Animal welfare

From both 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, and the efficacy of our pharmaceuticals. We enforce stringent animal welfare standards that exceed applicable laws and extend these high expectations to our suppliers, contract research organizations and other partners. We conduct animal testing within our Healthcare business sector as part of the official drug approval process. However, animal welfare is also a prominent issue for our Life Science business sector, which keeps laboratory animals for the production of antibodies, for instance. In addition, our subsidiary Bioreliance conducts animal testing as part of contract research work for third parties.

Our approach to animal welfare

Our Group-wide Use, Care and Welfare of Laboratory Animals Policy 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 tried and tested methods that ensure high-quality results and furthermore strive to replace animal testing with alternative methods wherever possible and permissible by law. We therefore subscribe to the internationally recognized 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. Under the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), for instance, 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 to the 3Rs of animal research to advance ethical science in academia and industry.

How we ensure animal welfare

As head of Corporate Animal Science and Welfare (EQ-A), our Chief Animal Welfare Officer is responsible for creating uniform animal welfare standards. This individual also initiates EQ-A audits, sometimes performing these himself within our company or on our partners. Moreover, all our animal science and welfare experts regularly interact through our global laboratory animal science network. A platform for sharing best practices and lessons learned, this network supports the animal welfare units at our sites along with all projects and processes related to animal science and welfare.

Our Group Animal Welfare Council convenes twice a year. Comprising representatives from all our business sectors, this council discusses relevant developments and makes decisions regarding our Animal Welfare Strategy. In 2017, our efforts focused on creating various guidelines and certifying contract research organizations, other partners and suppliers. To accomplish this, the council is developing a risk-based approach that will also apply to the procurement of products of animal origin.

In most cases, our sites are subject to additional national regulations. In order to assess the quality of animal husbandry practices and ensure 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. In 2017, for instance, we appointed an animal welfare officer for our Life Science business, who is greatly involved in conducting audits and identifying potential animal welfare risks in our supply chain.

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. Moreover, he represents EFPIA on the AAALAC International Board of Trustees, where he ensures adherence to European standards. At the end of 2016, he was appointed to the Executive Committee of AAALAC International for a term of three years. In addition to these positions, he is a member of the German Federal Animal Welfare Commission.

Our commitment: Group-wide methodology and standards

Through our Group-wide Use, Care and Welfare of Laboratory Animals Policy, 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 establish a basis for 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 contract animal research services we offer 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, in 2017 we created a new guideline entitled Housing and Husbandry Practices for Common Laboratory Animals, which applies to our external partners as well. We also drafted a Standard on Vendor Qualification, which describes our criteria for evaluating the quality of our suppliers’ and partners’ animal welfare practices. This standard took effect in March 2018.

Legal requirements

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 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

Approximately 97% 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 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 adverse effects with the necessary accuracy and include them in the risk assessment of a substance. In performing tests on non-rodents, we must meet additional requirements pertaining to animal care and study design.

Animal types

Auditing our research facilities

We perform regular audits on our animal research facilities to ensure adherence to our animal welfare standards. In 2017, for instance, our Corporate Animal Science and Welfare unit conducted two internal audits at our Healthcare sites in Billerica, MA (USA) and Ivrea (Italy). We have initiated the relevant corrective measures where necessary. No critical shortcomings were identified during these audits.

It goes without saying that we adhere to the highest international animal welfare standards at all times. 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). Furthermore, one of our Life Science laboratory animal facilities has also received AAALAC accreditation.

Collaborating with partners and suppliers

We perform the majority of animal studies ourselves and for the most part procure our animals from specialized breeders or, in very few cases, from our own breeding colony. 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 verify compliance with this policy through a risk-based qualification procedure and, where necessary, also conduct audits, generally every three years. In order to harmonize animal welfare efforts within our company, in 2017 we created a Group-wide standard entitled Housing and Husbandry Practices for Common Laboratory Animals, which also applies to our partners and vendors.

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 developed a cross-company audit concept that concentrates on those partners that are relevant to the maximum number of companies involved. In 2017, two audits were conducted in Europe. The results are shared among Interpharma member companies and treated confidentially. If critical defects are not corrected, we reserve the right to terminate our collaboration with the respective vendors.

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 and international legislation, as well as local requirements. The respective regulatory authorities monitor our activities to ensure 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).

How we implement the 3Rs

To minimize the discomfort and distress to animals before, during and after testing (refinement), in 2017 we introduced 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.

Moreover, 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 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:

  • 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
3R principle
The international guiding principle for all animal testing. The number of laboratory animals used as well as the stress placed on them before, during and after testing are to be kept to an absolute minimum by using methods to replace animal experiments (replacement), reduce the required number of tests and animals (reduction), and improve the test methods (refinement).
Adherence to laws and regulations as well as to voluntary codices that are internal to Merck KGaA, Darmstadt, Germany. Compliance is a component of diligent corporate governance.
The aim of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to promote uniform assessment criteria for product registration in Europe, the United States and Japan. The ICH makes recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration.
Investigational drug
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including approved as well as unapproved products when used or assembled (formulated or packaged) in a way different from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

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