The transnational legal space in theory and in practice: a study of unethical offshore clinical trials
Creators: name: FARRELL, Rebekah
Publisher: name: RMIT University
Year: 2024
Subjects: classificationCode: 350701
subject: Corporate governance
classificationCode: 441004
subject: Social change
classificationCode: 480307
subject: International humanitarian and human rights law
classificationCode: 480405
subject: Law and society and socio-legal research

description: This thesis contributes to the ongoing conversation on multinational corporate governance and establishes a framework for analysing opportunities for governance with the practical objective of governing unethical offshore clinical trials. 

A report from the Inspector General of the US Department of Health and Human Services found that over 80 percent of drugs approved for sale in the US market contained data that had been collected in a foreign country. The conduct of clinical trials offshore significantly reduces costs and expedites the time it takes pharmaceutical multinational corporations (MNCs) to get new drugs to the market. MNCs take advantage of the weaker regulatory regimes in the Global South so as to circumvent what may otherwise be an onerous development pipeline. Of course, weaker regulatory regimes allow for MNCs to externalise the risks associated with pharmaceutical trials. 

Motivated to address the global problem of unethical offshore clinical trials, this thesis tracks transnational legal, regulatory and normative developments. In doing so, this thesis conceptualises a complex social system, described here as the 'Transnational Legal Space' (TLS), which affords opportunities for private advocates to move towards more effective global governance of offshore clinical trials.

This thesis interprets existing bodies of international, transnational and national law to foreground opportunities for legal and regulatory interventions in cases of alleged unethical corporate practices. Interviews are conducted with legal advocates, medical practitioners, regulators, ethicists and civil society actors who are playing a leading role in holding pharmaceutical MNCs to account for their activities in the Global South. 

While being empirically driven, this thesis establishes a theoretical bricolage comprised of existing legal, sociolegal and complex social theories. This theoretical framing provides for a more thorough empirical inquiry than might otherwise have been the case, capturing the richness of normative development and actors' relations.

This thesis concludes that the TLS affords numerous opportunities to govern MNC operations and in so doing address a significant global problem, represented here through the example of unethical offshore clinical trials. It underscores the possibilities and limitations of the TLS in holding MNCs to account, specifically in the area of pharmaceutical innovation. In examining these issues, it advances understanding of complex governance formations through the lens of sociological and socio-legal theories and contributes to theory building efforts within transnational legal scholarship. At the same time, it extracts important lessons that advance understanding of the complexity of offshore clinical trials and their governance. This thesis foregrounds the urgency with which critical issues of demand for improved medicines, weak governance, contested medical research ethics, corporate power and human inequality converge to render the governance of offshore clinical trials problematic. Above all else, this thesis offers an optimistic view of transnational legal futures in an era of nationalism.