Technology & Trade

Regulating Access and Control of Dangerous Pathogens: Implications for the Pharmaceutical Industry

in Program

Seven days after the September 11 attacks on the World Trade Center and the Pentagon, anthrax spores were spread through the US Postal Service to a variety of news services and public officials. Within three months, eighteen people were known to have been infected, five of whom ultimately died. The personal tragedy was compounded by widespread economic and social disruption in the United States and around the world. Since then, the US Government has undergone a fundamental reordering of budgetary and institutional alignments to combat global weapons diffusion. Addressing the threat posed by dangerous pathogens has focused almost exclusively on controlling access to the most hazardous pathogens, and monitoring research on a defined list of potentially dangerous agents. To date, little attention has focused on the movement of these dangerous pathogens beyond their collection and R&D stages. We find that the rapidly expanding market for biologics for therapeutic uses generally, and medical bioagents and toxins specifically, may present new avenues for bioterrorists to attack the United States.

The following study represents the culmination of intensive research and discussions with the private sector, industry and security experts on the national security implications of potentially dangerous biological agents and products. It offers a wide spectrum of proposals and recommendations designed to provide a layered defense against the misuse or misapplication of ‘select agents’ as well as pharmaceuticals derived from that category of biological materials-what we term, ‘select products.’


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