We invest in an industry-leading, rigorous, intelligence-led product integrity strategy that is solely focused on protecting patients from the harm associated with counterfeit, diverted and other illicit medicines.
- Maintained ISO-accreditation for a global Forensic Services program that significantly enhances our capacity and capability for the robust forensic analysis of suspect counterfeit, diverted and illicit medicines
- Collaborated with industry peers and proactively shared anti-counterfeiting intelligence with other pharmaceutical companies as a way of protecting the public and raising awareness
- Trained approximately 4,750 law enforcement and customs officials worldwide
- Maintained internal company training programs focused on Supply Chain Security and Reporting of Counterfeit, Diversion and Tampering Events. More than 55,000 of our global employees have completed the Product Integrity training
We are committed to cooperating with relevant government agencies, other pharmaceutical manufacturers, wholesalers, distributors, health professionals, consumer groups and key related organizations in fighting the problem of counterfeit pharmaceutical products and in educating the public about the risks of counterfeit products and how to protect against them
Producing, distributing, marketing and/or selling counterfeit pharmaceutical products are serious criminal offenses, and the threat of these actions has become a real and significant risk to global public health. Counterfeit pharmaceuticals can include the wrong doses of an active ingredient, no active ingredient or, in some cases, harmful or poisonous ingredients.
We define a counterfeit medicine as a product that exhibits an unauthorized use of trademark, trade name, other identifying mark, imprint or device or any likeness thereof, to adulterate, falsely purport or falsely represent a product’s or material’s identity, source or history. As counterfeiters have become more sophisticated, counterfeit products have become so similar in appearance to authentic products that, without laboratory testing, it is often difficult to tell the authentic from the counterfeit medicines.
Product integrity strategy
Our company’s Global Security Group oversees the global Product Integrity strategy and leads its execution. The strategy seeks to protect our patients and the Company’s reputation from the negative impacts of counterfeit and illicit medicines. The overall strategy is supported by a cross-functional team comprised of senior leaders from Human Health, Quality, Manufacturing, Strategy, Global Safety, Legal, Public Policy, Supply Chain Management and Global Security.
Ensuring product efficacy and patient safety and protecting our reputation are paramount. This is why we maintain a comprehensive, worldwide anti-counterfeiting strategy and operational program.
Product and supply chain security
Our Product and Supply Chain Security strategy enables product protection through using sophisticated product security features and robust supply chain security measures.
The use of product security features is intended to make it more difficult to counterfeit our products, enable rapid authentication of suspicious products, identify instances of diversion, prevent and/or detect instances of tampering and support enforcement actions of confirmed illicit events.
Our supply chain security strategy is designed to enable the efficient and secure end-to-end movement of our products and materials. A focus on managing risk, leveraging best and recommended security standards, and analyzing relevant threat information, strengthens our ability to identify potential risks in the supply chain and prevent incidents that threaten product integrity.
Programs and initiatives
Our initiatives to protect the supply chain are aligned with our primary goal of providing safety and security of our products to ultimately promote patient safety. Proactive security risk management, documented policies and procedures, and engagement of internal and external stakeholders to promote security awareness are critical components to providing embedded protections ranging from raw materials to final product disposition. Current and ongoing efforts to further minimize exposure to risk involve the assessment and use of technology to improve domain awareness by enabling and improving real-time supply chain visibility. To that end, we routinely explore and evaluate innovative technologies and closely monitor industry security trends to select the right solutions.
Investigations and enforcement
The investigations and enforcement pillar of our strategy is focused on deterring, detecting and responding to suspected and/or confirmed counterfeit activity in ways that mitigate risks to patient safety.
Advocacy, engagement and awareness
Our efforts in the area of advocacy, engagement and awareness involve raising public and stakeholder awareness of the risks posed by counterfeits, and advocate for increased enforcement to shape relevant regulatory requirements. In 2019, we continued our commitment to increasing our focus in this area and have strategically enhanced our ability to make a long-term impact on patient safety through various education campaigns.
Product integrity operations
In keeping with our long-standing commitment to providing high-quality, safe and effective medicines and vaccines to patients who need them, we have executed a comprehensive Product Integrity Operations Program that delivers on our three primary strategic deliverables.
