Consumers and End-Users (S4)

General information related to the protection of consumers and end-users

As part of the materiality analysis, we identified impacts, risks and opportunities related to consumers and end-users. For the material sustainability matter of health and safety, we identified a negative impact that mostly relates to individual incidents, but may be widespread in some cases. We have used the general ESRS definition of consumers and end-users for the business sectors Life Science and Electronics and a more specific one for Healthcare. All impacts, risks and opportunities that exceed our materiality threshold relate to the Healthcare business sector.

Consumers

According to ESRS, consumers are individuals who acquire, consume or use goods and services for personal use, either for themselves or for others, and not for resale, commercial, trade, business, craft, or professional purposes. For the Healthcare business sector this applies primarily to individuals that acquire, consume, use or are intended to use our medicines and services e.g., patients, their relatives or carers.

End-users

According to ESRS, end-users are individuals who ultimately use or are intended to ultimately use a particular product or service.

In the Healthcare business sector, our primary end-users are adult and pediatric patients who use or are intended to ultimately use our medicines and services. End-users also include clinical trial subjects (patients or healthy volunteers participating in clinical studies) who use or are intended to use our unapproved or approved products.

Furthermore, our end-users include those who benefit from the information and services we offer, such as people who are made aware of diseases through campaigns and/or who make use of our diagnostic or screening services. The same applies to students or researchers who take part in initiatives to foster health skills in science.

All medicines carry both benefits and risks for patients; in this sense, our products can be harmful to some end-users due to adverse effects of and/or increase the risk for chronic diseases. The consumers and end-users of our products also depend on accurate and accessible product- or service-related information, such as manuals, product labels or package inserts, to use the product correctly and ultimately achieve the intended effect and minimize adverse reactions. Furthermore, some of our end-users, such as patients with medical needs, are particularly vulnerable to health impacts. In addition, our end-users may also include particularly vulnerable populations such as children or people who are financially disadvantaged.

All consumers and end-users who are likely to be materially impacted by our company were taken into account when describing our strategy and business model.

Health and safety of our patients

Our consideration of consumers and end-users as stakeholders for clinical trials and patient safety measures (S4 SBM-2)

Before obtaining regulatory approval for our medicines, we conduct clinical studies with patients and, if necessary, also with healthy volunteers to investigate the safety and efficacy of our products. We aim to do so only in countries where we intend to market our medicines to ensure accessibility to the medicine after successful marketing authorization. We also aim to conduct high-quality clinical research that complies with applicable laws and regulations. We set Group-wide requirements that aim to ensure that high ethical and scientific standards are met when conducting clinical studies. Our top priority is the safety, well-being, dignity, and rights of the sick and healthy people who participate in our clinical studies. In order to improve our recognition of consumers and end-users and include their perspectives in research and development (R&D), we are committed to patient-focused drug development that more actively involves patients, carers and their representatives in our work. We are convinced that their valuable insights into disease and treatment management will help us to make more informed decisions at every stage of drug development.

Once our products are commercially available, they can only be purchased from a pharmacy with a prescription from a licensed physician. This is to ensure the safe use of our medicines for our end-users, as access to the drug is only given when medically justified. We also continue to educate our consumers and end-users about the products themselves and support them in administering them safely. In addition, we conduct Patient Advisory Board meetings to obtain feedback on patient-facing materials, the patients’ disease journey or when developing patient support programs. Our processes for engaging with consumers and end-users involve patients and their carers and are detailed under S4-2; S4-3. Furthermore, we actively engage with healthcare professionals in the form of Medical Advisory Boards to exchange information on the treatment experiences of their patients and implement their feedback to ensure that patients receive the best possible treatment for their indication. The feedback received is thoroughly assessed and informs our company’s business strategy, for example, in the form of drug development activities, or the set-up and design of patient-support programs, with which we aim to enhance patient care.

We aim to ensure that our products are effective in combating disease, while posing the lowest possible risk for end-users. The Code of Conduct emphasizes that the safety of patients treated with our medicinal products is our top priority and that we strive to continuously monitor any treatment-related risks or adverse effects and take the necessary action to minimize them in order to safeguard the interests and the rights of our consumers and end-users of our products. Our safety monitoring encompasses the entire life-cycle of a medicine, from development and market launch to expiration or withdrawal of regulatory approval. Stakeholder views on the negative impact of misuse of medicines (S4-NI-01) are not explicitly considered.

Our material impacts, risks and opportunities in relation to consumers and end-users (S4 SBM-3)

We distinguish between the health and safety of our patients and access to our products and services, as well as access to (quality) information. This first part of the chapter focuses on the material sustainability matter of health and safety covering our clinical studies and patient safety approaches. Our disclosure focuses on the following material impacts, risks and opportunities:

As a science and technology company, we are committed to advance healthcare and to improve the health for our patients by using our innovations to deliver first-in-class or best-in-class medicines. The safety of the patients treated with our medicines is our top priority, and we continuously aim to adapt our strategy to address our material impacts.

Our focus on innovative solutions and transformative technologies aligns with our strategy to address high unmet medical needs across all our therapeutic areas, thereby driving our organic growth. Additionally, we continuously evaluate our R&D pipeline to prioritize investments in areas that best meet patient needs with a special focus on complex or rare chronic conditions. By ensuring effective communication and monitoring of our products post launch, we mitigate risks associated with adverse effects, maintaining our commitment to safety throughout the product life cycle.

With our oncology, neurology and immunology and fertility specialty business portfolio, we support patients with unmet medical needs. In our core business we offer solutions for treatments in cardiovascular disease, diabetes, thyroid disorders, and endocrine diseases.

To ensure the safety of patients during clinical studies, we select trial participants based on known risk factors, such as age and comorbidities. Notably, we only enroll the specific number of patients needed to answer the scientific and medical questions posed. We only conduct clinical studies to investigate issues relevant to patients, healthcare professionals or society and only when our established methodology finds that the given medicines show significant therapeutic promise and a positive benefit-risk ratio. In addition, we reconcile and review the safety reports from our clinical studies and marketed products and immediately address any unforeseen risks. Senior boards, such as the Pharmacovigilance Advisory Board and the Medical Safety and Ethics Board, maintain oversight of any emerging safety concerns. In addition, cross-functional teams assess the benefit-risk ratio and development strategy of each product to ensure it delivers maximum safety and efficacy to patients.

The implementation of clinical studies in vulnerable populations, such as children or people with disabilities, requires special attention and care to comply with high ethical and scientific standards. That is why we only conduct studies with participants from vulnerable population groups if scientifically justified and if there is no other way to achieve conclusive results. When performing such studies, especially when informing study participants and obtaining their consent, we aim to take statutory regulations into account.

We are conducting clinical studies within various patient populations that are expected to use our products after their regulatory approval. In order to carry out our activities in an ethical manner, we have strict internal requirements and compliance guidelines. Our clinical study processes and procedures are regularly audited internally and inspected by the relevant regulatory authorities to verify their compliance with applicable laws and guidelines.

Once the medicines enter into the downstream value chain, we work with wholesalers and pharmacies in the respective countries to deliver our medicines. The latter also help ensure that patients use our products correctly. Our medicines must be effective in treating the respective disease while posing the lowest possible risk to patients. That is why we have established a pharmacovigilance system which helps us ensure that adverse effects are monitored, including those that were not detected during clinical development. This enables us to reduce risks to patients and communicate them transparently. Our safety monitoring covers the entire life cycle of a medicine, including development, market launch and commercialization and the expiry or revocation of regulatory approval. We aim to adhere to international guidelines and standard procedures.

