Research involving animals has been imperative to advance medical innovation, especially drug development. It will continue to be important to further discoveries until viable non-animal alternatives are developed and accepted.

Animal studies are a legal and regulatory requirement when developing medicines to ensure safety and efficacy.  Janssen is committed to limiting the number of animals tested whenever possible.  Various European guidelines, national laws and regulations state testing must be performed in animals before human exposure.  These tests are conducted under the most stringent conditions and may only be performed if there are no alternatives.

Ethical and experimental control

The laws and guidelines impose strict rules on conducting and documenting animal tests and on the treatment and care of animals involved in scientific research. Janssen strictly complies with these laws and abides to the highest standards of animal welfare.

Every scientific study involving animals is presented to an ethics committee composed of at least seven specialists with expertise in ethics, alternative methods, animal health, animal welfare, scientific methodology, experimental design and statistics. With every research project, the committee verifies whether alternative testing methods are available and ensures that research is being conducted with the utmost respect for the wellbeing of the animal, in accordance with all legal and ethical standards. For studies where alternatives are not available, the following ethical questions are considered: What can science learn from this project and are the learnings appropriately proportional to the animal's welfare?

The Three Rs at Janssen

Janssen has a very strong commitment to the 3Rs principles: Replacement, reduction, and refinement.

• Replacement means that, whenever possible, studies are conducted without animals. 
  
  This can be done, for example, by using cell cultures, 3D cell structures, chip technology (e.g. organ-on-a-chip), physico-chemical methods, molecular biology or mathematical models. At Janssen, all medicines and therapies in development are tested in vitro first, for example, in cell cultures, or elsewhere outside of a living organism. This allows us to make initial, important assessments about the safety and efficacy of our compounds and significantly reduces the number of required tests that involve animals.

• Reduction means that the number of animals involved in scientific research must be as low as possible.
  
  This number should never be less than the minimum number required to obtain reliable results. All of our tests involving animals require input by a biostatistician to ensure an appropriate experimental design and that the right number of animals is involved to answer the research questions.

• Refinement refers to modification of husbandry or experimental procedures to minimize pain and distress and to enhance the well-being of the animals. 
  
  In addition to researchers, animal caregivers and veterinarians are part of the Janssen team that ensures the well-being of the animals. Janssen has an extensive and holistic enrichment program that provides species specific mental and environmental stimuli and social housing to enhance welfare, including positive reinforcement training and extensive human interactions, with playing, petting, grooming, outdoor walks and access to play areas.
  
  Furthermore, Janssen supports rehoming some of our research animals through experienced and approved partners.

One day we hope alternatives and non-animal models can replace all animal testing. Today, there is still a need to conduct animal testing to discover and develop innovating and safe treatments for both humans and animals.

For more information on our commitment to animal welfare and 3Rs please see: J&J Animal Welfare Policy.

Greater transparency

In November 2019, Janssen, along with twenty-one other Belgian research centers signed the Transparency Agreement on Animal Research in Belgium. Together, we are committed to communicating more frequently and openly about animals involved in research.

The agreement contains four commitments:

1. Being clear about how, when, and why animals are involved in research,
2. Enhancing our communication with the media and the public, including the implementation of alternative methods and the reduction or refinement of animal testing,
3. Being proactive in providing opportunities for the public to find out about the animals involved in research and the regulations that govern it,
4. Report progress annually and share our experiences.

At Janssen, we consider this agreement to be an important commitment in our communication about the animals involved in research.

More information and the full text of the transparency agreement can be found here