Health and safety

Our Impacts, risks, and opportunities [S4 SBM-3] Material impacts, risks, and opportunities and their interaction with strategy and business model

Our pledge Committed to Life underlines our mission: To save lives and improve patients’ health and quality of life. We want to achieve this by providing access to affordable, innovative medical products, offering high-quality clinical care, and creating a framework for the safe handling of medicines. This is associated with actual positive impacts on the health and safety of patients in our healthcare facilities and in our downstream value chain. The high quality of care is also in our own interest, as it is directly linked to the success and duration of medical treatments we offer. This is accompanied by complying with the strict hygiene provision in our health care facilities. High-quality care can help to shorten the duration of hospital stays and improve quality of life; thus leading to efficient use of the financial resources required for treatment. In addition, patients and their relatives are more satisfied with the processes and structures in our healthcare facilities.

In our business operations and in our downstream value chain, it is important to avoid potential negative impacts on patients’ health and safety: These impacts can be related to individual incidents as low treatment quality during a hospital stay, the manufacturing and distribution of medical products, and the administration or incorrect use of our products. This can result in short-term financial risks and impacts on the health of people, as well as long-term reputational damage. Such risks may arise if, for example, the trust placed in us is diminished, our social reputation is negatively affected, or compensation payments, e.g. as a result of personal injury, and other costs are incurred.

Our approach [S4-1] Policies related to consumers and end-users

Group-wide quality management for patient and product safety

Our aspiration is to provide patients with the best possible care. We have set this out in our Group-wide Code of Conduct. We offer medical treatments and products that meet our strict requirements for quality and safety. It is essential for the safety and well-being of our patients that we appropriately label our products, describe our services in a transparent manner, and provide all relevant information to patients or their relatives in our healthcare facilities. For healthcare professionals, relevant information on pharmaceutical products or medical equipment is provided through dedicated communication channels, for example websites, and trained experts from our business segments.

Our internal training also encompasses acting with integrity and responsibility with third parties, like relatives, if required for an individual function or an area of responsibility.

This Group-wide approach to quality management encompasses all business activities in the respective geographical areas, our upstream and downstream value chain, and all stakeholder groups that directly contribute to the safety and quality of our products and services. The requirements for ensuring the quality and safety of medicines and medical technology products on the one hand and the health and safety of patients on the other differ in our healthcare facilities and production sites. The two business segments Fresenius Helios and Fresenius Kabi have therefore implemented their own policies and management concepts, which are supported by corresponding guidelines.

In the area of quality management, we monitor, manage, and improve processes with the support of performance indicators. We measure the quality of patient care, patient safety, patient satisfaction, and product safety with various indicators. In addition, we monitor hygiene provisions in our healthcare facilities based on specific parameters. Internal specialists regularly review relevant data in the business segments, in some cases daily. If deviations occur, our specialists initiate root cause analyses or peer reviews; they evaluate deviations and, if necessary, determine corrective or preventive actions. Regular internal audits and self-inspections – at least annually – as well as external reviews and audits, support data verification and management approaches, for certified and non-certified entities. In this way, we want to ensure that patient health activities comply with internal guidelines and regulatory provisions. The overarching ambition is to enhance the efficiency and coverage of our quality management systems and, ultimately, the credibility of the procedures and systems in place.

Key Group regulations, in which we also formulate our high standards with regard to the quality and safety of our products, services, and therapies, e.g. the Fresenius Code of Conduct, are available for download on the website www.fresenius.com. Where guidelines specify the operational business activities of the business segments, these are also made available on the websites of national subsidiaries. Such guidelines, which deal with processes for patient safety and product quality, are available to employees on the intranet of the business segments.

You can find out how the interests of patients are taken into account in the section Engaging with patients.

Compliance with international requirements and internal guidelines

In order to ensure the health and safety of patients, transparency in the healthcare sector must be promoted and access to high-quality information must be made possible. This also corresponds to our own aspiration. At Fresenius Kabi, this particularly refers to labeling and product information. At Fresenius Helios, we summarize our efforts under the term patient information. The Group’s business segments must comply with sector-specific laws, which, for example, regulate the handling of payments to healthcare professionals and organizations, determine the disclosure of data from clinical or patient studies, or require transparency in pricing and reimbursement procedures for pharmaceutical products. They are also obliged to take our own ethical principles into account in their business activities.

Our quality management systems meet and are based on respective standards or are adapted to them. In addition to compliance with the applicable laws within quality management, internationally applicable frameworks are particularly important for product quality at our production sites and distribution centers and subsequently also for product safety. Meeting strict regulatory requirements is always our top priority.

In our clinics and healthcare facilities, we apply internationally recognized standards from the hospital sector and local regulatory requirements and laws for the outpatient and inpatient care of patients, e.g. the Fifth Book of the Social Code (SGB V) in Germany, which regulates basic requirements for quality assurance.

Our commitment to product safety and to patients’ health and well-being is reviewed and certified by external partners or regulatory bodies. We are expanding the number of production sites and healthcare facilities certified to ISO 9001 standard, applicable internationally acknowledged care or hospital standards, or quality standards provided for centers of expertise for certain areas of treatment. However, the locations adhere to internal quality standards at least, which consider the applicable regulatory provisions. In addition to the standard of the International Organization for Standardization (ISO) 9001, we use the following quality principles or standards, among others:

• The methodology of the Initiative for Quality Medicine (IQM), the model of the European Foundation for Quality Management (EFQM), the standards of the Joint Commission International (JCI), and the Spanish Association for Standardization UNE, for healthcare facilities, as well as
• Good Manufacturing Practice (GMP), current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), Guideline on Good Pharmacovigilance Practices (GVP), the Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration (FDA), and
• the ISO 13485 quality management standard for medical devices in our production business.

