Pharmaceutical Progress for Neglected Diseases: Using Non-Traditional Development Models to Overcome Market Deficiencies

Abstract

Technological advancements and developments in public and private sector medical research capacities have ushered an era of novel therapies and hopes against illness and disease at an unprecedented rate. However, not all diseases have fared similarly in this era of progress. Neglected diseases, those that afflict large numbers of the impoverished, continue to impart significant morbidity, mortality, and economic damage, largely unchecked, due to persistent deficiencies in treatment options. Inadequacies in pharmaceutical development comprise a major component of the problem, due to exorbitant costs associated with the drug approval process, combined with financial inabilities of the target clientele. Despite this market failure, in certain cases, drugs have in fact been developed and approved for use against neglected diseases. However, given the unique economic circumstances, such developments have often been funded, supported, and catalyzed through nontraditional means. The innovation and development policy mechanisms that yielded such progress against difficult odds can serve as models upon which to build and promote future pharmaceutical development for neglected diseases, if these mechanisms are explicitly characterized and common trends associated with successful drug production are identified. This thesis performs exactly such an analysis, by identifying relevant instances of approvals of drugs for neglected diseases, exploring their development histories, characterizing such histories into broad categories, and evaluating those broad categories against one another. In an examination of eighteen such approvals that occurred between 1989 and 2014, this thesis finds that six broad categories of development incentive policies were employed: (1) product development partnerships, (2) private pharmaceutical industry development, (3) corporate philanthropy, (4) military development, (5) priority review voucher issuance, and (6) intellectual property transfer. Of these policies, the product development partnership mechanism accounted for the most drug approvals, across a diverse array of diseases and jurisdictions, which suggests a particular robustness of this policy mechanism. As such, this thesis will contend that this particular policy mechanism theoretically, as well as empirically, represents the most propitious policy option for future endeavors to reduce the societally detrimental effects of the persistence of neglected diseases.