Impacts to patients resulting from illegal counterfeiting and diversion of our products have significantly shaped our overall anti-product-related crime strategy, which is structured around three main pillars: supply chain and product integrity, detection and investigations as well as collaboration with external partners and authorities.

Due to the diverse therapeutic areas for which we aim to improve healthcare and the nature of our business model, we also provide our treatments to consumers and end-users who may be at greater risk of harm as a result of particular characteristics or those using particular products or services:

• End-users participating in clinical studies for innovative treatments for severe diseases are exposed to a high risk due to the less-well-characterized efficacy and safety profile of the treatment solutions.
• Patients receiving drugs from our oncology portfolio may be exposed to a higher risk because cancer drugs can have inherently harmful adverse effects for humans due to their mode of action. However, when treating a life-threatening disease such as cancer, a higher risk for the patient is accepted if the treatment is beneficial in combatting the disease.
• Pediatric patients such as those receiving medicines for the treatment of schistosomiasis are vulnerable end-users.

Our contribution to health and safety

Clinical studies enable us to investigate and provide new treatments for people around the world, including those living in low- and middle-income countries. Clinical studies also have a positive impact on the participants, as they receive potentially life-saving medicines safely and prior to commercial availability. By thoroughly assessing all available data, we ensure that the potential benefits outweigh the potential risks for patients when we decide on whether a given medication should be developed further.

Based on our commitment to diversity, equity and inclusion, we strive to ensure that the different patient groups who are likely to use our product after regulatory approval are adequately represented in our studies. We therefore endeavor to prevent discrimination against study participants on the basis of factors such as gender, ethnicity, religion, disability, gender identity, or socio-economic status. This commitment is available in a statement accessible via our website. In any event, the selection of participants is determined by the inclusion and exclusion criteria of the clinical trial, which are designed to benefit the patients involved. We identify the positive impacts in our downstream value chain for clinical studies for all consumers and end-users.

Furthermore, we want to ensure early access to medicines through our Early Access Programs. Under specific circumstances, these enable patients to gain early access to new, potentially life-saving products. The offer is aimed at people with serious conditions who have already received all available therapies without success. It allows them to be treated with products that have already been clinically tested but have not yet been approved. Furthermore, we offer patients who participated in one of our clinical studies post-study access to the investigational product, provided that certain conditions are met.

There may also be inquiries about the therapeutic use of our products beyond the marketing authorization. While each medicine is authorized for use in specific indications, a physician may, based on an individual benefit-risk assessment, wish to administer a product to a patient suffering from a serious disease for which the product in question is not approved. While we promote our medicines strictly within the scope of their specific marketing approval, these unsolicited requests for use of our products outside the scope of their approval are assessed by our qualified medical personnel. This personnel decides on the medical and scientific rationale and whether the request complies with our strict internal standards. If all requirements are met under the specific circumstances, we can enable patients to gain access to potentially life-saving products that are not approved for their respective indication.

After conducting clinical studies involving hundreds of patients around the world and the demonstrating a beneficial benefit-risk ratio, we launch our products commercially once they are approved by the health authorities. To ensure the safe use of our products already on the market, we continuously review and assess any safety data updates on those products.

Material negative impacts related to product integrity and supply chain security can potentially occur in any market where we sell or provide our products. These impacts include incidents of illegal diversion of medicines or misuse of our products.

To mitigate these negative impacts and secure the supply of genuine products to our consumers and end-users, we strive to fulfill the regulatory requirements on product serialization and the implementation of track-and-trace technologies in many countries and regions. This includes clear barcoding of individual products and collectively packaged products for transport so that they can be traced in the supply chain and the likelihood of counterfeit and illegally diverted products reaching patients is reduced. Using a risk-based approach, we apply our own product security features on certain products. In this way, we ensure that our products can be quickly and reliably checked for authenticity and thus contribute to the safety of consumers and end-users.

All material health and safety risks and opportunities we have identified relate to consumers and end-users of our Healthcare business sector. Generally, the opportunities are relevant for the respective patient group suffering from diseases for which we offer products.

Our policies related to consumers and end-users (S4-1)

In cases where we face conflicts between our Group-wide standards and national laws, we will seek to act in accordance with whichever standard is stricter while ensuring respect for the laws of the countries in which we operate. Information on our policies regarding alignment with internationally recognized initiatives can be found in our policy tables under “Third-party standards/initiatives”. 

The policies related to our consumers and end-users are regularly monitored and updated. Our policies are generally available in English. Some are not publicly accessible and are only available internally. Others are also published on our website.

Our commitment: International guidelines and requirements

Our human rights commitments are detailed in our Human Rights Charter. Within this charter, relevant management processes and actions are set out for specific human rights issue areas such as research ethics, including clinical studies. Our commitment is based on the UN Guiding Principles on Business and Human Rights (UNGP). We expect our employees and our business partners to respect human rights. Compliance with the Human Rights Charter is currently not monitored with regard to consumers and end-users.

Our Quality Policy provides a strategic framework that aims to ensure that our products, services and systems offer patients high quality, safety and efficacy. It details the relevant laws and codes, criteria and guidance (e.g., for product development, manufacturing and access), and highlights the responsibility of our senior management to ensure quality is embedded in everything we do.

Our Standard on Human Research regulates the conduct of clinical studies. It helps us to comply with the applicable legal, ethical and scientific standards. Further quality documents detail the strategic direction of all quality-related activities or disclose our position on data privacy, for instance. In addition to the relevant national laws and regulations, these documents also include references to further guidelines and principles. Depending on the topic of a quality document, the respective guidelines and principles below have to be complied with as well:

• The Good Clinical Practice (GCP) guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
• The Declaration of Helsinki, published by the World Medical Association.
• Good Laboratory Practice (GLP); Good Manufacturing Practice (GMP); Good Distribution Practice (GDP).
• The International Ethical Guidelines for Health-related Research Involving Humans of the Council for International Organizations of Medical Sciences (CIOMS).
• The Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
• The EFPIA and PhRMA Principles for Responsible Clinical Trial Data Sharing and the IFPMA Principles for Responsible Clinical Trial Data Sharing.

Furthermore, we aim to follow international guidance and standard procedures for patient safety. These include, for example, the ICH guidelines, the Good Pharmacovigilance Practices (GVP) established by the European Medicines Agency (EMA), Title 21 of the Code of Federal Regulations governed by the U.S. Food and Drug Administration (FDA), and other pharmacovigilance regulations issued by national health authorities. We also aim to comply with relevant new statutory pharmacovigilance regulations in the countries where we market our products. We continuously monitor our service objectives through our pharmacovigilance quality strategy and annual quality plan. We also regularly monitor our performance and compliance through the internal and external reporting of key performance indicators. This includes submitting high-quality documents to health authorities in a timely fashion and performing assessments to support the monitoring of product safety throughout their life cycles.

Patient orientation

We aim to continuously improve our research and development approach and are committed to patient-focused drug development. We actively involve the patients, carers and their representatives as well as patient experts and patient advocacy groups throughout the entire drug development process and after the drugs become available to understand their unmet needs. Their valuable insights into disease and treatment management will help us make more informed decisions at each stage of the drug development process. We have compliance guidelines that define how we aim to ensure that such engagements take place within an ethical framework.