Furthermore, for example in the area of antibiotics production, we are committed to developing quality standards that go beyond the legal requirements, which take into account safety, health protection, and environmental protection. Additional information can be found in our topical standard E2 Pollution. In Germany, we set standards in the area of treatment quality by systematically recording key figures and reporting externally. We are a founding member of the industry initiative IQM – Initiative Qualitätsmedizin (Initiative for Quality Medicine). Not all locations have the same scope of certifications, as the coverage at business segment level depends on the standards or specifications to be applied.

Depending on the business area and market, we are subject to further specific regulatory requirements and standards. This includes legislation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Restriction of Hazardous Substances (RoHS), and the Medical Device Regulation (MDR), among other standards. In addition, we have to adhere to regulations that specify products used in patient treatments, e.g. product safety provisions with regard to hazardous materials in single-use products in hospitals.

In addition, the business segments follow their own guidelines, which contain concrete instructions for specific processes and are in some cases closely linked to existing legal requirements. Responsible marketing, advertising, and sales in our product segments are not only controlled by external regulatory provisions applicable to healthcare companies, but also by internal regulations, e.g. those concerning the approval management of national and international scientific marketing documents. For our healthcare services business, ethical marketing regulation applies based on regulatory provisions regarding reimbursement schemes by healthcare authorities and insurance providers. In Germany, the Model Professional Code for Physicians (Musterberufsordnung, MBO-Ä), the German Health Services and Products Advertising Act (Heilmittelwerbegesetz, HWG), and the Act against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb, UWG) apply to doctors and hospitals. These laws are designed to protect patients and prevent doctors from being guided by commercial interests and putting profit before patient well-being. These provisions and topics are therefore also partially addressed in the compliance guidelines of our business segments, insofar as they relate to the topic of granting benefits to doctors and representatives of other healthcare professions.

Our Group-wide Human Rights Program is aligned with internationally recognised instruments relevant to our consumers and end-users, including the United Nations Guiding Principles on Business and Human Rights. We report on our human rights policy commitments in the topical standard S2 Workers in the value chain.

In the 2024 reporting year, no violations of the UN Guiding Principles on Business and Human Rights, the International Labour Organization Declaration on Fundamental Principles and Rights at Work, or the OECD Guidelines for Multinational Enterprises in its downstream value chain were reported to Fresenius that affect consumers and / or end-users.

Group-wide governance and responsibilities

Within the Management Board, the Chief Executive Officer (CEO) is responsible, among other things, for the Group-wide strategy and Group-wide initiatives in the area of patient and product safety or quality management, which are developed by the Corporate Development function. Since August 1, 2024, there has also been the position of Fresenius Chief Medical Officer (CMO) for the Group.

The CMO represents our Group in interactions with medical and scientific decision-makers. In addition, he advises the Management Board and the business segments on medical issues and designs and implements his own projects. The CMO reports regularly to the Head of Corporate Development.

Each Management of the business segments is responsible for operational management. The responsibility for patient and product safety or quality management and quality assurance, respectively, is regulated by the respective managements, e.g. via a business allocation plan.

In the business segments, employees must ensure that the applicable quality and safety regulations are always applied in their areas of responsibility. The employees in the production facilities, outpatient centers, and hospitals have a special obligation to exercise due care. The organizational structures and controls are adapted to the requirements of the individual business segments.

Information on the Management Board and the Supervisory Board as well as related procedures are explained in standard ESRS 2, section GOV-1 Our sustainability organization.

Quality management at Fresenius Kabi

An important goal of the quality management at Fresenius Kabi is to monitor the applicability, efficacy, and safety of products and services and their continuous improvement. To ensure the functionality of product risk management, the company has established an integrated quality management system, as well as a monitoring and reporting system.

The quality management stipulates that employees at all levels, from global to local, must receive regular quality-related training appropriate to their functions. This also means that all new employees or those who change to a new function within the company must receive appropriate training or that the responsible manager must determine the training requirement.

Fresenius Kabi regularly reviews the effectiveness of the quality management system through internal quality audits. Suppliers are subject to a qualification process based on the relevance of the delivered material or service. In this context, the business segment also checks whether suppliers regularly conduct the necessary quality training. Suppliers are audited every three to five years. Inspections by regulatory authorities and audits by independent organizations are performed along the value chain at Fresenius Kabi. Fresenius Kabi promptly takes steps to deal with any possible weaknesses or deficiencies discovered during inspections.

The quality management system is binding for all organizations in the Fresenius Kabi business segment.

The central function Quality Management reports directly to the member of the extended leadership team of the business segment (Executive Leadership Team – ELT), which is responsible for the function Technical Operations & Quality. The central function defines overarching standards and requirements for the business segment. Additional quality assurance functions are defined throughout the business segment to ensure compliance with company-wide standards and guidelines. Fresenius Kabi’s Corporate Safety Officers are responsible for the global vigilance system. They shall ensure that the business segment can respond quickly to safety-relevant events.

