Falsified medicines deliberately and deceitfully attempt to pass themselves off as genuine approved medicines. They represent a serious threat to patients around the globe. It is a complex global health challenge, which requires an integrated, multi-stakeholder approach – led by the World Health Organization (WHO).
Strong coordination is necessary to ensure that all aspects of this global challenge are adequately addressed. Tackling falsified medicines requires strengthening legislative frameworks and regulatory systems, collecting data, implementing effective technologies, and raising awareness. An effective response must engage a variety of stakeholders, including patients, health professionals, public and private organizations, pharmaceutical manufacturers, distributers, wholesalers, retailers, and national regulatory and enforcement agencies.
Public awareness is vital to inform patients and the global population about the risk posed by falsified medicines.Go to this section
Technologies are essential tools for securing the legitimate supply chain and ensuring the authenticity of medicines.Go to this section
Innovative studies, research, and analysis provide the foundation for a coordinated response to the growing threat of falsified medicines.Go to this section
Strong national regulatory frameworks and multi-stakeholder collaboration are essential for ensuring safe medicines and protecting patients’ lives.Go to this section
Effective legislations and enforcement in all countries are key to deter falsified medicines and address the danger of illegal online pharmacies.Go to this section
A clear, widely accepted definition of “falsified medicines” is crucial for efficient and coordinated responses to this threat. However, the current lack of a globally approved definition impedes strong, coordinated national and international measures, as the meaning of “falsified” varies between countries and international organizations.
To fill this gap, a working definition of “falsified medical products” is proposed for adoption at the World Health Assembly 2017: “Medical products that deliberately/fraudulently misrepresent their identity, composition or source.” Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, or reproduction of an authorized medical product or the manufacture of a medical product that is not an authorized product. Any consideration related to intellectual property rights (IP) does not fall within this definition.
IFPMA welcomes this approach to use the term “falsified” for the purposes of the work within the Member State mechanism. Reaching this consensus is an important step forward. This proposal is in line with IFPMA’s position: as stated in our Ten Principles, patents have nothing to do with falsified medicines.
Falsified medicines are not an IP issue but a public health threat. Purely commercial patent infringement disputes which may arise in the ordinary course of business should not be confused with disputes related to the production of falsified versions of genuine approved medicines. In order to detect a product with a false representation of its identity, some intellectual property tools such as trademark could be used. However, they will not be a determining factor to declare a medicine falsified. Other criteria such as the intention to deceive are key.
As the WHO does not intend to “propose, or affect in any way, national and/or regional legislation either in existence or that may be drafted in the future”, the IFPMA and its members will continue to adapt their terminology to their interlocutor.
IFPMA and its members have demonstrated a robust, enduring commitment to medicines’ safety – based on ten principles published in 2010. Together, these principles state the need for common approaches that engage all stakeholders, across the supply chain, to pursue a long-term, sustainable strategy to fight this global threat to public health.
It’s important to understand the difference between substandard and falsified medicines. The WHO Expert Committee on Specifications for Pharmaceutical Preparations defines substandard medicines as “pharmaceutical products that do not meet their quality standards and specifications”. On the other hand, as defined by the WHO Member States Mechanism, the term falsified can be used “when the authorized manufacturer deliberately fails to meet these quality standards or specifications due to misrepresentation of identity, composition, or source (…).”
The intention to deceive is the key distinction between substandard and falsified medicines. A substandard medicine is approved and legally manufactured, but does not meet all quality criteria. Even though it may pose a significant health risk, it should not be regarded as falsified. However, falsified medicines are produced with the deliberate intention to mislead patients. And these falsified medicines are also, by definition, likely to be substandard.
Falsified medicines are a growing public health threat for every country, every medicine, and every person.
The Pharmaceutical Security Institute (PSI) documented a 34% increase in “counterfeit incidents” between 2014 and 2015. Though certain regions and countries, such as Asia, Latin America and China, are the most common sources of counterfeit incidents, falsified medicines are a threat for all countries. Once falsified medicines enter the supply chain, they endanger lives across the globe, including in high-income countries, and this international threat is magnified by the growing online market for falsified medicines.
Every medicine is affected by falsification, including life-saving medicines. Whether a medicine is brand-name, generic, prescription, or over-the-counter, it is at risk for falsification. And while counterfeiters often target lifestyle drugs, life-saving medicines are the fastest growing category of falsified medicines. A study published in The American Journal of Tropical Medicine and Hygiene found that 52.8% of all counterfeit medicines detected in the legitimate supply chain are life-saving-related treatments.
