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The Reasoning Structure in Legal Disputes on the International Trade of Biotechnology: From a Judicial Balance by Chance to a Judicial Balance by Design

Published online by Cambridge University Press:  04 May 2021

Alessandra GUIDAOpen the ORCID record for Alessandra GUIDA[Opens in a new window]
Alessandra GUIDA*
Affiliation:
Admitted lawyer, PhD candidate and casual academic at Macquarie Law School, Macquarie University, Sydney, Australia; email: alessandra.guida@mq.edu.au.
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Abstract

The international trade in biotech products boosts national economies and advances scientific as well as technology innovation. However, while trading these products increases the spread of benefits on a global scale, it also increases risks to human health and the environment (ie biosafety). This is because the effects of this technology on biosafety are still highly uncertain. Against this background, the judicial bodies under the World Trade Organization (WTO) find themselves in the middle of an intricate and polarised debate in which a proper judicial balance between free trade and biosafety becomes fundamental in order to determine whether requests for ensuring human and environmental health justify trade restrictions. This paper aims to highlight that the WTO is institutionally unready for balancing economic and non-economic values. In suggesting how to rationalise the judicial balance between the competing interests in the context of biotechnology, this paper demonstrates that the judicial adoption of a well-structured proportionality analysis can turn the current balance by chance into a balance by structure.

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European Journal of Risk Regulation , Volume 12 , Issue 3: Special Issue on Biotechnology in International Economic Law and Human Rights , September 2021, pp. 602 - 617
Copyright
© The Author(s), 2021. Published by Cambridge University Press

I. Introduction

In the current technology era, the international trade in biotech products is flourishing. Biotechnology is the result of revolutionary advances in science echoing the human capacity for controlling and managing nature to obtain benefits and profits. As of 19 February 2020, trading biotech products has a market capitalisation of billions of dollars per year.Footnote 1 Nevertheless, biotechnology and trade have also been described as “the elements from which modern nightmares are made”.Footnote 2 This is because while trading biotech products magnifies geographically the spread of benefits, it also magnifies the risks posed by these products to human health and the environment. Allergenicity to a novel gene product, antibiotic resistance and the increasing use of pesticides on genetically modified (GM) crops can irreversibly impact on the functioning of the human body.Footnote 3 Trading biotech products can also damage the environment where biotech products are cultivated for trade purposes.Footnote 4 This is because “[a]gricultural biotechnology is closely associated with modern intensive farming and, as part of that, with the massive use of synthetic agrochemicals (pesticides), [which can] lead to the destruction of the very foundation of agricultural production – the earth that feeds us and that provides for a number of ecological services vital for life on earth”.Footnote 5

The World Trade Organization (WTO), which is the only worldwide organisation that deals with trade rules between 164 states and resolves trade disputes between its Member States through a dispute settlement mechanism, finds itself in the middle of this polarised debate in which biotechnology is seen as a Pandora’s box. Since the Agreement establishing the WTO sets out economic and non-economic goals, it might be assumed that the WTO judicial bodies (ie WTO Panels and the Appellate Body (AB)) are equipped with a proper institutional structure to balance requests for enhancing free trade and biosafety. Nevertheless, it has been noted that the WTO is institutionally unready for balancing trade and non-trade values. Footnote 6 Arguably, this difficulty stems from the lack of an analytical structure under the WTO guiding decision-makers in achieving a reasoned balance between competing rights, interests, or values. This structure is embodied by the proportionality analysis, also known as proportionality balancing,Footnote 7 the appeal of which lies in its accommodating character in the face of conflicting interests, Footnote 8 such as in the context of biotechnology where the competing nature of requests for trading biotech products and ensuring biosafety makes for a difficult balancing exercise. As Kuo stresses, “the key component of this reasoning structure is balancing”.Footnote 9 “Whenever there is a conflict of rights, values and interests”, Andenas and Zleptnig add, “this conflict will often need to be resolved through a judicial balancing act”. Footnote 10

This paper shows how a well-structured proportionality analysis can guide the WTO judicial bodies towards the achievement of a reasoned balance between the enhancement of trade and the protection of biosafety when collisions arise and uncertainties occur. Accordingly, this paper endorses the notion that, despite scepticism, WTO decision-makers should adopt the proportionality analysis to turn the current judicial balance by chance into a judicial balance by design.

In approaching this task, this paper develops as follows. Section II introduces the legal criterion of proportionality and explores whether there is justification to use it under WTO law. Section III then illustrates Robert Alexy’s theory of balancing, which is a valuable model to support a rational structure of judicial reasoning that helps to address legal biotechnology disputes under the WTO. Section IV builds on this line of reasoning and provides a step-by-step explanation of how WTO decision-makers can perform a well-structured proportionality analysis to address biotechnology cases in practice. In doing so, it sheds light on some limits in transplanting Alexy’s theory to the context of biotechnology and offers suggestions for overcoming them. Section V draws final conclusions.

II. Proportionality analysis and justification to use it under the WTO

1. Concept and structure of proportionality: a brief overview

As Cannizzaro states and Cottier et al emphasize, “the requirement of proportionality is almost universally affirmed”.Footnote 11 Nevertheless, defining proportionality is not a straightforward task. This is because there are several conceptions of proportionality,Footnote 12 the meaning of which depends on the context to which it applies.Footnote 13 In legal contexts, proportionality, which Kumm describes as one of “the most successful legal transplants in the second half of the twentieth century”,Footnote 14 is conceived as a legal criterion addressed as a “principle”, “test” or “analysis”. Footnote 15

In spite of different conceptions of proportionality,Footnote 16 the common denominator is the capacity of this criterion to aid in solving cases concerning conflicting values. Additionally, it is agreed that balancing is at the core of proportionality.Footnote 17 Unsurprisingly, proportionality analysis is also termed “proportionality balancing”.Footnote 18 Balancing is, however, only the last step of the analytical structure supporting the proportionality analysis, which develops into the following three tests:

  • The suitability test requires that a state measure must be appropriate to achieve the desired and legitimate end.Footnote 19 This, accordingly, presupposes the existence of a causal linkage between the objective and the measure.

  • The necessity test requires the adoption of necessary measures, meaning the least restrictive and least onerous amongst equally effective alternatives.