Fresenius Kabi’s quality management system is organized in accordance with the ISO 9001 standard. Compliance with the standard is reviewed by TÜV SÜD in annual audits at a global level and covers 123 Fresenius Kabi organizations through a matrix certification; one further organization holds a local ISO 9001 certificate. In addition, numerous manufacturing plants have supplementary certifications, such as ISO 13485 for medical devices, a food safety management system according to FSSC 22000, or GMP in general for pharmaceuticals.

Early-warning systems in product risk management

Globally responsible safety officers react promptly when Fresenius Kabi becomes aware of potential quality-related issues. They initiate and coordinate necessary actions worldwide, such as product recalls. With its early-warning system, Fresenius Kabi evaluates any quality-related information from various risk areas to identify risks early and take corrective and preventive actions.

The early-warning system is designed so that trained complaints and safety officers worldwide record complaints and side effects in databases and forward the respective information to experts for review. In addition, Fresenius Kabi uses internal and external audits and key performance indicators to manage and optimize its quality processes. In this way, the safety profiles of the products can be continuously evaluated worldwide. Internal procedures ensure that we can react promptly and appropriately in the healthcare products segment if new side effects are identified for one of our products. These new side effects are communicated to healthcare professionals via a specified format called a Dear Healthcare Professional Letter in a timely manner. This is how we ensure that patients are treated with products that meet our safety standards.

Fresenius Kabi collects and assesses reports about individual side effects and reports them to health authorities worldwide in accordance with regulatory requirements. In addition, Fresenius Kabi regularly evaluates the benefit-risk ratio of its products based on safety-related information from various sources (e.g. adverse event reports, medical literature). The results of these analyses are submitted to authorities as periodic safety reports.

According to regulatory requirements, Fresenius Kabi, as a pharmaceutical company, is obliged to describe its vigilance system in a Pharmacovigilance System Master File (PSMF). Fresenius Kabi uses a global database to collect and evaluate vigilance data on a quarterly basis from all local marketing and sales units.

In addition to the timely evaluation and reporting of single side effects to authorities, cumulative evaluations on side effects are carried out to guarantee the safety of the products (signal detection). These include important events, e.g. reports about side effects with a fatal outcome, to evaluate if new information is available about a known side effect profile or a new side effect of a product leading to a changed benefit-risk profile.

Labeling and product information

Fresenius Kabi’s products are classified as pharmaceuticals, nutritional products, active pharmaceutical ingredients, or medical devices, for example, based on global or national regulations and standards. The marketing of these products is subject to various laws and regulations to ensure complete and fact-based product information.

Fresenius Kabi has a global policy and global standard operating procedures for its product information to ensure that it is in accordance with applicable laws and regulations and that the product information for correct use is clear, accurate, and not misleading.

The products of Fresenius Kabi are also subject to certain labeling requirements. The labeling of the products is checked regularly as part of the regulations and vigilance activities – e.g. compliance with laws relating to side effects of medicinal products – and updated if necessary. For example, product labeling is updated if competent authorities, e.g. the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), publish relevant information. The dedicated function at Fresenius Kabi uses an electronic management system for product labeling to manage the information necessary for labeling or printed packaging material and to ensure its correctness. The requirements of the European Falsified Medicines Directive or the U.S. Drug Supply Chain Security Act (DSCSA) lead the way in this context. Fresenius Kabi takes into account their specifications and has introduced appropriate processes for serialization, testing, and traceability for the relevant products.

Treatment quality at Fresenius Helios

The business segment Fresenius Helios is managed by the holding company Helios Health. Due to the different national regulatory frameworks and standards as well as differences in the business models, the responsibility for patient and product safety lies with the Management of Helios Germany and Helios Spain. The structure of the management approaches of the divisions is regulated within the respective managements, for example via a business allocation plan. The CMO of the Group also coordinates synergy projects between the segments in this area as well as in the areas of medical quality and research.

All Helios clinics in Germany and Spain apply the internal quality guidelines and are included in the external reporting on quality indicators or patient satisfaction. For more information, see the Metrics section.

Patients can use the publicly available quality indicators for the Fresenius Helios hospitals in Germany and the public hospitals in Spain to see, among other things, how often certain treatments are carried out. This gives them important information on the doctors’ experience and routine and helps them to make their own decisions about their treatment. Patient satisfaction is also published annually in the Helios Sustainability Report. This is intended to create transparency about the experiences of patients in our hospitals.

Quality management at Fresenius Helios in Germany

In Germany, we had been engaged in the development of a quality management system in recent years with the aim of creating transparency regarding the quality of treatment results in the clinics and making them comparable. In 2008, Helios clinics in Germany joined forces with 14 other hospital operators to form the Initiative for Quality Medicine (Initiative Qualitätsmedizin, IQM). IQM is now the largest voluntary quality initiative in the German healthcare system.

Helios Germany applies the IQM management system and the related G-IQI in all German clinics. Newly acquired entities are integrated into this management system from the start of the acquisition. Further certifications encompass acknowledgment as centers of medical expertise, e.g. for oncology, diabetes, endoprosthetics, or other areas.

The quality management system at Helios Germany is based on administrative data (routine data) from patient treatments. The hospitals document each treatment step for later billing with the health insurance companies. This routine data shows whether the healing process took longer than expected, and whether complications or even a death occurred. It also indicates whether a treatment took a normal course or if mistakes occurred. Mistakes are then reviewed in peer reviews.

