In my opinion, dropping the ban is a very bad decision. Repackaging eliminates the benefit of just about every practical anti-counterfeit tracking technology, including the emerging serialization requirements in some EU countries. Apparently, tablets can even be removed from blister packs under EU law. It’s hard to see how this will benefit consumers. “Hey, it’s a bit cheaper, but it might be fake. Good luck!”
The issue relates to our old friend parallel trade. Combining the European Union’s market integration principles with national price controls has created an enormous cross-border gray market, often called parallel trading. Wholesalers in countries such as
Surprisingly, the average European consumer receives almost no price break from parallel trade, especially in countries with flat-rate patient co-payments such as the
Unfortunately, parallel trade also means that products are often repackaged by multiple intermediaries along the supply chain and may pass through dozens of hands before being resold. Legitimate products can easily get mingled with counterfeits, with no feasible way to introduce pedigrees across countries. It’s no surprise that counterfeit cases are growing quickly in
Only one thing is certain – litigation over parallel trade will continue. In September, the European Court of Justice gave GlaxoSmithKline a partial victory in its long-running attempt to limit parallel exporting from
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FYI, I wrote two background posts on parallel trade in August 2006. Amazingly, all of the links in these posts still work if you are curious:
- London Calling: Fake Drugs Get Real, which provides a high-level overview of the winners and losers from parallel trade
- Curious about European Drug Distribution?, which has background material on the EU market
I'm amazed the below three articles are not getting more press. Pretty scare to know our "supply chain" is not as secure as the industry claims. Wonder why no one wants to utilize technology to minimize some of the risks.
ReplyDeleteFIRST FOREIGN NATIONAL EXTRADICTED FOR IMPORTING AND DISTRIBUTING COUNTERFEIT PHARMACEUTICALS DRUGS IN U. S. SENTENCED TO PRISON
http://www.usdoj.gov/criminal/cybercrime/gonzalesSent.pdf
Local pharmacist, businesses disciplined by state
http://www.nashuatelegraph.com/apps/pbcs.dll/article?AID=/20081130/NEWS01/311309954/-1/XML15
Miami Man Sentenced to 20 Years for Massive Drug Diversion Operation
http://myfloridalegal.com/newsrel.nsf/newsreleases/B9B14EB7496153B88525750B006FC641
Hi Adam,
ReplyDeleteAlways appreciate your comments but I think you may discount the advantage taken by UK Govt of the Parallel trade?
Between 1990-2000 Govt funded dispensing fees fell from roughly 20% to 10% of TO. This slack was reciprocally taken up by a mix of, primarly generic, but also PI margin.
The great re-balancing of 2005 with the new Pharmacy Contract sought to solve the problem, and it did for a while. But ever so slowly the system seems to be creeping back towards a mis-alignment between fees and reimbursement.
Totally agree the bigger picture is being missed, but it's hard to imagine any kind of quality investment premium being introduced in the current climate -the UK Govt needs its cut more than ever. Add EU core policy of opening boundaries and encouraging cross-border trade to further integration and I think you explain the decision.
Re: the 2nd comment
ReplyDeleteExcellent point. I'm not sure if I've ever written about it on the blog, but importation has indirect economic benefits for payers in importing countries due to cost avoidance from reduced compensation rates for pharmacies.
As I understand it, the NHS in the UK budgets for a certain level of parallel importing and then imposes a clawback on pharmacist sales. Thus, the NHS promotes parallel importing while also sharing in the financial gains from its use by pharmacies.
We have the same cross-subsidization here in the U.S. with regard to generics, which is why Wal-Mart has caused so much disruption.
Many thanks for your thoughtful comment.
Adam