Developing Facilitative Governance Frameworks for Emerging Biotechnologies: exploring new approaches to cross-border regulation

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Abstract

This thesis considers the applicability of ‘new governance’ techniques within the field of emerging biotechnologies. Through three contrasting case studies I construct an argument in favour of new governance, contending that the qualities of this regulatory trend (flexibility, reflexivity, nuance, open discourse, and participation – ‘regulatory desirables’ ) have much to offer the regulation of emerging biotechnologies. The first case study examines the existing European and international regulatory frameworks for genetically modified organisms (GMOs). This case study explores the role of (bio)ethics within the regulatory process through each progressive stage: design, operation, and assessment. The regime’s failure to provide adequate space for ethical reflection, and the limited role of ethics throughout the regulatory process prompts a proposal for an alternative approach that recognizes the multiple contexts in which regulation operates, and is able to accommodate the socio-ethical nuances of the GMO products being assessed. This case study analyses a traditionally structured regulatory framework. It exemplifies a number of qualities that I consider undesirable in the context of regulating biotechnologies: inflexibility, lack of reflexivity, lack of nuance within the regime, absence of ethical discussion, absence of participation from all interested/affected parties. In the second and third case studies I show how these ‘regulatory undesirables’ can be addressed through new governance techniques. The second case study focuses on the international regulation of stem cell research; I propose developing a polycentric, principles-based regulation (PBR) regime. The third case study centres on the international governance of the gene synthesis industry; here I recommend adopting a risk-based regulation (RBR) approach. In both these fields, voluntary, interdisciplinary, international organisations have collaborated to produce guidelines, codes, protocols, standards, and statements addressing matters of practice. I argue that these ‘soft law’ documents form the ideal starting point for the development of more sophisticated regulatory regimes in both fields. Furthermore, I argue that the informal organisations producing these documents are, in certain instances, best placed to step into the role of ‘regulator’ due to their in-depth, inside knowledge of the field, and network. Thus, I collapse the regulator-regulatee distinction held in traditional, ‘command and control’ style systems, as these organisations typically include those who would traditionally be seen as the ‘regulatee’. Each case study considers the nuances of context vis-à-vis the regulatory approach advocated.I conclude by engaging in a comparative analysis of these three case studies, drawing out the qualities, characteristics and considerations that I regard as essential to the construction of responsible, facilitative governance frameworks across the field of emerging biotechnologies. I conclude that new governance is best suited to achieving these (aforementioned) ‘regulatory desirables’.

Keyword(s)

emerging biotechnologies; knowledgeable regulator; new governance; polycentric regulation; principles-based regulation; regulation; regulatory desirables; risk-based regulation

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