PharmTech: Do you know of examples of counterfeit pharmaceuticals being used to fund terrorist organizations?

Glover: If a direct link between counterfeit goods and terrorist organizations is difficult to establish, then the linkage between counterfeit pharmaceuticals and terrorist organizations is even more knotty. There are, however, a few specific unclassified examples, although somewhat dated.

In the early 1990s, the Irish Republican Army (IRA) set up a laboratory in Florida to produce fake vials of an antiparasitic drug for livestock. The labels for the fake pharmaceuticals were printed on a Northern Ireland farm. Proceeds from the operation were sent to the IRA to purchase arms.

PharmTech: Have terrorists groups traditionally used counterfeiting to raise money, or is this a recent phenomenon?

Glover: Experts currently believe that because the traditional sources of funding for terrorists groups are being restricted by US law enforcement agencies and our allies, terrorist organizations have turned to profiting from the manufacture and sale of pirated and counterfeit goods. International law-enforcement activities are believed to be making a difference in the sources of funding of terrorist activities. Terrorists are avoiding formal financial channels, and are engaging in riskier behavior such as smuggling, pirating of goods, and counterfeiting.

PharmTech: Do you think stricter penalties are necessary to stop the flow of counterfeit goods?

Glover: Counterfeiting is a serious crime that poses a threat to health and safety, yet the criminal sanctions against this heinous behavior are light. Given the potential for large profit, coupled with a low detection rate and comparatively light sentences, there is little to deter potential violators. This needs to change, and laws need to be strengthened. Law enforcement sanctions should be more comprehensive, sentencing should be stronger, fines made larger, assets seized, and violators within the healthcare system prohibited from engaging in future medical-related activities.

PharmTech: What can be done to fight this problem at the governmental, industry, and consumer level?

Glover: At the governmental level, because the linkage between counterfeiting and terrorism takes place within an international framework, the solutions must also be international in scope. Intergovernmental cooperation is essential to addressing this problem. This includes harmonizing and strengthening international laws, and greater cooperation among law-enforcement agencies, customs officials, and the judiciaries. Additionally, governments should promote the creation of international standards to facilitate the development of track-and-trace technology.

Further, governments should alert the public of the dangers of purchasing medicines outside of the tightly regulated distribution chain, of the perceived level of counterfeiting believed to be in the supply chain, and the potential harmful effects of consuming them.

From an industry standpoint, manufacturers should place greater emphasis on technological solutions to vulnerabilities within the supply chain, not only using electronic track-and-trace technology with respect to packaging, but by using overt, covert, and forensic features directly on the product.

Consumers need to develop an understanding that "cheap" and Internet-purchased medicines have a high risk of being counterfeit or otherwise compromised in some potentially harmful way. They should also be made to understand that by purchasing product outside of the normal distribution chain, they may be supporting organized criminals and terrorists when this can be proven.

The issue of terrorist groups raising funds through the manufacture and sale of counterfeit goods must be addressed in a comprehensive way. This includes better intergovernmental cooperation, stronger laws, improved technology, and greater consumer awareness.

Regarding pharmaceutical supply-chain protection, most of the emphasis has been placed on package security, with a focus on electronic product codes such as radiofrequency identification (RFID) and two-dimensional (2D) barcoding. Package security is an important step that will provide a level of security, but it does not ensure the authenticity of the product. This is especially true when the majority of prescription medicines are legitimately repackaged before they reach the patient.

Therefore, greater attention needs to be paid to product, or on-dose security. On-dose security with overt, covert, and forensic features represents an ideal solution. The investigator in the field can authenticate a product through its overt and covert features. A more detailed level of authentication can be obtained by laboratory analysis when forensic-level authentication features are used.