Management of impacts and opportunities regarding the social involvement of consumers and/or end-users
Through our double materiality assessment, we have identified impacts related to the social inclusion of consumers and/or end-users, particularly through access to products and services. Our innovative strength gives us the opportunity to develop new products (such as pharmaceuticals) and to drive the development of business models (e.g. with a focus on demographic change) that can have positive impacts on society and the environment.
Our business model also has the potential to have a positive influence on agriculture through access to products and services. Our innovations – such as more efficient, more climate-resilient, less land-intensive crops – help to feed a growing world population. Through our efforts to advance both digitalization and the responsible application of technologies, we enable farmers, particularly smallholder farmers in low- and middle-income countries (LMICs), to increase their yields, improve the resilience of their crops and optimize the utilization of crop protection products. We want to increase the accessibility and availability of seeds, plants, food and nutrients through our Crop Science offerings. We support smallholder farmers through our products, services and partnerships to improve both food availability in rural communities and the farmers’ socioeconomic status. We also participate in initiatives to provide female farmers in LMICs with access to agricultural knowledge and the corresponding inputs.
In the healthcare sector, too, our products and services (such as through the availability of contraceptives) can have a positive impact on women’s independence, education and careers, which ideally helps to strengthen their role in society. This, in turn, can positively affect their families, communities and society at large. At the same time, we could reduce the affordability of medicines for larger, less wealthy parts of society through potentially high pricing.
Policies related to the social involvement of consumers and/or end-users [S4-1]
By promoting access to products, services and healthcare, we want to support the social involvement of consumers and/or end-users.
Access to products and services through intellectual property protection
The Code of Conduct underscores the relevance of our innovation capability. It is therefore established in the Code of Conduct that we protect the value of our research and development activities and the reputation of our company and our brands. At the same time, we respect the rights and claims of third parties.
Industrial property rights, including patents, business secrets, brands, samples and plant variety rights, along with supplementary protection certificates, are an important part of the innovation process, especially when associated with significant capital expenditures, specialized research and a high risk of failure. This is the case in areas such as plant breeding, pharmaceutical research and development, or crop protection R&D.
The Code of Conduct is supplemented by our intellectual property (IP) principles, which describe our commitments in connection with the protection of intellectual property rights. It is established there, for example, that we make use of industrial property rights to promote cooperation and enable partnerships that are beneficial to global health and sustainable food security. The principles apply to all Bayer employees and are discussed at least twice a year at internal workshops of our global IP function, which holds responsibility for this issue.
The value of Bayer’s portfolio depends on intellectual property protection according to the TRIPS agreement of the World Trade Organization (WTO), which demands certain measures to ensure an appropriate duration of product protection to sufficiently incentivize the development of innovative products. We advocate for high standards with regard to the protection of industrial property rights and capital expenditure protection that incentivize the development and manufacture of, and trade with, innovative products to enhance their accessibility within the framework of international coordination according to the TRIPS agreement. The IP principles are in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025. For more information on our Code of Conduct, please see the section “Holistic policies for managing material sustainability matters” [MDR-P]” in Chapter A 4.1 General Information on the Sustainability Statement.
Improving the social integration of smallholder farmers through our sustainability strategy
Our products and services can help farmers worldwide to increase production and thus feed a growing world population while consuming fewer natural resources. Farming is often the only source of income for many people in low- and middle-income countries. We want to contribute toward fighting poverty there through our engagement with smallholder farmers.
This strategy is monitored through various actions, including particularly by measuring our progress in attaining our goal of supporting 100 million smallholder farmers by 2030. For more information on our 100 million targets, please see the section “Targets for managing material negative impacts, advancing positive impacts, and managing material risks and opportunities [S4-5].”
Our strategy to empower smallholder farmers is embedded in our regional commercial strategies and entrusted to local management and the function responsible for sustainability and strategic engagement at Crop Science. The strategy is oriented toward the United Nations’ global Sustainable Development Goals (SDGs), which should be achieved by 2030. The strategy is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
Our sustainability strategy for empowering smallholder farmers takes account of the interests of all relevant stakeholders, including the farmers themselves, governmental authorities, nongovernmental organizations, market participants and society in general, to ensure effective and sustainable implementation.
Our strategy to empower smallholder farmers is publicly available on our website.
Our strategy for improving access to healthcare
As a pharmaceutical company, we believe we have a responsibility to improve access to healthcare and have developed a strategy to achieve that. Above all, this includes access to contraception methods and self-care products.
Responsibility for implementing the strategy to improve access to healthcare lies with the heads of the Pharmaceuticals and Consumer Health divisions, both of whom are members of the Board of Management of Bayer AG due to their positions. Improving access to healthcare remains one of the most important and, at the same time, one of the most complex global development challenges, as reflected in the third Sustainable Development Goal (SDG) of the United Nations. The strategy is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
We cooperate closely with various public sector partners to measure the results and impacts that our activities have on improving patients’ access to healthcare. This is reflected, for example, in our cooperation with the World Health Organization (WHO) and other organizations to eradicate neglected tropical diseases (NTDs), as well as in our collaboration with the German Society for International Cooperation (GIZ), the Ghana Heart Initiative and other programs to improve the effectiveness of cardiovascular treatment in Ghana, and the Challenge Initiative to improve women’s access to contraceptives and family planning resources.
