Partnerships and progress on counterfeit medicines

In Lilly's latest article, Bill Reid discusses the global challenge of counterfeit medicine and shares some of the ways in which the pharma industry are trying to overcome this challenge, such as serialization.

Pharmaceutical counterfeiting poses a grave threat to patient health around the world, including in the European Union. Fake medicines accounted for nearly a quarter of all counterfeit goods seized in the EU in 2011. The outsized profits and relatively small penalties – compared with trafficking illegal narcotics, for example – make counterfeiting medicines an attractive racket. According to a recent report by the Alliance for Safe Online Pharmacy (ASOP) EU, criminals making falsified medicines in Europe generate sales of more than €1.4 billion each year – and that may be a conservative figure. The World Economic Forum estimated that counterfeit drug sales generated approximately €150 billion worldwide in 2011.

Sadly, 100,000 people worldwide die each year because of counterfeit drugs, according to the American Enterprise Institute. The World Health Organization, in fact, estimates that 10 to 15 percent of the global drug supply is fake.

Criminals have become increasingly sophisticated, using high-tech methods to mimic packaged medicines and circumvent established regulatory protections. Because they're often moving goods internationally – between countries with sometimes vastly different legal frameworks – it can be difficult to effectively prosecute criminals even when they are caught. The advent of online pharmacies has further complicated the issue by allowing illicit suppliers to market falsified medicines directly to patients almost anywhere in the world.

There is no silver bullet that will stop counterfeit medicines. But our industry is aggressively forging new partnerships and implementing comprehensive strategies to secure the legal supply chain, helping the Internet become a safe place to buy medicines, and educate patients on the dangers of purchasing counterfeit drugs (whether they're buying online or on the street). Concerted action on the part of public and private stakeholders – and vigilance among patients – will help keep us a step ahead of criminal counterfeiting networks.

The Falsified Medicines Directive (Directive 2011/62/EU) was published in July 2011 and introduces by 2017 mandatory, harmonized pan-European safety features (such as a unique identifier applied to all prescription medicines and tamper-evident packaging). These features are designed to prevent falsified medicines from reaching patients without prior detection by authorities – including key stakeholders in the supply chain.

Serialization is a particularly promising technology. It involves assigning a unique, randomized number to a product package, for example, that is entered into a central database, where it can be reviewed alongside other information like the product's manufacturer and batch number. The package could then be scanned when dispensed to a patient to verify the product's integrity.

It is the joint position of the European Federation of Pharmaceutical Industries and Associations, the International Federation of Pharmaceutical Manufacturers and Associations, and the Pharmaceutical Research and Manufacturers of America that steps should be taken to effectively harmonize serialization systems – including agreement on a common global standard.

Adopting these technologies will require significant resources in capital equipment, software and training. At Lilly, we have estimated that systems to meet emerging track-and-trace standards in our own network alone will require an investment of roughly €85 million. So it's critical that serialization systems are implemented in a step-wise, scalable manner and in consultation with all relevant stakeholders to ensure the efficient use of resources. But make no mistake – these investments are worth making. Implemented correctly, serialization will not only help secure the legal supply chain, but also pave the way for automated checking of expiry dates and improved pharmacovigilance. It could even help reduce dispensing errors and fraudulent reimbursement claims related to medicines.

The Falsified Medicines Directive will additionally strengthen Good Manufacturing and Good Distribution Practices within the EU – including the sourcing of active ingredients – and improve through audits the supervision of wholesalers, traders and other key members of the distribution chain. As for the Internet, both national authorities and the European Medicines Agency will maintain and actively monitor white lists of approved online pharmacies, which will be required to display an EU common logo.

Our industry is being proactive by engaging patients to raise awareness of the dangers of unsafe medicines sold via the Internet. Lilly is a committed partner of ASOP EU and participates in the European Alliance for Access to Safe Medicines. Online pharmacies are legal in some countries and illegal in others – but by working hand-in-glove with these broad coalitions of public, private and NGO stakeholders, we are educating patients on the importance of using only safe and certified online pharmacies to purchase the medicines they need.

Progress is also being made on efforts to increase penalties for counterfeiters, notably through the MEDICRIME Convention to criminalize the manufacture and supply of falsified medicines. And earlier this year, a three-year €4.5 million agreement was forged between INTERPOL and 29 of the world's leading pharmaceutical companies to enhance the law enforcement community's response to all types of pharmaceutical crime. Notably, the program will actively target and prosecute the organized criminal networks behind these pernicious activities.

Fighting counterfeiters is not easy. We can only overcome the challenges by working collaboratively and creatively through strong partnerships that keep patient health at the core of our efforts. Harmonizing the use of new technologies like serialization – and taking concerted action to educate patients and make the Internet a safe place to purchase medicines – will ensure that patients continue to benefit from the innovative medicines our industry produces. We have everything to gain from making this a top priority.

The next article by Eli Lilly and Company will be published on 26th July.

About the author:

Bill Reid is the senior director of Global Anti-Counterfeiting Operations (GACO) at Eli Lilly and Company. In his role, Bill leads the implementation of Lilly's global anti-counterfeiting strategy, including external focus on shaping the public policy environment. He participates in strategic outreach efforts, represents Lilly in meetings with key external stakeholders to raise awareness, and works with global Lilly affiliates to help coordinate efforts to fight counterfeit medicines. Bill joined Lilly in 2001 as manager of public affairs. In 2009, he became director of global corporate affairs operations. Prior to joining Lilly, Bill served in the Office of the Governor, Wisconsin, followed by a position as director of governmental affairs for the Metropolitan Milwaukee Association of Commerce in Wisconsin.

How can we overcome the global challenge of counterfeit medicines?