Animal Care and Welfare

The guiding principles of the internationally established 3Rs underpin the humane use of animals in scientific research and testing. For as long as it remains necessary to use animals in the discovery, development and evaluation of new veterinary medicines and therapies, we embrace the principles known as the 3R’s of animal research. The 3R’s include replacing animals with alternative methods whenever possible, reducing the number of animals required and refining husbandry or experimental procedures to minimize pain and distress, and to enhance the welfare of an animal used in science.

To implement the 3Rs effort, Zoetis has an internal program called Transition Away from Animal Testing (TAFAT) where colleagues are committed to developing and validating in vitro tests as alternatives to traditional in vivo tests required by regulatory agencies for product release. We have targeted the reduction of the use of animals in product release testing as a vital aspect of adhering to the principles of the 3R’s.

The TAFAT program has successfully gained regulatory approval for non-animal release tests for one of our Leptospirosis vaccines for dogs and our Rabies vaccines in the EU which will replace the use of animals for routine release testing, as well as progressed other tests in development. Zoetis now also takes an “in vitro first” approach to potency test development for new vaccines.

In addition, Zoetis colleagues in Europe played a key role in the VAC2VAC project, a public, private partnership dedicated to developing quality control testing approaches for human and veterinary vaccines using non-animal methods. The six-year project concluded in February 2022 and has resulted in the validation of two in vitro assays that are approved as replacements for animal tests. Additional in vitro assays are still being explored. Moreover, the VAC2VAC project produced 21 peer-reviewed open access publications on both technical aspects and methods as well as promotion of regulatory acceptance.

Read more about how PHARMAQ, our aquaculture business, is committed to the 3Rs here.

For each study involving client-owned animals, we identify an appropriately experienced Sponsor Representative to act on our behalf as the Sponsor, and to be ultimately accountable for all aspects of study execution, including those of ethical conduct. This requirement is defined within study type-specific SOPs, including requirements for the study to be conducted both in accordance with our Policy on Animal Care and Welfare and with relevant local or national regulatory requirements. Our Council on Animal Welfare has a guideline for clinical studies that outlines further requirements for ethical conduct, including the need for written contracts, written informed consent, an existing veterinary client patient relationship (VCPR) and prior ethical review. This framework of requirements, in conjunction with the Veterinary Medicine Research and Development (VMRD) managerial line structure, gives robust responsibility for, and assurance of, ethical conduct in any study involving client owned animals.

All studies involving client-owned animals are reviewed by a panel of objective experts in accordance with our Policy on Animal Care and Welfare. The requirement for ethical review and conduct of such clinical studies is further defined within a specific Zoetis Council on Animal Welfare that also indicates that site-specific committees are responsible for such review. In addition, VMRD study-type specific SOPs outline requirements to adhere to prior ethical review for studies involving client-owned animals.

Only qualified personnel conduct our studies, following appropriate SOPs and a training system. We have an obligation to monitor studies on a regular basis to ensure protocol adherence. Beyond that, we have a regulatory obligation to report all adverse events through the study report if an investigational product is used. If an approved veterinary product is used in a study, potential adverse events are reported within strict timelines through the Zoetis Global Pharmacovigilance (PV) group and would be reported to regulatory authorities as applicable, including outcomes, violations and corrective actions. PV reporting requirements are determined by legislation and agency requirements, including frequency of reporting, timing of reporting and documentation of adverse events.

Oversight for all animal care and welfare programs begins with the Quality and Innovation Committee of our Board of Directors, with Executive Team members reporting at least annually to the Committee. Our policy is set by our Animal Welfare Board, comprised of Zoetis colleagues, and our Council on Animal Welfare ensures that the policy is implemented at all our sites that use animals. This policy is overseen by our Executive Team and applies to all colleagues, contractors and third-party affiliates who undertake any activity on behalf of Zoetis that involves animals. Zoetis conducts monitoring of animal welfare programs, both at onsite locations and with external partners around the globe. Regular welfare audits are conducted by individuals experienced in animal welfare regulations, auditing practices and sound professional judgment. The goal is to ensure compliance with local animal care and welfare standards and Zoetis policies. Site audits are conducted at least annually, and external third party sites are audited based on the outcomes of our third-party risk assessments.  

Zoetis is committed to cross-industry and cross-sectorial efforts to develop and refine new in vitro testing and predictive informatics-based systems that hold promise for reducing animal usage as well as fostering global regulatory acceptance. To drive our commitment, we are members of organizations and actively engage with and lead projects to move forward both the science and regulatory acceptance. A few examples include:

• The European Partnership for Alternatives to Animal Testing, which is instrumental for the 3R's harmonization efforts. Zoetis represented the Animal Health industry at the 2022 Partners forum on exposure considerations for human safety which is an important area of animal use for human safety assessment of animal medicines.
• The European Animal Research Association, a communication and advocacy group for animal research. Through EARA, we can further communication and understanding for stakeholders of the way in which animals are used by our industry and the work being done to reduce or replace animal use where possible.
• AnimalhealthEurope, the voice of the EU animal health industry, with a focus on the availability of animal medicines in a sustainable way, including through advocating for a high standard of animal welfare. Zoetis is an active member of the animal welfare task force as well as leading technical and regulatory input in this area. This interaction is critical to further regulatory understanding and acceptance, closely with both the European Medicines Agency (EMA) and national competent authorities and their testing laboratories.
• HealthforAnimals, the voice of the global animal health industry. Zoetis is an active member of the 3R's taskforce focused on advancing the regulatory acceptance of alternatives to animal testing globally. In 2022, Zoetis collaborated with HealthforAnimals, International Alliance for Biological Standardization (IABS) and Animal Free Safety Assessment (AFSA) on a series of webinars and a workshop to promote acceptance of non-animal methods for vaccine batch release, engaging with regulators from around the world. We also continue to lead the drive toward increasing acceptance of alternatives to animals for both routine product release and for product development where replacement or refinement is scientifically justified.