We have entered into a collaboration with the WHO Foundation to build countries’ capacities to include self-care interventions as part of universal health coverage, with a focus on underserved population groups in low- and middle-income countries.
We have been supporting global efforts to transition prenatal care policy for pregnant women from iron and folic acid (IFA) supplementation to the WHO-backed UNIMMAP multiple micronutrient supplementation (MMS) formula through our strategic partnership with the global health NGO Vitamin Angels since 2020, reaching more than 20 million women and babies with access to MMS free of charge. We will continue to lend our expertise in prenatal manufacturing and education to support country roadmaps for the transition from IFA to MMS.
We have joined forces with the Novartis Foundation to strengthen and scale up the CARDIO4Cities initiative. This proven model can reduce heart attacks in cities by strengthening heart health systems with interventions and policy evolutions chosen and driven by local city governments.
Information pertaining to our strategy to improve access to healthcare is publicly accessible.
Actions related to the social involvement of consumers and/or end-users [S4-4]
To promote the social inclusion of consumers and/or end-users, we have developed measures to enable access to products and services. No severe issues or incidents were reported in 2025 in connection with the human rights of our consumers and/or end-users.
Innovations and applications for our concept of regenerative agriculture
We aim to transform agriculture by driving forward a more sustainable food system guided by our concept of regenerative agriculture. Our concept of regenerative agriculture is an outcome-based production model based on two key building blocks: productivity, which focuses on helping farms to produce more with less, and regeneration, which focuses on delivering a positive impact on nature. Key outcomes we strive for are yield increase and improved social and economic well-being of farmers and communities, and positive impact on nature.
We are an innovation leader in the agricultural sector, with over €2 billion invested annually by our Crop Science Division in research and development and a strong global presence. Our research and development activities are not subject to any specified time horizon, but rather are continuous measures as part of our business model. The effectiveness of our research and development activities is reflected in our innovation pipeline.
Supporting smallholder farmers through our product and service portfolio
To reduce business risks for all partners in the value chain, including smallholder farmers, we are successively expanding our product and service portfolio for these farmers amid innovative business models and digital solutions. These include solutions from the areas of digital farming and market access, a differentiated product portfolio, biotechnological solutions and the formation of partnerships along the value chain. The continuous development of solutions tailored to the needs of smallholder farmers is crucial to help more of these farmers achieve better harvest yields. Through these solutions, we enable access to high-quality seeds for key crops that can better withstand difficult environmental conditions and insect pests, as well as to affordable and more effective crop protection products.
In impact studies, independent experts use surveys of randomly selected study participants to determine the impact of the programs on the livelihoods of smallholder farmers. We have conducted longitudinal studies on the social impacts of three programs in key smallholder farmer regions from 2022 through 2024, with the farmers being surveyed during the 2022-2023 growing season and a selection of them once again a year later. The majority of participants confirmed an increase in yields and farming income as well as a better way of farming and an improved quality of life since joining the programs. Allocated resources are spent particularly to expand our product and service range for smallholder farmers and to form strategic partnerships.
Initiatives to enable access to self-care
For more than half of the world’s population, basic health services are not effectively accessible or affordable. We are investing in making science-based self-care available and accessible for all, with a particular focus on an economically and medically underserved population. We leverage our trusted brands, portfolio of products, operational footprint and cross-sector partnerships to improve the full self-care value chain and ecosystem:
Access to essential formulations that address key needs for people who live on a low income, as informed by dedicated medical and consumer insights: prenatals, cardiovascular disease, allergy, pain, digestive health, fatigue, and cough & cold
Accessible format and pricing that fits end-consumer health expenditure and purchasing preferences, from individual packaging to bulk formats
Establishment of health distribution channels to reach the consumers in underserved communities in the places where they live, work and shop. This includes independent pharmacies, small family-owned businesses, social marketing companies and specialized distributors that reach second/third tier cities and rural areas, as well as retail stores in the low-cost segment.
Tailored training for healthcare professionals who serve the end-users (e.g. physicians, pharmacists, midwives, community health workers etc.), and for consumers to help them better understand therapeutic areas and safe treatment options
Advocacy for inclusion of self-care as a pillar in the healthcare ecosystem to help reduce costs for governments and individuals, as well as improve health and livelihood outcomes
These initiatives represent an important activity in the context of our 100 million targets, and we measure the success of this activity through the attainment of our targets. Our initiatives for access to self-care are not subject to any specified time horizon. For more information on our 100 million targets, please see the section “Targets for managing material negative impacts, advancing positive impacts, and managing material risks and opportunities [S4-5].”
