Animal research is key to many of the great medical advances of today, including vaccines for diseases like polio; cancer treatments; medicines to treat neurological diseases such as epilepsy, schizophrenia and depression; medicines for diseases that have high morbidity and mortality rates around the world like high blood pressure, diabetes, malaria and much more.
While the end of medical research involving animals might be a future possibility, it is not possible today. Often, animal studies are required by regulatory agencies around the world to better understand complex disease mechanisms and to prove that medicines are safe and effective.
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 (PDF X.X MB).
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 also added a unique new role: a specialty-trained veterinarian to liaise between internal scientists and those conducting sponsored animal studies at external partner sites. This change has facilitated greater implementation of the 3R principles, and enhanced 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.
We established 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.
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 by 86% via a cross-divisional collaboration between three different disease areas to profile neuroinflammation pathways in a model for Amyotrophic Lateral Sclerosis (ALS).
The Replacement and Reduction of animals needed to monitor and maintain high standards of rodent health through use of exhaust air dust analysis, replacing up to 60% of the sentinel animals each year.
The Reduction of animals needed for studies of nerve regeneration by 80% through use of artificial intelligence screening.
Refinement
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.
Minimally invasive telemetry to measure heart rate without handling, therefore reducing animal stress and substantially increasing the quality and amount of data collected.
A novel approach to studying tissues rather than live animals to screen for potential negative side effects on kidneys when assessing the safety of new medicines.
Replacement
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.
The Replacement of animals needed for specific tumorigenicity studies of new cell and gene therapies through the use of a soft agar-based benchtop assay.
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 third annual Biomedical Research Awareness Day (BRAD) in 2021. 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 Culture of Care, as well as recognizing 3Rs advancements achieved by our annual Local and Global 3Rs Award Winners.
Culture of Care Art Challenge
For our BRAD 2021 topic “Culture of Care” we invited Novartis associates to express their creative self by proposing an artistic interpretation of what a culture of care means to them within the area of animal research with the artistic medium of their choice.
This is just one of the contributions to our Culture of Care Art Challenge.
Art 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.