Product and supply chain security
We carefully manage our supply chain through strict policies and procedures designed to keep the legitimate drug distribution system safe and secure. In the U.S., for example, we require customers to purchase our products directly from our company or from company-authorized distributors and publish the names of company-authorized distributors on our corporate website.
Our established programs to conduct risk-based audits of our distributors and supply chain service providers are part of our commitment to ensure compliance with our policies, standards, and procedures. We complete proactive security risk assessments at facilities, along key supply routes and at various touch points throughout the supply chain to identify areas at high risk of theft, illicit activity, and other threats to the supply network. We have global resources dedicated to supply chain security who proactively monitor and manage our security programs and investigate incidents when they occur.
As a certified Importer under the Customs Trade Partnership Against Terrorism (CTPAT) Program, we are validated by U.S. Customs and Border Protection as a Tier 3 Member. Tier 3 Member companies are recognized as implementing best practices in supply chain security. Our consistent ability to meet the highest customs trade security standards, adds another layer to the security of our products and materials inbound to the United States.
Product-security features deployed on our products are a key measure taken to protect patients who use our products. Our pharmaceutical products are protected with best-in-class product-security features, uniquely applied on the basis of a global, risk-based assessment methodology. Our key focus in this assessment is the patient-safety threat should a counterfeit or illegally diverted product of our company be introduced into the supply chain.
Each of our new medicines and vaccines is assessed for risk using this methodology prior to regulatory approval. The risk level assigned to a new product is used to determine which product-security features will be included on the product and packaging prior to the product’s market release. A complementary threat assessment is also performed on marketed products for which a credible counterfeit threat has been identified and for which updates to packaging security features may be required. These product-security features, along with our advanced forensic detection capabilities, enable us to accurately authenticate all finished products in our portfolio.
Serialization—adding a 2D barcode with a unique identification number on each package that goes to market—is one of the tools we are investing in to secure our supply chain and prevent counterfeiting. A serial number on individual packages will enable anyone along the supply chain—from a distributor to a pharmacist to a patient—to scan the code and authenticate it as a genuine product of our company. Serialization adds a robust layer to the company’s product-security platform. When associated with a regulatory mandate that specifies effective implementation and reporting to a national database, this method of product tracking can become a more meaningful product-security tool.
Many jurisdictions around the world are requiring serialization on pharmaceutical packages or are considering such mandates. Serialization is required today in China, Turkey, Argentina, South Korea, Nigeria, India, Saudi Arabia, the Middle East, the U.S. and Europe and will soon be required in Indonesia, Russia, Brazil, South Africa and Pakistan. Each country’s regulations are different, making it very challenging for our packaging sites and distribution networks to meet these diverse and intricate requirements with additional complexity as reporting requirements are phased in.
We launched the Global Product Serialization Initiative in 2012, with the goal of meeting these varying requirements in a robust, standardized and effective way based upon GS-1 standards. We are working with industry associations and regulatory authorities to help shape these new requirements, and advocate for simple, standardized and common-sense regulations that can be effective at protecting against counterfeit medicines.
Investigation and enforcement
Our company’s anti-counterfeiting operations are driven by intelligence-led decisions to identify, prioritize and aggressively pursue criminal enterprises responsible for the manufacture and distribution of counterfeit and other illicit medications, and to identify and enable meaningful enforcement actions against those offenders.
Suspected counterfeit products are reported to our company by patients, providers and from internal and other health care stakeholders. We respond to every notification of suspected counterfeit or illicit medicine, in alignment with local regulatory requirements and in support of our global patient-safety mission. We also proactively conduct threat assessments and other risk-based operations to identify offenses that threaten the health and safety of patients. These proactive activities are intended to identify, assess and develop effective enforcement actions for high-value targets engaged in illegal activities involving our products that have the potential for negative patient-safety impact.
In 2019, the biggest risks to patient safety involved counterfeit versions of our company’s products sold in multiple countries, some involving the legitimate supply chain. Several incidents of both inter-market and intra-market diversion of our pharmaceutical products, and multiple cargo thefts and product thefts from MSD or third-party facilities, were also a concern.
