Counterfeit Drugs, One Click Away

Purchasing medications online can expose consumers to serious risk. It's a dangerous problem we can't afford to ignore.
Aug 31, 2007

Mark Mutterperl
If it looks too good to be true.... The price is unbeatable, the Web site proudly displays an accreditation seal of approval, medicines are advertised as "generics" of the branded versions (implying bioequivalence with respect to safety and efficacy), and patients never have to leave their homes. Marcia Bergeron, a 57-year-old Canadian resident likely had these things in mind when she purchased antianxiety and sedative medication from an online pharmacy. The pills she received from the Web site, however, caused hair loss and vision problems, and ultimately resulted in her death. The coroner's toxicology report showed that the pills she purchased online were laced with traces of dangerous metals, including uranium, strontium, selenium, aluminum, and arsenic. Bergeron, like many others around the world, was a victim of the counterfeit-medicine business, an industry that the US-based Center for Medicine in the Public Interest (CMPI) predicts will reach $75 billion in sales globally by 2010.

Bruce Longbottom
Counterfeit drugs are drugs that look like branded or generic medicines but have been deliberately and fraudulently mislabeled with respect to their source or origin. A counterfeit drug's composition will fall into one of these categories: no active ingredients, too much or too little of the active ingredients, or the wrong ingredients—as in Marcia Bergeron's case. Although distribution of counterfeit medicines in brick-and-mortar pharmacies has long plagued regulators and trademark owners, the Internet—with its electronic interface, user convenience, and seller anonymity—has greatly enhanced the international trade of counterfeit pharmaceuticals and made it more difficult to trace and prosecute counterfeiters. According to US Immigration and Customs Enforcement, the Internet has become "the primary tool for criminal organizations to advertise, communicate, and conduct sales of counterfeit pharmaceuticals" and is "the primary mechanism for consumers to find, order, and make payments for counterfeit pharmaceuticals."

Since counterfeiters went online, fighting counterfeiting has become more difficult. Laws that were enacted to address counterfeiting in the brick-and-mortar world (where stores and warehouses can be raided, counterfeits seized, and counterfeiters arrested) do not work well in the electronic, borderless, anonymous world of the Internet. There are several ways to mask the identity of people or companies operating a Web site. If they are located and a judgment is obtained against them in court, enforcement of that judgment in the countries where they are located may be difficult or impossible. Even if one Web site is successfully shut down, others are likely to pop up—the fight is reminiscent of the fairground game Whac-a-Mole.

Although attacking online counterfeiters is difficult (at least until better enforcement tools are provided), there are some steps that pharmaceutical companies can take. For instance, companies can use a Uniform Domain Name Dispute Resolution action to obtain a counterfeiting Web site's domain name if it contains the company's trademark. This action, if successful, will stop the counterfeiter from operating that site, but it will not stop the counterfeiter from operating another site that does not contain the company's trademark. Companies may also contact the Web site's host or the Web site registrar to take down the counterfeiter's site or disable the counterfeiter's domain name, respectively. Some hosts and registrars will cooperate, while others will require a court order.

But pharma companies should make sure they focus on internal measures as well. Some steps to consider include:

•securing the supply chain of products, including audits of wholesalers and use of track-and-trace technology

•using overt/covert technology features on products and packaging to help authenticate products

•deterring counterfeiters through targeted investigations and working with law-enforcement agencies on raids, arrests, and criminal prosecutions

•filing civil actions against select targets to obtain injunctions and impose financial penalties

•monitoring the Internet to try to disrupt online sales

•recording trademarks with customs to encourage seizures of counterfeits as they cross national borders