Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.

Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.

Promoting Decent Work in Global Supply Chains in Latin America and the Caribbean: Key Issues, Good Practices, Lessons Learned and Policy Insights

The report is based on a desk-based review, drawing upon existing studies of global supply chains (GSCs) to examine their impacts and implications for the development of domestic firms, their contribution to productive transformation and structural change and their impacts on the quantity and quality of jobs in the LAC region. It situates the expansion of GSCs in the region within an analytical framework that recognizes both the economic and social upgrading dimensions and the impacts on firms and workers. Special attention is given to the mechanisms for governing the terms and conditions of engagement between firms and between firms and workers in GSCs, with the aim of identifying ways to jointly pursue the goals of raising competitiveness and of promoting productive employment and decent work.