A total of 30 Helios specialist groups bring together the leading physicians in their respective fields. They ensure that the knowledge of their medical specialty is anchored in all hospitals and represent this internally and externally. They also advise and decide on the introduction of standard processes, the selection of medical products, sensible innovations, and on campaigns. Furthermore, they discuss results from clinical trials and derive possible changes in treatment approaches from them.

Each clinic and each department receives a monthly report on the results of medical treatment quality. In this way, key quality parameters can continuously be monitored and, if necessary, countermeasures can be taken at an early stage. This data illustrates how the hospitals perform compared to the national average, to other Helios hospitals, or to IQM member hospitals.

The medical departments of Helios Germany and Helios Spain exchange ideas and information on specific topics. For example, the German hospitals benefit from Helios Spain’s very close networking of outpatient and inpatient care, and can take advantage of this experience.

The task of the Quality Management Steering Committee in Germany is to coordinate the central steering processes of medical quality management and patient safety measures on a quarterly basis. Also on a quarterly basis, the medical management committees of the hospitals evaluate all reportable key figures together with the medical consultants. Reporting meetings are subsequently held with the steering committee on those facilities which report deviations such as suspicious quality indicators or reported cases relating to patient safety, in order to determine measures that still need to be implemented during the course of the year. These range from peer reviews at the hospital level, for example, to location-wide quality management measures at the corporate level, if necessary.

Quality management at Fresenius Helios in Spain

The quality management of Fresenius Helios in Spain focuses on three areas: safety and appropriateness of clinical practice, patient experience, and quality of service delivery.

To meet our standards, Fresenius Helios in Spain has implemented a quality management system that includes the definition and implementation of an annual quality plan. This plan contains defined objectives and the monitoring of KPIs and fosters the development of projects, the redesign of processes and their implementation in the company. The plan concludes with certification and accreditation by recognized organizations.

All Spanish hospitals of Helios Spain, once integrated in the business segment, are certified according to the ISO 9001 standard. They are also certified according to the Spanish Association for Standardization UNE, (e.g. for surveillance, prevention, and control of infections as well as for patient safety) or according to other standards recognized in the hospital sector (e.g. according to JCI and the EFQM model).

Fresenius Helios in Spain has a patient safety strategy that the Spanish segment regularly reviews and, if necessary, adjusts to ensure high-quality care in its hospitals and guarantee patient safety. This strategy covers all areas that directly impact patient safety and includes new approaches that are adapted to specific and innovative care processes.

The action lines included in the quality plan are implemented in the healthcare facilities through various methods, such as Helios Spain including the safety and appropriateness of clinical practice in its annual objectives. This also helps to align objectives with company policies and procedures.

In 2024, Fresenius Helios in Spain further deepened the casuistic analysis in its hospitals using the information contained in the Minimum Basic Data Set (MBDS). Casuistic analysis is the study of treated cases in order to draw conclusions about the course of the disease for future treatments. Helios Spain reviews the indicators twice a year to improve its processes.

The CMO function at Helios Spain is responsible for the coordination of patient care and safety, as well as research. The function receives support from the Corporate Operations department, whose focus is on improving therapies and other healthcare offerings, as well as developing and marketing digital applications in the outpatient sector. The Corporate Risk Function ensures the correct application of the Group’s risk management standards by supervising and advising, both at Corporate and the local level. Likewise, risk owners will have the obligation to identify, assess, control, and report the risks that must be managed under their responsibility. The Corporate Patient Safety Committee is responsible for implementing the central strategy for patient safety, which is supported by the targets described in the following section.

Hygiene management in our hospitals

In the area of hygiene management, Helios focuses in Germany and Spain on the following aspects, among others: close monitoring of infections and pathogens, regular hygiene training for hospital staff (e.g. on correct hand disinfection) and monitoring antibiotic consumption. The implementation of and compliance with hospital hygiene measures in our German and Spanish clinics is accompanied and monitored by specially trained staff – e.g. specialist hygiene nurses, hospital hygienists, and hygiene officers.

Patient information

Fresenius Helios provides information within its German and Spanish hospitals to its patients and their relatives about the patient admission process, if needed, with the help of the treatment contract, as well as special information documents and privacy statements. The therapeutic objective is discussed during admission and discharge discussions with the treating physicians. Throughout a hospital stay, nurses are an important point of contact and mediator for medical staff, patients and their relatives.

Fresenius Helios communicates general focus topics via an online magazine, social media, its German and Spanish websites, and in its communication campaigns for interested members of the public. In addition, information events on specific medical topics are held in many hospitals (known as patient academies).

Engaging with patients [S4-2] Process for engaging with consumers and end-users about impacts [S4-3] Process to remediate negative impacts and channels for consumers and end-users to raise concerns

Fresenius Kabi

Product monitoring

Fresenius Kabi regularly conducts user surveys and has integrated this activity into the quality management system via the Post-Market Surveillance System (PMS).

