To discover, develop, manufacture and market innovative medicines and vaccines that treat and prevent illness, laboratory animal research is indispensable for scientific and regulatory reasons.

Merck is dedicated to the ethical and responsible treatment of all animals used in the development of medicines and vaccines. Merck does not perform animal testing on cosmetic products. Decisions regarding animal care, use and welfare are made by balancing scientific knowledge and regulatory requirements with consideration of ethical and societal values.

The care and use of laboratory animals in biomedical research is highly regulated. In general, the regulations govern housing, feeding, veterinary care and research-project review, and include both internal and external inspections. Our standards for animal care and use meet or exceed all applicable local, national and international laws and regulations.

As further evidence of our commitment to the highest level of animal care, Merck Research Laboratories’ (MRL’s) research sites voluntarily seek and secure a third-party review and accreditation of our animal research programs and facilities by an independent organization—the Association for Assessment and Accreditation of Laboratory Animal Care-International (AAALACi). Merck also advocates for the development of best practices and dissemination of information by supporting and participating with nongovernmental organizations such as the Scientist Center for Animal Welfare, the Institute for Laboratory Animal Research at the National Academy of Sciences, and the American College of Laboratory Animal Medicine Foundation.

Merck's standing Institutional Animal Care and Use Committees (IACUCs)/Ethical Review Committees, which include veterinarians and independent, non-Merck members, provide oversight of the company's animal care and use programs. They review all proposed animal studies, review the animal care and use programs, inspect facilities, investigate any concerns and report all findings to the Institutional Official for Animal Welfare, who is globally accountable for compliance with all of our animal welfare policies and regulations.

To assist in this responsibility, an Animal Welfare Compliance group provides support and monitoring. Appropriately qualified veterinarians oversee the healthcare of all the animals. All employees who are involved with research animals are given animal-welfare training, which includes review of regulations and policies, instruction on how to search for animal research alternatives, explanation of the role of the IACUC/Ethical Review Committees and training on how to raise concerns. Merck places high value on its animal-welfare-stewardship responsibility; violating these policies would be grounds for employee disciplinary action, up to and including dismissal.

Merck holds similar expectations for standards of animal care and use at our contract laboratories. Merck performs due diligence and monitors external laboratories performing in vivo studies on our behalf, and holds them accountable to the same regulations and standards that govern our animal care and use. Additionally, in vivo research conducted at third-party laboratories is subject to protocol review by a Merck IACUC or equivalent committee. Noncompliance with regulations or standards can lead to termination of the relationship.

Replacement, Reduction and Refinement

Merck is committed to the philosophy of using the best scientific methodologies and animal alternatives whenever possible or permissible by law. To promote this commitment, we subscribe to the "3Rs"—Replacement, Reduction and Refinement for laboratory animal-based research.

• Replacement—using non-animal systems or less-sentient species (for example cell cultures, computer modeling, bacterial assays and fish models)
• Reduction—using the minimum number of research animals necessary to obtain valid scientific data (sophisticated animal models that yield precise data, such as telemetric monitoring models that monitor ECG and blood pressure, reduce the number of animals needed)
• Refinement—minimizing any distress or discomfort during a study (extensive literature searches contribute to the use of the best scientific models, and analgesics or tranquilizers are used whenever possible)

In 2012, Merck created a 3Rs Committee that will collect, promote and disseminate information on the 3Rs practice. Training in the 3Rs is part of staff orientation for in vivo research. It is our responsibility to use the most appropriate methodology and to aggressively seek scientifically valid 3Rs approaches to animal research. Merck also has extensive in vitro expertise and investments, including an In Vitro department that develops and utilizes nonanimal research methods (cell cultures) in the discovery and development of new medicines and therapies. Merck also provides funding to support 3Rs research at external organizations such as the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and the European Partnership for Alternative Approaches to Animal Testing (EPAA).

As an example of refinement and reduction in the number of animals used, Merck has created a world-class imaging department that allows scientists to view cancers and other pathologic diseases in animals and monitor the long-term effectiveness of new treatments in a noninvasive manner. In addition, the company employs internal and external information specialists in our research library, trained by the Animal Welfare Information Center of the U.S. National Agricultural Library, to assist our scientists in identifying potential animal alternatives.

Internal Merck Animal Alternative Award

To support the 3Rs philosophy, since 1994, Merck has presented an Animal Alternative Award annually to the team or teams of Merck scientists who develop new techniques that support the alternative principle, and has published their work to share with the scientific community. The 2011 Animal Alternatives Award went to process refinement in bladder catherization. The 2010 award was for validation of an electrocardiogram (ECG) parameters model in a guinea pig model that replaced a canine model.

Animal Alternative Award for Veterinary Research

The Dieter Lütticken Award, sponsored by Merck Animal Health, is used to promote scientists or life science research institutions working in areas that serve the 3Rs concept, i.e., replacing, reducing or refining the use of animals in testing, in the development and production of veterinary medicines. The total funding for this award is 20,000 euros.

The 2011 Award went to a scientist whose trendsetting work on the development, optimization and standardization of polymerase chain reaction (PCR) assays of extraneous agent testing of inactivated poultry vaccines replaced the need for testing on live chicks.

The 2010 Award went to a team in the United Kingdom that established a physiologically relevant, rapid and sensitive in vitro air interface respiratory tract organ culture model to analyze host-pathogen interactions following single and mixed infections with the respiratory pathogens Mannheimia haemolytica and bovine herpesvirus 1 (BHV-1).¹ This model has replaced the use of animals in some studies of respiratory disease and has the potential to be used in developing new vaccines.

¹Niesalla HS, Dale A, Slater JD, Scholes SFE, Archer J, Maskell DJ, Tucker AW. Critical assessment of an in vitro bovine respiratory organ culture system: a model of bovine herpesvirus-1 infection. Journal of Virological Methods 2009;158:123-129.