Product Protection
Illegitimate products are a threat to patient safety. As defined under the U.S. Drug Supply Chain Security Act, illegitimate product means a product for which credible evidence shows that the product:
is counterfeit, diverted, or stolen,
is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans,
is the subject of a fraudulent transaction, or
appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.
Illegitimate products may include those:
without active ingredients,
with incorrect quantities of active ingredients,
with wrong ingredients,
with correct quantities of active ingredients but with fake packaging,
with high levels of impurities and contaminants,
that are illegal copies of an original product
Illegitimate drugs have caused serious injury – and even death – around the globe. Dangerous, toxic ingredients have been found in counterfeit medications. People who take these drugs may ingest illicit or illegal drugs (e.g., fentanyl), arsenic, boric acid, brick dust, cement powder, chalk dust, floor polish, leaded road paint, nickel, shoe polish and talcum powder.
Unfortunately, the counterfeiting business is growing and continues to result in significant patient safety risk. Global criminal networks manufacture and distribute product counterfeits in all major therapeutic areas across the globe. This was evidenced in a March 2020 Organization for Economic Co-operation and Development (OECD) Report.
OECD estimates that the global trade in counterfeit and pirated goods generates more than $500 billion in illicit proceeds annually.
The nature of global counterfeiting has changed. Fraudulent products are traveling through small parcels directly to consumers and unscrupulous importers can avoid detection through a range of illegal activities. Trade in counterfeit pharmaceuticals has a serious impact on health, the economy and even the environment. The fakes are attractive to criminal organizations because they generate high profits with little risk.
Every year, according to the authors, some 72,000 to 169,000 children die from pneumonia and over 100,000 people die from malaria because they were treated with counterfeit medicines. Fake antimalarial drugs cause an additional 116,000 deaths.
The Internet (including illegal websites, marketplaces, and social media) continues to exacerbate the problem, creating an anonymous, global marketplace for the counterfeit drug trade. The following data provides evidence on the scope and nature of the global on-line pharmacy problem:
At any one time there are 35,000 – 45,000 active online pharmacies, most of which are operating illegally 1
According to the World Health Organization, the Internet is the world’s largest marketplace for counterfeit drugs as 50% of then prescription medicines sold online are by websites that hide their physical address and are considered substandard or falsified
A 2019 report by the National Association of Boards of Pharmacy (NABP)2 found:
approximately 95% of online pharmacies are operating illegally – out of compliance with state and federal laws or relevant pharmacy practice standards
Of those websites surveyed, approximately one-third offered controlled substances and other potentially lethal drugs. Ninety-nine percent of those websites did not require a valid prescription, and 94% advertised drugs that were not FDA-approved.
According to a study from the University of California San Diego, in a two-week period, there were over 45,000 tweets that promoted the purchase and non-medical use of prescription drugs through an actively marketed illegal online pharmacy.3
The Department of Homeland Security’s January 2020 report Combating Trafficking in Counterfeit and Pirated Goods underscores the importance of mitigating the risk posed by illegal online drug sellers and counterfeit prescription drugs.4 The report highlights that 97% of the United States’ seized drugs were manufactured in places such as China, India, and Singapore and further details significant concerns around patient health and safety related to counterfeit and otherwise dangerous products online. As the report notes, counterfeit drugs are found in all therapeutic categories, especially those in high demand and/or with the prospect of significant profits such as insulins, chemotherapy, and specialty medicines.
The COVID-19 pandemic has served as an opportunity for criminals to prey on consumer fear and profit from peddling misinformation. Countless warning letters by the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regarding pandemic-related frauds have been issued highlighting the reckless disregard that some have in foregoing safety for profit.5,6
The findings of a 2020 study by NABP7 only confirms the above:
Most active websites have clear ties to known criminal networks or their affiliates
Some newly created COVID-specific websites redirect users to established rogue network sites
Many domain names, both active and inactive, are clustered on “safe haven” registrars – a practice common among sophisticated internet pharmacy cybercriminals; and
The domain name registration information for almost all identified websites is anonymized, making it difficult for enforcement agencies to investigate these criminals.
