Annual Report 2021

Product-related crime

Our company develops and manufactures pharmaceutical and chemical products of the highest quality. We take resolute action against product-related crime in order to protect our patients and customers from the harm caused by illegal products. For this purpose, we have implemented a Group-wide strategy, which focuses on identifying and responding to the availability of counterfeit medicines as well as ensuring the integrity of our products and supply chains. Moreover, we are committed to collaborating both with government authorities and with national and international organizations. Together, we want to tackle product-related crime and raise awareness of the issue among stakeholders as well as the wider public.

By the end of 2022, we will introduce a Group-wide security audit management program, which is intended to further increase transparency and the security level performance within our organization and prove our compliance with security requirements. For this purpose, we are developing key figures to support this process. These key figures will be supplemented by the existing audit management tool.

Roles and responsibilities

The Corporate Security unit coordinates our approach to tackling product-related crime on the strategic level. A cross-functional team supports the operational implementation of the strategy. The team comprises experts from various units, including Legal/Trademarks, Product Security, Export Control, Supply Chain, Patient Safety, Regulatory Affairs, and Quality Assurance. Furthermore, all our sites have product crime officers who serve as central, local points of contact and act as the interface between both local and global stakeholders, internal and external alike.

Our commitment to Group-wide policies and standards

Globally applicable regulations are a key part of our approach to effectively and efficiently tackling product-related crime. The Group-wide guideline entitled “Illicit Trade & Product Crime Prevention” describes our goals and measures for reducing product-related crime and minimizing its impact. Our Group-wide Product Crime Incident Management standard sets out mandatory requirements for effectively managing incidents of product-related crime.

Detecting counterfeit drugs and withdrawing them from circulation

A team of experts examines, evaluates, and processes every notification we receive regarding suspected counterfeit medicines. Our response always complies with both the regulatory requirements and our own wider objectives for tackling counterfeit products. We pro-actively conduct investigations both online and offline in order to identify and disrupt the availability of illicit products in legitimate and illegitimate channels. We document all incidents using a central, Group-wide reporting system. Moreover, we support the prosecution of criminals by working closely with the authorities. As a member of the Pharmaceutical Security Institute (PSI), we routinely share intelligence about product crime with other pharmaceutical companies.

Tracking system for chemical substances

We monitor chemicals that could be misused to produce illegal weapons, explosives, or narcotics, tracking 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 defined in the statutory provisions on export control, we also report suspicious orders and inquiries 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 2021, we reported 745 orders placed for relevant substances. In addition, we helped to resolve six inquiries from authorities regarding specific suspected cases. 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.

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 people Group-wide on the subject to strengthen their competencies. All staff involved in security, such as product crime officers, participate in appropriate training programs. We are continuously evolving these programs and adapting them to new trends.

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