Wednesday, June 19, 2013
Editorial: Stricter Criminal Penalties Are Required Minimize

Editorial: Stricter Criminal Penalties Are Required
By Martin VanTrieste

Note: This editorial is the personal view of Martin VanTrieste and does not represent any other concerns, such as Rx-360.

Looking at events over the past several years, it is clear - unethical individuals and criminals are present in the pharmaceutical supply chain. The reason for this growing phenomenon is simple “greed”. Unethical individuals and criminals have learned that selling substandard, adulterated or counterfeit medicines is highly profitable and involves very little if any personal risks.
 
To put it into perspective, take this example of how the profitability of counterfeit products compares - a criminal can take $1,000 and convert it into $10,000 counterfeiting a consumer product like a DVD, watch or purse. That same $1,000 can be converted into $100,000 dealing in illicit drugs like cocaine. But a criminal can take $1,000 and make $1,000,000 counterfeiting pharmaceuticals. These numbers are rough but they illustrate in a very real way the severity of the issue - it costs $60/kg to buy Viagra API in China or India, which can be converted into 25 mg tablets that would sell in US for up to $200,000.1
 
For these individuals to be successful in their illegal activities they need a motive, and in the case of selling substandard, adulterated or counterfeit medicines the motive is money. But they also need an opportunity to commit the crime to be successful. Regulatory agencies, professional organizations, pharmaceutical companies and their suppliers are working diligently to close gaps and to decrease the number of opportunities for unethical individuals and criminals to enter the pharmaceutical supply chain. It is our job to minimize these opportunities.
 
When speaking with law enforcement professionals, they tell us that to prevent crime requires a three prong defense that involves deterring, detecting and disrupting criminal activity. As professionals within the pharmaceutical industry we can improve systems and techniques to deter and detect criminal activity that threatens our supply chain, but we need additional tools to help to deter and disrupt.
 
For example, several recent criminal convictions for counterfeiting involved very mild criminal penalties. Take the cases of:
1.    John Henry Atkinson who was illegally selling counterfeit impotence drugs in the UK worth £53,000 who has now received a nine month prison sentence in the UK2
2.    Hazim Gaber who has been sentenced to only three years in prison by a court in Phoenix, Arizona in the United States, for selling fake cancer drugs on the Internet3
3.   Kevin Xu who provided an undercover agent with a list of 25 pharmaceutical drugs he could manufacture that included drugs manufactured and marketed exclusively by several pharmaceutical companies. Beginning in December 2006 and continuing through June 2007, Xu shipped counterfeit pharmaceutical products to ICE agents in Houston that appeared identical to the drugs manufactured by the legitimate trademark holder. Xu is considered to be a significant supplier of counterfeit pharmaceuticals due to his ability to manufacture large quantities of various counterfeit pharmaceuticals and packaging that was identical to authentic pharmaceuticals. Chemists employed by the pharmaceutical companies and the Forensic Chemistry Center of the FDA have testified that the counterfeit drugs supplied by Xu contained active ingredients that varied from amounts listed on the label and unknown impurities. Agents discovered Xu had utilized the Internet and actually sold counterfeit drugs to citizens of the United States. In January 2009 he was sentenced to 78 months in federal prison.4
It’s one thing to break the law by copying consumer products such as watches and DVDs – implications can be severe from a financial, brand, and reputation perspective. But with counterfeit drugs we’re talking about products that people put into their bodies, that are supposed to improve their health, but actually can hurt or even kill. The repercussions for this kind of crime, as these recent court rulings in the United States and Europe show, are at best a slap on the wrist – in the case of Hazim Gaber, he’s serving the same sentence that a man in the United States received for robbing a restaurant twice. 
Looking at the other side of penalties for dealing in illicit drugs (such as cocaine), the punishment is much more significant and are closer to what should happen to criminals convicted of counterfeiting pharmaceuticals.
It’s clear the current system of criminal penalties is not sufficient to deter and disrupt illegal activities that threaten the pharmaceutical supply chain. The money to be made is too great versus the weak criminal penalties.  
It is obvious to me, if a certain type of criminal activity is more profitable and less risky than other forms criminal activity, then more unethical players and criminals will partake in the more profitable and safer form of crime. 
I fully support recent legislative initiatives that increase the penalties for counterfeiting pharmaceuticals to 20 years in prison and if a patient dies due to the counterfeit product the penalty is life in prison without the possibility of parole.
I strongly encourage legislators around the world to act promptly and assist regulatory agencies and pharmaceutical professionals to deter, detect and disrupt the selling of substandard and counterfeit pharmaceuticals.
 
 
1. Fake Drugs: Causes, Consequences, and Possible Solutions, American Enterprise Institute for Public Policy Research, Roger Bate, Harvard Medical School, March 03, 2010
http://www.aei.org/speech/100125

2. Canadian jailed for selling fake cancer meds online, SecuringPharma, September 3, 2010
 
     3. Impotence Drug Seller Jailed, 121 Doc: Private HealthCare Online,
        Mark Wilkinson, September 9, 2010
 
     4. US Immigration and Customs Enforcement News Release, May 23, 2010 http://www.ice.gov/news/releases/1004/100423houston.htm

  

 

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