  • Finally, the balancing test (or proportionality stricto sensu) requires the adoption of a measure that is not excessive or disproportionate in relation to the pursued objective. This means that “the limitation achieves the pursued end to a degree that justifies the extent of the constraint on the constitutional right”.Footnote 20

Bearing this in mind, the following analysis focuses on the justification and application of proportionality under the WTO, as discussed in the following sections.

2. Justification to use proportionality analysis under the WTO

Even though proportionality is not specified in any WTO Agreement, several courts in other regimes apply it without explicit entrenchment in their constitution. Hence, the question arises as to whether the WTO should do the same. The answer is affirmative. Indeed, several WTO provisions and judicial reasoning are sources that interpreters can use for justifying the use of proportionality under WTO law. There is an “inherent presence of some kind of proportionality in WTO law by reference to balancing and weighing of measures or interests”. Footnote 21 Specifically, in the context of the General Agreement on Tariffs and Trade (GATT Agreement), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), the Technical Barriers to Trade Agreement (TBT Agreement) and The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement), there are terms such as “proportionate”, “necessary”, “commensurate”, “less trade restrictive” and “weighing and balancing exercise” that reflect elements of the proportionality analysis.Footnote 22

For example, in interpreting the necessity requirement under Article XX(b) GATT Agreement, the AB developed in Korea – Various Measures on Beef the “necessity test”, which recalls the second step of the proportionality analysis. Footnote 23

Someone might argue that as the AB developed the “necessity test”, rather than a more sophisticated proportionality test, WTO decision-makers should adopt the former to weight and balance competing values. However, the “necessity test” is, on the one hand, “overbroad and underinclusive”Footnote 24 and, on the other hand, “it seems to elevate trade values to a pre-eminent status”.Footnote 25 Moreover, it does not take account of the chosen national level of protection.Footnote 26 Therefore, the “necessity test” cannot (and should not) replace a well-structured proportionality analysis.

Further elements of proportionality can be found in the Chapeau of Article XX GATT Agreement, according to which protective measures can be adopted in the context of the GATT, SPS and TBT Agreements if they are assessed as, inter alia, (1) not more trade restrictive than necessary and (2) not applied in a manner that would constitute a means of arbitrary or (3) unjustifiable discrimination between countries or (4) a disguised restriction on international trade. Footnote 27 This entails, as Cottier et al note, a “weighing and balancing exercise along the lines of the proportionality principle”. Footnote 28

There are implicit references to the proportionality analysis also in the context of the SPS and TBT Agreements. For example, Article 5.6 SPS Agreement clarifies that “Members shall ensure that [SPS] measures are not more trade-restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection”.Footnote 29 This reminds us of the “necessity test”.Footnote 30

In the context of the TBT Agreement, the WTO judicial bodies should establish whether states’ technical regulations are “prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade”.Footnote 31 This evaluation can be duly conducted by means of the proportionality analysis.

Elements of proportionality analysis can also be found in the TRIPs Agreement where, for instance, Article 46 stresses “the need for proportionality between the seriousness of the infringement and the remedies ordered as well as the interests of third parties”.Footnote 32

Furthermore, the interpretation of proportionality under WTO law is supported by several commentators who refer to this concept in order to emphasise the importance of balancing competing interests. For instance, it has been outlined that as the need for balancing Member States’ trade interests and other legitimate policy goals is “implicit to the WTO framework”,Footnote 33 proportionality “therefore is of inherent importance to international trade regulation in balancing divergent interests at stake”.Footnote 34

At the same time, other commentators claim that the WTO judicial bodies should not perform the “balancing test”, which is the last test of proportionality analysis where a true “weighing and balancing” exercise of competing values takes place,Footnote 35 chiefly for three reasons.

First, it is claimed that implementing the balancing test becomes a political tool that is (mis)used by decision-makers for judicial activism in legal decision-making. Footnote 36

This concern is only partially substantiated. “Certainly”, Barak observes, “the balancing component affords the judge discretion. But by what standard can that discretion be said to be too broad? … Proportionality is a framework that needs to be filled with content, and it allows for varied degrees of protection”.Footnote 37 Moreover, no proof has been offered that applying the “balancing test” has shaped decisions infused with broad judicial epistemic discretion. This criticism is, in fact, “not based on a systematic analysis of judicial practice. At best, it refers to individual cases as anecdotal evidence”.Footnote 38

A second criticism highlights that in performing the “balancing test”, the WTO judicial bodies should weight and balance incommensurable values,Footnote 39 meaning values that do not have a common metric allowing WTO decision-makers to evaluate and compare their importance.Footnote 40

This is not necessarily true if Alexy’s theory of balancing is operationalised. As Section III highlights, Alexy’s theory adopts triadic scales for evaluating the elements that decision-makers should take into account in balancing competing rights or interests.Footnote 41 These scales represent a common metric for comparing, balancing and weighting the values at stake. Accordingly, performing a “balancing test” in light of Alexy’s theory of balancing should not be subject to criticisms about the incommensurability of values. Alexy’s balancing model offers, in fact, a structure having “a common measure for comparing principles”, thereby “providing a predictable result that can be correctly justified in the law”.Footnote 42

Third, it has been argued that “WTO law does not, and … should not include … the principle of ‘proportionality stricto sensu’”,Footnote 43 as it “constitutes an extraordinary intrusion into national regulatory sovereignty”.Footnote 44 Its application, in turn, would lead to the issuing of unreasonable judgments in which WTO decision-makers tend “to prefer ‘trade’ (and thus ‘deregulation’) to ‘health [and/or environmental] protection’ (and thus Member States’ regulation)”.Footnote 45

This criticism disregards the fact that when the WTO judicial bodies are called to examine competing requests, the resulting judicial decisions will inevitably interfere with sovereign policy choices. For example, establishing that a ban on potentially harmful products to biosafety violates WTO norms and, as such, cannot be in force would affect the national regulatory choice of adopting a precautionary policy on such products. Accordingly, asking decision-makers to justify their decisions in light of a structured balancing test would only enhance the transparency and objectivity of final decisions that would interfere with national policies in any case.Footnote 46

To conclude, proportionality can be justified under WTO law and indeed should be applied. Even if deciding proportionally is not an obligation, the use of this legal criterion can bring clarity, transparency and equilibrium in balancing colliding interests under the WTO framework. In addition, although “proportionality – like any conceptual framework – is not a neutral process”,Footnote 47 the three main counterarguments against the judicial performance of a “balancing test” under the WTO should not discourage its performance. On the contrary, conducting a well-structured proportionality analysis, which means performing the suitability, necessity and balancing tests, is highly desirable in the context of biotechnology. How the WTO judicial bodies should conduct a well-structured proportionality analysis in practice is discussed in the next section.

