Pharmacoeconomics and Pharmaceutical Economics Commons^™

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

Will Reducing Drug Prices Slow Innovation?, Gregory Vaughan, Fred Ledley

Mathematical Sciences Faculty Publications

The pharmaceutical industry has long argued that high drug prices reflect the high cost of innovation and that reducing drug prices would necessarily slow the pipeline of new drugs. These arguments have been bolstered by studies of large pharmaceutical companies showing statistical associations between the projected market size or revenue for pharmaceutical products and research & development (R&D) activity. Our analysis recognizes the increasingly important role of small biopharmaceuticals in drug development , companies that typically have little revenue and negative earnings, but are now responsible for more than 40% of new drug approvals. We examine the relationship between changes …

Will Reducing Drug Prices Slow Innovation?, Gregory Vaughan, Fred Ledley

Natural & Applied Sciences Faculty Publications

The pharmaceutical industry has long argued that high drug prices reflect the high cost of innovation and that reducing drug prices would necessarily slow the pipeline of new drugs. These arguments have been bolstered by studies of large pharmaceutical companies showing statistical associations between the projected market size or revenue for pharmaceutical products and research & development (R&D) activity. Our analysis recognizes the increasingly important role of small biopharmaceuticals in drug development , companies that typically have little revenue and negative earnings, but are now responsible for more than 40% of new drug approvals. We examine the relationship between changes …

Government As The First Investor In Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019, Ekaterina Galkina Cleary, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The discovery and development of new medicines classically involves a linear process of basic biomedical research to uncover potential targets for drug action, followed by applied, or translational, research to identify candidate products and establish their effectiveness and safety.

This Working Paper describes the public sector contribution to that process by tracing funding from the National Institutes of Health (NIH) related to published research on each of the 356 new drugs approved by the U.S. Food and Drug Administration from 2010-2019 as well as research on their 218 biological targets.

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Pharmaceuticals And Intellectual Property: Meeting Needs Throughout The World, Thomas G. Field Jr.

Law Faculty Scholarship

To the extent that most people think about patents and other forms of intellectual property at all, they tend to be aware that the owners of such property may have the legal capacity to limit market entry--without fully appreciating the extent to which products or processes that can be easily copied might otherwise be unavailable. Focusing on their function in recouping risk capital, this article will survey the types and functions of intellectual property. Then it will attend to the situation in developing countries, particularly the role of intellectual property in meeting their needs for medical products.