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In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. Keywords: Stem cell research, cell therapy, bioethics, medical law, science regulation

Can a World Trade Organization (WTO) Member exclude an invention from patentability on the grounds of ordre public or morality whilst at the same time permitting the sale and distribution of the invention within its territory? This is a question raised by recent developments in Europe, where moral restrictions have been placed on the patentability of ‘uses of human embryos’, yet human embryonic stem cell (hESC) research, which involves the destruction of human embryos, is permitted and encouraged within numerous EU Member States, and indeed, also funded through the central EU science budget. This chapter assesses whether such an incoherent regulatory landscape would survive WTO scrutiny. The chapter argues that in general, if a WTO Member has not attempted to ban the commercial exploitation of a certain invention within its borders, measures prohibiting the patenting of that invention on moral grounds would likely be viewed as constituting an unjustified restriction on international trade. More concretely, it is suggested that the WTO Member would be found to be in violation of its obligation under the TRIPS Agreement to make patents available without ‘discrimination’ as to the field of technology.

Can a World Trade Organization (WTO) Member exclude an invention from patentability on the grounds of ordre public or morality whilst at the same time permitting the sale and distribution of the invention within its territory? This is a question raised by recent developments in Europe, where moral restrictions have been placed on the patentability of ‘uses of human embryos’, yet human embryonic stem cell (hESC) research, which involves the destruction of human embryos, is permitted and encouraged within numerous EU Member States, and indeed, also funded through the central EU science budget. This chapter assesses whether such an incoherent regulatory landscape would survive WTO scrutiny. The chapter argues that in general, if a WTO Member has not attempted to ban the commercial exploitation of a certain invention within its borders, measures prohibiting the patenting of that invention on moral grounds would likely be viewed as constituting an unjustified restriction on international trade. More concretely, it is suggested that the WTO Member would be found to be in violation of its obligation under the TRIPS Agreement to make patents available without ‘discrimination’ as to the field of technology.

This thesis shows how the perceptions of practitioners and other stakeholders in clinical research in India differ from how informed consent appears in the academic literature and the regulatory framework. My empirical research findings hint at apathy towards the purpose and process of informed consent. I argue that this apathy raises doubts as to the impact of prescriptive work on informed consent in clinical research. I reach the above conclusion in three broad parts. First, I outline the conceptual framework of informed consent (what makes consent ethically and legally valid) and show how this conceptual framework appears in practice in India and what problems have arisen with regard to the way informed consent is dealt within this contemporary context. Second, I show how informed consent has been legally translated by courts in India and the limits of law in dealing with informed consent in clinical research. Third, I lay out the findings of an empirical research that I conducted in India (between April 2016-October 2016) that reflect stakeholder perspectives on informed consent. The empirical findings are analysed using the contrasting method where stakeholder perspectives are juxtaposed with how informed consent appears in the academic literature and law. What emerges from my data is a picture that presents a situation where the process of informed consent is oftentimes followed neither as an ethical compulsion nor strictly as a legal obligation. It is not uncommon that researchers consider the process of consent as a mere procedural necessity, thereby performing the action without affording much consideration to either law or ethics. This often leads to apathy towards the ‘larger cause’ (or end goal) of informed consent which, I suggest, is a major reason for the misalignment between ethics, law and the practice of informed consent. To mitigate this misalignment I suggest some non-traditional tools of behaviour regulation alongside the traditional ones.

This thesis analyses the supra-national application of the morality provisions in the ‘European’ patent system by the judicial/quasi-judicial decision-making in the European Union (“EU”) and European Patent Organisation (“EPOrg”). In doing so, it focuses specifically on Article 53 of the European Patent Convention and Article 6 of Directive 98/44/EC on the legal protection of biotechnological inventions, with particular reference to the overlapping institutional matrix within which these legislative provisions are applied. The intended contribution of this research is in relation to how these decision-making entities of the EPOrg and the EU interpret and apply the morality provisions in the ‘European’ patent system as a feature of their operation as institutions. The research investigates specifically: to what extent and in what ways does an analysis of the institutional framework for the application of the morality provisions by the various institutions implicated in the ‘European’ patent system reveal new insights into the current position and suggest defensible approaches to the future development of these provisions. This has particular relevance in the current context, in light of the developing unitary patent scheme examined through an institutional lens in chapter six. Importantly, the contribution of this research will not be in relation to the specific principles or tests which should be used in applying the morality provisions per se in the ‘European’ patent system, nor does it seek to contribute specifically to the normative questions in relation to what morality should mean in this context or whether the morality provisions should exist within the patent system. Such matters have been explored extensively in the literature. Instead, this thesis uses doctrinal methods to build a theoretical framework by drawing specifically on institutional theories within law and sociology, which are used to devise a novel framework for assessing institutional influences on decision-makers. This framework is then applied to the EPOrg and EU with the aim of demonstrating the differing institutional pulls on each body in their application of the morality provisions, which is used as a single exemplar to achieve this kind of institutional analysis. The overall aim of this research is to contribute to an understanding of decision-making in this specific context by reference to understandings of how institutional contexts can have profound effects upon the end outcomes of decision-making. This reveals a hitherto un-exposed perspective not only on what is happening within patent law with respect to the morality provisions, but also novel insights that may help to explain the legal landscape that has emerged, and which can inform its future development.