Bioethics Position Statement
Animal Welfare
Baxter supports the conscientious use of animals in research only when the scientific purpose of the research is of sufficient potential significance to justify such use and no other reasonable scientific or regulatorily acceptable non-animal alternative exists to demonstrate the safety and effectiveness of the company's life-saving and life-sustaining products and therapies. The company embraces its ethical responsibility to ensure the well-being and humane care of the animals used for product development and testing. In the substantial majority of cases where Baxter uses animals, it is required by health authorities to do so.
The company is committed to using alternative protocols, methodologies and models which minimize or replace the use of animals. Baxter also works to refine current test systems to reduce animal use and improve animal welfare, while ensuring sound data are collected. For decades, the company has supported pre-clinical testing involving humane animal use that complies with all relevant local, national and transnational laws and regulations as well as additional voluntary guidelines.
Replacement, Reduction and Refinement
Baxter is committed to enhancing animal welfare through the 3Rs - replacement, reduction and refinement. The company applies a range of innovations in this area, including:
- Utilizing relevant available in vitro methods and the company’s strength in analytical characterization of materials to assess toxicological risk in lieu of animal testing.
- Using in silico methods, when possible eliminating the need for animal testing.
- Optimizing study design, data collection and analysis methods to reduce overall animal use, in cases when Baxter is required to conduct animal testing.
- Participating in the Extractables and Leachables Safety Information Exchange and utilizing other databases of test methods to share toxicity data and minimize animal use.
- Working closely with scientists outside Baxter and industry organizations to share best practices and demonstrate continual improvement.
External Service Providers
Baxter only sponsors animal use activities that comply with all relevant local, national and supranational laws, regulations and guidelines (e.g., Guide for the Care and Use of Laboratory Animals1). The company conducts animal welfare assessments as part of Baxter’s overall quality and regulatory compliance program. Baxter preferentially selects external service providers that are AAALAC accredited and have established animal welfare programs.
Genetically Modified Organisms (GMO)
Baxter Healthcare uses the latest developments and applications in the scientific field to innovate and discover new critical therapies. Some of our businesses routinely use standard, genetically modified organisms in research and development. We are not involved in genetically modifying plants. All research and development with GMO is conducted under full risk assessment with highest conditions of safety concerning use, storage, containment, and appropriate disposal of waste or used materials.
Cloning and the Use of Stem Cells and Fetal and Embryonic Tissue
Baxter recognizes and respects the intrinsic distinctiveness of human embryos and human adult stem cells. Any cell lines used, if at all, by Baxter or under its direction will utilize cells derived from human adults or human cell lines that were obtained as a result of a confirmed, naturally occurring event negatively affecting the continued viability of the fetus. In the event that cell lines derived from sources other than those described above are the only option for a safe and effective therapy such as the production of recombinant proteins, vaccines, and related products, Baxter's Chief Quality Officer and Chief Executive Officer must evaluate and unanimously affirm the use of such cell line. In making the decision, the Chief Quality Officer and Chief Executive Officer must give consideration to, among other things, the following criteria:
- Viability of alternative technologies or alternative sources of cells
- Potential benefits to be realized from such use
- Probability of success for the proposed use
- Compliance with Baxter's bioethics standard
Currently, Baxter does not utilize human stem cells or primary human fetal or embryonic tissue in its products (and its products are unrelated thereto) or for research (and does not participate in studies that do). In the future, Baxter may potentially use adult autologous (i.e., an individual adult’s own) stem cells for research in accordance with the above and Baxter’s Bioethics Policy.