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This technical report is an analysis of current trends and theories in consumer protection from both a legal and economic perspective. Traditional economic theory, especially the work of Akerlof (1970), suggests there are situations in which consumer protection is necessary to maintain healthy markets. Still, debate continues on the best methods of consumer protection. As an example, some economists argue for information disclosure, others paternalism, and still others so-called soft- or libertarian-paternalism. Any of these forms can be acheived through different bodies including government agencies, consumer associations, self-regulation, statutory and non-statutory standards bodies, ombudsman and professional organizations. Finally, the transition to digital economies has presented new challenges for consumer protection including security, privacy, complex liability chains, and the complexity of the products themselves.
The private sector is the primary investor in health research and development (R&D) worldwide, with investment annual investment exceeding $150 billion, although only an estimated $5.9 billion is focused on diseases that primarily affect low and middle-income countries (LMICs) (West et al., 2017b). Pharmaceutical companies are the largest source of private spending on global health R&D focused on LMICs, providing $5.6 billion of the $5.9 billion in total private global health R&D per year. This report draws on 10-K forms filed by Pharmaceutical companies with the U.S. Securities and Exchange Commission (SEC) in the year 2016 to examine the evidence for five specific disincentives to private sector investment in drugs, vaccines and therapeutics for global health R&D: scientific uncertainty, weak policy environments, limited revenues and market uncertainty, high fixed costs for research and manufacturing, and imperfect markets. 10-K reports follow a standard format, including a business section and a risk section which include information on financial performance, investment options, lines of research, promising acquisitions and risk factors (scientific, market, and regulatory). As a result, these filings provide a valuable source of information for analyzing how private companies discuss risks and challenges as well as opportunities associated with global health R&D targeting LMICs.