The pharmaceutical industry is highly regulated and heavily dependent on intellectual property rights (IPRs) to incentivize innovation and bring drugs to the market. However, the interaction between IPR regimes, drug regulations, and R&D choices leads to significant differences in pharmaceutical innovation across countries and regions and important disparities in drug access. This Special Session aims to explore pharmaceutical innovation and access to drugs through the lens of R&D investments, IPRs and regulatory frameworks. Each firm’s approach to patents, market exclusivity, and approval processes influences where and how new drugs are developed and distributed. Drug regulations play also a crucial role in determining the types of pharmaceutical innovation that emerge. Some policies encourage incremental improvements to existing drugs, while others support more radical breakthroughs, such as entirely new molecular entities or drug repurposing strategies.

In addition, the institutional framework varies considerably across places and various intellectual property mechanisms-including different forms of exclusivity, Supplementary Protection Certificates (SPCs), and patent extensions-create regional differences in pharmaceutical innovation and drug approval timelines. These policies affect how long firms can maintain market exclusivity and how quickly new drugs become available. Finally, firms’ decisions on pharmaceutical innovation and drug access and government decisions about IPRs and regulation do not take place in isolation; they spill over across borders in multiple ways. There are many types of knowledge flows between countries, regulatory decisions in one region can have ripple effects elsewhere, and cross-border licensing and trade agreements influence which drugs reach different markets. Regulatory decisions in one country can significantly impact pharmaceutical drug markets in another and policies such as parallel trade in the EU, patent linkage in the US, and compulsory licensing in India and Brazil could shape global drug markets by affecting pricing, availability, and investment in new drug development.

This Special Session aims to bring together scholars from different disciplinary fields to examine pharmaceutical R&D and innovation, providing insights into a better design of IPR and regulatory frameworks to promote health innovation globally. Good policies can reduce social costs and increase access to medicines and the experimentation of incentive mechanisms other than patents can contribute to a fairer and more efficient system.