To this end, we have established Patient Advisory Boards (PAB) as one of our most important channels to gather patient and carer insights. Our PAB guidelines describe how we involve patients and carers in our clinical research process. At advisory board meetings, patients, patient advocates and carers can provide actionable feedback that informs our strategy and improves outcomes. We use this opportunity to discuss various aspects of the product development process, including but not limited to protocol design, educational materials, technology, and innovative approaches to clinical studies.

The input of patients is crucial for us, as is evidenced by dedicated patient engagement activities between patient representatives and senior management. Patient organizations are invited to discuss and provide senior management with direct feedback on our patient focus at an annual summit meeting. This enables respectful and enduring relationships to be formed. At corporate events, such as town hall meetings, individual patients are also invited to share their experience and make their voices heard. In addition, we receive indirect feedback from treating physicians at Medical Advisory Board meetings and supplement this with feedback from patients on their treatment experience through patient-reported outcomes, which are also included as an endpoint in some of our clinical studies.

Actual and potential impacts on consumers and end-users of our medicinal products contribute to our product information documents. Our product information supports correct use and informed treatment decisions, including relevant details such as indications, ingredients, dosage, storage, warnings and precautions, and potential side effects. Package leaflets may also include disposal instructions for environmentally harmful ingredients. We regularly review and update these documents to ensure they reflect the latest safety, efficacy and formulation information.

Our approach to enable effective human rights remedies

Violations of our Code of Conduct or legal provisions as well as human rights and environmental concerns during clinical studies can be reported via our Group-wide whistleblowing and complaints system. Anyone can report suspected cases anonymously and free of charge.

If our safety risk assessments identify any new safety issues, or if safety observations in the downstream value chain require urgent safety measures or if we identify new safety information that could impact the benefit-risk balance of our medicines (e.g., in the event of a product recall as part of crisis management), we immediately notify the health authorities using the appropriate emergency response procedures. Emergency response procedures include seeking health authority approval for further actions and communicating the information to relevant healthcare professionals. In addition, we promptly share this information with our business partners and clinical study investigators, enabling them to take proper action where the medicinal product in question is used. Further information can be found under “Our complaint mechanisms”.

We are committed to upholding human rights, which is why we became a signatory to the UN Global Compact back in 2005. We endeavor to prevent the risk of human rights violations as far as possible, not only at our own sites but also along our entire supply chain. We have a Group-wide complaints system for reporting human rights risks and violations. Our employees and external stakeholders can anonymously report suspected violations free of charge using this Group-wide complaints system, either by telephone or using a web-based app. To identify further human rights risks and certain environmental risks, we carry out risk analyses for our own business and for our direct suppliers once a year and on an ad hoc basis in cases of mergers and acquisitions, for example. Risks relating to indirect suppliers are generally assessed on an ad hoc basis. We have also implemented the Supplier Code of Conduct, which applies to all providers of goods and/or services to our company (suppliers) and sales intermediates (e.g., dealers, distributors, wholesalers, agents, and resellers). The Supplier Code of Conduct sets forth the minimum standards that suppliers agree to fulfill as regards respecting human and labor rights, occupational health and safety, business integrity, environmental protection, continuous improvement, and supplier management. More information can be found under S2.

Our complaints mechanism applies generally and is not limited to cases relating to consumers and end-users in our downstream value chain. There were no reports for this target group in the reporting year. No severe human rights issues or incidents connected to consumers and end-user were reported in 2024.

Our processes for engaging with consumers and end-users (S4-2; S4-3)

The phases in which consumers and end-users are involved, as well as the type and frequency of involvement, vary from process to process. In principle, we work with consumers and end-users or their legitimate representatives either directly and/or through credible proxies. To transparently disclose to our consumers and end-users any relevant new achievements that have the potential to change the treatment patients receive, we aim to provide updates in press releases on critical development steps.

Furthermore, we further involve consumers and end-users in our Patient Advisory Boards, in the form of individual interviews and in the context of consulting agreements, surveys, or qualitative and quantitative research projects. We focus on exploring a specific topic or condition, and this includes feedback on living with a certain disease, disease trajectories and diagnoses or a variety of topics affecting clinical studies and their design to ensure that patients are able to adhere to the study protocols, for example. The knowledge gained in Patient Advisory Boards and further patient engagements is used for the subsequent decision-making processes of Medical, Digital Health, Communications, and other functions and informs the development of patient-facing materials to ensure they are understandable. In addition, they provide valuable information for the content of patient support programs, companion apps, awareness campaigns, and future company strategies. This way, we ensure that patient insights and perspectives are brought into internal decision making from the outset. All materials for the advisory board as well as the details around contracting and payment of the participating patients are pre-reviewed and approved by relevant departments, especially the medical, legal and compliance departments. The accountability for the Patient Advisory Boards lies with clinical and medical functions as well as overarching functions such as Government and Public Affairs and Communications. The guidelines of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the internal policy Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders, Carers, Patient and Carer-led Organization apply to all procedures.

We are specifically looking for suitable patients, carers, or patient organizations to participate in our Patient 360 program. The program has yielded valuable outcomes, such as insights that have informed our planning and validation of patient engagement initiatives and the identification of gaps in support for carers of individuals with multiple sclerosis and myasthenia gravis. Additionally, as part of our Patient 360 program, we have worked closely with patient advocates to co-create a medical information website. Involvement takes place four to five times during the program via e-mail, virtual meetings, or personal contact. After a session, a survey is usually conducted to assess the effective involvement of participants in the development of patient-focused medicines. We summarize the insights gained, including concrete recommendations for action, in a report and share them with the participants and internal functions that may benefit from the insights. The accountability for Patient 360 lies with the Director, Global Patient Insights & Advocacy for Neurology & Immunology and our Vice President, Global Patient Insights & Advocacy.

The Medical Advisory Board meetings are held as required with the relevant medical employees of the Healthcare business sector and external healthcare professionals. The feedback we receive during these advisory board meetings is taken into account when planning our clinical studies. For example, the outcome of such feedback might lead to increased caution when enrolling studies in specific countries in order to prevent bias, adapt treatments and patient populations or modify biomarker strategies to enhance the value of clinical data and improve patient stratification. We hope that this will bring us closer to the needs of patients during drug development, increase the benefits of the drugs and minimize the risks for participants in clinical studies. The accountability for the Medical Advisory Board meetings lies with the heads of the medical functions.

As part of our Individual Case Safety Report Management, several channels are available to consumers, end-users and healthcare professionals for reporting adverse events. This includes e-mail, fax, telephone number, web pages, and programs managed by our company. We conduct basic pharmacovigilance training throughout the Healthcare business sector to ensure that our employees are able to collect and report information on adverse events from all sources. Role-specific training plans are also in place for our employees who work in programs or tasks related to patient safety. We have introduced appropriate procedures for supplier management, pharmacovigilance agreements with business partners and audits. The accountability for the Individual Case Safety Report Management lies with the Head of the Global Patient Safety unit.

Once our products are on the market, we often engage via two-way communication with consumers and end-users, i.e. patients, their relatives, carers, and healthcare professionals. If this communication involves collecting safety and/or efficacy data, it is classified as a Patient Data Collection System (PDCS). The Global PDCS Team oversees all PDCSs globally, maintaining a comprehensive inventory and continuously monitoring to ensure compliance with applicable laws and regulations as part of our responsibilities as the marketing authorization holder.