An important aspect of product safety is the CE labeling (Conformité Européenne – European conformity). The CE label indicates that a product has been tested by the manufacturer and meets all EU-wide requirements for safety, health, and environmental protection. It is mandatory for all products manufactured worldwide that are marketed in the EU. With the PMS system, the business segment aims to ensure that data from production and post-production activities for CE-marked devices that are placed on the market, made available on the market, or put into service are collected and analyzed through one or more processes. To this end, the PMS system collects, records, and actively and systematically analyzes information to enable Fresenius Kabi to gain insight into relevant data on the quality, performance, and safety of a device throughout its life cycle, draw the necessary conclusions, and determine, implement, and monitor any preventive and corrective measures.

In detail, Post-Market Surveillance can help to:

• systematically identify the risks associated with the practical use of a product,
• check the performance of the products during use,
• detect product defects and unknown safety issues,
• continuously update the benefit-risk assessment and
• quickly initiate necessary measures such as product recalls.

For each corresponding product, a PMS plan documents over the life cycle how consumers and / or end-users are involved with regard to product monitoring, e.g. through training of specialists or communication via the existing reporting systems, which are described below. It also specifies how cooperation is organized. The same applies to the phases in which involvement can take place. Further information is available on the website www.fresenius-kabi.com.

As a manufacturer, we can only guarantee that our medical devices offer patients the promised benefits and that there are no uncontrolled manufacturer risks if we continuously and systematically monitor them after they have been placed on the market.

Side effect reporting and reporting systems

The monitoring of adverse reactions or events (side effects) associated with the use of medicinal products is referred to as pharmacovigilance (drug safety). The statutory pharmacovigilance commitments relate to our medicinal products for human use. Similar regulations exist for medical devices.

Fresenius Kabi includes patients in its early-warning system and in the risk-benefit monitoring of its products, as described in detail in this topical standard in section S4-1 Our approach, Quality management at Fresenius Kabi.

The business segment promptly informs its customers and the public about matters or measures concerning product and patient safety; this may be done directly or through appropriate public channels, if applicable.

The reporting of known or unknown side effects helps to gather more information on the safety of medicines or medical devices. For this purpose, the business segment provides contact details and forms to patients, their relatives and medical personnel. These can be used by the above-mentioned persons to report side effects that could be related to Fresenius Kabi’s medicinal products or medical devices. They can also use these channels to report possible intolerances of the business segment’s food products. All incoming reports are processed immediately.

In addition to the company’s own reporting channels, in Germany, for example, there is the option of submitting a report via the Federal Institute for Drugs and Medical Devices (BfArM – report risks). Similar processes are prescribed by the authorities in countries where we distribute our products and are listed on the package leaflet.

The availability of reporting channels for side effects or other reactions that occur in connection with the intake of medication or the use of medical devices is a mandatory regulatory requirement. Fresenius Kabi therefore lists its contact details in the respective package leaflets.

The timely processing of side effect reports from all sources and their reporting to the authorities is monitored by the business segment with the help of a performance indicator. Fresenius Kabi aims to submit all periodic safety reports worldwide to authorities in due time – and thus to be 100% in line with legal requirements. Information on Fresenius Kabi’s targets and compliance rates can be found in the Metrics section.

In addition to the officially regulated reporting of adverse drug reactions by patients and medical and nursing staff, no additional protection of individuals is necessary for this form of communication. The regulatory requirements aim to ensure that consumers and / or end-users are informed about and aware of structures and procedures. Furthermore, in the case of adverse reaction reports, no retaliatory measures are indicated, as these are not indications of potential compliance violations, but individual health effects in humans. The reporting itself contributes to the protection of patients and should therefore always be viewed positively.

Fresenius Helios

Patient satisfaction measurement and grievance processes

We conduct patient satisfaction surveys in all our hospitals – in Germany, the Helios Service Monitor is used for this purpose, while in Spain, the Net Promoter Score (NPS) is used. We do not differentiate between patient groups and take the views of all patients equally into account.

The business segment uses the Helios Service Monitor to measure the satisfaction of inpatients in its German hospital locations once a week. Employees on-site conduct short interviews on care and service. The anonymized results can currently be viewed individually by each clinic in a daily, weekly, or monthly cycle. The respective management of the hospital and other authorized persons receive the monthly survey results to obtain a general picture of satisfaction and to be able to identify areas of criticism. In addition, Helios Germany publishes the results of patient surveys and further data on medical treatment quality on its corporate website www.helios-gesundheit.de, see the menu item “Qualität bei Helios” (German language only). Statistically conspicuous results are examined by local management and measures are taken if necessary.

In Spain, Fresenius Helios uses the NPS to get specific feedback from patients who have been treated as inpatients, outpatients, or in emergencies. 48 hours after a hospital stay, an email is sent to patients asking if they would recommend the hospital and its services. The results are analyzed centrally and at hospital level by indication and medical area. The goal is to continuously improve the NPS results. The results can be found in the Metrics section.

Reporting systems

Fresenius Helios uses a reporting and learning system for critical events and near misses of patients in all hospitals in Germany and Spain (Critical Incident Reporting System – CIRS). This is anonymous, can be used in all areas of a hospital site, and primarily serves the preventive protection of both patients and employees. Based on the information collected via the reporting system, potential errors in processes and workflows can be identified. Fresenius Helios can derive measures for improvement accordingly. In addition, safety inspections are carried out at the hospitals on an annual basis. In this way, risks relevant for the entire business segment are identified and can be eliminated.

