Obama seeks to strengthen supply chain security, protect US intellectual property

Pharmaceutical CommercePharmaceutical Commerce - January/February 2012

But will anti-terrorism concerns trump commercial interests?

One element of the 2012 State of the Union address delivered on Jan. 24 was to create a “Trade Enforcement Unit” that will investigate unfair trading practices affecting US imports; it will include “more inspections to prevent counterfeit or unsafe goods from crossing out borders,” said President Obama. The next day, the White House released a new report, “National Strategy for Global Supply Chain Security,” which announces a new effort to coordinate planning, enforcement and risk management of supply chains that impact the US economy. Drill down into the footnotes, and mention is made of the June 2010 report, “Joint Strategic Plan for Intellectual Property Enforcement,” and following that paper trail leads to the March 2011 report, “Counterfeit Pharmaceutical Inter-Agency Working Group,” which called for an alphabet soup of federal agencies to coordinate investigations, and for legislative action on anti-counterfeit and track-and-trace rules.

The Inter-Agency report made mention of the capabilities of the Dept. of Homeland Security, which has investigative offices and enforcement staff worldwide. The new National Strategy, however, makes the anti-terrorism element of the issue more explicit: federal agencies will report up to the White House through the Assistant to the President for Homeland Security and Counterterrorism. There are two principal goals in the Strategy: to promote the “efficient and secure movement of goods;” and to foster a “resilient supply chain” that can overcome disruptions from terror strikes or natural disasters. The Strategy also identifies possible methods of streamlining global trade, including “trusted trader” programs and coordinated regulations with foreign governments.

All this is occurring as the Transportation Security Administration is grappling with a 100% inspection goal for air cargo (affecting, among other things, shipments of temperature-controlled pharmaceuticals); as FDA has initiated a concerted effort to share inspection and audit data with other countries; and as Congressional committees deliberate the chances of passing federal pedigree legislation for pharmaceuticals. So much is going on, there’s a danger that nothing will actually be accomplished; but it seems clear that supply chain issues will remain a relatively high priority in Washington.

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