Most online pharmacy websites do not require a valid prescription to sell a medicine; others issue an on-the-spot “prescription” after patients answer a simple questionnaire. This setting provides the perfect haven for counterfeiters to sell illegitimate medicines.
Any pharmacy that says it orders or ships prescription products from a foreign country (i.e., potentially diverted product) is operating illegally. These pharmacies are not operating under appropriate regulatory oversight, and therefore, no authority can guarantee the authenticity or safety of the medication they sell.
No single entity can stop counterfeiting. This is why Lilly has a well-established product protection program. As part of Lilly's strategy, we partner with global government regulatory and law enforcement agencies, other pharmaceutical companies and other parties who want to collaborate to ensure that patients receive only genuine medicines that are manufactured, distributed and sold by authorized/licensed wholesalers/distributors and pharmacies that care as much as we do about patient safety. Each of us plays an important role in the fight against counterfeit and diverted medicines.
Patient’s Role in Obtaining Safe Medicines
Buying through authorized or legal channels – for instance, obtaining a prescription from an in-person meeting with a physician and filling it at a reputable pharmacy – is the first step to help ensure patients obtain safe products.
Patients should check the packaging and look for anything "out of the ordinary" such as: changes in the shape and color of the medicine, foreign language, and/or signs of mishandling.
If patients become suspicious of their product for any reason (i.e., potentially counterfeit, diverted, adulterated, etc.), they should report it to their pharmacy, health care provider and/or the manufacturer. Patients should also save the medicine so that it can be tested. If a patient has additional questions or concerns about the safety of any of their Lilly medicines, please call 1-800-LillyRx (United States).
Lilly’s Role in Product Protection
Ensuring that patients can continue to benefit from safe medicines requires innovative approaches to expose and outwit counterfeiters. Lilly has made a sustained, long-term commitment to address this challenging problem. Our Product Protection Strategy includes:
Securing the integrity of Lilly products through the legitimate supply channels.
Deterring major counterfeiters of Lilly products through targeted investigations, Internet monitoring and legal actions.
Partnering with government, non-government organizations and trade associations to strengthen, enact and enforce anti-counterfeiting laws and raise awareness.
Patient safety is the driving force behind Lilly’s global product protection efforts. Our areas of focus include intellectual property protection (trademarks/patents/designs/copyrights), security investigations, internet monitoring, application of product protection features, supply chain security (including the use of serialization), forensic and product authentication analyses, expert witness testimony and partnership with support of external government and law enforcement agencies. Such efforts can lead to pursuing criminal prosecutions of counterfeiters around the world, as well as filing civil actions.
Deterring Counterfeiters Online and In the Field
As part of Lilly’s global product protection efforts, we engage and take leadership roles in various national, regional, and international industry association advocacy efforts related to patient safety. These groups are focused on promoting or supporting policies that support/address laws, regulations, organizations, industry groups and related initiatives that combat counterfeit, substandard, diverted, repackaged, misbranded, and adulterated drugs that may expose patients to serious health risks. Examples of these partnerships and engagements include:
Alliance for Safe Online Pharmacies (ASOP) – We are a founding member of ASOP, a global coalition of stakeholders with an interest in protecting patient safety and ensuring access to safe and legitimate online pharmacies. Lilly advocates to protect patients from the growing number of illegitimate and unsafe online drug sellers by supporting ASOP’s strategic efforts around the globe, including activities in research, education, internet commerce, company voluntary actions and advocacy.
Pharmaceutical Security Institute (PSI) – We are also a founding member of PSI, a not-for-profit group comprised of industry security professionals dedicated to protecting public health through the sharing of information concerning counterfeit, stolen, and diverted pharmaceutical products, and initiating enforcement actions through appropriate authorities. Additionally, we are an active member of the PSI Laboratory Technical Working Group, which provides advice and training to external law enforcement agencies and conducts technical benchmarking to ensure best practices and analytical technologies are utilized by our respective laboratories. Leveraging its PSI membership, Lilly contributed to efforts educating the public about the dangers of illicit medicines and supporting law enforcement actions through investigative, legal, and forensic analysis support.
