Structure-Function Analysis of Global Pharmaceutical Linkage Regulations

Linkage regulations tie generic drug approval and, thus, access to essential medications to existing drug patents through potentially long and costly litigation. The linkage regime is in the process of rapidly spreading worldwide through international free trade agreements. Even so, very little is known about how the regulations work in developed nations let alone how they impact public health systems across international borders. The authors constitute a network of eleven health policy experts and practicing lawyers in nine countries including those with mature linkage regulations, those with new regulations, those without regulations but with practices that parallel linkage, and those where regulations are currently subject to intense public debate and litigation.