Trade, Health and the Environment

The European Union Put to the Test

Marjolein van Asselt, Michelle Everson, Ellen Vos

• Publisher: Taylor & Francis
• Year: 2013
• eBook ISBN: 9781134595723
• Edition: 1
• Topic: Law
• Subtopic: International Law
• Index: Law

The trade conflicts that the EU has faced within the EU or WTO context demonstrate that the question of how to balance trade and other societal values in situations of uncertainty has not been solved by the regulatory model evolved by the EU in the aftermath of the BSE crisis – one which privileges processes of depoliticisation and scientification. This book addresses the current key dilemmas around science, law and the regulation of trade, both on a regime level and in the context of particular industrial sectors, e.g pharmaceuticals, climate change and nanotechnology. It will present possible future research avenues by looking at both theory and practice and learning from various disciplines (law and social sciences), legal realities (WTO, USA and EU) and actors (regulators, stakeholders, courts).

Part I
Introduction and conclusion

Trade versus health and the environment?

Marjolein B.A. van Asselt, Michelle Everson and Ellen Vos

European integration processes are increasingly being confronted with the dilemma of how to balance the free trade imperative, as well as ever more intense economic integration, against non-economic societal values, such as safety and human and environmental health. Measures designed to protect these values inevitably impact upon trade. Accordingly, the dilemma is often shaped in the terms of trade versus health and the environment.

The BSE (bovine spongiform encephalopathy) crisis, as well as subsequent food crises, have been highly influential in shaping the mode in which the EU currently deals with the science that underlies its decision-making. Crisis has resulted in a significant change in what is considered to be a legitimate governmental use of science and has also resulted in a quest to secure far better ‘quality’ scientific advice, as well as to establish increased transparency and broader participation in science-based decision-making.

Today, however, the issue is not merely one of how to ensure that the science used in EU governance is sound. Instead, it also encompasses the manner in which scientific opinions are balanced against far wider ethical and social values. New approaches introduced by the EU in the wake of the BSE crisis sought to repair alleged deficiencies in EU risk regulation. The aim was to make a clearer separation between risk assessment and risk management, as well as to clarify the distinct roles of scientists and decision-makers. Consequently, new principles, models and rules shaping the production of scientific advice have been introduced, such as European agencies, the precautionary principle for health protection reasons, transparency and participation (see e.g. Ansell and Vogel 2006; Fisher 2009; Harremoës et al. 2002; Zander 2010).

At the same time, internal market and free trade concerns are becoming increasingly intermingled with health and other concerns that can create barriers to free trade. In the EU and World Trade Organization (WTO) context, both Member States and the EU are increasingly being required to provide a scientific justification for any deviations from free trade in favour of interests relating to the protection of health, the environment or ethical concerns. This obligation to justify what might be considered to be political decisions in terms of science and scientific evidence has been introduced as a means to ensure that measures adopted are inspired by genuine non-trade, rather than protectionist, motives and intentions. The position of science as ‘neutral arbiter’ has solidified. Yet, the majority of controversial cases in the ambit of the free trade versus protection of human health and the environment dilemma involve high levels of scientific uncertainty.

We argue that the dilemma of balancing trade and non-trade issues increasingly boils down to a question of how to regulate ‘uncertain risks’.Our earlier workon the regulation of uncertain risks revealed a degree of ‘scientifica-tion' of EU risk regulation (Everson and Vos 2009; Van Asselt and Vos 2006, 2008). Striking controversies, however, clearly demonstrate that the question of how to balance trade and other societal values in situations of uncertainty has not been solved by the current regulatory model evolved by the EU in the aftermath of the BSE crisis – one which privileges processes of depoliticization and scientification.

Frederic Bouder’s identification of the development of a ‘post-trust’ environment in the regulation of pharmaceuticals¹ highlights public dissatisfaction with this model; as does the obscuring complexity of EU regimes designed to combat climate change (see Marjan Peeters² in this volume). The various contributions madeby young scholars toourrelatedvolume, Balancing between Trade and Risk(Van Asselt, Versluis and Vos 2013),similarlyconfirm the limits tothe current approach. Notwithstanding numerouseffortstodesign regulatory models for accommodating science, this problem continues to deserve our full academic attention.

Whilst the financial crisis does not form part of our study in this book, it nonetheless provides us with an important message: namely that not all risk can be modelled. Funtowicz and Ravetz have evolved a concept of ‘radical uncertainty’ in this context.³ This theme is echoed in contributions to this volume (see, especially, the contributions by Mariachiara Tallacchini and by Erik Millstone) and indicates that much work needs to be done infundamentally rethinking the role of science in risk regulation. Both identify a need for a certain degree of politicization (see also Everson and Vos 2009; Van Asselt and Vos 2006, 2008).

