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.

Merck defines 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, falsely purport, or 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 and are the principal goals underlying our corporate anti-counterfeiting strategy. 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 advocate for increasing enforcement and shaping relevant regulatory requirements.

Management

To focus our work in this area, Merck's Executive Committee established an Anti-Counterfeiting Steering Committee, in 2009, 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 in 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 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.

Detect and Stop Counterfeits

Merck 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, Merck has helped identify high-risk ports, borders and postal depots and has 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.