Initiative to enable access to important vitamins and minerals
In line with our mission “Health for all, Hunger for none,” we launched our signature program the Nutrient Gap Initiative (NGI) in 2021 to enable access to essential vitamins and minerals for 50 million people in underserved communities annually by 2030. Through interventions with accessible and affordable nutritional solutions, education and advocacy, the initiative addresses the main barriers to accessing essential micronutrients. In doing so, we leverage our expertise, portfolio and partners, from growing nutritious fruit and vegetables in smallholder farming communities to essential supplementation for all. We have established strategic partnerships to make progress, for example with Vitamin Angels to advance the roll-out of essential prenatal supplements in emerging markets, reaching over 20 million women and their babies since 2020. Furthermore, we collaborate with the social health enterprise reach52 to provide nutrition education to underserved communities, including smallholder farmers.
As the NGI is an important activity in the context of our 100 million targets, we measure its success through the attainment of our targets. For more information on our 100 million targets, please see the section “Targets for managing material negative impacts, advancing positive impacts, and managing material risks and opportunities [S4-5].” Allocated resources are spent particularly on forging strategic partnerships to support the supply of important vitamins and minerals.
Activities to improve access to healthcare
One of our fundamental objectives is to ensure global access by patients to our medicines. Against this background, we have amended the international pricing of our pharmaceutical products and implement programs to reduce all patients’ copayments. Our ambitions include improving access to our prescription products for people in low- and middle-income countries through improved availability and modified drug pricing, as well as through our patient access programs.
For some of our best-selling and most innovative products (Adempas™, Eylea™, Kerendia™, Kyleena™, Mirena™, Nexavar™, Stivarga™, Verquvo™ and Xarelto™), including individual new launches, we have established framework conditions for adjusted, equitable pricing that also account for per capita gross national income and thus enable the establishment of selling prices that reflect the local purchasing power in the respective countries.
Our patient access programs help patients in low- and middle-income countries (LMICs) to reduce the financial obstacles to acute or long-term access to prescription medicines. In this way, we want to not only enable patient access to these medicines but also ensure long-term treatment. We cooperate with insurance providers, charitable organizations and other partners to advance these options. Our patient access programs are developed according to the framework conditions in each country and take account of patient needs, which are supported in various ways, for example through:
Individual assessment of patients’ financial solvency and derivation of a corresponding financing and treatment plan
Reduction of the financial burden on patients, for example through the combined provision of free and payment-based medicines or the granting of discounts on the original selling price
Our price philosophy approach was initiated in 2020 and is being continuously rolled out worldwide. Our activities and progress in the specific partnerships are tracked and published, partly to ensure the effectiveness of the implementation and results of our actions.
In these approaches, we work together with global and local nongovernmental organizations, governmental authorities, charitable organizations and other partners to determine the correct actions and ensure that they are maximally effective. Our amended pricing and patient access programs improve access to healthcare and reduce negative impacts on consumers and/or end-users. The means of managing material impacts focus in particular on adapted pricing for some of our products.
Management of impacts and risks related to the personal safety of consumers and/or end-users
Through our double materiality assessment, we identified the impacts and risks related to the health and safety of consumers and/or end-users, which are managed through a comprehensive package of policies and actions.
To ensure the safe use of our products by end-users, we generally go beyond the legal requirements, wherever permissible, as regards providing personal safety information in this respect. Despite the use of labels, some end-users do not always use products as intended, which poses a health risk for farmers and patients, as well as a threat to the environment. Moreover, financial risks may arise from the incorrect application of our products or the misuse of crop protection products. Also, there may be revenue losses and loss of reputation if our products become subject to counterfeiting, fraud, misdirection or misuse.
There is also a risk of human rights violations when clinical trials are outsourced, as introduced in Chapter 4.3.2 Workers in the Value Chain. Compliance with relevant standards, transparency regarding the conduct of clinical trials and consideration of human rights, safety and inclusiveness are therefore extremely important – both for us and the clinical research organizations (CROs) contracted by us.
Policies related to the personal safety of consumers and/or end-users [S4-1]
Product safety is a central element of our policies to promote the personal safety of consumers and/or end-users.
Our policy for ensuring the quality and safety of pharmaceuticals
Extremely stringent safety standards for patients and medical professionals apply to pharmaceuticals and medical devices. That is why both the development and the manufacture of pharmaceuticals and medical devices are subject to very strict quality requirements. An important role is played here by our Product Safety and Quality: Reporting Obligations of Employees Policy.
This policy applies to all Bayer products for human use (pharmaceuticals including vaccines, nutritional products, cosmetics, medical devices, combination products and therapeutic aids).