Falsified medicines threaten patients' lives. An analysis of falsified medicines has found samples that contained no active pharmaceutical ingredient (API), or even worse, contained the wrong API, the wrong dosage, or other dangerous substances. No quality falsified medicines exist.
As a result, patients around the world face a life-threatening risk from falsified medicines, whether because they fail to receive the treatment they need or because a falsified medicine actively harms them. Falsified medicines can cause further illness, disability, resistance to authentic medicines, and even death. Further, falsified medicines undermine patients’ trust in health systems, government agencies, health care providers and manufacturers of genuine medicines.
Every country and stakeholder must respond to the widespread impacts of falsified medicines. Halting this global health threat demands an integrated multi-stakeholder approach. This must include strong national regulatory frameworks, as well as effective legislation, robust awareness efforts, and the prevention, control, detection, and monitoring of falsified medicines.
People participating in the production and traffic of falsified medicines are criminals. They intentionally deceive patients and put lives at risk. Yet, existing legislation and enforcement do not reflect the severity of this crime or sufficiently deter criminals.
A study presented by the Institute of Research Against Counterfeit Medicines (IRACM) finds that these criminal organizations fall into three categories:
IFPMA calls on all governments to strengthen their legislation and enforcement to deter falsified medicines. Currently, creating falsified medicines is easy, cheap and lucrative, with a low risk of apprehension or punishment. According to the WHO, only a few countries have enacted special national legislation focused on falsified medicines, and sanctions imposed on counterfeiters are rarely sufficient to stop this crime. Effective action requires strong legislative frameworks that criminalize falsification and respond with adequate penalties and strict enforcement.
IFPMA, EFPIA, PhRMA, together with associations representing generic manufacturers (IGBA, EGA, GPhA) invite governments to join and ratify the Medicrime Convention, a unique international tool to deter falsified medicines, thereby protecting public health, criminalizing counterfeiting, and ensuring national and international cooperation.
In particular, the Medicrime Convention:
The Internet is a growing global marketplace for falsified medicines. Tens of thousands of illegal websites sell unsafe and poor quality medicines online, while pretending to be legitimate pharmacies. This is a central challenge in the fight against falsified medicines: more than 50% of medicines purchased worldwide from illegal online sources that conceal their physical address are falsified.
Together, these websites form a multi-million dollar industry. For example, the Japanese Customs Office made over 500 discoveries of falsified medicines and seized almost 80,000 drugs in 2011, a majority of which were purchased online.
These websites are not just deceptive – they harm patients. A recent study found that 96% of websites delivering medicines to American patients did not meet patient safety standards and/or pharmacy practice standards according to US state and federal laws. Yet, few patients are aware of these dangers. 74% of Americans who purchased medicines online were not aware there was a risk involved, and 78% of Europeans who bought medications through online pharmacies felt that they were purchasing in a safe environment.
IFPMA, together with EFPIA, PhRMA and JPMA, encourages all governments to address the growing number of illegitimate online pharmacies by exploring opportunities to strengthen laws and enforcement tools.
Heightened public awareness and education are also critical. Governments and other stakeholders can develop robust awareness programs focused on the dangers of purchasing falsified medicines online and how to purchase safe medicines from lawful sources. Initiatives like the Alliance for Safe Online Pharmacies in the EU and US and CSIP (Center for Safe Internet Pharmacies) are raising public awareness and inviting authorities to “evaluate policies and legal measures to tackle illegal online sales”.
Strong national regulatory frameworks are essential for ensuring safe, authentic medicines. These frameworks provide regulatory and enforcement authorities with the power they need to fight falsified medicines, which flourish where regulatory oversight and enforcement are weak. The WHO has even spotlighted weak or nonexistent national regulatory systems as a key factor that encourages the falsification of medicines.
Yet, many countries still need to create or strengthen a regulatory framework. Currently, only 20% of WHO member states have effective, well-developed drugs regulation systems, and 30% of members have no or very limited regulation in place.
This endangers all patients across the globe, not just those in countries with weak regulation, as falsified medicines can move across national boundaries, even in countries with more robust regulatory systems.
IFPMA is playing a dynamic role in strengthening regulatory systems. In particular, IFPMA organized full-day workshops on falsified medicines coinciding with the IFPMA – DIA regulatory conferences in Asia and Africa. The workshops gathered international and regional experts and leaders to promote an integrated approach to fighting falsified medicines, focusing discussions on best practices in the current regulatory landscape and initiatives. Related topics included supply chain integrity; practices and technologies for prevention, detection, control and monitoring of falsified medicines; and collaboration within and between countries. These discussions tapped multi-stakeholder expertise through the participation of representatives from national regulatory authorities, regional intergovernmental organizations, international organizations, non-governmental organizations and private sectors.
