Drug counterfeiting, hype or health?

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Dolce Gabbana dressesCounterfeiting is a hot issue not only because it hits vendors in the pocket but because of the public health/safety implications.

Product counterfeiting ranges from fashion, such as Dolce & Gabbana handbags,  high performance bike frames such as Specialized Bikes to faking innovative drugs such as Viagra.

The Israeli onlline business daily “The Marker” recently ran an item on drug counterfeiting,  pegging the volume of drug counterfeiting in Israel at 80-100 million sheqels/year.  The source for the number is the Israeli Ministry of Health, the World Health Organization and an  organisation called “The Center for Pharmaceutical Security” (המכון לביטחון פרמצבטי)  I could not find any reference to this organization online – but from the name it sounds like a pharmaceutical industry lobby.

The core issue is public health and safety. This is why I personally believe that anti-counterfeiting supply chain initiatives such as ePedigree are well-intentioned but ineffective countermeasures to this threat.  I believe that the interest of public health and safety (you can be killed on a defective road bike frame…) requires involving consumers at the point of sale.

Israeli MK Plessner is sponsoring a supply-chain anti-counterfeiting law that would make pharmacists policemen responsible for enforcement.  It is a misdirected and stupid idea. It will not contribute to public health – since most of the counterfeiting is not OTC in a Superpharm  but online – drugs like Viagra and Cialis and certain anti-cancer drugs  are all sold over the Internet.

1) The numbers from the WHO and other organizations like OEC are inflated and based on  naive calculations of 7% of world pharma manufacturing.  I would be careful estimating pharmaceutical counterfeiting damage based on top-down revenue calculations – I would be much more impressed with even small samples based on damage to end-users caused by counterfeit products.

2) In many cases – vendors don’t object to counterfeiting since it may not directly impact their sales or even increase their sales from the free publicity.  Consider the case of fake DG handbags you can get in NYC on the street for $10. This does not diminish the threat to public health from fake drugs since people can die from a fake version of Viagra.
3) Supply chain compliance is the way the industry is going – if you look at the California ePedigree law.  However – like most American laws – the issue is not prevention and public safety but compliance to government regulation. From conversations with pharmaceutical manufacturers – I believe that they as a rule are more concerned with compliance than prevention and will implement ePedigree to some degree or another in order to comply with California law.

3) There is a simple and practical method of preventing pharma counterfeiting at the point of sale – using a unique bottle number that a consumer can call in to a central database and get a quick readout on his cell phone if the product is genuine or not

Read more on my post Threat modeling for the pharmaceutical Industry

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