Expanding Bioshield: a call for caution.

The Bioshield Initiative seeks to stimulate development of new drugs and vaccines to prevent and treat diseases caused by biological agents likely to be used by terrorists, and recent proposals have sought to expand patent protections in this context. To the extent that patent protections are needed as part of the incentive structure for new drug and vaccine development, it may be better to strengthen patent protections on nonterror-related drugs and vaccines to avoid production capacity problems, as well as follow-up research and development problems. However, at the same time, both practical and ethical considerations argue that the good that might be achieved through expanded patent protections come at costs that make this strategy unacceptable.