14-1190b-innovation-managing-risk-evidence

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136 accommodate their combined pressures in a way that will circumvent their potentially corrosive impact on innovative developments that could meet important societal needs. A more adaptive approach to the governance of risk and innovation During the twentieth century, the focus of innovation moved from chemistry to information and communication technologies, and the bio-economy is now expected to be the growth engine of the twenty-first century. The innovation trajectories in each of these areas are (or will be) very different, but research on ‘what works’ in innovative business models, taking account of the complexity in the innovation environment arising from new governance approaches, has been very limited. Likewise, there has been little socioeconomic research on the interactions between risk regulatory systems and innovation, as opposed to the very large amount of research on the new governance agenda. It is becoming increasingly clear that our governance systems for advanced innovative technologies are not always fit for purpose. Product regulatory systems that have built up by a process of slow accretion over a period of years are now so onerous that even multinational companies are finding it difficult to develop new innovative products. The new governance agenda was intended to improve policy and regulatory decisions by making them more democratic. Instead it has led to a less democratic and less evidencebased system, in which risk regulation and restriction of specific areas of scientific and innovative activity are seen by some governments and policy makers, particularly in the European Union, as valid responses to societal pressures or the need for public reassurance, rather than a means of dealing with risks for which there is an evidence base 25 . Until recently, flaws in regulatory systems related to overregulation of innovative products and processes have not been a matter of great concern for governments, except where there has been public pressure to address such problems, as in the case of the accelerated development of drugs to treat AIDS. This is in contrast to considerable government attention to the need for ‘better regulation’ in non-risk related areas. In a state of ignorance, or at least insouciance, the assumption has been that this hidden tax on innovation processes can be accommodated by companies while still delivering products at an affordable price. This chapter has focused on the areas where the current risk governance deficits are greatest and where the need for systemic change is most pressing, for example in areas linked to the bio-economy, but these challenges may spread in the near future to other advanced innovative technologies. Such systemic factors can mitigate against effective decision making in at least two ways: (i) the system can become so amorphous and unstructured that there is no clear basis for decisions and also no clearly identified locus for decision making; or (ii) it can become so complex, rigid and constrained by legal and customary precedent that it is incapable of adapting to new threats or opportunities. The bio-economy is in danger of experiencing the first of these threats in the context of the new governance agenda and the There has been little socio-economic research on the interactions between risk regulatory systems and innovation. second in the context of conventional risk regulation. Therefore recommendations related to the adoption of a precautionary approach (see the ‘NGO Perspective’ in Section 2’s fracking case study) should elicit a broadbased policy response that takes account of the interests and values of protagonists and the costs and benefits of alternative options, as outlined in Chapter 4’s neonicotinoid pesticide case study. In a similar vein, the case study on bisphenol A in Chapter 3 points to the need for an increased focus on scientific evidence as a basis for regulatory decision making even, or perhaps particularly, where this is undertaken within the European Union’s overall precautionary regulatory system. Changing the behaviour of innovation or regulatory systems will require finding the right policy levers that will adapt or re-align the relevant system components, and new smarter approaches to regulation and governance are the most likely pressure points to deliver better innovation-related value for money from public investment in basic science. The two case studies included in this chapter provide very interesting pointers to future directions that could be taken to meet these needs. Standards developed through dialogue between stakeholders and companies, to ensure the quality of products and processes and to govern health, safety and environmental impacts, have a much better record of being adaptive in the face of new technological developments than our current regulatory systems (see nanotechnology case study). This is not to suggest that standards could totally replace these regulatory systems, but much could be learned from the adaptive processes they have used so successfully. The alternative risk management strategy proposed for novel crops by David Baulcombe (see GM crops case study) could be a starting point for re-thinking the European regulatory system in a way that would be sufficiently radical to enable re-shaping and reinvigorating of innovation for European crop production. Each approach has the potential to complement the other, and together they could enable us to deploy our insights more intelligently than we have done to date. The above commentary should not be seen to counsel against the elements of the new governance approach or engagement, upstream or downstream. However, we need to learn how to overcome these systemic threats without jeopardizing the safety and effectiveness of the innovative products and processes that we will need to meet future societal challenges.
