The World Health Organization (WHO) defines counterfeit drugs as those which are deliberately and fraudulently produced and/or mislabelled with respect to identity and/or source.* Counterfeits are part of the broader problem of substandard pharmaceuticals: products whose composition do not meet correct scientific specifications and are consequently ineffective and often dangerous to the patient. Substandard medicines can result from negligence, human error, insufficient human and financial resources or counterfeiting. Both branded and generic medicines can be counterfeit or sub-standard.
Counterfeit drugs may include:
too much or not enough active ingredient
no active ingredient
the wrong active ingredient
dangerous excipients and dyes
the wrong ingredients but authentic packaging
the correct ingredients but fake packaging
the wrong ingredients as well as fake packaging.
At best, a counterfeit medicine carries the risk of being ineffective. At worst, it can be toxic. Even if the ingredients are correct, counterfeit packaging may include mislabelling, false expiry dates, inaccurate information about dosage and origin. In either case, the consequences for patients can be life-threatening.
*WHO Fact Sheet No. 275, November 2003
The real cost of counterfeit pharmaceuticals goes beyond the risk to human health. Counterfeits cause far-reaching social and economic problems that touch people at all levels of society: patients, healthcare organizations, governments and industry. Counterfeiting can also be used to fund other criminal or terrorist activities.
Drug counterfeiting first came to world attention in the 1980s. Increasing international trade of pharmaceuticals and sales via the internet has further facilitated the entry of counterfeit products into the supply chain. The U.S. Food and Drug Administration (FDA) considers that counterfeits already account for more than 10% of the global medicines market.
Both industrialized and developing countries are impacted by the problem of counterfeit pharmaceuticals. However, those in developing countries are hardest hit.
In wealthier countries, the most frequently counterfeited drugs are new, expensive “lifestyle” medicines, i.e., those used to treat non-life threatening conditions.
In developing countries, the most-copied drugs are those used to treat life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS.
Counterfeit pharmaceutical products frustrate efforts to deal with high-burden diseases, especially among poor populations. The risk of receiving a counterfeit medicine is as high as 25% in the developing world, where an estimated one in four packets of medicines sold in street markets is fake or substandard.
Internet purchases represent an even higher risk of receiving a counterfeit drug.
Legislation forms the basis of drug regulation. In industrialized countries a relatively comprehensive system of laws, regulations and enforcement by authorities provides a high level of security to patients who purchase their medicines through legitimate channels. Not all developing countries have the means, nor necessarily the willingness, to control the manufacture, importation, distribution and sale of medicines.
The economic effects of pirated medical products include lost revenues and fewer resources for governments, healthcare organizations and the pharmaceutical industry. For research-based companies like us, the loss of income is not just a matter of profits; it directly impacts our R&D investment. We invest over 20% of our revenues each year to develop new therapies to help patients with serious diseases.
Counterfeit drugs are also a problem of trust. How can people trust the medicines they take if they are not absolutely sure of their quality? We work very hard to earn our patients’ trust every day. And we are resolutely committed to fighting the global problem of drug counterfeiting to ensure that we keep it.
Our company is working in three main ways to combat the counterfeiting of medicines at global level:
We are pursuing a long-term strategy against product piracy. As a division of Merck KGaA, Darmstadt, Germany, we are continually investing in technologies to enhance patient safety and ensure value for shareholders. The gradual introduction of tamper-proof elements and other security features is enabling us to increase packaging integrity protection and facilitate product authentication.
In Europe, in conjunction with various associations, we support the introduction of serialization techniques permitting product tracking and/or verification of the product validity at the point of dispensing.
In the United States, we have launched the Track & Trace program on selected products: the electronic pedigree allows to precisely track any drug package along the entire supply and distribution chain, from production plant to pharmacy.
In collaboration with governmental agencies, the security of the Supply Chain itself is assessed and improved in order to prevent unauthorized drugs from entering legitimate distribution channels.
Working with key industry and government partners at the global level is the most efficient way to combat counterfeiting.
We are a member of the various industry associations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through our Corporate Security function, which contributes to the profitability and social responsibility of our company by protecting its employees, its intellectual and physical assets as well as its reputation in regard to security risks, we are a member of the Pharmaceutical Security Institute (PSI). Together, we support industry-wide initiatives to promote clear legislation and prosecution of violations to anti-counterfeiting laws. However, this can only happen by working in close cooperation with national and international authorities.
Our Anti-Counterfeiting Operational Network (MACON) is a cross-functional group of experts from legal, trademarks, compliance, supply chain, quality assurance, packaging, communication and technical operations managed and led by Corporate Security. The group works to pool resources within our company in order to more efficiently fight against counterfeiting of all our chemical and pharmaceutical products. Furthermore, we monitor world markets and report any incidences of counterfeits to the relevant authorities.
Global Pharma Health Fund
In some African nations, up to 50% of malaria drugs are fake; their use is either ineffective or damaging, ultimately leading to loss of life. Thanks to the Global Pharma Health Fund (GPHF) and innovative technology from us, a system for rapid, inexpensive detection of counterfeit medicines in developing countries is making a life-saving difference for millions of patients.
The mobile compact laboratory GPHF-Minilab® was developed to identify counterfeit drugs quickly and cheaply. The GPHF-Minilab® provides rapid drug quality verification and counterfeit medicines detection in a compact laboratory comprised of two suitcases filled with portable lab material.
More than 570 mini-lab units are in use in around 80 countries worldwide. They are mainly being deployed in Africa and Asia, where the conditions for effective drug control are often inadequate.
The mini-labs are distributed through GPHF, a charitable organization initiated and funded exclusively by donations from us. The majority of the mini-labs are provided at cost via WHO and other organizations such as Management Sciences for Health (MSH) and the International Technical Alliance of the United States Pharmacopeia Drug Quality and Information program (USP DQI). Our company has also donated a number of compact laboratories for use in especially needy countries like Burundi and Haiti.