Patients, Consumers and End-Users
ESRS S4 - Patients, Consumers and End-Users
Although we are currently an R&D-focused organization with no commercialized products, we identified elements of ESRS S4 as material to our business model and value chain. As patients constitute the end users of our candidate medicines, including those in clinical development, the impacts, risks and opportunities (IROs) relate to how we manage patient data, generate safety evidence and conduct research in an inclusive manner.
The table below summarizes the nine material IROs identified for patients, consumers and end-users in our double materiality assessment.
Material Topic |
Description |
IRO Type |
Value Chain |
|---|---|---|---|
Information-related impacts for consumers and/or end-users
|
The processing of patient and end-user data during clinical development and related operations may create negative impacts if personal information is exposed, misused or accessed without authorization. The involvement of multiple third-party vendors who require access to sensitive data can increase the potential for privacy breaches, which may compromise individuals’ rights to data protection and confidentiality. |
Potential |
Entire |
We are subject to extensive legislative, regulatory, and other requirements during preclinical and clinical development, as well as transparency, privacy and data protection and other requirements. |
Risk |
Entire |
|
Personal safety of consumers and/or
|
Providing insufficient, unclear or non-compliant information on product risks and side effects can lead to inappropriate use, adverse outcomes and harm to patients. |
Actual |
Entire |
Issues with patient safety or product quality within our clinical trials may limit our ability to bring our product to market. Not obtaining access would have a financial impact exceeding our financial materiality threshold. |
Risk |
Entire |
|
Social inclusion of consumers and/or
|
Insufficient diversity and inadequate representation of patient groups in clinical trials may lead to biased clinical evidence and medicines that do not meet the needs of all patient populations. |
Potential |
Downstream |
Social inclusion of consumers and/or
|
As a biotech company, it is our responsibility to ensure our medicines and knowledge are accessible. Patient engagement helps ensure our medicines reach the populations that need them, creating a positive societal impact by improving health outcomes and strengthening trust. |
Actual |
Downstream |
By sharing knowledge transparently and engaging with patient organizations, we can generate positive impacts by helping identify non-clinical unmet needs and supporting improvements in patients’ quality of life. |
Actual |
Own operations |
|
Our commitment to ensuring access and affordability for patients may lead to financial impacts for us. Pricing decisions and access initiatives or affordability commitments may generate costs or limit revenue in ways that could exceed our financial materiality threshold. |
Risk |
Own operations |
|
Improved access to, and greater affordability of, our medicines may lead to growth in specific markets. |
Opportunity |
Own operations |
All material IROs identified under ESRS S4 fall within the short‑term time horizon (i.e., <3 years).
Overview of how material impacts, risks and opportunities relate to our strategy and business model (SBM-3)
Privacy
Privacy is material to our business model as we collect and process sensitive personal data throughout clinical research. Protecting patient data is essential for maintaining ethical standards in clinical development, meeting regulatory expectations and sustaining trust among clinical trial participants. Privacy considerations influence how we design clinical operations, work with partners and ensure that data handling practices support compliance and safeguard patient rights.
Patient safety and product quality
Patient safety and the quality of our investigational therapies are central to our R&D activities. They are fundamental to maintaining regulatory trust, securing timely market access, and supporting long term value creation. This materiality informs our strategy and business model, which prioritize generating robust safety evidence, transparent communication with regulators, and a strong quality culture throughout our development programs. At the same time, material risks arise if safety concerns or quality issues emerge during clinical studies, as these may delay or prevent regulatory approval and limit our ability to bring new therapies to patients.
Social inclusion of consumers
Access to products and services
Social inclusion is material to our business model because the relevance of clinical evidence depends on diverse and representative patient populations. Ensuring that clinical research reflects the needs of such populations can generate positive impacts by improving access to medicines, supporting patient understanding, and helping ensure that the investigational therapies we develop have the potential to benefit a broad range of patient groups, including those with high unmet medical needs.
Patient engagement
Patient engagement remained material to our business model in FY25 because the relevance and usability of clinical development activities depend on incorporating patient and caregiver perspectives, for example through engagement with patient organizations, the collection of patient and caregiver insights, and consideration of these insights in clinical design and communication to support transparent and health-literate information. The decision to pursue an intention to wind down our cell therapy activities, as described in section “A New Strategic Direction”, impacted delivery in this area.