III. The rationality of balancing according to Robert Alexy

Balancing has become “an essential methodological criterion for adjudication”.Footnote 48 Nevertheless, it is not a straightforward procedure, especially under the WTO, which is considered institutionally unready for balancing economic and non-economic values. Additionally, there are ongoing theoretical and practical discussions on whether balancing is a rational procedure or a purely rhetorical device.Footnote 49 This, in turn, invites the question of what structure of reasoning should a balancing process have to be reasoned and rational under the WTO? The jurist and a legal philosopher Robert Alexy in his book A Theory of Constitutional Rights develops a conception of the structure of balancing that helps to provide an answer to this question.Footnote 50

In Alexy’s view, three elements form a rational structure of balancing: the law of balancing, the weight formula and the burden of argumentation. Footnote 51 By taking account of these three elements, the judicial balance of competing values can become a rationale procedure based on a well-structured proportionality analysis. Footnote 52

The law of balancing (ie the first factor of the structure of balancing) comprises and puts in relation the three factors to be taken into account in any balancing process, which are the abstract weight, the intensity of interference and the reliability of the empirical premises of the principles, rights or interests at stake. A brief explanation of each factor will aid in understanding their roles in balancing processes.

First, according to Dworkin and Alexy, unlike rules, principles “operate as reasons that can be accorded different degrees of ‘weight’ according to both the case at hand and interplay with other principles”.Footnote 53 The “weight” of a principle can be assessed in abstract (namely, without any link to a concrete case) or in concrete (under the circumstances of a case).Footnote 54

In light of this, the abstract weight (ie the first factor of the law of balancing) considers the possible different legal hierarchies between the competing principles or rights under examination. It might be argued, for instance, that the right to life has a greater abstract weight than the right to development, if only because, unlike the right to development, the right to life is non-derogable.Footnote 55

Second, the intensity of interference (ie the second factor of the law of balancing) stands for the intensity of interference by non-satisfaction of, or detriment to, the principles, rights, values or interests at stake. For instance, spraying GM crops with greater levels of herbicides than the maximum amount established by the competent authorities would inevitably interfere with the enjoyment of the right to health of people living in areas surrounding fields of GM crops. There are, in fact, numerous scientific studies showing the adverse effects on the health of people exposed to massive doses of herbicides.Footnote 56

Importantly, Alexy points out the close linkage between the degree of non-satisfaction of one interest and the abstract weight of the other(s) through the so-called “first law of balancing”, according to which:

The greater the degree of non-satisfaction of, or detriment to, one principle [right], the greater must be the importance of satisfying the other.Footnote 57

At this point, the question is how the degree of non-satisfaction of an interest or the abstract weight of the interests at stake can be expressed and compared. In this respect, Alexy adopts the triadic scale of light, moderate and serious, which was developed by the German Federal Constitutional Court in the Tobacco caseFootnote 58 and can be “facilitated” by using numbers following the geometrical sequence of 1, 2 and 4 for, respectively, light, moderate and serious intensity of interference.

The third factor of Alexy’s law of balancing is the reliability of empirical premises, in the sense of certitude of the underlying empirical assumptions. The reliability of empirical premises refers to the degree of knowledge of factual data of a concrete case.

The intensity of interference and the reliability of empirical premises are interrelated according to the Alexy’s “second law of balancing”, which reads as follows:

The more heavily an interference in a constitutional right [or legal principle] weighs, the greater must be the certainty of its underlying premises.Footnote 59

For the reliability of empirical assumption, Alexy adopts a triadic scale developed by the German Federal Constitutional Court that, in the cannabis judgment, refers to reliable/certain, average or plausible and uncertain empirical premises.Footnote 60 As for the abstract weight and the intensity of interference, this triadic scale can also be exemplified by assigning, respectively, the numerical values of 1, $${1 \over 2}$$ and $${1 \over 4}$$ .

Alexy’s weight formula (ie the second factor of the structure of balancing) answers the question of how the theoretical law of balancing can aid decision-makers in dealing with real cases and obtaining a concrete balancing outcome.Footnote 61 This formula is certainly the most innovative and, at the same time, the most criticised element of Alexy’s balancing theory. As Bernal Pulido observes, “there are diverse rationality limits that leave a margin of discretion to judges” without, nonetheless, impairing “the analytical value of the weight formula”.Footnote 62 The weight formula encompasses the three factors of the law of balancing to obtain the concrete weight (CW) of the competing interests at stake.Footnote 63

When translated to our context of investigation, the judicial application of the weight formula should consider the abstract weight (AW), intensity of interference (IoI), reliability of empirical premises (Re) pertaining to the interest in trading biotech products (t) and the interest in ensuring biosafety from risks posed by trading these products (b), so as to read as follows:

$$CW\left( t \right)\left( b \right) = {{AW\left( t \right)\; \times \;IoI\left( t \right)\; \times \;{R^e}\left( t \right)\;} \over {AW\left( b \right)\; \times \;IoI\left( b \right)\; \times \;{R^e}\left( b \right)\;}}$$

The third element of Alexy’s structure of balancing is the burden of argumentation that operates when the application of the weight formula results in a stalemate, which is when the weight of the principles is identical. Footnote 64 However, Alexy does not provide a straightforward explanation of how to break a stalemate by means of this third element. Footnote 65

Bearing all this in mind, the next section provides a step-by-step suggestion of how the WTO judicial bodies can apply and refine Alexy’s theory in order to address biotechnology legal disputes.

IV. Proportionality analysis applied and refined to fit biotechnology scenarios

This section illustrates how a well-structured proportionality analysis, the core of which lies in achieving a reasoned balance between the competing values of free trade and biosafety by means of Alexy’s theory, can lead the WTO judicial bodies to obtain a concrete outcome in biotechnology legal disputes.

As a first step, it is necessary to identify the competing rights, principles or interests to balance that, in our case, are the interests in trading biotech products and ensuring biosafety.

