Counterfeit pharmaceutical products are a growing global problem and a serious threat to public health.
They can include wrong doses of active ingredient, no active ingredient or, in some cases, harmful or poisonous ingredients.
We define a counterfeit medicine as a product that contains an unauthorized use of trademark, trade name, other identifying mark, imprint, or device, or any likeness thereof, to adulterate or falsely represent that the product was manufactured or distributed by the identified manufacturer or distributor. As counterfeiters have become more sophisticated, counterfeit products have become so similar in appearance to authentic products that, without laboratory testing, it is difficult to tell the authentic from the counterfeit medicines.
For Merck, maintaining patient safety and protecting our reputation are paramount. We maintain a comprehensive worldwide anti-counterfeiting program that has three goals:
- Secure the supply chains
- Deter, rapidly detect and respond to counterfeit activity
- Raise public and stakeholder awareness of the risks posed by counterfeits, and advocate, for increased enforcement and to shape relevant regulatory requirements
Management
To focus our work in this area, our Anti-Counterfeiting Steering Committee oversees our global anti-counterfeiting strategy to ensure that our anti-counterfeiting goals are reached.
The cross-functional team is led by senior leaders from Global Human Health, Merck Manufacturing Division, and Global Security. These areas are responsible for the worldwide marketing and sale of our products, investigating suspected counterfeit events, testing suspected counterfeit products and preparing investigative reports.
Other functional areas involved in our anti-counterfeiting efforts include: Packaging Technology, which incorporates security features into our products; Legal, which works with regulatory and law enforcement authorities to prosecute offenders; and Global Public Policy, which coordinates our advocacy activities to support stronger anti-counterfeiting laws.
Maintaining a Secure Supply Chain
Merck has in place strict policies and procedures designed to keep our drug distribution system safe and secure, and to deter counterfeit products from entering the supply chain.
In the United States, for example, we require customers to purchase our products directly from Merck or Merck-authorized distributors. In addition, we publish the names of authorized distributors on Merck’s website and we audit a majority of our distributors to ensure compliance with Merck policies and procedures.
Merck also partners with law enforcement agencies to detect and respond to counterfeit products, including U.S. authorities on importing counterfeit pharmaceuticals and EU authorities on importing or trans-shipping counterfeit pharmaceuticals through the European Union. Working with customs authorities, we have helped identify high-risk ports, borders and postal depots and have drafted a framework of action for use by customs authorities to detect and respond to counterfeit activities.
In a number of developing countries, moreover, we have provided training to customs officials, in conjunction with the Pharmaceutical Security Institute, on trademarks and industry import and export practices.
In the United States, the greatest identified threat to patients receiving counterfeit medicines is through the distribution of pharmaceutical products via illegitimate online drug sellers. In response to this threat, Merck maintains an proactive internet monitoring program designed to identify threats to our patients from illegitimate online drug sellers, and mitigation of those threats through civil and criminal enforcement actions.
Merck promptly reports all confirmed counterfeit activities to regulatory and/or law enforcement agencies. We work with regulators and distributors to remove counterfeit products from the market, and with law enforcement officials to trace counterfeit products back to an original source of supply.
We continue to work with industry associations and regulatory agencies to develop a standardized system that will uniquely identify or code products to create a more secure pharmaceutical product supply chain. Through our own pilot programs, we have gained insights into the use of innovative technologies—such as radio-frequency identification (RFID) and two-dimensional (2D) data-matrix bar coding—that we believe are effective ways to secure the supply chain and identify counterfeits. In 2009, we supported the 2D bar code technology pilot project sponsored by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Forensic Laboratory
A key part of our ability to identify suspected counterfeits is our advanced forensic laboratory that analyzes suspected counterfeit products and, if possible, identifies an origin of counterfeit material. Lab findings are shared with regulatory and/or law enforcement agencies, and may be used to support subsequent enforcement actions and legal proceedings. Merck also has forensic detection devices in the field to analyze and detect counterfeits in different regions around the world.
As counterfeiters improve their skills and techniques, our forensic scientists have pioneered the use of several analytical tools for pharmaceutical-counterfeits detection, and continue to explore new analytical tools that increase their forensic testing capabilities.
Public Awareness
Finally, we support efforts to educate the public about the risks of counterfeit drugs and how to protect against them. We work with Partnership for Safe Medicines and supported publication of a revised report on counterfeits issued by the American Council on Science and Health in February 2009 entitled "Counterfeit Drugs: Coming to a Pharmacy Near You," which describes the growing threat of counterfeit medicines to public health.
