Regenerative Medicine Innovation in Emerging Economies: A Case Study Comparison of China, Brazil and India.

摘要

Regenerative medicine (RM) has the potential to develop new treatments for chronic disease and injury that are desperately needed in developing countries. Several emerging economies are actively participating in RM, producing new knowledge and initiating clinical trials. This thesis presents case studies of RM in China and Brazil and a comparative analysis of RM across Brazil, China and India. I aim to better understand the state of RM, how it has developed and what is needed for RM innovation to succeed within these countries. Case studies were conducted using face-to-face in-depth semi-structured interviews with RM experts from different areas including research institutes, hospitals, firms, educational institutes, government, policy agencies, and bioethics groups. Interviews were analysed using thematic analysis and triangulated with the analysis of research articles, government reports, laws and other primary and grey literature. China is now the 5th most prolific publisher on stem cells in the world. Chinese RM benefits from permissive regulations and the expertise of Chinese returnees that have trained abroad, but the field's reputation is challenged by a weak regulatory system and the clinical availability of untested stem cell therapies. Brazil has created a small but strong RM program, but needs to address challenges to the field including inconsistent funding, slow importation of materials, and weak linkages between stake-holders. Comparative analysis of the three countries identifies several common elements that support RM, including linkages between stake-holders, government support, infrastructure, human resources, and good governance. RM capacity is clustered in large urban centres, which could exacerbate socio-economic and health disparities unless measures are taken to ensure equitable distribution of benefits. RM does not adhere to classical views of southern innovation, suggesting that new models are needed to describe innovation in emerging technologies, where countries are keeping up instead of catching up.