We operate a wide range of programs worldwide, some of which are classified as PDCS. These include, but are not limited to, market research, digital media, digital health management tools, patient assistance programs, patient support programs, patient access solutions, and call centers or hotlines. The PDCS certification process is designed to ensure consistency in the safety practices of all the Healthcare business sector programs that qualify as PDCS. This process ensures proper planning and execution of PDCSs, focusing on identifying, collecting, and processing adverse events (AE) and special situations in patients using our authorized and marketed medicinal products. The Global PDCS Team is responsible for certifying all PDCSs. Each PDCS is assigned a PDCS Program Lead alongside a PDCS Safety Representative. All personnel involved in PDCS operations must undergo annual training in adverse event collection to ensure compliance.

Ultimately, the General Manager of the PDCS Program Lead is accountable for establishing the infrastructure and securing the resources needed to support effective operation of the PDCS. The frequency of engagement varies depending on the program structure and requirements. When collecting information, we include vulnerable patient groups, such as children, senior citizens and patients who are pregnant or breastfeeding. If necessary, we also take into account accompanying medications and existing medical conditions. The Head of Regulatory, Quality and Safety Operations is accountable for the PDCS process.

Once a medicine has been approved by the regulatory authority, the authority may request a study to collect further safety data. In this context, healthcare professionals may register for our Post-Authorization Safety Studies (PASS) to report safety data. The frequency of engagement varies depending on the program structure and requirements. When collecting safety information from PASS, we also take into account the vulnerable patient groups already mentioned. Once the PASS protocol is established, reviewed, and approved by the Pharmacovigilance Advisory Board, clinical study authorizations are established and tracked in accordance with Good Pharmacovigilance Practices guidelines. The study is disclosed through the entry of the PASS in the catalogues of Real-World Data Sources and Studies. The Clinical studies Transparency Officer also enters the relevant information in ClinicalTrials.gov. Accountability for the PASS process lies with the Head of the Global Patient Safety unit.

In the post-market phase, consumers and end-users as well as healthcare professionals receive drug information and labeling in the form of product information documents, such as package inserts, summaries of product characteristics, United States prescribing information, instructions for use, or illustrations on the medicinal product. We also ensure necessary training for affected employees working on the process. The procedures for medicinal product information should ensure that safety information is updated in the available public portals, package inserts and illustrations for all marketed medicines. It should also ensure the availability of safety information about the known product characteristics, indications, warnings, and precautions as well as potential side effects to healthcare professionals, consumers and end-users as required. The Head of the Global Labeling unit is responsible for drug information and labeling.

If our ongoing safety monitoring activities of our medicinal products identify important new safety findings with a potential impact on the benefit-risk balance, we organize the respective safety communication after obtaining the necessary approvals from the relevant regulatory authorities. The safety communication message is delivered to the target group (such as our business partners, healthcare professionals and consumers and end-users) in the appropriate format. Depending on the life cycle of the medical product in question and applicable requirements, communication takes the form of a letter, e.g., a “Dear Doctor Letter” or a “Dear Investigator Letter”, an e-mail, a video, a written statement on a website, or via other Internet-based channels such as social media. Safety communication messages disseminated to healthcare professionals are tracked. Employee training for the safety communication processes are covered by role-specific trainings, and the responsibility of such processes lies with the Global Patient Safety unit. In 2024, we had 5 drug product recalls affecting 46,465 units in total.

Our complaint mechanisms

We have set up a Group-wide whistleblowing and complaints system that can be used to report actual and potential violations. A central component of this is our free and anonymous compliance hotline. Complaints received via our compliance hotline are received by a central, independent, and qualified team within Group Compliance. This team evaluates the reports and either initiates an investigation directly or, depending on the type, content, and nature of the report, may forward the report to the responsible function. If the complaint involves concerns from consumers and end-users regarding medicines, the report is forwarded to the appropriate function (e.g., Global Patient Safety) for further follow-up and measures. The end-to-end investigation process and remedial action lies within the responsibility of the respective function. Generally, if communication with the reporting person is possible, we would confirm receipt of the report within seven days and aim to provide information on the status of reported concerns within three months after the confirmation of receipt. Our central compliance hotline is available in more than 40 languages and countries as a telephone service or online platform. Both employees and external parties can use it. The accessibility of the compliance hotline is reviewed annually and is also contractually guaranteed by the external provider. We do not assess whether consumers and end-users are aware of and trust our compliance hotline as a way to raise concern.

Our general call center 720 serves all customer groups, including healthcare professionals, patients, and carers. Contact information, such as phone numbers and e-mail addresses, is provided in the package leaflets or the summaries of product characteristics of medicines as well as on the websites of the therapeutic areas. In addition, they are communicated on websites for specific therapeutic areas. We are legally obligated to be available for reporting adverse events and product complaints, and reconciliation processes are in place for such requests to ensure that all cases are processed appropriately. To meet this responsibility and comply with standards, we have established various procedures. Our call center services, which may be outsourced, are closely monitored for quality and efficiency and supported by service level agreements with the aim of ensuring high standards. We regularly review reports and analyses to maintain the availability and functionality of our communication channels. Documenting and tracking adverse event and product complaint reports are integral to our quality management system. We also record and analyze medical information requests to gain insights and assess the recognition and trustworthiness of our call center 720. We do not assess whether consumers and end-users are aware of and trust our call center 720 as a way to raise concerns.

With a centralized follow-up of corrective and preventive actions (CAPA), we help to verify the effectiveness of procedures in connection with complaints about product quality. To this end, we carry out regular trend analyses of complaints and their causes in order to identify areas that require improvement. All complaints received are anonymized. Digital systems are used to track complaints, while regular meetings with service providers in accordance with the service level agreements are intended to ensure effectiveness.

In accordance with our standards on product and supply chain integrity, we aim to maintain the integrity of our supply chains and reduce the likelihood of illegal medicines circulating, as counterfeit and substandard medicines pose a significant risk to public health. That is why we have safety rules and regulations for products and supply chains. We strive to comply with the regulatory requirements for product serialization and implementation of track-and-trace technologies as prescribed in many countries and regions. Track-and-trace technologies help us increase supply chain transparency and protect the integrity of our products, which is consistent with our corporate targets for patient health and safety. They work by making it possible to identify illegal medicines within the legitimate supply chain and prevent them from being dispensed, while ensuring that healthcare or regulatory authorities are notified.

We actively combat the illegal counterfeiting and diversion of our products. Our Group-wide standard Illicit Trade & Product Crime Prevention sets out binding procedures for effectively identifying and responding to incidents of pharmaceutical crime. In close cooperation with the authorities, we support the prosecution of offenders. A team of security personnel and experts from a range of fields, including legal and trademarks, supply chain, patient safety, regulatory affairs and quality assurance, pool their expertise to ensure the implementation of and compliance with the standard. We monitor online pharmacies, websites, online marketplaces, and social media to identify and remove illicit listings of our medicines and have established processes to ensure rapid and reliable authentication of suspected counterfeit products. We conduct proactive investigations both online and offline to identify and disrupt the availability of illicit products in both legitimate and illegitimate channels. All reports of suspected product-related crime are documented in a separate central, group-wide reporting system, enabling us to build intelligence, link incidents and respond more effectively. To protect patients, we also sponsor global initiatives, such as the Global Pharma Health Fund (GPHF), a non-profit organization that provides the GPHF-Minilab^®. This mobile compact laboratory enables users to quickly and effectively test the presence and quantity of 113 different active ingredients, particularly in regions with limited access to healthcare solutions.