As a second step, the WTO judicial bodies should establish the values of the abstract weight of the interests in trading biotech products and ensuring biosafety. In doing so, they might decide that the former has the same, lesser or greater abstract weight than the latter.

Considering that the WTO represents an international organisation that deals with trade rules between its Member States, it might be assumed that greater abstract weight will be ascribed to free trade. However, this assumption would be wrong for two reasons. First, as WTO Panels and the AB acknowledge, “few interests are more ‘vital’ and ‘important’ than protecting human beings from health risks”.Footnote 66 Second, WTO law does not establish a paramount goal to be pursued or facilitated: “free trade is neither the only nor the overriding purpose”. Footnote 67 As such, the judicial attribution of the same abstract weight to the interests in trading biotech products and ensuring biosafety would properly echo the lack of an overriding WTO goal. Nonetheless, this would overlook human rights implications in trade contexts.Footnote 68

Consequently, establishing the values of the abstract weights of the competing interests in the context of biotechnology might be particularly difficult for WTO decision-makers, especially because neither WTO law nor Alexy’s theory of balancing suggests how to address such a challenge.

In light of this, the present analysis recommends the judicial consideration of the pro homine (or pro personae) principle. This principle embodies the broad acknowledgment that “individuals [rather than states] are subjects of international human rights law and, consequently, have interests that need to be taken into consideration developing and applying international law”.Footnote 69 Importantly, human rights courts are not the only judicial bodies taking account of the pro homine principle.Footnote 70 Indeed, “[t]his principle sets an imperative rule to all international law actors”,Footnote 71 which should take account of the pro homine principle if only because it pursues the joint goal of protecting human beings.Footnote 72

Thus, by adopting the pro homine principle, the WTO decision-maker should ascribe a prima facie higher weight to the protection of human health – and, arguably, the environment, the safeguard of which is strictly related to the well-being of people. This can, in turn, help WTO decision-makers to overcome the discussed issues in establishing the abstract weight of the interests in the context of biotechnology.

As a third step, the WTO judicial bodies should determine the values of the intensity of interference of the interests in trading biotech products and ensuring biosafety. As the degree of interference is not a variable that should be assessed in abstract, these values depend on the concrete case. For instance, a total ban on the import/export of a contested GM organism (GMO) represents a serious interference with trade. A high tax on the import/export of such a product is, arguably, a moderate interference, while a low tax on the contested product reflects a light interference with trade.

Although establishing the intensity of interference requires a case-by-case analysis, it is important to bear in mind that the Chapeau of Article XX GATT Agreement clarifies that protective measures triggered in the context of the GATT, SPS and TBT Agreements do not apply in a manner that would constitute “a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade [occurs]”.Footnote 73 Accordingly, performing the “necessity test” can guide the WTO judicial bodies in determining whether the contested biosafety measure represents the least restrictive and least onerous amongst equally effective alternatives. At the same time, in establishing the intensity of interference of the interest in trading biotech products compared with the interest in ensuring biosafety, the WTO judicial bodies can (and should) also adopt the “suitability test”. Its adoption would aid the appointed WTO Panel in determining whether there is a causal linkage between the objective and the contested measure and, as such, whether the contested measure is appropriate to achieve the desired and legitimate end.Footnote 74

As a fourth step, the WTO judicial bodies should determine the values of the reliability of the empirical premises of the interests in trading biotech products and ensuring biosafety. As with the intensity of interference, the reliability of empirical premises is a variable to be assessed under concrete circumstances. Nevertheless, the still high level of scientific uncertainty regarding the effects posed by trading biotech products on biosafety makes such judicial evaluation particularly difficult. Facing contrasting scientific evidence claiming, on the one hand, the safety of biotech products and, on the other hand, their harmfulness to biosafety, the question is: how should a WTO Panel determine the reliability of related empirical assumptions? The question becomes even more intricate considering that the Alexy’s second law of balancing, which applies to circumstances where “there is fully reliable knowledge of the intensity of interference, but the underlying empirical premises are unreliable”,Footnote 75 cannot guide decision-makers in handling the unreliability of empirical premises in the context of biotechnology. This is because the uncertainties surrounding this technology also make unreliable the knowledge of the intensity of interference with the interest in ensuring biosafety.

In light of this, the present analysis suggests filling this lacuna in Alexy’s theory of balancing by performing a thorough evaluation of the reliability of evidence that, notably, WTO Panels seem to overlook. In determining the appreciation (or quality) of evidence, WTO Panels assess the “credibility and weight … ascribed to … a given piece of evidence”.Footnote 76 Nevertheless, the judicial appreciation of evidence is generally described as a process, also termed weight of evidence (WoE), weighting, among others, the credibility and reliability of pieces of evidence for determining the quality of the body of evidence submitted by parties.Footnote 77 As such, the reliability of evidence supporting the competing requests in the context of biotechnology should be part of the judicial appreciation of evidence.

At this point, a pertinent question might be: what makes a piece of evidence reliable? Arguably, there is no single answer to this question. WTO Panels might, for instance, invite all experts involved (ie parties’ experts and experts appointed by Panellists) to submit evidence arising from the same WoE process. This would enhance transparency and consistency in performing risk assessments to guide WTO decision-makers in evaluating the reliability of evidence and, accordingly, the reliability of related empirical premises. To enhance the reliability of evidence, WTO Panels might also perform a thorough evaluation of the appropriateness of risk assessments supporting the evidence brought to their attention. Risk assessment is indeed the process generating the body of evidence supporting requests in biotechnology legal disputes. Nevertheless, the WTO normative framework and the WTO jurisprudence neglect to define what can be considered “appropriate” in circumstances involving scientific uncertainties. For example, in the context of the SPS Agreement, any risk assessment complying with Article 5.1 and Annex A.4 of such Agreement is considered “appropriate”. Nevertheless, both of these provisions are science-centric and, for such reason, do not suit the scientifically uncertain circumstances surrounding the international trade in biotech products.

