Global approach sought to anti-counterfeiting

Phony Internet pharmacies and other illegitimate outlets are driving the massive counterfeit medicine market to consumers worldwide, according to a recent report by Cambridge Consultants. The technology product design and development firm interviewed leaders from pharmaceutical and biotech businesses, as well as technology developers and industry bodies. As part of the report, Cambridge Consultants identified the need for more consumer education, along with new and improved regulatory standards to address counterfeit medicine. The report also included recommendations for solutions that businesses can use to address the global drug counterfeiting epidemic.

“Although there has been some debate around the size of the worldwide counterfeit medicine market that has been estimated at $75 billion and upward, one cannot dispute that the unregulated growth of Internet pharmacies will only contribute to this problem,” said Rainuka Gupta, group manager of medical technologies at Cambridge Consultants. “Our research concluded that this presents threat to consumers and the industry alike. Easier access to cheaper drugs has exposed consumers to dangerous mixes of fake drugs and placebos. Meanwhile, pharmaceutical companies risk losing credibility and regulatory bodies risk losing control with the spread of these counterfeit medicines. As an industry, we need to better educate consumers on the threats associated with fake drugs, but we also must work together to coordinate and implement technologies that can detect and deter counterfeiters.”

Already a global problem, especially in Africa and Southeast Asia where the World Health Organization (WHO) has estimated that about 50% of medicines could be fake, counterfeit drugs have also been flooding the U.S. market. In 2009, the U..S Customs and Border Protection Agency stated that the value of seizures of counterfeit pharmaceuticals had increased by 500% over the previous three years. Despite increased efforts to stop the flow of counterfeit medicine, the growth of Internet pharmacies has exacerbated the issue and put consumers at further risk. According to LegitScript, which monitors Web sites that facilitate the sale of prescription drugs, approximately 97% of the nearly 50,000 pharmacy Web sites in its database do not meet their standards for being verified as a legitimate pharmacy (licensed pharmacy, appropriate registrations, requiring a valid prescription, etc).

“As an advocacy organization, we were pleased to participate in this research and we thank Cambridge Consultants for bringing attention to the growing issues around the counterfeit medicine market,” said Andrew Emmett, managing director for science & regulatory affairs for Biotechnology Industry Organization (BIO). “While there have been recent improvements in enforcements and regulations, there continues to be a need for a comprehensive private-public response to criminal counterfeiting focusing on education, legislation, enforcement, investigation, and international collaboration.”

Packaging addresses counterfeits

Cambridge Consultants organized a panel on the topic during the 2010 BIO International Convention earlier this year, which featured industry leaders from Amgen, Genzyme, and BIO discussing measures to address counterfeit medicine. Currently, there are three different types of technologies that can be deployed (anti-tamper packaging, serialization, and authentication) to fight against counterfeit pharmaceuticals. However, due to the complex, global nature of counterfeiting and diversion carried out by organized criminals, the panel and research participants all agreed that collaboration among different stakeholders, including manufacturers, supply chain and law enforcement, is critical to address the problem.

Against the backdrop of a need for wider education concerning the dangers behind buying drugs from Internet pharmacies, the research by Cambridge Consultants highlighted the need for today’s technologies to tie into business processes to form an integrated solution that continuously evolves, especially considering that counterfeiters have demonstrated that they can quickly adjust and respond to any one-off approaches.

A key complexity of tackling anti-counterfeit and product diversion is that it needs to be addressed globally at a system level, otherwise criminals will simply move to less protected markets. As a result, the report states that this requires everything from coordination of customs and law enforcement, through the adoption of legislation along with public education campaigns. In addition, the report also highlights how companies can take concrete steps to address threats to their businesses and their customers based on the product-specific risks.

The regulatory, technical, and business responses related to biotech and pharmaceutical counterfeiting issues were discussed during a panel session during the BIO 2010 chaired by Pamela McNamara, president, Cambridge Consultants. Panelists included Lew Kontnik, director of brand protection, Amgen, David Kent, vp of global risk, Genzyme, Hugh Burchett, director of defence & security, Cambridge Consultants, and Andrew Emmett, director for science & regulatory affairs, BIO.

A downloadable white paper addresses the impact counterfeits could have on business in the future.