Impact, risk and opportunity management
Policies
We maintain a set of specific policies and standards to appropriately manage the risks in the development of new medicines. These include:
ESRS sub-topics |
Policy |
Description |
|---|---|---|
Information-related impacts for consumers and/or end-users |
Data Protection Policy |
Our Data Protection Policy, aligned with the requirements of GDPR, defines how personal data must be processed within the Galapagos group. The General Counsel is accountable for this policy. |
Personal safety of consumers and/or end-users |
Quality Manual |
Our Quality Manual sets out the structure and operation of our Quality Management System (QMS) to ensure that all activities are of the highest quality and comply with applicable regulatory expectations including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), and with a strong focus on patient safety. In 2025, the manual underwent minor updates, primarily to reflect revised references and current documentation. The Global Head of Quality is accountable for this policy. |
Clinical Trial Oversight Policy |
Our Clinical Trial Oversight Policy ensures that we maintain appropriate oversight and governance of Galapagos-sponsored clinical studies. The Head of R&D is accountable for this policy. |
|
GxP Risk Management Policy |
The GxP Risk Management Policy forms a core component of our QMS, and ensures risks are managed or eliminated across GxP processes and activities. The Global Head of Quality is accountable for this policy. |
|
Business Continuity & Crisis Management |
Business Continuity & Crisis Management sets out the mechanisms required to prevent, mitigate and respond to high-impact incidents. Its purpose is to minimize disruption to critical operations, protect our employees, preserve our reputation and ensure continuity of our license to operate. The Global Head of Quality is accountable for this policy. |
|
Issues & Escalation Management |
Defines the governance structure and processes required to ensure that critical and major issues are escalated to senior management in a timely and transparent manner. The Global Head of Quality is accountable for this policy. |
|
Medical Safety Policy |
In 2025, our previous Pharmacovigilance Policy was replaced by a Medical Safety Policy supported by a comprehensive framework of Standard Operating Procedures (SOP). This updated policy strengthens our governance, monitoring and management of patient safety across the lifecycle of our investigational therapies and marketed products. The Head of Medical Safety is accountable for this policy. |
|
Principles for Patient and Patient Organization Interactions |
This sets out the ethical and compliance framework within which we engage with patients and patient organizations. It covers what and how to communicate and what sort of activities are appropriate to conduct in conjunction with these stakeholders. Overall accountability for interactions with patients and patient organizations resides with the Patient Advocacy Team. The General Counsel as Head of Compliance & Ethics is accountable for this policy. |
Actions
Privacy
We have taken steps to minimize the risk of potential data breaches and established controls to limit the likelihood of data breaches relating to patient data. We maintain GDPR-aligned data protection practices, including applying structured oversight of third party data processors, and operating cybersecurity controls to protect sensitive information throughout the value chain. These measures are designed to safeguard clinical study data, protect patient information, and uphold our ethical and regulatory commitments.
Patient safety and engagement, product quality, and access to products and services
We apply processes to ensure that safety and quality considerations are integrated into our clinical development activities. It is critical that we implement an appropriate risk-benefit approach throughout the entire drug development lifecycle to ensure we bring safe and effective medicines to the market and ultimately the broadest patient population, while monitoring, assessing, and managing side effects, including adverse events that may pose an unacceptable risk.
We operate an Independent Data Monitoring Committee composed of independent medical, scientific, and biostatistics experts, which conducts ongoing benefit-risk assessments of safety and efficacy data at regular intervals throughout our clinical studies. We implement comprehensive risk management plans and conduct formalized Quality audits to identify potential issues and drive continuous improvement. We also collect data across the lifecycle of our medicines, including the collection and analysis of Phase 4 real‑world evidence studies, to identify emerging safety signals and maintain an appropriate benefit-risk balance from a regulatory and patient‑protection perspective. In addition, we work to strengthen our interactions with patients and patient organizations, which could enhance quality of life and help identify the non-clinical unmet needs.
Together, these measures support our ability to progress R&D activities responsibly and to develop innovative medicines that bring value to patients and healthcare systems.
Regarding patient engagement, our Patient Partnership Charter remained in place throughout FY25, setting out our ambition, underpinned by our values and principles, to pioneer for patients and work in partnership with patients and patient organizations. The Charter continued to guide how we considered patient perspectives in our research activities and stakeholder interactions. During the reporting year, no further structured patient‑engagement activities were carried out, and the Patient Engagement Council (PEC) was discontinued as part of the 2025 organizational restructuring. While dedicated activities concluded, the principles within the Charter continued to support transparent, respectful and health‑literate interactions with patients and caregivers.
Application of Phase-in Relief
In accordance with ESRS 1 Appendix C, we are making use of the phase‑in relief for ESRS S4. As a result, we are not disclosing S4‑related metrics or targets for this reporting year. Given the organizational restructuring underway, it would not be appropriate to define meaningful or consistent S4 targets at this time.