Anti-Counterfeiting Roles

Patient’s Role in Anti-Counterfeiting

Buying through established channels – for instance, obtaining a prescription from an in-person meeting with a physician and filling it at a reputable pharmacy – is the first step to help ensure patients obtain safe products.

Patients should check the packaging and look for any changes in the shape and color of the medicine.

If patients suspect a counterfeit or tampered product, they should report it to their pharmacy, health care provider and the manufacturer. Patients should also save the medicine so that it can be tested. If you have additional questions or concerns about the safety of any of your Lilly medicines, please call 1-800-LillyRx.

Lilly’s Role in Anti-Counterfeiting

Ensuring that patients can continue to benefit from safe medicines requires innovative approaches to expose and outwit counterfeiters. Lilly has made a sustained, long-term commitment to address this challenging problem. Our efforts include:

  • Securing the integrity of Lilly products through the legitimate supply channels.
  • Deterring major counterfeiters of Lilly products through targeted investigations, Internet monitoring and legal actions.
  • Partnering with government, non-government organizations and trade associations to strengthen, enact and enforce anti-counterfeiting laws and raise awareness.

Patient safety is the driving force behind Lilly’s global anti-counterfeiting efforts. Lilly is deeply engaged in efforts to combat counterfeiters. We are a founder and board member of the Alliance for Safe Online Pharmacies (ASOP), a broad coalition of stakeholders with an interest in protecting patient safety and ensuring patients have access to safe and legitimate online pharmacies. In Europe, we are an active partner in the European Alliance for Access to Safe Medicines (EAASM) and ASOP EU to further patient education about the dangers of counterfeit medicine.

Lilly is working collaboratively with European stakeholders (pharmacists, wholesalers and parallel distributors) on the successful implementation of the Falsified Medicines Directive to help ensure counterfeit medicines cannot be dispensed to patients through legitimate supply chain channels in the European Union.

In the U.S., Lilly has been involved in advocating for federal legislation that will help to protect patients from counterfeit drugs. One of Lilly’s major legislative efforts has been to advocate for the establishment of a uniform federal standard for coding, serializing and tracking pharmaceutical products.

Lilly also supports the Online Pharmacy Safety Act, which would update U.S. law to protect patients from the growing number of illegitimate and unsafe online drug sellers. Lilly also supports the National Association of Boards of Pharmacy (NABP) as it plans to launch the “.pharmacy” top-level domain name as a home for safe and legal online pharmacies.

In addition, Lilly supports law enforcement in the criminal prosecution of counterfeiters around the world, through gathering evidence, testing samples, testifying in court, and filing civil actions. Lilly also participates in the World Customs Organization’s Interface Public-Members (IPM) database of products, used by customs agents to identify legitimate versus counterfeit products that cross national borders.

To stop counterfeit medicines, we must combine the efforts of governments, patient organizations, medical networks, manufacturers (brand owners) and others. We will succeed in stopping this threat only if we act together – and act globally.

Government’s Role on Anti-Counterfeiting

Lilly is partnering with governments, non-government organizations and trade associations to strengthen, enact and enforce anti-counterfeiting laws, and to raise awareness of this important public health issue. Lilly encourages organizations and governmental regulatory agencies to speak up about the counterfeit drug threats they encounter. Lilly also is joining forces with non-governmental organizations such as the World Health Organization, World Health Professionals Association, Project Hope, World Customs Organization, International Federation of Pharmaceutical Manufacturers Association, Pharmaceutical Research Manufacturers Association, European Federation of Pharmaceutical Industries and others to alert patients, health care providers and government officials about alarming global trends in counterfeit medicine distribution. Increasing awareness is critical to combating the growing technological sophistication and capabilities of today’s counterfeiters.

In March 2013, INTERPOL and 29 of the world’s leading pharmaceutical companies joined forces to launch a landmark agreement to combat counterfeit medicines. The three-year initiative is funded by an investment of nearly $5.9 million combined from the companies involved, and is designed to forge strong partnerships between law enforcement and industry to enhance the global response to pharmaceutical crime.

The INTERPOL program targets multiple issues, including combating branded and generic drug counterfeiting as well as the identification and dismantling of organized crime networks linked to this illegal activity. Lilly was a leader in the formation of this important public-private partnership.