate criteria for determining the justifiability and the justification of biosafety measures in trade contexts.


Table of Contents

Part I: Context - International trade in biotechnology -- Chapter 1: International trade in biotechnology and protection of biosafety: an uneasy combination -- Part II: Addressing normative, judicial and epistemic challenges in trading biotechnology under the WTO -- Chapter 2: Normative, judicial and epistemic challenges for the WTO: free trade and biosafety -- Chapter 3: Proportionality analysis to address WTO normative and judicial challenges in the context of biotechnology -- Chapter 4: The precautionary principle to address WTO epistemic challenges in the context of biotechnology -- Part III: Analysis of WTO biotechnology legal disputes -- Chapter 5: Introduction to and key reasons for a critical analysis of WTO biotechnology legal disputes -- Chapter 6: Allocation of the burden of proof to establish a prima facie case and standard of review to examine biotechnology matters: preliminary issues in the WTO jurisprudence on biotechnology -- Chapter 7: Adopting precautionary measures on biosafety in contexts of sufficient scientific evidence -- Chapter 8: Adopting precautionary measures on biosafety in contexts of insufficient scientific evidence -- Part IV: Final insights -- Chapter 9: Conclusion – Bibliography


A thesis in fulfilment of the requirements for the degree of Doctor of Philosophy

Awarding Institution

Macquarie University

Degree Type

Thesis PhD


Thesis (PhD), Macquarie Law School, Faculty of Arts, Macquarie University

Department, Centre or School

Macquarie Law School

Year of Award


Principal Supervisor

Carlos Bernal Pulido

Additional Supervisor 1

Aline Jaeckel

Additional Supervisor 2

Kirsten Davies


Copyright: The Author Copyright disclaimer:




452 pages