As previously mentioned, consumers and end-users can use multiple channels, including the Compliance Hotline, the call center 720 and the regular patient safety and product complaint channels to raise their concerns about dubious products. All reports of suspected product crime are documented in a separate central, Group-wide reporting system. This enables us to collect information, link incidents and respond more effectively.

Our actions related to consumers and end-users (S4-4)

Our actions in relation to consumers and end-users follow our policies and aim to improve the protection and advance the healthcare of consumers and end-users. Through the following measures, we aim to make progress toward the targets we have set ourselves, which are detailed under S4-5. This primarily affects consumers and end-users, R&D functions and the associated business sector Healthcare as well as external service providers. Unless otherwise stated, all measures mentioned are to be regarded as ongoing and have no fixed completion date.

Inspections and audits to ensure patient safety

We conduct global internal audits to ensure compliance with legal and further requirements such as Good Clinical or Pharmacovigilance Practices and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as well as our internal standards, and to verify the effectiveness of protection measures for consumers and end-users. These audits affect our R&D function as well as further Healthcare units and external service providers. We carried out 113 audits in 2024. Regular quality management reviews with Senior Management involve sharing identified trends and risks from audits and inspections. Internal audits that detected relevant observations trigger a root cause analysis and the definition of corrective and preventive actions, which are checked and approved by the Quality Assurance department. In addition, regulatory authorities check whether we are complying with legal requirements and our internal standards to verify compliance with applicable guidelines and patient safety. In 2024, 17 health authority inspections took place. We follow up on the findings of these inspections and take necessary actions to ensure the ongoing compliance of our pharmacovigilance system. For each critical and major audit/inspection observation that requires corrective and/or preventive actions (CAPAs), an effectiveness check must be defined and the result documented to verify that actions taken were effective to eliminate the root cause. If the effectiveness check does not meet the predefined criteria, new root cause analyses and/or additional CAPAs must be defined, followed by new effectiveness checks. Based on feedback from inspectors, inspections are either closed or reworked. All audits were completed without significant safety risks to subjects or impact on subject rights or data integrity that could lead to legal action. In addition, all inspections were completed without legal action by an authority.

By conducting audits according to pre-defined audit plans, we ensure that our processes are appropriate and that the safety and rights of our consumers and end-users are at no time at risk. Audits and inspections accordingly also constitute a means to allow us to compliantly develop drugs, mitigating the risks for the company arising from dependencies on our consumers and end-users including liability claims.

In 2024, no significant capital expenditures (CapEx) or operating expenditures (OpEx) were allocated to the actions in relation to inspections and audits. For 2025, we also do not intend to allocate any significant OpEx or CapEx.

Patient Safety Day

The aim of Patient Safety Day is to raise awareness of patient safety and the importance of pharmacovigilance in the local subsidiaries. This annual event is held within the WHO celebration event schedule. The global awareness campaign, which took place in September 2024, aims to raise employee awareness of the need to proactively report and communicate adverse events to the responsible unit (i.e. Global Patient Safety). We currently have no specific effectiveness tracking in place. Generally, the campaign is intended to help to prevent serious safety problems and medication errors by pointing them out at an early stage. Raising awareness of pharmacovigilance helps to protect patient safety, thus reducing the risk of our company being exposed to liability claims regarding pharmaceutical products.

In 2024, no significant operating expenditures (OpEx) or capital expenditures (CapEx) were allocated to Patient Safety Day. For 2025, we also do not intend to allocate any significant OpEx or CapEx.

We do not have any actions in place related to the identified material negative impact (S4-NI-01). However, we have established processes to manage this impact effectively. These processes are intended to enhance supply chain security by ensuring compliance with strict quality standards in both manufacturing and distribution processes. Furthermore, we strive to fulfill the regulatory requirements on product serialization and the implementation of track-and-trace technologies. More information can be found under S4-2/S4-3.

Roles and responsibilities

Our Global Development unit is responsible for clinical development, including clinical studies and the associated management processes (Reference to S4-PI-01; S4-PI-03; S4-R-01; S4-O-01). The Head of Global Research and Development reports to the CEO of the Healthcare business sector, who is a Member of the Executive Board. We review the progress of the development of new products based on predefined milestones. Depending on the results of the clinical studies, we decide whether to continue, change or discontinue development.

Two internal boards monitor our clinical studies. The Integrated Protocol Review Committee is responsible for the studies we conduct with products that are in clinical development. The integrated Medical Study Governance Board is responsible for our own studies on products that have already been approved as well as for all studies conducted by independent investigators that are supported by our company (so-called investigator-sponsored studies). Both boards consist of medical and scientific experts as well as managers with many years of experience in clinical research. We only take the critical step of a first clinical study on humans after carefully conducting extensive preclinical tests. The Human Exposure Group, a separate committee headed by our Chief Medical Officer, is responsible for making this decision. Before and during our clinical studies, we continuously analyze the potential risks for the participants in clinical studies. Our Medical Safety and Ethics Board monitors the safety of participants in our clinical studies and reviews the benefit-risk profiles of investigational medicinal products as required. In addition, it also convenes as required to resolve any questions related to patient safety and the benefit-risk profile of our marketed products. To this end, and when particular actual or potential negative safety events are detected for a certain drug, these events and their implications on the safety of our consumers and end-users will be discussed in the Medical Safety and Ethics Board. This board constitutes the most senior decision-making body that ensures that the usage of our medicines is safe and that they exhibit a positive benefit-risk ratio. Depending on the type of issue, the board might mandate the termination of a trial, the adaptation of a clinical study protocol, or a product batch recall, among other actions, to ensure the safety of patients.

Our Global Patient Safety unit is responsible for managing patient safety (Reference to S4-NI-01; S4-PI-01; S4-PI-02; S4-PI-04; S4-PI-05; S4-R-01). The unit analyzes all safety data and reassesses the risk profile on this basis, if necessary. If applicable, we inform regulatory authorities, healthcare professionals and patients about new risks, additional risk mitigation measures and potential changes to the benefit-risk profile. Our Healthcare Quality unit handles quality complaints in connection with our products.

Our Corporate Security team manages all security risks across our organization, including our strategies and initiatives against product-related crime (Reference to S4-NI-01; S4-PI-05). Supported by experts from Legal, Export Control, Supply Chain, Patient Safety, Regulatory Affairs, and Quality Assurance at both global and local levels, they work collaboratively to safeguard our products and patients.

Our targets related to consumers and end-users (S4-5)

At present, we are not able to share specific information about our target-setting process in relation to the stated target. Furthermore, we lack systematic mechanisms to compare our performance with consumer expectations and experiences, and we have not implemented structured processes for collaborative learning and improvement with consumers. For both audits and inspections, we conduct internal learning sessions. Our current approach does not involve direct engagement with consumers and end-users at this stage. In addition, we are looking for ways to improve our understanding of the expectations and experiences of consumers and end-users. We recognize the importance of learning from our achievements and working with consumers and end-users to identify areas for improvement.