Considering the complexity surrounding this technology, proper assessments of biotechnology risks should encompass not only a scientific but also a holistic approach, which takes account of both the physical and social impacts of biotech products. Footnote 78 Not surprisingly, Geelhoed notes that the European legislator has introduced the new Article 26-b to Directive 2001/18/EC – disciplining the introduction of GMOs into the European market – relying on Ganzheitliche Gesichtspunkte (ie “holistic factors”): “holistic, trans-scientific aspects that bridge risk assessment and risk management, to justify [national] bans [to GMOs]”. Footnote 79

As a final step, the WTO judicial bodies should insert the established values of the abstract weight, the intensity of interference and the reliability of the empirical premises into Alexy’s weight formula to obtain the concrete weight of both the interests in question. The scenarios that might be brought to the attention of the WTO judicial bodies are manifold as they depend on concrete circumstances. Nonetheless, the application of the weight formula can result in three possible outcomes.

First, the operationalisation of the formula shows that the interest in ensuring biosafety weights more than the interest in trading biotech products. In this case, the WTO judicial bodies should not have discretion, but support national requests for ensuring biosafety from adverse risks posed by the international trade of these products.

Second, the application of the formula reveals that the interest in trading biotech products weights more than the interest in ensuring biosafety. As such, national requests for enhancing the international trade in biotech products should be supported in WTO courtrooms.

In the third possible scenario, the judicial balance results in a stalemate, meaning that the two interests at stake have the same concrete weight. Accordingly, the judicial balance through Alexy’s weight formula is meaningless. This means that the WTO judicial bodies have (only in this case) genuine empirical epistemic discretion, which is the situation in which decision-makers have complete discretion because uncertainty concerning empirical premises is given.Footnote 80

Facing this third scenario, according to Alexy’s theory, the burden of argumentation (ie the third element of Alexy’s structure of balancing) operates, although it is not clear how it can break a stalemate. Consequently, the present analysis suggests the judicial adoption of the precautionary principle as a means to break stalemates and, as such, reduce the judicial epistemic discretion of WTO decision-makers in biotechnology cases.

The precautionary principle is an international environmental law principle that “calls for actions at an earlier stage, even in a time of doubt when there is not yet conclusive scientific evidence as to the harmfulness”.Footnote 81 For such reason, it plays a key role in the field of biotechnology, which is riddled with uncertainties. Unsurprisingly, the jurisprudence of international courts contains plenty of cases in which precaution was invoked to support biosafety requests aimed at addressing risks to human health and/or the environment caused by biotechnology.Footnote 82 What is more, the precautionary principle can be implemented in judicial contexts through procedural means, including reversing the burden of proof:

[N]ormative rules such as the [precautionary principle] can be regarded as fair when they ensure “distributive justice” – that is, when “an appropriate or proper allocation of burdens and benefits [is] secured by the rules themselves”. Footnote 83

In other words, the precautionary principle can reverse the burden of proof and places it on the proponents of biotech products. Furthermore, the precautionary approach does affect the standard of proof by lowering the evidentiary threshold.Footnote 84 Accordingly, by reversing the burden of proof, or simply by affecting the standard of proof, precaution represents a valid means to break a stalemate.

At the same time, the consideration of precaution as an additional factor of the balancing process might alleviate the concerns of some commentators who discourage the application of the “balancing test”, as it would lead WTO decision-makers to prefer free trade over health and/or environmental protection.Footnote 85 Indeed, although precaution does not dictate an outcome, it requires decision-makers to consider biosafety measures in spite of remaining uncertainties.

Additionally, the judicial operationalisation of the precautionary principle would also be a coherent consequence of the judicial adoption of the pro homine principle, which ascribes a prima facie priority to rights or legal interests protecting individuals from, in our case, risks posed by trading biotech products.

To conclude, performing a well-structured proportionality analysis under the WTO is desirable and feasible in the context of biotechnology. By taking the five steps developed in this section, the WTO judicial bodies would conduct a judicial balance by structure, rather than by chance. The application of the suggested methodology might, in turn, lead to different judicial decisions. For instance, in EC–Hormones, EC–Biotech and US/Canada–Hormones Continued Suspension, the appointed Panels have found that the measures to prevent the importation of certain products were contrary to WTO law, especially the SPS Agreement. Those decisions were reached without adopting a balancing structure. Arguably, the application of the suggested methodology would have led to a different result in any of those cases, if only because its employment would have favoured a more precautionary and balanced conclusion than happened at the time.

V. Conclusion

The analysis in this paper demonstrates that performing proportionality analysis in the context of biotechnology under the WTO has compelling justifications in spite of the lack of explicit reference to proportionality in WTO agreements and the scepticism about running the “balancing test”. In light of the foundations provided by Alexy’s theory of balancing, the WTO judicial balance between trade and non-trade interests can be the result of a well-structured proportionality analysis – rather than a decision confined to the epistemic discretion of the appointed WTO Panel.

Transplanting proportionality analysis to the field of biotechnology, however, carries some limits that this paper attempts to overcome by suggesting the judicial consideration of three new factors in the balancing process: the pro homine principle, the reliability of evidence and the precautionary principle.

By adopting the pro homine principle, WTO decision-makers should ascribe a prima facie higher weight to human rights and, accordingly, biosafety protection. The judicial consideration of the pro homine principle in the balancing process would, accordingly, aid WTO decision-makers in ascribing the abstract weight of the interests in trading biotech products and ensuring biosafety.

Considering the reliability of evidence as a further factor to take account of in balancing the competing interests in trading biotech products would aid WTO decision-makers in establishing the reliability of empirical premises, the determination of which might be difficult in the chasm of antithetical scientific studies on biotech products. The analysis in this paper highlights that a consistent risk assessor’s adoption of a WoE process along with a comprehensive judicial evaluation of the “appropriateness” of risk assessments might enhance the reliability of evidence supporting requests in biotechnology cases.

Finally, the precautionary principle is another key factor that should be taken into account in any balancing process concerning biotechnology. Indeed, by reversing the burden of proof and affecting the standard of proof, the precautionary principle can break potential stalemates and, in turn, reduce the judicial epistemic discretion of WTO Panels in these cases. In addition, by calling for actions at an earlier stage, even when scientific uncertainties remain, this principle can aid WTO decision-makers to handle the numerous uncertainties surrounding biotechnology.

Therefore, the application of the suggested refinements of Alexy’s theory of balancing to the uncertain scientific circumstances surrounding the international trade of biotech products would lead the WTO judicial bodies to turn the current judicial balance between free trade and biosafety by chance into a judicial balance by design.

