A joint Senate HELP-Judiciary Committee hearing to examine additional incentives needed to entice biotechnology and pharmaceutical firms to develop medical countermeasures for bioterrorism-related threats is tentatively planned for Oct. 6, HELP Committee Counsel Steve Irizarry said.

Speaking at a Sept. 23 Equity International briefing on biodefense issues, Irizarry said the hearing likely will feature two panels - one with representatives from large and small biotechnology/pharmaceutical firms, and one with attorneys familiar with industry's concerns over the existing BioShield law.

The committee postponed a BioShield II hearing that was to have taken place Sept. 8 (¹ Also see "Senate “BioShield II” Hearing Postponed" - Pink Sheet, 7 September, 2004.).

The hearing is aimed at advancing additional biodefense legislation that would alleviate industry concerns over intellectual property issues and the lack of liability protection in the law. The initial BioShield measure was signed by President Bush July 21.

"BioShield was a first step," Irizarry said, but additional incentives to assuage private sector concerns and encourage companies to enter the biodefense arena are "critical" because industry concerns persist that the "relatively small" amount of money allocated for BioShield is not sufficient.

"One of the most significant concerns" heard from industry has been the need for protection against litigation stemming from adverse events associated with new biodefense products, Irizarry said.

"The question is not whether we should have liability protection," he asserted, but "what kind of protection we should have."

Irizarry outlined several liability protection models that could be tapped in an effort to provide such protection, and pointed out that each has its own difficulties.

Among the possibilities is a liability protection system modeled after the National Vaccine Injury Program, which was enacted as a no-fault alternative to the tort law system to resolve injuries related to childhood vaccines.

However, NVIP is based on "a table of injuries," Irizarry said, which could not be assembled for bioterror countermeasures that would likely not be tested in humans due to ethical problems.

An indemnificatation model also could inform future liability protection under BioShield II. Such an approach is used to protect facilities and healthcare workers administering smallpox vaccine, for example, and could be adapted to protect manufacturers of bioterrorism countermeasures.

Another possibility would be an "express limitation of tort activity" strategy, such as what is used to protect manufacturers of terrorism-response gear that is used following an attack.

Irizarry also assessed the political hurdles that would need to be overcome in passing liability-related provisions in an expanded biodefense bill.

"Passing liability protection for companies will not be easy," Irizarry said, noting that the prospect could be made difficult by some distrust in Congress of the pharmaceutical industry.

Aside from liability protection, other incentives likely to be discussed at the October HELP/Judiciary hearing include the possibility of including a limited antitrust exemption for companies interested in pursuing biodefense products. Such a provision was considered in earlier versions of the original BioShield bill, but was met with "stiff resistance" from several members of Congress, Irizarry noted.

The HELP attorney also maintained that in addition to liability and antitrust provisions, it is important to ensure that any forthcoming legislation allows the "dual-use" of products, so that the bill is not limited to those products without potential commercial benefit.

- Scott Jenkins

Senate “BioShield II” Hearing On Incentives Slated Tentatively For Oct. 6

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