Baxalta believes that biotechnology can provide significant benefits to life and that these technologies carry with them responsibilities. Any Baxalta decision to commercialize a biotechnology-derived product or therapy will receive careful consideration of the risks and the benefits of the technology in light of the information available. The ability to perform an activity will not automatically justify the activity. As a company, these principles and processes govern our efforts to research, develop, and provide products for critical therapies for patients worldwide.
Bioethics Guiding Principles
Baxalta places the highest priority on the safety and efficacy of our products, and we support government agencies in safeguarding health and well-being throughout the world.
Baxalta listens to and considers feedback from the public and responds to concerns about the social, ethical, and technical application of biotechnology in the research, development, manufacture, and sale of our therapies and products. Baxalta's response to these concerns will be based on ethical considerations and scientifically sound hypotheses, theories, and data.
Baxalta actively participates in public discussions and professional forums encouraging science-based policies and regulations that serve the public interest as an ethical priority.
Baxalta will determine the potential benefit of our applied biotechnology.
Baxalta will ensure that any research undertaken by Baxalta or at its direction is designed to produce valued health enhancements or advancement of scientific knowledge while seeking to identify and minimize relevant risks.
Baxalta complies with applicable legislation and regulatory requirements, and supports accepted ethical and professional standards in the research, development, manufacture, and sale of its products. Specifically, Baxalta is sensitive and responsive to concerns related to the conduct of all research on humans. Baxalta is committed to protecting the life, health, privacy and dignity of those participating in clinical trials, as well as to protecting the integrity of the data obtained from these studies. These standards are found in, but are not limited to, the following documents:
- Guidelines for Good Clinical Practice (GCP), edited by the International Conference on Harmonization (ICH), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP)
- Declaration of Helsinki
- International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Applicable privacy and data protection standards Baxalta supports the conscientious use of animals in research when no other valid scientific alternative exists. To the extent possible,
Baxalta will minimize the use of animals in our research and, where utilized, will treat them humanely and with the highest standards of care.
Baxalta recognizes that protecting the environment and maintaining the biological diversity of our planet is of vital importance to human life. Baxalta believes in the importance of maintaining global biodiversity and sustainable use of global resources.
This bioethics standard applies to work performed at the direction of Baxalta by external contract research organizations, consultants, and third-party vendors. Where Baxalta performs as a third party vendor, Baxalta will take into account the bioethical conduct of the contracting organization in determining whether or not to take on the work.
Framework for Application of Bioethics Guiding Principles
Baxalta's planning processes, policies, and procedures consider these "Bioethics Guiding Principles" as we carry out research and develop, manufacture, and sell our products.
Baxalta will assess the potential risks and benefits of proposed research and development. Research and development is justifiable where:
- The potential risks to individual subjects are minimized.
- The potential benefits to individual subjects are enhanced.
- The potential benefits to individual subjects and society are proportionate to or outweigh such risks.
Baxalta's Operations Committee, through the application of the "Bioethics Guiding Principles" and with the advice of appropriate scientific and ethical advisors, will make the final decision on whether to proceed in areas that require a consideration of bioethical issues.
This bioethics policy, and the decisions that have been made under its guidelines, will be reviewed and revised as appropriate based on technological advancements, legal and regulatory changes, and current social and ethical considerations.
Bioethics Position Statements
In response to debates regarding social, ethical, and technical application of specific biotechnology, Baxalta may issue position statements under the guidance of this bioethics standard. Baxalta has developed position statements that can be accessed from Baxalta's Internet.
Responsible Use of Animals in Research and Testing
Baxalta produces vital medical products that are used in the treatment of patients with chronic or critical illnesses throughout the world. Patients, their families and health care professionals rely on the safety and efficacy of our products—which are overseen by government health authorities and proven through clinical trials and the use of animals. The company is both ethically required to ensure the safety and efficacy of our products and legally required by health authorities throughout the world to use animals to develop and test its products. In doing so, we conduct our work in a manner that is humane and minimizes the number of animals used. We are committed to the highest standards of animal care and welfare. Baxalta’s animal facilities and programs meet all local, national and transnational laws and regulations (as verified by regular inspections by those authorities/agencies), and are operated in accordance with relevant international guidelines, including:
- U.S. Animal Welfare Act Standards
- Health Research Extension Act (based on The Guide for the Care and Use of Laboratory Animals)
- Directive 86/609/EEC, Council Animal Protection Directive
- CIOMS (WHO), International Guiding Principles for Biomedical Research Involving Animals
Our animal facilities and programs are operated by licensed, certified and accredited veterinary professionals and are overseen by Animal Use and Care Committees or local authorities, which are required to include at least one independent (not affiliated with Baxalta in any other way) representative.
These teams not only oversee the care and welfare of animals used, but they also review and approve research and testing protocol to ensure that the minimum number of animals are used, that the information derived is essential and meaningful and that any pain and distress to the animals is minimized.
The animals that we use in research and testing are sourced only through special breeders or suppliers that our veterinary professionals carefully select and regularly monitor. We expect that any contract research organizations that we use follow similarly high standards for animal care and welfare, and Baxalta’s veterinary professionals carefully review and monitor these organizations to ensure compliance.
Further, we are committed to using and developing alternative protocols, methodologies and models which eliminate the use of or reduce the number of animals required for research and testing. While we may never be able to completely replace the use of animals, we hope that our efforts to refine and improve our research and testing methods will both minimize their use and maximize the positive impact that our products have on the health and welfare of people and animals worldwide.
Genetically Modified Organisms (GMO)
Baxalta 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, manufacturing and quality control processes to develop recombinant proteins and vaccines. 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 Fetal and Embryonic Tissue
Baxalta recognizes and respects the intrinsic distinctiveness of human embryos. Any cell lines or primary cells used by Baxalta or under its direction will utilize cells derived from human adults or cells and tissues that were either obtained from human cord blood or as a result of a confirmed, naturally occurring event negatively affecting the continued viability of the fetus. Baxalta is not involved in human cloning or embryonic stem cell research. The company does use well-established cell lines in its research and development. 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, Baxalta’s Chief Scientific Officer and Chief Executive Officer must evaluate and unanimously affirm the use of such cell line. In making the decision, the Chief Scientific Officer and Chief Executive Officer must give consideration to 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 Baxalta’s bioethics standard
Baxalta’s somatic gene therapy platform aims to improve patients’ quality of life. The program does not in any way target or aim to alter the germ line. Baxalta is not involved in human genomics research, as defined as involvement in human genome sequencing efforts and similar work.