Merck maintains a comprehensive worldwide anti-counterfeiting program that has three goals: (1) secure the supply chains, (2) rapidly deter, detect and respond to counterfeit activity, and (3) raise public and stakeholder awareness of the risks posed by counterfeits, and deliver effective advocacy to increase enforcement and shape key regulatory requirements.

Management

In furtherance of the work that Merck has done in combatting counterfeits and recognizing the growing nature of the counterfeit problem, in 2008 Merck's Executive Committee established an Anti-Counterfeiting Steering Committee to oversee our global anti-counterfeiting strategy and 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 on 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. The following are specific examples of how we maintain a secure supply chain.

Authorized Distributors

In the United States, we require customers to purchase our products directly from Merck or a Merck authorized distributor. In addition, we publish the names of authorized distributors on Merck's website and we audit our distributors to ensure compliance with Merck policies and procedures.

Detect and Stop Counterfeits

In the European Union, Merck works with law enforcement agencies to detect and respond to counterfeit products, including importation or trans-shipment of counterfeit pharmaceuticals through the European Union. Working with Customs authorities, Merck has helped identify high-risk ports, borders and postal depots and drafted a framework of action for use by Customs authorities to detect and respond to counterfeit activities.

Training

In a number of developing countries, Merck has provided training to Customs officials, in conjunction with the Pharmaceutical Security Institute, on trademarks and industry import and export practices.

Identifying Counterfeits

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 Merck's own pilot programs, we have gained insights into the use of new technologies — such as radio-frequency identification (RFID) and two-dimensional (2D) data matrix bar coding – that we believe are effective means of deterring counterfeit activity. In 2009, we supported the 2D bar code technology pilot project sponsored by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

A key part of Merck's 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.

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.

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.

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¹ Counterfeits should be distinguished from diverted products. Diverted products are authentic products that have been intended for one market and diverted by price arbitragers to other (higher-priced) markets.