Animal Ethics

Our long-term ambition is to phase out animal use in all our work. Until then, we are committed to the highest ethics and welfare for all animals used in our activities.

As humanity, the ultimate goal of all our efforts must be to use our technological evolution to integrate ourselves into the ecosystem, flora and fauna, rather than to continue to consume them. In this context, replacing the use of animals with animal-free methods in research field as well as for commercial purposes is essential.

Kerstin Kleinschmidt-Doerr

Chief Veterinary Officer

Why we use animals

Science progresses quickly and we firmly believe that the continued development of technologies will one day bring an end to use of animals in research and allow our sustainable integration into the ecosystem without compromising patient or environmental safety. We want to be at the forefront of this evolution.

While several animal tests have already been replaced, many alternatives are still in development. We also do not yet have an idea for every animal experiment that is currently urgently needed on how we can replace it. These tests are necessary to find solutions to severe medical problems and to protect the safety of our environment and ourselves – and many are therefore also legally required. Until we have alternatives to all our animal methods, we are committed to enforcing and pioneering the highest possible animal welfare standards in every area of our work.

In addition to the internationally recognized 3Rs principles – Replacement, Reduction and Refinement - we have adopted Responsibility as our fourth animal welfare principle. This reflects our responsibility for all animals in our reach internally and among our service providers and is in line with the latest international thinking on ethical use of animals in research [1].

Why is animal work necessary?

Almost every significant medical advance of the last century has depended on research involving animals. This research has helped us to scientifically understand how the body works, how diseases develop and to understand what a drug does to that disease and to the body. It is still required to understand that potential treatments are effective and safe for human and animal patients – from surgery to vaccines to cancer treatments. Using animals in research can help us better understand and treat complex diseases such as Parkinson’s and multiple sclerosis.

In addition, some essential products used in research are also derived from animals – for example materials for growing cells in an artificial environment. Animals are also used in mandatory safety testing of chemicals used in everyday products – from paints and dyes to household cleaners – to protect consumers, workers, wildlife and the environment.

As a company we are uncompromising in our mission to deliver the safest and most effective products and services. However, animals are only used by us where there is absolutely no other alternative. We already have many more alternatives today than we did a few years ago, and the number is constantly increasing.

While all this makes animal research a necessity, at least for now, we intend to do it responsibly and transparently. That’s why we’ve brought into force strict ethics and welfare standards to all animals used in our work

The Marseille Declaration

Together we prioritize animal welfare. When it comes to taking responsibility for the animals used in our sphere of impact, we do not compete but collaborate. In 2022, Merck KGaA, Darmstadt, Germany, formed a coalition of pharmaceutical companies to create a common statement that we prioritize animal welfare not only internally but also with all our business partners. Together with other pharma companies leading in animal science and welfare we signed the first joint pharmaceutical industry declaration asking for worldwide implementation of highest possible ethical and animal welfare standards – the Marseille declaration.

Learn more

Exceeding animal welfare standards

Although we aspire not to use animals in our work where possible, we are proud of the high ethical standards we uphold to ensure their welfare.

Not only do we enforce stringent animal welfare standards that often exceed applicable laws, but we also expect our external partners who use animals on our behalf to adhere to those same standards. For example, we require adherence to European Union regulatory animal welfare conditions, which are the strictest in the world, for all non-rodent species used on our behalf.

We ensure that the number of animals used is minimal and there is no alternative available via our animal usage review boards which approve all work conducted by or on behalf of our company involving the use of animals.

As a result, all animals within our reach receive high standards of housing, husbandry, and care – and we continuously improve our animal research processes to enhance the animals’ quality of life.

We are very proud of our colleagues who take such diligent care of our animals and thank them for their important work with the animals and daily loving care and concern.

Explore our award winning Rat Colony Cage

The well-being of our animals is very close to our hearts, so we are constantly looking for improvements that increase their life quality. The love for animals is a necessity in our profession.

