How Civil Society Organisations Changed the Regulation of Clinical Trials in India.

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.

Influencing policy change: the experience of health think tanks in low- and middle-income countries.

In recent years there has been a growth in the number of independent health policy analysis institutes in low- and middle-income countries which has occurred in response to the limitation of government analytical capacity and pressures associated with democratization. This study aimed to: (i) investigate the contribution made by health policy analysis institutes in low- and middle-income countries to health policy agenda setting, formulation, implementation and monitoring and evaluation; and (ii) assess which factors, including organizational form and structure, support the role of health policy analysis institutes in low- and middle-income countries in terms of positively contributing to health policy. Six case studies of health policy analysis institutes in Bangladesh, Ghana, India, South Africa, Uganda and Vietnam were conducted including two NGOs, two university and two government-owned policy analysis institutes. Case studies drew on document review, analysis of financial information, semi-structured interviews with staff and other stakeholders, and iterative feedback of draft findings. Some of the institutes had made major contributions to policy development in their respective countries. All of the institutes were actively engaged in providing policy advice and most undertook policy-relevant research. Relatively few were engaged in conducting policy dialogues, or systematic reviews, or commissioning research. Much of the work undertaken by institutes was driven by requests from government or donors, and the primary outputs for most institutes were research reports, frequently combined with verbal briefings. Several factors were critical in supporting effective policy engagement. These included a supportive policy environment, some degree of independence in governance and financing, and strong links to policy makers that facilitate trust and influence. While the formal relationship of the institute to government was not found to be critical, units within government faced considerable difficulties.

Impact of ethics and economics on end-of-life decisions in an Indian neonatal unit.

OBJECTIVE: The aim of this article was to describe how providers in an Indian NICU reach life-or-death treatment decisions. METHODS: Qualitative in-depth interviews, field observations, and document analysis were conducted at an Indian nonprofit private tertiary institution that provided advanced neonatal care under conditions of resource scarcity. RESULTS: Compared with American and European units with similar technical capabilities, the unit studied maintained a much higher threshold for treatment initiation and continuation (range: 28-32 completed gestational weeks). We observed that complex, interrelated socioeconomic reasons influenced specific treatment decisions. Providers desired to protect families and avoid a broad range of perceived harms: they were reluctant to risk outcomes with chronic disability; they openly factored scarcity of institutional resources; they were sensitive to local, culturally entrenched intrafamilial dynamics; they placed higher regard for "precious" infants; and they felt relatively powerless to prevent gender discrimination. Formal or regulatory guidelines were either lacking or not controlling. CONCLUSIONS: In a tertiary-level academic Indian NICU, multiple factors external to predicted clinical survival of a preterm newborn influence treatment decisions. Providers adjust their decisions about withdrawing or withholding treatment on the basis of pragmatic considerations. Numerous issues related to resource scarcity are relevant, and providers prioritize outcomes that affect stakeholders other than the newborn. These findings may have implications for initiatives that seek to improve global neonatal health.