Bioscope '03
by Dr. Barbara Price

          On March 19, 2003, Senators Lieberman and Hatch introduced a bill (S.666 Biological, Chemical, and Radiological Weapons Countermeasures Research Act) to give incentives to private industry to conduct research in biomedical areas to fill gaps in the US defense procurement programs. According to the Senators, "past efforts by agencies of the Federal Government to contract for the development and manufacture of countermeasures have been, and likely will continue to be, ineffective. These efforts have been under-funded, too complex, financially restrictive, and unreliable and therefore have failed to attract the commitment of capital and research-intensive biotechnology, pharmaceutical, medical device, and research tool companies." Someone does read the "DoD's Chemical and Biological Defense Program (CBDP) Annual Report to Congress" and understand the implications. The restrictions on biomedical countermeasures is likely to become even more restrictive if the government invests in research and manufacturing using the government owned, contractor operated facilities.

          S.666 is proposed as an amendment to the Homeland Security Act of 2002 (Public Law 107-296). So far the bill has been read twice in the Senate and has been referred to the Committee on Finance. Senator Chuck Grassley is the chairman of this committee (the other members are: Max Baucus, MT , John D. Rockefeller IV, WV, Tom Daschle, SD, John Breaux, LA, Kent Conrad, ND , Bob Graham, FL, James M. Jeffords, VT , Jeff Bingaman, NM, John F. Kerry, MA, Blanche L. Lincoln, AR , Charles Grassley, IA, Orrin G. Hatch, UT, Don Nickles, OK, Trent Lott, MS, Olympia J. Snowe, ME, Jon Kyl, AZ, Craig Thomas, WY, Rick Santorum, PA, Bill Frist, TN, Gordon Smith, OR, Jim Bunning, KY). Some of the provisions recognize the need for biotechnology companies to retain rights to patents and other licenses and agreements for their research tools. The return on investment for costly biotechnology research is also acknowledged. Obviously tax credits do not help biotechnology firms who may not yet have revenues or tax liabilities. The Lieberman-Hatch bill introduces incentives for capital gains exclusions or R&D limited partnerships, which will help biotechnology firms raise capital.

          The bill covers countermeasures, diagnostics, detectors and research tools. All are broadly defined. The bill requires the Secretary of Homeland Security, at least annually, to define a list of CBR agents to be detected, along with "standards and regulations under which detection equipment will be evaluated and approved." To define list of the diagnostics and diagnostics for contraindicators to vaccines or drugs and a list of the research tools that need to be developed.

          We should all be watching this closely. Those of us who have been in the field for a while are heartened that the difficulties of trying to respond to biodefense and chemical defense needs have gotten the ears of some of the country's leaders. The difficulties however, may be in assigning this to the Department of Homeland Security. This Department, which stands to control many of DoD's former research and even procurement, is still in the process of forming. While we wait for the Department to begin its work, the budgets and status of many of DoD's projects are unclear.