The commitments described in this policy must be complied with by all employees who implement the policy, irrespective of which division or supporting function the employees work for. It must be implemented by all Bayer companies worldwide that hold market approvals or medical device registrations for pharmaceutical or consumer health products, conduct pharmaceutical or consumer health business practices, or perform services for pharmaceutical or consumer health companies. For Bayer products, this policy summarizes the following commitments:
Commitments to implement safety- and quality-related processes
Commitments for employees who receive knowledge of safety- or quality-related information
Commitments for employees responsible for digital activities sponsored by us
Commitments for employees who conclude agreements with external partners
Commitments for our legal department
Internal experts and external assessors regularly conduct risk-based audits to verify compliance with the statutory requirements and relevant standards in the development and production of medicines, as well as for registered product specifications. Such audits also cover our subcontracted institutes, service providers, suppliers and contract manufacturing organizations (CMOs). In addition to the internal quality assurance mechanisms, all our sites are regularly inspected by the respective countries’ health authorities to verify compliance with the various national and international requirements, and certified according to the respective product category (e.g. through GMP certificates or in the form of an official manufacturing license).
The quality management system of the Pharmaceuticals and Consumer Health divisions is based on internationally recognized standards and applicable legal, regulatory and ethical requirements for all stages of the provision of a pharmaceutical or a medical device – from development to registration, production and distribution. In particular, these standards include the rules for good working practice (GxP) in the development and manufacture of pharmaceuticals – such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), ISO certifications such as those for the manufacture of medical devices (e.g. ISO 17025 and 13485), and the guidelines of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The quality management system is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
We consider the interests of our stakeholders through continuous dialogue to enable the needs of customers, patients, healthcare professionals and regulatory authorities to be taken into consideration in the development and implementation of our quality and safety strategy.
To maintain the high quality of our pharmacovigilance system, our medical and scientific experts undergo regular training. Furthermore, in line with our Product Safety and Quality: Reporting Obligations of Employees Policy, all Bayer employees are required to undergo training as regards their obligation to immediately report safety- and quality-relevant information to the Pharmacovigilance department.
Product safety and responsible handling of our products
We have specified our principles of responsible product management in the Crop Science Division in our Product Stewardship Commitment, Principles and Key Requirements Policy. Among other issues, the policy stipulates that suitable programs be implemented to train and instruct our employees and customers in the responsible use of our products and services over their entire life cycle. For more information on this corporate policy, please see the section “Product responsibility and responsible marketing at Crop Science as part of our Product Stewardship Policy.”
Accounting for potential risks through new technologies and bioethical principles
Our bioethical principles serve as clear, company-wide guidelines for research and development activities, innovations and the utilization of technologies and play an important role in leveraging our material opportunities relating to our innovative strength. Our bioethical principles are based on our business ethics principles and our company values.
They are subdivided into the following six current focal point areas and guide our work from a bioethical perspective:
Responsible use of gene technologies
Responsible use of human stem cells
Responsible use of human biological samples
Responsible conduct of studies involving humans
Responsible use of artificial intelligence in the context of human healthcare
Animal welfare
Accountability for bioethical decisions is anchored in our governance structures, and responsibility for implementing this procedure lies with the R&D heads and upper management in the countries/country groups and divisions at all our sites. We commit to compliance with applicable laws, regulations and international conventions related to bioethics. The strategy is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
We review our high ethical standards and obtain advice from a group of leading experts, including the members of our independent Bioethics Council. This is an independent advisory body without executive powers for business operations that supports all divisions and convenes twice a year to deliberate. The Bioethics Council offers us expertise and consultation in bioethical matters related to research and development innovations in the life sciences. The focus lies on medical issues, bioengineering and artificial intelligence – as well as questions in the context of the discovery, development, production and application of treatment forms and therapies to promote human health – and on agricultural products and services. The Bioethics Council acts in an advisory capacity in assisting us to make bioethics an integral part of research and development activities, analyzes our bioethical guidelines and gives recommendations on strategic changes, examines our progress in implementing our bioethics strategies and guidelines, and counsels us on the most important drivers of current bioethical issues (such as technological progress and societal change) that are of relevance to our work.
As part of a training course dealing with this issue, special bioethical learning resources are offered to our employees, the purpose of which is to create a fundamental understanding of our bioethical values and guiding principles. Our bioethical principles are publicly accessible online on our website.
Ethical standards for conducting clinical trials in drug development
Compliance with ethical standards also plays an important role when developing innovations. With respect to our clinical trials, we strictly align ourselves to the Declaration of Helsinki, an ethical standard in place since 1964 that regulates medical research involving humans. This is stipulated in our Human Rights Policy and also applies to all research institutes (clinical research organizations, CROs) tasked with conducting clinical trials on our behalf. For more information on our Human Rights Policy, please see the section “Holistic policies for managing material sustainability matters [MDR-P]” in Chapter A 4.1 General Information on the Sustainability Statement.
We conduct research in humans according to the strictest medical, scientific and ethical standards. We pay great attention to the well-being, dignity, safety and rights of the patients, and the Chairman of the Board of Management (CEO) is responsible for ensuring this in his oversight of the human rights strategy.
