From both an ethical and scientific perspective, animal studies for medical purposes and chemical safety are indispensable and furthermore mandated by law. We comply with strict animal welfare standards that meet and frequently exceed applicable laws. Moreover, we oblige our suppliers, contract research organizations and other partners to meet our high expectations with respect to animal welfare.
Our approach to animal welfare
Animal studies enable us to test both the safety of our medicinal and chemical products, and the efficacy of our pharmaceuticals. We conduct animal studies within our Healthcare business sector as part of the official drug approval process, for chemical safety (REACH) and for biological quality control. Animal welfare is also of importance to the Life Science business sector, where laboratory animals are kept, for instance, for the generation of antibodies. Our subsidiary BioReliance conducts animal studies within the scope 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 studies, we pursue well established methods that ensure high-quality results. We strive to replace animal studies 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 animals required
- Refinement – minimizing distress or discomfort before, during and after testing
- Replacement – replacing animal studies with non-animal systems
With our internal 3Rs Award, we recognize best practice and further strengthen our commitment to apply and actively promote the 3Rs in our animal studies.
We also promote the 3Rs outside our company. Under the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), for instance, we joined forces with other pharmaceutical 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 studies to advance ethical science in academia and industry.
How we ensure animal welfare
Through our Corporate Animal Science and Welfare 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. Our animal science and welfare officers and experts regularly interact through our global laboratory animal science network, sharing best practices and lessons learned. This 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 meets twice a year. The council discusses relevant developments, advises the Chief Animal Welfare Officer and makes decisions regarding our Animal Welfare Strategy.
If employees identify an issue regarding animal welfare, they can report it directly to the Chief Animal Welfare Officer or via our SpeakUp Line.
All our animal sites are subject to 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 is a member of 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. In 2019, he was appointed Vice Chair Elect to the Board of Directors of AAALAC International, entailing a four-year commitment (2021 Vice Chair, 2022 Chair, and 2023 Immediate Past Chair). He is also a member of the German Federal Animal Welfare Commission. Our animal welfare officers are members of the National Committee pursuant to section 15 of the German Animal Welfare Act, the German professional veterinary commission for laboratory animals and the German federal professional veterinary commission for animal welfare, for example.
Our commitment: Group-wide methodology and standards
Through our Group-wide Policy on the Use, Care and Welfare of Laboratory Animals, we have expressed our commitment to global animal welfare principles and the highest possible ethical standards in animal studies. The policy further sets out principles on the housing, care and feeding of laboratory animals. We strive to provide our animals with the best quality of life possible and consistently seek ways to make improvements. This ethos applies equally to the contracted animal study 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. Our Vendor Qualification Standard describes our criteria for evaluating the quality of animal welfare practices in our suppliers and partners.
Animal testing 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 testing, such as the housing conditions of laboratory animals, the conduct and approval of studies and the reliability and expertise of all involved individuals.
Number of laboratory animals used for medical study purposes
In 2019, 180,372 animals were used at our company. This represents an increase of 8% compared to 2018. This is attributable mainly to the Life Science business sector, specifically the subsidiary BioReliance. This increase is directly related to government-required safety testing of the compounds of our customers, in particular the testing and determination of clinical toxicological safety profiles.
The majority (96%) of the laboratory animals we use are rodents (mice or rats). In addition, around 10,240 animals were used by contract research organizations (CROs) on our behalf and in collaboration with academia, which represents a decrease of 5% compared to 2018. Regulatory agencies sometimes require the safety of investigational drugs to be investigated in 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 testing facilities to ensure adherence to our animal welfare standards. In 2019, three internal audits (sites in Israel and Scotland) and one authority visit in Darmstadt were conducted. Where necessary, we initiated the relevant corrective measures. No critical shortcomings were identified during these audits.
We strive to adhere to the highest international animal welfare standards. All our Healthcare laboratory animal facilities and one of our Life Science laboratory animal facilities in the United States were accredited to the standards of AAALAC International.
Collaborating with partners and suppliers
We perform the majority (95%) of animal studies ourselves and procure the animals required from specialized breeders. Sometimes, however, we also hire contract research organizations (CROs) to conduct animal studies on our behalf. Furthermore, we work with academic institutions. Whenever collaborating with such organizations, we expect them to share our high standards, as set out in our Use, Care and Welfare of Laboratory Animals Policy and in the Group standard entitled Animal Welfare CRO, CMO and Supplier Qualification.
Regularly auditing our partners
We verify compliance with our animal welfare policy and standards through a risk-based qualification procedure together with regular audits of our animal breeders and contract research organizations. As part of our collaboration with Interpharma, we worked with other member companies to develop a cross-company audit concept. 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. In 2019, the association conducted three audits in Germany, France and the United Kingdom, respectively. We, ourselves, conducted one audit at a CRO in Israel.
In October 2019, one of our CROs in Germany conducting animal studies was accused of having violated our animal welfare and legal animal protection regulations. Following a comprehensive internal investigation, we decided not to commission any further animal studies from this CRO. The last study activities ended in December 2019. If this legally required study had been terminated earlier, it would have had to be repeated elsewhere with other animals. To protect the animals and minimize any potentially harmful impacts, our experts oversaw the completion of the study. Through our rigorous and diligent on-site supervision at the laboratory we could ensure full compliance with all applicable animal protection standards and statutory regulations.
In consultation with the authorities, we work with recognized animal welfare organizations to find appropriate accommodation for the remaining laboratory animals. You can find more information in our NEWS section online (only in German).
Comprehensive employee training
We regularly train all employees who work with laboratory animals. This way we want to ensure that animal studies are conducted according to the latest scientific standards and that animals receive the best care possible. We held training sessions in Darmstadt (Germany), and at several U.S. sites. The training covered topics such as roles and responsibilities of Institutional Animal Care and Use Committees (IACUCs) and clinical care of animals. The nature and scope of the training courses are 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).
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. In 2019, for example, we established the use of less invasive imaging technologies (magnetic resonance imaging and ultrasound) for longitudinal and individual investigations in preclinical studies in rodents.
We also put in place an 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 re-homing program using recognized animal welfare organizations that specialize in laboratory animals.
Further, our scientists continuously develop alternative methods for animal studies and received numerous accolades for their efforts.
In 2019, we invited once again to apply for our 3Rs Award. The internal award honors employees who provide innovative ways of implementing the 3Rs principle for animal-based research.
We actively support the development of alternative testing methods and their official recognition at an international level. There is serious need for action here because animal studies 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 industry sectors seeks to pool knowledge and resources to accelerate the development of alternative approaches to animal use in regulatory studies. Through our membership in the German Association of Research-based Pharmaceutical Companies (vfa), we also support the German set Foundation, which is dedicated to finding and developing new alternatives in animal experimenting and 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 Chair of the set Foundation Board of Trustees.