Our Bioethical Principles
As a life science company, committed to innovation in the areas of human health and agriculture, we align our actions with our mission ‘Health for all, Hunger for none’. Science and technology are advancing rapidly and creating new opportunities. We strive to utilize their potential for improving people´s lives. We are fully aware of our responsibility to deliver solutions and products to our patients and growers that are socially acceptable and sustainable.
Our commitments:
- We are dedicated to conducting comprehensive risk/benefit assessment for any research and development work we undertake either within Bayer or with third parties
- We strictly comply with the applicable legal and regulatory frameworks as well as international convention
- We are committed to using innovative scientific approaches in an ethically responsible and transparent manner across all our divisions and to being thoughtful about the societal perception of science and use of technology
Bioethics at Bayer
Bioethics at Bayer
Thus, we have defined Bioethical Principles that set clear and company-wide* guardrails for R&D activities, innovation, and technology use. Our Bioethical Principles are grounded in our business ethics fundamentals and our company values. We continually review our high ethical standards and seek advice from a diverse group of leading experts, including our independent Bioethics Council members.
*The Bayer Bioethical Principles are valid for Bayer AG and all Bayer group companies.
Bayer´s Bioethical Principles are structured along six current focus areas to guide our work from a bioethical perspective:
Gene Technologies
Use of Gene Technologies for Healthcare:
At Bayer, we consider gene technologies to be powerful tools in drug discovery and development. We use gene technology tools to study human diseases, improve manufacturing processes, and develop new treatments, including regenerative gene therapies. Bayer believes that gene therapies have a promising potential to bring tremendous value to patients suffering from rare monogenic diseases (such as Pompe disease) or to broader patient populations with complex pathway diseases (like heart failure). As such gene technologies provide novel treatment options for conditions for which there is a lack of alternative treatments, or where the current standard of care only addresses symptoms to different degrees. Bayer also recognizes the potential of gene technologies to develop more targeted, personalized treatment options.
- We use gene technologies following ethical guidelines and conventions. We also support the recommendations made by scientists in 2015 and 2023 and the ethics report in 2020 to define a responsible path forward.
- For each case, we thoroughly evaluate the potential benefits and potential risks of therapeutic applications targeting genetic material.
- We want to understand when and why the benefits are greater than the risks, and we take steps to reduce any potential harm because people's health is our highest priority. We do not manipulate the human germline, which means, that Bayer does not conduct human gene editing with the intention to be heritable, i.e., to be passed on to future generations.
Gene technologies describe the intended and directed change or modification of nucleic acid sequences using biotechnology tools (e.g., gene editing such as CRISPR/Cas, genetic engineering, synthetic biology).
Use of Gene Technologies for Agriculture:
In our Crop Science business, we use gene technology tools to produce seed, plants, and microbes with beneficial traits that provide nutritional, agronomic, and economic benefits that significantly reduce the environmental footprint and impact of agriculture while increasing productivity.
In the face of challenges posed by climate change, gene technologies provide rapid methods of developing and selecting for more resilient crops, which complement conventional breeding methods.
We are conscious of potential environmental and ethical considerations related to agricultural applications of gene technologies. We take the principles of stewardship seriously, for example by establishing guidelines for our own sites and those of our seed producers, which must be followed. These measures include protecting locally important landraces. Bayer is committed to providing continuous, collaborative support to farmers. This includes the co-design of sustainable farming practices, stewardship, quality management activities, and training programs related to agricultural applications of our gene technologies.
- We use and commercialize gene technologies only after comprehensive risk assessment and if the potential benefits clearly outweigh the potential risks, in compliance with legal, regulatory, and ethical principles.
- We commit to be transparent about the rationale of how and why gene technologies are applied.
- During the development of new products, we engage with stakeholders along the value chain on what is important to them, including e.g., product identification and freedom of choice to facilitate transparency along the value chain.
- Bayer promotes the adoption of product stewardship programs and quality management systems for the full life cycle of genetically engineered agricultural products.
- We use gene technologies in commercial products that could apply to farms of any size, from large farms to smallholders.
Gene technologies describe the intended and directed change or modification of nucleic acid sequences using biotechnology tools (e.g., gene editing such as CRISPR/Cas, genetic engineering, synthetic biology).
Genetically Modified Crops I Bayer´s contribution to a fact-based public discourse:
Download Executive Summary (419 KB)
Human Stem Cells
Human stem cells have great potential for regenerative medicine and drug discovery. There are two types of pluripotent stem cells which can turn into virtually any kind of cell in the human body: embryonic stem cells and induced pluripotent stem cells which are generated from adult cells e.g., blood cells. Bayer wants to use these cells to develop regenerative therapies for severe and life-threatening diseases, such as Parkinson’s or heart failure. In addition, Bayer also utilizes those cells to test new drugs on human cells. However, we are aware that some people have concerns about using human embryonic stem cells.