Our trials involving human subjects respect the following four basic ethical principles:
The self-commitment to consider the benefit for the trial participants or to help others (beneficence)
The self-commitment to not harm the participants or others (nonmaleficence)
The self-commitment to treat the participants fairly (justice)
Respect for the participants’ autonomy
Additional statutory regulations, directives and ethical codes supplementing the Declaration of Helsinki have been further developed and introduced worldwide to ensure that the health and safety of participants in clinical trials are the top priority. We follow the Harmonised Guideline on Good Clinical Practice (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice, ICH-GCP). Its requirements include the deployment of an independent ethics committee for each clinical trial involving human subjects. A clinical trial on our behalf cannot begin without a positive vote from such an ethics committee. The commitment to complying with the ICH-GCP is also included in the agreements with the clinical research organizations (CROs) we commission to conduct clinical trials and this is regularly monitored. Our Human Rights Policy is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
Patient centricity and cooperation with important patient organizations are fundamental to identify and fulfill the extensive needs of a particular population group. To address the various structural and ethical challenges, we are advancing in our continuous efforts to improve and innovate research methodologies and data collection techniques, for example through real-world evidence approaches.
Conducting clinical trials with participants from various demographic groups, for example in terms of ethnicity, gender and age, helps ensure that trial results are applicable to broader patient populations. To ensure diversity and inclusion are foundational in our research and development practices, we consult and partner with a variety of relevant stakeholders, including clinicians, scientists, health and regulatory authorities, ethics committees and patient advocacy groups.
As participation in a clinical trial is voluntary, patients can decide freely whether or not to take part and have the right to discontinue the trial at any time without giving any reasons and without this having any impact on their standard medical care. Patients must be immediately notified by the examining physicians if new findings become known during the trial about benefits, risks or side effects of the trial medication. Pharmaceutical law also prescribes that the sponsor of a clinical trial must provide health insurance for all participating patients. This ensures that compensation is possible if a patient experiences health impairment during the trial or in the subsequent observation period despite all precautionary measures. To protect the collected personal and trial-related data of the participants, all data is encrypted during and after the trial so that the patients’ identities remain confidential.
Actions related to the personal safety of consumers and/or end-users [S4-4]
We aim to protect the personal safety of consumers and/or end-users through education, training and transparency measures. In cooperation with our consumers and/or end-users and through continuous monitoring of the use of our products and services, as well as the occurrence of problems, we determine which measures are necessary and appropriate to react to certain actual or potential negative impacts on consumers and/or end-users.
Activities for the responsible use of crop protection products
In accordance with the Product Stewardship Commitment, Principles and Key Requirements Policy, which governs the responsible use of crop protection products, we have developed a plan of action that includes, for example, training programs on the proper use of our products and services. There is no overarching process for measuring the effectiveness of this activity. The use of our products and services and the occurrence of associated problems are, however, actively monitored to identify any need for changes in the labeling, user instructions, formulation or product availability.
If compulsory training measures and accreditation requirements to ensure the safe and responsible use of products and services are inadequate or not in place at all in the countries, we continuously support the responsible use of our products and services by implementing suitable training measures – through our own activities and/or those of industry associations, as well as through cooperation with various stakeholder groups, including governments and advisory services. We focus on training activities in countries where there are no statutory certification requirements for the handling of crop protection products. As a member of CropLife International, we additionally help to train nearly four million farmers in 82 countries in the responsible and appropriate use of crop protection products.
With our Bayer Safe Use Ambassador initiative, we also help to train agricultural students. Our goal is to improve farmers’ safety and reduce the environmental impact of crop protection products through knowledge transfer and empowerment. Since 2017, through the initiative, we have partnered with more than 60 universities across Asia/Pacific and Africa. We offer students training in the safe use of crop protection products in cooperation with agricultural universities. Additionally, we have been regularly conducting webinars and online events on the sustainable use of crop protection products since 2020. In the medical sector, we provide physicians and poison control centers with guidance about the hazards, toxicity and treatment of crop protection product poisoning, as well as the treatment of snake bites. Looking ahead, we plan to expand the Bayer Safe Use Ambassador initiative to more universities, countries and regions.
We record and monitor all reported adverse events connected with the use of our products. We also work actively with regulatory authorities and a number of industry stakeholders to offer appropriate measures.
A multi-stakeholder approach is required for effective management. Together with CropLife International, we help to establish capacities, particularly in countries that do not yet have efficient local structures in accordance with the FAO-WHO code. The buildup of capacities encompasses effective structures for risk-based regulatory assessments of existing and innovative technologies, the reporting and management of incidents, training and certification in the safe use of products by farmers/distributors, professional applications (e.g. using drones), the availability and use of personal protective equipment (PPE), empty container management and the sharing of counterfeit protection measures and best practices between regulatory authorities. In the rare case that a product does not satisfy our quality standards (such as packaging problems or contamination), we conduct a procedure to bring about a product suspension, return or recall depending on the specific case. Every two years, general quality performance risks and improvement needs are reported and reviewed together with management within the scope of a compulsory quality management assessment that summarizes how our efforts and corrective measures reduce or mitigate potential quality risks. Funding for managing material impacts goes mainly into the organization of suitable training measures that are designed to ensure the responsible use of our products.
