Understanding Expectations As Techniques Of Legitimation

Understanding Expectations As Techniques Of Legitimation The Case Of Imagined Futures Through Global Bioethics Standards For Health Research Presented by: Mr. Helex Date: 10 November 2021 Combining Law And STS - The special issue is a first step towards further law-led dialogue between law and STS. - As such, it takes up the call for law-led dialogue found across sociolegal studies. - I outline this call, before turning to explain 'imaginaries' and how they link to expectations, and then putting these concepts to work in respect of global bioethics standards. Taking Up The Call For Further Law- Led Dialogue - Resonant with imaginaries by exploring how legal technicality includes the 'hopes, ambitions, fantasies and day-dreams of armies of legal engineers' (at 975). - Call for law-led dialogue • NB other disciplines may colonies legal territory, perhaps crowding out or sidelining law- led contributions and concerns e.g. for technicalities. Expectations And Imaginaries - Expectations or strong beliefs about what will occur produce 'imagined futures' - 'Collectively imagined forms of social life and social order reflected in the design and fulfilment of nation-specific scientific and/or technological projects' ICH - ICH • International Council on Harmonizations of Technical Requirements for Registration of Pharmaceuticals for Human Use (founded 1990). - ICH and its global bioethics standards matter • It sets key global bioethics standards relating to medicinal products (also applied to medical devices) e.g. Good Clinical Practice; • These standards are applicable and de facto binding in Members (and often non-Members) through reference in law. - Focus of my article and argument • How expectations or strong beliefs about what can occur, and an imaginary, flow from the ICH's mission and technological framing; • Some of the key implications of this for legitimation i.e. in terms of who and what are legitimized. • Arguing that expectations are a technique of public legitimation for the ICH and its standards, and implementing regulators, among stakeholders, non-ICH countries who conform, and wider publics. 'Harmonizations for better health' - Public participation is sidelined in ICH governance, thus undermining a further technique of legitimation (infra) - Supports and legitimates focus on technological development (legitimating the ICH, its (technological) risk- based governance and standards, and regulators and laws that implement them) - This focus in turn marginalizes wider systemic issues relating to social justice, particularly those affecting the global South (infra) - The focus limits the boundaries of responsibility and accountability to the production of safe, quality, and effective pharmaceuticals, and individual ethical conduct to achieve it (market orientation) - The ICH's Focus Marginalizes Issues Relating To Social Justice, Particularly Those Affecting The Global South • The ICH's focus does so by engendering a distortion of attention and resources toward the management of consequences through technical solutions i.e. treatment using pharmaceutical responses; • Expectations (and imaginary) mask this by providing legitimating cover; • The Covid-19 pandemic underscores how this may operate:  Wider social conditions that cause the virus' spread seem marginal;  The distortion of priorities may undermine the social infrastructures needed to address all public health problems (these may be cheaper, more effective, and beneficial).  Agreement on Trade-Related Aspects of Intellectual Property (TRIPS): o Provides all technologies, including medicines and vaccines, patentable in all o World Trade Organization states i.e. globally. • Patent holder (usually also the marketer) is able to prevent generic equivalents from entering the market for duration of patent grant (20 years). o Patents provide market exclusivity; ICH standards provide a key basis for marketing and benefiting from exclusivity. - Public Participation Is Sidelined • Focus on scientific knowledge and expertise abets this; • There have been notable reforms of ICH governance since it became an international association under Swiss law in 2015 e.g. greater transparency and an assembly with wider participation and increased say in decision-making; • But these compare unfavorably with those at, say, the European Medicines Agency. - STS points to the potential of public participation e.g. around the framing of risk, who benefits and experiences harm, and how we might know. - I argue for increased public participation in the ICH to: • Enhance transparency; • Improve the quality, safety, and efficacy of • Pharmaceuticals; • Widen the focus to include other social justice issues; and further bolstering legitimation. - This would supplement reliance on the current main technique of legitimation: communication of expectations and transparency to demonstrate that practices are in accordance with them (i.e. expectations are met). Conclusion - Overall, discussion of the ICH underscores the way expectations may be shaped to produce an imaginary. - The public legitimation these provide appears central to ensuring take up of the ICH's standards and accomplishing the mission of 'harmonization for better health'. - Yet, this is not without concerns for adverse effects relating to social justice and relatedly, raises concerns about who has a say in shaping the mission and all that flows from it in the first place. - Such discussion thus further attests to the importance of law-led work that uses concepts drawn from STS, and cognate fields and disciplines, to widen space for discussion and illuminate that which may otherwise remain hidden.