From both an ethical and scientific perspective, animal research is indispensable and is furthermore mandated by law. We enforce stringent animal welfare standards that meet and frequently exceed applicable laws and extend these high expectations to our suppliers, contract research organizations and other partners.
Our approach to animal welfare
Animal studies enable us to test both the safety of our chemical and medicinal products, and the efficacy of our pharmaceuticals. We conduct animal testing within our Healthcare business sector as part of the official drug approval process and for biological quality control. Animal welfare is also a prominent issue for our Life Science business sector, where laboratory animals are kept, for instance, for the production of antibodies. Our subsidiary BioReliance conducts animal testing as part of contract research work for third parties.
Our Group-wide Policy on the Use, Care and Welfare of Laboratory Animals sets forth our commitment to consistently uphold the highest ethical standards regarding the housing, care and feeding of laboratory animals. When conducting animal research, we pursue well established and tested methods that ensure high-quality results. We strive to replace animal testing with alternative methods wherever possible and permissible by law. We therefore subscribe to the internationally recognized 3Rs for animal-based research:
- Reduction - using the minimum number of required animals
- Refinement - minimizing distress or discomfort before, during and after testing
- Replacement - replacing animal studies with non-animal systems
In 2018, we launched our internal 3Rs Award, which is open to all our employees and which further strengthens our commitment to apply and actively promote the 3Rs in our animal research activities.
We also promote the 3Rs outside our company. Under the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), for instance, we have joined forces with other companies to introduce the Global 3Rs Awards Program. In partnership with the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), the IQ Consortium recognizes innovative contributions to the 3Rs of animal research to advance ethical science in academia and industry.
How we ensure animal welfare
Through our Corporate Animal Science and Welfare (EQ-A) unit, we endeavor to create uniform high-quality animal welfare standards. To ensure adherence to these standards, we initiate animal welfare audits within both our company and our partners. In 2018, we expanded the animal welfare auditing team in order to accommodate for increased auditing and AAALAC International reaccreditation demands. All our animal science and welfare officers and experts regularly interact through our global laboratory animal science network. This platform for sharing best practices and lessons learned supports the animal welfare units at our sites as well as all projects and processes related to animal science and welfare.
Our Group Animal Welfare Council is made up of representatives from all our business sectors and convenes twice a year to support and advise the Chief Animal Welfare Officer. This council discusses relevant developments and makes decisions regarding our Animal Welfare Strategy. If an employee identifies an internal issue regarding animal welfare, they can file an incident report which will be sent directly to the Chief Animal Welfare Officer or report it via our SpeakUp Line.
In most cases, our sites are subject to additional national regulations. In order to assess the quality of animal husbandry practices and ensure compliance with our standards as well as all statutory requirements, we appoint animal welfare officers and establish animal welfare councils across our Group, even where not required by law.
Work with committees and associations
As part of our efforts to improve animal welfare, we are involved in several organizations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA), the German Association of Research-based Pharmaceutical Companies (vfa) and Interpharma, a federation of research-based pharmaceutical companies in Switzerland. As a member of Interpharma, we have joined a continuous dialogue with Swiss Animal Protection to identify common interests and find synergies regarding the 3Rs.
Our Chief Animal Welfare Officer sits on various committees and takes an active role in order to advocate our position on animal welfare. Moreover, he represents EFPIA on the AAALAC International Board of Delegates, where he ensures adherence to European standards. He has been appointed to the Board of Directors of AAALAC International since the end of 2016 for a three-year term. He is also a member of the German Federal Animal Welfare Commission.
Our commitment: Group-wide methodology and standards
Through our Group-wide Policy on the Use, Care and Welfare of Laboratory Animals, we have made a commitment to global animal welfare principles and the highest possible ethical standards in animal research. In 2017, we updated this policy to include the work of our Group Animal Welfare Council. The policy further sets out principles on the housing, care and feeding of laboratory animals. We strive to provide our animals with high-quality living conditions and consistently seek ways to make improvements. This ethos applies equally to the contracted animal research services we offer third parties such as contract research organizations, academia or partnerships and to those services we contract from these third parties. In addition to our policy, our Group-wide Animal Science and Welfare manual describes the requirements for implementing, maintaining and improving animal welfare practices. Moreover, our standard entitled Housing and Husbandry Practices for Common Laboratory Animals also applies to our external partners. In 2018, we implemented the Vendor Qualification Standard, which describes our criteria for evaluating the quality of animal welfare practices in our suppliers and partners.
Animal research is only permitted if there are no recognized alternative methods available. In many fields, however, animal studies are indispensable and legally mandated by ICH guidelines or REACH, which place priority on the safety of humans. Laws and regulations govern all aspects of animal research, such as the housing conditions of laboratory animals, the conduct and approval of studies and the reliability and expertise of all involved individuals.
The majority of laboratory animals are rodents
In 2018, around 166,000 animals were used at Merck KGaA, Darmstadt, Germany. This represents a decrease of 12% compared to 2017. The majority (96%) of the laboratory animals we use are rodents (mice or rats). In addition, approximately 10,800 animals were used by contract research organizations (CROs) in our name and in collaborations with academia. Regulatory agencies sometimes require investigational drugs to be safety tested on non-rodent species. This allows researchers to identify potential adverse effects with the necessary accuracy and include them in the risk assessment of a substance.
