In February 2012, news of fake Avastin in the United States hit the news wires. Cancer patients were being administered water while under the impression that it was the actual cancer treatment drug, Avastin. People were outraged. Weeks later, another shipment of the counterfeit drug was discovered in the United States. “What’s being done about this?” was the outcry from the press. Shortly thereafter, the Senate passed the Counterfeit Drug Penalty Enhancement Act of 2011,1 a bill that had been sitting in committee for months. If its companion bill in the House is passed, and the president signs it, it will represent the U.S. government’s best attempt to curb tragedies such as the one described above, right?
As with any new law passed in a panic, you must first ask if it will accomplish what the politicians say it will. On March 7, 2012, Senator Bennett, one of the sponsors of the bill, issued a press release extolling its benefits.2 He said, among other things, “Right now, the penalties for producing a fake company logo on a bottle of counterfeit drugs are more severe than they are for actually making and selling a counterfeit drug. We can help prevent these drugs from reaching hospitals, pharmacies and consumers by giving law enforcement the tools they need to crack down on these crimes and creating a universal system to track these drugs through the supply and distribution chains.”
Unfortunately, the Senator is flat out wrong.
The only thing that the bill does is double the existing penalties under 18 U.S.C. § 2320, which deals with trafficking in goods bearing counterfeit marks. The current maximum penalties for an individual who violates that statute are a $2,000,000 fine and 10 years imprisonment. All this bill does is double the maximum penalties to $4,000,000 and 20 years imprisonment. Does Senator Bennett seriously think that someone willing to risk a $2,000,000 fine and 10 years in prison would balk at a potential $4,000,000 fine and 20 years in prison?
Also, if no counterfeit marks are used in connection with the sale of a fake drug, 18 U.S.C. § 2320 does not even apply. That means that this bill does not affect such criminals at all. So, even if Senator Bennett is right, and there are people who would change their behavior because of the increase in the already steep penalties, they are more likely to simply remove all counterfeit marks from their fake drugs than to stop selling them altogether.
Finally, a wide array of statutes and regulations that the government could use to go after such people already existed before this bill was even introduced. These include FDA charges of distributing a misbranded and adulterated drug as well as state and federal criminal charges such as various prescription violations, fraud, battery, reckless endangerment, and possibly even manslaughter.
Given these preexisting tools available to prosecutors, will this bill, one that simply doubles the already steep penalty for distributing drugs with a counterfeit marks, do anything to deter crime? Of course not. All it really does is give a tiny bit of extra protection to pharmaceutical companies who don’t want their trademarks to be used without their consent. But that doesn’t make a very good press release, does it? Senator Bennet knows that it is much better to claim you are helping people than to tell people that your bill is just a way to help large companies minimally increase their already tremendous ability to protect their intellectual properties.
It is sadly ironic that a bill touted as preventing the distribution of drugs that don’t do what they claim to do, doesn’t do what its sponsor claims it does, either.
Sources
1. http://www.gpo.gov/fdsys/pkg/BILLS-112s1886es/pdf/BILLS-112s1886es.pdf
2. http://bennet.senate.gov/newsroom/press/release/?id=f199f4b0-46db-4cf9-aa99-41607bc6990c