Footnotes

I gratefully acknowledge the financial support for this study provided by Macquarie University.

1 “Biotech stocks: how to invest and the best companies to watch” (IG Analyst, 16 April 2020) <https://www.ig.com/au/news-and-trade-ideas/biotech-stocks--how-to-invest-and-the-best-companies-to-watch-200415> (last accessed 15 June 2020).

2 C Carlarne, “From the USA with love: sharing home-grown hormones, GMOs, and clones with a reluctant Europe” (2007) 37 Environmental Law 301, 302.

3 M Weimer, Risk Regulation in the Internal Market: Lessons from Agricultural Biotechnology (Oxford, Oxford University Press 2019) pp 5–6; A Smith and CA Carter, “Estimating the market effect of a food scare: the case of genetically modified StarLink corn” (2007) 89 Review of Economics and Statistics 522; T Netherwood et al, “Assessing the survival of transgenic plant DNA in the human gastrointestinal tract” (2004) 22 Nature Biotechnology 204.

4 A Lang et al, “Laboratory tests with Lepidoptera to assess non-target effects of Bt maize pollen: analysis of current studies and recommendations for a standardised design” (2019) 31 Environmental Sciences Europe 39; A Agi et al, “Efficacy of seed mixes of transgenic Bt and nontransgenic cotton against bollworm, Helicoverpa zea Boddie” (2001) 5 Journal of Cotton Science 74.

5 Weimer, supra, note 3, 5; C Robinson, M Antoniou and J Fagan, GMO Myths and Truths: A Citizen’s Guide to the Evidence on the Safety and Efficacy of Genetically Modified Crops and Foods, 3rd edition (London, Earth Open Source 2015) pp 88–96.

6 M Andenas and S Zleptnig, “Proportionality: WTO law: in comparative perspective” (2007) 42 Texas International Law Journal 371; J Neumann and E Turk, “Necessity revisited: proportionality in World Trade Organization law after Korea–Beef, EC–Asbestos and EC–Sardines” (2003) 199 World Trade Journal 199.

7 K Möller, The Global Model of Constitutional Rights (Oxford, Oxford Constitutional Theory 2012); MS Kuo, “Resolving the question of inter-scalar legitimacy into law? A hard look at proportionality balancing in global governance” (2018) 31 Leiden Journal of International Law 793.

8 Kuo, supra, note 7, 799.

9 Footnote ibid.

10 Andenas and Zleptnig, supra, note 6, 385.

11 E Cannizzaro, “The role of proportionality in the law of international countermeasures” (2001) 12 European Journal of International Law 889; T Cottier et al, “The principle of proportionality in international law: foundations and variations” (2017) 18 Journal of World Investment & Trade 628, 639.

12 B Schlink, “Proportionality (1)” in M Rosenfeld & A Sajó (eds), The Oxford Handbook of Comparative Constitutional Law (Oxford, Oxford University Press 2012) p 719.

13 V Vadi, Proportionality, Reasonableness and Standards of Review in International Investment Law and Arbitration (Cheltenham, Edward Elgar 2018) pp 57–62.

14 M Kumm, “Constitutional rights as principles: on the structure and domain of constitutional justice. A review essay on a theory of constitutional rights” (2004) 2 International Journal of Constitutional Law 574, 595.

15 Andenas and Zleptnig, supra, note 6, 373; V Vadi, “The migration of constitutional ideas to regional and international economic law: the case of proportionality” (2015) 35 Northwestern Journal of International Law & Business 568.

16 As regards the meaning of proportionality in mathematical contexts, see M Livio, The Golden Ratio: The Story of Phi, the World’s Most Astonishing Number (New York, Broadway Books 2002) p 3. For further insights into the meaning of proportionality in arts contexts, see LB Alberti, On the Art of Building in Ten Books (Cambridge, MA, MIT Press 1988); TM Poole, “Proportionality in perspective” (2010) 2010 New Zealand Law Review 369, 387.

17 A Barak, “Proportionality (2)” in M Rosenfeld & A Sajó (eds), The Oxford Handbook of Comparative Constitutional Law (Oxford, Oxford University Press 2012) p 738.

18 AS Sweet and J Mathews, “Global constitutionalism and transnational governance” in AS Sweet and J Mathews (eds), Proportionality Balancing and Constitutional Governance: A Comparative and Global Approach (Oxford, Oxford University Press 2019); Kuo, supra, note 7; F Ortino, “Investment treaties, sustainable development and reasonableness review: a case against strict proportionality balancing” (2017) 30 Leiden Journal of International Law 71; AS Sweet and J Mathews, “Proportionality balancing and global constitutionalism” (2008) 1 Faculty Scholarship Series 1.

19 Some authors address the two elements of the “suitability test” (ie the factual appropriateness and the legitimate end) separately so as to state that proportionality has four tests (or sub-principles). See Sweet and Mathews, “Proportionality balancing and global constitutionalism”, supra, note 18, 75; Barak, supra, note 17, 743–44; Vadi, supra, note 13, 60.

20 C Bernal Pulido, “The migration of proportionality across Europe” (2013) 11 New Zealand Journal of Public and International Law 483.

21 Cottier et al, supra, note 11, 641.

22 Vadi, supra, note 13, 83; AD Mitchell, “Proportionality and remedies in WTO disputes” (2007) 17 European Journal of International Law 985, 987.

23 WTO, Korea–Measures Affecting Imports of Fresh, Chilled and Frozen Beef (11 December 2000) WT/DS161/AB/R, WT/DS169/AB/R [161] (“Korea–Various Measures on Beef”).

24 JP Trachtman, “Trade and … problems, cost–benefit analysis and subsidiarity” (1998) 9 European Journal of International Law 32, 72; Vadi, supra, note 13, 85.

25 Vadi, supra, note 13, 85; Trachtman, supra, note 24.

26 Vadi, supra, note 13, 85.

27 General Agreement on Tariffs and Trade (15 April 1994) LT/UR/A-1A/12 Art XX, Chapeau (“GATT Agreement”) <http://docsonline.wto.org>.

28 Cottier et al, supra note 11, 644.

29 Agreement on the Application of Sanitary and Phytosanitary Measures (15 April 1994) LT/UR/A-1A/12 Art 5.6 (“SPS Agreement”) <http://docsonline.wto.org> (emphasis added).