- At Bayer, we only use existing human embryonic stem cells that have been generated in accordance with applicable laws and have been approved by the appropriate national authorities.
- We commit to work towards a technology platform for induced pluripotent stem cells (iPSC) that will give preference to working with iPSCs over human embryonic stem cells, where feasible.
- We do not engage in or support any activities through which new human embryonic stem cells are created.
- We do not engage in or support any activities that could lead to generation of a complete and viable human embryo.
Induced pluripotent stem cells (iPSC) are stem cells that have the ability to create virtually any cell type of the adult human body. They are generated from adult cells (e.g., blood cells) by reprogramming them into a pluripotent state. In contrast to human embryonic stem cells, they are not derived from embryos, but possess the same biological potential and ability to be cultured and expanded indefinitely in theory.
Human Biological Samples
Research using human biological samples (HBS), such as tissue and blood, is performed to enhance the knowledge of human diseases, improve diagnosis and to discover and develop new treatments.
Conducting research on human biological samples is critical for the development of safe and efficacious new drugs and therapies.
- Bayer handles HBS in an ethical and responsible manner, compliant with all legal and regulatory requirements.
- We only use samples that were collected based on a freely given informed consent and without coercion. Any reimbursement must be consistent with the principles of voluntary donation and must be appropriate to the local economy.
- We only conduct research on human biological samples within the purpose of what they were collected for and the consent the donor has given.
- We protect donors’ privacy and treat personal data derived from the sample with the highest confidentiality.
- We do not conduct research on human fetuses or fetal tissue.
Studies Involving Humans
Studies in humans play a vital role in the Pharmaceutical and Consumer Health product development process as they provide essential insights into the safety and effectiveness of new products.
At Bayer, we pay utmost attention to the individual’s well-being, dignity, safety, and rights. Our ethical considerations for studies in humans revolve around four fundamental principles:
- Obligation to consider the benefit for the study participant or to help others (Beneficence)
- Obligation to avoid causing harm to the participant or to others (Nonmaleficence)
- Concerns that participants are treated with fairness and equity (Justice)
- Respect for Autonomy of the participant.
- We are committed to ensuring trial participants have freely given consent and are informed about the potential risks and burdens of the study.
- We ensure the study protocol and informed consent have been approved by an independent institutional review board/ethics committee, as required by applicable regulations.
- We ensure measures are taken to minimize risks to individual privacy and confidentiality.We ensure public disclosure of study information.
- We only conduct studies that have a legitimate scientific purpose.
- We do not design studies that by nature of their design would discriminate against certain populations or without consideration for special populations (i.e., pediatrics, geriatrics), as appropriate.
Artificial Intelligence (AI) in the Context of Human Healthcare
AI is becoming increasingly important for bringing new advances in areas such as the life sciences and many areas of society. At Bayer, we believe that AI is an important technical enabler for many aspects of our business and operations. For example, AI already plays a crucial role in drug discovery and development, personalized medical treatments and improving diagnostics. Since AI is constantly evolving, we will keep refining our bioethical stance and principles to ensure responsible and thoughtful use of this technology.
- At Bayer, we commit to use AI transparently and responsibly. We respect personal autonomy, strive to promote individual and collective wellbeing and preventing harm, while also striving for inclusion in our data sets, fairness and accountability.
- We always comply with all applicable laws, regulations, and professional codes of conduct.
- We regularly cooperate with researchers, regulatory bodies, and other relevant professional organizations to jointly develop trustworthy AI-enabled solutions.
- We hold companies that Bayer partners with or whose products or services are procured to the same standard.
- We strive for clear relevance, provenance, diversity, and sufficient quality in data sources.
- We verify the data sets used for AI training are representative of the environment the AI system will be deployed in.
- We do not use poor, incomplete or non-verified data that may produce incorrect or biased results in our AI applications.
- We will protect human autonomy in AI solutions that we develop, sell or use. We will develop, dedicate, and put into practice internal resources, structures, and safeguards to support proper internal oversight, inspections, and maintenance of AI solutions.
Artificial intelligence (AI) AI is the development of computer systems that can perform tasks requiring human intelligence, like analyzing data, recognizing patterns, and making decisions. It involves creating algorithms and models to enable machines to learn and mimic human cognitive abilities.
Animal Welfare
Animal studies still play an important role in ensuring that the benefits of our products outweigh the potential risks to humans, animals and the environment, and therefore remain part of the current standard data requirements and approval process of our products by regulatory authorities.
- At Bayer, we apply the highest standards to ensure the maximal possible animal welfare.
- We are strongly committed to the 3R principle: refine, reduce, or replace animal studies wherever and whenever feasible.
- We actively partner in research for alternatives to animal testing known as new approach methodologies (NAMs) e.g., the development of tests using cell lines rather than whole animals.
- We are actively engaged in advocacy with regulatory agencies, policy makers and other stakeholders to ensure that evolving regulations are fit for purpose and science based and to enable a timely transition to NAMs where appropriate.