International and national legislation mandate animal testing of medicinal compounds and chemicals during their development and prior to their approval for commercial use. In addition, from an ethical and scientific perspective, animal research is indispensable based on the current state of knowledge. We perform animal-using activities in all three of our business sectors.
Our approach to animal welfare
Our long-term aspiration is to entirely dispense with work involving the use of animals and to replace it with better, cutting-edge alternatives. We aim to outperform as a leader in non-animal-derived products and testing in the life science and pharmaceutical industries. Our business sectors develop individual strategic roadmaps, priorities and timelines towards this aspiration.
Animal testing will be an unavoidable necessity for many more years, especially in drug development, to ensure the safety and efficacy of certain medical products, medicines and vaccines. As long as animal usage cannot be completely avoided, we are committed to applying the highest ethical and animal welfare standards related to the housing, husbandry and veterinary care of all animals involved in our work. Our definition of "highest possible standards" goes beyond the legal requirements and is specified in our internal quality documents. For example EU Directive 2010/63 on cage and kennel sizes is also applied in theUnited States. In addition, the ILAR Guide also applies to mice and rats. Moreover, we are aiming to ensure comprehensive transparency as well as ongoing assessment, monitoring, auditing, and improvement of all work involving the use of animals by our company and by trusted third parties. We aim to continuously optimize our animal testing processes, striving to enhance the animals’ quality of life. We use as few animals as possible and replace their use with alternative methods wherever feasible. In addition, we advocate for the global acceptance of replacement methods. To this end, we collaborate with other companies and scientific institutions.
We subscribe to the internationally recognized 3Rs for animal-based research and have added Responsibility as our fourth animal welfare principle in line with the ethical considerations published in 2019 by David DeGrazia and Tom Beauchamp in Principles of Animal Research Ethics:
- Replacement – replacing animal studies with non-animal systems
- Reduction – using the minimum number of animals required
- Refinement – minimizing distress or discomfort before, during and after testing
- Responsibility – accepting responsibility for all animals in our reach internally and among our business partners
Within our Life Science business sector, animal activities include required regulatory safety testing of our own products and on behalf of customers. The Life Science product portfolio also includes various materials needed for research that are derived from animals or by-products from food production, such as blood, plasma, serum, or items specifically produced in animals such as antibodies. Our Healthcare business sector conducts animal testing as mandatory part of the drug and medical devices development process and conducts biological quality control in animals. Our Electronics business sector conducts animal tests as required by applicable chemical regulations. According to the EU Cosmetics Regulation, no animal tests are allowed for cosmetic ingredients.
Roles and responsibilities
Our Corporate Animal Affairs unit governs the implementation of the Corporate Animal Welfare strategy. The unit acts globally and locally, setting and overseeing guardrails for the use of laboratory animals based on four pillars:
- Animal Welfare
- Animal-Using Vendor Management
- Vivarium Oversight
- The 4R principle
The Group Animal Welfare Council, sponsored by the CEO of our company, comprises representatives from all business sectors and usually meets three times per year under the leadership of Corporate Animal Affairs and may meet more often if required. The council acts as a sounding and advisory board, assessing which of our services and product innovations can help to avoid animal testing in the future. Moreover, it consults on business-critical issues, adopts key indicators and serves as an escalation body.
In Europe, the Group’s Animal Usage Review (MAUR) board reviews and approves all internal animal work planned for our vivaria. In the United States and Israel, these tasks are performed by comparable company boards such as the Institutional Animal Care and Use Committees (IACUC, in accordance with the U.S. ILAR Guide). In addition, a global MAUR/IACUC board reviews and approves all animal-based activities at all our vendors, contract research organizations and academic partners. We use digital systems for both processes, namely internal review by MAUR or IACUCs as well as externally commissioned studies. Those responsible for internal animal testing or those who commission external activities involving animals enter information relevant to an audit of our animal welfare standards. The data records entered enable transparency and allow us to reliably collect and monitor our key figures.
Global and local official representatives and animal welfare officers who are independent of the business report directly to Corporate Animal Affairs and see themselves as advocates of the animals. Their tasks entail animal science and welfare management as well as acknowledging the individual skills and abilities of all personnel working with animals. Furthermore, they regularly inspect the animal facilities as well as review and approve protocols.
The Animal Using Vendor Management unit plans the review and carries out the qualification of our suppliers and business partners with regard to aspects relevant to laboratory animal science and animal welfare. It uses a digital system with an integrated approval process that also allows the monitoring of suppliers, universities, contract research institutes, and business partners. This system is an important part of our efforts to collaborate exclusively with qualified external institutions.
If employees identify an animal welfare problem, they can use various routes to report it either directly to Corporate Animal Affairs, to local and global animal welfare officers or via our compliance hotline.
The 4R team and cross-functional workstreams develop and guide projects to implement our 4R principles. The 4R team regularly reports progress made with the 4Rs to the Group Animal Welfare Council. It also coordinates the 4R Award, with which we recognize contributions to the Replacement, Reduction, Refinement of, and Responsibility for our animal work.
Comprehensive employee training
Through our new Animal Affairs Academy, we offer a holistic training program for the entire company. We conduct courses on animal welfare and animal testing, and we supervise and support training for the workforce on practical work as well as on the applicable rules and regulations. Employees involved in animal activities receive appropriate training and continuing education. Initiated in 2022, our Vivarium Rotation Program enables individual employees from each of our vivaria to visit another vivarium every year to exchange knowledge and share best practices. To promote ongoing dialogue outside the program as well, the Vivarium Rotation Program community was formed; it meets once per quarter.
Additionally, our employees regularly participate in external continuing education programs.