The problems emerging in controversies around trade, human health and the environment also relate to trust issues. As Bouder depicts in relation to pharmaceuticals, we are living in a ‘post-trust society’ where ‘the critical voices of new opinion leaders and NGOs have become more trustworthy than those of government or scientists’ (Bouder, p. 92). The concept of ‘post trust’ should not be equated with that of ‘no trust’. Yet, it does indicate that we cannot simply assume a degree of trust in regulators and science. Who is trusted by whom is a critical question, but not necessarily an easy one to answer. Yet, it has become a critical question within decision-making processes focusing on socially controversial issues. Trust matters.

Theory also matters, but must likewise be sufficiently grounded in reality. Reintroducing the notion of ‘politics’ to the theoretical risk debate, Robert V. Percival⁴ notes that a major current problem is that risk regimes also suffer from their failure to recognize the presence of ‘power’ within trade relations, or the fact that political interests play a major role in the complex balancing of science-based regulation of trade and other societal concerns. As a consequence, in the global and EU frameworks, problem-solving is delegated to the relevant courts, which are often unable to address the core problem of scientific uncertainty (see the contributions by Prévost and Vos). An inherently political process of the weighing-up of trade, safety and human and environmental interests should and cannot solely take place in courts. If we are concerned for the enduring health of the rule of law, we must be concerned that the legitimacy of courts is also challenged by processes of depoliticization and scientification.

Millstone explicitly challenges the role of scientific risk assessment within the regulatory process. He convincingly demonstrates how the process of risk assessment within current frameworks is a central point of passage in any decision-making process (see also Van Asselt, Versluis and Vos 2013 and Lee 2010), but accordingly also – in its focus on neutral application of science – heightens the concomitant problem whereby non-scientific socio-economic and ethical concerns are disregarded. Societal concerns can only be considered within science-based risk assessments where they can themselves be framed as ‘risks’. As a consequence, the current balance in regulation appears to be tilted in favour of trade. Although the current regulatory regimes at the level of the Member States and at the EU and the global (WTO) level have been developed to protect free trade against purely protectionist measures, the question, which runs through this volume, is one of whether trade is – in practice – afforded too great a degree of protection at the expense of other societal values.

There is still much room for further research on the manner in which the EU balances trade interests against the protection of health and the environment. Above all, we still need to pay specific attention to the problem of scientific uncertainty within a multi-level system of governance. Which shortcomings beset this system, and how might we improve its functioning? A critical question asked throughout this volume is accordingly one of the degrees to which scientification needs likewise to be balanced by repoliticiza-tion: to which extent should non-scientific concerns be reintegratedwithin EU risk regulation and how might this be best achieved? In short: can and should we repoliticize decision-making on issues that involve trade, human health, environment and other societal concerns?

The book will present possible future research avenues by looking at both theory and practice and learning from various disciplines(law and social sciences), legal realities (WTO, USA and EU) and actors (regulators, stakeholders, courts). It particularly addresses the interplay between trade, health and the environment, both on a regime level and in the context of particular industrial sectors, e.g. pharmaceuticals, climate change and nanotechnology. In thesefields, the EU is wrestling with the dilemma of how to balance the various interests at stake and, above all, with conflicts within its own development agenda, or telos – one which envisages the establishment by 2020 of an Innovation Union and a European knowledge society, but which still posits the existence of a European Union which pays sufficient regard to health, safety and environmental and other social interests.

As trade concerns are central to the EU, both with regard to its internal market and in its relationships with other parts of the world, divergences and deadlocks concerning trade, health and the environment have very visibly put the EU to the test. How did the EU perform in this test? That is the question addressed in this book.

The book consists of five sections. Following this introduction and a conclusion included in Part I, Part II provides a broader context for the modelling of science and precaution. The contribution by Robert V. Percival draws lessons from US environmental law, showing the enormous political influence of regulated industries. He concludes that politics do matter in environmental regulation. This is even the case for the judiciary, which remains split between opponents and proponents of precautionary regulation, thus revealing the difficulties for the judiciary to deal with these issues and how politics may even creep into judicial decision-making. Erik Millstone analyses the role of scientific evidence and expertise in EU regulatory policy-making and their interactions with non-scientific considerations. He points to the limits of the so-called ‘Red Book’ model, developed in the USA, whereby policy-making is supposedly premised upon science rather than policy considerations. He calls for evolution of a co-dynamic model in which the relationship between risk assessment and risk management is at least two-sided. Mariachiara Tallacchini discusses the evolving meaning and role of the precautionary principle in European governance of emerging technologies and calls for a more diffused and participatory idea of precaution that networks individual and collective responsibilities.

