Animal research is key to many of the great medical advances of today, including cancer treatments; medicines to treat neurological diseases such as multiple sclerosis, medicines for diseases that have high morbidity and mortality rates around the world like high blood pressure, diabetes, malaria and much more.
In addition, animal research is important for the development of new treatments such as radioligand, and cell and gene therapies.
Novartis fully supports the replacement of animals with non-animal alternatives wherever feasible, while meeting our obligations to patients and the expectations of regulatory agencies. More information about the Novartis position on animal research is provided in our position statement:
The welfare of animals in Novartis studies is a primary concern to us for reasons of ethics, accuracy, reliability and applicability of scientific studies. Good animal welfare is a prerequisite for good science.
We have a Global Animal Welfare Policy and a set of Animal Welfare Standards that define key principles, responsibilities and explicit requirements governing animal research. All Novartis sponsored studies, whether conducted internally or externally, must adhere to this policy and set of standards.
We transparently report the numbers of animals needed for research and development at Novartis each year. Data on the internal animal numbers is reported in our Novartis in Society Integrated Report.
Our Commitments to Animal Welfare
Promote high standards of animal welfare.
All individuals working with animals are trained to ensure proper care and handling.
Actively advance the 3Rs Principles (Reduce, Refine, Replace).
Ensure animals needed for research are treated and cared for respectfully.
Special attention is given to species-specific needs.
Any discomfort, distress, or pain is minimized in accordance with current veterinary practices.
Did you know?
Animal research is still necessary to discover and develop innovative, safe and life-saving medicines for patients.
Discovery and development
Because of animal studies, organ transplantation, antibiotics, artificial heart valves, and now personalized medicine have all been made possible. Once prevalent diseases, like polio and small pox are now rare or eradicated through the development of effective vaccines using animal research.
Until recently, patients suffering from some acute lymphoblastic leukemias had very few effective treatment options. But through study of mice with humanized immune systems, a revolutionary new type of therapy, CAR-T, is now available and is saving lives.
Regulatory Requirements
The health and welfare of our patients is the top priority for Novartis and regulatory authorities around the world. In most cases animal studies are required to prove that our medicines are safe and effective for patients.
AAALAC International Accreditation
All Novartis Institutes for BioMedical Research in-vivo research sites earned independent, voluntary, international gold-standard accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC international), underscoring our commitment to achieving the highest standards in responsible research with animals. AAALAC international is an independent, non-profit organization that promotes the humane treatment of animals in science with the aid of voluntary evaluation and accreditation programs.
Unique Animal Welfare Role
We have a specialty-trained veterinarian to liaise between internal scientists and those conducting sponsored animal studies at external partner sites. This role facilitates greater implementation of the 3R principles, and enhances the level of ethical oversight before, during and after animal studies conducted by third parties. Further, our team of animal welfare experts prospectively and continually audit third parties.
Emerging technologies
New emerging technologies, such as specialized digital rodent housing, allows our scientists to study mice in their home environments. This reduces stress on the animals from handling and eliminates the need to disturb them while they are resting. These technologies are leading the way for the discovery of better and more targeted medicines.
Digital housing allows mice to engage in normal behaviors such as nest building and wheel running, undisturbed, and in their natural circadian rhythm, while simultaneously measuring important clinical metrics such as motion and respiratory rate.
Our commitment to the 3Rs
Novartis is committed to the 3Rs principles (Reduction, Refinement, Replacement) and is driving innovation and efforts to advance the 3Rs both internally and in collaboration with external organizations.
Reduction - Improve existing methods so fewer animals are required.
Refinement - Refine studies so animals experience as little stress and as much comfort as possible.
Replacement - Develop & implement alternatives to replace animals in research wherever possible.
Further “R” awards:
Responsibility – the award for our 4th R was launched in 2022 to acknowledge colleagues that work outside of the in-vivo community and have gone above and beyond to support animal welfare.
The Novartis Exemplary Award was launched in 2018 to recognize employees who have contributed outstanding and continuous efforts to implement the 3Rs.
We have an animal welfare Ph.D.-trained 3R Scientist role to further strengthen our culture of ethical science at Novartis and to help advance the reduction, replacement and refinement of animal studies.