Disclosure measures to ensure transparency of clinical trials
We are fully committed to disclosing information about our planned and ongoing clinical trials. We also publish results of trials in patients and provide free access to this information on the internet, irrespective of whether they are positive or negative for one of our products. There is no systematic process for measuring the effectiveness of this activity.
Public disclosure of clinical trial information is an ongoing measure and performed in line with the position of the global pharmaceutical industry associations laid down in the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases.
As a member company of the European and US pharmaceutical federations (EFPIA and PhRMA), we comply with their declared principles on the responsible sharing of clinical trial data, the goal of which is to foster scientific discovery. Increased transparency while maintaining patient privacy is intended to encourage innovation and ultimately benefit patients.
Through our disclosure measures, we support efforts by the European Medicines Agency (EMA) and the European Parliament to further increase the transparency of data from clinical trials, as laid down in the EMA policy on publication of clinical data for medicinal products for human use and the EU Clinical Trials Regulation (EU) No. 536/2014.
We have introduced a monitoring and quality control process to ensure that the high standards for the transparency of clinical trial information for our medicines are fully met and that information on clinical trials as outlined in this policy is publicly disclosed in time and is of high quality. The means of managing material impacts focus in particular on free provision of the results of information on our clinical trials.
Management of impacts related to access to information by consumers and/or end-users
Through our double materiality assessment, we have identified positive impacts related to access to quality information by consumers and/or end-users. We strive to have responsible marketing practices and go beyond the legal requirements, wherever permissible, as regards providing personal safety information in this respect in order to ensure that end-consumers can take individual measures when using our products. Since 1994, we have supported the voluntary Responsible Care™ initiative of the chemical industry and the associated Responsible Care Global Charter. We are also actively involved in the further development of scientific risk assessment through our work in associations and initiatives.
Policies related to access to information by consumers and/or end-users [S4-1]
We manage impacts related to access to information by consumers and/or end-users through our product safety strategy and responsible marketing practices, for example.
Transparency and responsible marketing through rules of conduct and pharmaceutical industry codes
With our rules of conduct on responsible marketing and the Bayer Societal Engagement (BASE) principles, we establish how we interact with various stakeholders worldwide. Through these, we undertake to uphold ethical principles in advertising and communication for all our products and services. We respect the preferences of patients and customers and empower them to make informed decisions. In these BASE principles, which apply to all employees, we also state that we work together with our business partners throughout the value chain and assume responsibility.
Through our Code of Conduct, we also communicate anti-corruption rules that prescribe that Bayer employees may not confer benefits to improperly influence someone’s decision, action or opinion. As part of our compliance management system, we register and investigate any suspected violation of our responsible marketing principles.
Sales employees may, for example, lose their entitlement to variable compensation if violations of our principles on responsible marketing that they could have prevented have occurred in their sphere of responsibility. Third parties acting on our behalf in countries with a high corruption risk undergo a separate due diligence process that involves criteria related to anti-corruption. The respective corporate policies and training programs are implemented in the divisions and enabling functions, and general global training measures are supplemented with training courses pertaining to local codes. The respective countries or, in some cases, the central legal department, are primarily responsible for implementing these training measures. Employees with customer contact and/or business responsibility undergo especially intensive training.
We regularly conduct audits to verify conformity with internal compliance rules and external regulations in the area of marketing. The audit program is focused on compliance with local codes and with antitrust and anti-corruption rules by the marketing departments of the divisions and country organizations. Coverage of this issue is achieved by way of an audit cycle that regularly assesses the country organizations, as well as audits of management systems (compliance program audits). The audit plan is regularly discussed with the Board of Management and the Supervisory Board and approved by both bodies.
We also apply industry codes in our marketing and distribution activities. All codes of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) serve as a binding minimum global standard for all our human pharmaceutical products in their area of application.
In addition, we observe the codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in our interaction with healthcare professionals and patient organizations. Regarding the advertising of human pharmaceutical products, we comply with the regulations set out in the IFPMA Code of Practice as the minimum global standard along with those set forth in regional and national codes. The strategy is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
We observe the applicable transparency rules and participate in voluntary programs such as the EFPIA Disclosure Code. In accordance with the EFPIA Disclosure Code, we disclose benefits in kind to medical specialists and health organizations in connection with the development and marketing of prescription (and, where legally required, nonprescription) medicines. The rules of conduct for responsible marketing are publicly accessible on our website.
Product responsibility and responsible marketing at Crop Science as part of our Product Stewardship Policy
We have specified our principles of responsible product management in the Crop Science Division in our Product Stewardship Commitment, Principles and Key Requirements Policy. In the chapter on research and development, the policy establishes precise rules regarding transparent and exact information on product handling. Product containers and the corresponding exterior packaging must be labeled with appropriate and accurate information according to the product’s registered or approved use. In countries in which no specific labeling requirements exist, crop protection products are labeled according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and the FAO’s guidance on good labeling practice for crop protection products. Specific information on the safety of a product when used as intended is only permitted if allowed for under local legislation and if scientific evidence is available to underscore the information.