Jasmin

Animal Technician

Animals used in our work

The number of animals we use changes, and we register a continuous decrease especially when looking at the number of animals used per project. As a snapshot, in 2023, a total of almost 145,000 animals were used in our work, either in our own vivariums or on the premises of organizations contracted on our behalf.

The animals used in our work are primarily rodents (mice or rats) which account for 97% of all animals used in 2023. Other species used are guinea pigs, rabbits, hamsters, fish, non-human primates, dogs, minipigs, tadpoles, goats, sheep, camelids, and chickens.

For our most recent animal use numbers, you can read our sustainability report.

Use of non-human primates

Humans belong to the primate group. Therefore, non-human primates are necessary to understand and model certain diseases that occur only in the primate system. However, non-human primates are used exclusively where the required tests cannot be performed on other species or with non-animal methods.

We acknowledge that non-human primates have a high level of development and a social nature including individual preferences for their environment. Therefore, we do everything we can to ensure special attention is paid to their housing, training, socialization, and environmental enrichment. We want to maximize the quality of life of these animals and reduce their burden to an absolute minimum.

We also strive to avoid the use of non-human primates and are actively researching alternatives, such as human-on-a-chip technologies.

Who carries out animal studies?

We perform the majority (87%) of animal studies used for our work ourselves. But for certain work, we commission contract research organizations (CROs) or partner with universities to conduct animal studies on our behalf. This is sometimes the best choice as they may have particular expertise or animal models that we do not have access to ourselves.

No matter where the work is carried out, we strive to adhere to our global Animal Science and Welfare policy and standards.

Our vivariums

Curious about our vivariums and our animals?

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Our 4Rs in action

The 3Rs - Replace, Reduce, Refine were formulated by William Russel and Rex Burch and have been adopted as an ethical framework for improving the welfare of animals used in research around the world [2]. Our company has adopted a fourth principle of Responsibility. You can read more details and examples of how we are putting our 4Rs into action below.

“We are committed to our own Merck KGaA, Darmstadt, Germany, 4R approach, whereby each individual life matters. Based on the internationally recognized 3Rs for animal-based research: reduce, refine and replace animal utilization, we aim to create value for our company without compromise on patient or consumer safety” – Kerstin Kleinschmidt-Doerr, Chief Veterinary Officer

Our long-term vision is to phase out the use of animals. Until then we are pioneering alternative tests and working with regulators to look at implementing these alternatives wherever possible.

We are working on several innovative projects right now that could replace or have already replaced animal use with non-animal-based alternatives. Examples include:
- PyroMAT® – Any pharmaceutical products which enter the body by routes other than the mouth – such as drugs, dialysis solutions, and medical devices – are required to undergo mandatory safety testing to confirm the absence of pyrogens. Pyrogens are substances such as bacterial endotoxins and chemicals that can cause life-threatening fever reactions. In the past, testing for pyrogens in rabbits was required by international guidelines. We have since developed the PyroMAT®, which is now accepted as an alternative.
- ZooMAb® recombinant antibodies platform applies innovative engineering technologies to the generation of antibodies for use in research. These antibodies can be manufactured in cells without the need to harm or sacrifice any animals.
- Blazar™ reduces dependence on using animal models for detection of viruses by replacing the mouse, hamster, and rat antibody production tests typically used.
- Organ-on-a-chip – our researchers are currently working on this advanced cell culture model that could ultimately deliver a powerful non-animal alternative for drug testing.
We also convinced EU regulatory authorities to approve an alternative method that does not involve guinea pigs for testing some of the plastic parts in medical pumps. While the animal-based test is not forbidden yet, it is now no longer specified as a requirement in the regulation for this medical device.
We reduce the number of animals we use by applying professional statistical expertise to any research protocol involving animals. This means we only use the minimum number of animals needed to accurately answer the scientific question being explored.

We actively contribute to the Innovative Medicines Initiative 2 (IMI 2) project called eTRANSAFE. This project aims to improve the efficiency of safety assessments during the drug development process through the sharing of ‘control’ data within the pharmaceutical industry, which reduces the number of animals that need to be used for certain drug tests. We are also convincing regulators to reduce the requirements for animal use during these safety assessment stages, where suitable alternatives are available.

