In our Healthcare and Performance Materials business sectors, we conduct animal studies as part of the official drug development process and, as required by law, for chemical safety and biological quality control. Animal testing enables us to verify the safety of our medicinal and chemical products and the efficacy of our pharmaceuticals. Our Life Science business sector uses animals to, for instance, generate substances essential for in vitro methods or to generate antibodies for diagnostics.
Our approach to animal welfare
As part of our internal due diligence, all work by our company involving the use of animals was subjected to a stringent internal audit conducted from the end of 2019 to the beginning of 2020. In 2020, we adopted a new animal welfare strategy in response to the audit and the improvement potential it had identified. The new strategy aligns with our high ethical standards. It enables our company to meet the most rigorous animal welfare standards and to adopt a consistent and transparent Group-wide approach. We already started implementing the organizational changes and the new processes in 2020 and expect to complete this work by the end of 2021.
Our long-term ambition to replace all our animal use with non-animal alternatives is firmly embedded in the strategy. Until then, 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. These standards also apply to the quality of all animal work as well as related activities, such as data assessment. We ensure comprehensive transparency and ongoing assessment, monitoring, auditing, and improvement of all work involving the use of animals by our company and by trusted third parties. We always use as few animals as possible and replace their use whenever feasible with alternative methods. We continuously improve our animal testing processes, striving to enhance the animals’ quality of life.
We subscribe to the internationally recognized 3Rs for animal-based research and have now added Responsibility as our fourth animal welfare principle:
- Reduction – using the minimum number of animals required
- Refinement – minimizing distress or discomfort before, during and after testing
- Replacement – replacing animal studies with non-animal systems
- Responsibility – accepting the responsibility for all animals in our reach internally and among our business partners
With our internal 4Rs Award, we recognize best practice and further strengthen our commitment to apply and actively promote the 4Rs in our animal work. The 2020 winners were recognized for their project “Organ-on-a-chip”, which stands to deliver improved, predictable and translational cell culture models for the liver and intestine and their application in the drug development process. Furthermore, we plan to hold an internal virtual 4Rs Day in early 2021.
In addition, we advocate for the global acceptance of replacement methods. To this end, we join forces with industry and academia, communicate with authorities and the public. Our aim is to launch products and processes to replace, reduce or refine the use of animals in our work.
How we ensure animal welfare
Based on our new corporate Animal Welfare strategy, which has been endorsed by the Executive Board and all Group entities, we are introducing fundamental organizational changes in line with our corporate sustainability strategy.
In 2020, we reformed our existing Animal Science and Welfare governance and set up a new Animal Affairs unit with clear roles and responsibilities. The unit will deliver a comprehensive corporate framework of rules and implement organizational changes and processes to enable the businesses to conduct animal testing in line with our requirements.
Within the new Animal Affairs unit, we reorganized our Animal Science and Welfare governance and sectoral compliance under four thematic pillars:
- Animal Welfare and Veterinary Care
- Vivarium Oversight
- Animal Using Vendor and Supplier Qualification
- The Group-wide 4Rs program
Our Group Animal Welfare Council, chaired by the Vice Chair of the Executive Board and Deputy CEO of Merck KGaA, Darmstadt, Germany, is comprised of representatives from all our business sectors and meets at least twice annually. The council steers the Animal Affairs unit and acts as a decision-making and escalation body as needed.
Currently, all work involving the use of animals by our company is overseen by designated regional bodies or committees. As part of our organizational changes, independent, cross-sectoral and multidisciplinary Animal Usage Review Boards will be implemented Group-wide in 2021. These boards will be responsible for approving all work involving the use of animals conducted by or on behalf of our company.
If employees identify an issue regarding animal welfare, they can report it directly to the Animal Affairs unit, to local Animal Welfare officers or via our SpeakUp Line.
Comprehensive employee training
Along with the establishment of the new Animal Affairs unit, we launched our Animal Affairs Academy in 2020. The Animal Affairs Academy will ensure regular, comprehensive, high-quality, and up-to-date staff training on practical work and governance documents.
Our employees also regularly participate in external continuing education programs, such as accredited laboratory animal science courses offered by the Federation of European Laboratory Animal Science Associations (FELASA), the American Association for Laboratory Animal Science (AALAS), the Society of Laboratory Animal Science, the Laboratory Animal Science Association (LASA) and the Interessengemeinschaft Tierpfleger (Community of Animal Technicians).
Work with committees and associations
As part of our efforts to improve animal welfare, we are involved in several organizations and industry initiatives, including the European Federation of Pharmaceutical Industries and Associations (EFPIA). The goal is to create efficiencies and learn from one another regarding the improvement of animal welfare. Activities include joint auditing processes, knowledge exchange and shared responsibility when phasing out animal use and fostering the approval of alternative methods.
As part of our collaboration with Interpharma, a federation of research-based pharmaceutical companies in Switzerland, we also worked with other member companies to develop a cross-company audit concept for suppliers of animal studies and animal breeders. The results are shared among Interpharma member companies and treated confidentially. Based on the audit results, it is up to the discretion of each company whether or not to collaborate with the respective suppliers.
Our commitment: Group-wide standards
Beyond compliance with all applicable laws and regulations, we are committed to following our own internal guidelines. In 2020, as part of our strategic realignment, we adopted a new Animal Affairs Policy and rewrote our Group animal welfare standards and procedures for animal testing conducted internally and by trusted third parties. These guidelines corroborate a comprehensive and stringent governance framework based on our four pillars of animal use governance.
Our new standards and procedures entail, for example, the definition of housing and husbandry standards that also apply to external partners. The Animal Using Vendor Management standard describes the requirements from planning to the approval of vendors and suppliers by Animal Affairs. The standard entitled “Audit Management of Animal Affairs and of Animal Using Vendors” defines how we evaluate the quality of animal welfare practices employed in our own vivariums and by our suppliers and partners. Further documents, including guidance for our 4Rs efforts and our risk management, augment the Animal Affairs governance framework.
Number of laboratory animals used for medical study purposes
In 2020, a total of 179,425 animals were used within the scope of our business activities, either in our own vivariums or on the premises of organizations contracted on our behalf. This represents an overall decrease of 5.9% compared with 2019. Rodents (mice or rats) comprised 95% of all animals used in 2020, compared with 96% in 2019. Regulatory agencies sometimes require studies of the safety of investigational drugs in non-rodent species. This allows researchers to identify potential adverse effects accurately and include them in the risk assessment of a substance.
Collaborating with partners and suppliers
We perform the majority (89%) of animal studies ourselves and procure the required animals from specialized breeders. We also hire CROs 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.
Covid-19 and animal welfare
In 2020, it was our policy to restrict travel on a Group-wide scale as part of our Covid-19-related measures to protect our employees. Therefore, only limited audits could be performed in the reporting year. With the help of partners, we were able to perform a total of 11 on-site audits of CRO facilities. Additionally, we set up five remote audits by carrying out virtual facility tours either with photos or with pre-casted videos. In the future, the Animal Using Vendor governance team will perform regular audits every three years to assess all animal testing vendors.
Employee safety and animal well-being remained our highest priorities throughout the pandemic. Employees of all vivariums worked alternate shifts, for example, to reduce the number of contacts and to protect our teams. We began new studies only if they were indispensable for the business, for example to ensure the ongoing supply of medicines for patients.