In accordance with our Product Stewardship Policy, we also declare that ethical sales and marketing practices that satisfy the applicable regulations and Bayer’s internal standards must be complied with. Responsible marketing and sales also entail monitoring the implementation of procedures, systems and processes by all relevant Bayer companies and distributors of our products and services. We observe all applicable laws and regulations on marketing practices, the global, regional and local industry codes of conduct of relevance for our business, and all of our internal standards. The Product Stewardship Policy pertains to the life cycle of all seeds & traits, biological and crop protection products, and services in our portfolio. Product stewardship aims to ensure the availability of high-quality products and services, as well as proven processes to enable compliance with all legal and regulatory requirements, facilitate trade, maximize product potential and sustainability, and minimize risks to human and animal health, as well as the environment. The principles are directed at all Bayer employees. Responsibility for product stewardship in the Crop Science Division lies with the Research and Development divisional function, which reports directly to the Crop Science Leadership Team, the highest decision-making body within the division. The Leadership Team is led by the head of the Crop Science Division, whose position makes him a member of the Board of Management of Bayer AG.
Our high internal product stewardship standards are based on the International Code of Conduct on Pesticide Management issued by the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO). These can be found in our Product Stewardship Commitment, Principles and Key Requirements Policy. This also strengthens partnerships and opens up dialogue with our most important stakeholders and customers, with the goal of fostering long-lasting trust in Bayer products and services, maintaining the foundation of our business in the long term and ultimately increasing public trust as far as possible. The strategy is in line with the United Nations Guiding Principles on Business and Human Rights (UNGPs). No cases of noncompliance with the UNGPs were reported in 2025.
We sensitize all our employees and our suppliers to their product stewardship responsibilities through our Bayer Supplier Code of Conduct (please see the section “Holistic policies for managing material sustainability matters [MDR-P]” in Chapter A 4.1 General Information on the Sustainability Statement). We require all employees to adhere to the commitments, principles and key requirements pertaining to product stewardship and promote these in their scope of activity. All employees have a responsibility to actively support the appropriate development and use of our products and services both internally and externally. It is a clear expectation of Bayer management that every single employee is aware of specific aspects of product stewardship that apply in their scope of activity. The contents are publicly available on our website.
Actions related to access to information by consumers and/or end-users [S4-2]
Our actions to improve access to information focus on responsible marketing.
Measures for responsible marketing
To act as a role model as regards transparency, we are committed on a global and company-wide basis to accurate and scientifically substantiated communication at all times, and we also demand this commitment from our external partners through our Bayer Supplier Code of Conduct. Our commitments have the primary goal of achieving clarity by avoiding ambiguous statements. Furthermore, advertising is always reviewed internally to ensure accurate content and the observance of all relevant guidelines. Information is presented uniformly, irrespective of the type and place of publication (such as news releases, social media or letters to customers). We track effectiveness in practice through the regular overall review of our marketing processes. The goal of interactions with healthcare professionals and organizations (HCPs and HCOs) is to support medical care and ultimately benefit patients. These interactions should, above all, inform HCPs and HCOs about products, pass on scientific, medical and educational information or supporting research results, and provide them with educational materials. Nothing must be offered or granted to HCPs and HCOs in a way that would improperly influence prescribing behavior. Company employees must also act fairly and ethically when interacting in the context of the marketing or sale of agricultural products such as seed and crop protection products. We expect our partners to meet their obligation to ensure truthful and accurate descriptions when producing sales, advertising and marketing materials.
We undertake to implement and monitor procedures, systems and processes and conduct regular reviews and risk assessments of our marketing processes with the goal of ensuring the best possible quality of our products and the protection of people and the environment. Based on the risk assessments, we implement the necessary corrective measures and report transparently on reassessments. This may also involve restrictions on product marketing.
We use our continuous risk assessments to review the effectiveness of these corrective measures. We also carry out regular training measures to familiarize our employees with laws, regulations and internal rules.
Processes for engaging with consumers and end-users about impacts [S4-2]
Company-wide principles established in the Bayer Code of Conduct determine how we engage not just with our own employees, but also with patients, customers, consumers and other stakeholders. This is how we want to live up to our social responsibility as a transparent company that acts sustainably and is respected for its contribution to progress in healthcare and agriculture. We want to listen, understand, take concerns seriously and conduct a respectful dialogue. Responsibility for implementing the principles established in the Code of Conduct lies with the Chairman of the Board of Management (CEO).
We have established processes throughout the company to continuously address inquiries about product safety or problems with products of ours that are already available on the market. This feedback from direct contact with consumers, end-users and their representatives, such as physicians or pharmacists, is also taken into account in our risk assessment. We continue to observe and evaluate our products following their approval and throughout their entire life cycle. This enables adverse impacts to be identified as early as possible and a decision to be taken as regards the necessary risk mitigation measures. We have established suitable policies and management systems to implement statutory and voluntary product stewardship requirements.
