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The Effects of Pharmaceutical Price Regulation on Probability of Patenting in OECD Countries

by Rachel Korn

The introduction of parallel trade mechanisms allowing for the free trade of pharmaceutical goods in the European Economic Area represents a significant departure from the standard monopolistic competition pricing structure in the pharmaceutical market, in which firms have a great deal of control over pricing. Another mechanism, external reference pricing, also contributes to undermining traditional price structures by imposing a price ceiling on drugs. As these methods of regulating pricing in the healthcare market are receiving growing interest in countries such as the United States, it is prudent to consider their effects. It is apparent that parallel trade and external reference pricing decrease average drug costs, but little has been said about their effects on drug availability. Using global patent data from the European Patent Office PATSTAT database as a proxy for drug availability, I investigate how parallel trade and external reference pricing affect the decision of firms to file a pharmaceutical patent in a given country. I accomplish this through a logistic regression model with a difference-in-differences approach to estimate the probability of patenting a pharmaceutical in an OECD country, given that a patent has previously been approved in the United States. I find that the presence of parallel trade in a country significantly decreases the probability of patenting and increases patent lag time while external reference pricing unexpectedly increases the probability of patenting and decreases patent lag time. These findings demonstrate the complexity in attempting to create policy to regulate rising pharmaceutical prices, as doing so may increase affordability of existing drugs in a country while decreasing availability of new ones.

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Advisors: Professor Michelle Connolly | JEL Codes: I1, I11, I19

Incentive Programs for Neglected Diseases

By Pranav Ganapathy   

We propose and evaluate an auction mechanism for the priority review voucher program. The 2007 voucher program rewards drug developers for regulatory approval of novel treatments for neglected tropical diseases. Previous papers have proposed auctioning vouchers for the priority review voucher program but have offered neither a mathematical model nor a framework. We present a mechanism design problem with one pharmaceutical company producing one drug for a neglected tropical disease. The mechanism that maximizes the regulator’s expected surplus is a take-it-or-leave-it offer, with three different offers based on low, intermediate, and high neglected disease burdens. We demonstrate how mechanism design can be applied to settings in which the buyer pays for public access to a product with regulatory speed. Finally, this paper may be useful to policymakers seeking to improve access to voucher drugs through modifications of the program.

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Advisors: Professor David Ridley, Professor Giuseppe Lopomo, Professor Michelle Connolly| JEL Codes: I1, D44, D82

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