Patients, Consumers and End-Users

ESRS S4 Patients, Consumers and End-Users

Despite the fact that we are currently a pure-play R&D organization with no commercialized products, we consider elements of S4 topics to be of material relevance. As we consider patients to be the end users of our candidate medicines, even when these are in clinical development, we have taken steps to manage the risks associated with our activities. The most significant risk relates to patient safety, including product quality. 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, whilst limiting side effects, especially adverse events which may pose an unacceptable risk.  Additionally, we recognize the importance of equitable access and social inclusion in healthcare, ensuring that our investigational treatments are developed with the broadest possible reach, particularly for patients with high unmet medical need. Given that privacy is of material relevance to our end-users as we collect sensitive personal data in our clinical studies, we have also 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 have not yet established specific targets in relation to these topics, however, steps will be taken in the following months to identify relevant metrics and determine appropriate targets to measure progress on these topics in the future.

Material impacts, risks and opportunities and their interaction with strategy and business model

Privacy

Protecting patient privacy and ensuring data security across the entire value chain is a critical area of risk, particularly in the short term. Cybersecurity vulnerabilities, the potential for data breaches, and non-compliance with regulations such as GDPR pose significant risks. To address these risks, we are investing in advanced cybersecurity systems, we conduct third-party risk assessments, and maintain strict GDPR compliance measures. These actions are designed to safeguard clinical study data, protect patient information, and uphold our ethical and regulatory commitments.

Access and Social Inclusion of Diverse Patients to Products and Services

Ensuring accessibility, with respect for the social inclusion of diverse patient populations, and affordability of therapies is both an ethical responsibility and a business imperative. While this represents a mixed impact—both a risk and an opportunity—it is a cornerstone of our commitment to patients and healthcare systems. In the short term, our research programs focus on developing innovative therapies with the potential to improve access, addressing unmet medical needs, and contributing to sustainable healthcare. Additionally, we promote diversity in patient participation, recognizing that equitable representation is essential for the development of effective and safe medicines. By integrating access considerations into our R&D strategy, we aim to develop medicines that deliver value to patients and the broader healthcare community.

Patient Safety and Product Quality

Ensuring patient safety and the quality of our investigational therapies are critical focus areas, representing both a risk and an opportunity across the entire value chain. In the short term, our actions include real-time benefit/risk assessments, the implementation of robust risk management plans, and the strengthening of quality controls during clinical studies. By embedding these measures into our development processes, we aim to uphold the highest standards of safety, address unknown risks during drug development, and ensure that patients trust our innovations.

Policies related to patients, consumers and end-users

We have established specific policies and standards to appropriately manage the risks in the development of new medicines. These include:

• Data Protection Policy, aligned with the requirements of GDPR, which describes how personal data must be processed within the Galapagos group of companies. The General Counsel is accountable for this policy.
• Quality Manual – defines the quality management system to ensure that all Galapagos activities are of the highest quality and comply with regulatory expectations including GCP and GMP, and with a strong focus on patient safety. The Global Head of Quality is accountable for this policy.
• Clinical Trial Oversight Policy – to ensure that we have adequate oversight of our sponsored clinical studies. The Head of R&D is accountable for this policy.
• GxP Risk Management Policy – this policy is a component of an effective Quality Management System (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 – to ensure that, in the event of high impact incidents, a mechanism is in place to avoid or minimize damage to our employees, to our reputation and/or license to operate. The Global Head of Quality is accountable for this policy.
• Issues & Escalation Management – sets out the governance set up to ensure that critical and major issues are brought to the attention of senior management in a timely manner. The Global Head of Quality is accountable for this policy.
• Pharmacovigilance Policy – which comprises requirements for Safety Reporting and Product Quality Complaints related to our (candidate) products. The Head of Medical Safety is accountable for this policy.

Mitigating, Preventing and Remediating Actions

We have established an Independent Data Monitoring Committee composed of independent medical, scientific and biostatistics experts, which conducts real-time risk/benefit assessments of safety and efficacy data at regular intervals during a clinical study. We implement comprehensive risk managements plans and undertake monitoring through formalized Quality audits to identify areas for continuous improvement. Together we believe these measures enable our R&D activities to deliver potential transformational medicines which bring value to patients and the healthcare systems.