PSM: PSM has written at length about a
batch of Levemir, which was stolen in North
Carolina in February and surfaced in a Texas medical facility four months later.
Could the EFPIA's coding system have prevented these stolen medicines from
entering the supply chain? How so?
AB: Currently, the ability to identify
and trace medicines in the supply chain is done only at batch level, meaning
that it's impossible to uniquely identify medication once it's split up into
individual packs. This makes it difficult to ensure a complete recall of
Identification could be
much improved if medications were uniquely identified at the pack level in
combination with online verification to provide real-time information on the
status of the product, which is what is currently under trial by EFPIA in Sweden.
The use of a unique product
identifier would allow pharmacists and wholesalers to verify the status of each
pack in the pilot before dispensing, alerting them to the potential existence
of a counterfeit product before it reaches the patient.
PSM: Can you talk about the challenges
you're working to overcome in regard to parallel trade?
AB: While parallel trade is legal in
the EU, the practice of repackaging medications can cause serious weaknesses in
the integrity of the supply chain. That's because original packaging contains safety
measures to ensure that the pack has not been opened or tampered with. Removing
these features makes it easier for counterfeits to enter the supply chain
The simplest solution to
this problem would be to ban repackaging. However, to date, the Commission does
not support such measures. Thus, EFPIA maintains that repackagers should be
subject to the same obligations as the original manufacturers.
In addition, repackaged
medicines should also carry unique codes to be created in accordance with the
national coding requirements of the receiving country. Ideally, these unique
codes would be linked to the original code from the manufacturer-allowing us to
trace the product from the patient back to the manufacturer.
PSM: Do you have any words of wisdom for
policymakers who might be considering drug importation in healthcare reform
AB: U.S. policymakers should proceed
cautiously in opening importation of medicines from other countries.
So far, most warnings of
counterfeit issues in the U.S.
were related to drugs purchased on the Internet as opposed to supply chain
failures-a stark contrast to the cases of counterfeit drugs found in the UK's legitimate
supply chain mentioned earlier.
But as the number of
commercial parties involved in the sourcing, brokering and distribution of
medicines increases, so too does the risk of counterfeits entering the system.
should gauge the effectiveness of their current systems against the risks
associated with making the pharmaceutical supply chain more vulnerable.
Learn more about the EFPIA's coding project and visit our Consumer
Resources section for tips on protecting yourself from substandard and