Our ambition is to systematically identify, manage and report risks associated with consumers and end-users. Beyond this, we have not set any targets related to consumers and end-users for the material sustainability matter of health and safety. Further information on our actions can be found under S4-4.

Access to our products and services and access to (quality) information

Our material impacts, risks and opportunities in relation to consumers and end-users (S4 SBM-3)

We distinguish between the health and safety of our patients (see previous section) and access to our products and services, as well as access to (quality) information. Given the clear thematic links, we will look at the latter two sustainability matters together. Our disclosure focuses on the following impacts:

Our approach to providing access to our products and services and to (quality) information

Health is a fundamental human right. However, half the global population still lacks adequate access to health, which is why we have made it a priority to drive health equity in order to address this global health disparity. We understand health equity as a concerted effort to ensure that all people, regardless of socioeconomic, geographical or other differences, can achieve the best possible care. We work with partners to tackle these complex challenges and are committed to systematically integrating the interests and perspectives of our stakeholders into our strategy and business model. To this end, we have adopted a holistic approach that focuses on integrating the pillars of innovation, access and community engagement:

• Availability: Catalyze innovative solutions for global health challenges through needs-based Research & Development (R&D), and responsible handling of intellectual property. We strive to foster the fastest and broadest access to innovation.
• Accessibility: Support countries in building up infrastructure and strengthening health services to enable patient access to the best possible care.
• Affordability: Implement innovative mechanisms for equitable and sustainable access to our innovations and established products.

We strive to increase our company’s competitiveness and value while delivering long-term benefits to society by reaching populations in need with our products and technologies. Besides enabling access to our healthcare portfolio, our global health engagement extends to the fight against diseases that disproportionally impact populations in low- and middle-income countries (LMICs). These include the neglected tropical disease (NTD) schistosomiasis as well as malaria.

Our LMIC access strategy aims to achieve our target of reaching more than 170 million patients per year in these countries by 2030: more than 80 million patients with access to our healthcare portfolio and more than 90 million people with our global health portfolio. More information on our targets can be found under S4-5.

Partnerships and dialogue with stakeholders are essential to improve access to healthcare. That is why our approach also involves close cooperation with governments of various countries, international and non-governmental organizations, academic institutions, the private sector and independent experts. When it comes to pricing, we monitor the dynamic healthcare environment and markets, pricing and reimbursement systems as well as legal and regulatory guidelines and adjust our prices where necessary. Through a consistent, data-driven approach we intend to ensure that these meet patients’ needs.

In the context of access to (quality) information, our business model focuses on strengthening healthcare systems and local capacity by enhancing the skills and expertise of scientists and medical professionals through a network of experts. Through health education and awareness initiatives, we also intend to drive behavioral change and to empower health professionals and patients to make informed decisions about treatment pathways. We implement these initiatives along the value chain in cooperation with our local partners on the ground. We concentrate primarily on the diseases in which we have the greatest expertise. In the area of global health, we have been primarily active in four key areas to improve healthcare systems: local research and development, manufacturing and supply chains, education and awareness raising, and health infrastructure and training.

Our contribution to improving access to our products and services as well as (quality) information

With our strategy, we seek to understand the prevalence of disease, the extent of unmet medical need and the availability of existing therapies. On this basis, we decide whether development is justified and how an appropriate access strategy for these diseases can be defined in the relevant regions, countries and communities. In developing this strategy, we balance our commitment to improving access globally while maintaining a sustainable business model that favors long-term investment in innovative research and development, as well as production of high-quality, safe products that are intended to improve patients’ lives.

In the area of global health, we work with respected international and local organizations to jointly assess priorities. When it comes to schistosomiasis, for example, we align and contribute to the requirements of the World Health Organization’s 2021-2030 Roadmap for Neglected Tropical Diseases. We do this by investing in our programs and specifically providing treatments for controlling disease, developing innovations, implementing health interventions for behavioral change through awareness campaigns and fostering partnerships to accelerate progress. Based on the results of our programs, we review and refine the analysis to identify and focus on the priorities that we can best address.

To ensure affordable access to our healthcare portfolio, we conduct annual price analyses to validate price thresholds and provide guidance on local pricing to our subsidiaries for the following year. We aim to ensure that they meet patient access needs by taking a consistent, data-driven approach together with equitable pricing initiatives. Moreover, we have adopted the Systematic Health Access and Patient Enablement (SHAPE) program with its holistic approach to addressing key barriers to access to healthcare, including affordability in addition to availability and accessibility, and consequently to improving access for underserved patient populations in LMICs. Our commitment to improve patient access to health also goes beyond LMICs to acknowledge and address affordability issues in some populations within high-income countries.

Our policies related to consumers and end-users (S4-1)

Compliance with strict regulatory requirements means that, unless otherwise stated, no interviews were conducted, nor were the interests of consumers and end-users directly included. Instead, the information reference is based exclusively on regulatory sources and credible proxies, without direct interaction with the consumers and end-users. Focusing on LMICs, our access-related policies cover people and patients who are supposed to use our medicinal products.

Our access-related policies are not aligned with an internationally recognized guideline. They are regularly monitored and updated. They are available in English and are either published internally (in which case they are not publicly accessible) or on our website.

Our commitment: International guidelines and requirements

As stated in our human rights charter, we respect the right to health and are committed to providing high-quality, safe health solutions for all. Our philosophy follows the guidance from the World Health Organization (WHO), which demands “the right to the highest attainable standard of physical and mental health”. We apply the concept of implementing this for populations in LMICs as well as populations with access challenges in high-income countries.

As regards mechanisms for compliance and more details on how we follow laws and regulations but also international guidelines and principles concerning our products as well as how we report human rights incidents, the same apply as for the health and safety of our patients. Further information can be found under health and safety.

Our processes for engaging with consumers and end-users (S4-2)

For our activities regarding access to products and services, as well as access to (quality) information, we do not have specific processes in place for involving consumers and end-users. Further information on our processes for engaging with consumers and end-users can also be found under health and safety.

We conduct regular stakeholder dialogue with relevant groups such as payers, payer advisors, patient representatives and healthcare professionals to understand the care landscape and the needs of patients and healthcare systems. Our exchange also extends to international organizations, non-governmental organizations, local institutions and universities. When it comes to global health challenges, we focus particularly on LMICs. Stakeholder dialogue takes place in all phases of the life cycle of our products – from research and development to market launch and post-launch. Engagement takes place through various platforms and in the form of market research projects, roundtables, discussions with stakeholders, education and awareness programs, public consultations and the involvement of payers. The Member of the Executive Board and CEO of Healthcare is the most senior role responsible for ensuring the engagement.

Our actions related to consumers and end-users (S4-4)

Our actions in relation to consumers and end-users follow our strategy and aim to improve access to our products and services as well as to (quality) information.

In 2024, we served around 103 million patients with our healthcare portfolio, thereof around 65 million patients in LMICs. Furthermore, we enabled the treatment of around 81 million people with Praziquantel against schistosomiasis. The total number of people reached in 2024 amounted to 184 million, which we show as a strategic sustainability key indicator (Number of people treated with our Healthcare products) under ESRS 2 (SBM-1). Through the following actions, we aim to make progress toward the targets we have set ourselves. Unless otherwise stated, all actions mentioned are to be regarded as ongoing and have no fixed completion date.