Auditing our research facilities
We perform regular audits on our animal research facilities to ensure adherence to our animal welfare standards. In 2018, ten internal audits and ten authority visits occurred. We have initiated the relevant corrective measures where necessary. No critical shortcomings were identified during these audits.
We adhere to the highest international animal welfare standards at all times. All our Healthcare laboratory animal facilities and one of our Life Science laboratory animal facilities in the United States have been accredited to the standards of AAALAC International.
Collaborating with partners and suppliers
We perform the majority (95%) of animal studies ourselves and procure our animals from specialized breeders. Sometimes, however, we also hire contract research organizations (CROs) to conduct animal research on our behalf. Furthermore, we work with both the private sector and, to a much lesser degree, academic institutions. However, whenever collaborating with such organizations, we expect them to adhere to comparably high standards as we do, as set out in our Use, Care and Welfare of Laboratory Animals Policy. We verify compliance with this policy through a risk-based qualification procedure and, where necessary, conduct audits, typically every three years.
Regularly auditing our partners
We perform regular audits on our animal breeders and contract research organizations to ensure compliance with our animal welfare standards. As part of our work with Interpharma, we have worked with other member companies to develop a cross-company audit concept that concentrates on those partners that are relevant to the maximum possible number of companies involved. The results are shared among Interpharma member companies and treated confidentially. Based on the results of the audits, it is up to the discretion of each company whether or not to collaborate with the respective suppliers. In 2018, the association conducted two audits in Denmark, one in France and one in the United Kingdom.
Comprehensive employee training
We regularly train all employees who work with laboratory animals, thereby ensuring that animal studies are conducted according to the latest scientific standards and that animals receive the best care possible. The nature and scope of this training is based on national, international and local legislative requirements. 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). The respective local, national and international regulatory authorities monitor our activities to ensure compliance.
How we implement the 3Rs
We implement the 3Rs by way of various measures – both within our own company and as part of industry associations. To minimize discomfort and distress to animals before, during and after testing (refinement), in 2017 and 2018 we successfully implemented our own innovative group housing concept for rabbits and rats at one of our sites. By keeping animals together in groups, they are generally healthier and less stressed.
Wherever possible we adopt out our animals and employ a special rehoming program using accepted animal welfare organizations that specialize in laboratory animals. In 2018, for example, we closed down our own dog breeding colony and gave the animals away for adoption.
We actively support the development of alternative testing methods and their official recognition at an international level. There is a serious need for action here because animal research can only be truly reduced if a new methodology is internationally accepted. Without this global recognition, both animal studies and alternative testing have to be conducted in parallel when developing pharmaceuticals intended for worldwide distribution.
To help improve this situation, we support the European Partnership for Alternative Approaches to Animal Testing (EPAA). This collaboration between the European Commission, European trade associations and companies from various sectors seeks to pool knowledge and resources to accelerate the development of alternative approaches to animal use in regulatory testing. Through our membership in the German Association of Research-based Pharmaceutical Companies (vfa), we also support the set Foundation dedicated to researching and developing new alternatives in animal experimenting, which seeks to reduce and replace animal testing. To achieve this objective, the foundation funds projects that conduct research into alternative methods. Our Chief Animal Welfare Officer is currently Vice Chairman of the set Foundation Board of Trustees.
Our own scientists are also working on developing alternative methods and have received numerous accolades for their efforts, which includes being presented with the 2018 Animal Welfare Research Award by the Hessian government in Germany. One of our Global Research & Development teams was recognized for demonstrating how animal welfare and cutting-edge research can go hand in hand through the use of innovative housing systems for rabbits and rats that are used in legally required animal experiments when developing medication to treat arthritis.
Other awards that our teams have received include:
- 2014: The Hessian Animal Welfare Research Prize for Alternative Methods to Replace or Reduce Animal Testing
- 2010: The IUTox Bo Holmstedt Scientists Award for Alternative Test Strategies according to the 3Rs
- 2009: The Eurotox Gerhard Zbinden Young Scientists Award
- 2008: The Eurotox Bo Holmstedt Young Scientists Award for Alternative Test Strategies according to the 3Rs
- 2007: The Hessian Animal Welfare Research Prize for Alternative Methods to Replace or Reduce Animal Testing
- 2006: The German Animal Welfare Research Prize awarded by the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) for alternative methods to replace or reduce animal studies
- 2005: The Eurotox Gerhard Zbinden Young Scientists Award
In 2018, we also launched an internal 3Rs Award, which is open to all our employees. The three winning teams in 2018 were recognized for providing innovative ways of implementing the 3Rs for animal-based research. One of the winning teams is based in Israel. It found a way to produce monoclonal antibodies using an in-vitro method instead of the animal itself, which has the added benefit of achieving higher yields than conventional production methods. A bio-monitoring team in France was awarded for developing a pyrogene test that does not need to use rabbits as test subjects. This project is currently awaiting regulatory approval. We moreover recognized a team from Italy that developed an in-vitro method, which replaces mandatory growth hormone testing on animals.