The Global Governance of HIV/AIDS

The Global Governance of HIV/AIDS

Intellectual Property and Access to Essential Medicines

Elgar Intellectual Property and Global Development series

Edited by Obijiofor Aginam, John Harrington and Peter K. Yu

The Global Governance of HIV/AIDS explores the implications of high international intellectual property standards for access to essential medicines in developing countries. With a focus on HIV/AIDS governance, the volume provides a timely analysis of the international legal and political landscape, the relationship between human rights and intellectual property, and emerging issues in global health policy. It concludes with concrete strategies on how to improve access to HIV/AIDS medicines.

Chapter 4: Access to paediatric medicines: The global political economy of drug production and supply for children in the developing world

Avram Denburg and Kelley Lee

Subjects: development studies, law and development, law - academic, health law, intellectual property law, international economic law, trade law, law and development, politics and public policy, international relations, public policy

Extract

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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