Furthermore, a dedicated system is used to regularly measure patient safety at its hospitals. Fresenius Helios has an obligation to report what are referred to as preventable serious adverse events, which the business segment categorizes using patient safety indicators (PSI). These refer to easily avoidable adverse events that can lead to particularly serious harm to patients. These include, for example, patient and side mix-ups during an operation or foreign bodies inadvertently left in the body. The PSI include both internationally established and Helios’ own patient safety indicators.

Helios Spain uses an online reporting system for all types of incidents – from near misses to sentinel events. Based on the definition from JCI, the latter are serious patient safety events that result in death, permanent harm, or severe temporary harm. The system is accessible for all healthcare professionals and hospital employees. The reported events are analyzed at least quarterly by each hospital Patient Safety Commission. Trends and causes are identified in order to implement the necessary improvements. This analysis is also recorded in the reporting system, and feedback is provided to the notifier.

We track the effectiveness of the channels described above by monitoring their use in the form of reports received.

Procedure for dealing with adverse events

An important part of Fresenius Helios’ error management is the recording of allegations of treatment errors, justified or unjustified. These allegations include, to varying degrees, all specialties and all stages of treatment, from patient information, diagnostics, surgery, and therapy to aftercare. In our hospitals, we actively encourage our employees as well as patients to report incidents, including dangerous or unsafe conditions and near misses, as a way of promoting patient safety. Remediation measures are effective, if no recurring event is reported in the respective healthcare facility.

Clinical alerts are also an important tool used by the Medical Directorate of Helios Spain to prevent patient safety incidents. These are designed to inform hospitals of important information related to adverse events and the implementation of timely interventions.

Helios Germany has anchored the implementation of measures derived from liability cases in a focus target on patient safety for hospital management as well as chief physicians. This aims to promote the processing of patient-safety-related incidents and the development of preventive measures.

Patients, our employees and third parties can also use our other reporting channels to report their concerns or needs. Information on our whistleblower systems and the protection of whistleblowers can be found in the topical standard G1 Business conduct, section G1-1 Our approach, Grievance and whistleblower mechanisms.

Our actions [S4-4] Taking action on material impacts on consumers and end-users, and approaches to managing material risks and pursuing material opportunities related to consumers and end-users, and effectiveness of those actions

In the reporting year, no incident was reported on consumer and end-user issues through the established reporting channels that could have significantly impacted the reputation or financial position of Fresenius and from which we would have had to derive direct measures on Group level. This applies to reports related to patient health and safety as well as to reports of non-compliance with relevant laws and regulations. The company therefore assumes that measures and initiatives have proven effective in the reporting year.

We report on any human rights incidents or potential issues that come to our attention through our established reporting channels in the topical standard S2 Workers in the value chain.

With our preventive measures, which we continued to implement in the reporting year, we aim to counter the material impacts, risks, or opportunities we have identified in connection with the health and safety of patients. This encompasses those reported at the start of this topical standard. We want to enable our employees to react appropriately if they discover misconduct or non-compliance with our internal or external regulations.

In Spain, we worked intensively during the reporting year on implementing measures arising from liability cases, as well as reported incidents indicating room for improvement in clinical practice and safety. In this way, Fresenius Helios aims to promote the introduction of preventive measures in all hospitals in Spain to avoid a repetition of such incidents. In this context, the medical management of Helios Spain has organized meetings on patient safety and risk management in 2024 to share experiences. There is also a Corporate Medical Claims Committee that meets quarterly to analyze high-impact claims together with the medical management of the participating hospitals.

In addition, Fresenius Helios has implemented the following preventive measures in 2024, as part of its quality management program.

Peer reviews

Fresenius Helios analyzes the cases – including treatments and medical routines – in hospitals in Germany that fail to meet individual quality targets, in order to identify and implement improvements. Particularly important are the specific audit procedures in the medical and nursing sectors, and the peer reviews – expert discussions of cases. In Germany, trained physicians from the hospitals of Helios Germany and from the IQM network in particular cooperate in the peer review, and question statistical abnormalities. Their insights are translated into concrete recommendations for action in the hospital with the aim of increasing patient safety.

Training

Fresenius Helios in Germany has three simulation and emergency facilities: in Erfurt, Krefeld, and Hildesheim. Among other things, surgical procedures or crisis scenarios in the operating room are trained there. In addition, such training courses take place in the clinics directly. In the fields of emergency medicine, anesthesia, intensive care medicine, and obstetrics, decisions on the content and number of participants in the mandatory training courses are based on resolutions of the respective specialist groups.

In Spain, Fresenius Helios provides training on patient safety, quality management, and topics relevant to hospital workflows. Furthermore, Helios Spain offers several online training courses on patient safety. They are mandatory for new employees and for those whose work is directly related to care. The exchange of knowledge among the hospital network should be promoted through interhospital clinical training and meetings. Key figures on the training completed in 2024 can be found in the topical standard S1 Own workforce, section S1-13 Training and skills development metrics.

The preventive measures described are not part of an action plan to which significant operational expenditure (OpEx) and capital expenditure (CapEx) are allocated. Any resources required are defined on a case-by-case basis.

Our goals and ambitions [S4-5] Targets related to managing material negative impacts, advancing positive impacts, and managing material risks, and opportunities

The application of the highest possible quality and safety standards, the efficacy of products and services, and compliance with regulatory assessment and compliance requirements are essential to supporting our ambition: ensuring the long-term success of the company and enabling patient care. To achieve this, we set specific goals for each of our business segments.

