Confidence in the face of counterfeits

When you think of counterfeit goods, what comes to mind? Many would say fake purses, fake watches and other similar products you might find being hawked on street corners. What about counterfeit drugs? Would counterfeiters dare to enter such a highly regulated industry? Or attempt to replicate a product that is potentially life-changing and even life-saving, and so difficult to manufacture and distribute safely and correctly? Sadly, yes—drugs are among the many types of products targeted by counterfeiters.

Across the planet, drugs in all major therapeutic categories have been counterfeited. Annual counterfeit drug sales were estimated to generate $200 billion in 2011. And incidences of counterfeit medicines continue to rise on a global level as the technology to copy drugs and to reach patients advances.

Genuine medicines are manufactured and packaged under strict regulations to meet quality standards that ensure safety and efficacy. Counterfeit drugs are manufactured outside of that safety net, may be contaminated, or may contain the wrong active ingredients, harmful ingredients, or no active ingredients—all of which compromise the drugs’ safety and efficacy.

In February of this year, the US Food and Drug Administration (FDA) warned that counterfeit versions of a cancer drug used to treat cancers of the colon, lung, kidney and brain had been found in the US market. The counterfeit product did not contain any of the active ingredients of the genuine product.

But even if some counterfeit drugs turn out not to be harmful, they are still illegal. The bottom line is there are no ‘good’ counterfeit drugs. They pose a serious public health risk and have caused serious injury—and even death—around the globe.

Counterfeits and the Internet

The Internet has further complicated the battle against drug counterfeiting. As a semi-unregulated environment, with virtual anonymity and a direct link to the public, the Internet has become a widely used channel for the distribution of counterfeit drugs.

Search engines are the gateway for navigating the Internet for most consumers. Counterfeiters infiltrate search results with websites selling counterfeit drugs to unsuspecting consumers. Many websites are difficult to monitor because they can be activated and deactivated at the click of a button. Moreover, the actual operators of these sites can be difficult to locate and often these cybercrimes go unresolved.

A review by the National Association of Boards of Pharmacy (NABP) of more than 10,000 websites offering drugs to the US market found that 97 percent operate out of compliance with US pharmacy laws. Specifically, the review found that:

Despite these worrying statistics, an estimated 36 million Americans have purchased at least one prescription drug online without a doctor’s prescription—risking their health and sharing their credit card information with criminals.

Without efficient global regulatory oversight, there is a much higher risk of counterfeit drugs infiltrating the international drug supply and distribution networks. These cybercrimes are being perpetrated across all jurisdictions.

“An estimated 36 million Americans have purchased at least one prescription drug online without a doctor’s prescription—risking their health and sharing their credit card information with criminals.”

For example, some online drug sellers wrap themselves in the Canadian flag, taking advantage of Canada’s reputation for having a strong healthcare system and affordable medicine. To this point, Canadian regulators have said outright that they cannot guarantee the safety and effectiveness of medicines purchased from so-called ‘Canadian’ pharmacies.

It is understandable that many consumers fall victim to purchasing counterfeit drugs online. The websites they encounter are very attractive and sophisticated, as are the packaging and appearance of the drugs themselves.

A constant tsunami of spam emails, often referencing men’s health or weight loss treatments, entices us to purchase medicines without a prescription. Many consumers are duped by these trademark-based fraudulent schemes, often believing they are purchasing the genuine product. Unscrupulous Internet sellers of prescription drugs also contribute to the growing problem of drug abuse as more people, including teenagers, use the Internet to get medicines without a prescription, sometimes with deadly results.

The way forward

Lilly remains committed to patient safety, and our company’s global anticounterfeiting efforts are an important component of our concern for public health.

Lilly is a founding member of the Alliance for Safe Online Pharmacies (ASOP), the goal of which is to make the purchase of prescription medicines online as safe as it is in local brick-and-mortar pharmacies. ASOP is also an ex officio member of the Center for Safe Internet Pharmacies (CSIP), a non-profit organisation for voluntary efforts against illegal online drug sellers whose members include Internet companies and financial payment service providers.

These companies share information, fund education, support an expanded ‘white list’ of legitimate online pharmacies, and take enforcement action where appropriate. From November 2011 to December 2012 CSIP companies shut down 3,127,235 illegal online pharmacy sites.

Lilly also supports of the National Association of Boards of Pharmacy’s (NABP) efforts to operate the .pharmacy new generic top-level domain name. Later this year NABP hopes to begin permitting legitimate online pharmacies to use .pharmacy domain names so that consumers can ‘look to the right of the dot’ for the word ‘pharmacy’ to confirm that websites have been certified as safe and legitimate places to obtain medicines in the Internet marketplace.

In March 2013, Interpol announced a new partnership with Lilly and 28 other pharmaceutical companies that will expand the work of its Medical Product Counterfeiting and Pharmaceutical Crime Unit. The three-year programme will establish the Pharmaceutical Industry Initiative to Combat Crime (PIICC), and focus on preventing many types of pharmaceutical crime, including branded, generic, and medical product counterfeiting, along with identifying and dismantling organised crime networks linked to these illegal activities.

In addition to these partnerships, Lilly is working on several other fronts in the battle against pharmaceutical counterfeiters. For example, Lilly is working to secure the integrity of its product supply chain, including the use of new technologies to track product, and through advanced record-keeping practices. Lilly is also deterring major counterfeiters of its products through targeted investigations, litigation, prosecution and use of overt/ covert packaging technology.

While no single entity or company can completely eradicate counterfeiting alone, by partnering with governments, non-government organisations and trade associations actively involved in this issue, such as the International Trademark Association (INTA), we can collectively strengthen, enact and enforce anticounterfeiting laws to protect consumers. Finally, by raising awareness of the dangers of counterfeit drugs, we can empower consumers to better ensure their own safety and purchase their trusted brands from legitimate sources.

Bruce Longbottom is assistant general counsel—trademarks, Eli Lilly and Company. www.lilly.com