IFPMA members are also deeply engaged in this fight. Companies are actively sharing expertise with regulatory and enforcement officials around the world, building awareness of the dangers of falsified medicines and establishing programs to dismantle organized crime networks involved in falsification. IFPMA members are also working closely with local authorities and international bodies to improve the identification of falsified medicines, collect information and monitor incidents of falsification and improve procedures for dealing with suspected counterfeiters.
Accurate data and research on falsified medicines is critical for designing effective responses. However, it’s difficult to collect, analyze and distribute data on this criminal activity, as counterfeiters conceal their operations. For example, the UN Office of Drugs and Crime (UNODC) has recognized that quantitative information on falsified crime and criminal justice is very limited. Therefore, global health policy stakeholders must build a fact-based infrastructure to understand the current and changing dynamics of this illicit activity, which threatens patient safety and public health.
In this regard, the Pharmaceutical Security Institute (PSI) is a pioneering organization that is directly addressing the need for data on falsified medicines. In 2002, the Security Directors of innovative pharmaceutical manufacturers established PSI to collect, analyze and disseminate information about falsified, illegally diverted and stolen medicines.
PSI’s primary tool is the Falsified Incident System (CIS), which is recognized as one of the only continuous and functioning databases focused on the global incidence of counterfeit medicines. Established 10 years ago, this database includes 13,439 incidents of counterfeit, illegally diverted, and stolen medicines. Approximately 70% of this data is obtained from members, with additional data provided by credible and first-hand data sources. PSI utilizes this data through multi-lingual, open source reviews, liaison contacts with authorities, and special studies that provide a broader picture of the extent and dangers of the falsified medicines market.
The global health community must recognize preventing falsification as an integral element of efforts to protect public health worldwide. Prevention efforts are directly connected to improving access to authentic, effective, high-quality medicines. However, improving prevention will require greater efforts to collect data on this public health threat.
Two innovative studies provide insightful data and analysis on the global challenges of falsified medicines. The first was conducted by the University College London School of Pharmacy and the international research agency Matrix Insight, and it highlights opportunities for a better coordinated international response to falsified medicines. The report examines governments’ growing recognition of the importance of preventing falsification and emphasizes the need for more collaborative action between all stakeholders. The report concludes that more investment is needed to both quantify falsification and provide early warning of potentially hazardous products when they are detected in legitimate supply chains.
The second report, from PSI and the University of California, San Diego School of Medicine, is a ground-breaking analysis of the penetration of counterfeit medicines into legitimate supply chains, published in April 2015.6 It assesses counterfeit reports involving the legitimate supply chain using 2009–2011 data from the PSI Counterfeit Incident System database.
This study is part of a special supplement of The American Journal of Tropical Medicine and Hygiene, titled “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives.” The supplement includes 17 articles on falsified and substandard medicines, creating a vital resource for information on this public health topic. This includes suggested policy interventions, such as an international framework and the adoption of stricter national laws against drug counterfeiting.
The research-based pharmaceutical industry is committed to contribute to securing the legitimate supply chain. Given the complexity of the supply chain, this is an essential, but arduous effort that requires an efficient, multi-faceted strategy. As IFPMA, EFPIA and PhRMA state in their joint position paper, “no single solution will prevent counterfeiting. Rather, a holistic approach comprising the use of covert and overt anti-counterfeiting features, a well-regulated, secure supply chain and appropriate laws and penalties to deter and punish counterfeiters is necessary to provide maximum patient protection”.
Four types of technologies provide the foundation for authenticating medicines. These technologies are essential tools for securing the legitimate supply chain and ensuring the authenticity of medicines, though additional
caution is always necessary.
( Explore these four technologies by clicking on the icons below )
These technologies are visible to the naked eye, and require end-users and healthcare providers to be familiarised with them. They are often incorporated within tamper-evident features, such labels that transfer “VOID” onto the surface of the container when peeled off. This avoids the reuse of genuine components for falsified products. Another example are holograms, which typically incorporate images with the illusion of three-dimensional construction, thus combining three-layered security features.
These technologies can only be seen by specially equipped individuals. Therefore, verification is checked on a “need to know” basis, with security value deeply connected to secrecy. These often include using special inks for invisible printing, including ink visible only under ultraviolet light, infrared fluorescent pigments, and thermosensitive inks.