30 See the AB’s interpretation of Art 2.2 in WTO Japan–Measures Affecting Importation of Apples (26 November 2003) WT/DS245/AB/R (“Japan–Apples”).

31 Agreement on Technical Barriers to Trade Agreement (15 April 1994) LT/UR/A-1A/2 Art 2.2 (“TBT Agreement”) <http://docsonline.wto.org> (emphasis added).

32 Agreement on Trade-Related Aspects of Intellectual Property Rights 15 April 1994) LT/UR/A-1A/2 Art 4.6 (“TRIPS Agreement”) <http://docsonline.wto.org> (emphasis added). Further elements of proportionality can be found in the Agreement on Subsidies and Countervailing Measures (15 April 1994) LT/UR/A-1A/2 Annex 1A 4.10 (footnote 9) (“SCM Agreement”) <http://docsonline.wto.org>. See Vadi, supra, note 13, 87.

33 Cottier et al, supra, note 11, 644.

34 P Van den Bossche, “Looking for proportionality in WTO law” (2008) 35 Legal Issues of Economic Integration 284 (emphasis added); see also Cottier et al, supra, note 11; M Hilf, “Power, rules and principles – which orientation for WTO/GATT law?” (2001) 4 Journal of International Economic Law 111; Mitchell, supra, note 22; Sweet and Mathews, “Global constitutionalism and transnational governance”, supra, note 18; Neumann and Turk, supra, note 6; A Sykest, “The least restrictive means” (2003) 70 The University of Chicago Law Review; Vadi, supra, note 15; T Megiddo, “Beyond fragmentation: on international law’s integrationist forces” (2019) 44 Yale Journal of International Law 4; Sweet and Mathews, “Proportionality balancing and global constitutionalism”, supra, note 18.

35 Bernal Pulido, supra, note 20.

36 Among others, see G Huscroft, “Proportionality and pretense” (2014) 29 Constitutional Commentary 229, 255; J von Bernstorff, “Proportionality without balancing – why judicial ad hoc-balancing is unnecessary and potentially detrimental to the realization of individual and collective self-determination” in L Lazarus, C McCrudden and N Bowles (eds), Reasoning Rights: Comparative Judicial Engagement (Oxford, Hart Publishing 2014) p 66; D Kennedy, “A transnational genealogy of proportionality in private law” in R Brownsword et al (eds), The Foundations of European Private Law (Oxford, Hart Publishing 2011) p 187.

37 Barak, supra, note 17, 750.

38 N Petersen, Proportionality and Judicial Activism – Foundamental Rights Adjudication in Canada, Germany and South Africa (Cambridge, Cambridge University Press 2017); Sweet and Mathews, “Proportionality balancing and global constitutionalism”, supra, note 18; C Bernal Pulido, “The rationality of balancing” (2006) 92 Archiv fuer Rechts- und Sozial Philosophie 195, 195–97.

39 On the concept of incommensurability, see J Raz, “Incommensurability and agency” in J Raz (ed.), Engaging Reason (Oxford, Oxford University Press 2001); Sweet and Mathews, “Global constitutionalism and transnational governance”, supra, note 18, 38–40; R Alexy, A Theory of Legal Argumentation: The Theory of Rational Discourse as Theory of Legal Justification (Oxford, Oxford University Press 2009) pp 33–173.

40 For criticisms about the “balancing test” in relation to incommensurability, see TA Aleinikoff, “Constitutional law in the age of balancing” (1987) 96 Yale Law Journal 973; L Tribe, “Constitutional calculus: equal justice or economic efficiency” (1985) 98 Harvard Law Review 595; C Sunstein, “Incommensurability and valuation in law” (1994) 92 Michigan Law Review 779.

41 R Alexy, “Discourse theory and fundamental rights” in AJ Menéndez and EO Eriksen (eds), Arguing Fundamental Rights (Berlin, Springer 2006) pp 24–26.

42 Bernal Pulido, supra, note 38; R Alexy, A Theory of Constitutional Rights (Oxford, Oxford University Press 2002); A Barak, Proportionality: Constitutional Rights and Their Limitations (Cambridge, Cambridge University Press 2012).

43 F Ortino, Basic Legal Instruments for the Liberalisation of Trade – A Comparative Analysis of EC and WTO Law (Oxford, Hart Publishing 2004) p 472 (emphasis in original).

44 Footnote ibid. See A Desmedt, “Proportionality in WTO law” (2001) 4 Journal of International Economic Law 441; Neumann and Turk, supra, note 6; GC Shaffer, “A structural approach to WTO jurisprudence: why institutional choice lies at the center of the GMO case” (2008) 4 New York University Journal of International Law and Politics 1; Van den Bossche, supra, note 34.

45 Ortino, supra, note 43, 420.

46 M Andenas and S Zleptnig, “Proportionality and balancing in WTO law: a comparative perspective” (2007) 20 Cambridge Review of International Affairs 71, 90.

47 Vadi, supra, note 15, 573.

48 Bernal Pulido, supra, note 38, 195.

49 Footnote ibid.

50 Alexy, supra, note 42, 47–48.

51 R Alexy, “On balancing and subsumption. A structural comparison” (2003) 16 Ratio Juris 433.

52 Footnote ibid.

53 R Bellamy, “Ronald Dworkin, taking rights seriously” in JT Levy (ed.), The Oxford Handbook of Classics in Contemporary Political Theory (Oxford, Oxford University Press 2017) pp 1, 4; R Dworkin, Taking Rights Seriously (Cambridge, MA, Harvard University Press 1978) p 14; Alexy, supra, note 42, 44.

54 Dworkin, supra, note 53; Alexy, supra, note 42.

55 United Nations Human Rights, Core Human Rights in the Two Covenants (September 2013) <https://nhri.ohchr.org/EN/IHRS/TreatyBodies/Page%20Documents/Core%20Human%20Rights.pdf> (last accessed 19 June 2020).