Part III of the book involves the in-depth analysis of three case studies in the fields of pharmaceuticals, climate change and nanotechnologies. The contribution by Frederic Bouder reveals the ‘post-trust’ environment in which scientists and policy-makers have to operate, where expert-based decision-making is increasingly challenged. He provides a detailed analysis of the handling of scientific evidence in two specific cases, the anti-HIV (human immunodeficiency virus) drug Viracept and the anti-HPV (human papillomavirus) vaccine Gardasil, where societal perceptions and preferences played a key role in the balancing of risk assessment and protection measures. Bärbel Dorbeck-Jung analyses the regulatory activities by the EU to control therapeutic nanoproducts. She explores the governance responses to the regulatory problems of such products and examines them in the light of responsiveness and stakeholder and scientific legitimacy. The contribution by Marjan Peeters discusses the complex design of the Emission Trading Scheme adopted by the EU in its efforts to combat climate change. She highlights the lack of a scientific body to underpin the technical decision-making under this regime and the difficulties for accommodating competitive trade concerns within it. She further investigates how courts will deal with this highly complex regulatory framework. In doing so, this chapter provides an appropriate bridge to the next section.

Part IV deals with the role that courts have in judging on conflicts between trade and human health, environment and other concerns. The contributions by Denise Prévost and Ellen Vos illustrate how WTO panel(s) and the EU courts visibly struggle with the technicalities of disputes involving both science-based measures and high levels of scientific uncertainty. Both contributions show that, in practice, judicial authorities may ‘promise’ limited judicial review, but nonetheleless overstep their mandate and do not shy away from actively engaging in substantive review of the disputes at hand. The impact of risk scientification accordingly also echoes within the court room. Both contributions underline the need for interdisciplinary research on the role that courts can and should play vis-à-vis science-based measures. Repoliticization of regulation is also away to improve the circumstances in which the court must rule and may result in less delegation of problem-solving to the courts.

The last section of the book, Part V, deals with practitioners’ perspectives as well as an interview with a Member of the European Parliament. The contribution by Sofia Kaliarnta, Maria Hage and Sabine Roeser highlights the many problems relating to stakeholder participation in science-based decision-making, and they thus reflect on the stakeholder panels to the 2012 conference. They harvest practical considerations brought up by the participating stakeholders and emphasize the importance of trust and the emotional concerns of the public.

The interview with Kartika Liotard, with which we close this book, is of great interest as it reveals the various elements that the EU legislator faces in dealing with very politically sensitive dossiers, such as the amendment of the novel foods regulation. It perfectly illustrates the struggle around the interplays between trade, science, the precautionary principle and ethical concerns that has been addressed academically in other chapters. In this case, the gulf between trade interests and ethics exhibited within US government pressure on the EU to allow marketing of meat derived from cloned animals, and ethical concerns, was so great that the Council and the Parliament failed to come to an agreement. This account provides compelling reasons for us to take very seriously indeed the question of whether free trade interests have now been afforded far too great a degree of protection, to the detriment of other social values.

Through the analyses carried out by the individual contributors, this book thus seeks to give a vital contribution to the debate on science-based regulatory regimes and in particular the need to bring politics back in, including at the international level.

Notes

1 See Chapter 4 in this book.

2 See Chapter 6 in this book.

3 See the contribution by Tallacchini, Chapter 3.

4 See Chapter 1 in this volume.

References

Ansell, C. and Vogel, D. (eds) (2006) What’s the Beef? The Contested Governance of European Food Safety, London: MIT Press.

Everson, M. and Vos, E. (2009) ‘Scientification of Politics and Politicisation of Science’,in M. Everson and E. Vos (eds), Uncertain Risks Regulated, London: Routledge/Cavendish Publishing, 1–17.

Fisher, E. (2009) Risk Regulation and Administrative Constitutionalism, London: Hart Publishing.

Funtowicz, S.O. and Ravetz, J.R. (1992) ‘Risk Management as a Post-normal Science’, Risk Analysis, 12(1): 95–97.

Harremoës, P., Vas, S., Stirling, A. and Wynne, B. (eds) (2002) The Precautionary Principle in the 20th Century: Late Lessons from Early Warnings, London: Earthscan.

Lee, M. (2010) ‘Beyond Safety? The Broadening Scope of Risk Regulation’, in...

Table of contents

• Cover
• Title
• Copyright
• Contents
• List of figures
• List of contributors
• Acknowledgement
• List of abbreviations
• PART I Introduction and conclusion
• PART II Science and precaution in regulatory decision-making
• PART III Regulatory practice: Pharmaceuticals, nanotechnology and climate change
• PART IV Role of courts
• PART V Role of stakeholders
• Index