Access to health in low- and middle-income countries

As part of the implementation of our Access Strategy for LMICs, SHAPE is our long-term, systematic program for improving the availability, accessibility and affordability of our Healthcare medicines for underserved patient populations. The program includes both existing and upcoming products in our healthcare portfolio. Specifically, we pursue a three-pronged approach that goes deeper, wider and faster. We are going deeper in our collaborative efforts to remove barriers to access in individual countries, including launching equitable pricing strategies and health system strengthening initiatives. We are going wider by making our medicines available in more countries, focusing on those with significant prevalence. And lastly, we are going faster when introducing new products to LMICs, reducing the time between the first global launch and regulatory filings in those countries. We anticipate that the implementation and expansion of SHAPE will continue to positively impact our consumers and end-users, leading to more equitable access and further initiatives to strengthen the healthcare system in LMICs.

In 2024, we served around 103 million patients with our healthcare portfolio, thereof around 65 million patients in LMICs. As of 2024, 17 pilot projects have been initiated in countries such as Peru, Argentina, Brazil, Egypt, Indonesia, and Mexico as well as several countries in Central America. In Egypt, for example, we have implemented a SHAPE project for Erbitux^®. The program aims to reduce the prevalence and mortality rates of colorectal cancers by increasing public awareness, providing continuous medical education for healthcare practitioners and supporting diagnosis and treatment. We also collaborate with the Cancer Early Detection Presidential initiative by providing education programs for healthcare professionals.

We continue to drive forward activities in and for LMICs through our health equity accessibility initiatives that help strengthen local healthcare systems. In this way, we prepare and promote access to our innovations and products for high-burden, non-communicable diseases. We adopt a partnership approach to maximize our impact in this complex and challenging environment. This includes the shared value program, which supports our teams in LMICs in implementing initiatives that address health system barriers to patient access through capacity building and training for healthcare professionals. Our stakeholders are patients, health authorities, payers and healthcare providers.

Our Access Strategy for LMICs is contributing to fulfilling our target of serving over 80 million patients by 2030 with our healthcare solutions and portfolio of products for non-communicable diseases, such as cancer indications and endocrine disorders.

The implementation of our aforementioned initiatives is supplemented by monitoring and evaluation processes. We have created an impact evaluation protocol, which is available as needed. This protocol contains a clear definition of the key indicators that are crucial for tracking the effectiveness of our initiatives on an ongoing basis and deciding on actions to improve the effectiveness of our programs in achieving the desired results.

In our SHAPE program, the number of patients is the most important key indicator. This is tracked and evaluated on a quarterly basis. In addition, we continuously monitor the progress of the projects regarding important milestones, especially in the initial phase. We conduct annual target setting and validation for patient numbers and need for investment at the end of the year to ensure effectiveness in the implementation of approved projects.

In 2024, we allocated € 4 million of operating expenditures (OpEx) to our Access Strategy initiatives for LMICs, which are included in the respective lines of the income statement. No capital expenditure (CapEx) was allocated. For 2025, we intend to allocate € 5 million of OpEx and no CapEx.

Eliminating schistosomiasis as a public health problem

We aim to eliminate schistosomiasis as a public health problem by 2030, in accordance with the Neglected Tropical Diseases (NTD) Roadmap 2021-2030 of WHO. We are committed to the targets of the Kigali Declaration on NTDs: Participating companies, governments and private organizations pledge to contain and ultimately eliminate the 21 most prevalent of these diseases, including schistosomiasis. Schistosomiasis, also known as bilharzia, is caused by parasitic worms and affects over 250 million people worldwide, mainly in sub-Saharan Africa. To fight this disease, we have adopted an integrated strategy, which we are implementing in close collaboration with multiple partners worldwide. Our approach is based on four pillars:

• Treatment: As part of our partnership with WHO, we donate up to 250 million praziquantel tablets every year for the treatment in endemic countries. In 2024, we provided 203 million tablets. Based on the treatment guidance of WHO, we estimate that this number of tablets enabled the treatment of around 81 million people. Nearly 50 years after its development, praziquantel remains the standard of care for the effective treatment of schistosomiasis around the world. Our target is to reach over 90 million people per year with praziquantel by 2030.
• Research and Development (R&D): Within the Pediatric Praziquantel Consortium, we developed arpraziquantel – a new pediatric treatment option for children aged three months to six years. We are also advancing R&D for a next generation of drugs, and supporting, through a collaboration, the development of new and more sensitive diagnostics.
• Health education for behavioral change: We believe prevention is the most effective health intervention. That is why we invest in behavioral change initiatives to raise awareness of the causes and risks of schistosomiasis and provide information on preventive measures.
• Advocacy and partnerships: We intend to make even faster progress in the fight against schistosomiasis. That is why we collaborate with partner organizations and maintain a continuous dialogue with the wider stakeholder community, for example via the Global Schistosomiasis Alliance (GSA).

Further information on our targets can be found under S4-5.

The demand for praziquantel tablets through WHO, the production and supply of tablets, the number of people reached (school-aged children and adults), and the countries in which they are used are tracked. We continuously monitor the program and outcomes. Final figures are consolidated and assessed on an annual basis.

After the scientific positive opinion by the European Medicines Agency in December 2023, arpraziquantel for schistosomiasis in preschool-aged children was included in WHO’s List of Prequalified Medicines in May 2024. The availability of arpraziquantel dispersible tablets in the first African country, Uganda, was confirmed in December 2024 to prepare for the first preschool-aged children to receive the drug through the Consortium’s ADOPT program. This program aims to identify routine practices for wider use of the new medicine into countries where schistosomiasis is endemic.

Through our research activities we have identified a promising candidate to prevent and cure schistosomiasis. Furthermore, we also invest in health education and capacity-building initiatives to strengthen local expertise and healthcare systems to promote adequate availability and accessibility.

Through our significant investment in the fight against schistosomiasis, we expect to continue positively impacting our consumers and end-users through the availability of our products via new, diversified mechanisms for sustainable access, to reach people of all ages who are in need.

In 2024, we allocated € 29 million of operating expenditures (OpEx) for our initiatives to eliminate schistosomiasis, which are included in the respective lines of the income statement. No capital expenditure (CapEx) was allocated. For 2025, we intend to allocate € 36 million of OpEx and no CapEx.

Preventing and controlling malaria to support elimination

According to WHO estimates, almost half of the world’s population is at risk of contracting malaria. The latest annual figures report over 240 million cases of malaria and more than 600,000 related deaths, with around 80% occurring in children under the age of five. Currently, 95% of cases and deaths occur in Africa.

Increasing drug resistance and the need for additional preventive measures require innovations in this area. We have invested in our As One Against Malaria program to develop a new medicine to cure and prevent the disease. This medicine is currently undergoing Phase IIa clinical studies. Additionally, we are evaluating a new technology for the long-lasting efficacy of our insect repellent IR3535^®, implementing research initiatives to strengthen the resilience of healthcare systems in Africa, and defining sustainable business models for new access pathways to reach patients in need with our innovations.

The investment in new health solutions aims to create a significantly positive impact from health and socio-economical perspectives in the countries where malaria is endemic. However, we are not yet able to quantify the impact.

We monitor the progress of the As One Against Malaria program on an ongoing basis. Reports to governance bodies are submitted upon reaching key milestones, which are used as a basis for making decisions. The development of innovations is complemented by the evaluation of mechanisms that will ensure sustainable and more equitable access to products, once available.

