No Re-Packaging Ban in EU

StevenSimske — Sat, 13 Dec 2008 01:26:00 GMT

Under pressure from repackagers, who have convinced the EU in this time of economic meltdown that banning repackaging would be a misstep, the EU has changed its decision.

http://www.forbes.com/afxnewslimited/feeds/afx/2008/12/05/afx5786503.html

"EU Industry Commissioner Guenter Verheugen faced heavy pressure from parallel traders who said such a ban would have wiped them out, as they have to repackage drugs so that explanatory leaflets to patients are in the right language."

However, the EU is going to provide a more US/New Zealand like model of advertising for the pharmaceutical providers, another contentious issue (generic pharma feels it is unfair): "Direct-to-consumer advertising of prescription drugs is permitted only in the United States and New Zealand and was heavily attacked by consumers in the wake of the 2004 withdrawal of Merck & Co's heavily promoted painkiller Vioxx."

The main thrust of the legislative reform is to increase customer safety, and to do so requires deft political maneuvering, since repackagers, generic manufacturers and brand manufacturers will all find elements of the legislation against their best wishes. There is to be a more powerful system of safety monitoring for patients, improved anti-counterfeiting legislation, and more direct-to-consumer (DTC) information on the products allowed.

The biggest safety concern is response time--getting all potentially dangerous products out of customer-facing locations as soon as possible. The Irish pork recall showed that the response system is indeed fast, and generally seems to provide patient welfare. But, it needs to be more cost-effective. Full provenance track and trace, then, is more or less inevitable.

Cheers,

Steve

ePedigree Delay a Sign of An Eventual Supply Chain U.N.?

StevenSimske — Thu, 20 Nov 2008 05:49:00 GMT

I have been remiss in discussing the delay in the California ePedigree until 2015. This has been interpreted as a long-term delay for track and trace and overall product safety. For a nice overview and analysis of the problem, see http://www.industryweek.com/ReadArticle.aspx?ArticleID=17793.

However, ePedigree initiatives are underway by the WHO, FDA, EU, AQSIQ (China), GS1 and other standards/regulatory organizations. A full serialization+pedigree requirement may be delayed until 2015, but it is unlikely that ePedigree will not already be in place before then. Recent passing of PRO-IP and Country-of-origin labeling (COOL) legislation in the US indicates that the US,too, will continue with initiatives before 2015.

The delay of California ePedigree legislation, moreover, may be indicative of another passing of the torch. Much as the recent Presidential (and Congressional) election results likely signal a more collaborative, less "independent" US foreign policy, the delay in ePedigree may signal a more collaborative, less independent nation-to-nation legislation in the future.

Will the big players--WHO, FDA, EU, AQSIQ, GS1, ISO, and others--work together to create a reasonable roadmap for product track and trace, pedigree and provenance? In effect, create a "United Nations" for track and trace? I, for one, hope so. With the increasingly convoluted supply chains for virtually all products resulting in chaos during recall, fraud and even normal node-node shipping situations (how many retailers can confidently tell you everywhere a product has been on its way to their shelves?), how long can it be before the legitimate market says, "enough is enough"? Plus, a universal process will reduce confusion, lower cost, and improve response time around the planet.

Is the current combination of counterfeiting, diversion, factory overrun, smuggling, return fraud and other supply chain crime the commerce equivalent of the two World Wars? A series of events so drastic that the set of collective players decides to band together into a United Nations to try to prevent such a meltdown in the future? (I realize the United Nations is by no means perfect--but we have been without nuclear combat for 63 years...). Maybe so. And maybe the delay in the California ePedigree shows that the US, rather than defining the path forward, is willing to work with the rest of the Supply Chain United Nations in formulating the optimum set of requirements moving forward.

-Steve

Security Printing and Imaging : EU

No Re-Packaging Ban in EU

ePedigree Delay a Sign of An Eventual Supply Chain U.N.?