By Lisa Seachrist

Washington Editor

WASHINGTON — With the continuing crisis in Iraq, the specter of biological warfare has become an ever present topic of discussion.

The arrest in Nevada of two men for illegally possessing the anthrax bacteria is likely to further heighten awareness of the potential for biological warfare.

Even before these two situations heated up, President Clinton, in his State of the Union address, made a commitment to establishing a rigorous protocol for inspections under the 1972 Biological Weapons Convention (BWC).

"We must act to prevent...the use of disease as a weapon of war and terror," Clinton said. "The Biological Weapons Convention has been in force for almost 25 years, but frankly, it lacks the teeth of tough enforcement measures. This year, we must strengthen that treaty with an international inspection system to help detect and deter cheating."

The administration favors a protocol that will require the 140 signatory nations to make annual declaration to the BWC about both private and public facilities and activities that are suited for the development of biological weapons. In addition, the president supports voluntary visits, clarifying visits, and challenge visits of the BWC implementing organization to all facilities included in the declarations.

While the administration has stated it intends to protect confidential business information, the biotechnology and pharmaceutical industries remain concerned that implementation of BWC will be used to engage in industrial espionage against companies in the United States.

"When you've got inspectors going into a facility, industrial espionage is always an issue," said Allan Goldhammer, vice president of technical affairs at the Biotechnology Industry Organization. "We have had a lot of discussion with the administration on this; until the past State of the Union address, the administration had not identified what elements they were looking at."

The administration's thinking on BWC provisions are simply a sketchy outline of elements deemed important for enforcing the treaty. However, that outline has some worried the protocol will unduly expose the pharmaceutical and biotechnology industries to intellectual piracy.

"We at PhRMA are strong proponents for a good protocol," said Gillian Woollett, assistant vice president for biologics and biotechnology at the Pharmaceutical Research and Manufacturers Association (PhRMA). "A bad protocol only provides a false sense of security while exposing those with the equity to unnecessary liability. We are not yet convinced the U.S. government fully understands what is needed to get a good protocol."

Inspections Could Harm Legitimate Firms

Woollett noted that a bad protocol could result in the loss of legitimate proprietary information, the loss of a company's good name by being linked to biological weapons and onerous implementation regulations.

"We are concerned that the administration is unfairly targeting potential to create biological weapons," Woollett said, noting that pharmaceutical and biotechnology companies arguably have the greatest physical capabilities.

However, any facility capable of large scale fermentation including breweries, large scale cheese-making operations and some academic centers could use those facilities to produce biological weapons.

Woollett said the plan to include regular facility visits or inspections would not only create an opportunity for industrial espionage, but wouldn't serve as a useful way to monitor biological weapons because most facilities can eradicate the evidence of production in a matter of hours.

"Unlike chemical weapons, it is quite simple to destroy biological weapons and send them unnoticed through the [sewage system]," Woollett said.

PhRMA, she noted, prefers a protocol that would rely only on surprise challenge inspections. Any country that had a claim against a facility would have to present a substantial case to the BWC organization showing unusual outbreaks of disease or the like. The organization would then need a three-fourths vote agreeing with the presenting country that something is amiss in order to send inspectors to the site.

In addition, PhRMA maintains that all testing should be done on site and no sample should leave the facility.

"It only takes a small amount of a genetically engineered bug leaving the building to cost a company millions of dollars," Woollett said. "A single sample could be a devastating loss." *

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