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Full text PDF - International Policy Network

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Increasing access to medicines 151bodies such as the US FDA. However, the extreme inefficiency of theMCC means that drugs which have already been registered for usein the US, EU and Japan wait an average 39 months for approval inthe South African system.Another example comes from Namibia, which announced in2002 that all medicines registered in the country prior to independence(1990) should be re-registered (Bate et al., 2005).The low purchasing power of the majority of citizens in poorcountries means they do not constitute significant markets forforeign manufacturers. In the face of such non-tariff barriers, companieswill often forego the regulatory complexity and expense ofregistering their products in that country (and will instead investtheir resources elsewhere). The result is that fewer medicines areapproved – even when they are desperately needed – and there is alower level of local competition in the marketplace which wouldotherwise drive prices down and increase access.To make matters worse, many governments now adopt theWHO’s list of ‘essential medicines’ as the basic formulary, denyingtheir citizens access to medicines not on the list (see Box).WHO Essential medicines listDr John Kilama, Director, Global Bioscience DevelopmentInstituteIf poor people in the U.S. and the EU had access only tothe limited range of options on the World HealthOrganization’s Model List of Essential Medicines (EML),most doctors would denounce that situation asunacceptable. So, too, would most healthcare workers inother developed countries around the world. Why then hasno one questioned the rationale behind the WHO’s List ofEssential Medicines – frequently the authority that dictatesthe drug selection process for many health Ministries inpoorer countries?The WHO EML represents the most comprehensive

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