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