From an ethical and scientific perspective, animal research is indispensable and is furthermore mandated by law. Through animal studies, we test both the safety of our chemical and medicinal products, as well as the efficacy of our pharmaceuticals. We enforce stringent animal welfare standards that exceed applicable laws and expect our suppliers, contract research organizations and other partners to do likewise.
The majority of our animal testing is conducted in our Healthcare business sector as part of the official drug approval process. However, animal welfare has also become a more prominent issue for our Life Science business sector. The acquisition of the U.S.-based life science company Sigma-Aldrich in autumn 2015 has increased the number of products of animal origin in our Life Science portfolio. For instance, certain animals are kept so that their blood can be used to produce antibodies. Before the acquisition, Sigma-Aldrich also conducted animal studies as part of contract research work for third parties, a line of business we are continuing to pursue.
Our principles
The 3Rs of animal welfare
In the housing, care and feeding of our lab animals, we are committed to consistently applying the most stringent ethical standards and are continuously working to improve upon them. When conducting research, we adhere to established methodology and endeavor to use animal alternatives 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
We promote the 3Rs outside our company as well. For instance, under the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), we have joined forces with other companies to support the Global 3Rs Awards Program. In partnership with the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), this initiative recognizes innovative contributions toward the 3Rs of animal research to advance ethical science in academia and industry. In 2016, one of the Global 3R Awards went to Madhav Paranjpe, a scientist from our Life Science business sector. He was recognized for publishing a study showing how the number of mice used to evaluate the carcinogenicity of a new drug can be reduced by 25%.
Legal requirements
Animal research is only permitted if there are no recognized alternative methods available. However, in many fields, animal studies are indispensable and legally mandated by the ICH guidelines or REACH. The safety of humans is our number one priority. Laws and regulations govern all aspects of animal research, such as the housing conditions of research animals, the conduct and approval of studies, and the reliability and expertise required of all involved individuals.
Group-wide methodology and guidelines
Through our Group-wide Use, Care and Welfare of Laboratory Animals policy, we make a commitment to global animal welfare principles and the highest possible ethical standards in animal research.
This 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 contract animal research services we’ve been offering third parties since acquiring Sigma-Aldrich.
In addition to our policy, our Group-wide Animal Science and Welfare manual describes the requirements for implementing, maintaining and improving animal welfare practices.
Organizational structures
Our Corporate Animal Science and Welfare (EQ-A) unit is headed by the Chief Animal Welfare Officer, who is responsible for creating uniform animal welfare standards. The Chief Animal Welfare Officer also initiates audits, sometimes performing these themself, and consistently works to drive improvements in our own animal welfare practices as well as those of our partners. Moreover, all our animal science and welfare experts meet on a regular basis through our global laboratory animal science network, which monitors the animal welfare units at our sites and supports all projects and processes related to animal science and welfare.
In 2016, we furthermore established the Group Animal Welfare Council, which convenes several times a year. Comprising representatives from all our business sectors, this council monitors policy developments, updating our Animal Welfare Strategy where necessary.
Our sites are generally 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 when 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. Our Chief Animal Welfare Officer has an active role in various committees to advocate our position on animal welfare. In 2015, for instance, he chaired the IQ Consortium and currently represents EFPIA on the AAALAC International Board of Trustees, where he ensures adherence to European standards. Moreover, at the end of 2016 he was appointed to the Executive Committee of AAALAC International for a term of three years.
Collaborating with partners and suppliers
We perform the majority of animal studies ourselves and for the most part procure our lab animals from specialized animal 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 academic institutions. When collaborating with such organizations, we expect them to adhere to the same high standards as we do, as set out in our Use, Care and Welfare of Laboratory Animals policy. We review compliance with this policy by performing regular audits.
The suppliers gained from the Sigma-Aldrich acquisition are also subject to our strict animal welfare requirements. Since 2016, we have been working on harmonizing our standards and developing a suitable audit concept.
Employee training
We regularly provide training to all employees working 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 and international legislation, as well as local requirements. The respective regulatory authorities monitor our activities to ensure they are in compliance. In addition to this training, our employees regularly participate in external continuing education programs such as accredited laboratory animal science courses offered by the Federation of European Laboratory Animal Science Associations, the American Association for Laboratory Animal Science, the Society of Laboratory Animal Science, the Laboratory Animal Science Association, and the Interessengemeinschaft Tierpfleger (Community of Animal Caregivers).
Progress
The majority of laboratory animals are rodents
Roughly 96% of the laboratory animals we use are rodents (mice and rats). Other animal species are only used if specified by statutory regulations or if deemed necessary for scientific reasons. For example, regulatory agencies sometimes require investigational drugs to also be safety tested on a non-rodent species such as monkeys, dogs or pigs. Guidelines such as REACH also require testing on non-rodents under certain circumstances. This allows researchers to identify potential side effects with the necessary accuracy and include them in the risk assessment of a substance. In performing tests on non-rodents, researchers must meet additional requirements pertaining to animal care and study design.
Animal types
Auditing our animal research facilities
We perform regular audits on our animal research facilities to ensure adherence to our animal welfare standards. In 2016, for instance, our Corporate Animal Science and Welfare unit conducted three internal audits at our sites in the United States, the United Kingdom and Israel. These audits identified the need for better environmental enrichment to promote species-typical behavior. They also suggested improvements relating to occupational safety, veterinary care and organizational issues. Corrective actions have since been taken.
It goes without saying that we adhere to the highest international animal welfare standards at all times. Since early 2016, all our Healthcare laboratory animal facilities have been certified to the standards of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International). One facility in our Life Science business sector is also AAALAC-accredited.
Conducting audits of 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 developed a cross-company audit concept that concentrates on those partners we feel to harbor potential risks. In the 2015-2016 period, a total of three audits were conducted in European countries excluding Germany. The audit results are shared among Interpharma member companies and treated confidentially.
Developing alternative testing methods
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 acceptance, both animal studies and alternative testing would have to be conducted in parallel when developing pharmaceuticals intended for worldwide distribution.
To help rectify 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, 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 Board of Trustees.
Our own scientists are also working on developing alternative methods and have received numerous accolades for their efforts.
Awards for developing alternative testing methods
- 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