Grant: CIHR New Investigator

Global drug development and regulation are undergoing a substantial transition. This has been accompanied by growing debate over the validity of the claim that a properly functioning public health system requires acceptance of emerging lifecycle models of drug regulation that promote early access to therapeutic products and privilege strong intellectual property and regulatory (IPR) rights. IPR rights are presumed to be necessary for all stages of product development, including publicly-funded medical research, university technology transfer and private research and development activities. Without these rights, advocates claim pioneering drug development would not occur and the public would be without breakthrough drugs. The goal of the proposed research is to investigate this claim empirically. The project is split into three components. The first is an assessment of new and follow-on drugs approved during the time regulatory incentives intended to stimulate innovation came into force. The second is a study of patents and patent litigation associated with these approvals, and thus the subsequent shaping of the market for brand-name and generic products. The third is the development of an analytical model of regulated pharmaceutical innovation, focusing on the effectiveness of regulatory incentives intended to encourage innovation. Of particular interest will be the synchronization of drug approval, patenting and litigation data to specific legislative and policy initiatives intended to stimulate access to novel therapeutic products, including linkage regulations tying drug approval to drug patenting and the lifecycle regulation regime for drug approval. Combined, these regulatory initiatives provide bookends for a novel and unique "natural experiment" to evaluate the strength of the claim that strong IPR rights are necessary for breakthrough pharmaceutical innovation.