According to the World Health Organization (WHO), a considerable proportion of the medicines in low- and middle-income countries are illegal, counterfeit or substandard. In industrialized nations, however, such products are also becoming increasingly available on the market through unlicensed Internet pharmacies and dubious online platforms, posing a risk to public health. Moreover, chemical products can also be used for criminal purposes, such as the manufacture of illicit drugs.
Our approach to product-related crime
Our company develops and manufactures products of the highest quality. In order to protect customers and patients, we secure our products against counterfeiting. We are also resolute in our fight against product-related crime by, for instance, collaborating closely with health, regulatory and law enforcement agencies at the regional, national and international level. In taking preventive action, we cooperate with representatives, Interpol and the World Customs Organization. Our guidelines, standards and processes apply to all our business sectors and markets worldwide.
How we define product-related crime
- Counterfeit products: In line with the relevant WHO standard, we define a counterfeit product as “a product that is deliberately and fraudulently produced and/or mislabeled with respect to its identity and/or source to make it appear to be a genuine product.”
- Illegal diversion of products: This term refers to the diversion of either pharmaceuticals or chemical substances from within the legitimate supply chain either to sell or export them through illegal channels to produce narcotics, weapons or explosives, or to use them for other illegitimate purposes.
- Misappropriation of products: This refers to theft from production sites, warehouses or while in transit.
How we are tackling product-related crime
Our Group Corporate Security function coordinates all our activities for fighting product-related crime. All measures are overseen by the Chief Security Officer and head of “Environment, Health, Safety, Security, Quality” (EQ). Furthermore, all our sites have a product crime officer, who is responsible for responding to potential cases of counterfeiting, acting as the interface between local regulatory and law enforcement authorities, national associations, our Group functions, and our sites.
Group-wide anti-counterfeiting network
Our Anti-Counterfeiting Operational Network (MACON) is responsible for globally monitoring and executing all anti-counterfeiting measures for our products. As well as coordinating preventative measures and the development of security systems, this organization also oversees investigations. Comprising experts from various units such as Legal/Trademarks, Product Security, Export Control, Supply Chain, Patient Safety, and Quality Assurance, this network is coordinated by our Corporate Security unit.
To investigate suspected cases, MACON collaborates with the competent law enforcement agencies and regulatory authorities. In 2020, the Merck Anti-Counterfeiting Operational Network (MACON) investigated and pursued numerous incidents that primarily involved counterfeits within the legitimate and illegitimate supply chains as well as theft and illegal diversion.
Our commitment: Group-wide guidelines and standards
Our guideline entitled “Illicit Trade & Product Crime Prevention” describes our goals and strategies for combating product-related crime. The Group-wide Product Crime Incident Management standard sets out mandatory requirements and defines the procedures we follow within the Group, thereby ensuring cases are managed efficiently. Moreover, it creates a clear framework for dealing with illicit products.
Enhanced monitoring and reporting systems
We analyze and document all counterfeit product incidents using a Group-wide reporting system. This approach provides us with a comprehensive picture of the security situation, enabling us to identify possible links between different cases and effectively tackle them. Our standard operating procedure entitled “Data and Documentation Quality Management” describes the corresponding process, making the risks more transparent and the processes more efficient.
Tracking system for chemical substances
We monitor chemical substances that could be misused to produce illegal weapons, explosives or narcotics, tracking them through an internal system that flags suspicious orders or orders of sensitive products. These are released only once we have confirmed the existence of a verified end-user declaration.
In addition to fulfilling the duties stipulated by statutory provisions on export control, we also report suspicious orders, inquiries and requests to the competent authorities. Through these efforts, we are honoring a voluntary commitment of the German Chemical Industry Association (VCI) and meeting the terms of the Guideline for Operators published by the European Commission. In 2020, we reported 1,148 orders placed for relevant substances. In addition, we received 15 inquiries from authorities regarding specific suspected cases that we helped to resolve. We evaluate the effectiveness of our measures for avoiding product misuse based on, among other things, the number of incidents suggested to us by the authorities and solved.
Supporting customers and patients
To protect patients, the identity and authenticity of pharmaceuticals must be verifiable. We ensure this by rigorously implementing the requirements of the EU Falsified Medicines Directive. We apply a unique serial number to the packaging of all the prescription medicines we commercialize in the European Union (Track and Trace). We also comply with similar government-stipulated systems in other countries around the world.
In addition, we also pursue our own initiatives:
- We apply the Security M label to some of our products, enabling users to easily verify authenticity. We take a risk-based approach to identifying the products to be labeled in this manner.
- In the Mobile Anti-Counterfeiting System (MAS) project in Nigeria, we are working closely with one of our suppliers on a text message-based identification system. Patients scratch off a barcode that is printed on the product packaging then text this code to a number that has been specifically set up for this purpose. They immediately receive a response telling them whether their code is authentic.
- According to a WHO report, more than 10% of all medicines in low- or middle-income countries and emerging countries are counterfeit or substandard. That is why we sponsor the non-profit Global Pharma Health Fund (GPHF), which supplies the GPHF-Minilab®, a compact laboratory used mainly in countries with inadequate access to health solutions to test the quality of up to 100 different active ingredients quickly and inexpensively. The test methods are described in a manual, which has also been available in French and Spanish since 2020. More than 890 Minilabs are currently in use. In 2020, 29 Minilabs were delivered: 21 went to Africa, particularly to countries in the Economic Community of West African States (ECOWAS), and seven went to Asia (Afghanistan and Bangladesh). One remained in Germany for future training sessions as part of the “Global Health Protection Program” run by the Germany Federal Ministry of Health.
- Since 2018, we have been collaborating with Boston University. Together, we are testing, investigating and optimizing a new user-friendly instrument (PharmaChk), which identifies and quantifies active ingredients and helps us to detect counterfeit and substandard medicines. We are planning to use the portable instrument primarily for antimicrobial and anti-malarial compounds in low- and middle-income countries.
- We offer our customers in the pharmaceutical industry Candurin® pearl effect pigments with unique color properties. When used to coat of tablets and capsules, these pigments make it more difficult to create counterfeit copies.
Raising awareness of product-related crime
We aim to continuously raise awareness of product-related crime among our business partners and employees, educating and training our employees Group-wide on the subject. All staff involved in security, such as product crime officers, participate in appropriate training programs aimed at building their capacities and promoting best-practice sharing. We are continuously evolving these programs and adapting them to new trends.
Security audits for contract manufacturers and distributors
We regularly check whether our distributors and contract manufacturers are complying with GMP- and GDP-Standards (Good Manufacturing Practice/Good Distribution Practice). These audits are based on the “EMA ICH Q10” pharmaceutical quality assurance standard and allow us to ascertain the extent to which our security requirements are being met by contract manufacturers and distributors. In addition, we conduct special security audits if a concrete need is identified. This applies to both pharmaceutical contract manufacturers and companies that print packaging. Defects that we deem as critical must be rectified either before we enter into a contract, or a detailed corrective action plan must be submitted for our approval. In 2020, we conducted this type of security audit in China, which found four critical, two significant and three minor defects. No contract was entered into.