Sponsor of Import Data Sharing Bill Says New Customs Rule Too Relaxed
A new federal interim rule aims to help customs officials filter out fake medical devices at the U.S. border by providing for the early release of commercially sensitive data to devicemakers that hold rights to incoming products. But it is too wobbly to ensure consistency, a GOP backer of related import legislation says.
Under the U.S. Customs and Border Protection (CBP) rule, the agency could release data on the incoming product to the devicemaker, or rights holder, so it can authenticate the product. This information sharing has been a problem in the past because of CBP’s previous interpretation of the Trade Secrets Act.
It also could make it easier for rights holders to initiate their own investigations, and legal actions, against importers, based on evidence that CBP shares with them in advance of a seizure.
If the agency detains a device, it must inform the importer within five days that it may disclose identifying information to the rights holder. An importer receiving such notice has seven days to establish that the marks are not counterfeit.
If no timely response is made, or the notice is ignored, the CBP may release photographs, serial numbers and other data to the rights holder, according to the rule, which implements a section of the National Defense Authorization Act.
The interim rule is well intentioned but lacks language that would make it permanent, leaving CBP free to alter the rule at a later date, Shaylyn Hynes, a spokeswoman for Rep. Ted Poe (R-Texas), told GMP.
Poe is a co-sponsor of the “Foreign Counterfeit Prevention Act,” H.R. 4216, which would essentially accomplish the same thing, clarifying that it is not a violation of the Trade Secrets Act for CBP officers to provide samples and data to a devicemaker to authenticate the product it is importing.
The bill is a direct response to a 2008 CBP edict that required field officers to remove or redact key information on products or their packaging before sharing information with a rights holder.
Aside from questioning the agency’s interpretation of the Trade Secrets Act, Poe argued at a recent House hearing that CBP officers are under tight time constraints to evaluate huge amounts of inbound products, and having use of tracking codes and other data would greatly assist them.
Thomas Kubic, president and CEO of the Pharmaceutical Security Institute and a former FBI deputy assistant director, said the proposal is something industry would likely support.
“Some organizations moving [medical products] illegally into the United States are also trading worldwide, so without those critical pieces of information, we could have counterfeiting cases all over the world and not get them connected,” Kubic told GMP.
The CBP rule is effective immediately, but the CBP is accepting public comment on it until June 25.
The April 24 interim rule can be viewed at www.fdanews.com/ext/files/05-02-2012-CBP-Import-Rule.pdf. — Johnathan Rickman