Goals of Fresenius Kabi

Fresenius Kabi has set itself the following goals in relation to the health and safety of patients.

Benefit-risk ratio surveillance of our products

Compliance rates with the goal of 100% based on quality-related reporting:

• Individual Case Safety Reports: Fresenius Kabi’s goal is to report all periodic safety reports worldwide to authorities in due time.
• Reporting of periodic safety reports: The business segment aims to submit all safety reports in accordance with the applicable regulations and therefore strives to report 100% of periodic safety report to the authorities in time.
• Transmission of vigilance data: The goal is to receive timely data from all marketing and sales units worldwide.

The defined goals are based on official requirements for submitting the corresponding reports. These requirements are documented in process descriptions and are part of the specialized training. Further, these goals are reported for many years in the sustainability reports.

The progress of the goal and the evaluation of the key figures are measured at least annually as part of Fresenius’ financial reporting. In the reporting year 2024, Fresenius Kabi accomplished very good compliance ratios for the reporting of vigilance indicators. The risk-benefit profile of all pharmaceutical products remained unchanged in 2024.

Audit & Inspection Score

Fresenius Kabi has set itself the goal of continuously achieving an Audit & Inspection Score of 2.3 or better. The score indicates the average number of major nonconformities identified in the inspections and audits considered.

The target value was initially set on the basis of the historical results of governmental inspections and audits. On this basis, Fresenius Kabi derived a target value that should not be exceeded. As this is a purely internal instrument, no other stakeholders were involved.

The Supervisory Board of Fresenius Management SE, as the responsible body for the Management Board compensation, has integrated the Audit & Inspection Score in the short-term variable compensation of the Management Board and approved the goal.

The achievement of the goal is reviewed annually using the Audit & Inspection Score. The goal was achieved in 2024. Further information on the results can be found in the following section Metrics.

Goals of Fresenius Helios

In our healthcare facilities in Germany and Spain, we focus on targets that consider quality of treatment and care, as well as patient satisfaction. Besides quality of treatment, we also measure and control metrics related to patient safety.

Quality indicator achievement rate

Fresenius Helios sets relative company goals to measure the quality of treatment in its hospitals, using the España Inpatient Quality Indicator (E-IQI) methodology in Spain and the G-IQI methodology in Germany. The rate of treatment quality achieved in 2024 is part of the short-term variable compensation of the Management Board:

• G-IQI (Germany, German Inpatient Quality Indicators): target 88%
• E-IQI (Spain, España Inpatient Quality Indicators): target 55%

Fresenius Helios sets the ongoing targets annually, reviews them internally at the end of the financial year and adjusts the target values for the following year. These indicators are collected as metrics and are a quantitative measure that can be used to assess and evaluate medical quality. The target is in each case to be better than the national average for the respective indication.

No stakeholders were involved in setting the goals. However, the goals and the results themselves are publicly disclosed comprehensively and per hospital and are made public per indication on the website www.helios-gesundheit.de (German language only).

In Germany, quality control of the degree of target achievement during the year is carried out by the Central Medical Service as part of an internal monthly evaluation, so that any deviations in the quality of treatment can be quickly evaluated and, if necessary, action can be taken. Target achievement is reviewed annually on the basis of the quality indicators, which we report on in the Metrics section. In the reporting year, the targets were achieved.

Prevention of avoidable incidents

The goal of Fresenius Helios is to avoid any avoidable incidents in its German and Spanish hospitals.

The business segment checks the achievement of its targets annually based on the number of avoidable incidents that have occurred. Further information can be found in the following Metrics section.

Goals of Fresenius Helios Spain

Helios Spain also has additional annual targets in the areas of quality, patient safety and satisfaction, the definition of which is the responsibility of the CMO.

In our hospitals in Spain, these targets related to patient satisfaction are measured via the Net Promoter Score (NPS), among other methods.

As part of the annual performance appraisals, the responsible managers at Helios Spain assess whether and how the targets have been achieved. In the reporting year the NPS targets were achieved with a NPS of 65.4 (2023: 60.1) for Spain and 81.5 for Colombia.

Metrics S4-Company-specific

Fresenius Kabi

Quality standards

The key figures for quality standards at Fresenius Kabi show the absolute and relative number of the business segment’s units certified according to ISO 9001, ISO 13485, and GMP / cGMP.

When calculating the percentage coverage of certified entities, the number of absolute entities is set in relation to the entities for which the respective standard is relevant. These may be production facilities, distribution centres and other units for which the responsible central function requires certification.

Audits and inspections

Based on the respective deviations during audits and inspections, an Audit & Inspection Score is calculated by Fresenius Kabi. The score is calculated by addition of the number of critical and major observations identified during GMP inspections by the authorities mentioned above and the number of non-conformities identified during TÜV SÜD ISO 9001 audits, divided by the overall number of these inspections and audits. This includes all audits and inspections carried out in the reporting year for which information on deviations is available by the end of January of the following year. Critical observations or deviations, if any, or certification status withdrawal are weighted with a defined multiplier to take the significance into account. The score shows the average number of major deviations identified during the inspections and audits considered.

