Sariola Salla, Ravindran Deapica, Kumar Anand, Jeffery Roger
Department of Anthropology, University of Durham, UK.
Centre for Studies in Ethics and Rights, Mumbai, India.
Soc Sci Med. 2015 Apr;131:239-46. doi: 10.1016/j.socscimed.2014.11.052. Epub 2014 Nov 26.
The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to achieve them. These changes have reinvigorated public concerns that stress not only access to new medicines but also the 'price' of innovation on research participants.
世界贸易组织的《与贸易有关的知识产权协定》（TRIPS）旨在在全球范围内协调知识产权和专利保护。在印度，该协定的签署导致自2005年以来临床试验急剧增加。印度政府以及印度大型制药公司认为，他们可以通过促进基础研究以及吸引国际临床试验来改变现有的商业研究文化，从而创建一个国际水平的、以创新为基础的制药行业。这些外包和离岸临床试验的增长对印度当地商业知识生产的影响仍不明确。临床研究规模的扩大和商业化对印度企业科学产生了什么影响？在本文中，我们描述了印度的“大型制药化”，即当地制药行业正从仿制药制造转向创新研究。本文运用制药化和创新的概念框架，分析了2010 - 2012年进行的研究数据，并描述了合同研究组织（CRO）如何使随机对照试验外包到印度。以对CRO工作人员的25次半结构化访谈为重点，我们梳理了印度制药行业的变化及其对当地研究文化的影响。我们用“大型制药化”来扩展制药化的概念，以描述制药研究在全球的传播，并说明TRIPS如何鼓励资本在印度集中，大公司获得越来越大的市场份额，并利用其市场力量为自身利益改写法规并引入新的监管做法。合同研究组织凭借相关的、新的认知技能和能力，既是商业研究文化变化的体现，也是实现这些变化的工具。这些变化再次引发了公众的担忧，这种担忧不仅关乎新药的可及性，还涉及创新给研究参与者带来的“代价”。