Clinical trials are usually conducted with adults between 18 and 64 years of age, which is also why safety data for specific population groups is only available to a limited extent. For this reason, the risk of possible side effects in specific population groups is generally estimated based on the available data or experience with similar products. As the needs of these specific population groups can differ from those of other groups, however, it is important to also conduct trials in these groups in order to find new ways of treating, controlling and preventing diseases. Another way pharmaceutical companies can support specific population groups is by providing information material about a disease or medication. One example is hemophilia, for which we have produced information videos to teach patients more about their condition and its treatment. Other patients – especially elderly people – can have difficulty swallowing tablets due to their age or to neurological or physical disorders. Pharmaceutical companies can support these patients by offering information material with advice on taking their medicine.
Processes to remediate negative impacts and channels for consumers and end-users to raise concerns [S4-3]
We undertake to exercise our operations in an ethical and legally compliant manner and encourage our employees and third parties to raise their compliance concerns. The impact of our general approach is assessed through the specific remedial measures and management systems described below in more detail.
Our Speak Up Channel offers an accessible process for reporting human rights and environment-related risks, along with corresponding violations; the confidentiality of anybody submitting such a report is protected, and they are also protected against any reprisals. This channel is available not only to our employees, but also to all third parties who would like to report a potential compliance violation. This applies irrespective of whether the third party has a business relationship with us or whether the company’s own rights are affected and thus includes all of our consumers and end-users. Users of our products can also contact us if they have inquiries or grievances, or wish to report incidents, using various communication channels that are explained in greater detail below for our different business areas.
As described in our Bayer Supplier Code of Conduct, suppliers throughout the supply chain must also encourage their employees and give them the means to report concerns, grievances or potentially unlawful activities resulting from economic activities at their own workplace or that of another supplier without the threat of reprisals, intimidation or harassment. All reports must be treated confidentially and can be filed anonymously wherever legally permissible. Suppliers must investigate such reports and take remedial measures, if necessary.
We draw attention to our Speak Up Channel on the internet, including by means of an infographic and FAQs. The relevant channels for product-specific questions, grievances or incident reports can be found on the product packaging. Based on the use of the various channels, we can tell that consumers and/or end-users are familiar with and trust these structures and processes. Beyond this, there are currently no specific methods for measuring the confidence of end-users in these channels. For more information on our Speak Up Channel, please see Chapter 4.4.1 Business Conduct. To learn how we protect individuals from retaliatory measures, please see Chapter A 4.2.3 Pollution.
Crop Science
Users of our products can contact us through a range of communication channels should they have inquiries or grievances, or if they wish to report any incidents. These channels include both direct contact with our sales staff and hotline numbers printed on our product packaging.
We follow up every incident relating to our crop protection and seed products reported anywhere in the world and manage the incidents with the aid of a dedicated incident management system and the CAIRnew software, a solution for reporting, administering, documenting and analyzing incidents, grievances and product recalls. Reported incidents are classified based on severity and risk. Our incident management system and continuous product use screenings form the key reference points when it comes to monitoring the safety of our products and to identifying necessary improvements. In general, steps to mitigate risks can vary from increased training efforts, change of formulation, revised application recommendations and use limitations, to product withdrawal.
We work with hospitals and poison control centers to further improve the quality of their reports and data and thus ensure the effectiveness of our channels. Since 2022, we have also engaged with medical professionals through our Bayer Safe Use Ambassador initiative, in which we encourage physicians in locations where there are no national incident monitoring institutions to report any incidents related to the use of our crop protection products directly to us.
Pharmaceuticals and Consumer Health
SafeTrack is Bayer’s proprietary web-based tool that patients, caregivers and healthcare professionals can use to report adverse events digitally. Our teams evaluate internal benefit and safety data, clinical trials, post-marketing studies, external databases and scientific publications to identify potential safety concerns at an early stage and detect possible changes in the benefit-risk profile. All reported side effects are entered into our pharmacovigilance database. The data is regularly evaluated in collaboration with the regulatory and supervisory authorities at both the national and international level. It is particularly important not only to collect data during the clinical development of a medical product, but also to monitor the product after marketing authorization has been granted.
We pass on to the regulatory authorities suggestions derived from these reports regarding possible supplementary safety-relevant information for the package inserts. Such suggestions usually go to the authorities from the respective pharmaceutical manufacturers. The relevant health authorities decide on the steps resulting from the reports and suggestions in close cooperation with us as the producer.
Should risks be identified, we immediately take steps in coordination with the authorities to safeguard the health of patients and consumers. These measures range from updating product information for patients, users, pharmacists and physicians through patient education brochures and further training measures for medical professionals to direct communication with medical experts (Direct Healthcare Professional Communication, DHPC) and even product withdrawals. Implementation of risk mitigation activities is coordinated by our local safety management teams (SMTs) in the country organizations. All these processes are documented, regularly updated and integrated into the quality management system. To maintain the high quality of our pharmacovigilance system and ensure its effectiveness, our medical and scientific experts additionally undergo regular training. Furthermore, all of our employees are required to undergo training as regards their obligation to immediately report safety- and quality-relevant information to the Pharmacovigilance department.