Material Risks (alphabetical order) Risk Description and Potential Impacts Managing the Risk 4. Global Economic Conditions, Government Policies and Geopolitics • E xposure to challenging economic conditions including inflationary pressures, increased interest rates and volatility in credit and capital markets could have an adverse effect on our operations and/or financial position and performance. • E xposure to changes in government policies and regulatory frameworks that influence the pricing, reimbursement and market access of CSL’s therapies, including price controls, health technology assessment requirements and government tender processes. These changes could increases costs, reduce revenue and limit access in key markets. • E xposure to geopolitical developments and government-imposed trade measures, including tariffs on pharmaceuticals and other supply chain restrictions which could disrupt operations, increase costs and adversely impact financial performance. • C SL engages in dialogue with multiple stakeholders – including governments, payers/insurers, patient advocacy groups, medical societies and non-governmental organisations to help ensure that government policies reflect the innovation, clinical value and special characteristics of our product portfolio and operations, while supporting sustainable and broad patient access to our therapies. • T he Company works closely with stakeholders in all countries where it markets its products so that CSL therapies are accessible, and that its pricing remains competitive, responsible and reflects the value its therapies bring to patients and health systems. • G overnment, (geo)political or market-related risks are overseen by the ARMC and the Board. 5. Patient Safety When CSL talks about patient safety, CSL means both in the use and administration of registered products, as well as in the conduct of CSL clinical trials. • A risk that failures in the development, manufacture, clinical evaluation, or use of CSL products could result in harm to patients or clinical trial participants, arising from deficiencies in product quality or safety monitoring, or unexpected side effects. • S uch events may also lead to adverse outcomes, regulatory action, product withdrawal, litigation, reputational damage and financial loss. • C linical trial activities introduce additional risks, including those related to difficulty in enrolling or identifying patients for our clinical studies, participant protection, protocol adherence, data integrity and compliance with ethical and regulatory requirements. • C SL’s manufacturing, product quality assurance and pharmacovigilance practices serve to provide high standards of safety to protect study participants and patients and to preserve CSL’s reputational integrity in compliance with regulatory requirements worldwide. • C SL’s processes and procedures adhere to global good pharmacovigilance practices (GVP) and good clinical practice (GCP) standards. • P roduct information is maintained to ensure it contains relevant information for patients and supports healthcare practitioners in the appropriate prescribing of CSL products. • F or clinical trials, CSL protects the rights, safety and wellbeing of participants by ensuring they fully understand the study’s risks, benefits, and procedures before and during the research. • P articipants are informed about and acknowledge awareness of the potential benefits and risks of participation in the trial through use of Informed Consent Forms approved by relevant regulators, institutional review boards and independent ethics committees. • C omprehensive safety risk monitoring, including safety data collection and safety signal detection, is performed throughout the development programs and the lifecycles of CSL’s marketed products, to safeguard study participants and patients and to ensure that adequate risk mitigation strategies are in place. • P atient safety-related risks and measurement against risk appetite are overseen by the Innovation and Development Committee (IDC). Also refer to page 16 (Clinical Trials) of this Annual Report. Material Risks 20 Performance
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