56 See, eg, K-H Kima, E Kabirb and SA Jahanc, “Exposure to pesticides and the associated human health effects” (2017) 575 Science of the Total Environment 525; AF Hernándeza et al, “Toxic effects of pesticide mixtures at a molecular level: their relevance to human health” (2013) 307 Toxicology 136; V Rizzatia et al, “Effects of pesticide mixtures in human and animal models: an update of the recent literature” (2016) 254 Chemico-Biological Interactions 231; DC Bellinger, “A strategy for comparing the contributions of environmental chemicals and other risk factors to neurodevelopment of children” (2012) 120 Environmental Health Perspectives 501.

57 R Alexy, “Formal principles: some replies to critics” (2014) 12 International Journal of Constitutional Law 511, 513.

58 Decisions of the German Federal Constitutional Court, (BVerfGE) 95, 173; Alexy, supra, note 41, 25.

59 Alexy, supra, note 57, 514.

60 Decisions of the German Federal Constitutional Court (BVerfGE) 90, 145; Alexy, supra, note 42.

61 Alexy, supra, note 51, 435.

62 C Bernal Pulido, “On Alexy’s weight formula” in AJ Menéndez and EO Eriksen (eds), Arguing Fundamental Rights (Berlin, Springer 2006) p 109.

63 Alexy, supra, note 51; M Klatt and M Meister, The Constitutional Structure of Proportionality (Oxford, Oxford University Press 2012) p 12.

64 R Alexy, “The absolute and the relative dimensions of constitutional rights” (2017) 37 Oxford Journal of Legal Studies 31, footnote 52; Bernal Pulido, supra, note 62, 104.

65 Bernal Pulido, supra, note 62, 104.

66 WTO, Brazil–Measures Affecting Imports of Retreaded Tyres (12 June 2007) WT/DS332/R [7.108] (“Brazil–Retreaded Tyres”); WTO, Brazil–Measures Affecting Imports of Retreaded Tyres (3 December 2007) WT/DS332/AB/R [144], [179] (“Brazil–Retreaded Tyres”); WTO, European Communities–Measures Affecting Asbestos and Asbestos-Containing Products (5 April 2001) WT/DS135/AB/R [172] (“EC–Asbestos”); WTO, Brazil–Certain Measures Concerning Taxation and Charges (30 August 2017) [7.873] WT/DS472/R WT/DS497/R (“Brazil–Taxation”).

67 P-T Stoll and F Schorkopf, WTO – World Economic Order, World Trade Law (Leiden, Martinus Nijhoff 2006); FX Perrez, “The mutual supportiveness of trade and environment international law” (2006) 100 Proceedings of the Annual Meeting (American Society of International Law) 65.

68 See S Joseph, Blame It on the WTO? A Human Rights Critique (Oxford, Oxford University Press 2011).

69 V De Oliveira Mazzuoli and D Ribeiro, “The pro homine principle as a fundamental aspect of international human rights law” (2017) 47 European Journal of International Law 457.

70 HR Berbera, “The pro personae principle and its application by Mexican courts” (2017) 4 Queen Mary Human Rights Law Review 1, 10.

71 De Oliveira Mazzuoli and Ribeiro, supra, note 69, 457.

72 Footnote ibid, 461.

73 GATT Agreement, Chapeau, supra, note 27; SPS Agreement, Art 2.3, supra, note 29.

74 WTO, Korea–Various Measures on Beef, supra, note 23, [161].

75 Klatt and Meister, supra, note 63, 128.

76 WTO, European Communities–Measures Concerning Meat and Meat Products (Hormones) (16 January 1998) WT/DS26/AB/R-WT/DS48/AB/R [132] (emphasis added) (“EC–Hormones”).

77 F Smarandache and J Dezert, Advances and Applications of DSmT for Information Fusion, Vol. IV (Santa Fe, NM, American Research Press 2015) 413; G Suter, S Cormier and M Barron, “A weight of evidence framework for environmental assessments: inferring qualities” (2017) 13 Integrated Environmental Assessment and Management 1038; AT Hall et al, “New approach to weight-of-evidence assessment of ecotoxicological effects in regulatory decision-making” (2017) 13 Integrated Environmental Assessment and Management 573.

78 A Roger, “In the public interest? A comparative analysis of Norway and EU GMO regulations” (2015) 24 Review of European, Comparative and International Environmental Law 264. See also A Guida, “Are WTO decisionmakers regulating technological risks or are technological risks steering WTO biotechnology legal decisions?” (2021) Risk Analysis, early view.

79 M Geelhoed, “Divided in diversity: reforming the EU’s GMO regime” (2016) 18 Cambridge Yearbook of European Legal Studies 20.

80 Klatt and Meister, supra, note 63, 120–21.

81 AL Jaeckel, The International Seabed Authority and the Precautionary Principle – Balancing Deep Seabed Mineral Mining and Marine Environmental Protection (Leiden, Brill Nijhoff 2017) p 29.

82 See, among others, EC–Hormones, supra, note 76; WTO, United States–Continued Suspension of Obligations in the EC–Hormones Dispute (21 March 2008) WT/DS320/AB/R (“US/Canada–Hormones Continued Suspension”); WTO, European Communities–Measures Affecting the Approval and Marketing of Biotech Products (29 September 2006) WT/DS291/R, WT/DS292/R, WT/DS293/R (“EC–Biotech”); Case 111/16 Giorgio Fidenato and Others [2017] ECR 431; Joined Cases C-58/10 and 68/10 Monsanto SAS et al. v Ministre de l’Agriculture et de la Pêche [2011] ECR 553; Joined Cases C-439/05 P and 454/05 P Land Oberosterreich and Republic of Austria v Commission of the European Communities [2007] ECR 510; Case 236/01 Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others [2003] ECR 431; Case 6/99 Pfizer Animal Health SA v Council [2002] ECR 209; C-6/99 Greenpeace France and Others [2000] ECR148.

83 M Ambrus, “The precautionary principle and a fair allocation of the burden of proof in international environmental law” (2012) 21 Review of European Community and International Environmental Law 259, 260; I Scobbie, “Tom Franck’s fairness” (2002) 13 European Journal of International Law 909, 910.

84 Jaeckel, supra, note 81, 55; A Trouwborst, “The precautionary principle in general international law: combating the Babylonian confusion” (2007) 16 Review of European Community & International Environmental Law 185, 192; J Peel, The Precautionary Principle in Practice: Environmental Decision-Making and Scientific Uncertainty (Alexandria, Federation Press 2005) p 6.

85 Ortino, supra, note 43, 420.

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