In 2024, Fresenius Kabi conducted a total of 33 internal audits. The external audits and inspections in the reporting year amounted to 92 (2023: 111), of which 19 were regarding GMP and carried out by the FDA, the Australian Therapeutic Goods Administration (TGA), Health Canada, and European pharmaceutical authorities, and 15 were regarding the Quality Management System audits from TÜV SÜD (notified body for ISO 9001).

The Audit & Inspection Score in 2024 was 1.7¹ (2023: 1.9). Observations have been and will continue to be addressed by corrective and preventive actions (CAPAs) and effectiveness checks have been and will continue to be defined. The observations neither impacted the GMP certification nor the ISO 9001 certificate. In 2024, no events with a material adverse impact were recorded that conflict with achieving the aforementioned quality management objectives.

¹ The Audit & Inspection Score (Fresenius Kabi) as part of the short-term variable remuneration (STI) of the Management Board is assured with reasonable assurance, as explained in the assurance report of the independent german public auditor on pages 407 ff. of the Annual Report.

Compliance rate quality

The compliance rates indicate the percentage of periodic safety reports submitted to the authorities on time. In addition, Fresenius Kabi regularly evaluates the benefit-risk ratio of its products based on safety-related information from various sources (e.g. adverse event reports, medical literature). The results of these analyses are submitted to authorities as periodic safety reports. Fresenius Kabi quarterly collects and evaluates vigilance data from all local marketing and sales organizations in the PSMF to comply with the regulatory requirements for the pharmacovigilance master file. In the reporting year, the risk-benefit ratio did not change for any product due to new side effects.

Communication of new side effects

As explained in the section Early-warning systems in product risk management on page 259, pharmaceutical manufacturers are obliged to record and evaluate adverse reaction reports and report them to the competent authorities. If an authority comes to the conclusion that the risk-benefit profile of a medicinal product has changed due to a new or unregistered adverse reaction report, all medicinal product manufacturers concerned are notified in a coordinated manner.

New side effects affect all manufacturers of a pharmaceutical product that contains the pharmaceutical ingredient that caused the side effect. All companies who sell the product are therefore engaged in this communication. In the reporting year, one communication was made to healthcare professionals regarding new adverse reactions (2023: 1).

Fresenius Helios

Helios quality indicators

The indicators collected as key figures are a quantitative measure that can be used to assess and evaluate medical quality. The key figures indicate how many of the individual IQI targets were achieved in Germany and Spain, both in absolute and relative terms. For each inpatient treatment or case, the business segment uses comparative measurements with reference values from the German Federal Statistical Office to determine the national average in Germany or comparable national values in Spain. The aim is to be better than the national average for the respective indication. In 2024, hybrid DRGs (Diagnosis Related Group) were also taken into account in the inpatient calculation procedure in order to ensure comparability. This is a new form of reimbursement that includes both outpatient and, if necessary, inpatient treatments.

In Spain, we include those indicators that the management believes are relevant to the specific country.

Considering the individual G-IQI results of the clinics in Germany, 90.7%¹ of the targets were achieved (2023: 88.7%). 20% of the clinics achieved a rate of 100%. A further 39% achieved a rate of 90% or better. In Spain, 22 targets were achieved. In Spain, a target rate of 73.3%¹ was achieved (2023: 76.7%), based on the 30 total targets set.

Quality standards

The key figures on quality standards at Fresenius Helios show the absolute and relative number of units in the business segment certified in accordance with ISO 9001 and IQM.

When calculating the percentage coverage of certified units, the number of absolute units is set in relation to the units for which the respective standard is relevant. In Spain, this also includes, for example, certain administrative units and service units.

Peer reviews

The key figure describes the number of peer reviews conducted by Fresenius Helios in Germany in the reporting year. For further information see the Peer reviews section. In 2024, 27 peer reviews were conducted (2023: 22).

Service Monitor Germany

The business segment uses the Helios Service Monitor to measure the satisfaction of inpatients in its German hospital locations once a week. Employees on-site conduct short interviews on care and service.

In 2024, 56.0% of treated patients were interviewed. Typical points of criticism relate, for example, to food supply and waiting times.

Net Promoter Score (NPS)

The NPS is a key performance indicator for measuring patient satisfaction at Fresenius Helios in Spain; the value is also collected for our hospitals in Colombia. We calculate the score from the ratio of positive to negative feedback and recommendations.

At the end of 2024, the growth of the NPS Spain compared to the previous year was more than 8%, influenced by improvements in the area of emergency medicine.

Patient-relevant reports: Avoidable incidents

We record patient safety indicators in our hospitals in Germany and Spain. These include certain harmful events that must be reported to health authorities in other countries. There, these events are also referred to as Never Events, Adverse Events, Sentinel Events or Serious Reportable Events. Those can be performing surgery on the wrong side or the wrong patient, or unintended retention of a foreign body in a patient after surgery, among others. Not all of these indicators are preventable (adverse) events.

To enable better comparability between countries, we report on avoidable serious adverse events. In 2024, a total of 43 avoidable serious adverse incidents were reported, which have a negative impact on the company’s goal, which is to avoid them.

Quality KPIs based on IQM are further evaluated within this initiative through independent experts.

¹ The calculation of the success rate for the compensation is based on 30 of the total of 45 targets.

² The Inpatient Quality Indicators (Fresenius Helios) as part of the short-term variable compensation (STI) of the Management Board are assured with reasonable assurance, as explained in the assurance report of the independent german public auditor on pages 407 ff. of the Annual Report.