By Lisa Seachrist
WASHINGTON — As U.S. representatives continue negotiating a compliance protocol for the Biological Weapons Convention (BWC) this week in Geneva, Switzerland, industry sources are dismayed that the negotiators are circulating a discussion document that proposes facility inspections known as "clarification visits."
Originally placed before the Ad Hoc Group in Geneva on July 9 — the final day of summer negotiations — the document could not be circulated to the entire group because there wasn't enough time to translate the document into all necessary languages. The move was vehemently opposed in a July 24 letter to National Security Advisor Sandy Berger, Commerce Secretary William Daley and Under Secretary of State John Holum by the presidents of the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization and the Animal Health Institute, an animal medicines industry organization.
In their letter, the industry organizations urged the U.S. delegation to withdraw the discussion document before the next meeting and offered to work with the Clinton administration to draft a proposal that would not jeopardize the intellectual property and reputations of the industry that would fall under the BWC. However, the industry heard no response during the six weeks that followed, and the document was put on the table Monday at the beginning of the next round of negotiations.
"We are looking to support a regime that is cost-effective and identifies [treaty violators]," said an industry source, speaking on the condition of anonymity. "But we haven't been given a model of how these inspections will help. No one can tell us why such inspections will be good."
Rules Allow 'Low-Hurdle Challenge Inspection'
The document, which has now been translated and circulated to the Ad Hoc Group negotiating the compliance protocol, calls for "clarification visits." Under BWC, each public and private facility capable of producing biological weapons must declare the extent and purpose of its fermentation operations. A clarification visit would result when a country has a question about aspects of the declaration.
Industry members oppose such a procedure as essentially a "low-hurdle challenge inspection whose risk to the legitimate concerns of our innovative industry far outweigh any benefits" BWC seeks to provide. A company subjected to a clarification visit would receive the bad press associated with a challenge inspection — and risk a knowledgeable inspector learning valuable proprietary information that could result in a competitor gaining insight into the company's operations.
"Some declaration proposals have called for listing the exact number of fermenters contained in a facility," the industry source pointed out. "On any given day, that is impossible to guarantee. Having such a detail serve as the basis of a clarification visit is unacceptable."
In spring meetings with industry representatives, the administration said the proposal for clarification visits was needed to defeat proposals for random/routine visits to facilities. Because these types of inspections would be scheduled well in advance of the site visits, they are unlikely to unearth the production of biological weapons, industry officials have said, noting such an operation can be quickly cleaned up by flushing systems with bleach. The life-sciences business organizations oppose these types of visits as useless in enforcing BWC.
However, in their July 24 letter, industry members point out that the discussion document nowhere mentions that clarification visits would replace random/routine inspections, leaving the industry open to both types of inspection — neither of which appears likely to catch treaty violators, in the opinion of the letter's signatories. As a result, industry sources fear that the U.S. has weakened its negotiating position by circulating the document.
Industry Pushes Due Process Rules For Visits
Industry members advocate a protocol that would call for "extensive declaration" and challenge inspections only. In other words, a country that fears another is breaking the treaty would present its case, unbeknownst to the suspected violator, to a tribunal, which would quickly weigh the evidence. Should the tribunal agree there is good reason to suspect a violation, it would send inspectors to the facilities within hours of the decision.
However, with the clarification visits as part of the protocol, industry sources point out it would be in the best interest of businesses to declare as little as possible about their facilities, in order to avoid raising eyebrows and potentially risking a clarification visit.
"Whatever else has happened, the U.S. has lost the window of opportunity to pull back from this position without a major loss of face," the industry representative told BioWorld Today. "We regard this as a major loss of trust in the administration and it puts a real strain on our ability to negotiate with them. It's an 'extreme disappointment,' is the best way to phrase it." *