Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science

Abstract

The global political economy of stem cell therapies is characterised by an established biomedical hegemony of expertise, governance and values in collision with an increasingly informed health consumer demand able to define and pursue its own interest. How does the hegemony then deal with the challenge from the consumer market and what does this tell us about its modus operandi? In developing a theoretical framework to answer these questions, the paper begins with an analysis of the nature of the hegemony of biomedical innovation in general, its close relationship with the research funding market, the current political modes of consumer incorporation, and the ideological role performed by bioethics as legitimating agency. Secondly, taking the case of stem cell innovation, it explores the hegemonic challenge posed by consumer demand working through the global practice based market of medical innovation, the response of the national and international institutions of science and their reassertion of the values of the orthodox model, and the supporting contribution of bioethics. Finally, the paper addresses the tensions within the hegemonic model of stem cell innovation between the key roles and values of scientist and clinician, the exacerbation of these tensions by the increasingly visible demands of health consumers, and the emergence of political compromise.

Hybrid practices in cord blood banking. Rethinking the commodification of human tissues in the bioeconomy

“…It constitutes what has been called a hegemonic model or paradigm of medical innovation (Salter et al 2015). , adopting Gramsci's terminology, define blocco storico (historical block) the alliance of social forces that sustains the process of hegemony.…”

Distributive Justice and Regenerative Medicine

“…(This is in contrast to the past, in which biomedical R&D was dominated by industry and a concern with commercial value, and healthcare governance was dominated by a concern for cost-effectiveness.) If future science group www.futuremedicine.com this does indeed occur, then innovation in this new health bioeconomy will better align with the values of wider society, and will be better directed toward societal need -both of which are key tenets of the EU Commission's Responsible Research and Innovation framework [44]. It is in this vein that this paper has sought to foreground the issue of distributive justice.…”

Global Regulatory Developments for Clinical Stem Cell Research: Diversification and Challenges to Collaborations

“…As a result, the hospital exemption scheme has been implemented unevenly across EU member states [1]. In some countries, the scheme has been used to approve large numbers of experimental interventions and has created "the opportunity for a legal market of authorised stem cell therapy products to emerge within the province of the clinical professionalism" [24]. More recently, EMA has also introduced a "conditional market approval" scheme [25], which can be used also for stem cell interventions.…”

“…First is the emergence of a growing number of regulatory exceptions and exemptions that were initiated by drug regulatory authorities in high-income countries. These exceptions/exemptions facilitate processes of clinical translation, and sometimes commercial clinical applications [24], outside of the multiphase trial system, but within the confines and review procedures of national regulatory agencies. Salter, Zhou and Datta have described this process as a form of "hegemonic adjustment", through which national governments have altered regulatory frameworks and clinical methodologies to enable greater responsiveness to health consumer needs [24].…”

“…With a growing number of regulatory alternatives in the European Union [1] and the USA [11,50], and the introduction of conditional, limited-term market approval of stem cell products after early-phase trials in Japan [30], the EBM paradigm of medical research (with the multi-phase trial system at its core) seems to gradually lose its hegemonic status [24]. It remains to be seen whether other countries will follow the Japanese regulatory model.…”