Innovation in 3Rs
In 2022, we launched our Innovation in 3Rs grant program. It aims to inspire and support Novartis scientists to reimagine how they conduct their research by providing them with the resources they need to innovate and validate new ways to Replace, Reduce, and Refine animal studies. This program complements the 3Rs Awards, which retrospectively recognize and celebrate recently achieved 3Rs advancements. The Innovation in 3Rs grant program selects and prospectively supports novel research projects that further strengthen the implementation of the 3Rs.
Newly funded 3Rs Innovation research projects explore the use of microphysiological systems to reduce the number of animals needed for safety assessments. They also examine organoid development to reduce animals needed for early discovery research, and the use of new home cage monitoring technologies to improve animals’ experience.
Replacement of animals with non-animal alternatives
Novartis fully supports the replacement of animals with non-animal alternatives wherever feasible, while meeting our obligations to patients and the expectations of regulatory agencies. In fact, Novartis has made great strides in adopting and even creating advancements in non-animal methods for drug discovery and development from computer and cell-based culture to organ-on-a-chip technology. For example, our scientific team developed a new method of using brain cells cultured in the lab to replace animals when screening new therapeutic compounds for potential negative neurological side effects.
Tissue cell culture is one of many non-animal alternatives utilized at Novartis.
Despite these advancements, there are still many areas where better understanding of disease mechanisms cannot be achieved without animals. The knowledge acquired through such studies is essential for the development of innovative treatments for unmet medical needs.
Reduction and Refinement
In addition to Novartis requirements to replace animals with non-animal alternatives whenever possible, our scientists and animal care experts lead efforts in developing new and innovative ways to leverage data, statistics, and study design to significantly reduce the number of animals needed for study and improve the animals’ experience on study.
Examples of 3Rs advancements at Novartis
Since 2007, Novartis has recognized significant advancements in the 3Rs through annual local and global 3Rs Awards which are evaluated for:
their impact on numbers of animals required for study
optimizing the animals state of being
replacement by a less sentient species
replacement of procedures involving animals entirely
Reduction
The reduction of the number of animals needed for studying tumor metastasis through use of luciferase labelled cancer cells.
The 10-fold reduction in the number of animals needed for an ophthalmology study via adoption of a novel study design.
The reduction of the number of animals needed for study through creation of infrared fluorescent protein labeled Chimeric Antigen Receptor (CAR) T-cells enabling serial, noninvasive imaging measurements of anti-tumor activity in the same animals over time.
Refinement
The adoption of a non-invasive alternative technique for genotyping transgenic fish.
Use of a new artificial intelligence approach for automated image analysis strengthened reproducibility and eliminated the need for repeat experiments.
Use of digital technologies for the observation and study of mice in their home environments, without disturbing their natural cycles of rest, while also improving the scientific quality of the data.
Replacement
The replacement of mice in a rheumatoid arthritis study through use of a novel human cell-based in-vitro test.
The replacement of animals needed to train scientific associates on key principles of surgery through the creation of a novel digital surgical training platform that allows the trainee to receive initial and refresher training on demand.
Successfully achieving regulatory approval of a non-animal alternative in lieu of previously required animal data.
Training and outreach
Training is provided to all associates responsible for internally and externally conducted animal research in order to ensure consistent high standards of animal welfare. In addition, special educational events and advanced training are offered throughout the year to help associates stay current with best practices.
Novartis celebrated our fourth annual Biomedical Research Awareness Day (BRAD) in 2022. BRAD was launched in 2016 by Americans for Medical Progress (AMP) in the US and is now celebrated globally. On this day we raise awareness about the continued need for and critical contributions of animals to the development of new medications and therapies for patients. Novartis celebrated BRAD globally with numerous presentations highlighting our efforts to support openness, as well as recognizing 3Rs advancements achieved by our annual Local and Global 3Rs Award Winners and new 3Rs Innovation Grant Award winners.
For our 2022 BRAD focus on openness, we invited Novartis associates to express their creative self by proposing an artistic interpretation of what openness means to them with the artistic medium of their choice.
This is the winner of our 2022 Art Challenge.
Annual art challenge submissions ranged from poetry, charcoal drawings, and graphic illustrations to needle point embroidery and wood cutting.
External Resources
Together, with external organizations, such as the Swiss 3R Competence Center, we are working to evolve the field to find alternatives to animal research, reduce the number of animals needed for research, and improve animal welfare. We also partner with organizations that help share the impact of these advancements.
