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 be a pioneer in phasing out animal use and replacing animal work by better, cutting-edge alternatives. We aim to outperform as the leader in non-animal-derived products and testing in the life science and healthcare 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 medical devices, 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. 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 continuously improve our animal testing processes, striving to enhance the animals’ quality of life. We always use as few animals as possible and replace their use whenever feasible with alternative methods. In addition, we advocate for the global acceptance of replacement methods. To this end, we join forces with industry and academia.
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, or 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. In line with the EU Cosmetics Regulation, no animal tests are conducted 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
- Merck Vivarium Oversight
- The 4R principle
Our Group Animal Welfare Council, sponsored by the CEO of Merck, comprises representatives from all business sectors and meets quarterly. The council acts as 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 2021, we established multidisciplinary boards in Europe and the United Kingdom that review and approve all work conducted by or on behalf of our company involving the use of animals. They are known as Merck Animal Usage Review Boards. In the United States and Israel, these boards already exist as Institutional Animal Care and Use Committees (IACUC, in accordance with the U.S. ILAR Guide).
Global and local animal welfare officers from the business report directly to Corporate Animal Affairs and are advocates of the animals. Their tasks entail animal science and welfare management as well as acknowledging the individual skills and abilities of the animal caretakers. Furthermore, they regularly inspect the animal facilities as well as review and approve protocols.
The Animal Using Vendor Management unit qualifies our suppliers with regard to animal science and welfare. The group also continuously monitors our contract research organizations, suppliers and business partners.
If employees identify an issue regarding animal welfare, they can report it directly to Corporate Animal Affairs, to local and global animal welfare officers or via our compliance hotline.
We set up a 4R team and cross-functional workstreams for each of the 4Rs. They 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
With our new Animal Affairs Academy we will define training specifications and oversee and provide staff training on practical work, rules, and regulations.
Our employees also regularly participate in external continuing education programs.
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) and 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.
Our commitment: Group-wide standards
Beyond compliance with all applicable laws and regulations, we are committed to our own set of internal guidelines. Our Animal Affairs Policy, our Group animal welfare standards and our procedures for animal testing conducted internally and by trusted third parties corroborate a comprehensive and stringent governance framework based on our four pillars of animal use governance.
Our standards and procedures entail, for example, the housing and husbandry standards that also apply to external partners, and how we monitor them, including audit procedures. The Animal Using Vendor Management standard describes the requirements for the approval of contract research organizations and suppliers. Further documents, including guidance for our 4R efforts, incident reporting, and risk management, augment the governance framework.
We are convinced that the right level of transparency has the potential to improve the scientific outcome and value of animal testing and to create benefit for society, for patients, and for animal well-being. We committed ourselves to transparency by signing the German Transparency Initiative in 2021. The objective of this initiative is to drive forward an open discussion on animal research. It aims to provide easily accessible information and insights into husbandry and animal testing techniques and facilitates sharing of experiences.
Number of laboratory animals used for medical study purposes
In 2021, a total of 181,392 animals were used within the scope of our business activities, either in our own vivaria or on the premises of organizations contracted on our behalf. This represents an overall increase of 1% compared with 2020. Rodents (mice or rats) comprised 97% of all animals used in 2021, compared with 95% in 2020. 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 (87%) of our animal studies ourselves and procure the required animals from specialized breeders. We also hire 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 2021, two vivaria were audited. Furthermore, we improved Corporate Animal Affairs’ oversight of internal animal work with regards to aspects such as animal usage, purpose and incidents. In the reporting year we selected a digital solution that will promote this and further support the monitoring of our key indicators. We aim to implement this IT tool in 2022.
An integral part of our strategy is the qualification of all animal-using vendors we conduct business with. We completed the implementation of an auditing strategy and developed procedures to identify and train auditors. In 2021, a total of 58 vendor audits were performed, 19 of them on-site, 39 virtually due to the pandemic.
4R Award for animal welfare
We want to motivate all our employees to contribute to the 4R principle. With the biannual 4R Award, we recognize best practices in animal work as well as pioneering mindset to Reduce, Replace or Refine or leading by example in proving Responsibility.
To further promote the 4R principle throughout Merck, we initiated an annual 4R Day. The 2021 event focused on the new Corporate Animal Welfare Strategy and gave an overview of current 4R activities.