To support and enable enforcement actions, we partner with law enforcement agencies to detect and respond to threats due to counterfeit products. This includes working with U.S. authorities on the importation of counterfeit pharmaceuticals and with European authorities on the importation and/or transshipment of counterfeit pharmaceuticals throughout the European Union.
Working with customs authorities, we have helped identify high-risk ports, borders and postal depots, and have provided a framework of action for use by customs authorities to detect and respond to counterfeit activities. This training enables customs agents to identify suspicious pharmaceutical shipments and take appropriate actions to detain suspicious shipments and/or have suspect products analyzed.
We have launched a global Forensic Services program that significantly enhances our capacity and capability for the robust forensic analysis of suspect counterfeit, diverted and illicit medicines. The Forensic Services program focuses on both the identification and characterization of illicit medicines, and will further support our efforts in the detection, characterization and enforcement of criminal enterprises engaged in the manufacture and distribution of illicit medicines.
The global Forensics Services capacity is supported by three laboratories. Strategically placed in the United States, the EU and Asia-Pacific regions, the forensic services laboratories follow international standards and best practices for forensic testing, including the World Health Organization (WHO) Guidance on Testing of Suspect Falsified Medicines and all three forensic laboratories hold ISO 17025 accreditation.
The threat to patient safety from counterfeit medicines is not specific to our company. Consequently, we work with industry peers and proactively share anti-counterfeiting intelligence with other pharmaceutical companies as a way of protecting the public and raising awareness.
Advocacy, engagement and awareness
We are committed to cooperating with relevant government agencies, other pharmaceutical manufacturers, wholesalers, distributors, health professionals, consumer groups and key related organizations in fighting the problem of counterfeit pharmaceutical products and in educating the public about the risks of counterfeit products and how to protect against them.
This effort includes a multipronged approach to communicating the threat that counterfeit medicines pose and to mitigating this threat as effectively as possible, while recognizing that it cannot be entirely eliminated.
Collaboration and information-sharing in order to raise public and stakeholder awareness of the issue and risks are a crucial focus of our product integrity program. Through active partnerships with other pharmaceutical companies, and with organizations focused on security, patient safety and public health, we provide effective advocacy on high-priority anti-counterfeiting policy initiatives.
Highlights of our 2019 activities include:
- Maintained compliance with U.S. Customs C-TPAT Program, to include readiness for pending 2020 revalidation, which in part helps to facilitate global trade of our company’s products
- Received ISO 17025 Accreditation for Singapore Forensic Services Lab. Each forensic lab is now ISO accredited, and remain the first forensic or counterfeit detection labs in the pharmaceutical industry to achieve this significant distinction.
- Assisted in the development and distribution of the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) “Roadmap to Promote Global Medical Product Quality and Supply Chain Security” with direct engagement on the 2019 APEC Harmonization Center Global Supply Chain Integrity Training and participation in the APEC Medical Product Security Roadmap Steering Committee
- Actively participated in the U.S. Pharmacopeia-Council of Experts Review of Surveillance and Screening Technologies for the Quality Assurance of Medicines Expert Panel
- Supported an educational program focused on the link between importation and counterfeit medicine for U.S. federal policymakers
- Provided testimony to the U.S. Congressional Trademark Caucus and Homeland Security Committees and to the Senate Finance Committee in support of Senate efforts around counterfeit medicines in response to the April 2019 Presidential Memo on the impact of counterfeit goods
- Provided testimony to U.S. Customs and Border Protection in order to advocate for increased information sharing as part of the 21st Century Customs Framework
- Trained approximately 4,750 law enforcement and customs officials worldwide
- Launched internal company training programs focused on Supply Chain Security and Reporting of Counterfeit, Diversion and Tampering Events. More than 55,000 of our global employees have completed the Product Integrity training.
We support the 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 board members of the ASOP-EU we support initiatives and advocacy in the U.S., Europe and Asia to raise awareness about the dangers of illegal online drug sellers and to steer patients to safe sources of medicines
- As a member of the Global Innovation Policy Center, we support the White House’s Intellectual Property Enforcement Coordinator, as well as policy matters related to anti-counterfeiting and enforcement in Congress and with federal agencies
- As a member of the Pharmaceutical Distribution Security Alliance (PDSA), we supported the passage of the Drug Quality and Security Act (DQSA), U.S. legislation that creates a national system and uniform standards for tracking products across the pharmaceutical supply chain. PDSA includes over 20 partners in the domestic pharmaceutical distribution supply chain working to achieve a national solution toward product tracking.