Work with committees and associations
We are involved in several organizations and initiatives, including as Vice Chair in the Research and Animal Welfare Group (RAW) of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and as well at Interpharma, a federation of research-based pharmaceutical companies in Switzerland. Interpharma conducts audits at contract research organizations and animal breeders together with selected member companies.
We are also involved with the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). This private, nonprofit organization promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. In 2023, one of our own employees served as Immediate Past Chair of the AAALAC International Board of Directors. We continue to support the European Partnership for Alternative Approaches to Animal Testing (EPAA) and participate in its working groups developing alternatives to animal testing. In 2023, we were appointed Chair of the Leadership Coalition of the Marseille Declaration for 2024. Moreover, we participated in the Germany REACH Roundtable – Industry, established and led by the Humane Society International, the objective of which is to reduce the number of animals used in chemicals testing.
Our commitment: Group-wide standards
We consider compliance with statutory animal welfare requirements to be a matter of course. However, the standards that we define in our Animal Affairs Policy go beyond this and are based on species-specific basic needs. We have defined our set of rules based on these and strictly monitor compliance with them. This also applies to tests carried out for us by third parties.
Our standards and procedures entail, for example, the housing and husbandry standards that also apply to external partners, and how we monitor them, for instance through audits. The Animal Using Vendor Management standard governs the qualification process when working with contract research organizations and suppliers. The Global Blood Sampling Standard (GBSS) sets parameters and methods for drawing blood samples as well as maximum blood sampling frequencies and quantities within a defined time period. Further documents, for instance guidance on our 4R efforts, incident reporting and risk management, augment the governance framework.
In 2022, we initiated the Marseille Declaration in order to advance the global implementation of high animal protection standards. This is voluntary commitment by companies with commercial animal husbandry activities and extends beyond local legislation. Further companies became signatories in 2023.
We are convinced that the right level of transparency can lead to better scientific outcomes, increase the value created by animal testing and significantly improve animal health and welfare. In addition, it can create benefits for society, patients and animal well-being. We therefore conducted several activities in 2023 in line with the commitments of the Transparency Initiative Germany, of which we are a signatory. Noteworthy examples include the presentation by our Chief Veterinary Officer at the 12th World Congress on Alternatives to Animal Testing in the Life Sciences and the interview by our Executive Board in the Frankfurter Allgemeine Zeitung on the abolition of animal testing.
Number of laboratory animals used for medical study purposes
We want to increase transparency regarding the laboratory animals we use by reporting both the number of laboratory animals used by the entire company as well as the numbers used by the Life Science and Healthcare business sectors separately. In Life Science, as well as the absolute number of laboratory animals, we also show the number in relation to sales because in this business sector, we perform animal-using activities on behalf of customers. In the pharmaceutical industry, it is stipulated by legislation that animal testing must be carried out to determine the efficacy and adverse effects of medicines.
In addition to the absolute number of laboratory animals, we show this for Life Science in relation to sales, as in this business area we carry out activities in animals on behalf of customers, as there is a direct correlation between profits and animal numbers. In the pharmaceutical sector, on the other hand, animal experiments are primarily carried out in preclinical research to test the efficacy and safety of drugs that are still in development. Accordingly, the number of animals is not directly related to the sales generated by approved drugs.
Number of laboratory animals in Healthcare and Electronics
Number of laboratory animals in Life Science relative to sales
In 2023, we used a total of 143,376 animals for animal testing within the meaning of Directive 2010/63/EU. Of this total, we used 132,522 animals in our own vivaria; organizations contracted on our behalf as well as academic partners used 10,824 animals. In our Life Science business sector, 87,144 animals were used in our own vivaria; 1,703 animals were used by organizations contracted by our customers and for production. For our Healthcare business sector, we used 45,408 animals in our own vivaria and 7,577 animals were used by contract organizations and academic partners. Of this total, Healthcare used 1,544 animals to test chemical safety on behalf of our Electronics business sector.
Regulatory agencies sometimes require studies of the safety of investigational drugs in nonrodent species. This allows researchers to identify potential adverse effects accurately and include them in the risk assessment of a substance.
Animal types
Collaborating with partners and suppliers
We perform the majority (92%) of animal testing in our own animal husbandry facilities. We source our laboratory animals from specialized animal breeding operations. We also commission contract research organizations to conduct animal studies on our behalf. Furthermore, we work with academic institutions. Whenever collaborating with such organizations, we require them to abide by our standards.
Conducting animal welfare audits
Corporate Animal Affairs conducts an audit of each of our vivaria every three years. In 2023, two vivaria were audited, namely in Billerica, Massachusetts (USA) and in Darmstadt, Germany. Additionally, we further improved Corporate Animal Affairs’ oversight of internal animal work regarding aspects such as animal usage, purpose and incident reporting.
An integral part of our strategy is the qualification of all vendors who conduct work with animals on our behalf. Quality assurance of these qualifications is based on our established and robust audit process well as on an existing process to select and train our auditors. In 2023, a total of 37 vendor audits were performed, 33 of them on-site, and 4 virtually.
4R Day in 2023
We want to firmly embed the 4R principle in our company and to motivate our employees to contribute to it. To this end, we hold an annual 4R Day and with our biannual 4R Award worth € 10,000, we recognize best practices in animal-using activities, such as innovative alternatives to reduce, refine and replace animal testing. In addition, we honor exemplary behavior that demonstrates how we meet our responsibility for animal well-being. The next 4R Award will be granted in 2024.
The theme of our 4R Day in 2023 was “Compassion Fatigue and Culture of Care”. This dealt on the one hand with the symptoms of fatigue that can arise when working with animals and on the other hand about fostering a culture of appreciation towards living beings. Both internal and external experts held presentations on these topics.