These are a subset of covert technologies that require laboratory testing to assess authenticity. They include a wide range of methods, ranging from chemical taggants, detected only by highly specific reagent systems, to more complex protein and DNA taggants.
These technologies utilize serialization, which assigns a unique identifier to an item like a pack, case or pallet. This identifier is stored in a database, enabling authenticity checks and product tracking. Many countries have already issued traceability regulations, though significant resources and investments are required for total implementation of track and trace models.
There are three key principles for an efficient technological anti-counterfeiting strategy, according to EFPIA’s “White Paper on the Anti-Counterfeiting of Medicines”. These are: tamper-evident packaging; overt and covert authentication features; and a harmonized coding system to enhance product identification at the individual pack level.
These three principles must be applied throughout the legitimate supply chain to ensure greater product security and patient safety.
Serialization and product verification systems are an increasingly common measure to protect the legitimate supply chain worldwide. These systems assign a unique identifier to an item like a pack, case or pallet, which is stored in a database, along with other information about the item. Items are then scanned and verified against the database to ensure authenticity and provide tracking information throughout the legitimate supply chain.
These systems must be implemented in a step-wise, scalable manner – including realistic timelines and suitable consultation with relevant stakeholders – given the significant resources and investments in capital equipment and software systems necessary. These systems should also use globally recognized common standards to minimize fragmentation and increase international harmonization, while also providing sufficient flexibility to accommodate various packaging and supply chain differences. Additionally, these systems should be tested ahead of implementation.
Further, EFPIA, IFPMA and PhRMA believe that serialization initiatives should conform to internationally recognized standards. For example, the GS1 2D barcode allows manufacturers to deploy a single set of standards across their operations and with supply chain partners. In contrast, using multiple standards complicates operations, increasing costs and introducing a higher risk of error. Using GS1 standards also ensures that a single barcode can be used across multiple countries.
Beyond patient safety, serialization and product verification systems also allow for additional supply chain benefits. Potential advantages include:
Public awareness and education are vital to addressing the impact of falsified medicines. Effective awareness campaigns equip patients with the knowledge to help avoid this threat and safeguard their own health. Therefore, awareness is identified as one of the nine components of the work plan of the WHO mechanism.
However, many patients around the globe have not received information about the threat of falsified medicines and the resulting health risk. For example, a recent survey focusing on European consumers identified that “77% of those surveyed feel they do not receive sufficient information about falsified medicines. While a majority (66%) has heard of drug counterfeiting, respondents seem to have little information on the issue of falsified medicines: 77% say they have not been adequately informed or are ignorant on the subject”.
IFPMA seeks to inform patients and the global population about the risk posed by falsified medicines. To achieve this goal, IFPMA has developed a variety of educational materials in partnership with like-minded organizations, which are designed to build productive awareness and avoid sensational claims. In particular, IFPMA collaborated with the International Pharmaceutical Federation (FIP) to publish a brochure on the danger of purchasing medicines online, titled “The threat of false friends.”
IFPMA and FIP are building on this effort by calling on governments, international organizations and the private sector to work, individually and collaboratively, to address the sale of falsified medicines by illegitimate online pharmacies. To achieve this partnership approach, the focus should be placed on driving behavioral change with robust awareness and education initiatives, as well as effective legislation for tough sanctions and effective enforcement.
IFPMA has joined as a founding partner of the global, multi-stakeholder Fight the Fakes campaign. Fight the Fakes raises awareness about the dangerous impacts of falsified medicines on communities and healthcare systems, giving a voice to those who have been personally affected and those working to stop this crime. The campaign seeks to build a global movement of organizations and individuals who will spotlight the complex, worldwide threat of falsified medicines and strive to reduce its negative consequences.
Fight the Fakes features a broad-based partnership of major stakeholders, including doctors, nurses, disease-specific organizations, foundations and research institutes, product-development partnerships, foundations, non-profits, wholesalers, pharmacists, mobile app services, coalitions for consumer protection and the generic and research-based pharmaceutical industries.
The campaign gathers and develops resources on falsified medicines and shares them on its website, including videos, infographics, studies and toolkits, available in languages such as French, Spanish, Portuguese, Swahili and Japanese.
This collaboration is central to raising the profile of falsified medicines, disseminating information to policy-makers, healthcare professionals, patients, the public and media, promoting the implementation of initiatives that fight falsified medicines and outlining opportunities for action.
Fight the Fakes is a campaign that aims to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It seeks to build a global movement of organizations and individuals who will shine light on the negative impact that fake medicines have on people around the globe and to reduce the negative consequences on individuals worldwide.