National Association of Manufacturers (NAM) – We are a member of NAM’s Anti-Counterfeiting Task Force, a diverse stakeholder group formed in 2020 because of the unprecedented challenges related to the COVID-19 pandemic. We believe the global health crisis has provided new opportunities for counterfeiters to prey on the public’s anxiety and use of on-line resources to procure health-related goods, which has led to significant increases in fake and counterfeit products that harm consumers and undermine manufacturing in the U.S. The rise in e-commerce has created a pipeline to consumers that counterfeiters exploit while hiding their identities and evading oversight. NAM is focused on advancing innovative policy solutions to address this rising counterfeit problem. We are also a member of NAM’s Regulatory Policy Committee, a group formed in 2021 to review and assess counterfeit-related regulatory and legislative proposals.
Europe Falsified Medicines Directive (FMD) – We worked collaboratively with European stakeholders (pharmacists, wholesalers, and parallel distributors) on the successful implementation of the FMD to help prevent the entry of counterfeit medicines into legitimate supply chain channels in the European Union.
National Association of Boards of Pharmacy (NABP) – We support the dedicated domain name “dot pharmacy,” an initiative of the NABP, that helps patients find safe and legal online pharmacies. Lilly is the only pharmaceutical company that is a member of the Dot Pharmacy Executive Committee.
Health Canada and FDA-Forensic Chemistry Center (FCC) and FDA-OCI – In 2021 representatives from Lilly’s Pharmaceutical Investigations Team and Global Security presented to these parties on the emerging issues we saw with our COVID-19 EUA medications and how to identify counterfeits.
Beyond industry associations, we also advocated for the U.S. Drug Quality and Security Act, federal legislation which established a process for detection and subsequent reporting of illegitimate products, as well as a uniform standard for coding, serialization and tracking of products. We continue to provide input into FDA guidance documents to further clarify expectations/regulations for manufacturers and trading partners. In 2021 we reviewed and provided comments to the Drug Supply Chain Security Act Guidance documents through PhRMA. We also participate in the RX360 Supply Chain Security Industry Working Group, which interprets these documents and provides industry-wide feedback to FDA. Furthermore, Lilly cooperates with customs, police, and other law enforcement officials around the world to investigate and prosecute those who make and distribute counterfeit Lilly medicines without regard to the law or patient safety.
To stop illegitimate, falsified, and substandard medicines, we must combine the efforts of governments, patient organizations, medical networks, manufacturers (brand owners) and others. We will succeed in stopping this threat only if we act together – and act globally.
Government’s Role in Ensuring a Safe Supply of Medicine
Lilly partners with governments, non-government organizations and trade associations to strengthen, enact and enforce laws to address illegitimate, falsified, and substandard medicines, and to raise awareness of this important public health issue. Lilly encourages organizations and governmental regulatory agencies to speak up about any concerns with the safety of their medicines. Lilly also actively collaborates with non-governmental organizations such as the Alliance for Safe Online Pharmacies, International Federation of Pharmaceutical Manufacturers and Associations, Pharmaceutical Research and Manufacturers of America, European Federation of Pharmaceutical Industries and Associations, the Pharmaceutical Security Institute, and others to alert patients, health care providers and government officials about alarming global trends in illegitimate, falsified, and substandard medicine distribution. Increasing awareness is critical to combating the growing technological sophistication and capabilities of today’s criminals who threaten the safety of patients who rely on safe and efficacious medicines.
Serialization
Serialization is the unique identification of individual saleable packs (cartons or bottles) of medications to help ensure the legitimate supply chain. As each batch of finished product is packaged, a globally unique code is assigned and physically marked on the packaging in the form of a two-dimensional code known as a datamatrix. At the conclusion of the packaging order, the serial numbers are electronically linked to the product’s batch number in Lilly’s global SAP environment.
To track and trace the movement of individual packs, serial numbers can be recorded and electronically linked to outbound deliveries to customers. This is a regulatory requirement in some countries, where a documented chain of custody is further established by requiring wholesalers and pharmacies to record shipments and receipts of serialized products.
