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 strategy and operational 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 to shape relevant regulatory requirements
To focus our work in this area, our Anti-Counterfeiting Steering Committee oversees our global anti-counterfeiting strategy to ensure that our goals are reached.
The cross-functional team is led by senior leaders from Global Human Health, Manufacturing 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 threats from 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 a proactive Internet monitoring program designed to identify threats to our patients from illegitimate online drug sellers and to mitigate 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.
Protecting authentic Merck product is an integral part of Merck’s anti-counterfeit mission. Each new Merck drug is assessed using a standard methodology for risk prior to regulatory approval. Our key focus in this process is the patient-safety threat should a counterfeit or illegally diverted Merck product be introduced into the supply chain. The risk level assigned to a new Merck product is used to determine which product security features will be included on the product and packaging prior to the product’s market release.
Serialization—or putting a unique identification number on each package that goes to market—is one of the tools Merck is investing in to secure its supply chain and prevent counterfeiting. A serial number on individual packages makes it possible for anyone along the supply chain—from a distributor to a pharmacist or a patient—to scan the code and authenticate it as genuine Merck product. Serial numbers may take the form of a 2D barcode or scratch-off labels. A Radio Frequency Identification (RFID) tag is another way, but is currently not part of the company’s serialization plans.
Serialization is an important part of the company’s efforts to combat the threat of counterfeit drugs, as it adds a robust layer to the company’s product-security platform. It provides the ability to uniquely identify and rapidly authenticate individual packs which, in turn, helps to detect counterfeit medicines.
Although still in its early stages, serialization is expected to be mandated in many markets by 2015, including the United States, Europe, Turkey, China, Brazil, Argentina and South Korea. As these requirements evolve, the challenge for Merck and other pharmaceutical companies will be how best to address them, given that each market may have its own (and, perhaps, conflicting) requirements. As a result, 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 global pharmaceutical-product supply chain.
A key part of our ability to identify suspected counterfeits is our advanced forensic laboratory that analyzes suspected counterfeit products and, if possible, identifies where they came from. 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.
We support efforts to educate the public about the risks of counterfeit drugs and how to protect against them, as well as efforts to develop industry collaborations to support a unified response to the threat of counterfeit medicines. Our partnerships with the Pharmaceutical Security Institute (PSI), the Association of Safe Online Pharmacies (ASOP), the International Anti-Counterfeiting Coalition (IACC), the Partnership for Safe Medicines and the Rx360 Consortium are a few examples of industry collaborations in which we participate. These collaborative efforts support the production of reports, whitepapers and data-circulation initiatives, as well as promote intelligence sharing necessary to combat threats from counterfeit medicines.
Merck supports increased enforcement of existing anti-counterfeiting laws and the adoption of new public policies to strengthen existing laws and enforcement programs, including increased criminal and civil penalties for counterfeiters.
We advocate for such change in a number of ways:
- As a member of the Alliance for Safe Online Pharmacies, Merck supports the efforts of the White House’s Intellectual Property Enforcement Coordinator to combat online pharmaceutical crime. We support initiatives to raise awareness of the dangers of purchasing from rogue sites and of the options to access legitimate online pharmacies.
- As a member of the Pharmaceutical Distribution Security Alliance (PDSA), Merck supports the passage of U.S. legislation that would create a national system and uniform standards to track product across the pharmaceutical supply chain. PDSA includes over 20 partners in the domestic pharmaceutical distribution supply chain working to achieve a national solution towards product tracking
- Merck supports the Anti-Counterfeiting Trade Agreement, which would increase protection against a wide range of intellectual property infringements
- In 1997, Merck and other pharmaceutical companies created the Pharmaceutical Security Institute (PSI) to develop global security strategies focused on both prevention and enforcement to ensure public safety and product integrity. Merck continues to be an active participant in this organization, and is pushing for increased levels of intelligence sharing among the members.
- Merck supports the SAFE DOSES Act legislation which was signed into law in the U.S. in October, 2012. The bipartisan legislation modernizes the U.S. criminal code to increase criminal penalties for medical product cargo theft and provides law enforcement tools in order to deter this criminal behavior and take down the organizations that are perpetrating it.
- Continue in the execution of a proactive, worldwide corporate anti-counterfeit strategy focused on securing the supply chain, detecting and responding to counterfeit events, and raising awareness of the risks of counterfeit pharmaceutical products
- Take proactive measures to identify, assess and mitigate threats to our patients associated with counterfeit and other fraudulent products
- Take actions to raise public awareness of the risks posed by counterfeits and advocate for increased enforcement to shape relevant regulatory requirements
- Train key stakeholders and business partners in the identification of suspicious activities and/or suspected counterfeit products
- Continue to partner with industry groups to provide advocacy on high-priority anti-counterfeiting policy initiatives, and explore new partnership opportunities with patients and other external stakeholders
- Develop metrics to gauge the impact of specific actions to ensure that resources remain focused on the areas that can have greatest benefit
- Continue advocacy efforts to support the development of a standardized system to identify and code medical products
Last Updated July 29, 2013