Increasing competition in pharmaceutical tenders: Patents, treatment guidelines, and centralised procurement of Hepatitis C drugs in Brazil.

This article investigates how therapeutic substitutability and patent exclusivity influence the centralised procurement of Hepatitis C drugs in Brazil. Combining data on treatment guidelines, registered products, and patent applications, this article analyses how the government can increase competition in tenders. Since 2019, the public procurement rationale has shifted from the cost-effectiveness of discrete products to simply buying the cheapest among treatment alternatives that are virtually equal in effectiveness, with originators of different patented drugs competing against each other. Moreover, rigorous examination of patent applications and robust opposition mechanisms led to limited patent exclusivity in some cases, allowing generic manufacturers to compete with the originators of their drugs and other drugs. The findings are discussed based on a matrix of competition scenarios and the literature on patent exclusivity, drug prices, and public procurement. The strategy of having both on- and off-patent competition in the same tender significantly increased the government's bargaining power and reduced drug prices. However, market concentration has limited this strategy. While helpful, local production and price control policies were less relevant than suggested. Therefore, this article provides lessons on how to combine different public policies to increase bargaining power and thereby promote access to high-quality treatments.