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 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 Merck's commitment to the highest level of animal care, Merck Research Laboratories' 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 (AAALAC). 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 Science, and the American College of Laboratory Animal Medicine Foundation.

Merck's standing Institutional Animal Care and Use Committees (IACUC)/Bioethics committees or their equivalent, 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, which is globally accountable for compliance with all Merck animal welfare policies and animal welfare 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 regulations, policies, the use of animal research alternatives, the role of the IACUC/Bioethics committees and how to raise any concerns. Merck places high value on its animal welfare stewardship responsibility, and violating of 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 Merck 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, Merck subscribes 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 model, and analgesics or tranquilizers are used whenever po.ssible)

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 3R approaches to animal research. Merck also has extensive in vitro expertise and investments, as the In Vitro department develops and utilizes non-animal research methods (cell cultures) in the discovery and development of new medicines and therapies. Merck also provides funding to support 3R research at external organizations like the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and 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 rodents and monitor the long-term effectiveness of new treatments in a noninvasive manner. In addition, Merck employs internal and external information specialists in our research library, trained by the Animal Welfare Information Center of the U.S. National Agriculture Library, to assist Merck scientists in identifying potential animal alternatives.

Internal Merck Animal Alternative Award

To support the 3Rs philosophy, since 1994, Merck has annually presented an Animal Alternative Award to the teams of Merck scientists who develop new techniques to support the alternative principle and has published their work to share with the scientific community.

The 2009 Animal Alternative Award went to two teams that used state-of-the-art imaging in cancer research studies that represented a refinement in technique and resulted in an overall reduction in the number of animals needed for studies while enhancing the data collected.

The 2008 Animal Alternative Award went to two teams that demonstrated a refinement in study techniques and a reduction in the number of animals needed through the use of quantitative 3D-Micro-Ultrasound in mice for hypertensive model development and atherosclerosis biomarker studies.

Animal Alternative Award for Veterinary Research

The Dieter Lütticken Award, sponsored by Intervet/Schering-Plough Animal Health, is used to promote scientists or life science research institutions working in areas that serve the 3R concept, i.e. reducing, refining or replacing 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 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).* 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.

The 2009 award went to a European team that developed an in vitro potency test for the routine quality control of inactivated Newcastle Disease Virus (NDV) vaccines. Previously, quality control of NDV vaccines included an in vivo potency assay in chickens. The new method avoids the use of chickens and has now been included in the respective European Pharmacopoeia monograph as an additional potency assay to release NDV vaccines.

*Reference: Niesalla 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.