- We support the Anti-Counterfeiting Trade Agreement, which increases protection against a wide range of intellectual property infringements
- Together with other pharmaceutical companies we created the Pharmaceutical Security Institute (PSI) to develop global security strategies focused on both prevention and enforcement in order to ensure public safety and product integrity. We continue to be an active participant in this organization and are advocating for increased levels of intelligence-sharing among the members.
- Our company supported the SAFE DOSES Act, 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 to deter this criminal behavior and take down the organizations that are perpetrating it.
- Our company supported the Trade Facilitation and Enforcement Act, which was signed into law in February 2016. Known as the Customs Reauthorization Act, this bill provides additional resources to Customs and Border Protection (CBP) and formalizes the capacity for public-private partnership to strengthen intellectual property enforcement.
In keeping with our mission to protect global public health, we actively collaborate with international law enforcement agencies that prioritize the investigation, prosecution and disruption of counterfeit medicines and associated criminal enterprises.
We further 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.
- Alliance for Safe Online Pharmacies—Global
- International Anti-Counterfeiting Coalition
- International Chamber of Commerce’s Business Action to Stop Counterfeiting and Piracy
- International Federation of Pharmaceutical Manufacturers (IFPMA) Fight the Fakes Partnership
- International Trademark Association Anti-Counterfeit Committee
- Partnership for Safe Medicines
- Pharmaceutical Cargo Security Coalition
- Pharmaceutical Security Institute
- Quality Brands Protection Committee of China Association of Enterprises with Foreign Investment
- Rx360 Consortium
- The Center for Anti-Counterfeiting and Product Protection at Michigan State University
- U.S. Chamber of Commerce’s Global Innovation Policy Center
These collaborative efforts support the production of reports, whitepapers and data-circulation initiatives, as well as promote the intelligence-sharing necessary to combat threats from counterfeit medicines.
The following table details the number of new suspected and substantiated counterfeit events in 2019, as well as the number of events introduced in previous years and the subsequent outcome for these events.
The category for any event can change as the event develops and further information is collected, typically as a result of forensic testing or other review of associated samples: the data below reflects the current status of each event as of May 2020.
|Investigations of suspected counterfeit products||76||134||137||274||577|
|Substantiated cases of counterfeit products||73||102||76||226||198|
|1Prior-year data have been adjusted to reflect the current status of each event as of April, 2020.|
Throughout 2019, Global Security addressed 1,870 product integrity events in 86 countries, involving counterfeit, diversion, supply chain security, tampering, financial integrity, and brand security (non-MSD, unapproved generic product), which led to 199 arrests and the seizure of more than 22,000 units of counterfeit or illicit Company product. There were 88 prosecutions resulting from product integrity investigations in 2019.
Another key aspect of investigations is the forensic analysis of questioned products. This forensic testing is aimed at concluding whether a questioned product is counterfeit, diverted, or otherwise illicit. Counterfeit products are characterized in order to gain further intelligence and understanding of the counterfeiters and the threats to public health. Our company also has forensic detection devices in the field to analyze and detect counterfeits in 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 would increase their forensic testing capabilities. Lab findings are shared with regulatory and/or law enforcement agencies and may be used to support subsequent enforcement actions and legal proceedings. There were approximately 708 unique questioned samples received as evidence and prepared for forensic testing in relation to active events in 2019.
In 2019, there were 88 prosecutions resulting from product integrity investigations; 79 occurred in the United States and LATAM regions, four in EMEA, and five in APAC.
As part of our proactive awareness program, throughout 2019, Global Security trained approximately 4,750 law enforcement personnel in more than 50 countries regarding the patient safety danger related to counterfeit and diverted medication.
Global Security also launched an internal training program on the Counterfeit, Diversion and Tampering (CDT) reporting process in late 2017. To date, more than 55,000 employees and contractors have completed this training globally.
Approximately 30 percent of these events have been proactively investigated by Global Security to identify new or emerging product-integrity threats, or to further characterize and mitigate known product-integrity threats.