Intellectual Property and Access to Essential Medicines
Elgar Intellectual Property and Global Development series
Edited by Obijiofor Aginam, John Harrington and Peter K. Yu
Chapter 4: Access to paediatric medicines: The global political economy of drug production and supply for children in the developing world
Amid ongoing tensions between economic globalization and access to medicines, centred on the World Trade Organization (WTO) and its Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) (‘t Hoen, 2003; CIPIH, 2006; Correa, 2002; Matthews, 2006; Westerhaus and Castro, 2006; WHO, 2002), limited attention to date has been given to access to medicines for children. Pharmaceutical research into, and development of, drugs for children lags markedly behind drugs for adults. Drug disposition and dynamics change as children grow, necessitating evidence and treatment tailored to age and developmental stage (Hoppu, 2008). Yet there is a relative paucity of pharmacokinetic studies, safety and efficacy data, and drug indications, dosages and formulations for paediatric medicines (Schaller, Lie and Hoppu, 2007). Most often, drugs licensed for use by children were developed for, and evaluated, in adults, with evidence of their clinical utility in children derived largely from data generated ex post (AAP, 1995). The implications of this inattention are significant. First, an inherent lag time exists in bringing paediatric drugs to market, as child indications necessarily follow adult ones. Second, fewer drugs are developed with paediatric physiology and pathology specifically in mind (IFPMA, 2008). As a corollary, many drugs prescribed to children are unlicensed for paediatric use: in Europe this figure approximates 50 per cent (Conroy, Choonara, Impicciatore, Mohn, Arnell, Rane, Knoeppel, Seyberth, Pandolfini, Raffaeli, Rocchi, Bonati, Jong, de Hoog and Anker, 2000). While the challenges facing paediatric medicines are global, this neglect is felt most acutely in developing countries.
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