Serialization not only helps secure the legitimate supply chain but offers other potential benefits. These include automated checking of expiry dates, a way to record the batch number of specific medicines in a patient’s electronic medical records, and other tools that offer value to patients and health care providers.
Lilly had made a considerable investment in its packaging operations, distribution centers, and IT infrastructure to support this initiative, which includes new technology deployments on more than 30 packaging lines around the world.
Global Advocacy, Partnerships and Leadership
Lilly advocates for the establishment of a uniform standard for coding, serializing, and tracking of pharmaceutical products globally. These efforts will help ensure that doctors, pharmacists, and patients can be confident in the medicines they prescribe, dispense, and receive. We believe it is important for legislative efforts and policies around serialization and product traceability to follow global uniform standards. Non-standardized requirements not only increase the implementation costs for manufacturers and trading partners, but also open the door to counterfeit and illegally diverted products entering the legitimate supply chain, increasing the potential for patient harm. We actively partner with industry groups such as The Alliance for Global Pharmaceutical Serialization (RxGPS), global standards bodies such as Global Standards 1 (GS1), country-level groups and think tanks, and regulators in many markets around the world to advocate for global standards to create a harmonized approach to product traceability initiatives.
Our efforts include education and increased awareness of global standards for serialization, and the importance of harmonizing product traceability. Additionally, we speak at various conferences organized by regulatory bodies, industry groups and global standard bodies in many countries to share our leading implementation of serialization solutions, and our experiences and best practices. Our commitment to harmonized and effective solutions on a global basis has been recognized by various constituencies. Key highlights include:
Asia Pacific Economic Cooperation (APEC) – We participated in the APEC Regulatory Harmonization Steering Committee and were a key contributor to the Supply Chain Security Toolkit. Lilly also participated in the APEC Center of Excellence training programs and provided training to more than 200 regulators from APEC member countries in sessions conducted in the Philippines and Malaysia. Lilly’s training focused on global standards on serialization and product traceability, and the importance of harmonization of regulatory requirements to improve supply chain security.
International Coalition of Medical Regulatory Authorities (ICMRA) – Lilly was selected for a special workgroup by ICMRA to develop recommendations on Common Technical Denominators for Track and Trace Systems to allow for interoperability. The workgroup was coordinated by European Medicines Agency with participants from many regulatory agencies and industry groups. The effort, which completed in June 2020, complements the Track and Trace policy created by the World Health Organization, and focuses on the technical features that would be required to create interoperable systems.
Partnership for DSCSA Governance (PDG) – In 2020, Lilly was invited by industry peers to join PDG, a newly formed independent nonprofit governance body focused on defining a governance structure and a foundational blueprint for full traceability as defined in the U.S. Drug Supply Chain Security Act (DSCSA). The DSCSA will go into effect in 2023. Lilly currently acts as a co-chair of the Tracing workgroup under PDG, and is also serving on Board of Directors for a two-year term starting in January 2021. We believe our involvement with PDG is vital to helping the industry achieve an effective interoperable traceability system.
COVID-19 Vaccines Global Access Facility (COVAX) – In November 2020, Lilly was selected to a COVAX Traceability Expert Advisory Board organized by a Global Steering Committee under the World Bank. This important initiative will shape an interoperable traceability framework that could be adopted globally to aid in the secure distribution and verification of COVAX products and protect patients from an upsurge of falsified products in this category.
National Medical Products Administration (NMPA) – Our advocacy efforts with NMPA, a regulatory body in China, have created positive and tangible outcomes to enhance patient safety. In China, we helped influence a shift from a non-standard product traceability requirement to a policy that will accommodate global standards and achieve a tangible outcome. NMPA has published new specifications and guidance documents that now includes GS1, and our affiliate in China will launch a pilot in 2022 to demonstrate the benefits of adopting global standards and measure the rate of acceptance in the supply chain in the Chinese market.
Other Advocacy – In Malaysia and India, Lilly continues to invest in advocacy efforts to educate and inform regulatory authorities on the importance of adhering to global standards as they evaluate upcoming legislation.