In 2024, we allocated € 12 million of operating expenditures (OpEx) to our malaria initiatives which are included in the respective lines of the income statement. No capital expenditure (CapEx) was allocated. For 2025, we intend to allocate € 13 million for OpEx and no CapEx.

Health education and capacity building

The private sector is a crucial partner in responding to global health threats. For this, we help to ensure that healthcare systems are prepared to address emergencies and to sustainably deliver care to patients in need.

In the area of global health, we have established a portfolio of collaborative projects that build up capacity and strengthen healthcare systems in LMICs by investing in four key areas: local research and development, production and supply chains, education and awareness, as well as health infrastructure and training.

We contribute to health equity by building scientific capacity and competencies through our R&D programs with a primary focus on schistosomiasis and malaria. Through technology transfers, we support local production to help countries to become self-sufficient and serve local in-need populations. We built sustainable supply chains of local distributors in Africa through partnership. We also invest in education and behavioral change initiatives to raise awareness on schistosomiasis, through our collaboration with the NALA Foundation as well as our storytelling approach in Kenya, Rwanda, and Ethiopia as examples. We collaboratively develop and implement new approaches and initiatives to strengthen healthcare systems and improve access to, for example, thyroid care in Indonesia and the Philippines.

Equitable pricing approaches

The prices of our products should not be a barrier to accessing treatment. We have therefore implemented a multitude of equitable approaches including value-based contracting, Patient Access Programs (PAP) and second brands.

We are committed to advancing value-based healthcare through pricing and contracting mechanisms that comply with applicable local laws and regulations. In collaboration with payers, such as health insurance companies, we have developed various product- and market-specific reimbursement and contracting models. These help to provide patients with prompt access to our innovations. In 2024, we continued to implement and maintain innovative risk-sharing agreements, which give patients with multiple sclerosis direct access to Mavenclad^® with agreements in Europe, Latin America and the Middle East. We also implemented an adherence-based agreement for Saizen^® in Spain and value-based contracting for Bavencio^® in Korea.

Our PAPs are self-sustaining commercial programs through which we provide approved medicines to underserved populations in LMICs as well as patients with affordability challenges in high-income countries. In 2024, we operated PAPs for nine of our innovative products in around 20 global markets. In India, for example, we offer a PAP for our oncology drug Erbitux^® through whichfinancial assistance to eligible underprivileged patients in line with local laws and regulations is provided. Since we initiated the program in 2013, it has been made available to approximately 8,500 patients nationally. In 2024, around 1,500 patients benefited from the program. In Indonesia, we started implementing an oncology access initiative featuring PAPs and affordable pricing for low- and middle-income patient groups. This initiative supported over 600 patients in 2024. In the United Arab Emirates and Kuwait, we introduced a patient affordability initiative to provide access to our oncology and multiple sclerosis treatments to patients who cannot afford the cost. This program is carried out in collaboration with third-party providers and charitable organizations. In 2024, 62 patients benefited from this program.

For some of our existing high-quality products, we offer second brands at affordable prices, especially in countries where many patients live on low incomes. Second brands of the beta-blocker bisoprolol (Concor^®) are available at affordable prices in Brazil, Chile, Peru, Poland, Greece, Slovakia, Botswana and South Africa. Similarly, a second brands of levothyroxine (Euthyrox^®) is available in Brazil, Peru and Mexico, and a second brand of extended-release metformin (Glucophage^® and Glucophage XR^®) is available in Mexico and Chile.

We expect that the introduction and expansion of our equitable pricing initiatives will continue to have a positive impact on our consumers and end-users over the next 3-5 years and beyond. We monitor the effectiveness of our equitable pricing initiatives on an ongoing basis; mechanisms used to assess the effectiveness vary. For example, the effectiveness of our value-based contracting programs is assessed against pre-set outcomes in the contract, such as financial indicators, performance, and patient adherence-based outcomes. We monitor the outcome of our Patient Access Programs (PAPs) based on patient numbers reached in the respective target populations.

In 2024, we allocated € 3 million of operating expenditures (OpEx) for our equitable pricing approaches which are included in the respective lines of the income statement. No capital expenditure (CapEx) was allocated. For 2025, we intend to allocate € 3 million of OpEx and no CapEx.

Roles and responsibilities

The member of the Executive Board and CEO of Healthcare has overarching responsibility for the initiatives related to access to our products and access to (quality) information.

Our Global Health & Health Equity organization is responsible for Group-wide initiatives and programs with the aim of developing and providing access to health solutions and driving health equity by creating equitable and sustainable access mechanisms for patients and society (Reference to S4-PI-06; S4-PI-08). Our team works closely with the various sectors to leverage our collective strengths and expertise internally as well as with a large number of international and local partners. Beyond enabling extended access to our healthcare portfolio by leveraging strategic approaches and shared value initiatives, we also focus on diseases that disproportionally impact populations in LMICs by prioritizing efforts for disease control toward the elimination of schistosomiasis as a public health problem, and catalyzing innovations for global health challenges, including for malaria.

Our Global Value Demonstration, Market Access & Pricing (GVAP) unit sets the prices for the market launch in coordination with the respective franchises and is responsible for the cross-functional global SHAPE program (Reference to S4-PI-06; S4-PI-07). It reports directly to a member of our Healthcare Executive Committee. In addition, the GVAP unit systematically evaluates our medicine portfolios and implements equitable access initiatives. Our local subsidiaries are responsible for price management and adapt prices to changing local conditions. This is done in accordance with our pricing governance and the defined price approval process.

Our targets related to consumers and end-users (S4-5)

The measurement of metrics related to consumers and end-users has not been separately validated by an external body.

To set the targets for our SHAPE program in the context of the implementation of our LMICs access strategy, we worked closely with our regional and local teams who have experience evaluating the needs of consumers and end-users. We take into account various factors such as epidemiology, unmet patients’ needs, ability to pay or existing relevant healthcare infrastructures such as testing and diagnostic facilities.

We use a quarterly tracking system to ensure that we are on track to meet our targets and particularly the number of patients benefiting from the SHAPE program per product and country. In many LMICs, our teams on the ground are often confronted with unforeseen circumstances, for example, when external stakeholders change or additional investments are required to further strengthen the healthcare infrastructure. As a result, the implementation of our programs and initiatives can take a long time. Despite the challenges, our teams are committed to implementing our programs as close to planned timelines as possible with regular tracking and reporting. Our patients should be able to get diagnoses, especially early diagnoses, and have access to our innovative products through the SHAPE program, which covers both the public and private sectors where appropriate.

For our praziquantel donation program to combat schistosomiasis for school-aged children and adults, we work with WHO concerning targets on disease prevalence and unmet medical need. We track targets annually on the basis of the figures provided by the WHO. We continue working with selected partners to further improve our monitoring.

Referring to arpraziquantel for preschool-aged children, we develop targets on expected uptake of the medication in the endemic countries, combined with the estimated number of preschool-aged children at risk of schistosomiasis and the projected supply situation. As soon as the first children receive arpraziquantel in 2025, the supply of tablets and the number of preschool-aged children will be tracked. Together with our partners, we are working on a process to assess and track the epidemiological impact of arpraziquantel in terms of control and elimination of schistosomiasis, and the ultimate effect on the population in need (consumers and end-users).