Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage*


Global drug development is undergoing a redefinition of the responsibilities of those who develop, regulate, and consume therapeutic products. This shift has been accompanied by growing debate over the validity of the claim that an efficiently functioning public health system requires acceptance of lifecycle models of drug regulation that promote early access to innovative therapeutic products in exchange for strong intellectual property and regulatory (IPR) rights. Indeed, IPR rights are assumed necessary for all stages of the therapeutic product lifecycle, including publicly funded medical research, university technology transfer, private ...

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