A View from Inside Regulation and Ethical Conflicts in Peru推荐.pdfVIP

Chapter 12 A View from Inside: Regulation and Ethical Conflicts in Peru ´ Gabriela E. Minaya-Martınez, Susy Y. Olave-Quispe, and Duilio J. Fuentes-Delgado 12.1 Introduction After a discussion on the evolution of clinical trials in Peru, this chapter reviews the development of legislation governing clinical trials and the ethical problems that have occurred during their implementation. Peru (population 29.2 million in 2009) is a multi-ethnic and predominantly urban (72 %) country (World Population Data 2009). It has a young population with 32 % below 15 years of age and only 6 % older than 65 years. In 2010, the population over 15 years of age had an illiteracy rate of 7.4 % and an average of 9 years of education. There are no reliable statistics for functional illiteracy, but it is a safe assumption that the majority of the adult population falls into this category. Although declining, the rates of people in poverty and extreme poverty remain high- at 45 and 16 % respectively. Inequality levels are also high with a Gini index of wealth distribution of 0.51. Poverty indexes among the Andean, the Amazonian and Costal regions—Peru’s three distinct geographic areas, each with its own climate and cultures—are 64, 57, and 29 % respectively (INEI 2004–2006). Nationally, life expectancy is 72 years, infant mortality is 20 per 1,000 live births, and maternal mortality, 15 per 100,000 live births (INEI 2008). The morbi-mortality data in the country reflect a society in transition with an increase in chronic conditions co-existing with a relatively high rate of transmissible diseases. For example, mortality rates for cardiovascular diseases and cancer are 190 and 175 per 100,000 respectively (WHO 2007). Among children under five years of age, 25 % suffer with chronic malnutrition, and within this age group there are 240 episodes of acute diarrhea and