In addition, we significantly reduced the number of guinea pigs used to test if substances are unintentionally present in certain drugs or active ingredients that may cause unwanted effects. This was achieved by demonstrating our responsibility and convincing the customers to use an in vitro alternative.

Furthermore, we are constantly gathering information and developing new methods and models so that we need fewer and fewer animals. For example, we were able to significantly reduce the use of dogs by rethinking the study design based on available data.
We are continuously refining our work with animals to ensure they experience minimum distress and discomfort. Our approach goes beyond meeting legal requirements not only to uphold animal welfare but also to ensure high quality and outcomes of experiments and helping us towards developing the highest quality, safest reagents and products.

Our commitment to animal welfare goes beyond words: our animal caretakers, scientists and vets are dedicated to the animals in their care and our management understand their holistic responsibility for the animals we use. We invest in our facilities to ensure they meet animals’ needs. It is especially important to us those species-specific needs are always satisfied, including species-appropriate housing, environmental and social conditions. This means looking at the needs of each individual animal species and providing an environment allowing them to carry out their normal behaviours and feel as safe and comfortable as possible.

For example, we recently implemented ‘tunnel handling’ of rodents, where rats and mice are trained to move into transparent tubes for cage changes or clinical examination. This causes them less stress than being handled by hand.

In 2018 we received the Animal Welfare Award of the State of Hesse for this innovative social group housing of rodents and rabbits allowing them social interaction, considerably more freedom of movement and the establishment of functional units (such as sleep, eat, play, and defecation) [2] [3].
Our fourth R is to our responsibility for all animals in our reach internally and among our service providers. To turn this into action, we rolled out a global learning program on the 4R principles to all our employees (both those who work with animals and those who do not) as we strongly believe it is everyone’s responsibility to apply these principles wherever we can.

We have also set up a 4R team and cross-functional workstreams for each of the 4Rs. The 4R team regularly reports progress made with the 4Rs to our Group Animal Welfare Council. It also coordinates the 4R Award, with which we recognize contributions to the Replacement, Reduction, Refinement of, and Responsibility for our animal work.

Many new ideas for improving animal welfare and reducing animal numbers needed in our research are proactively initiated by our researchers – and our 4R awards recognize these achievements.

For us, responsibility also means that we report transparently on our work. We do this in the hope that our approaches to refinement will set a precedent, but also with the goal that globally as few animals as possible need to be used. We not only publish our successes and particularly well performing approaches and methods so that others can build on them, rather than starting the same work from scratch. We also document and share our unexpected or unfavourable results to prevent such approaches from being tried again by others.

Everyone in our company takes responsibility for the animals we use somewhere along the value chain, from start to finish, by always questioning their decisions and doing their best to value every animal.

Frederic Christian Pipp

Global Animal Welfare Officer

Turning our commitments into action

As part of our responsibility for all the animals within our reach, we have global re-homing programs for all species we use in our work.

More information

You can find out more about our animal welfare ethics and standards and our research into alternatives to animal testing below:

References

_{[1] DeGrazia D, Beauchamp TL. Beyond the 3 Rs to a More Comprehensive Framework of Principles for Animal Research Ethics. ILAR J. 2021;60(3):308-317. doi:10.1093/ilar/ilz011

[2] 'Russell WMS and Burch RL. The Principles of Humane Experimental Technique. Methuen, London, 1959.'

[3] Brenneis C, Westhof A, Holschbach J, Michaelis M, Guehring H, Kleinschmidt-Doerr K. Automated Tracking of Motion and Body Weight for Objective Monitoring of Rats in Colony Housing. J Am Assoc Lab Anim Sci. 2017;56(1):18-31.

[4] Chang YM, Menges S, Westhof A, Kleinschmidt-Doerr K, Brenneis C, Pitsillides AA. Systematic analysis reveals that colony housing aligns gait profiles and strengthens link between histological and micro-CT bone markers in rat models of osteoarthritis. FASEB J. 2021;35(4):e21451. doi:10.1096/fj.202002009R}