The Quest for Innovation and Sustainability
Innovation, Co-operation and Development series
Edited by Wilfred Dolfsma, Geert Duysters and Ionara Costa
Chapter 4: Facing the Trial of Internationalizing Clinical Research to Developing Countries: Evidence from Mexico
Fernando Santiago-Rodríguez INTRODUCTION Recent years witness trends towards outsourcing and internationalization of clinical research by multinational pharmaceutical firms. Increasingly clinical trials are run at numerous sites around the world. Several developing countries are emerging as relevant investigative sites. Although India and China appear as preferred destinations, good prospects to participate are also available for other advanced developing economies, such as Brazil, South Africa and, as discussed here, Mexico. In addition to large domestic markets, such countries have consolidated major regional manufacturing and export bases for foreign-owned subsidiaries as well as for some domestic firms. Moreover, these emerging economies feature some country specific conditions shaping their attractiveness as investigative sites. This chapter analyses recent developments in the markets for clinical trials in developing countries. It leans on the Mexican case to illustrate some factors driving the dynamics and attractiveness of such countries as investigative sites. It also points to some challenges developing countries face to adjust and modernize their local regulatory environment governing clinical trials. The chapter brings together scholarly literature on internationalization of R&D by multinationals and on ethical implications and regulations of clinical trials. The analysis in this chapter builds on both primary and secondary data sources. Primary data were gathered through semi-structured interviews carried out in Mexico between February and August 2007. Informants included representatives from foreign-owned multinational subsidiaries and Mexican pharmaceutical firms as well as representatives from the main local trade organizations in this industry, CANIFARMA and AMIIF. The chapter also benefits from interviews with...