Here's a nice article from the New England Journal of Medicine (NEJM) looking at legislation that conferred market-exclusivity incentives to pharma manufacturers to promote innovation. The article discusses the pros and cons that ensued. Many tmes the legislation did drive the effects it was seeking but usually got some significant unintended consequences -- which in many cases may have outweighed the value.
Five pieces of legislation were examined in brief. These included:
- Patent and Trademark Act amendments (Bayh-Dole)
- The Orphan Drug Act
- Drug Price Competition and Patent Restoration Act (Waxman-Hatch)
- The Prescription Drug User Fee Act
- FDA Modernization Act Section 111 (pediatric exclusivity extension)
The following slide neatly summarizes the intentions of the sponsors and congress in introducing each piece of legislation. It also points out the flaws discovered on implementation that critics frequently point to for each.
The author, Aaron S Kesselheim, MD, JD, MPH, conlcudes that use of market-exclusivity incentives to promote innovation has potential as good public policy. But, and this is a significant but, future legislatin of this type should be linked to a demonstration of positive public outcomes. Without linkage as a countermeasure, the results of incentives may be more damaging to the public health than they are worth as policy instruments.
Posted by Bruce Lehr November 6th 2010.