Lisa Jardine (University College London) 137 CHAPTER 12: ULTIMATELY A DECISION HAS TO BE MADE A wide-ranging consultation on mitochondrial-replacement procedures offers a successful example of engagement with the public on a controversial innovation.
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INNOVATION: MANAGING RISK, NOT AVOI
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FOREWORD Advances in science and te
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EDITOR AND CHAPTER AUTHORS 6 Editor
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8 CASE STUDY AUTHORS Framing Risk -
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Global Alliance for Vaccines and Im
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14 INTRODUCTION In today’s global
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16 Investors face additional risks
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18 unclear patent law), or barriers
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More problematically, system-wide r
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22 is unwilling or unable to undert
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24 innovation process, or one secto
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2 1. TRENDS IN INNOVATION AND GLOBA
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28 the body. Nanoparticles generate
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access to education that are occurr
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to seek opportunities for more subs
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34 Middle East and Africa mean that
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At their core, decisions are about
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38 CASE STUDY CONSISTENCY AND TRANS
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40 within Her Majesty’s Inspector
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42 liabilities. The coalition gover
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44 Advances in the life sciences co
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SECTION 2: UNCERTAINTY, COMMUNICATI
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Andy Stirling (Science Policy Resea
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as a whole, for seeding and selecti
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information concerning public polic
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Kingdom. It has 34 participating an
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Cinderella, too often uninvited to
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have been awarded in rational choic
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ecomes easier to accept and justify
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Tim O’Riordan (University of East
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CASE STUDY HUMAN RIGHTS AND RISK Ka
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give the impression that certain ki
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adioactive waste in many countries
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David Spiegelhalter (University of
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course, means that 1% are violent,
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level was announced on 22 January 2
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Even in situations with limited evi
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Steve Elliott (Chemical Industries
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THE NGO PERSPECTIVE Harry Huyton (R
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SECTION 3: FRAMING RISK — THE HUM
Page 87 and 88: David Halpern and Owain Service (Be
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Page 91 and 92: measures have been put in place and
Page 93 and 94: Nick Pidgeon and Karen Henwood (Car
Page 95 and 96: equity of risk distribution, the pe
Page 97 and 98: individual include the emergence of
Page 99 and 100: domain of biosecurity risks. In the
Page 101 and 102: Edmund Penning-Rowsell (University
Page 103 and 104: — that is, governed by random pro
Page 105 and 106: 90% 80% Media scare stories linking
Page 107 and 108: Judith Petts (University of Southam
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Page 115 and 116: Nick Beckstead (University of Oxfor
Page 117 and 118: CASE STUDY POLICY, DECISION-MAKING
Page 119 and 120: might be developed, and what the li
Page 121 and 122: Julia Slingo (Met Office Chief Scie
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Page 125 and 126: the premiums that we have received
Page 127 and 128: Only three GM crops have been appro
Page 129 and 130: Joyce Tait (University of Edinburgh
Page 131 and 132: evidence used to support policy and
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Page 139 and 140: debate, which enabled the non-scien
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Page 145 and 146: ANNEX: INTERNATIONAL CONTRIBUTIONS
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Page 153 and 154: • How can we give entrepreneurs s
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Page 157 and 158: nanodashboard.nano.gov/. 77. See Ma
Page 159 and 160: 41. Vanichkorn, S. and Banchongduan
Page 161 and 162: 22. OECD. Dynamising National Innov
Page 163 and 164: engagement. London: Zed Books; 2005
Page 165 and 166: science and technology. Washington
Page 167 and 168: structural model. Risk Analysis 12(
Page 169 and 170: Chalmers, David John. (2010). “Th
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