Abstract
Global drug development and regulation is undergoing a substantial transition, including redefinition of the roles of public and private actors responsible for developing, regulating, and paying for therapeutic products. This shift has been accompanied by growing debate over the validity of the claim that an efficiently functioning global public health system requires acceptance of models of drug development that promote early access to therapeutic products in exchange for strong intellectual property rights. Without these rights, advocates claim pioneering drug development will not occur. Here, we challenge this view, arguing that recent regulatory efforts designed to encourage the development of new and innovative drugs through the provision of strong patent and ―linkage‖ rights, which legally tie drug patenting and drug approval, have in fact had the opposite effect. We provide data to suggest that the pharmaceutical industry is leaning away from the development of new drugs and towards incremental changes in existing drugs as a result of firms locking in to discrete rights targets provided for by law.
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