PURPOSE: To demonstrate the methodological challenges and pitfalls in assessing the impact of International Reference Pricing on patients and pharmaceutical innovation, and to provide guidance for future research in the topic.

DESCRIPTION: International Reference Pricing (IRP) is applied by a large number of countries and its use is growing: using the prices for the same product from other countries to set or negotiate initial pharmaceutical prices for price regulation at launch or their revision later. Several authors investigated the intended and unintended consequences of IRP. All were facing numerous challenges in conducting their research including: limited availability and reliability of price sources; ambiguity when trying to match the same product across all countries; normalizing the prices to the same level – e.g., ex-factory; choosing the most appropriate foreign exchange rate for conversion; picking the IRP basket and algorithm to use for so-called “soft rule” countries; assessing the patient access to the treatment; and assessing the impact on innovation. The Discussion Leaders have extensive academic, publication and practical experience in the area, from different perspectives: as author on the economic impact of IRP from the US; as former WHO advisor and leader of IRP research from a large European country; as author of IRP impact on lower-income countries; as former global industry professional. Coming from these different perspectives the Discussion Leaders will explore the methodological challenges in identifying and quantifying the consequences of IRP on patient access and on pharmaceutical innovation, including if the US were to implement such a policy. They will bring examples and cases from their own research to illustrate these challenges and propose approaches to overcome the methodological challenges inherent in such research and the complications it creates in understanding its impact.