Project Bioshield

The Project BioShield II Act of 2005, introduced to the U.S. Senate in April 2005, contains a proposal for so-called Transferable Intellectual Property Rights, in which a firm that developed a vaccine for a disease such as AIDS would obtain a wildcard patent extension that could be applied to a drug of its choice in the United States. The proposal has received the endorsement of the International AIDS Vaccine Initiative, which sees any proposal to increase research into AIDS vaccines positively. This is therefore a proposal that deserves serious scrutiny. 

There are at least three very important flaws in the basic mechanism proposed by Project BioShield II (and Transferable Intellectual Property Rights in general). First, the way the reward for the innovator is financed through a patent extension is inefficient and inequitable. Second, the incentive mechanism is poorly defined, and does not offer a clear methodology to determine how large a reward to pay for a given innovation. Third, the mechanism discriminates against small firms. 

Stapleton, S. 2004. Project BioShield. American Medical News 47(31) 19. 

In addition to creating such an incentive structure for the biotech industry, the Project Bioshield Act of 2004 also allows for expedited peer review procedures for research and development of bioterrorism countermeasures and allows the Secretary of Health and Human Services together with the Food and Drug Administration (FDA) to permit the distribution of pharmaceuticals and other products for emergency use prior to FDA approval for general use. 

Remarks by the President at the Signing of S.15-Project BioShield Act of 2004, The White House, July 21, 2004. 

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